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Autistic youth face higher risks from online child pornography
Prevention efforts include advising adolescent patients about puberty and sex.
AUSTIN, TEX. – It is important to understand the legislative and social lay of the land for child pornography and related issues, such as sexting and revenge porn, according to Nicole Sussman, MD.
Dr. Sussman of Cambridge (Mass.) Health Alliance provided an overview of the history of child pornography legislation before discussing the current landscape and the unique challenges and risks it presents to autistic youth at the annual meeting of the American Academy of Psychiatry and the Law.
History of U.S. child pornography laws
The Protection of Children Against Sexual Exploitation Act, passed in 1977, criminalized the act of forcing a child to engage in sexual activity. But it wasn’t widely cited. Little awareness existed around the issue until New York v. Ferber in 1982, which upheld a New York statute that outlawed distribution of material depicting children under 16 years of age engaged in sexual acts. The U.S. Supreme Court linked child porn to sexual abuse of a child and determined that the only way to control production of child pornography was to regulate distribution of it.
Shortly thereafter, the Child Protection Act of 1984 limited the production, distribution, and possession of “materials involving the sexual exploitation of minors even if the material is not found to be ‘obscene.’ ” The law also raised the age of a minor for the law’s purposes to anyone younger than age 18 years, removed the requirement that the materials be sold (free distribution was now also regulated), and authorized interception of communications to investigate offenses.
Two years later, the Child Sexual Abuse and Pornography Act and the Child Abuse Victims’ Rights Act strengthened child pornography laws; the first made it a federal offense to advertise “any product depicting sexually explicit conduct with a minor or the opportunity to engage in such conduct with a minor.”
More regulation followed with the Child Protection and Obscenity Enforcement Act of 1988, which added regulation of child pornography on computers, and the Child Pornography Prevention Act of 1996, which regulates all forms of online/virtual child pornography.
The first weakening of these laws came with Ashcroft v. Free Speech Coalition in 2002, which held that the 1996 law was overly broad, with the potential to violate free speech, since prohibition of images that “appear to be” or “convey the impression” of child pornography might not necessarily have actually involved child exploitation.
Finally, the Adam Walsh Child Protection and Safety Act of 2006 established the national sex offender registry and mandated convicted offender requirements for reporting their whereabouts based on the “tier” of their crime.
Today’s landscape: Internet use and pornography
With all that legislation as a backdrop, the intersection of growing use of mobile technology, online pornography and sexting can become thorny.
Recent data show that 95% of teens aged 13-17 years have access to a smartphone – independent of their race, sex, ethnicity, or socioeconomic status. Nearly half of teens (45%) report that they are online nearly constantly, Dr. Sussman said.
And pornography is free and easy to find online. A 2006 survey of New Hampshire college students found that 72% of them had seen porn before age 18 years – and that’s decade-old data.
A 2013-2014 survey of 16- and 17-year-olds in Boston found that about half (51%) reported watching porn at least weekly, and 54% watched porn to learn how to do something. Further, 30% of youth in that survey said porn was their primary source of sexual education, followed by parents, cited by 21%.
Put these realities together, and you encounter sexting, the act of sharing “sexually explicit images, videos, or messages through electronic media.” Research on the prevalence of sexting varies widely, with estimates up to 60% of teens. Though prevalence estimates depend on definitions, recent studies suggest that one in four teens send “sexts” and one in seven teens receive them, Dr. Sussman said.
But these figures should be considered alongside an understanding normal sexual development among adolescents. Sexting might simply represent a normal emerging component of sexual development within the context of today’s society, Dr. Sussman said. Sexting often is viewed by youth as a way to initiate and maintain relationships, she said.
Nevertheless, teens might not be able to fully appreciate the risks associated with sending or receiving sexually explicit texts. One in eight teens report being involved in nonconsensual sexting, whether as recipient of an unsolicited sext or as the subject of one.
Sexting also can take the form of “revenge porn” and “sextortion,” in which sexually explicit electronic images are distributed as a form of revenge or are threatened to be distributed.
Early legislation related to sexting has led to litigation, such as the case of 16-year-old A.H., who was charged with producing child pornography after she emailed her 17-year-old boyfriend images of the two of them engaged in sexual activity. She argued she had a right to privacy. But the court disagreed, finding the state had a compelling interest “in protecting children from sexual exploitation,” regardless of “whether the person sexually exploiting the child is an adult or a minor.”
By 2008-2009, about 4,000 cases involving minors sexting were making their way through the courts, demonstrating a “need for laws to evolve and to consider developmental context,” Dr. Sussman said. Punishment could be severe, including requirements for youth to register in the national sex offender registry. Today, however, 25 states have laws differentiating sexting from child pornography.
Child pornography and autistic youth
Teens with autism spectrum disorder might be particularly at higher risk for accessing child pornography and subsequent conviction. Autistic youth’s weaknesses in social skills make it difficult for them to understand the unwritten rules and subjectivity of dating. While their bodies and hormones are changing, their mental age might lag, and their weak interpersonal skills limit their ability to move a relationship in a romantic direction.
Meanwhile, autistic youth might feel more comfortable interacting with others on their computers. Paired with a difficulty in judging others’ age and a limited awareness or understanding of the potential outcomes of their actions, autistic youth can easily fall into a trap of accessing child pornography.
Porn might become a substitute for human interaction, and the accessibility of porn online makes it easy to discover child pornography whose “mere existence implies legality,” Dr. Sussman said. Further, youth are drawn toward images depicting people they personally identify with in terms of their social or emotional age.
Given that pornography typically is not discussed by parents or in sex education, “there have been some cases where people who have autism spectrum disorders have gotten in trouble,” Dr. Sussman said. Autistic youth also might struggle to make the connection between what’s wrong in real life versus what might appear abstract and more acceptable on a computer.
The realities of this special population have several implications courts should consider, Dr. Sussman said. For one, their actions may be misinterpreted as criminal when they might not pose the same level of danger to society as someone else who accesses child pornography. In general, criminal behavior is statistically lower among autistic individuals, but victimization of them is higher than average.
Yet it might be difficult for courts to perceive deficits in individuals with stronger (“high-functioning”) skills in some areas. Courts also should consider how an autistic person might fare in a correctional facility, where inability to understand and adhere to the prison environment’s social structure could prove fatal.
Autistic individuals might be more inclined to report those who break rules and might have an eagerness to please that makes them easily manipulated. Prison staff might misinterpret their behavior, and autistic inmates might be at risk for higher rates of isolation for their own protection.
Dr. Sussman said. Physicians should provide anticipatory guidance when it comes to puberty, sex, romantic interests, and masturbation, she said, and parents can us parental controls.
Youth, especially autistic youth, should be taught the difference between acceptable (“good”) touch, versus unacceptable (“bad”) touch, respect of personal space, and the difference between public and private behavior. Discussions of reality vs. fantasy – especially considering how unrealistic online porn often is – and the definition of consent are also vital preventive strategies.
Dr. Sussman had no conflicts of interest.
Prevention efforts include advising adolescent patients about puberty and sex.
Prevention efforts include advising adolescent patients about puberty and sex.
AUSTIN, TEX. – It is important to understand the legislative and social lay of the land for child pornography and related issues, such as sexting and revenge porn, according to Nicole Sussman, MD.
Dr. Sussman of Cambridge (Mass.) Health Alliance provided an overview of the history of child pornography legislation before discussing the current landscape and the unique challenges and risks it presents to autistic youth at the annual meeting of the American Academy of Psychiatry and the Law.
History of U.S. child pornography laws
The Protection of Children Against Sexual Exploitation Act, passed in 1977, criminalized the act of forcing a child to engage in sexual activity. But it wasn’t widely cited. Little awareness existed around the issue until New York v. Ferber in 1982, which upheld a New York statute that outlawed distribution of material depicting children under 16 years of age engaged in sexual acts. The U.S. Supreme Court linked child porn to sexual abuse of a child and determined that the only way to control production of child pornography was to regulate distribution of it.
Shortly thereafter, the Child Protection Act of 1984 limited the production, distribution, and possession of “materials involving the sexual exploitation of minors even if the material is not found to be ‘obscene.’ ” The law also raised the age of a minor for the law’s purposes to anyone younger than age 18 years, removed the requirement that the materials be sold (free distribution was now also regulated), and authorized interception of communications to investigate offenses.
Two years later, the Child Sexual Abuse and Pornography Act and the Child Abuse Victims’ Rights Act strengthened child pornography laws; the first made it a federal offense to advertise “any product depicting sexually explicit conduct with a minor or the opportunity to engage in such conduct with a minor.”
More regulation followed with the Child Protection and Obscenity Enforcement Act of 1988, which added regulation of child pornography on computers, and the Child Pornography Prevention Act of 1996, which regulates all forms of online/virtual child pornography.
The first weakening of these laws came with Ashcroft v. Free Speech Coalition in 2002, which held that the 1996 law was overly broad, with the potential to violate free speech, since prohibition of images that “appear to be” or “convey the impression” of child pornography might not necessarily have actually involved child exploitation.
Finally, the Adam Walsh Child Protection and Safety Act of 2006 established the national sex offender registry and mandated convicted offender requirements for reporting their whereabouts based on the “tier” of their crime.
Today’s landscape: Internet use and pornography
With all that legislation as a backdrop, the intersection of growing use of mobile technology, online pornography and sexting can become thorny.
Recent data show that 95% of teens aged 13-17 years have access to a smartphone – independent of their race, sex, ethnicity, or socioeconomic status. Nearly half of teens (45%) report that they are online nearly constantly, Dr. Sussman said.
And pornography is free and easy to find online. A 2006 survey of New Hampshire college students found that 72% of them had seen porn before age 18 years – and that’s decade-old data.
A 2013-2014 survey of 16- and 17-year-olds in Boston found that about half (51%) reported watching porn at least weekly, and 54% watched porn to learn how to do something. Further, 30% of youth in that survey said porn was their primary source of sexual education, followed by parents, cited by 21%.
Put these realities together, and you encounter sexting, the act of sharing “sexually explicit images, videos, or messages through electronic media.” Research on the prevalence of sexting varies widely, with estimates up to 60% of teens. Though prevalence estimates depend on definitions, recent studies suggest that one in four teens send “sexts” and one in seven teens receive them, Dr. Sussman said.
But these figures should be considered alongside an understanding normal sexual development among adolescents. Sexting might simply represent a normal emerging component of sexual development within the context of today’s society, Dr. Sussman said. Sexting often is viewed by youth as a way to initiate and maintain relationships, she said.
Nevertheless, teens might not be able to fully appreciate the risks associated with sending or receiving sexually explicit texts. One in eight teens report being involved in nonconsensual sexting, whether as recipient of an unsolicited sext or as the subject of one.
Sexting also can take the form of “revenge porn” and “sextortion,” in which sexually explicit electronic images are distributed as a form of revenge or are threatened to be distributed.
Early legislation related to sexting has led to litigation, such as the case of 16-year-old A.H., who was charged with producing child pornography after she emailed her 17-year-old boyfriend images of the two of them engaged in sexual activity. She argued she had a right to privacy. But the court disagreed, finding the state had a compelling interest “in protecting children from sexual exploitation,” regardless of “whether the person sexually exploiting the child is an adult or a minor.”
By 2008-2009, about 4,000 cases involving minors sexting were making their way through the courts, demonstrating a “need for laws to evolve and to consider developmental context,” Dr. Sussman said. Punishment could be severe, including requirements for youth to register in the national sex offender registry. Today, however, 25 states have laws differentiating sexting from child pornography.
Child pornography and autistic youth
Teens with autism spectrum disorder might be particularly at higher risk for accessing child pornography and subsequent conviction. Autistic youth’s weaknesses in social skills make it difficult for them to understand the unwritten rules and subjectivity of dating. While their bodies and hormones are changing, their mental age might lag, and their weak interpersonal skills limit their ability to move a relationship in a romantic direction.
Meanwhile, autistic youth might feel more comfortable interacting with others on their computers. Paired with a difficulty in judging others’ age and a limited awareness or understanding of the potential outcomes of their actions, autistic youth can easily fall into a trap of accessing child pornography.
Porn might become a substitute for human interaction, and the accessibility of porn online makes it easy to discover child pornography whose “mere existence implies legality,” Dr. Sussman said. Further, youth are drawn toward images depicting people they personally identify with in terms of their social or emotional age.
Given that pornography typically is not discussed by parents or in sex education, “there have been some cases where people who have autism spectrum disorders have gotten in trouble,” Dr. Sussman said. Autistic youth also might struggle to make the connection between what’s wrong in real life versus what might appear abstract and more acceptable on a computer.
The realities of this special population have several implications courts should consider, Dr. Sussman said. For one, their actions may be misinterpreted as criminal when they might not pose the same level of danger to society as someone else who accesses child pornography. In general, criminal behavior is statistically lower among autistic individuals, but victimization of them is higher than average.
Yet it might be difficult for courts to perceive deficits in individuals with stronger (“high-functioning”) skills in some areas. Courts also should consider how an autistic person might fare in a correctional facility, where inability to understand and adhere to the prison environment’s social structure could prove fatal.
Autistic individuals might be more inclined to report those who break rules and might have an eagerness to please that makes them easily manipulated. Prison staff might misinterpret their behavior, and autistic inmates might be at risk for higher rates of isolation for their own protection.
Dr. Sussman said. Physicians should provide anticipatory guidance when it comes to puberty, sex, romantic interests, and masturbation, she said, and parents can us parental controls.
Youth, especially autistic youth, should be taught the difference between acceptable (“good”) touch, versus unacceptable (“bad”) touch, respect of personal space, and the difference between public and private behavior. Discussions of reality vs. fantasy – especially considering how unrealistic online porn often is – and the definition of consent are also vital preventive strategies.
Dr. Sussman had no conflicts of interest.
AUSTIN, TEX. – It is important to understand the legislative and social lay of the land for child pornography and related issues, such as sexting and revenge porn, according to Nicole Sussman, MD.
Dr. Sussman of Cambridge (Mass.) Health Alliance provided an overview of the history of child pornography legislation before discussing the current landscape and the unique challenges and risks it presents to autistic youth at the annual meeting of the American Academy of Psychiatry and the Law.
History of U.S. child pornography laws
The Protection of Children Against Sexual Exploitation Act, passed in 1977, criminalized the act of forcing a child to engage in sexual activity. But it wasn’t widely cited. Little awareness existed around the issue until New York v. Ferber in 1982, which upheld a New York statute that outlawed distribution of material depicting children under 16 years of age engaged in sexual acts. The U.S. Supreme Court linked child porn to sexual abuse of a child and determined that the only way to control production of child pornography was to regulate distribution of it.
Shortly thereafter, the Child Protection Act of 1984 limited the production, distribution, and possession of “materials involving the sexual exploitation of minors even if the material is not found to be ‘obscene.’ ” The law also raised the age of a minor for the law’s purposes to anyone younger than age 18 years, removed the requirement that the materials be sold (free distribution was now also regulated), and authorized interception of communications to investigate offenses.
Two years later, the Child Sexual Abuse and Pornography Act and the Child Abuse Victims’ Rights Act strengthened child pornography laws; the first made it a federal offense to advertise “any product depicting sexually explicit conduct with a minor or the opportunity to engage in such conduct with a minor.”
More regulation followed with the Child Protection and Obscenity Enforcement Act of 1988, which added regulation of child pornography on computers, and the Child Pornography Prevention Act of 1996, which regulates all forms of online/virtual child pornography.
The first weakening of these laws came with Ashcroft v. Free Speech Coalition in 2002, which held that the 1996 law was overly broad, with the potential to violate free speech, since prohibition of images that “appear to be” or “convey the impression” of child pornography might not necessarily have actually involved child exploitation.
Finally, the Adam Walsh Child Protection and Safety Act of 2006 established the national sex offender registry and mandated convicted offender requirements for reporting their whereabouts based on the “tier” of their crime.
Today’s landscape: Internet use and pornography
With all that legislation as a backdrop, the intersection of growing use of mobile technology, online pornography and sexting can become thorny.
Recent data show that 95% of teens aged 13-17 years have access to a smartphone – independent of their race, sex, ethnicity, or socioeconomic status. Nearly half of teens (45%) report that they are online nearly constantly, Dr. Sussman said.
And pornography is free and easy to find online. A 2006 survey of New Hampshire college students found that 72% of them had seen porn before age 18 years – and that’s decade-old data.
A 2013-2014 survey of 16- and 17-year-olds in Boston found that about half (51%) reported watching porn at least weekly, and 54% watched porn to learn how to do something. Further, 30% of youth in that survey said porn was their primary source of sexual education, followed by parents, cited by 21%.
Put these realities together, and you encounter sexting, the act of sharing “sexually explicit images, videos, or messages through electronic media.” Research on the prevalence of sexting varies widely, with estimates up to 60% of teens. Though prevalence estimates depend on definitions, recent studies suggest that one in four teens send “sexts” and one in seven teens receive them, Dr. Sussman said.
But these figures should be considered alongside an understanding normal sexual development among adolescents. Sexting might simply represent a normal emerging component of sexual development within the context of today’s society, Dr. Sussman said. Sexting often is viewed by youth as a way to initiate and maintain relationships, she said.
Nevertheless, teens might not be able to fully appreciate the risks associated with sending or receiving sexually explicit texts. One in eight teens report being involved in nonconsensual sexting, whether as recipient of an unsolicited sext or as the subject of one.
Sexting also can take the form of “revenge porn” and “sextortion,” in which sexually explicit electronic images are distributed as a form of revenge or are threatened to be distributed.
Early legislation related to sexting has led to litigation, such as the case of 16-year-old A.H., who was charged with producing child pornography after she emailed her 17-year-old boyfriend images of the two of them engaged in sexual activity. She argued she had a right to privacy. But the court disagreed, finding the state had a compelling interest “in protecting children from sexual exploitation,” regardless of “whether the person sexually exploiting the child is an adult or a minor.”
By 2008-2009, about 4,000 cases involving minors sexting were making their way through the courts, demonstrating a “need for laws to evolve and to consider developmental context,” Dr. Sussman said. Punishment could be severe, including requirements for youth to register in the national sex offender registry. Today, however, 25 states have laws differentiating sexting from child pornography.
Child pornography and autistic youth
Teens with autism spectrum disorder might be particularly at higher risk for accessing child pornography and subsequent conviction. Autistic youth’s weaknesses in social skills make it difficult for them to understand the unwritten rules and subjectivity of dating. While their bodies and hormones are changing, their mental age might lag, and their weak interpersonal skills limit their ability to move a relationship in a romantic direction.
Meanwhile, autistic youth might feel more comfortable interacting with others on their computers. Paired with a difficulty in judging others’ age and a limited awareness or understanding of the potential outcomes of their actions, autistic youth can easily fall into a trap of accessing child pornography.
Porn might become a substitute for human interaction, and the accessibility of porn online makes it easy to discover child pornography whose “mere existence implies legality,” Dr. Sussman said. Further, youth are drawn toward images depicting people they personally identify with in terms of their social or emotional age.
Given that pornography typically is not discussed by parents or in sex education, “there have been some cases where people who have autism spectrum disorders have gotten in trouble,” Dr. Sussman said. Autistic youth also might struggle to make the connection between what’s wrong in real life versus what might appear abstract and more acceptable on a computer.
The realities of this special population have several implications courts should consider, Dr. Sussman said. For one, their actions may be misinterpreted as criminal when they might not pose the same level of danger to society as someone else who accesses child pornography. In general, criminal behavior is statistically lower among autistic individuals, but victimization of them is higher than average.
Yet it might be difficult for courts to perceive deficits in individuals with stronger (“high-functioning”) skills in some areas. Courts also should consider how an autistic person might fare in a correctional facility, where inability to understand and adhere to the prison environment’s social structure could prove fatal.
Autistic individuals might be more inclined to report those who break rules and might have an eagerness to please that makes them easily manipulated. Prison staff might misinterpret their behavior, and autistic inmates might be at risk for higher rates of isolation for their own protection.
Dr. Sussman said. Physicians should provide anticipatory guidance when it comes to puberty, sex, romantic interests, and masturbation, she said, and parents can us parental controls.
Youth, especially autistic youth, should be taught the difference between acceptable (“good”) touch, versus unacceptable (“bad”) touch, respect of personal space, and the difference between public and private behavior. Discussions of reality vs. fantasy – especially considering how unrealistic online porn often is – and the definition of consent are also vital preventive strategies.
Dr. Sussman had no conflicts of interest.
REPORTING FROM THE AAPL ANNUAL MEETING
Empowering women through self-managed abortion
Consider Ashley, a 22-year-old G3P2, 8 weeks pregnant, on Medicaid and living in rural Arkansas. The victim of intimate partner violence, she just broke up with her boyfriend and feels she does not have the financial or emotional resources to raise another child; she has no family in town to turn to and wants to be the best parent she can be to her 10-month-old and 3-year old.
In Arkansas, as in many other states and the District of Columbia, Medicaid covers abortion only for rape, incest, or danger to the woman’s life. Arkansas, as well as many other states, requires women to wait 48 hours following counseling before they can proceed with abortion. Waiting periods exacerbate Ashley’s tenuous situation. Will her boss give her time off from work? How will she get to the clinic? Who will watch her children? And lost wages and greater expenses are not the only problems she faces. Arkansas requires a legal contract between the abortion provider and a physician with hospital admitting privileges to provide medical abortion. The result: Only one clinic in Arkansas can legally provide medical abortion for its entire female population. For our impoverished young mother of two, the best choice is the most difficult. And she is far from alone.
Since 2010, many states have passed numerous laws restricting access to safe abortion. As geography plays a growing role in determining access, women and health care providers actively seek ways to circumvent barriers. Telemedicine, initially designed to expedite primary care for patients whose access was hampered by Boston traffic, now brings quality health care to areas lacking providers.1 Telemedicine works for a variety of medical services, from prescribing antibiotics to performing neurosurgery; reproductive health care is part of this digital revolution.2 In 2008, Iowa’s Planned Parenthood of the Heartland began using telemedicine to offer medical abortion.3
As approved by the Food and Drug Administration, medical abortion is the termination of a pregnancy of up to 10 weeks’ gestation using a combination of mifepristone and misoprostol, the former taken to block progesterone receptors, the latter to cause expulsion of the pregnancy. Today, about a third of all abortions in the United States are medical abortions. Because current FDA regulations require that mifepristone be dispensed by a physician, patients usually receive the medications after an in-person evaluation by a health care provider in a clinic.
Two models of telemedicine could improve access for Ashley.
In the first, like the Iowa Planned Parenthood model, remote clinic staff evaluate patients with history and physical examination, ultrasonography, and hemoglobin measurement; the information is forwarded to an off-site physician who has a video discussion with the patient and remotely dispenses the medication for eligible candidates. Between 2008 and 2015, Iowa Planned Parenthood provided 8,765 medical abortions using this model.3 Clinically adverse events, such as hospital admission, surgery, blood transfusion, and death occurred in 16 (0.18%) with no ectopic pregnancies or death.3 For comparison, the rate of severe maternal morbidity in the United States is 1.4%, approximately 10 times the rate with this model of medical abortion.4
In the second model of fully self-managed telemedicine abortion, patients complete a checklist that is reviewed by a provider who sends the medications through the mail. For safety, women must be able to determine their eligibility through the checklist, manage the medications, and self-assess for abortion completion. The World Health Organization endorses self-managed abortion as an option when there is “a source of accurate information and access to a health care provider should they need or want it at any stage of the process.”5 Women on Web, an organization that has provided telemedicine abortion to women globally, has recently begun providing services to the United States after sweeping restrictions vastly increased the number of requests from U.S. women. The U.S. service, Aid Access, operates similarly and for $95 provides online consultation, shipping of the medications, and Skype or phone calls for questions.6
Self-managed abortion has a bad reputation, in part from anti-abortion activists who seek to punish women who attempt to end their pregnancies themselves, but also because of its association with pre–Roe v. Wade “back alley” unsafe abortions. Neither perspective recognizes the benefits of safe self-managed abortion. Some states have criminalized self-induced abortion; both the American College of Obstetricians and Gynecologists and the American Medical Association have voiced opposition to such laws to ensure that women do not fear prosecution for seeking medical care for complications.
Given the landscape of abortion access in the United States, where legal constraints, lack of insurance, and a dearth of providers may create insurmountable barriers, we support self-managed abortion for the following reasons:
- Access barriers: The complexity and number of legal restrictions to abortion care have made it unavailable/unaffordable through traditional clinic visits in many parts of the United States. With the addition of Justice Brett M. Kavanaugh to the Supreme Court, restrictions are likely to increase.
- Safety: The evidence-based assessment of the World Health Organization is that in-person clinical evaluation is unnecessary if the appropriate checklists, educational information, and access to a provider are available.
- Autonomy and equity: Even without the barriers mentioned above, self-managed telemedicine abortion remains a patient-centered option. Often more accessible and less expensive, inherently more private, it is bound to appeal to many women.
This decade has seen unprecedented challenges to comprehensive safe reproductive health care, with no relief in sight. In the decades prior to Roe v. Wade, illegal abortions were responsible for 20% of all maternal mortality in the United States. As government, national medical organizations, and the public become more aware of our intolerably high maternal mortality rate, these actors are increasingly driven to bring our maternal health to parity with our industrialized peers. Restricting access to safe abortion runs counter to that goal. Two hundred forty years of American history teach us that legal restrictions do not prevent abortions, because they do not eliminate the reasons for which women seek abortion. Legal restrictions do, however, prevent women from ending pregnancies in the safest manner possible. The inability to obtain safe abortions invariably leads to dead women – our mothers, daughters, sisters, and wives. In this country’s harsh political climate, we must protect a woman’s right to choose. By advocating for innovative approaches to protect women’s reproductive choices, we empower women and save lives.
Dr. Anwar is an obstetrician/gynecologist at Michigan State University in Flint and Dr. Espey is professor and chair of obstetrics and gynecology at the University of New Mexico, Albuquerque. Neither of them have conflicts of interest. Email them at [email protected].
References
1. “How a ‘Stupid Idea’ Gave Birth to Telemedicine,” MedPageToday. Dec 15, .
2. J Neurosurg Pediatr. 2016 Dec;25(6):753-7.
3. Obstet Gynecol. 2017 Oct;130(4):778-82.
4. Centers for Disease Control and Prevention. Severe Maternal Morbidity in the United States.
5. Guttmacher Rep Public Policy. 2018;21:41-7.
6. “International ‘safe abortions by mail’ service can now ship to women in US,” The Hill, Nov 7, 2018.
Consider Ashley, a 22-year-old G3P2, 8 weeks pregnant, on Medicaid and living in rural Arkansas. The victim of intimate partner violence, she just broke up with her boyfriend and feels she does not have the financial or emotional resources to raise another child; she has no family in town to turn to and wants to be the best parent she can be to her 10-month-old and 3-year old.
In Arkansas, as in many other states and the District of Columbia, Medicaid covers abortion only for rape, incest, or danger to the woman’s life. Arkansas, as well as many other states, requires women to wait 48 hours following counseling before they can proceed with abortion. Waiting periods exacerbate Ashley’s tenuous situation. Will her boss give her time off from work? How will she get to the clinic? Who will watch her children? And lost wages and greater expenses are not the only problems she faces. Arkansas requires a legal contract between the abortion provider and a physician with hospital admitting privileges to provide medical abortion. The result: Only one clinic in Arkansas can legally provide medical abortion for its entire female population. For our impoverished young mother of two, the best choice is the most difficult. And she is far from alone.
Since 2010, many states have passed numerous laws restricting access to safe abortion. As geography plays a growing role in determining access, women and health care providers actively seek ways to circumvent barriers. Telemedicine, initially designed to expedite primary care for patients whose access was hampered by Boston traffic, now brings quality health care to areas lacking providers.1 Telemedicine works for a variety of medical services, from prescribing antibiotics to performing neurosurgery; reproductive health care is part of this digital revolution.2 In 2008, Iowa’s Planned Parenthood of the Heartland began using telemedicine to offer medical abortion.3
As approved by the Food and Drug Administration, medical abortion is the termination of a pregnancy of up to 10 weeks’ gestation using a combination of mifepristone and misoprostol, the former taken to block progesterone receptors, the latter to cause expulsion of the pregnancy. Today, about a third of all abortions in the United States are medical abortions. Because current FDA regulations require that mifepristone be dispensed by a physician, patients usually receive the medications after an in-person evaluation by a health care provider in a clinic.
Two models of telemedicine could improve access for Ashley.
In the first, like the Iowa Planned Parenthood model, remote clinic staff evaluate patients with history and physical examination, ultrasonography, and hemoglobin measurement; the information is forwarded to an off-site physician who has a video discussion with the patient and remotely dispenses the medication for eligible candidates. Between 2008 and 2015, Iowa Planned Parenthood provided 8,765 medical abortions using this model.3 Clinically adverse events, such as hospital admission, surgery, blood transfusion, and death occurred in 16 (0.18%) with no ectopic pregnancies or death.3 For comparison, the rate of severe maternal morbidity in the United States is 1.4%, approximately 10 times the rate with this model of medical abortion.4
In the second model of fully self-managed telemedicine abortion, patients complete a checklist that is reviewed by a provider who sends the medications through the mail. For safety, women must be able to determine their eligibility through the checklist, manage the medications, and self-assess for abortion completion. The World Health Organization endorses self-managed abortion as an option when there is “a source of accurate information and access to a health care provider should they need or want it at any stage of the process.”5 Women on Web, an organization that has provided telemedicine abortion to women globally, has recently begun providing services to the United States after sweeping restrictions vastly increased the number of requests from U.S. women. The U.S. service, Aid Access, operates similarly and for $95 provides online consultation, shipping of the medications, and Skype or phone calls for questions.6
Self-managed abortion has a bad reputation, in part from anti-abortion activists who seek to punish women who attempt to end their pregnancies themselves, but also because of its association with pre–Roe v. Wade “back alley” unsafe abortions. Neither perspective recognizes the benefits of safe self-managed abortion. Some states have criminalized self-induced abortion; both the American College of Obstetricians and Gynecologists and the American Medical Association have voiced opposition to such laws to ensure that women do not fear prosecution for seeking medical care for complications.
Given the landscape of abortion access in the United States, where legal constraints, lack of insurance, and a dearth of providers may create insurmountable barriers, we support self-managed abortion for the following reasons:
- Access barriers: The complexity and number of legal restrictions to abortion care have made it unavailable/unaffordable through traditional clinic visits in many parts of the United States. With the addition of Justice Brett M. Kavanaugh to the Supreme Court, restrictions are likely to increase.
- Safety: The evidence-based assessment of the World Health Organization is that in-person clinical evaluation is unnecessary if the appropriate checklists, educational information, and access to a provider are available.
- Autonomy and equity: Even without the barriers mentioned above, self-managed telemedicine abortion remains a patient-centered option. Often more accessible and less expensive, inherently more private, it is bound to appeal to many women.
This decade has seen unprecedented challenges to comprehensive safe reproductive health care, with no relief in sight. In the decades prior to Roe v. Wade, illegal abortions were responsible for 20% of all maternal mortality in the United States. As government, national medical organizations, and the public become more aware of our intolerably high maternal mortality rate, these actors are increasingly driven to bring our maternal health to parity with our industrialized peers. Restricting access to safe abortion runs counter to that goal. Two hundred forty years of American history teach us that legal restrictions do not prevent abortions, because they do not eliminate the reasons for which women seek abortion. Legal restrictions do, however, prevent women from ending pregnancies in the safest manner possible. The inability to obtain safe abortions invariably leads to dead women – our mothers, daughters, sisters, and wives. In this country’s harsh political climate, we must protect a woman’s right to choose. By advocating for innovative approaches to protect women’s reproductive choices, we empower women and save lives.
Dr. Anwar is an obstetrician/gynecologist at Michigan State University in Flint and Dr. Espey is professor and chair of obstetrics and gynecology at the University of New Mexico, Albuquerque. Neither of them have conflicts of interest. Email them at [email protected].
References
1. “How a ‘Stupid Idea’ Gave Birth to Telemedicine,” MedPageToday. Dec 15, .
2. J Neurosurg Pediatr. 2016 Dec;25(6):753-7.
3. Obstet Gynecol. 2017 Oct;130(4):778-82.
4. Centers for Disease Control and Prevention. Severe Maternal Morbidity in the United States.
5. Guttmacher Rep Public Policy. 2018;21:41-7.
6. “International ‘safe abortions by mail’ service can now ship to women in US,” The Hill, Nov 7, 2018.
Consider Ashley, a 22-year-old G3P2, 8 weeks pregnant, on Medicaid and living in rural Arkansas. The victim of intimate partner violence, she just broke up with her boyfriend and feels she does not have the financial or emotional resources to raise another child; she has no family in town to turn to and wants to be the best parent she can be to her 10-month-old and 3-year old.
In Arkansas, as in many other states and the District of Columbia, Medicaid covers abortion only for rape, incest, or danger to the woman’s life. Arkansas, as well as many other states, requires women to wait 48 hours following counseling before they can proceed with abortion. Waiting periods exacerbate Ashley’s tenuous situation. Will her boss give her time off from work? How will she get to the clinic? Who will watch her children? And lost wages and greater expenses are not the only problems she faces. Arkansas requires a legal contract between the abortion provider and a physician with hospital admitting privileges to provide medical abortion. The result: Only one clinic in Arkansas can legally provide medical abortion for its entire female population. For our impoverished young mother of two, the best choice is the most difficult. And she is far from alone.
Since 2010, many states have passed numerous laws restricting access to safe abortion. As geography plays a growing role in determining access, women and health care providers actively seek ways to circumvent barriers. Telemedicine, initially designed to expedite primary care for patients whose access was hampered by Boston traffic, now brings quality health care to areas lacking providers.1 Telemedicine works for a variety of medical services, from prescribing antibiotics to performing neurosurgery; reproductive health care is part of this digital revolution.2 In 2008, Iowa’s Planned Parenthood of the Heartland began using telemedicine to offer medical abortion.3
As approved by the Food and Drug Administration, medical abortion is the termination of a pregnancy of up to 10 weeks’ gestation using a combination of mifepristone and misoprostol, the former taken to block progesterone receptors, the latter to cause expulsion of the pregnancy. Today, about a third of all abortions in the United States are medical abortions. Because current FDA regulations require that mifepristone be dispensed by a physician, patients usually receive the medications after an in-person evaluation by a health care provider in a clinic.
Two models of telemedicine could improve access for Ashley.
In the first, like the Iowa Planned Parenthood model, remote clinic staff evaluate patients with history and physical examination, ultrasonography, and hemoglobin measurement; the information is forwarded to an off-site physician who has a video discussion with the patient and remotely dispenses the medication for eligible candidates. Between 2008 and 2015, Iowa Planned Parenthood provided 8,765 medical abortions using this model.3 Clinically adverse events, such as hospital admission, surgery, blood transfusion, and death occurred in 16 (0.18%) with no ectopic pregnancies or death.3 For comparison, the rate of severe maternal morbidity in the United States is 1.4%, approximately 10 times the rate with this model of medical abortion.4
In the second model of fully self-managed telemedicine abortion, patients complete a checklist that is reviewed by a provider who sends the medications through the mail. For safety, women must be able to determine their eligibility through the checklist, manage the medications, and self-assess for abortion completion. The World Health Organization endorses self-managed abortion as an option when there is “a source of accurate information and access to a health care provider should they need or want it at any stage of the process.”5 Women on Web, an organization that has provided telemedicine abortion to women globally, has recently begun providing services to the United States after sweeping restrictions vastly increased the number of requests from U.S. women. The U.S. service, Aid Access, operates similarly and for $95 provides online consultation, shipping of the medications, and Skype or phone calls for questions.6
Self-managed abortion has a bad reputation, in part from anti-abortion activists who seek to punish women who attempt to end their pregnancies themselves, but also because of its association with pre–Roe v. Wade “back alley” unsafe abortions. Neither perspective recognizes the benefits of safe self-managed abortion. Some states have criminalized self-induced abortion; both the American College of Obstetricians and Gynecologists and the American Medical Association have voiced opposition to such laws to ensure that women do not fear prosecution for seeking medical care for complications.
Given the landscape of abortion access in the United States, where legal constraints, lack of insurance, and a dearth of providers may create insurmountable barriers, we support self-managed abortion for the following reasons:
- Access barriers: The complexity and number of legal restrictions to abortion care have made it unavailable/unaffordable through traditional clinic visits in many parts of the United States. With the addition of Justice Brett M. Kavanaugh to the Supreme Court, restrictions are likely to increase.
- Safety: The evidence-based assessment of the World Health Organization is that in-person clinical evaluation is unnecessary if the appropriate checklists, educational information, and access to a provider are available.
- Autonomy and equity: Even without the barriers mentioned above, self-managed telemedicine abortion remains a patient-centered option. Often more accessible and less expensive, inherently more private, it is bound to appeal to many women.
This decade has seen unprecedented challenges to comprehensive safe reproductive health care, with no relief in sight. In the decades prior to Roe v. Wade, illegal abortions were responsible for 20% of all maternal mortality in the United States. As government, national medical organizations, and the public become more aware of our intolerably high maternal mortality rate, these actors are increasingly driven to bring our maternal health to parity with our industrialized peers. Restricting access to safe abortion runs counter to that goal. Two hundred forty years of American history teach us that legal restrictions do not prevent abortions, because they do not eliminate the reasons for which women seek abortion. Legal restrictions do, however, prevent women from ending pregnancies in the safest manner possible. The inability to obtain safe abortions invariably leads to dead women – our mothers, daughters, sisters, and wives. In this country’s harsh political climate, we must protect a woman’s right to choose. By advocating for innovative approaches to protect women’s reproductive choices, we empower women and save lives.
Dr. Anwar is an obstetrician/gynecologist at Michigan State University in Flint and Dr. Espey is professor and chair of obstetrics and gynecology at the University of New Mexico, Albuquerque. Neither of them have conflicts of interest. Email them at [email protected].
References
1. “How a ‘Stupid Idea’ Gave Birth to Telemedicine,” MedPageToday. Dec 15, .
2. J Neurosurg Pediatr. 2016 Dec;25(6):753-7.
3. Obstet Gynecol. 2017 Oct;130(4):778-82.
4. Centers for Disease Control and Prevention. Severe Maternal Morbidity in the United States.
5. Guttmacher Rep Public Policy. 2018;21:41-7.
6. “International ‘safe abortions by mail’ service can now ship to women in US,” The Hill, Nov 7, 2018.
RAS inhibitors improve outcomes in TAVR patients
After transcatheter aortic valve replacement (TAVR), treatment with a renin-angiotensin system (RAS) inhibitor at hospital discharge is associated with lower risk of mortality and heart failure–related readmission, according to an analysis of Medicare patients.
RAS inhibitors may reverse left ventricular remodeling and improve function, which could explain the association, noted lead investigator Taku Inohara, MD.
The researchers analyzed data from consecutive Medicare patients who underwent TAVR, drawn from the Society of Thoracic Surgeons/American College of Cardiology TVT Registry. They included 15,896 propensity-matched patients from 417 U.S. centers.
At 1 year, a RAS inhibitor prescription at discharge was linked to a statistically significant relative 18% reduction in all-cause mortality (12.5% vs. 14.9%) and a 16% drop in heart failure readmissions (12.0% vs. 13.8%).
The researchers conducted a propensity-scored analysis of 12,942 patients with preserved left ventricular ejection fraction (greater than 40%) and 2,954 with LVEF up to 40%. In the preserved LVEF group, RAS inhibitor prescription was associated with a significant 22% reduction in mortality (11.1% vs. 13.9%), but there was no statistically significant association in patients with reduced LVEF (18.8% vs. 19.5%).
There was no clinically meaningful difference in quality of life between those who received a RAS inhibitor and those who did not, but the subgroup analysis could be performed on only 30% of the overall cohort, Dr. Inohara and his colleagues at the Duke Clinical Research Center in Durham, N.C., wrote.
They added that most patients undergoing TAVR are eligible for RAS inhibitors because of frequently comorbid hypertension, coronary artery disease, and renal dysfunction.
The study was funded by the American College of Cardiology Foundation’s National Cardiovascular Data Registry and the Society of Thoracic Surgeons. Study authors have wide-ranging financial relationships with pharmaceutical companies.
SOURCE: Inohara T et al. JAMA. 2018 Dec 4;320(21):2231-41.
After transcatheter aortic valve replacement (TAVR), treatment with a renin-angiotensin system (RAS) inhibitor at hospital discharge is associated with lower risk of mortality and heart failure–related readmission, according to an analysis of Medicare patients.
RAS inhibitors may reverse left ventricular remodeling and improve function, which could explain the association, noted lead investigator Taku Inohara, MD.
The researchers analyzed data from consecutive Medicare patients who underwent TAVR, drawn from the Society of Thoracic Surgeons/American College of Cardiology TVT Registry. They included 15,896 propensity-matched patients from 417 U.S. centers.
At 1 year, a RAS inhibitor prescription at discharge was linked to a statistically significant relative 18% reduction in all-cause mortality (12.5% vs. 14.9%) and a 16% drop in heart failure readmissions (12.0% vs. 13.8%).
The researchers conducted a propensity-scored analysis of 12,942 patients with preserved left ventricular ejection fraction (greater than 40%) and 2,954 with LVEF up to 40%. In the preserved LVEF group, RAS inhibitor prescription was associated with a significant 22% reduction in mortality (11.1% vs. 13.9%), but there was no statistically significant association in patients with reduced LVEF (18.8% vs. 19.5%).
There was no clinically meaningful difference in quality of life between those who received a RAS inhibitor and those who did not, but the subgroup analysis could be performed on only 30% of the overall cohort, Dr. Inohara and his colleagues at the Duke Clinical Research Center in Durham, N.C., wrote.
They added that most patients undergoing TAVR are eligible for RAS inhibitors because of frequently comorbid hypertension, coronary artery disease, and renal dysfunction.
The study was funded by the American College of Cardiology Foundation’s National Cardiovascular Data Registry and the Society of Thoracic Surgeons. Study authors have wide-ranging financial relationships with pharmaceutical companies.
SOURCE: Inohara T et al. JAMA. 2018 Dec 4;320(21):2231-41.
After transcatheter aortic valve replacement (TAVR), treatment with a renin-angiotensin system (RAS) inhibitor at hospital discharge is associated with lower risk of mortality and heart failure–related readmission, according to an analysis of Medicare patients.
RAS inhibitors may reverse left ventricular remodeling and improve function, which could explain the association, noted lead investigator Taku Inohara, MD.
The researchers analyzed data from consecutive Medicare patients who underwent TAVR, drawn from the Society of Thoracic Surgeons/American College of Cardiology TVT Registry. They included 15,896 propensity-matched patients from 417 U.S. centers.
At 1 year, a RAS inhibitor prescription at discharge was linked to a statistically significant relative 18% reduction in all-cause mortality (12.5% vs. 14.9%) and a 16% drop in heart failure readmissions (12.0% vs. 13.8%).
The researchers conducted a propensity-scored analysis of 12,942 patients with preserved left ventricular ejection fraction (greater than 40%) and 2,954 with LVEF up to 40%. In the preserved LVEF group, RAS inhibitor prescription was associated with a significant 22% reduction in mortality (11.1% vs. 13.9%), but there was no statistically significant association in patients with reduced LVEF (18.8% vs. 19.5%).
There was no clinically meaningful difference in quality of life between those who received a RAS inhibitor and those who did not, but the subgroup analysis could be performed on only 30% of the overall cohort, Dr. Inohara and his colleagues at the Duke Clinical Research Center in Durham, N.C., wrote.
They added that most patients undergoing TAVR are eligible for RAS inhibitors because of frequently comorbid hypertension, coronary artery disease, and renal dysfunction.
The study was funded by the American College of Cardiology Foundation’s National Cardiovascular Data Registry and the Society of Thoracic Surgeons. Study authors have wide-ranging financial relationships with pharmaceutical companies.
SOURCE: Inohara T et al. JAMA. 2018 Dec 4;320(21):2231-41.
REPORTING FROM JAMA
Key clinical point:
Major finding: Treatment was linked to reductions in 1-year mortality and heart failure of 18% and 16%, respectively.
Study details: Propensity matched, retrospective analysis of 15,896 Medicare patients.
Disclosures: The study was funded by the American College of Cardiology Foundation’s National Cardiovascular Data Registry and the Society of Thoracic Surgeons. Study authors have wide-ranging financial relationships with pharmaceutical companies.
Source: Inohara T et al. JAMA. 2018 Dec 4;320(21):2231-41.
Comorbid TBI & PTSD raise the risk for sleep disturbances, pain
Veterans living with comorbid traumatic brain injury (TBI) and posttraumatic stress disorder were at increased risk for worse pain and sleep disturbances, reported Nadir M. Balba and colleagues at the VA Portland (Ore.) Health Care System.
The authors conducted a retrospective review of medical records at the VA Portland Health Care System (VAPORHCS) that evaluated 639 veterans who were referred to the VAPORHCS Sleep Disorders Clinic between May 2015 and November 2016. They wrote, “The purpose of this study was to determine whether Veterans with comorbid TBI and PTSD exhibit a higher prevalence of sleep disturbances (determined via self-report and objective polysomnography) and pain compared to Veterans with only TBI or PTSD.”
Patients were recruited to participate in the cross-sectional study, which included participation in an overnight sleep clinic as well as patient self-reported sleep quality, pain, and TBI and PTSD symptom severity. Sleep disturbances included insomnia, nightmares, sleep fragmentation, obstructive sleep apnea, and parasomnias. The survey tools used in the study included the Rivermead Post Concussion Questionnaire (RPCQ), the PTSD Checklist DSM-5 (PSTD-5), the Insomnia Severity Index (ISI), and the Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10). Sleep studies were recorded using Polysmith version 9.0 and sleep staging was performed by a certified sleep technician and verified by a board-certified sleep medicine physician.
Patients were grouped into one of four trauma exposure classifications based on their prior history of trauma, including neither (n = 383), TBI (n = 67), PTSD (n = 126), and TBI+PTSD (n = 63).
Self-reported sleep disturbance, which was the worst among those with PTSD and those with comorbid TBI and PTSD, indicated that PTSD plays a more significant role in the occurrence of disturbed sleep than TBI, the researchers noted. “Participants in the TBI+PTSD and PTSD groups had significantly worse ISI scores (i.e., higher scores) compared to both the TBI and neither groups (P less than .001). Furthermore, participants in the TBI+PTSD and PTSD groups had significantly worse FOSQ-10 scores (ie, lower scores) compared to both the TBI and neither groups (P less than .001),” they wrote.
In terms of pain, patients with comorbid TBI and PTSD reported the greatest severity of pain, including more frequent headaches and worse photo and phono sensitivities. The TBI and PTSD groups, however, both scored significantly higher in their pain reports than those in the neither group, which suggests “that each of these conditions independently contributes to increased pain,” the authors observed. Ultimately, they cited multiple linear regression models, which attributed sleep disturbances and TBI symptom severity as the primary contributors to pain presentation.
“It is well established that sleep disturbances and pain are inextricably linked,” they said. The results of this study serve to validate that connection “but also suggest this link may be even stronger in those with comorbid TBI and PTSD,” they added.
The researchers cited self-report data as a possible study limitation. They also conceded that comorbid depression and substance use disorder could both play a role in further exacerbating sleep disturbance and pain.
Future research should evaluate how TBI and PTSD, along with other unidentified comorbid conditions, may work together in exacerbating symptoms so that more effective treatment interventions can be developed to address sleep and pain disturbance following multiple traumas.
The authors had no relevant financial disclosures to report.
SOURCE: Balba N et al. J Clin Sleep Med. 2018;14(11):1865-78.
Veterans living with comorbid traumatic brain injury (TBI) and posttraumatic stress disorder were at increased risk for worse pain and sleep disturbances, reported Nadir M. Balba and colleagues at the VA Portland (Ore.) Health Care System.
The authors conducted a retrospective review of medical records at the VA Portland Health Care System (VAPORHCS) that evaluated 639 veterans who were referred to the VAPORHCS Sleep Disorders Clinic between May 2015 and November 2016. They wrote, “The purpose of this study was to determine whether Veterans with comorbid TBI and PTSD exhibit a higher prevalence of sleep disturbances (determined via self-report and objective polysomnography) and pain compared to Veterans with only TBI or PTSD.”
Patients were recruited to participate in the cross-sectional study, which included participation in an overnight sleep clinic as well as patient self-reported sleep quality, pain, and TBI and PTSD symptom severity. Sleep disturbances included insomnia, nightmares, sleep fragmentation, obstructive sleep apnea, and parasomnias. The survey tools used in the study included the Rivermead Post Concussion Questionnaire (RPCQ), the PTSD Checklist DSM-5 (PSTD-5), the Insomnia Severity Index (ISI), and the Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10). Sleep studies were recorded using Polysmith version 9.0 and sleep staging was performed by a certified sleep technician and verified by a board-certified sleep medicine physician.
Patients were grouped into one of four trauma exposure classifications based on their prior history of trauma, including neither (n = 383), TBI (n = 67), PTSD (n = 126), and TBI+PTSD (n = 63).
Self-reported sleep disturbance, which was the worst among those with PTSD and those with comorbid TBI and PTSD, indicated that PTSD plays a more significant role in the occurrence of disturbed sleep than TBI, the researchers noted. “Participants in the TBI+PTSD and PTSD groups had significantly worse ISI scores (i.e., higher scores) compared to both the TBI and neither groups (P less than .001). Furthermore, participants in the TBI+PTSD and PTSD groups had significantly worse FOSQ-10 scores (ie, lower scores) compared to both the TBI and neither groups (P less than .001),” they wrote.
In terms of pain, patients with comorbid TBI and PTSD reported the greatest severity of pain, including more frequent headaches and worse photo and phono sensitivities. The TBI and PTSD groups, however, both scored significantly higher in their pain reports than those in the neither group, which suggests “that each of these conditions independently contributes to increased pain,” the authors observed. Ultimately, they cited multiple linear regression models, which attributed sleep disturbances and TBI symptom severity as the primary contributors to pain presentation.
“It is well established that sleep disturbances and pain are inextricably linked,” they said. The results of this study serve to validate that connection “but also suggest this link may be even stronger in those with comorbid TBI and PTSD,” they added.
The researchers cited self-report data as a possible study limitation. They also conceded that comorbid depression and substance use disorder could both play a role in further exacerbating sleep disturbance and pain.
Future research should evaluate how TBI and PTSD, along with other unidentified comorbid conditions, may work together in exacerbating symptoms so that more effective treatment interventions can be developed to address sleep and pain disturbance following multiple traumas.
The authors had no relevant financial disclosures to report.
SOURCE: Balba N et al. J Clin Sleep Med. 2018;14(11):1865-78.
Veterans living with comorbid traumatic brain injury (TBI) and posttraumatic stress disorder were at increased risk for worse pain and sleep disturbances, reported Nadir M. Balba and colleagues at the VA Portland (Ore.) Health Care System.
The authors conducted a retrospective review of medical records at the VA Portland Health Care System (VAPORHCS) that evaluated 639 veterans who were referred to the VAPORHCS Sleep Disorders Clinic between May 2015 and November 2016. They wrote, “The purpose of this study was to determine whether Veterans with comorbid TBI and PTSD exhibit a higher prevalence of sleep disturbances (determined via self-report and objective polysomnography) and pain compared to Veterans with only TBI or PTSD.”
Patients were recruited to participate in the cross-sectional study, which included participation in an overnight sleep clinic as well as patient self-reported sleep quality, pain, and TBI and PTSD symptom severity. Sleep disturbances included insomnia, nightmares, sleep fragmentation, obstructive sleep apnea, and parasomnias. The survey tools used in the study included the Rivermead Post Concussion Questionnaire (RPCQ), the PTSD Checklist DSM-5 (PSTD-5), the Insomnia Severity Index (ISI), and the Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10). Sleep studies were recorded using Polysmith version 9.0 and sleep staging was performed by a certified sleep technician and verified by a board-certified sleep medicine physician.
Patients were grouped into one of four trauma exposure classifications based on their prior history of trauma, including neither (n = 383), TBI (n = 67), PTSD (n = 126), and TBI+PTSD (n = 63).
Self-reported sleep disturbance, which was the worst among those with PTSD and those with comorbid TBI and PTSD, indicated that PTSD plays a more significant role in the occurrence of disturbed sleep than TBI, the researchers noted. “Participants in the TBI+PTSD and PTSD groups had significantly worse ISI scores (i.e., higher scores) compared to both the TBI and neither groups (P less than .001). Furthermore, participants in the TBI+PTSD and PTSD groups had significantly worse FOSQ-10 scores (ie, lower scores) compared to both the TBI and neither groups (P less than .001),” they wrote.
In terms of pain, patients with comorbid TBI and PTSD reported the greatest severity of pain, including more frequent headaches and worse photo and phono sensitivities. The TBI and PTSD groups, however, both scored significantly higher in their pain reports than those in the neither group, which suggests “that each of these conditions independently contributes to increased pain,” the authors observed. Ultimately, they cited multiple linear regression models, which attributed sleep disturbances and TBI symptom severity as the primary contributors to pain presentation.
“It is well established that sleep disturbances and pain are inextricably linked,” they said. The results of this study serve to validate that connection “but also suggest this link may be even stronger in those with comorbid TBI and PTSD,” they added.
The researchers cited self-report data as a possible study limitation. They also conceded that comorbid depression and substance use disorder could both play a role in further exacerbating sleep disturbance and pain.
Future research should evaluate how TBI and PTSD, along with other unidentified comorbid conditions, may work together in exacerbating symptoms so that more effective treatment interventions can be developed to address sleep and pain disturbance following multiple traumas.
The authors had no relevant financial disclosures to report.
SOURCE: Balba N et al. J Clin Sleep Med. 2018;14(11):1865-78.
FROM THE JOURNAL OF CLINICAL SLEEP MEDICINE
Key clinical point: The combination of traumatic brain injury and posttraumatic stress disorder is linked to a higher risk for sleep disturbances, pain, and light and noise sensitivities.
Major finding: Participants with comorbid TBI and PTSD and PTSD only had higher Insomnia Severity Index scores than those with TBI only or neither condition (P less than .001).
Study details: Retrospective medical record review.
Disclosures: The authors noted no relevant financial disclosures.
Source: Balba N et al. J Clin Sleep Med. 2018;14(11):1865-78.
Hepatitis C debrief: Therapy has matured, access issues remain
SAN FRANCISCO – Hepatitis C therapy has matured and now offers excellent sustained viral response (SVR) in the vast majority of cases, but key challenges remain in getting the therapy to those who need it.
“Unfortunately, we’re not making some of the progress we might have hoped to see, particularly in North America,” said Jordan Feld, MD, MPH, who gave a debrief of hepatitis C abstracts during a wrap-up session at the annual meeting of the American Association for the Study of Liver Diseases.
The problem is particularly acute in young adults aged 18-39 years – only about 9% of those who tested positive for HCV RNA saw a specialist, and about 23% of those who saw a specialist went on to receive treatment, according to an analysis of over 17 million patients in the United States (abstract 1567). The numbers were better for older adults but still far from optimal, with 23% who tested positive seeing a specialist, and just 32% of those patients getting treatment.
Another study (abstract 0147) looked state by state at the percentage of Medicaid patients who received a prescription for direct-acting antiviral (DAA) medication and then went on to fill the prescription. The rates ranged from 0% in Alaska to 96% in Connecticut. Eight states were higher than 70%, six were between 50% and 70%, and 15 states were below 50%.
“Despite our efforts, there continue to be major access barriers across the U.S., particularly for Medicaid individuals,” said Dr. Feld, who is a clinician-scientist at the Toronto Western Hospital Liver Clinic and the McLaughlin-Rotman Centre for Global Health.
A study examining the Chronic Hepatitis (CHeCS) cohort (abstract 0585) described a big spike in treatment uptake shortly after approvals of the new HCV regimens, but by 2016, only about one-third of individuals who required treatment actually began treatment. Factors associated with nontreatment largely reflected marginalization, including low income, being on Medicaid, and lack of long-term follow-up.
Even as health systems struggle to get treatment to those who need it, new studies are showing how to expand existing treatments into new populations.
Results from the EXPEDITION 8 study (abstract LB-7) showed efficacy of an 8-week regimen of the glecaprevir/pibrentasvir combination in patients with compensated cirrhosis. It looked at genotypes 1, 2, and 4-6. In an intention-to-treat analysis, 98% attained SVR and there were no viral failures or safety concerns. A follow-up trial is ongoing that includes patients with genotype 3. “This is exciting to be able to shorten therapy in patients with cirrhosis,” said Dr. Feld.
Although first-line DAAs are extremely effective, there are a few patients who do not achieve a cure. One study (abstract 0227) examined the combination of sofosbuvir, velpatasvir, and voxilaprevir in retreatment of these patients. The drugs resulted in SVR rates similar to those in registration trials, but the regimen was somewhat less effective in patients previously treated with sofosbuvir and velpatasvir. “I think we need to investigate that further,” said Dr. Feld.
The combination of glecaprevir and pibrentasvir also proved effective for retreatment in patients with genotype 1/1A who had failed treatment with an NS5A inhibitor plus sofosbuvir with or without ribavirin (abstract 226). SVR rates at 16 weeks were quite good, but lower in genotype 1a patients at 12 weeks (87% week 12 versus 94% week 16).”I think this is a really good regimen for genotype 1b. For 1a, serum definitely needs 16 weeks [to clear],” said Dr. Feld.
Other abstracts presented at the meeting detailed some of the benefits of SVR, not all of which are broadly appreciated. An analysis of the Hepatitis Testers Cohort in British Columbia (abstract 145), which includes over 7,000 patients who were followed for a median of 2 years (DAA) or 9.5 years (interferon-based), showed survival advantages to SVR in both cirrhotic (adjusted hazard ratio, 0.14) and noncirrhotic patients (aHR, 0.13). Other benefits include lower risk of diabetes (aHR, 0.53), chronic kidney disease/endstage renal disease (aHR, 0.48), stroke (aHR, 0.67), and mood and anxiety disorders (aHR, 0.53) (abstract 148).
As is generally accepted, SVR reduces the risk of hepatocellular cancer (HCC), according to analyses of VA and Gilead data (abstract 635), with a benefit in both cirrhotic and noncirrhotic patients. The risk almost disappears in patients without cirrhosis (incidence rate 0.07 per 100 person-years and is curbed in cirrhotic patients (incidence rate 1.30 in compensated, 4.05 in decompensated cirrhosis).
“There is really very significantly high incidence in cancer in decompensated cirrhosis, which just highlights that these patients continue to need ongoing surveillance. Although there have been efforts at developing strategies to risk stratify patients with cirrhosis, at least for now we’re stuck with surveillance, but I think for patients without cirrhosis there are now enough data showing a low enough incidence of primary HCC that we can probably avoid surveillance in that group,” said Dr. Feld.
Injectable drug users represent a special challenge in hepatitis C treatment, but new studies show cause for optimism in this population. These patients are harder to reach, and they may be less medication compliant, but one study (abstract 1632) found that imperfect adherence doesn’t necessarily undermine results – in a 12-week regimen, patients who didn’t finish until 14 weeks had no significant difference in SVR rates.
“So these therapies have a bit of forgiveness. We probably shouldn’t tell that to the patients, but it’s reassuring that we can use these therapies even in tough-to-reach populations,” said Dr. Feld.
SAN FRANCISCO – Hepatitis C therapy has matured and now offers excellent sustained viral response (SVR) in the vast majority of cases, but key challenges remain in getting the therapy to those who need it.
“Unfortunately, we’re not making some of the progress we might have hoped to see, particularly in North America,” said Jordan Feld, MD, MPH, who gave a debrief of hepatitis C abstracts during a wrap-up session at the annual meeting of the American Association for the Study of Liver Diseases.
The problem is particularly acute in young adults aged 18-39 years – only about 9% of those who tested positive for HCV RNA saw a specialist, and about 23% of those who saw a specialist went on to receive treatment, according to an analysis of over 17 million patients in the United States (abstract 1567). The numbers were better for older adults but still far from optimal, with 23% who tested positive seeing a specialist, and just 32% of those patients getting treatment.
Another study (abstract 0147) looked state by state at the percentage of Medicaid patients who received a prescription for direct-acting antiviral (DAA) medication and then went on to fill the prescription. The rates ranged from 0% in Alaska to 96% in Connecticut. Eight states were higher than 70%, six were between 50% and 70%, and 15 states were below 50%.
“Despite our efforts, there continue to be major access barriers across the U.S., particularly for Medicaid individuals,” said Dr. Feld, who is a clinician-scientist at the Toronto Western Hospital Liver Clinic and the McLaughlin-Rotman Centre for Global Health.
A study examining the Chronic Hepatitis (CHeCS) cohort (abstract 0585) described a big spike in treatment uptake shortly after approvals of the new HCV regimens, but by 2016, only about one-third of individuals who required treatment actually began treatment. Factors associated with nontreatment largely reflected marginalization, including low income, being on Medicaid, and lack of long-term follow-up.
Even as health systems struggle to get treatment to those who need it, new studies are showing how to expand existing treatments into new populations.
Results from the EXPEDITION 8 study (abstract LB-7) showed efficacy of an 8-week regimen of the glecaprevir/pibrentasvir combination in patients with compensated cirrhosis. It looked at genotypes 1, 2, and 4-6. In an intention-to-treat analysis, 98% attained SVR and there were no viral failures or safety concerns. A follow-up trial is ongoing that includes patients with genotype 3. “This is exciting to be able to shorten therapy in patients with cirrhosis,” said Dr. Feld.
Although first-line DAAs are extremely effective, there are a few patients who do not achieve a cure. One study (abstract 0227) examined the combination of sofosbuvir, velpatasvir, and voxilaprevir in retreatment of these patients. The drugs resulted in SVR rates similar to those in registration trials, but the regimen was somewhat less effective in patients previously treated with sofosbuvir and velpatasvir. “I think we need to investigate that further,” said Dr. Feld.
The combination of glecaprevir and pibrentasvir also proved effective for retreatment in patients with genotype 1/1A who had failed treatment with an NS5A inhibitor plus sofosbuvir with or without ribavirin (abstract 226). SVR rates at 16 weeks were quite good, but lower in genotype 1a patients at 12 weeks (87% week 12 versus 94% week 16).”I think this is a really good regimen for genotype 1b. For 1a, serum definitely needs 16 weeks [to clear],” said Dr. Feld.
Other abstracts presented at the meeting detailed some of the benefits of SVR, not all of which are broadly appreciated. An analysis of the Hepatitis Testers Cohort in British Columbia (abstract 145), which includes over 7,000 patients who were followed for a median of 2 years (DAA) or 9.5 years (interferon-based), showed survival advantages to SVR in both cirrhotic (adjusted hazard ratio, 0.14) and noncirrhotic patients (aHR, 0.13). Other benefits include lower risk of diabetes (aHR, 0.53), chronic kidney disease/endstage renal disease (aHR, 0.48), stroke (aHR, 0.67), and mood and anxiety disorders (aHR, 0.53) (abstract 148).
As is generally accepted, SVR reduces the risk of hepatocellular cancer (HCC), according to analyses of VA and Gilead data (abstract 635), with a benefit in both cirrhotic and noncirrhotic patients. The risk almost disappears in patients without cirrhosis (incidence rate 0.07 per 100 person-years and is curbed in cirrhotic patients (incidence rate 1.30 in compensated, 4.05 in decompensated cirrhosis).
“There is really very significantly high incidence in cancer in decompensated cirrhosis, which just highlights that these patients continue to need ongoing surveillance. Although there have been efforts at developing strategies to risk stratify patients with cirrhosis, at least for now we’re stuck with surveillance, but I think for patients without cirrhosis there are now enough data showing a low enough incidence of primary HCC that we can probably avoid surveillance in that group,” said Dr. Feld.
Injectable drug users represent a special challenge in hepatitis C treatment, but new studies show cause for optimism in this population. These patients are harder to reach, and they may be less medication compliant, but one study (abstract 1632) found that imperfect adherence doesn’t necessarily undermine results – in a 12-week regimen, patients who didn’t finish until 14 weeks had no significant difference in SVR rates.
“So these therapies have a bit of forgiveness. We probably shouldn’t tell that to the patients, but it’s reassuring that we can use these therapies even in tough-to-reach populations,” said Dr. Feld.
SAN FRANCISCO – Hepatitis C therapy has matured and now offers excellent sustained viral response (SVR) in the vast majority of cases, but key challenges remain in getting the therapy to those who need it.
“Unfortunately, we’re not making some of the progress we might have hoped to see, particularly in North America,” said Jordan Feld, MD, MPH, who gave a debrief of hepatitis C abstracts during a wrap-up session at the annual meeting of the American Association for the Study of Liver Diseases.
The problem is particularly acute in young adults aged 18-39 years – only about 9% of those who tested positive for HCV RNA saw a specialist, and about 23% of those who saw a specialist went on to receive treatment, according to an analysis of over 17 million patients in the United States (abstract 1567). The numbers were better for older adults but still far from optimal, with 23% who tested positive seeing a specialist, and just 32% of those patients getting treatment.
Another study (abstract 0147) looked state by state at the percentage of Medicaid patients who received a prescription for direct-acting antiviral (DAA) medication and then went on to fill the prescription. The rates ranged from 0% in Alaska to 96% in Connecticut. Eight states were higher than 70%, six were between 50% and 70%, and 15 states were below 50%.
“Despite our efforts, there continue to be major access barriers across the U.S., particularly for Medicaid individuals,” said Dr. Feld, who is a clinician-scientist at the Toronto Western Hospital Liver Clinic and the McLaughlin-Rotman Centre for Global Health.
A study examining the Chronic Hepatitis (CHeCS) cohort (abstract 0585) described a big spike in treatment uptake shortly after approvals of the new HCV regimens, but by 2016, only about one-third of individuals who required treatment actually began treatment. Factors associated with nontreatment largely reflected marginalization, including low income, being on Medicaid, and lack of long-term follow-up.
Even as health systems struggle to get treatment to those who need it, new studies are showing how to expand existing treatments into new populations.
Results from the EXPEDITION 8 study (abstract LB-7) showed efficacy of an 8-week regimen of the glecaprevir/pibrentasvir combination in patients with compensated cirrhosis. It looked at genotypes 1, 2, and 4-6. In an intention-to-treat analysis, 98% attained SVR and there were no viral failures or safety concerns. A follow-up trial is ongoing that includes patients with genotype 3. “This is exciting to be able to shorten therapy in patients with cirrhosis,” said Dr. Feld.
Although first-line DAAs are extremely effective, there are a few patients who do not achieve a cure. One study (abstract 0227) examined the combination of sofosbuvir, velpatasvir, and voxilaprevir in retreatment of these patients. The drugs resulted in SVR rates similar to those in registration trials, but the regimen was somewhat less effective in patients previously treated with sofosbuvir and velpatasvir. “I think we need to investigate that further,” said Dr. Feld.
The combination of glecaprevir and pibrentasvir also proved effective for retreatment in patients with genotype 1/1A who had failed treatment with an NS5A inhibitor plus sofosbuvir with or without ribavirin (abstract 226). SVR rates at 16 weeks were quite good, but lower in genotype 1a patients at 12 weeks (87% week 12 versus 94% week 16).”I think this is a really good regimen for genotype 1b. For 1a, serum definitely needs 16 weeks [to clear],” said Dr. Feld.
Other abstracts presented at the meeting detailed some of the benefits of SVR, not all of which are broadly appreciated. An analysis of the Hepatitis Testers Cohort in British Columbia (abstract 145), which includes over 7,000 patients who were followed for a median of 2 years (DAA) or 9.5 years (interferon-based), showed survival advantages to SVR in both cirrhotic (adjusted hazard ratio, 0.14) and noncirrhotic patients (aHR, 0.13). Other benefits include lower risk of diabetes (aHR, 0.53), chronic kidney disease/endstage renal disease (aHR, 0.48), stroke (aHR, 0.67), and mood and anxiety disorders (aHR, 0.53) (abstract 148).
As is generally accepted, SVR reduces the risk of hepatocellular cancer (HCC), according to analyses of VA and Gilead data (abstract 635), with a benefit in both cirrhotic and noncirrhotic patients. The risk almost disappears in patients without cirrhosis (incidence rate 0.07 per 100 person-years and is curbed in cirrhotic patients (incidence rate 1.30 in compensated, 4.05 in decompensated cirrhosis).
“There is really very significantly high incidence in cancer in decompensated cirrhosis, which just highlights that these patients continue to need ongoing surveillance. Although there have been efforts at developing strategies to risk stratify patients with cirrhosis, at least for now we’re stuck with surveillance, but I think for patients without cirrhosis there are now enough data showing a low enough incidence of primary HCC that we can probably avoid surveillance in that group,” said Dr. Feld.
Injectable drug users represent a special challenge in hepatitis C treatment, but new studies show cause for optimism in this population. These patients are harder to reach, and they may be less medication compliant, but one study (abstract 1632) found that imperfect adherence doesn’t necessarily undermine results – in a 12-week regimen, patients who didn’t finish until 14 weeks had no significant difference in SVR rates.
“So these therapies have a bit of forgiveness. We probably shouldn’t tell that to the patients, but it’s reassuring that we can use these therapies even in tough-to-reach populations,” said Dr. Feld.
REPORTING FROM THE LIVER MEETING 2018
Age-related gene expression may affect responses to RCC therapy
Older patients with ccRCC may respond better than younger patients to phosphoinositide 3-kinase (PI3K) or checkpoint inhibition because of age-related changes in gene expression, according to investigators.
This possibility was raised by in silico results from a broader study of gene expression patterns in clear cell renal carcinoma (ccRCC) and normal kidney tissues, reported lead author, Lara Feulner, MD, of the department of human genetics at McGill University and Genome Quebec Innovation Centre in Montreal.
“Several factors could contribute to the interindividual diversity among cancer patients,” the investigators wrote in a report published in Urologic Oncology.
“Their disease course could be affected not only by cell-intrinsic factors, but also by age-related changes impacting the vasculature, immune system and stroma. Little is known in this regard about ccRCC, a disease which affects adults across a wide age spectrum. Whether and how aging and comorbidities such as atherosclerosis may affect the biology and therapy of ccRCC has scarcely been considered,” they wrote.
The investigators explored this territory by analyzing datasets from The Cancer Genome Atlas (TCGA) and the Cancer Genomics of the Kidney (CAGEKID) program of the International Cancer Genome Consortium. Using regression, pathway enrichment, and connectivity mapping analyses, they were able to determine associations between age and gene expression, cellular processes, and drug treatment responses, respectively.
The investigators reported that age-related gene expression patterns occurred commonly in both normal and tumor tissues. Associations were reproducible between TCGA and CAGEKID datasets for both classes of tissue (tumor samples, R equal to 0.416, P less than 2.2 x 10-16; normal samples, R equal to 0.403, P less than 2.2 x 10-16). Out of the top 1,000 age-associated genes in tumor samples from each dataset, 383 were commonly downregulated with age and 294 were commonly upregulated with age in both datasets (P less than 2.2 x 10-16).
Among cellular pathways, the investigators found opposite age-relationship patterns. For example, normal tissues upregulated extracellular matrix and cell adhesion pathways with age, whereas tumor tissues downregulated the same pathways. Similar patterns of opposition were found in metabolism and oxidation pathways. Other age-related patterns were noted in some immune pathways, such as upregulation of toll-like receptor and tumor necrosis factor 2 noncanonical NF-kappa-B signaling in tumors, which became more common with age. A closer look showed that upregulation of tumor necrosis factor signaling was more common in female patients, who also downregulated Notch pathways more often than men.
Analysis of treatment responses showed possible relationships with age-dependent gene expression and immunotherapy. Specifically, of 532 genes tied to programmed cell death protein 1 (PD-1) resistance, 69 were among the 383 genes downregulated in older patients with ccRCC (P less than 2.2 x 10-16; 4.05 fold-enrichment), suggesting that older patients may respond better to anti-PD-1 therapy than younger patients. Similarly, connectivity map analysis showed that age-dependent gene expression may improve candidacy of older ccRCC patients for PI3K inhibition.
“We now have evidence that there are notable differences in tumor-associated pathway regulation between younger and older ccRCC patients, which may be therapeutically actionable,” the authors concluded.
The study was funded by the Cancer Research Society operation grant, a Canadian Cancer Society Research Institute Innovation-to-Impact grant, and a Canadian Institutes of Health Research Foundation grant. The authors reported no conflicts of interest.
SOURCE: Feulner et al. Urol Onc. 2018 Nov 23. doi: 10.1016/j.urolonc.2018.11.006.
Older patients with ccRCC may respond better than younger patients to phosphoinositide 3-kinase (PI3K) or checkpoint inhibition because of age-related changes in gene expression, according to investigators.
This possibility was raised by in silico results from a broader study of gene expression patterns in clear cell renal carcinoma (ccRCC) and normal kidney tissues, reported lead author, Lara Feulner, MD, of the department of human genetics at McGill University and Genome Quebec Innovation Centre in Montreal.
“Several factors could contribute to the interindividual diversity among cancer patients,” the investigators wrote in a report published in Urologic Oncology.
“Their disease course could be affected not only by cell-intrinsic factors, but also by age-related changes impacting the vasculature, immune system and stroma. Little is known in this regard about ccRCC, a disease which affects adults across a wide age spectrum. Whether and how aging and comorbidities such as atherosclerosis may affect the biology and therapy of ccRCC has scarcely been considered,” they wrote.
The investigators explored this territory by analyzing datasets from The Cancer Genome Atlas (TCGA) and the Cancer Genomics of the Kidney (CAGEKID) program of the International Cancer Genome Consortium. Using regression, pathway enrichment, and connectivity mapping analyses, they were able to determine associations between age and gene expression, cellular processes, and drug treatment responses, respectively.
The investigators reported that age-related gene expression patterns occurred commonly in both normal and tumor tissues. Associations were reproducible between TCGA and CAGEKID datasets for both classes of tissue (tumor samples, R equal to 0.416, P less than 2.2 x 10-16; normal samples, R equal to 0.403, P less than 2.2 x 10-16). Out of the top 1,000 age-associated genes in tumor samples from each dataset, 383 were commonly downregulated with age and 294 were commonly upregulated with age in both datasets (P less than 2.2 x 10-16).
Among cellular pathways, the investigators found opposite age-relationship patterns. For example, normal tissues upregulated extracellular matrix and cell adhesion pathways with age, whereas tumor tissues downregulated the same pathways. Similar patterns of opposition were found in metabolism and oxidation pathways. Other age-related patterns were noted in some immune pathways, such as upregulation of toll-like receptor and tumor necrosis factor 2 noncanonical NF-kappa-B signaling in tumors, which became more common with age. A closer look showed that upregulation of tumor necrosis factor signaling was more common in female patients, who also downregulated Notch pathways more often than men.
Analysis of treatment responses showed possible relationships with age-dependent gene expression and immunotherapy. Specifically, of 532 genes tied to programmed cell death protein 1 (PD-1) resistance, 69 were among the 383 genes downregulated in older patients with ccRCC (P less than 2.2 x 10-16; 4.05 fold-enrichment), suggesting that older patients may respond better to anti-PD-1 therapy than younger patients. Similarly, connectivity map analysis showed that age-dependent gene expression may improve candidacy of older ccRCC patients for PI3K inhibition.
“We now have evidence that there are notable differences in tumor-associated pathway regulation between younger and older ccRCC patients, which may be therapeutically actionable,” the authors concluded.
The study was funded by the Cancer Research Society operation grant, a Canadian Cancer Society Research Institute Innovation-to-Impact grant, and a Canadian Institutes of Health Research Foundation grant. The authors reported no conflicts of interest.
SOURCE: Feulner et al. Urol Onc. 2018 Nov 23. doi: 10.1016/j.urolonc.2018.11.006.
Older patients with ccRCC may respond better than younger patients to phosphoinositide 3-kinase (PI3K) or checkpoint inhibition because of age-related changes in gene expression, according to investigators.
This possibility was raised by in silico results from a broader study of gene expression patterns in clear cell renal carcinoma (ccRCC) and normal kidney tissues, reported lead author, Lara Feulner, MD, of the department of human genetics at McGill University and Genome Quebec Innovation Centre in Montreal.
“Several factors could contribute to the interindividual diversity among cancer patients,” the investigators wrote in a report published in Urologic Oncology.
“Their disease course could be affected not only by cell-intrinsic factors, but also by age-related changes impacting the vasculature, immune system and stroma. Little is known in this regard about ccRCC, a disease which affects adults across a wide age spectrum. Whether and how aging and comorbidities such as atherosclerosis may affect the biology and therapy of ccRCC has scarcely been considered,” they wrote.
The investigators explored this territory by analyzing datasets from The Cancer Genome Atlas (TCGA) and the Cancer Genomics of the Kidney (CAGEKID) program of the International Cancer Genome Consortium. Using regression, pathway enrichment, and connectivity mapping analyses, they were able to determine associations between age and gene expression, cellular processes, and drug treatment responses, respectively.
The investigators reported that age-related gene expression patterns occurred commonly in both normal and tumor tissues. Associations were reproducible between TCGA and CAGEKID datasets for both classes of tissue (tumor samples, R equal to 0.416, P less than 2.2 x 10-16; normal samples, R equal to 0.403, P less than 2.2 x 10-16). Out of the top 1,000 age-associated genes in tumor samples from each dataset, 383 were commonly downregulated with age and 294 were commonly upregulated with age in both datasets (P less than 2.2 x 10-16).
Among cellular pathways, the investigators found opposite age-relationship patterns. For example, normal tissues upregulated extracellular matrix and cell adhesion pathways with age, whereas tumor tissues downregulated the same pathways. Similar patterns of opposition were found in metabolism and oxidation pathways. Other age-related patterns were noted in some immune pathways, such as upregulation of toll-like receptor and tumor necrosis factor 2 noncanonical NF-kappa-B signaling in tumors, which became more common with age. A closer look showed that upregulation of tumor necrosis factor signaling was more common in female patients, who also downregulated Notch pathways more often than men.
Analysis of treatment responses showed possible relationships with age-dependent gene expression and immunotherapy. Specifically, of 532 genes tied to programmed cell death protein 1 (PD-1) resistance, 69 were among the 383 genes downregulated in older patients with ccRCC (P less than 2.2 x 10-16; 4.05 fold-enrichment), suggesting that older patients may respond better to anti-PD-1 therapy than younger patients. Similarly, connectivity map analysis showed that age-dependent gene expression may improve candidacy of older ccRCC patients for PI3K inhibition.
“We now have evidence that there are notable differences in tumor-associated pathway regulation between younger and older ccRCC patients, which may be therapeutically actionable,” the authors concluded.
The study was funded by the Cancer Research Society operation grant, a Canadian Cancer Society Research Institute Innovation-to-Impact grant, and a Canadian Institutes of Health Research Foundation grant. The authors reported no conflicts of interest.
SOURCE: Feulner et al. Urol Onc. 2018 Nov 23. doi: 10.1016/j.urolonc.2018.11.006.
FROM UROLOGIC ONCOLOGY
Key clinical point: Older patients with ccRCC may respond better than younger patients to phosphoinositide 3-kinase or checkpoint inhibition due to age-related changes in gene expression.
Major finding: Out of the top 1,000 age-associated genes in tumor samples, 383 were commonly downregulated with age and 294 were commonly upregulated with age in two large data sets (P less than 2.2 x 10-16).
Study details: An analysis of data from The Cancer Genome Atlas (TCGA) and the Cancer Genomics of the Kidney (CAGEKID) program of the International Cancer Genome Consortium.
Disclosures: The study was funded by the Cancer Research Society operation grant, a Canadian Cancer Society Research Institute Innovation-to-Impact grant, and a Canadian Institutes of Health Research Foundation grant.
Source: Feulner et al. Urol Oncol. 2018 Nov 23. doi: 10.1016/j.urolonc.2018.11.006.
DOAC pause yields favorable outcomes for AF patients
San Diego – In patients with atrial fibrillation who had direct oral anticoagulant (DOAC) interruption for an elective surgery, a simple and standardized management strategy yielded low rates of bleeding and thromboembolism, according to results of a prospective study of more than 3,000 patients.
Rates of major bleeding were less than 2% and rates of arterial thromboembolism were less than 1% in patients managed in accordance with the strategy, which foregoes heparin bridging and preoperative coagulation testing, according to investigator James D. Douketis, MD, of St. Joseph’s Healthcare and McMaster University, Hamilton, Ont.
“This is the first study to demonstrate the safety of a standardized perioperative management approach in a patients with atrial fibrillation who are taking a DOAC, and we hope will establish a standard and will have an effect on our clinical practice guidelines,” Dr. Douketis said during a press briefing at the annual meeting of the American Society of Hematology.
This trial offers the “most definitive evidence to date” that atrial fibrillation patients can – in an organized fashion based on bleeding risk – safely stop taking DOACs, said Mark Crowther, MD, chair and professor of medicine at McMaster University.
“This study will almost instantaneously establish a treatment practice and a treatment standard for the vast number of patients in North America and around the world who take these drugs,” added Dr. Crowther, who moderated the press briefing.
The PAUSE study included three parallel cohorts of atrial fibrillation patients taking DOACs (apixaban, dabigatran, or rivaroxaban) who required anticoagulant interruption for an elective surgery or procedure.
The DOAC interruptions were done using standardized protocols based on the pharmacokinetic properties of each DOAC, procedure-associated bleeding risk, and creatinine clearance, the investigators reported.
The interruptions occurred 1 day before and after low bleeding risk surgeries, and 2 days before and after high bleeding risk surgeries, while longer interruptions were used in patients receiving dabigatran who had a creatinine clearance below 50 mL/min.
A total of 3,007 patients at 23 sites in Canada, the United States, and Europe were managed by this approach in the PAUSE study – 1,257 patients receiving apixaban, 668 receiving dabigatran, and 1,082 receiving rivaroxaban – and were evaluated weekly for 30 days post-procedure.
PAUSE is the largest study to date that addresses how to manage the common problem of perioperative DOAC management. It is likely to have a practice-changing impact and will inform future practice guidelines in perioperative care.
The 30-day postoperative rate of major bleeding was low, according to investigators, at 1.35% (95% confidence interval, 0-2.00%) for apixaban, 0.90% (95% CI, 0-1.73%) for dabigatran, and 1.85% (95% CI, 0-2.65%) for rivaroxaban, Dr. Douketis reported.
Likewise, the rate of arterial thromboembolism was low at 0.16% (95% CI, 0-0.48%) for apixaban, 0.6% (95% CI, 0-1.33%) for dabigatran, and 0.37% (95% CI, 0-0.82%) for rivaroxaban, he said.
Most patients (greater than 90%) had minimal to no residual DOAC levels at the time of surgery, the investigator added.
The study was funded by the Canadian Institutes of Health Research and the H&S Foundation of Canada. Dr. Douketis reported disclosures related to Janssen, which makes rivaroxaban; Boehringer-Ingelheim, which makes dabigatran; and other companies. Dr. Crowther reported financial relationships with Bristol-Myers Squibb and other companies.
SOURCE: Douketis J et al. ASH 2018, Abstract LBA-5.
San Diego – In patients with atrial fibrillation who had direct oral anticoagulant (DOAC) interruption for an elective surgery, a simple and standardized management strategy yielded low rates of bleeding and thromboembolism, according to results of a prospective study of more than 3,000 patients.
Rates of major bleeding were less than 2% and rates of arterial thromboembolism were less than 1% in patients managed in accordance with the strategy, which foregoes heparin bridging and preoperative coagulation testing, according to investigator James D. Douketis, MD, of St. Joseph’s Healthcare and McMaster University, Hamilton, Ont.
“This is the first study to demonstrate the safety of a standardized perioperative management approach in a patients with atrial fibrillation who are taking a DOAC, and we hope will establish a standard and will have an effect on our clinical practice guidelines,” Dr. Douketis said during a press briefing at the annual meeting of the American Society of Hematology.
This trial offers the “most definitive evidence to date” that atrial fibrillation patients can – in an organized fashion based on bleeding risk – safely stop taking DOACs, said Mark Crowther, MD, chair and professor of medicine at McMaster University.
“This study will almost instantaneously establish a treatment practice and a treatment standard for the vast number of patients in North America and around the world who take these drugs,” added Dr. Crowther, who moderated the press briefing.
The PAUSE study included three parallel cohorts of atrial fibrillation patients taking DOACs (apixaban, dabigatran, or rivaroxaban) who required anticoagulant interruption for an elective surgery or procedure.
The DOAC interruptions were done using standardized protocols based on the pharmacokinetic properties of each DOAC, procedure-associated bleeding risk, and creatinine clearance, the investigators reported.
The interruptions occurred 1 day before and after low bleeding risk surgeries, and 2 days before and after high bleeding risk surgeries, while longer interruptions were used in patients receiving dabigatran who had a creatinine clearance below 50 mL/min.
A total of 3,007 patients at 23 sites in Canada, the United States, and Europe were managed by this approach in the PAUSE study – 1,257 patients receiving apixaban, 668 receiving dabigatran, and 1,082 receiving rivaroxaban – and were evaluated weekly for 30 days post-procedure.
PAUSE is the largest study to date that addresses how to manage the common problem of perioperative DOAC management. It is likely to have a practice-changing impact and will inform future practice guidelines in perioperative care.
The 30-day postoperative rate of major bleeding was low, according to investigators, at 1.35% (95% confidence interval, 0-2.00%) for apixaban, 0.90% (95% CI, 0-1.73%) for dabigatran, and 1.85% (95% CI, 0-2.65%) for rivaroxaban, Dr. Douketis reported.
Likewise, the rate of arterial thromboembolism was low at 0.16% (95% CI, 0-0.48%) for apixaban, 0.6% (95% CI, 0-1.33%) for dabigatran, and 0.37% (95% CI, 0-0.82%) for rivaroxaban, he said.
Most patients (greater than 90%) had minimal to no residual DOAC levels at the time of surgery, the investigator added.
The study was funded by the Canadian Institutes of Health Research and the H&S Foundation of Canada. Dr. Douketis reported disclosures related to Janssen, which makes rivaroxaban; Boehringer-Ingelheim, which makes dabigatran; and other companies. Dr. Crowther reported financial relationships with Bristol-Myers Squibb and other companies.
SOURCE: Douketis J et al. ASH 2018, Abstract LBA-5.
San Diego – In patients with atrial fibrillation who had direct oral anticoagulant (DOAC) interruption for an elective surgery, a simple and standardized management strategy yielded low rates of bleeding and thromboembolism, according to results of a prospective study of more than 3,000 patients.
Rates of major bleeding were less than 2% and rates of arterial thromboembolism were less than 1% in patients managed in accordance with the strategy, which foregoes heparin bridging and preoperative coagulation testing, according to investigator James D. Douketis, MD, of St. Joseph’s Healthcare and McMaster University, Hamilton, Ont.
“This is the first study to demonstrate the safety of a standardized perioperative management approach in a patients with atrial fibrillation who are taking a DOAC, and we hope will establish a standard and will have an effect on our clinical practice guidelines,” Dr. Douketis said during a press briefing at the annual meeting of the American Society of Hematology.
This trial offers the “most definitive evidence to date” that atrial fibrillation patients can – in an organized fashion based on bleeding risk – safely stop taking DOACs, said Mark Crowther, MD, chair and professor of medicine at McMaster University.
“This study will almost instantaneously establish a treatment practice and a treatment standard for the vast number of patients in North America and around the world who take these drugs,” added Dr. Crowther, who moderated the press briefing.
The PAUSE study included three parallel cohorts of atrial fibrillation patients taking DOACs (apixaban, dabigatran, or rivaroxaban) who required anticoagulant interruption for an elective surgery or procedure.
The DOAC interruptions were done using standardized protocols based on the pharmacokinetic properties of each DOAC, procedure-associated bleeding risk, and creatinine clearance, the investigators reported.
The interruptions occurred 1 day before and after low bleeding risk surgeries, and 2 days before and after high bleeding risk surgeries, while longer interruptions were used in patients receiving dabigatran who had a creatinine clearance below 50 mL/min.
A total of 3,007 patients at 23 sites in Canada, the United States, and Europe were managed by this approach in the PAUSE study – 1,257 patients receiving apixaban, 668 receiving dabigatran, and 1,082 receiving rivaroxaban – and were evaluated weekly for 30 days post-procedure.
PAUSE is the largest study to date that addresses how to manage the common problem of perioperative DOAC management. It is likely to have a practice-changing impact and will inform future practice guidelines in perioperative care.
The 30-day postoperative rate of major bleeding was low, according to investigators, at 1.35% (95% confidence interval, 0-2.00%) for apixaban, 0.90% (95% CI, 0-1.73%) for dabigatran, and 1.85% (95% CI, 0-2.65%) for rivaroxaban, Dr. Douketis reported.
Likewise, the rate of arterial thromboembolism was low at 0.16% (95% CI, 0-0.48%) for apixaban, 0.6% (95% CI, 0-1.33%) for dabigatran, and 0.37% (95% CI, 0-0.82%) for rivaroxaban, he said.
Most patients (greater than 90%) had minimal to no residual DOAC levels at the time of surgery, the investigator added.
The study was funded by the Canadian Institutes of Health Research and the H&S Foundation of Canada. Dr. Douketis reported disclosures related to Janssen, which makes rivaroxaban; Boehringer-Ingelheim, which makes dabigatran; and other companies. Dr. Crowther reported financial relationships with Bristol-Myers Squibb and other companies.
SOURCE: Douketis J et al. ASH 2018, Abstract LBA-5.
REPORTING FROM ASH 2018
Key clinical point:
Major finding: The 30-day postoperative rate of major bleeding was 1.35% (95% CI, 0-2.00%) for apixaban, 0.90% (95% CI, 0-1.73%) for dabigatran, and 1.85% (95% CI, 0-2.65%) for rivaroxaban.
Study details: A prospective study of more than 3,000 subjects with atrial fibrillation who underwent DOAC interruption due to an elective surgery or procedure.
Disclosures: The study was funded by the Canadian Institutes of Health Research and H&S Foundation of Canada. Dr. Douketis reported disclosures related to Janssen, which makes rivaroxaban; Boehringer-Ingelheim, which makes dabigatran; and other companies.
Source: Douketis J et al. ASH 2018, Abstract LBA-5.
Clear cell RCC with papillary features is still ccRCC
Clear cell renal cell carcinoma (ccRCC) with predominant papillary features is best classified as a rare morphologic variant of ccRCC, not MiT family translocation or papillary RCC, according to an analysis of 23 tumors.
Areas of papillary pattern made up anywhere from 40% to 100% of the 23 tumors. Even so, cytology and immunohistochemical and genetic testing was most consistent with ccRCC, and tumors were negative for TFE3 protein, which ruled out MiT family translocation RCC, reported Reza Alaghehbandan, MD, and his associates. The report is in Annals of Diagnostic Pathology.
The findings help clarify where ccRCC fits in the diagnostic tree when there’s significant papillary morphology, something that hasn’t been clear until now. The proper classification matters because it carries treatment implications; for instance, ccRCC generally responds well to immunotherapy and targeted therapy, but papillary RCC does not, so doctors often recommend treatment through a clinical trial.
“The presence of mixed morphologic components in renal neoplasms in general and in ccRCCs in particular can be puzzling in routine practice, which can potentially lead to misdiagnosis.” Getting it right is “crucial” to ensure the best treatment, said Dr. Alaghehbandan, of the University of British Columbia, Vancouver, and his associates.
Cytokeratin 7 (CK7) staining was negative in the nonpapillary areas of 20 tumors (87%), and only focally positive in three (13%). In contrast, clear cell papillary RCC is strongly and diffusely positive for CK7.
In papillary areas, Alpha-methyl CoA racemase was positive or focally positive in 17 tumors (73.9%); in nonpapillary areas, it was positive or focally positive in 22 (95.6%). Carbonic anhydrase IX was mainly negative in both nonpapillary and papillary areas, while vimentin and CD10 were positive or focally positive in both.
Patients were a mean of 65.2 years old, and 19 were men. The median tumor size was 6.5 cm. At a median follow-up of 2.5 years, two patients had died of their disease, and two had developed metastasis.
There was no industry funding, and the investigators didn’t have any disclosures.
SOURCE: Alaghehbandan R et al. Ann Diagn Pathol. 2018 Nov 22. doi: 10.1016/j.anndiagpath.2018.11.004.
Clear cell renal cell carcinoma (ccRCC) with predominant papillary features is best classified as a rare morphologic variant of ccRCC, not MiT family translocation or papillary RCC, according to an analysis of 23 tumors.
Areas of papillary pattern made up anywhere from 40% to 100% of the 23 tumors. Even so, cytology and immunohistochemical and genetic testing was most consistent with ccRCC, and tumors were negative for TFE3 protein, which ruled out MiT family translocation RCC, reported Reza Alaghehbandan, MD, and his associates. The report is in Annals of Diagnostic Pathology.
The findings help clarify where ccRCC fits in the diagnostic tree when there’s significant papillary morphology, something that hasn’t been clear until now. The proper classification matters because it carries treatment implications; for instance, ccRCC generally responds well to immunotherapy and targeted therapy, but papillary RCC does not, so doctors often recommend treatment through a clinical trial.
“The presence of mixed morphologic components in renal neoplasms in general and in ccRCCs in particular can be puzzling in routine practice, which can potentially lead to misdiagnosis.” Getting it right is “crucial” to ensure the best treatment, said Dr. Alaghehbandan, of the University of British Columbia, Vancouver, and his associates.
Cytokeratin 7 (CK7) staining was negative in the nonpapillary areas of 20 tumors (87%), and only focally positive in three (13%). In contrast, clear cell papillary RCC is strongly and diffusely positive for CK7.
In papillary areas, Alpha-methyl CoA racemase was positive or focally positive in 17 tumors (73.9%); in nonpapillary areas, it was positive or focally positive in 22 (95.6%). Carbonic anhydrase IX was mainly negative in both nonpapillary and papillary areas, while vimentin and CD10 were positive or focally positive in both.
Patients were a mean of 65.2 years old, and 19 were men. The median tumor size was 6.5 cm. At a median follow-up of 2.5 years, two patients had died of their disease, and two had developed metastasis.
There was no industry funding, and the investigators didn’t have any disclosures.
SOURCE: Alaghehbandan R et al. Ann Diagn Pathol. 2018 Nov 22. doi: 10.1016/j.anndiagpath.2018.11.004.
Clear cell renal cell carcinoma (ccRCC) with predominant papillary features is best classified as a rare morphologic variant of ccRCC, not MiT family translocation or papillary RCC, according to an analysis of 23 tumors.
Areas of papillary pattern made up anywhere from 40% to 100% of the 23 tumors. Even so, cytology and immunohistochemical and genetic testing was most consistent with ccRCC, and tumors were negative for TFE3 protein, which ruled out MiT family translocation RCC, reported Reza Alaghehbandan, MD, and his associates. The report is in Annals of Diagnostic Pathology.
The findings help clarify where ccRCC fits in the diagnostic tree when there’s significant papillary morphology, something that hasn’t been clear until now. The proper classification matters because it carries treatment implications; for instance, ccRCC generally responds well to immunotherapy and targeted therapy, but papillary RCC does not, so doctors often recommend treatment through a clinical trial.
“The presence of mixed morphologic components in renal neoplasms in general and in ccRCCs in particular can be puzzling in routine practice, which can potentially lead to misdiagnosis.” Getting it right is “crucial” to ensure the best treatment, said Dr. Alaghehbandan, of the University of British Columbia, Vancouver, and his associates.
Cytokeratin 7 (CK7) staining was negative in the nonpapillary areas of 20 tumors (87%), and only focally positive in three (13%). In contrast, clear cell papillary RCC is strongly and diffusely positive for CK7.
In papillary areas, Alpha-methyl CoA racemase was positive or focally positive in 17 tumors (73.9%); in nonpapillary areas, it was positive or focally positive in 22 (95.6%). Carbonic anhydrase IX was mainly negative in both nonpapillary and papillary areas, while vimentin and CD10 were positive or focally positive in both.
Patients were a mean of 65.2 years old, and 19 were men. The median tumor size was 6.5 cm. At a median follow-up of 2.5 years, two patients had died of their disease, and two had developed metastasis.
There was no industry funding, and the investigators didn’t have any disclosures.
SOURCE: Alaghehbandan R et al. Ann Diagn Pathol. 2018 Nov 22. doi: 10.1016/j.anndiagpath.2018.11.004.
FROM ANNALS OF DIAGNOSTIC PATHOLOGY
Key clinical point: Clear cell renal cell carcinoma (ccRCC) with predominant papillary features is best classified as a rare morphologic variant of ccRCC, not MiT family translocation or papillary RCC. The distinction has treatment implications.
Major finding: Areas of papillary pattern made up anywhere from 40% to 100% of the 23 tumors. Even so, cytology and immunohistochemical and genetic testing was most consistent with ccRCC, and tumors were negative for TFE3 protein, which ruled out MiT family translocation RCC.
Study details: Analysis of 23 tumors.
Disclosures: There was no industry funding, and the investigators didn’t have any disclosures.
Source: Alaghehbandan R et al. Ann Diagn Pathol. 2018 Nov 22. doi: 10.1016/j.anndiagpath.2018.11.004.
Obesity linked to 10% of childhood asthma
Around one-quarter of new asthma cases in children with obesity may be attributable to their obesity, according to research published in Pediatrics.
Jason E. Lang, MD, MPH, of Duke University, Durham, N.C., and his coauthors used the PEDSnet clinical data research network to conduct a retrospective cohort study of 507,496 children aged 2-17 years from 2009-2015, comparing the incidence of asthma in overweight and obese children to the incidence in healthy weight children.
The overall rate of new diagnoses of asthma was 2.4 per 1,000 patient years among normal-weight children and 3.2 per 1,000 patient years among obese children.
After adjustment for factors such as age, ethnicity, insurance status, sex, allergic rhinitis, food allergy, and proton pump inhibitor use, overweight children had a 17% higher risk of incident asthma, and obese children had a 26% higher risk of asthma, compared with children of normal weight. The relative risk of spirometry-confirmed asthma was 29% higher in obese children compared with normal-weight children, and the association between obesity and asthma persisted even when a second asthma encounter was required for the diagnosis.
Overall, the authors estimated that 23%-25% of clinically diagnosed asthma in children with obesity could be specifically attributed to obesity, and that in the overall population of children 10% of asthma was attributable to obesity.
“Currently, there are few known preventable risk factors that can be used to reduce childhood asthma,” wrote Dr. Lang and his coauthors. “With these data, it is suggested that reducing the onset of obesity in childhood would significantly reduce the public health burden of asthma in children.”
They noted that with current estimates of U.S. pediatric asthma prevalence being around 6-8 million cases, obesity could therefore account for up to 1 million of these cases.
The study was funded by the Patient-Centered Outcomes Research Institute, the Nemours Children’s Hospital and Nemours Children’s Health System. One author declared advisory board positions and consultancies with the pharmaceutical industry. The remaining researchers said they had no conflicts of interest.
SOURCE: Lang J et al. Pediatrics. 2018 Dec;142(6):e20182119.
While there has long been recognition of an association between childhood obesity and childhood asthma, the incidence of pediatric obesity–related asthma has not been well known. This study therefore addresses that gap in knowledge, and does so among children with a range of racial and ethnic backgrounds and while addressing potential confounders such as comorbidities and sociodemographic variables.
The findings show how significant a contribution obesity makes to the burden of childhood asthma, and also points to the potential increase in childhood asthma incidence that may arise with the increase in childhood obesity.
However, the good news is that this offers what may be the first modifiable risk factor for childhood asthma, which presents an opportunity for primary prevention of this common childhood condition.
Deepa Rastogi, MBBS, MS, is from the department of pediatrics at the Albert Einstein College of Medicine, New York. These comments are taken from an editorial (Pediatrics. 2018 Dec;142(6):e20182979.). No conflicts of interest were declared.
While there has long been recognition of an association between childhood obesity and childhood asthma, the incidence of pediatric obesity–related asthma has not been well known. This study therefore addresses that gap in knowledge, and does so among children with a range of racial and ethnic backgrounds and while addressing potential confounders such as comorbidities and sociodemographic variables.
The findings show how significant a contribution obesity makes to the burden of childhood asthma, and also points to the potential increase in childhood asthma incidence that may arise with the increase in childhood obesity.
However, the good news is that this offers what may be the first modifiable risk factor for childhood asthma, which presents an opportunity for primary prevention of this common childhood condition.
Deepa Rastogi, MBBS, MS, is from the department of pediatrics at the Albert Einstein College of Medicine, New York. These comments are taken from an editorial (Pediatrics. 2018 Dec;142(6):e20182979.). No conflicts of interest were declared.
While there has long been recognition of an association between childhood obesity and childhood asthma, the incidence of pediatric obesity–related asthma has not been well known. This study therefore addresses that gap in knowledge, and does so among children with a range of racial and ethnic backgrounds and while addressing potential confounders such as comorbidities and sociodemographic variables.
The findings show how significant a contribution obesity makes to the burden of childhood asthma, and also points to the potential increase in childhood asthma incidence that may arise with the increase in childhood obesity.
However, the good news is that this offers what may be the first modifiable risk factor for childhood asthma, which presents an opportunity for primary prevention of this common childhood condition.
Deepa Rastogi, MBBS, MS, is from the department of pediatrics at the Albert Einstein College of Medicine, New York. These comments are taken from an editorial (Pediatrics. 2018 Dec;142(6):e20182979.). No conflicts of interest were declared.
Around one-quarter of new asthma cases in children with obesity may be attributable to their obesity, according to research published in Pediatrics.
Jason E. Lang, MD, MPH, of Duke University, Durham, N.C., and his coauthors used the PEDSnet clinical data research network to conduct a retrospective cohort study of 507,496 children aged 2-17 years from 2009-2015, comparing the incidence of asthma in overweight and obese children to the incidence in healthy weight children.
The overall rate of new diagnoses of asthma was 2.4 per 1,000 patient years among normal-weight children and 3.2 per 1,000 patient years among obese children.
After adjustment for factors such as age, ethnicity, insurance status, sex, allergic rhinitis, food allergy, and proton pump inhibitor use, overweight children had a 17% higher risk of incident asthma, and obese children had a 26% higher risk of asthma, compared with children of normal weight. The relative risk of spirometry-confirmed asthma was 29% higher in obese children compared with normal-weight children, and the association between obesity and asthma persisted even when a second asthma encounter was required for the diagnosis.
Overall, the authors estimated that 23%-25% of clinically diagnosed asthma in children with obesity could be specifically attributed to obesity, and that in the overall population of children 10% of asthma was attributable to obesity.
“Currently, there are few known preventable risk factors that can be used to reduce childhood asthma,” wrote Dr. Lang and his coauthors. “With these data, it is suggested that reducing the onset of obesity in childhood would significantly reduce the public health burden of asthma in children.”
They noted that with current estimates of U.S. pediatric asthma prevalence being around 6-8 million cases, obesity could therefore account for up to 1 million of these cases.
The study was funded by the Patient-Centered Outcomes Research Institute, the Nemours Children’s Hospital and Nemours Children’s Health System. One author declared advisory board positions and consultancies with the pharmaceutical industry. The remaining researchers said they had no conflicts of interest.
SOURCE: Lang J et al. Pediatrics. 2018 Dec;142(6):e20182119.
Around one-quarter of new asthma cases in children with obesity may be attributable to their obesity, according to research published in Pediatrics.
Jason E. Lang, MD, MPH, of Duke University, Durham, N.C., and his coauthors used the PEDSnet clinical data research network to conduct a retrospective cohort study of 507,496 children aged 2-17 years from 2009-2015, comparing the incidence of asthma in overweight and obese children to the incidence in healthy weight children.
The overall rate of new diagnoses of asthma was 2.4 per 1,000 patient years among normal-weight children and 3.2 per 1,000 patient years among obese children.
After adjustment for factors such as age, ethnicity, insurance status, sex, allergic rhinitis, food allergy, and proton pump inhibitor use, overweight children had a 17% higher risk of incident asthma, and obese children had a 26% higher risk of asthma, compared with children of normal weight. The relative risk of spirometry-confirmed asthma was 29% higher in obese children compared with normal-weight children, and the association between obesity and asthma persisted even when a second asthma encounter was required for the diagnosis.
Overall, the authors estimated that 23%-25% of clinically diagnosed asthma in children with obesity could be specifically attributed to obesity, and that in the overall population of children 10% of asthma was attributable to obesity.
“Currently, there are few known preventable risk factors that can be used to reduce childhood asthma,” wrote Dr. Lang and his coauthors. “With these data, it is suggested that reducing the onset of obesity in childhood would significantly reduce the public health burden of asthma in children.”
They noted that with current estimates of U.S. pediatric asthma prevalence being around 6-8 million cases, obesity could therefore account for up to 1 million of these cases.
The study was funded by the Patient-Centered Outcomes Research Institute, the Nemours Children’s Hospital and Nemours Children’s Health System. One author declared advisory board positions and consultancies with the pharmaceutical industry. The remaining researchers said they had no conflicts of interest.
SOURCE: Lang J et al. Pediatrics. 2018 Dec;142(6):e20182119.
FROM PEDIATRICS
Key clinical point: Obesity may be responsible for around 10% of childhood asthma.
Major finding: Obesity in children is associated with a 26% higher risk of asthma compared with normal-weight children.
Study details: A retrospective cohort study of 507,496 children.
Disclosures: The study was funded by the Patient-Centered Outcomes Research Institute and the Nemours Children’s Hospital and Nemours Children’s Health System. One author declared advisory board positions and consultancies with the pharmaceutical industry.
Source: Lang J et al. Pediatrics. 2018 Dec;142(6):e20182119. doi: 10.1542/peds.2018- 2119
Early intervention initiative cut oncology patient hospitalizations
, according to a report from a large, independent, community-based oncology practice.
The program saved nearly $3.2 million in Medicare costs over the course of the year, said Molly Mendenhall, RN, of Oncology Hematology Care in Cincinnati.
“By keeping those patients out of the hospital, we were able to improve patient quality of life, and increase patient satisfaction by treating them in their home clinic instead of the hospital,” Ms. Mendenhall said at a symposium on quality care sponsored by the American Society of Clinical Oncology.
The campaign was developed in anticipation of participating in the Oncology Care Model (OCM), a program focused on providing coordinated and high-quality care for Medicare oncology patients at the same or lower cost.
Prior to participating in OCM, Ms. Mendenhall and her colleagues set up an after-hours phone triage system, proactive chemotherapy follow-up calls, and a Saturday-Sunday urgent care clinic designed to help avoid any unnecessary hospitalizations over the weekend.
They also set up a 2-hour structured OCM treatment planning visit to prioritize shared decision making between the patient and the clinical team regarding diagnosis, symptom management, financial assistance, and other aspects of care.
The most influential part of the initiative, according to Ms. Mendenhall, was a patient-directed “Call Us Early – Call Us First” campaign that included symptom management teaching sheets, a 34-page teaching book, and branded buttons, pens, and magnets all designed to emphasize the patient responsibility to use the phone.
“All of those previous steps really wouldn’t make a difference if the patients still weren’t calling us,” Ms. Mendenhall explained.
Over the first year of participation in the OCM program, the oncology practice saw a 16% statistically significant reduction in hospital admissions (P = .005). The number of inpatient admissions per 100 patients dropped from 26.8 at baseline to 22.6 at the most recent follow-up in a report published simultaneously in the Journal of Oncology Practice.
Reduced admissions translated into a drop of $798,000 in inpatient costs per quarter over 1,600 patients, or $3.129 million in savings for the Centers for Medicare & Medicaid Services over the first year of participation in OCM, according to the researchers.
Patient satisfaction scores trended positively over the course of that year based on a review of blinded surveys that asked patients to rate clinical care, communication, access, information exchange, and other aspects of their experience.
Scores on those surveys were 8.03 on a scale of 0-10 (low to high) during the baseline period of January to September 2016, the researchers said. Scores were 8.29 and 8.26 for two follow-up surveys.
Ms. Mendenhall had no disclosures to report. Coauthors on the study provided disclosures related to Janssen Oncology, Pfizer, Amgen, Abbvie, Merck, Pharmacyclics, Bristol-Myers Squibb, Celgene, Genentech/Roche, AZTherapies, and Lilly. Two coauthors reported leadership, stock, or other ownership interests in Oncology Hematology Care/US Oncology.
SOURCE: Mendenhall M et al. Quality Care Symposium, Abstract 30.
, according to a report from a large, independent, community-based oncology practice.
The program saved nearly $3.2 million in Medicare costs over the course of the year, said Molly Mendenhall, RN, of Oncology Hematology Care in Cincinnati.
“By keeping those patients out of the hospital, we were able to improve patient quality of life, and increase patient satisfaction by treating them in their home clinic instead of the hospital,” Ms. Mendenhall said at a symposium on quality care sponsored by the American Society of Clinical Oncology.
The campaign was developed in anticipation of participating in the Oncology Care Model (OCM), a program focused on providing coordinated and high-quality care for Medicare oncology patients at the same or lower cost.
Prior to participating in OCM, Ms. Mendenhall and her colleagues set up an after-hours phone triage system, proactive chemotherapy follow-up calls, and a Saturday-Sunday urgent care clinic designed to help avoid any unnecessary hospitalizations over the weekend.
They also set up a 2-hour structured OCM treatment planning visit to prioritize shared decision making between the patient and the clinical team regarding diagnosis, symptom management, financial assistance, and other aspects of care.
The most influential part of the initiative, according to Ms. Mendenhall, was a patient-directed “Call Us Early – Call Us First” campaign that included symptom management teaching sheets, a 34-page teaching book, and branded buttons, pens, and magnets all designed to emphasize the patient responsibility to use the phone.
“All of those previous steps really wouldn’t make a difference if the patients still weren’t calling us,” Ms. Mendenhall explained.
Over the first year of participation in the OCM program, the oncology practice saw a 16% statistically significant reduction in hospital admissions (P = .005). The number of inpatient admissions per 100 patients dropped from 26.8 at baseline to 22.6 at the most recent follow-up in a report published simultaneously in the Journal of Oncology Practice.
Reduced admissions translated into a drop of $798,000 in inpatient costs per quarter over 1,600 patients, or $3.129 million in savings for the Centers for Medicare & Medicaid Services over the first year of participation in OCM, according to the researchers.
Patient satisfaction scores trended positively over the course of that year based on a review of blinded surveys that asked patients to rate clinical care, communication, access, information exchange, and other aspects of their experience.
Scores on those surveys were 8.03 on a scale of 0-10 (low to high) during the baseline period of January to September 2016, the researchers said. Scores were 8.29 and 8.26 for two follow-up surveys.
Ms. Mendenhall had no disclosures to report. Coauthors on the study provided disclosures related to Janssen Oncology, Pfizer, Amgen, Abbvie, Merck, Pharmacyclics, Bristol-Myers Squibb, Celgene, Genentech/Roche, AZTherapies, and Lilly. Two coauthors reported leadership, stock, or other ownership interests in Oncology Hematology Care/US Oncology.
SOURCE: Mendenhall M et al. Quality Care Symposium, Abstract 30.
, according to a report from a large, independent, community-based oncology practice.
The program saved nearly $3.2 million in Medicare costs over the course of the year, said Molly Mendenhall, RN, of Oncology Hematology Care in Cincinnati.
“By keeping those patients out of the hospital, we were able to improve patient quality of life, and increase patient satisfaction by treating them in their home clinic instead of the hospital,” Ms. Mendenhall said at a symposium on quality care sponsored by the American Society of Clinical Oncology.
The campaign was developed in anticipation of participating in the Oncology Care Model (OCM), a program focused on providing coordinated and high-quality care for Medicare oncology patients at the same or lower cost.
Prior to participating in OCM, Ms. Mendenhall and her colleagues set up an after-hours phone triage system, proactive chemotherapy follow-up calls, and a Saturday-Sunday urgent care clinic designed to help avoid any unnecessary hospitalizations over the weekend.
They also set up a 2-hour structured OCM treatment planning visit to prioritize shared decision making between the patient and the clinical team regarding diagnosis, symptom management, financial assistance, and other aspects of care.
The most influential part of the initiative, according to Ms. Mendenhall, was a patient-directed “Call Us Early – Call Us First” campaign that included symptom management teaching sheets, a 34-page teaching book, and branded buttons, pens, and magnets all designed to emphasize the patient responsibility to use the phone.
“All of those previous steps really wouldn’t make a difference if the patients still weren’t calling us,” Ms. Mendenhall explained.
Over the first year of participation in the OCM program, the oncology practice saw a 16% statistically significant reduction in hospital admissions (P = .005). The number of inpatient admissions per 100 patients dropped from 26.8 at baseline to 22.6 at the most recent follow-up in a report published simultaneously in the Journal of Oncology Practice.
Reduced admissions translated into a drop of $798,000 in inpatient costs per quarter over 1,600 patients, or $3.129 million in savings for the Centers for Medicare & Medicaid Services over the first year of participation in OCM, according to the researchers.
Patient satisfaction scores trended positively over the course of that year based on a review of blinded surveys that asked patients to rate clinical care, communication, access, information exchange, and other aspects of their experience.
Scores on those surveys were 8.03 on a scale of 0-10 (low to high) during the baseline period of January to September 2016, the researchers said. Scores were 8.29 and 8.26 for two follow-up surveys.
Ms. Mendenhall had no disclosures to report. Coauthors on the study provided disclosures related to Janssen Oncology, Pfizer, Amgen, Abbvie, Merck, Pharmacyclics, Bristol-Myers Squibb, Celgene, Genentech/Roche, AZTherapies, and Lilly. Two coauthors reported leadership, stock, or other ownership interests in Oncology Hematology Care/US Oncology.
SOURCE: Mendenhall M et al. Quality Care Symposium, Abstract 30.
REPORTING FROM THE QUALITY CARE SYMPOSIUM
Key clinical point: An initiative designed to reduce avoidable emergency room visits and hospitalizations reduced both admissions and inpatient costs.
Major finding: The program cut admissions by 16% and saved nearly $3.2 million in Medicare costs savings over the course of a year.
Study details: Analysis of first-year experience including 1,600 patients per quarter for a large, independent, community-based oncology practice participating in the Oncology Care Model (OCM) of the Centers for Medicare and Medicaid Services.
Disclosures: Authors on the study provided disclosures related to Janssen Oncology, Pfizer, Amgen, Abbvie, Merck, Pharmacyclics, Bristol-Myers Squibb, Celgene, Genentech/Roche, AZTherapies, Lilly, and Oncology Hematology Care/US Oncology.
Source: Mendenhall M et al. Quality Care Symposium, Abstract 30.