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Aren’t all mass shooters mentally ill?
On June 12, 2016, a man walked into an Orlando, Fla., nightclub and committed the worst mass shooting in U.S. history. When it was over, 49 people lay dead and more than 50 others were wounded. The shooter must have been mentally ill. Only someone with a serious mental illness would commit such a horrible crime, right?
Wrong. Evidence indicating that the perpetrator’s motives lay in his political/religious ideology and possible homophobia quickly knocked mental illness out of the debate about motivation behind this particular shooting. Nevertheless, media speculation about mental illness invariably accompanies mass shootings.
Mass shootings are the most sensational, gut wrenching, and widely publicized form of firearm violence. Nevertheless, statistically speaking, mass shooting homicides are the rarest form of firearm death. These incidents account for less than 1% of firearm mortality each year. About 33,000 people a year are killed by firearms. Firearm suicide accounts for about 65% of these deaths; the rest are overwhelmingly the result of interpersonal violence, not violence committed by a stranger with a gun.
All of us recognize the images of mass shooters who were in fact mentally ill, such as the young man with the dazed look and red hair in Aurora, Colo., and the chilling images of the Virginia Tech shooter posing with his weapons. Individuals in the first throes of psychotic illness are at increased risk of committing some type of violence as their functioning deteriorates, their thoughts become more disordered, and their lack of insight often leads to treatment refusal.
However, most mass shooters are not suffering from serious mental illness. As has been discussed in a recent article, mass shooters often hold “extreme overvalued ideas,” that is, nondelusional, strongly held beliefs, a concept that does not fit neatly into DSM-5 diagnostic categories. As Dr. Tahir Rahman, an assistant professor of psychiatry at the University of Missouri, Columbia, and his colleagues wrote in a recent study: “An extreme overvalued belief is one that is shared by others in a person’s cultural, religious, or subcultural group. The belief is often relished, amplified, and defended by the possessor of the belief and should be differentiated from a delusion or obsession. The idea fulminates in the mind of the individual, growing ever more dominant over time, more refined, and more resistant to challenge. The individual has an intense emotional commitment to the belief and may carry out violent behavior in its service. It is usually associated with an abnormal personality” (p. 33). We used to refer to people who hold such beliefs as “fanatics.”
The line between psychotic delusions and extreme overvalued ideas is not always clear, but some markers and signposts can differentiate between the two. Psychiatric illness is suggested, for example, by the presence of other recognizable symptoms of mental illness, such as other delusions, hallucinations, or thought disorders. In addition, individuals with psychiatric illness demonstrate related functional impairment preceding and unrelated to the mass shooting. Finally, delusions are rarely shared by even two individuals; they are not shared by large groups.
Examples in which large groups of people share social, religious, or political beliefs and some believers resort to violence can be found throughout history: from Masada to 19th century abolitionists such as John Brown to 20th century animal rights activists and 21st century “sovereign citizens.” Finding groups that reinforce and validate extreme beliefs has become even easier in the age of social media.
However, fanatics often function adequately in society until something happens to trigger a choice to act violently. Absent a history of felonious violence, these individuals are not likely to be barred from owning firearms. More non–evidence based firearm ownership restrictions for those with mental illness are not likely to slow down or decrease the rising rate of mass shootings.
We do not have more people with psychosis in the United States nor do we have more people who hold extremist ideology. What we do have are more legally purchased, military-grade weapons in the hands of a civilian population than any other comparable country. An overwhelming number of mass shootings involve assault weapons.
One popular definition of insanity is doing the same thing over and over again and expecting different results. Only one intervention could make a difference in the increasing number of heartbreaking mass shootings. Military-grade semiautomatic weapons and their high-capacity magazines should not be available to civilians with or without mental illness or fanaticism. Moreover, as the Newtown, Conn., families are doing in their lawsuit against Remington Arms, the manufacturers who sell and market such weapons to civilians must be held legally accountable for valuing their profits over our lives.
Dr. Gold is a clinical professor of psychiatry at Georgetown University, Washington. She also is editor of and contributing writer to the book “Gun Violence and Mental Illness” (Arlington [Va]: American Psychiatric Association Publishing, 2016).
On June 12, 2016, a man walked into an Orlando, Fla., nightclub and committed the worst mass shooting in U.S. history. When it was over, 49 people lay dead and more than 50 others were wounded. The shooter must have been mentally ill. Only someone with a serious mental illness would commit such a horrible crime, right?
Wrong. Evidence indicating that the perpetrator’s motives lay in his political/religious ideology and possible homophobia quickly knocked mental illness out of the debate about motivation behind this particular shooting. Nevertheless, media speculation about mental illness invariably accompanies mass shootings.
Mass shootings are the most sensational, gut wrenching, and widely publicized form of firearm violence. Nevertheless, statistically speaking, mass shooting homicides are the rarest form of firearm death. These incidents account for less than 1% of firearm mortality each year. About 33,000 people a year are killed by firearms. Firearm suicide accounts for about 65% of these deaths; the rest are overwhelmingly the result of interpersonal violence, not violence committed by a stranger with a gun.
All of us recognize the images of mass shooters who were in fact mentally ill, such as the young man with the dazed look and red hair in Aurora, Colo., and the chilling images of the Virginia Tech shooter posing with his weapons. Individuals in the first throes of psychotic illness are at increased risk of committing some type of violence as their functioning deteriorates, their thoughts become more disordered, and their lack of insight often leads to treatment refusal.
However, most mass shooters are not suffering from serious mental illness. As has been discussed in a recent article, mass shooters often hold “extreme overvalued ideas,” that is, nondelusional, strongly held beliefs, a concept that does not fit neatly into DSM-5 diagnostic categories. As Dr. Tahir Rahman, an assistant professor of psychiatry at the University of Missouri, Columbia, and his colleagues wrote in a recent study: “An extreme overvalued belief is one that is shared by others in a person’s cultural, religious, or subcultural group. The belief is often relished, amplified, and defended by the possessor of the belief and should be differentiated from a delusion or obsession. The idea fulminates in the mind of the individual, growing ever more dominant over time, more refined, and more resistant to challenge. The individual has an intense emotional commitment to the belief and may carry out violent behavior in its service. It is usually associated with an abnormal personality” (p. 33). We used to refer to people who hold such beliefs as “fanatics.”
The line between psychotic delusions and extreme overvalued ideas is not always clear, but some markers and signposts can differentiate between the two. Psychiatric illness is suggested, for example, by the presence of other recognizable symptoms of mental illness, such as other delusions, hallucinations, or thought disorders. In addition, individuals with psychiatric illness demonstrate related functional impairment preceding and unrelated to the mass shooting. Finally, delusions are rarely shared by even two individuals; they are not shared by large groups.
Examples in which large groups of people share social, religious, or political beliefs and some believers resort to violence can be found throughout history: from Masada to 19th century abolitionists such as John Brown to 20th century animal rights activists and 21st century “sovereign citizens.” Finding groups that reinforce and validate extreme beliefs has become even easier in the age of social media.
However, fanatics often function adequately in society until something happens to trigger a choice to act violently. Absent a history of felonious violence, these individuals are not likely to be barred from owning firearms. More non–evidence based firearm ownership restrictions for those with mental illness are not likely to slow down or decrease the rising rate of mass shootings.
We do not have more people with psychosis in the United States nor do we have more people who hold extremist ideology. What we do have are more legally purchased, military-grade weapons in the hands of a civilian population than any other comparable country. An overwhelming number of mass shootings involve assault weapons.
One popular definition of insanity is doing the same thing over and over again and expecting different results. Only one intervention could make a difference in the increasing number of heartbreaking mass shootings. Military-grade semiautomatic weapons and their high-capacity magazines should not be available to civilians with or without mental illness or fanaticism. Moreover, as the Newtown, Conn., families are doing in their lawsuit against Remington Arms, the manufacturers who sell and market such weapons to civilians must be held legally accountable for valuing their profits over our lives.
Dr. Gold is a clinical professor of psychiatry at Georgetown University, Washington. She also is editor of and contributing writer to the book “Gun Violence and Mental Illness” (Arlington [Va]: American Psychiatric Association Publishing, 2016).
On June 12, 2016, a man walked into an Orlando, Fla., nightclub and committed the worst mass shooting in U.S. history. When it was over, 49 people lay dead and more than 50 others were wounded. The shooter must have been mentally ill. Only someone with a serious mental illness would commit such a horrible crime, right?
Wrong. Evidence indicating that the perpetrator’s motives lay in his political/religious ideology and possible homophobia quickly knocked mental illness out of the debate about motivation behind this particular shooting. Nevertheless, media speculation about mental illness invariably accompanies mass shootings.
Mass shootings are the most sensational, gut wrenching, and widely publicized form of firearm violence. Nevertheless, statistically speaking, mass shooting homicides are the rarest form of firearm death. These incidents account for less than 1% of firearm mortality each year. About 33,000 people a year are killed by firearms. Firearm suicide accounts for about 65% of these deaths; the rest are overwhelmingly the result of interpersonal violence, not violence committed by a stranger with a gun.
All of us recognize the images of mass shooters who were in fact mentally ill, such as the young man with the dazed look and red hair in Aurora, Colo., and the chilling images of the Virginia Tech shooter posing with his weapons. Individuals in the first throes of psychotic illness are at increased risk of committing some type of violence as their functioning deteriorates, their thoughts become more disordered, and their lack of insight often leads to treatment refusal.
However, most mass shooters are not suffering from serious mental illness. As has been discussed in a recent article, mass shooters often hold “extreme overvalued ideas,” that is, nondelusional, strongly held beliefs, a concept that does not fit neatly into DSM-5 diagnostic categories. As Dr. Tahir Rahman, an assistant professor of psychiatry at the University of Missouri, Columbia, and his colleagues wrote in a recent study: “An extreme overvalued belief is one that is shared by others in a person’s cultural, religious, or subcultural group. The belief is often relished, amplified, and defended by the possessor of the belief and should be differentiated from a delusion or obsession. The idea fulminates in the mind of the individual, growing ever more dominant over time, more refined, and more resistant to challenge. The individual has an intense emotional commitment to the belief and may carry out violent behavior in its service. It is usually associated with an abnormal personality” (p. 33). We used to refer to people who hold such beliefs as “fanatics.”
The line between psychotic delusions and extreme overvalued ideas is not always clear, but some markers and signposts can differentiate between the two. Psychiatric illness is suggested, for example, by the presence of other recognizable symptoms of mental illness, such as other delusions, hallucinations, or thought disorders. In addition, individuals with psychiatric illness demonstrate related functional impairment preceding and unrelated to the mass shooting. Finally, delusions are rarely shared by even two individuals; they are not shared by large groups.
Examples in which large groups of people share social, religious, or political beliefs and some believers resort to violence can be found throughout history: from Masada to 19th century abolitionists such as John Brown to 20th century animal rights activists and 21st century “sovereign citizens.” Finding groups that reinforce and validate extreme beliefs has become even easier in the age of social media.
However, fanatics often function adequately in society until something happens to trigger a choice to act violently. Absent a history of felonious violence, these individuals are not likely to be barred from owning firearms. More non–evidence based firearm ownership restrictions for those with mental illness are not likely to slow down or decrease the rising rate of mass shootings.
We do not have more people with psychosis in the United States nor do we have more people who hold extremist ideology. What we do have are more legally purchased, military-grade weapons in the hands of a civilian population than any other comparable country. An overwhelming number of mass shootings involve assault weapons.
One popular definition of insanity is doing the same thing over and over again and expecting different results. Only one intervention could make a difference in the increasing number of heartbreaking mass shootings. Military-grade semiautomatic weapons and their high-capacity magazines should not be available to civilians with or without mental illness or fanaticism. Moreover, as the Newtown, Conn., families are doing in their lawsuit against Remington Arms, the manufacturers who sell and market such weapons to civilians must be held legally accountable for valuing their profits over our lives.
Dr. Gold is a clinical professor of psychiatry at Georgetown University, Washington. She also is editor of and contributing writer to the book “Gun Violence and Mental Illness” (Arlington [Va]: American Psychiatric Association Publishing, 2016).
Kids and accidents
Summer is upon us, a season of delight for children and teens. School is out, the days are long, warm, and full of activities they get to choose. But we know that summer is also the season of accidents. While adventurous activities can lead to scratches, sprains, and broken bones, many accidents are far more serious. The Centers for Disease Control and Prevention reported that in 2014 (the most recent data available), accidental injuries were the leading cause of death for children from the age of 1 year through young adulthood (age 24 years). Car accidents, drowning, burns, suffocation, poisoning, and being struck while on a bike or other vehicle are the most prominent causes of injury or death in youth.
When something is an “accident,” we understand it to be an unfortunate event that happened by chance, without deliberate cause, and not easily foreseeable or preventable. But many accidents that befall children, while not deliberate, might be more foreseeable and preventable than they first appear. With younger children, parents directly oversee their children, ensuring they wear bike helmets, are placed in appropriate car restraints, cannot play with lighters, are always in sight when learning to swim (with a family pool well fenced and locked), and have no access to guns (and the guns are not loaded and have trigger locks!).
As their children grow older, parents must manage the challenging task of teaching their children to manage risk as they cultivate independence: learning to always put on their bike helmet before riding home from school, avoiding diving into shallow water, and not riding in a car with an impaired driver. Both the direct supervision of younger children and the teaching of older children and teenagers are very demanding of time and energy for parents. Terrible accidents can occur during truly unpredictable moments of distraction, but for too many parents, these moments of distraction are in fact predictable. If parents are strained by financial troubles, a disintegrating marriage, a serious illness in a spouse or elderly parent, or their own mental illness, their ability to be fully present and patient to supervise their children will be predictably impaired. During the summer months, when children may be home all day and looking for adventure, parental stress and distraction result in a high-risk environment that makes serious accidents more likely.
You as a child care provider are wonderful at providing supportive reminders to parents about the basics of child safety and supervision. Every checkup includes questions about whether anyone smokes at home and whether there is a working smoke detector. You ask about bike helmets and booster seats, and whether there are firearms in the home and if so, whether they are properly stored and locked. While there are often no formal questions about the level of family stress at a checkup, it would be simple to add: “Would you say the stress level at home is low, moderate, or high?” Such an open-ended question could lead to discussion of those factors that might be causing stress and give you a quick sense of how equipped the parent (or parents) are to handle it. Without a doubt, physicians’ practices are themselves stressed for time, and asking parents about their own stress may seem like opening Pandora’s box. But by being curious, bringing the important matter of domestic stress into the conversation about a child’s health and well being can by itself be therapeutic. The parents found the time to bring their child to this appointment, despite their stress. By simply bringing their awareness to the impact their stress could have on the safety of their children, you may have made a critical difference.
When parents report a high level of stress, you might follow up with more specific questions about their supports. Who provides them with practical help or a supportive ear? Do they have a strong community of friends, nearby family, or a supportive faith community? Are there practical ways to outsource some of the demands they may be juggling? You should be prepared to offer resources if a parent reports domestic violence. Some pediatric practices will employ social workers who can facilitate connecting stressed families with appropriate resources. But if your practice does not, a little time online can build a database of virtual and community resources that a family can start with.
You are also in a unique position to appreciate that certain children are themselves at higher risk for accidents. Children and adolescents with attention-deficit/hyperactivity disorder may be more distractible and impulsive than their peers. And summer is often a season when families decide to suspend stimulant treatment to promote weight gain or growth. These children and teens are at elevated risk to “leap before they look,” and parents should be reminded of their higher level of risk and need for supervision, at least when having a conversation about whether to suspend stimulant treatment. Children with a history of oppositional behaviors also can prove more challenging to supervise than their peers. Beyond the risk of self-injury or suicide, youth with depressive disorders can have impaired concentration and attention, and may not assess the risk of certain activities very well. These children can be challenging to parent at all times, so their parents likely manage a higher general level of parenting stress, and can benefit from your inquiry and additional resources.
A parent’s task of supervising is different with adolescents than with younger children. It is as much about effective communication and modeling how to assess risk and make judgments as it is about time spent watching the children. But these tasks take time and patience, perhaps even more than the supervision of younger kids. And while a teenager may have good judgment, who her friends are matters as much as her own judgment. Teenagers take more chances when they are with friends, and particularly with thrill-seeking friends. If parents are too distracted or busy to know who their teenager is spending time with, that itself raises the teenager’s chances of risky behaviors and accidental injury.
Of course, when teenagers are experimenting with alcohol or drugs, the risk of serious accidents increases significantly. The Centers for Disease Control and Prevention estimates that approximately half of the nonmedical deaths of 15- to 24-year-olds involve drug or alcohol use. Stressed parents are less likely to be spending time with their teenagers to ask about drugs and alcohol: Who is using them? When and where? What else are they hearing about drugs and alcohol? It also takes time and a calm, clear, and open presence to talk with teenagers about expectations and ground rules around drug or alcohol experimentation (which has been shown to diminish the rate of regular use of drugs or alcohol in teens by as much as half). It takes time for parents to explain to their teenager that they should ALWAYS call home if they are anywhere they do not feel safe, even if it involves drugs or alcohol. It is complex to set rules and expectations while also being clear that their safety always comes first. You can encourage parents to know their teen’s friends, and to have a conversation about the rules around drug and alcohol use and to set a safety plan. Parents who are too stressed to even know where to start will benefit from a longer conversation, and can be referred to some good websites or for a mental health consultation.
Summer should be a time of skill building, adventure, growing independence, and some rest and relaxation. Helping parents to pay attention to their own stress level and access needed supports may be the critical factor in preventing accidents and promoting the health and well being of their children during this wonderful, but risky season.
Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton (Mass.) Wellesley Hospital. Dr. Jellinek is professor of psychiatry and of pediatrics at Harvard Medical School, Boston.
Summer is upon us, a season of delight for children and teens. School is out, the days are long, warm, and full of activities they get to choose. But we know that summer is also the season of accidents. While adventurous activities can lead to scratches, sprains, and broken bones, many accidents are far more serious. The Centers for Disease Control and Prevention reported that in 2014 (the most recent data available), accidental injuries were the leading cause of death for children from the age of 1 year through young adulthood (age 24 years). Car accidents, drowning, burns, suffocation, poisoning, and being struck while on a bike or other vehicle are the most prominent causes of injury or death in youth.
When something is an “accident,” we understand it to be an unfortunate event that happened by chance, without deliberate cause, and not easily foreseeable or preventable. But many accidents that befall children, while not deliberate, might be more foreseeable and preventable than they first appear. With younger children, parents directly oversee their children, ensuring they wear bike helmets, are placed in appropriate car restraints, cannot play with lighters, are always in sight when learning to swim (with a family pool well fenced and locked), and have no access to guns (and the guns are not loaded and have trigger locks!).
As their children grow older, parents must manage the challenging task of teaching their children to manage risk as they cultivate independence: learning to always put on their bike helmet before riding home from school, avoiding diving into shallow water, and not riding in a car with an impaired driver. Both the direct supervision of younger children and the teaching of older children and teenagers are very demanding of time and energy for parents. Terrible accidents can occur during truly unpredictable moments of distraction, but for too many parents, these moments of distraction are in fact predictable. If parents are strained by financial troubles, a disintegrating marriage, a serious illness in a spouse or elderly parent, or their own mental illness, their ability to be fully present and patient to supervise their children will be predictably impaired. During the summer months, when children may be home all day and looking for adventure, parental stress and distraction result in a high-risk environment that makes serious accidents more likely.
You as a child care provider are wonderful at providing supportive reminders to parents about the basics of child safety and supervision. Every checkup includes questions about whether anyone smokes at home and whether there is a working smoke detector. You ask about bike helmets and booster seats, and whether there are firearms in the home and if so, whether they are properly stored and locked. While there are often no formal questions about the level of family stress at a checkup, it would be simple to add: “Would you say the stress level at home is low, moderate, or high?” Such an open-ended question could lead to discussion of those factors that might be causing stress and give you a quick sense of how equipped the parent (or parents) are to handle it. Without a doubt, physicians’ practices are themselves stressed for time, and asking parents about their own stress may seem like opening Pandora’s box. But by being curious, bringing the important matter of domestic stress into the conversation about a child’s health and well being can by itself be therapeutic. The parents found the time to bring their child to this appointment, despite their stress. By simply bringing their awareness to the impact their stress could have on the safety of their children, you may have made a critical difference.
When parents report a high level of stress, you might follow up with more specific questions about their supports. Who provides them with practical help or a supportive ear? Do they have a strong community of friends, nearby family, or a supportive faith community? Are there practical ways to outsource some of the demands they may be juggling? You should be prepared to offer resources if a parent reports domestic violence. Some pediatric practices will employ social workers who can facilitate connecting stressed families with appropriate resources. But if your practice does not, a little time online can build a database of virtual and community resources that a family can start with.
You are also in a unique position to appreciate that certain children are themselves at higher risk for accidents. Children and adolescents with attention-deficit/hyperactivity disorder may be more distractible and impulsive than their peers. And summer is often a season when families decide to suspend stimulant treatment to promote weight gain or growth. These children and teens are at elevated risk to “leap before they look,” and parents should be reminded of their higher level of risk and need for supervision, at least when having a conversation about whether to suspend stimulant treatment. Children with a history of oppositional behaviors also can prove more challenging to supervise than their peers. Beyond the risk of self-injury or suicide, youth with depressive disorders can have impaired concentration and attention, and may not assess the risk of certain activities very well. These children can be challenging to parent at all times, so their parents likely manage a higher general level of parenting stress, and can benefit from your inquiry and additional resources.
A parent’s task of supervising is different with adolescents than with younger children. It is as much about effective communication and modeling how to assess risk and make judgments as it is about time spent watching the children. But these tasks take time and patience, perhaps even more than the supervision of younger kids. And while a teenager may have good judgment, who her friends are matters as much as her own judgment. Teenagers take more chances when they are with friends, and particularly with thrill-seeking friends. If parents are too distracted or busy to know who their teenager is spending time with, that itself raises the teenager’s chances of risky behaviors and accidental injury.
Of course, when teenagers are experimenting with alcohol or drugs, the risk of serious accidents increases significantly. The Centers for Disease Control and Prevention estimates that approximately half of the nonmedical deaths of 15- to 24-year-olds involve drug or alcohol use. Stressed parents are less likely to be spending time with their teenagers to ask about drugs and alcohol: Who is using them? When and where? What else are they hearing about drugs and alcohol? It also takes time and a calm, clear, and open presence to talk with teenagers about expectations and ground rules around drug or alcohol experimentation (which has been shown to diminish the rate of regular use of drugs or alcohol in teens by as much as half). It takes time for parents to explain to their teenager that they should ALWAYS call home if they are anywhere they do not feel safe, even if it involves drugs or alcohol. It is complex to set rules and expectations while also being clear that their safety always comes first. You can encourage parents to know their teen’s friends, and to have a conversation about the rules around drug and alcohol use and to set a safety plan. Parents who are too stressed to even know where to start will benefit from a longer conversation, and can be referred to some good websites or for a mental health consultation.
Summer should be a time of skill building, adventure, growing independence, and some rest and relaxation. Helping parents to pay attention to their own stress level and access needed supports may be the critical factor in preventing accidents and promoting the health and well being of their children during this wonderful, but risky season.
Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton (Mass.) Wellesley Hospital. Dr. Jellinek is professor of psychiatry and of pediatrics at Harvard Medical School, Boston.
Summer is upon us, a season of delight for children and teens. School is out, the days are long, warm, and full of activities they get to choose. But we know that summer is also the season of accidents. While adventurous activities can lead to scratches, sprains, and broken bones, many accidents are far more serious. The Centers for Disease Control and Prevention reported that in 2014 (the most recent data available), accidental injuries were the leading cause of death for children from the age of 1 year through young adulthood (age 24 years). Car accidents, drowning, burns, suffocation, poisoning, and being struck while on a bike or other vehicle are the most prominent causes of injury or death in youth.
When something is an “accident,” we understand it to be an unfortunate event that happened by chance, without deliberate cause, and not easily foreseeable or preventable. But many accidents that befall children, while not deliberate, might be more foreseeable and preventable than they first appear. With younger children, parents directly oversee their children, ensuring they wear bike helmets, are placed in appropriate car restraints, cannot play with lighters, are always in sight when learning to swim (with a family pool well fenced and locked), and have no access to guns (and the guns are not loaded and have trigger locks!).
As their children grow older, parents must manage the challenging task of teaching their children to manage risk as they cultivate independence: learning to always put on their bike helmet before riding home from school, avoiding diving into shallow water, and not riding in a car with an impaired driver. Both the direct supervision of younger children and the teaching of older children and teenagers are very demanding of time and energy for parents. Terrible accidents can occur during truly unpredictable moments of distraction, but for too many parents, these moments of distraction are in fact predictable. If parents are strained by financial troubles, a disintegrating marriage, a serious illness in a spouse or elderly parent, or their own mental illness, their ability to be fully present and patient to supervise their children will be predictably impaired. During the summer months, when children may be home all day and looking for adventure, parental stress and distraction result in a high-risk environment that makes serious accidents more likely.
You as a child care provider are wonderful at providing supportive reminders to parents about the basics of child safety and supervision. Every checkup includes questions about whether anyone smokes at home and whether there is a working smoke detector. You ask about bike helmets and booster seats, and whether there are firearms in the home and if so, whether they are properly stored and locked. While there are often no formal questions about the level of family stress at a checkup, it would be simple to add: “Would you say the stress level at home is low, moderate, or high?” Such an open-ended question could lead to discussion of those factors that might be causing stress and give you a quick sense of how equipped the parent (or parents) are to handle it. Without a doubt, physicians’ practices are themselves stressed for time, and asking parents about their own stress may seem like opening Pandora’s box. But by being curious, bringing the important matter of domestic stress into the conversation about a child’s health and well being can by itself be therapeutic. The parents found the time to bring their child to this appointment, despite their stress. By simply bringing their awareness to the impact their stress could have on the safety of their children, you may have made a critical difference.
When parents report a high level of stress, you might follow up with more specific questions about their supports. Who provides them with practical help or a supportive ear? Do they have a strong community of friends, nearby family, or a supportive faith community? Are there practical ways to outsource some of the demands they may be juggling? You should be prepared to offer resources if a parent reports domestic violence. Some pediatric practices will employ social workers who can facilitate connecting stressed families with appropriate resources. But if your practice does not, a little time online can build a database of virtual and community resources that a family can start with.
You are also in a unique position to appreciate that certain children are themselves at higher risk for accidents. Children and adolescents with attention-deficit/hyperactivity disorder may be more distractible and impulsive than their peers. And summer is often a season when families decide to suspend stimulant treatment to promote weight gain or growth. These children and teens are at elevated risk to “leap before they look,” and parents should be reminded of their higher level of risk and need for supervision, at least when having a conversation about whether to suspend stimulant treatment. Children with a history of oppositional behaviors also can prove more challenging to supervise than their peers. Beyond the risk of self-injury or suicide, youth with depressive disorders can have impaired concentration and attention, and may not assess the risk of certain activities very well. These children can be challenging to parent at all times, so their parents likely manage a higher general level of parenting stress, and can benefit from your inquiry and additional resources.
A parent’s task of supervising is different with adolescents than with younger children. It is as much about effective communication and modeling how to assess risk and make judgments as it is about time spent watching the children. But these tasks take time and patience, perhaps even more than the supervision of younger kids. And while a teenager may have good judgment, who her friends are matters as much as her own judgment. Teenagers take more chances when they are with friends, and particularly with thrill-seeking friends. If parents are too distracted or busy to know who their teenager is spending time with, that itself raises the teenager’s chances of risky behaviors and accidental injury.
Of course, when teenagers are experimenting with alcohol or drugs, the risk of serious accidents increases significantly. The Centers for Disease Control and Prevention estimates that approximately half of the nonmedical deaths of 15- to 24-year-olds involve drug or alcohol use. Stressed parents are less likely to be spending time with their teenagers to ask about drugs and alcohol: Who is using them? When and where? What else are they hearing about drugs and alcohol? It also takes time and a calm, clear, and open presence to talk with teenagers about expectations and ground rules around drug or alcohol experimentation (which has been shown to diminish the rate of regular use of drugs or alcohol in teens by as much as half). It takes time for parents to explain to their teenager that they should ALWAYS call home if they are anywhere they do not feel safe, even if it involves drugs or alcohol. It is complex to set rules and expectations while also being clear that their safety always comes first. You can encourage parents to know their teen’s friends, and to have a conversation about the rules around drug and alcohol use and to set a safety plan. Parents who are too stressed to even know where to start will benefit from a longer conversation, and can be referred to some good websites or for a mental health consultation.
Summer should be a time of skill building, adventure, growing independence, and some rest and relaxation. Helping parents to pay attention to their own stress level and access needed supports may be the critical factor in preventing accidents and promoting the health and well being of their children during this wonderful, but risky season.
Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton (Mass.) Wellesley Hospital. Dr. Jellinek is professor of psychiatry and of pediatrics at Harvard Medical School, Boston.
Key Medicare Fund Could Exhaust Reserves in 2028: Trustees
WASHINGTON—The U.S. federal program that pays elderly Americans' hospital bills will exhaust reserves in 2028, two years sooner than last year's estimate, trustees of the program said on Wednesday.
In their annual financial review, the trustees also said that the combined Social Security and disability trust fund reserves are estimated to run out in 2034, the same projection as last year.
The Medicare program's trust fund for hospital care is still scheduled to have sufficient funding 11 years longer than the estimate given before the Affordable Care Act was passed, the trustees said.
They put the shortening of the timeline down to changes in estimates of income and cost, particularly in the near term.
A depletion in funds available for Medicare and Social Security does not mean the programs would suddenly stop. At the current rate of payroll tax collections, Medicare would be able to cover 87 percent of costs in 2028. This would fall to 79 percent by 2043 and then gradually increase.
Social Security would be able to pay about three-quarters of scheduled benefits from 2034 to 2090, the trustees said.
WASHINGTON—The U.S. federal program that pays elderly Americans' hospital bills will exhaust reserves in 2028, two years sooner than last year's estimate, trustees of the program said on Wednesday.
In their annual financial review, the trustees also said that the combined Social Security and disability trust fund reserves are estimated to run out in 2034, the same projection as last year.
The Medicare program's trust fund for hospital care is still scheduled to have sufficient funding 11 years longer than the estimate given before the Affordable Care Act was passed, the trustees said.
They put the shortening of the timeline down to changes in estimates of income and cost, particularly in the near term.
A depletion in funds available for Medicare and Social Security does not mean the programs would suddenly stop. At the current rate of payroll tax collections, Medicare would be able to cover 87 percent of costs in 2028. This would fall to 79 percent by 2043 and then gradually increase.
Social Security would be able to pay about three-quarters of scheduled benefits from 2034 to 2090, the trustees said.
WASHINGTON—The U.S. federal program that pays elderly Americans' hospital bills will exhaust reserves in 2028, two years sooner than last year's estimate, trustees of the program said on Wednesday.
In their annual financial review, the trustees also said that the combined Social Security and disability trust fund reserves are estimated to run out in 2034, the same projection as last year.
The Medicare program's trust fund for hospital care is still scheduled to have sufficient funding 11 years longer than the estimate given before the Affordable Care Act was passed, the trustees said.
They put the shortening of the timeline down to changes in estimates of income and cost, particularly in the near term.
A depletion in funds available for Medicare and Social Security does not mean the programs would suddenly stop. At the current rate of payroll tax collections, Medicare would be able to cover 87 percent of costs in 2028. This would fall to 79 percent by 2043 and then gradually increase.
Social Security would be able to pay about three-quarters of scheduled benefits from 2034 to 2090, the trustees said.
Forget Privatization, How About Better Integration for Federal Health Care?
Even as the Commission on Care considers ways to change VA health care, a Viewpoint published in the June 2016 issue of JAMA argues that integrating federal health care systems would be more efficient and provide better care. About $1.3 trillion is spent annually on more than 100 million beneficiaries who receive health care services from the VA, DoD, PHS, Medicare, Medicaid, and other federal health care programs. “A more integrated federal health system would, above all, improve the beneficiary experience,” wrote Dhruv Khullar, MD, MPP, of Massachusetts General Hospital and Dave A. Chokshi, MD, MSc, of New York University Langone Medical Center. “Individuals would enroll in fewer programs, with greater harmonization of policies and procedures.”
Dr. Chokshi and Dr. Khullar propose 5 changes, though they admit that “many of these proposals will require significant administrative action and cooperation among government branches.” As the authors note, the Captain James A. Lovell Federal Health Care Center in Chicago, Illinois, has already showcased some of this integration.
The first proposal is to minimize overlapping service delivery and procurement. As the authors note, 42 separate programs in 6 different federal departments offer nonemergency medical transportation service. However, drug procurement could be the true opportunity for cost savings. “Joint procurement efforts for drugs, as well as for medical and surgical supplies, could result in significant savings,” they argue.
Adopting technology systems that talk to each other is a second important step. “At minimum, federal agencies should lead the adoption of these standards in their own EHRs—just as the VA and Centers for Medicare & Medicaid Services led in ensuring that patients could access their own electronic health data,” the authors insist. Both the VA and DoD already have taken significant steps toward ensuring their electronic health record systems are able to share data.
Other suggestions included repurposing underutilized facilities for use by other health care programs, expanding value-based purchasing, and reducing duplicate payments. As the authors point out more than 1 million beneficiaries use both the Medicare Advantage and the VA systems.
Better integration could make the system more efficient and improve beneficiary care, the authors argue. “Improved communication across agencies, ideally through an integrated health record, would ensure that patients receive more seamless care; that clinicians could more readily access medical histories and provide comprehensive services; and that government programs could more effectively manage the health of the populations they serve.”
Even as the Commission on Care considers ways to change VA health care, a Viewpoint published in the June 2016 issue of JAMA argues that integrating federal health care systems would be more efficient and provide better care. About $1.3 trillion is spent annually on more than 100 million beneficiaries who receive health care services from the VA, DoD, PHS, Medicare, Medicaid, and other federal health care programs. “A more integrated federal health system would, above all, improve the beneficiary experience,” wrote Dhruv Khullar, MD, MPP, of Massachusetts General Hospital and Dave A. Chokshi, MD, MSc, of New York University Langone Medical Center. “Individuals would enroll in fewer programs, with greater harmonization of policies and procedures.”
Dr. Chokshi and Dr. Khullar propose 5 changes, though they admit that “many of these proposals will require significant administrative action and cooperation among government branches.” As the authors note, the Captain James A. Lovell Federal Health Care Center in Chicago, Illinois, has already showcased some of this integration.
The first proposal is to minimize overlapping service delivery and procurement. As the authors note, 42 separate programs in 6 different federal departments offer nonemergency medical transportation service. However, drug procurement could be the true opportunity for cost savings. “Joint procurement efforts for drugs, as well as for medical and surgical supplies, could result in significant savings,” they argue.
Adopting technology systems that talk to each other is a second important step. “At minimum, federal agencies should lead the adoption of these standards in their own EHRs—just as the VA and Centers for Medicare & Medicaid Services led in ensuring that patients could access their own electronic health data,” the authors insist. Both the VA and DoD already have taken significant steps toward ensuring their electronic health record systems are able to share data.
Other suggestions included repurposing underutilized facilities for use by other health care programs, expanding value-based purchasing, and reducing duplicate payments. As the authors point out more than 1 million beneficiaries use both the Medicare Advantage and the VA systems.
Better integration could make the system more efficient and improve beneficiary care, the authors argue. “Improved communication across agencies, ideally through an integrated health record, would ensure that patients receive more seamless care; that clinicians could more readily access medical histories and provide comprehensive services; and that government programs could more effectively manage the health of the populations they serve.”
Even as the Commission on Care considers ways to change VA health care, a Viewpoint published in the June 2016 issue of JAMA argues that integrating federal health care systems would be more efficient and provide better care. About $1.3 trillion is spent annually on more than 100 million beneficiaries who receive health care services from the VA, DoD, PHS, Medicare, Medicaid, and other federal health care programs. “A more integrated federal health system would, above all, improve the beneficiary experience,” wrote Dhruv Khullar, MD, MPP, of Massachusetts General Hospital and Dave A. Chokshi, MD, MSc, of New York University Langone Medical Center. “Individuals would enroll in fewer programs, with greater harmonization of policies and procedures.”
Dr. Chokshi and Dr. Khullar propose 5 changes, though they admit that “many of these proposals will require significant administrative action and cooperation among government branches.” As the authors note, the Captain James A. Lovell Federal Health Care Center in Chicago, Illinois, has already showcased some of this integration.
The first proposal is to minimize overlapping service delivery and procurement. As the authors note, 42 separate programs in 6 different federal departments offer nonemergency medical transportation service. However, drug procurement could be the true opportunity for cost savings. “Joint procurement efforts for drugs, as well as for medical and surgical supplies, could result in significant savings,” they argue.
Adopting technology systems that talk to each other is a second important step. “At minimum, federal agencies should lead the adoption of these standards in their own EHRs—just as the VA and Centers for Medicare & Medicaid Services led in ensuring that patients could access their own electronic health data,” the authors insist. Both the VA and DoD already have taken significant steps toward ensuring their electronic health record systems are able to share data.
Other suggestions included repurposing underutilized facilities for use by other health care programs, expanding value-based purchasing, and reducing duplicate payments. As the authors point out more than 1 million beneficiaries use both the Medicare Advantage and the VA systems.
Better integration could make the system more efficient and improve beneficiary care, the authors argue. “Improved communication across agencies, ideally through an integrated health record, would ensure that patients receive more seamless care; that clinicians could more readily access medical histories and provide comprehensive services; and that government programs could more effectively manage the health of the populations they serve.”
LEADER: Liraglutide lowers CVD risk in type 2 diabetes
Liraglutide is associated with a decreased risk of cardiovascular events, compared with placebo, in individuals with type 2 diabetes, according to results from the randomized, placebo-controlled, double-blind LEADER trial.
In the 9,340 patients with type 2 diabetes in LEADER, those treated with the glucagonlike peptide–1 (GLP-1) analogue liraglutide had a 13% lower risk of a composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke over a median follow-up of 3.8 years (hazard ratio, 0.87; 95% confidence interval, 0.78-0.97; P less than .001 for noninferiority; P = .01 for superiority).
This significant reduction in the primary outcome in LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome) makes liraglutide (Victoza) the second antihyperglycemic drug to be shown to reduce cardiovascular outcomes since the Food and Drug Administration mandated that all such agents be tested in such a way in 2008. The first was the sodium-glucose cotransporter–2 inhibitor empagliflozin, which reduced the risk of the composite endpoint of hospitalization for heart failure or death due to cardiovascular disease by 34% in the EMPA-REG OUTCOME trial (N Engl J Med. 2015;373:2117-28).
In LEADER, the rate of death from cardiovascular causes was 22% lower in the liraglutide group than in the placebo group (95% CI, 0.66-0.93; P = .007). However, the lower incidences of nonfatal MI, stroke, and hospitalization for heart failure in the liraglutide group did not reach statistical significance.
The participants in LEADER all had a hemoglobin A1c level of 7.0%, and were either aged over 50 with at least one cardiovascular condition such as coronary heart disease, or aged over 60 with at least one cardiovascular risk factor such as hypertension or microalbuminuria.
The participants, who were recruited from 410 sites in 32 countries, were randomized to 1.8 mg or the maximum tolerated dose of subcutaneous liraglutide once daily or to equivalent placebo, in addition to standard care (N Engl J Med. 2016 June 13. doi: 10.1056/NEJMoa1603827).
“Although glycemic control is associated with reductions in the risk of microvascular complications, the macrovascular benefits of glycemic control are less certain,” wrote Dr. Steven P. Marso of the University of Texas Southwestern Medical Center, Dallas, and his coauthors.
“Furthermore, concern has been raised about the cardiovascular safety of antihyperglycemic therapies, [and] consequently, regulatory authorities have mandated cardiovascular safety assessments of new diabetes treatments.”
The study did see a significant interaction between liraglutide and renal function. Patients who had an estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m2 showed more benefits from the liraglutide in terms of the primary outcomes than did those with an eGFR of at least 60 mL/min.
Individuals aged over 50 years with established cardiovascular disease also showed greater benefits in reductions in the primary outcome from liraglutide than did patients aged over 60 years with cardiovascular risk factors.
The authors commented that their findings contrast with those of the Lixisenatide in Acute Coronary Syndrome (ELIXA) trial using the shorter-acting and structurally dissimilar GLP-1 receptor agonist lixisenatide. This trial failed to show any cardiovascular benefit of the drug in patients with diabetes and a recent acute coronary syndrome, as did several other trials looking at cardiovascular outcomes in high-risk patients with type 2 diabetes treated with drugs including insulin, thiazolidinediones, and dipeptidyl peptidase–4 inhibitors.
“Our trial had greater statistical power and included patients with a higher baseline glycated hemoglobin level than did most previous studies,” the authors wrote. “However, no obvious single explanation in terms of either the study designs or the included populations is apparent to explain the divergent findings across this body of medical literature.
The study also examined the incidence of adverse events, finding a nonsignificantly higher overall rate of benign or malignant neoplasms with liraglutide, compared with placebo. However, there was a trend toward an increased risk of pancreatic cancer in those taking liraglutide, which approached statistical significance.
“There has been considerable interest in a potential association between the use of GLP-1 receptor agonists and pancreatitis and pancreatic cancer, although there is no consistent preclinical, pharmacovigilance, or epidemiologic evidence to date,” the authors commented.
The study was supported by Novo Nordisk and the National Institutes of Health. Several authors declared grants, consultancies and funding from the pharmaceutical industry, including from Novo Nordisk. Several authors are employees of Novo Nordisk, are on steering committees, and/or own shares in the company.
Liraglutide is associated with a decreased risk of cardiovascular events, compared with placebo, in individuals with type 2 diabetes, according to results from the randomized, placebo-controlled, double-blind LEADER trial.
In the 9,340 patients with type 2 diabetes in LEADER, those treated with the glucagonlike peptide–1 (GLP-1) analogue liraglutide had a 13% lower risk of a composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke over a median follow-up of 3.8 years (hazard ratio, 0.87; 95% confidence interval, 0.78-0.97; P less than .001 for noninferiority; P = .01 for superiority).
This significant reduction in the primary outcome in LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome) makes liraglutide (Victoza) the second antihyperglycemic drug to be shown to reduce cardiovascular outcomes since the Food and Drug Administration mandated that all such agents be tested in such a way in 2008. The first was the sodium-glucose cotransporter–2 inhibitor empagliflozin, which reduced the risk of the composite endpoint of hospitalization for heart failure or death due to cardiovascular disease by 34% in the EMPA-REG OUTCOME trial (N Engl J Med. 2015;373:2117-28).
In LEADER, the rate of death from cardiovascular causes was 22% lower in the liraglutide group than in the placebo group (95% CI, 0.66-0.93; P = .007). However, the lower incidences of nonfatal MI, stroke, and hospitalization for heart failure in the liraglutide group did not reach statistical significance.
The participants in LEADER all had a hemoglobin A1c level of 7.0%, and were either aged over 50 with at least one cardiovascular condition such as coronary heart disease, or aged over 60 with at least one cardiovascular risk factor such as hypertension or microalbuminuria.
The participants, who were recruited from 410 sites in 32 countries, were randomized to 1.8 mg or the maximum tolerated dose of subcutaneous liraglutide once daily or to equivalent placebo, in addition to standard care (N Engl J Med. 2016 June 13. doi: 10.1056/NEJMoa1603827).
“Although glycemic control is associated with reductions in the risk of microvascular complications, the macrovascular benefits of glycemic control are less certain,” wrote Dr. Steven P. Marso of the University of Texas Southwestern Medical Center, Dallas, and his coauthors.
“Furthermore, concern has been raised about the cardiovascular safety of antihyperglycemic therapies, [and] consequently, regulatory authorities have mandated cardiovascular safety assessments of new diabetes treatments.”
The study did see a significant interaction between liraglutide and renal function. Patients who had an estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m2 showed more benefits from the liraglutide in terms of the primary outcomes than did those with an eGFR of at least 60 mL/min.
Individuals aged over 50 years with established cardiovascular disease also showed greater benefits in reductions in the primary outcome from liraglutide than did patients aged over 60 years with cardiovascular risk factors.
The authors commented that their findings contrast with those of the Lixisenatide in Acute Coronary Syndrome (ELIXA) trial using the shorter-acting and structurally dissimilar GLP-1 receptor agonist lixisenatide. This trial failed to show any cardiovascular benefit of the drug in patients with diabetes and a recent acute coronary syndrome, as did several other trials looking at cardiovascular outcomes in high-risk patients with type 2 diabetes treated with drugs including insulin, thiazolidinediones, and dipeptidyl peptidase–4 inhibitors.
“Our trial had greater statistical power and included patients with a higher baseline glycated hemoglobin level than did most previous studies,” the authors wrote. “However, no obvious single explanation in terms of either the study designs or the included populations is apparent to explain the divergent findings across this body of medical literature.
The study also examined the incidence of adverse events, finding a nonsignificantly higher overall rate of benign or malignant neoplasms with liraglutide, compared with placebo. However, there was a trend toward an increased risk of pancreatic cancer in those taking liraglutide, which approached statistical significance.
“There has been considerable interest in a potential association between the use of GLP-1 receptor agonists and pancreatitis and pancreatic cancer, although there is no consistent preclinical, pharmacovigilance, or epidemiologic evidence to date,” the authors commented.
The study was supported by Novo Nordisk and the National Institutes of Health. Several authors declared grants, consultancies and funding from the pharmaceutical industry, including from Novo Nordisk. Several authors are employees of Novo Nordisk, are on steering committees, and/or own shares in the company.
Liraglutide is associated with a decreased risk of cardiovascular events, compared with placebo, in individuals with type 2 diabetes, according to results from the randomized, placebo-controlled, double-blind LEADER trial.
In the 9,340 patients with type 2 diabetes in LEADER, those treated with the glucagonlike peptide–1 (GLP-1) analogue liraglutide had a 13% lower risk of a composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke over a median follow-up of 3.8 years (hazard ratio, 0.87; 95% confidence interval, 0.78-0.97; P less than .001 for noninferiority; P = .01 for superiority).
This significant reduction in the primary outcome in LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome) makes liraglutide (Victoza) the second antihyperglycemic drug to be shown to reduce cardiovascular outcomes since the Food and Drug Administration mandated that all such agents be tested in such a way in 2008. The first was the sodium-glucose cotransporter–2 inhibitor empagliflozin, which reduced the risk of the composite endpoint of hospitalization for heart failure or death due to cardiovascular disease by 34% in the EMPA-REG OUTCOME trial (N Engl J Med. 2015;373:2117-28).
In LEADER, the rate of death from cardiovascular causes was 22% lower in the liraglutide group than in the placebo group (95% CI, 0.66-0.93; P = .007). However, the lower incidences of nonfatal MI, stroke, and hospitalization for heart failure in the liraglutide group did not reach statistical significance.
The participants in LEADER all had a hemoglobin A1c level of 7.0%, and were either aged over 50 with at least one cardiovascular condition such as coronary heart disease, or aged over 60 with at least one cardiovascular risk factor such as hypertension or microalbuminuria.
The participants, who were recruited from 410 sites in 32 countries, were randomized to 1.8 mg or the maximum tolerated dose of subcutaneous liraglutide once daily or to equivalent placebo, in addition to standard care (N Engl J Med. 2016 June 13. doi: 10.1056/NEJMoa1603827).
“Although glycemic control is associated with reductions in the risk of microvascular complications, the macrovascular benefits of glycemic control are less certain,” wrote Dr. Steven P. Marso of the University of Texas Southwestern Medical Center, Dallas, and his coauthors.
“Furthermore, concern has been raised about the cardiovascular safety of antihyperglycemic therapies, [and] consequently, regulatory authorities have mandated cardiovascular safety assessments of new diabetes treatments.”
The study did see a significant interaction between liraglutide and renal function. Patients who had an estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m2 showed more benefits from the liraglutide in terms of the primary outcomes than did those with an eGFR of at least 60 mL/min.
Individuals aged over 50 years with established cardiovascular disease also showed greater benefits in reductions in the primary outcome from liraglutide than did patients aged over 60 years with cardiovascular risk factors.
The authors commented that their findings contrast with those of the Lixisenatide in Acute Coronary Syndrome (ELIXA) trial using the shorter-acting and structurally dissimilar GLP-1 receptor agonist lixisenatide. This trial failed to show any cardiovascular benefit of the drug in patients with diabetes and a recent acute coronary syndrome, as did several other trials looking at cardiovascular outcomes in high-risk patients with type 2 diabetes treated with drugs including insulin, thiazolidinediones, and dipeptidyl peptidase–4 inhibitors.
“Our trial had greater statistical power and included patients with a higher baseline glycated hemoglobin level than did most previous studies,” the authors wrote. “However, no obvious single explanation in terms of either the study designs or the included populations is apparent to explain the divergent findings across this body of medical literature.
The study also examined the incidence of adverse events, finding a nonsignificantly higher overall rate of benign or malignant neoplasms with liraglutide, compared with placebo. However, there was a trend toward an increased risk of pancreatic cancer in those taking liraglutide, which approached statistical significance.
“There has been considerable interest in a potential association between the use of GLP-1 receptor agonists and pancreatitis and pancreatic cancer, although there is no consistent preclinical, pharmacovigilance, or epidemiologic evidence to date,” the authors commented.
The study was supported by Novo Nordisk and the National Institutes of Health. Several authors declared grants, consultancies and funding from the pharmaceutical industry, including from Novo Nordisk. Several authors are employees of Novo Nordisk, are on steering committees, and/or own shares in the company.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Liraglutide is associated with a decreased risk of cardiovascular events, compared with placebo, in patients with type 2 diabetes.
Major finding: Patients with type 2 diabetes at high risk for cardiovascular disease taking liraglutide had a 13% lower risk of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, compared with those on placebo, a significant difference.
Data source: A randomized, double-blind, placebo-controlled trial in 9,340 patients with type 2 diabetes and either established cardiovascular disease or cardiovascular risk factors.
Disclosures: The study was supported by Novo Nordisk and the National Institutes of Health. Several authors declared grants, consultancies, and funding from the pharmaceutical industry, including from Novo Nordisk. Several authors are employees of Novo Nordisk, are on steering committees, and/or own shares in the company.
The end of polypill – statins for everyone
At a time when therapeutics is emphasizing personalized therapy, it is reassuring that someone is interested in the big picture. Treating a single patient with drugs that cost $500 a pill seems in conflict with the needs of millions of individuals who might have the expression of cardiovascular disease delayed with a pill that might cost pennies.
Dr. Saleem Yusuf originated the concept of the polypill more than 10 years ago by proposing to make one simple pill to mitigate the effect of aging on cardiovascular mortality, particularly in the underdeveloped and rapidly aging countries of the world. Working at the Population Health Research Institute at the McMaster University in Canada, he has moved through a number of iterations of the original Polypill, the most recent reported from the Heart Outcomes Evaluation (HOPE-3) trial (N Engl J Med. 2016 May; 374:2021-31). HOPE-3 distilled the initial polypill array of five drugs (three antihypertensives, a statin, and an aspirin) down to a combination of three drugs; two hypertensives and a statin. One hypertension drug was discarded in the face of concerns of the potential of symptomatic hypotension, and aspirin because of its bleeding potential.
HOPE-3 included 12,705 patients in 21 countries around the world with 50% coming from Asia and China, 80% of whom were nonwhite. Patients aged at least 55 (men) and 65 (women) years with only one cardiovascular risk factor and with systolic pressure less than 160 mm Hg, were followed for 5.6 years. Patients were randomized to a combination of hypertension medications (candesartan, 16 mg, and hydrochlorothiazide, 12.5 mg), a statin (rosuvastatin, 10 mg) or both, or to placebo. The hypertension drug combination was successful in lowering the systolic pressure at randomization of 138/81 by 10 mm Hg but had no effect on cardiovascular mortality or morbidity. In contrast, the rosuvastatin arm successfully lowered the mean LDL cholesterol of 127.8 mg/dL by 26.5% at the conclusion of the trial. This was associated with a 24% decrease in the combined cardiovascular morbidity and mortality endpoint and a decrease in myocardial infarction and stroke of 35% and 30% respectively. The addition of the hypertension drugs to rosuvastatin added little to the morbidity and mortality benefit observed with rosuvastatin alone.
The initial concept of the polypill was greeted with considerable skepticism by the medical community, which has viewed attacking cardiovascular mortality as a one-on-one experience between patient and doctor. This, despite the benefit of a broad array of prevention efforts, including lifestyle and hypertension therapy that has occurred over the last half-century.
The concept of a polypill with five different medications appears to have failed, but its outcome refined to just to one statin is a message of great importance. In a universe of indigent and undertreated humans, the need for some form of intervention seems to be a crying one. The results of HOPE-3 are consistent with JUPITER and other statin lipid-lowering trials and indicates that just treating cholesterol alone in this low-risk population achieved significant benefit of itself. Application of such an intervention in the Third World could have an important benefit. The cost of such an intervention is minimal, compared with the recent additions to the cardiovascular pharmacopeia in both heart failure and lipid therapy.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
At a time when therapeutics is emphasizing personalized therapy, it is reassuring that someone is interested in the big picture. Treating a single patient with drugs that cost $500 a pill seems in conflict with the needs of millions of individuals who might have the expression of cardiovascular disease delayed with a pill that might cost pennies.
Dr. Saleem Yusuf originated the concept of the polypill more than 10 years ago by proposing to make one simple pill to mitigate the effect of aging on cardiovascular mortality, particularly in the underdeveloped and rapidly aging countries of the world. Working at the Population Health Research Institute at the McMaster University in Canada, he has moved through a number of iterations of the original Polypill, the most recent reported from the Heart Outcomes Evaluation (HOPE-3) trial (N Engl J Med. 2016 May; 374:2021-31). HOPE-3 distilled the initial polypill array of five drugs (three antihypertensives, a statin, and an aspirin) down to a combination of three drugs; two hypertensives and a statin. One hypertension drug was discarded in the face of concerns of the potential of symptomatic hypotension, and aspirin because of its bleeding potential.
HOPE-3 included 12,705 patients in 21 countries around the world with 50% coming from Asia and China, 80% of whom were nonwhite. Patients aged at least 55 (men) and 65 (women) years with only one cardiovascular risk factor and with systolic pressure less than 160 mm Hg, were followed for 5.6 years. Patients were randomized to a combination of hypertension medications (candesartan, 16 mg, and hydrochlorothiazide, 12.5 mg), a statin (rosuvastatin, 10 mg) or both, or to placebo. The hypertension drug combination was successful in lowering the systolic pressure at randomization of 138/81 by 10 mm Hg but had no effect on cardiovascular mortality or morbidity. In contrast, the rosuvastatin arm successfully lowered the mean LDL cholesterol of 127.8 mg/dL by 26.5% at the conclusion of the trial. This was associated with a 24% decrease in the combined cardiovascular morbidity and mortality endpoint and a decrease in myocardial infarction and stroke of 35% and 30% respectively. The addition of the hypertension drugs to rosuvastatin added little to the morbidity and mortality benefit observed with rosuvastatin alone.
The initial concept of the polypill was greeted with considerable skepticism by the medical community, which has viewed attacking cardiovascular mortality as a one-on-one experience between patient and doctor. This, despite the benefit of a broad array of prevention efforts, including lifestyle and hypertension therapy that has occurred over the last half-century.
The concept of a polypill with five different medications appears to have failed, but its outcome refined to just to one statin is a message of great importance. In a universe of indigent and undertreated humans, the need for some form of intervention seems to be a crying one. The results of HOPE-3 are consistent with JUPITER and other statin lipid-lowering trials and indicates that just treating cholesterol alone in this low-risk population achieved significant benefit of itself. Application of such an intervention in the Third World could have an important benefit. The cost of such an intervention is minimal, compared with the recent additions to the cardiovascular pharmacopeia in both heart failure and lipid therapy.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
At a time when therapeutics is emphasizing personalized therapy, it is reassuring that someone is interested in the big picture. Treating a single patient with drugs that cost $500 a pill seems in conflict with the needs of millions of individuals who might have the expression of cardiovascular disease delayed with a pill that might cost pennies.
Dr. Saleem Yusuf originated the concept of the polypill more than 10 years ago by proposing to make one simple pill to mitigate the effect of aging on cardiovascular mortality, particularly in the underdeveloped and rapidly aging countries of the world. Working at the Population Health Research Institute at the McMaster University in Canada, he has moved through a number of iterations of the original Polypill, the most recent reported from the Heart Outcomes Evaluation (HOPE-3) trial (N Engl J Med. 2016 May; 374:2021-31). HOPE-3 distilled the initial polypill array of five drugs (three antihypertensives, a statin, and an aspirin) down to a combination of three drugs; two hypertensives and a statin. One hypertension drug was discarded in the face of concerns of the potential of symptomatic hypotension, and aspirin because of its bleeding potential.
HOPE-3 included 12,705 patients in 21 countries around the world with 50% coming from Asia and China, 80% of whom were nonwhite. Patients aged at least 55 (men) and 65 (women) years with only one cardiovascular risk factor and with systolic pressure less than 160 mm Hg, were followed for 5.6 years. Patients were randomized to a combination of hypertension medications (candesartan, 16 mg, and hydrochlorothiazide, 12.5 mg), a statin (rosuvastatin, 10 mg) or both, or to placebo. The hypertension drug combination was successful in lowering the systolic pressure at randomization of 138/81 by 10 mm Hg but had no effect on cardiovascular mortality or morbidity. In contrast, the rosuvastatin arm successfully lowered the mean LDL cholesterol of 127.8 mg/dL by 26.5% at the conclusion of the trial. This was associated with a 24% decrease in the combined cardiovascular morbidity and mortality endpoint and a decrease in myocardial infarction and stroke of 35% and 30% respectively. The addition of the hypertension drugs to rosuvastatin added little to the morbidity and mortality benefit observed with rosuvastatin alone.
The initial concept of the polypill was greeted with considerable skepticism by the medical community, which has viewed attacking cardiovascular mortality as a one-on-one experience between patient and doctor. This, despite the benefit of a broad array of prevention efforts, including lifestyle and hypertension therapy that has occurred over the last half-century.
The concept of a polypill with five different medications appears to have failed, but its outcome refined to just to one statin is a message of great importance. In a universe of indigent and undertreated humans, the need for some form of intervention seems to be a crying one. The results of HOPE-3 are consistent with JUPITER and other statin lipid-lowering trials and indicates that just treating cholesterol alone in this low-risk population achieved significant benefit of itself. Application of such an intervention in the Third World could have an important benefit. The cost of such an intervention is minimal, compared with the recent additions to the cardiovascular pharmacopeia in both heart failure and lipid therapy.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Plant-based therapies reduce some menopause symptoms
Plant-based therapies were associated with “modest reductions” in the frequency of hot flashes and vaginal dryness in menopause, but did not significantly reduce night sweats, according to a systematic review from Dr. Oscar H. Franco and his associates.
A total of 62 studies covering 6,653 women were included in the review. Phytoestrogen use decreased vaginal dryness scores by 0.31 and reduced the number of daily hot flashes by 1.31, but did not reduce the number of night sweats. Individual phytoestrogen interventions, such as dietary and supplementary soy isoflavones, decreased vaginal dryness scores by 0.26 and reduced the number of daily hot flashes by 0.79.
While evidence was limited, Chinese medicinal herbs had no association with a reduction in menopausal symptoms, while non-Chinese medicinal herbs reduced the number of daily hot flashes by 1.62 in one randomized controlled trial.
“This review underscores the lack of data on adverse effects associated with long-term use of plant-based therapies. Information on any detrimental health effects, typically available in long-term intervention studies, is essential, given their potential relevance to postmenopausal health,” Dr. Franco and his colleagues wrote.
Read the full study in JAMA (doi: 10.1001/jama.2016.8012).
Plant-based therapies were associated with “modest reductions” in the frequency of hot flashes and vaginal dryness in menopause, but did not significantly reduce night sweats, according to a systematic review from Dr. Oscar H. Franco and his associates.
A total of 62 studies covering 6,653 women were included in the review. Phytoestrogen use decreased vaginal dryness scores by 0.31 and reduced the number of daily hot flashes by 1.31, but did not reduce the number of night sweats. Individual phytoestrogen interventions, such as dietary and supplementary soy isoflavones, decreased vaginal dryness scores by 0.26 and reduced the number of daily hot flashes by 0.79.
While evidence was limited, Chinese medicinal herbs had no association with a reduction in menopausal symptoms, while non-Chinese medicinal herbs reduced the number of daily hot flashes by 1.62 in one randomized controlled trial.
“This review underscores the lack of data on adverse effects associated with long-term use of plant-based therapies. Information on any detrimental health effects, typically available in long-term intervention studies, is essential, given their potential relevance to postmenopausal health,” Dr. Franco and his colleagues wrote.
Read the full study in JAMA (doi: 10.1001/jama.2016.8012).
Plant-based therapies were associated with “modest reductions” in the frequency of hot flashes and vaginal dryness in menopause, but did not significantly reduce night sweats, according to a systematic review from Dr. Oscar H. Franco and his associates.
A total of 62 studies covering 6,653 women were included in the review. Phytoestrogen use decreased vaginal dryness scores by 0.31 and reduced the number of daily hot flashes by 1.31, but did not reduce the number of night sweats. Individual phytoestrogen interventions, such as dietary and supplementary soy isoflavones, decreased vaginal dryness scores by 0.26 and reduced the number of daily hot flashes by 0.79.
While evidence was limited, Chinese medicinal herbs had no association with a reduction in menopausal symptoms, while non-Chinese medicinal herbs reduced the number of daily hot flashes by 1.62 in one randomized controlled trial.
“This review underscores the lack of data on adverse effects associated with long-term use of plant-based therapies. Information on any detrimental health effects, typically available in long-term intervention studies, is essential, given their potential relevance to postmenopausal health,” Dr. Franco and his colleagues wrote.
Read the full study in JAMA (doi: 10.1001/jama.2016.8012).
FROM JAMA
The grass is not greener on the other side of the pond
I was in London for the just-concluded EULAR congress. Oh, the United Kingdom, that bastion of socialist medicine, where the National Health Service is the great equalizer. Heaven sent to some, death spiral of long wait times and old-fashioned medicine to others. While there, I chatted with people who have had experience with the NHS.
I spoke with a health care consultant, whose job is to make hospitals less wasteful. He says the U.K.’s health care expenditure as a percent of GDP [gross domestic product] is too high, compared with other Western nations. I suspect this was a line that he probably heard somewhere and blindly repeated, because when I pressed, he could not tell me what the numbers were, nor could he name the countries he was referring to.
I asked him for examples of how he thought the hospitals he’d served might save money. His biggest complaint was that many patients stay in hospital for months not out of medical necessity but because there is no system in place for lower-level care.
Another friend is the director of a home care service just outside Central London. She tells me that patients have access to an extraordinary amount of resources that allows them to stay at home: suction machines, dialysis machines, home aides. This is great for patients, but she is astounded by how many people got services that she thought were undeserved.
She also told me that, apropos of the impending Brexit, many of their home health aides come from other Eurozone countries. The British do not want to do these jobs, so should the Brexit happen, home health aides will be much harder to come by.
Of course, the most common complaint I heard was that wait times to see a physician are ridiculous. Those who can afford it, can get private insurance, which would allow them access to physicians sooner. In fact, private insurance is often an incentive for people to get promoted.
The British think their health care system is wasteful, as we do for ours. But according to the World Bank’s data from 2014, their health care spending as a percent of GDP is 9.1%, which is much better than ours at 17.1%. And although I was told by the health care consultant that their figure is higher than their neighbors, that just isn’t true. France’s figure is 11.5%, Belgium’s 10.6%, and Spain’s 9.0%. So what I took away from it was this: As different as our health care systems are, they are problematic in the same ways. People have health care that works. But hospital stays are often unnecessary, people take advantage of social safety nets, and there are jobs that mostly only immigrants are willing to perform. Wealthy people can afford to pay for private insurance. And the wait times! People will always complain about wait times, just like they do here, and elsewhere.
Dr. Chan practices rheumatology in Pawtucket, R.I.
I was in London for the just-concluded EULAR congress. Oh, the United Kingdom, that bastion of socialist medicine, where the National Health Service is the great equalizer. Heaven sent to some, death spiral of long wait times and old-fashioned medicine to others. While there, I chatted with people who have had experience with the NHS.
I spoke with a health care consultant, whose job is to make hospitals less wasteful. He says the U.K.’s health care expenditure as a percent of GDP [gross domestic product] is too high, compared with other Western nations. I suspect this was a line that he probably heard somewhere and blindly repeated, because when I pressed, he could not tell me what the numbers were, nor could he name the countries he was referring to.
I asked him for examples of how he thought the hospitals he’d served might save money. His biggest complaint was that many patients stay in hospital for months not out of medical necessity but because there is no system in place for lower-level care.
Another friend is the director of a home care service just outside Central London. She tells me that patients have access to an extraordinary amount of resources that allows them to stay at home: suction machines, dialysis machines, home aides. This is great for patients, but she is astounded by how many people got services that she thought were undeserved.
She also told me that, apropos of the impending Brexit, many of their home health aides come from other Eurozone countries. The British do not want to do these jobs, so should the Brexit happen, home health aides will be much harder to come by.
Of course, the most common complaint I heard was that wait times to see a physician are ridiculous. Those who can afford it, can get private insurance, which would allow them access to physicians sooner. In fact, private insurance is often an incentive for people to get promoted.
The British think their health care system is wasteful, as we do for ours. But according to the World Bank’s data from 2014, their health care spending as a percent of GDP is 9.1%, which is much better than ours at 17.1%. And although I was told by the health care consultant that their figure is higher than their neighbors, that just isn’t true. France’s figure is 11.5%, Belgium’s 10.6%, and Spain’s 9.0%. So what I took away from it was this: As different as our health care systems are, they are problematic in the same ways. People have health care that works. But hospital stays are often unnecessary, people take advantage of social safety nets, and there are jobs that mostly only immigrants are willing to perform. Wealthy people can afford to pay for private insurance. And the wait times! People will always complain about wait times, just like they do here, and elsewhere.
Dr. Chan practices rheumatology in Pawtucket, R.I.
I was in London for the just-concluded EULAR congress. Oh, the United Kingdom, that bastion of socialist medicine, where the National Health Service is the great equalizer. Heaven sent to some, death spiral of long wait times and old-fashioned medicine to others. While there, I chatted with people who have had experience with the NHS.
I spoke with a health care consultant, whose job is to make hospitals less wasteful. He says the U.K.’s health care expenditure as a percent of GDP [gross domestic product] is too high, compared with other Western nations. I suspect this was a line that he probably heard somewhere and blindly repeated, because when I pressed, he could not tell me what the numbers were, nor could he name the countries he was referring to.
I asked him for examples of how he thought the hospitals he’d served might save money. His biggest complaint was that many patients stay in hospital for months not out of medical necessity but because there is no system in place for lower-level care.
Another friend is the director of a home care service just outside Central London. She tells me that patients have access to an extraordinary amount of resources that allows them to stay at home: suction machines, dialysis machines, home aides. This is great for patients, but she is astounded by how many people got services that she thought were undeserved.
She also told me that, apropos of the impending Brexit, many of their home health aides come from other Eurozone countries. The British do not want to do these jobs, so should the Brexit happen, home health aides will be much harder to come by.
Of course, the most common complaint I heard was that wait times to see a physician are ridiculous. Those who can afford it, can get private insurance, which would allow them access to physicians sooner. In fact, private insurance is often an incentive for people to get promoted.
The British think their health care system is wasteful, as we do for ours. But according to the World Bank’s data from 2014, their health care spending as a percent of GDP is 9.1%, which is much better than ours at 17.1%. And although I was told by the health care consultant that their figure is higher than their neighbors, that just isn’t true. France’s figure is 11.5%, Belgium’s 10.6%, and Spain’s 9.0%. So what I took away from it was this: As different as our health care systems are, they are problematic in the same ways. People have health care that works. But hospital stays are often unnecessary, people take advantage of social safety nets, and there are jobs that mostly only immigrants are willing to perform. Wealthy people can afford to pay for private insurance. And the wait times! People will always complain about wait times, just like they do here, and elsewhere.
Dr. Chan practices rheumatology in Pawtucket, R.I.
Wedge resection showed improved survival over SBRT for early-stage NSCLC
BALTIMORE – Wedge resection was associated with significantly improved overall 5-year survival, compared with stereotactic body radiation therapy (SBRT) in patients with operable clinical Stage IA non–small cell lung cancer, according to a study of more than 8,000 patients.
Despite the fact that surgical resection has been the standard of care for early-stage non–small cell lung cancer (NSCLC), an increasing number of patients with potentially operable early-stage NSCLC are now being treated with SBRT, study investigator Dr. Babatunde A. Yerokun said at the annual meeting of the American Association for Thoracic Surgery.
“Our data show that thoracic surgeons should be included in the evaluation of these patients, and operative candidates with ct1A NO MO NSCLC should continue to receive a wedge resection vs. SBRT when technically feasible,” said Dr. Yerokun of Duke University, Durham, N.C. “Prospective studies are needed to determine the appropriate role of SBRT in management of these patients,” he concluded.
Dr. Yerokun and his colleagues examined overall survival of patients with cT1N0 lung cancer who underwent SBRT or wedge resection as reported in the National Cancer Data Base from 2003 to 2011. Survival was assessed using Kaplan-Meier and propensity-score matched analysis. The researchers matched groups according to common prognostic covariates, including age, sex, race, education, insurance status, facility type, and Charlson/Deyo comorbidity score, as well as tumor histology, size, and location.
Patients identified as having cT1N0 NSCLC with a tumor less than 2 cm underwent SBRT (1,514 patients) or wedge resection (6,923). Compared with the wedge resection cohort, the SBRT patients were significantly older (74 vs. 69 years) and significantly more likely to be treated at an academic comprehensive cancer program (47% vs. 37%). The median Charlson/Deyo score was lower in the SBRT patients (0 vs. 1).
In unmatched analysis, SBRT was associated with significantly lower survival than wedge resection (5-year overall survival: 32% vs. 55%). In the propensity matching, all baseline covariates, including co-morbidity scores, facility type, and tumor size, were well balanced between the SBRT and wedge groups, with 1,398 patients in each group.
However, even in the matched groups, SBRT was associated with significantly lower 5-year overall survival than wedge (33% vs. 52%). When the investigators performed a propensity matched subgroup analysis in younger patients (age less than 60 years) who had a Charlson/Deyo score of 0, SBRT was associated with worse survival with a 5-year overall survival of 59% vs. 82% for SBRT and wedge resection, respectively.
Additionally, Dr. Yerokun and his colleagues conducted a sensitivity analysis comparing centers that performed predominately wedge resection with centers that performed predominately SBRT. After the exclusion of centers with low-volume and centers that conducted either 100% wedge resection or 100% SBRT only, centers that performed predominately wedge resection were more likely to have significantly better 3-year survival.
A video of the original presentation from the AATS Annual Meeting is available online.
Dr. Yerokun reported that he had no disclosures related to this presentation.
On Twitter @ThoracicTweets
BALTIMORE – Wedge resection was associated with significantly improved overall 5-year survival, compared with stereotactic body radiation therapy (SBRT) in patients with operable clinical Stage IA non–small cell lung cancer, according to a study of more than 8,000 patients.
Despite the fact that surgical resection has been the standard of care for early-stage non–small cell lung cancer (NSCLC), an increasing number of patients with potentially operable early-stage NSCLC are now being treated with SBRT, study investigator Dr. Babatunde A. Yerokun said at the annual meeting of the American Association for Thoracic Surgery.
“Our data show that thoracic surgeons should be included in the evaluation of these patients, and operative candidates with ct1A NO MO NSCLC should continue to receive a wedge resection vs. SBRT when technically feasible,” said Dr. Yerokun of Duke University, Durham, N.C. “Prospective studies are needed to determine the appropriate role of SBRT in management of these patients,” he concluded.
Dr. Yerokun and his colleagues examined overall survival of patients with cT1N0 lung cancer who underwent SBRT or wedge resection as reported in the National Cancer Data Base from 2003 to 2011. Survival was assessed using Kaplan-Meier and propensity-score matched analysis. The researchers matched groups according to common prognostic covariates, including age, sex, race, education, insurance status, facility type, and Charlson/Deyo comorbidity score, as well as tumor histology, size, and location.
Patients identified as having cT1N0 NSCLC with a tumor less than 2 cm underwent SBRT (1,514 patients) or wedge resection (6,923). Compared with the wedge resection cohort, the SBRT patients were significantly older (74 vs. 69 years) and significantly more likely to be treated at an academic comprehensive cancer program (47% vs. 37%). The median Charlson/Deyo score was lower in the SBRT patients (0 vs. 1).
In unmatched analysis, SBRT was associated with significantly lower survival than wedge resection (5-year overall survival: 32% vs. 55%). In the propensity matching, all baseline covariates, including co-morbidity scores, facility type, and tumor size, were well balanced between the SBRT and wedge groups, with 1,398 patients in each group.
However, even in the matched groups, SBRT was associated with significantly lower 5-year overall survival than wedge (33% vs. 52%). When the investigators performed a propensity matched subgroup analysis in younger patients (age less than 60 years) who had a Charlson/Deyo score of 0, SBRT was associated with worse survival with a 5-year overall survival of 59% vs. 82% for SBRT and wedge resection, respectively.
Additionally, Dr. Yerokun and his colleagues conducted a sensitivity analysis comparing centers that performed predominately wedge resection with centers that performed predominately SBRT. After the exclusion of centers with low-volume and centers that conducted either 100% wedge resection or 100% SBRT only, centers that performed predominately wedge resection were more likely to have significantly better 3-year survival.
A video of the original presentation from the AATS Annual Meeting is available online.
Dr. Yerokun reported that he had no disclosures related to this presentation.
On Twitter @ThoracicTweets
BALTIMORE – Wedge resection was associated with significantly improved overall 5-year survival, compared with stereotactic body radiation therapy (SBRT) in patients with operable clinical Stage IA non–small cell lung cancer, according to a study of more than 8,000 patients.
Despite the fact that surgical resection has been the standard of care for early-stage non–small cell lung cancer (NSCLC), an increasing number of patients with potentially operable early-stage NSCLC are now being treated with SBRT, study investigator Dr. Babatunde A. Yerokun said at the annual meeting of the American Association for Thoracic Surgery.
“Our data show that thoracic surgeons should be included in the evaluation of these patients, and operative candidates with ct1A NO MO NSCLC should continue to receive a wedge resection vs. SBRT when technically feasible,” said Dr. Yerokun of Duke University, Durham, N.C. “Prospective studies are needed to determine the appropriate role of SBRT in management of these patients,” he concluded.
Dr. Yerokun and his colleagues examined overall survival of patients with cT1N0 lung cancer who underwent SBRT or wedge resection as reported in the National Cancer Data Base from 2003 to 2011. Survival was assessed using Kaplan-Meier and propensity-score matched analysis. The researchers matched groups according to common prognostic covariates, including age, sex, race, education, insurance status, facility type, and Charlson/Deyo comorbidity score, as well as tumor histology, size, and location.
Patients identified as having cT1N0 NSCLC with a tumor less than 2 cm underwent SBRT (1,514 patients) or wedge resection (6,923). Compared with the wedge resection cohort, the SBRT patients were significantly older (74 vs. 69 years) and significantly more likely to be treated at an academic comprehensive cancer program (47% vs. 37%). The median Charlson/Deyo score was lower in the SBRT patients (0 vs. 1).
In unmatched analysis, SBRT was associated with significantly lower survival than wedge resection (5-year overall survival: 32% vs. 55%). In the propensity matching, all baseline covariates, including co-morbidity scores, facility type, and tumor size, were well balanced between the SBRT and wedge groups, with 1,398 patients in each group.
However, even in the matched groups, SBRT was associated with significantly lower 5-year overall survival than wedge (33% vs. 52%). When the investigators performed a propensity matched subgroup analysis in younger patients (age less than 60 years) who had a Charlson/Deyo score of 0, SBRT was associated with worse survival with a 5-year overall survival of 59% vs. 82% for SBRT and wedge resection, respectively.
Additionally, Dr. Yerokun and his colleagues conducted a sensitivity analysis comparing centers that performed predominately wedge resection with centers that performed predominately SBRT. After the exclusion of centers with low-volume and centers that conducted either 100% wedge resection or 100% SBRT only, centers that performed predominately wedge resection were more likely to have significantly better 3-year survival.
A video of the original presentation from the AATS Annual Meeting is available online.
Dr. Yerokun reported that he had no disclosures related to this presentation.
On Twitter @ThoracicTweets
AT THE AATS ANNUAL MEETING
Key clinical point: Wedge resection outperformed SBRT in terms of mortality for early-stage NSCLC.
Major finding: In matched groups, SBRT was associated with significantly lower 5-year overall survival than was wedge resection (32% vs. 50%).
Data source: The study assessed more than 8.000 patients with early stage NSCLC who had either wedge resection or SBRT from the National Cancer Database from 2003 to 2011.
Disclosures: Dr. Yerokun had no relevant disclosures.
Esophagectomy 30-day readmission rate pegged at 19%
BALTIMORE – Approximately one in five patients is readmitted after esophagectomy, and leading risk factors for readmission are longer operative time, post-surgical ICU admission, and preoperative blood transfusions, according to a single-center study of 86 patients.
As one of the first reports on readmissions following esophagectomy with complete follow-up, this study, conducted at the Mayo Clinic in Rochester, Minn., demonstrates that even in a high volume center with specialization in esophageal and foregut surgery, readmission after esophagectomy is not uncommon, researchers reported at the annual meeting of the American Association for Thoracic Surgery.
“In the context of increasing pressures to reduce length of stay, we must also put in the effort to better understand our readmission rates and the important factors that affect them,” said study investigator Dr. Stephen Cassivi. “Reporting on ‘improved’ lengths of stay without accompanying data on readmission rates is not telling the whole story.”
According to the Mayo Clinic research team, identifying risk factors that predict readmissions might permit improved patient management and outcomes.
“Careful collection of data regarding patient outcomes, including unplanned hospital readmissions is essential to improve the quality of patient care since national databases can leave gaps in data regarding follow-up of these patients by failing to identify all readmissions after their surgery,” said Dr. Karen J. Dickinson, who presented the study at the meeting.
The study was designed such that all patients undergoing an elective esophagectomy between August 2013 and July 2014 were contacted directly to follow up on whether they had been readmitted to any medical institution within 30 days of dismissal from the Mayo Clinic. Among all patients who underwent esophagectomy during the one-year study period, 86 patients met the study inclusion criteria. Follow-up was complete in 100% of patients, according to Dr. Dickinson.
Median age of the patients at the time of surgery was 63 years, and the majority of patients were men (70 patients). The most common operative approach was transthoracic (Ivor Lewis) esophagectomy (72%); 7% of cases were performed using a minimally invasive approach. Overall 30-day mortality was 2% (2/86), and anastomotic leak occurred in 8% of the patients.
Median length of stay was 9 days, and the rate of unplanned 30-day readmission was 19% (16 patients). Of these patients, 88% were readmitted to the Mayo Clinic and 12% were readmitted to other medical institutions.
The most common reasons for readmission were due to respiratory causes such as dyspnea, pleural effusions or pneumonia and gastrointestinal causes, including bowel obstruction and anastomotic complications.
Using multivariable analysis, the researchers found that the factors significantly associated with unplanned readmission were postoperative ICU admission (13% in non-readmitted, 38% in admitted), perioperative blood transfusion (12% vs. 38%), and operative length (368 vs. 460 minutes). Importantly, initial hospital length of stay was not associated with the need for readmission. Furthermore, ASA score, sex, BMI, neoadjuvant therapy, and postoperative pain scores also were not associated with unplanned readmission.
“Identifying these risk factors in the perioperative and postoperative setting may provide opportunities for decreasing morbidity, improving readmission rates, and enhancing overall patient outcomes,” Dr. Dickinson concluded.
A video of this presentation at the AATS Annual Meeting is available online.
Dr. Dickinson and her colleagues reported having no relevant disclosures.
On Twitter @ThoracicTweets
BALTIMORE – Approximately one in five patients is readmitted after esophagectomy, and leading risk factors for readmission are longer operative time, post-surgical ICU admission, and preoperative blood transfusions, according to a single-center study of 86 patients.
As one of the first reports on readmissions following esophagectomy with complete follow-up, this study, conducted at the Mayo Clinic in Rochester, Minn., demonstrates that even in a high volume center with specialization in esophageal and foregut surgery, readmission after esophagectomy is not uncommon, researchers reported at the annual meeting of the American Association for Thoracic Surgery.
“In the context of increasing pressures to reduce length of stay, we must also put in the effort to better understand our readmission rates and the important factors that affect them,” said study investigator Dr. Stephen Cassivi. “Reporting on ‘improved’ lengths of stay without accompanying data on readmission rates is not telling the whole story.”
According to the Mayo Clinic research team, identifying risk factors that predict readmissions might permit improved patient management and outcomes.
“Careful collection of data regarding patient outcomes, including unplanned hospital readmissions is essential to improve the quality of patient care since national databases can leave gaps in data regarding follow-up of these patients by failing to identify all readmissions after their surgery,” said Dr. Karen J. Dickinson, who presented the study at the meeting.
The study was designed such that all patients undergoing an elective esophagectomy between August 2013 and July 2014 were contacted directly to follow up on whether they had been readmitted to any medical institution within 30 days of dismissal from the Mayo Clinic. Among all patients who underwent esophagectomy during the one-year study period, 86 patients met the study inclusion criteria. Follow-up was complete in 100% of patients, according to Dr. Dickinson.
Median age of the patients at the time of surgery was 63 years, and the majority of patients were men (70 patients). The most common operative approach was transthoracic (Ivor Lewis) esophagectomy (72%); 7% of cases were performed using a minimally invasive approach. Overall 30-day mortality was 2% (2/86), and anastomotic leak occurred in 8% of the patients.
Median length of stay was 9 days, and the rate of unplanned 30-day readmission was 19% (16 patients). Of these patients, 88% were readmitted to the Mayo Clinic and 12% were readmitted to other medical institutions.
The most common reasons for readmission were due to respiratory causes such as dyspnea, pleural effusions or pneumonia and gastrointestinal causes, including bowel obstruction and anastomotic complications.
Using multivariable analysis, the researchers found that the factors significantly associated with unplanned readmission were postoperative ICU admission (13% in non-readmitted, 38% in admitted), perioperative blood transfusion (12% vs. 38%), and operative length (368 vs. 460 minutes). Importantly, initial hospital length of stay was not associated with the need for readmission. Furthermore, ASA score, sex, BMI, neoadjuvant therapy, and postoperative pain scores also were not associated with unplanned readmission.
“Identifying these risk factors in the perioperative and postoperative setting may provide opportunities for decreasing morbidity, improving readmission rates, and enhancing overall patient outcomes,” Dr. Dickinson concluded.
A video of this presentation at the AATS Annual Meeting is available online.
Dr. Dickinson and her colleagues reported having no relevant disclosures.
On Twitter @ThoracicTweets
BALTIMORE – Approximately one in five patients is readmitted after esophagectomy, and leading risk factors for readmission are longer operative time, post-surgical ICU admission, and preoperative blood transfusions, according to a single-center study of 86 patients.
As one of the first reports on readmissions following esophagectomy with complete follow-up, this study, conducted at the Mayo Clinic in Rochester, Minn., demonstrates that even in a high volume center with specialization in esophageal and foregut surgery, readmission after esophagectomy is not uncommon, researchers reported at the annual meeting of the American Association for Thoracic Surgery.
“In the context of increasing pressures to reduce length of stay, we must also put in the effort to better understand our readmission rates and the important factors that affect them,” said study investigator Dr. Stephen Cassivi. “Reporting on ‘improved’ lengths of stay without accompanying data on readmission rates is not telling the whole story.”
According to the Mayo Clinic research team, identifying risk factors that predict readmissions might permit improved patient management and outcomes.
“Careful collection of data regarding patient outcomes, including unplanned hospital readmissions is essential to improve the quality of patient care since national databases can leave gaps in data regarding follow-up of these patients by failing to identify all readmissions after their surgery,” said Dr. Karen J. Dickinson, who presented the study at the meeting.
The study was designed such that all patients undergoing an elective esophagectomy between August 2013 and July 2014 were contacted directly to follow up on whether they had been readmitted to any medical institution within 30 days of dismissal from the Mayo Clinic. Among all patients who underwent esophagectomy during the one-year study period, 86 patients met the study inclusion criteria. Follow-up was complete in 100% of patients, according to Dr. Dickinson.
Median age of the patients at the time of surgery was 63 years, and the majority of patients were men (70 patients). The most common operative approach was transthoracic (Ivor Lewis) esophagectomy (72%); 7% of cases were performed using a minimally invasive approach. Overall 30-day mortality was 2% (2/86), and anastomotic leak occurred in 8% of the patients.
Median length of stay was 9 days, and the rate of unplanned 30-day readmission was 19% (16 patients). Of these patients, 88% were readmitted to the Mayo Clinic and 12% were readmitted to other medical institutions.
The most common reasons for readmission were due to respiratory causes such as dyspnea, pleural effusions or pneumonia and gastrointestinal causes, including bowel obstruction and anastomotic complications.
Using multivariable analysis, the researchers found that the factors significantly associated with unplanned readmission were postoperative ICU admission (13% in non-readmitted, 38% in admitted), perioperative blood transfusion (12% vs. 38%), and operative length (368 vs. 460 minutes). Importantly, initial hospital length of stay was not associated with the need for readmission. Furthermore, ASA score, sex, BMI, neoadjuvant therapy, and postoperative pain scores also were not associated with unplanned readmission.
“Identifying these risk factors in the perioperative and postoperative setting may provide opportunities for decreasing morbidity, improving readmission rates, and enhancing overall patient outcomes,” Dr. Dickinson concluded.
A video of this presentation at the AATS Annual Meeting is available online.
Dr. Dickinson and her colleagues reported having no relevant disclosures.
On Twitter @ThoracicTweets
AT THE AATS ANNUAL MEETING
Key clinical point: Operative length, perioperative blood transfusions, and postoperative ICU admission were significant risk factors for readmission after esophagectomy.
Major finding: The rate of unplanned 30-day readmission was 19%.
Data source: The study assessed 86 patients who underwent esophagectomy at the Mayo Clinic between August 2012 and July 2014.
Disclosures: Dr. Dickinson and her colleagues reported having no relevant disclosures.