Breast cancer: More pathogenic variants detected as multiple-gene sequencing takes over

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The introduction of multiple-gene sequencing led to a substantial increase in detection of pathogenic variants in a study of women with breast cancer treated in community practice, results of one retrospective study show.

Multiple-gene sequencing rapidly replaced BRCA1/2 only testing over a 2-year period in the study, driven in part by technological advances and regulatory changes that made comprehensive low-cost genetic testing more accessible, investigators wrote. The report was published in JAMA Oncology.

That quick uptake increased detection of genetic variants that could change care, with no associated increase in prophylactic mastectomy over that same time period, said Allison W. Kurian, MD, of Stanford (Calif.) University, and her coinvestigators.

“The greater yield of clinically relevant information with multiple-gene sequencing offers a major potential advantage over more limited BRCA1/2-only tests,” noted Dr. Kurian and her colleagues.

Their analysis included 5,026 women with stage 0-II breast cancer diagnosed from January 2013 to December 2015 and enrolled in the Individualized Cancer Care (iCan Care) study. That study started enrolling 1 month before a U.S. Supreme Court decision on gene patents, which led to lower costs for multiple-gene sequencing tests for breast cancer risk, Dr. Kurian and her coinvestigators said.

Overall, about one-quarter of women in the study had genetic testing, and that did not change over time. What did change over time was the number of women undergoing multiple-gene testing: In 2013, only 25.6% underwent multiple-gene sequencing, versus 74.4% for BRCA1/2-only testing; by 2015, those figures flipped to 66.5% and 33.5%, respectively.

Multiple-gene sequencing increased detection of pathogenic variants in women at average pretest risk (4.2% versus 2.2% for BRCA1/2-only testing), according to the reported data. Detection was increased in women at high pretest risk due to young age, triple-negative breast cancer, or other factors (12% versus 7.8%).

 

 


Prophylactic mastectomy was most strongly associated with detection of pathogenic BRCA1/2 variants, according to Dr. Kurian and her coinvestigators. More women with those variants strongly considered the procedure and had it recommended by their surgeons, and ultimately, significantly more underwent the procedure (79.0% versus 37.6% for other pathogenic variants; P less than .001).

While those mastectomy outcomes were reassuring, Dr. Kurian and her colleagues said, their research uncovered two “important limitations” to multiple-gene sequencing that should be addressed.

They found that testing was done post surgically in 32.5% of women who had multiple-gene sequencing, compared with 19.9% of women who had BRCA1/2-only testing. Postsurgical testing is “too late” and limits its use to make decisions about surgical prevention of second cancers, they said.

They also found racial disparities in detection of variants of unknown significance (VUS). In particular, VUS were detected in 23.7% of white patients, compared with 44.5% of black patients and 50.9% of Asian patients. That’s because most of the genes were first sequenced in white patients, the investigators noted.
 

 


In previous experience with BRCA1/2 testing, extensive VUS reclassification occurred after broader testing within the population over 2 decades.

“It is a crucial priority to resolve persistent racial/ethnic disparities in genetic information, particularly as increasingly comprehensive sequencing tests enter clinical practice,” the investigators wrote.

Dr. Kurian reported that Stanford University received research funding from Myriad Genetics for an unrelated project. No other conflicts of interest were reported.

SOURCE: Kurian AW et al. JAMA Oncol. 2018 May 10. doi: 10.1001/jamaoncol.2018.0644.

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The introduction of multiple-gene sequencing led to a substantial increase in detection of pathogenic variants in a study of women with breast cancer treated in community practice, results of one retrospective study show.

Multiple-gene sequencing rapidly replaced BRCA1/2 only testing over a 2-year period in the study, driven in part by technological advances and regulatory changes that made comprehensive low-cost genetic testing more accessible, investigators wrote. The report was published in JAMA Oncology.

That quick uptake increased detection of genetic variants that could change care, with no associated increase in prophylactic mastectomy over that same time period, said Allison W. Kurian, MD, of Stanford (Calif.) University, and her coinvestigators.

“The greater yield of clinically relevant information with multiple-gene sequencing offers a major potential advantage over more limited BRCA1/2-only tests,” noted Dr. Kurian and her colleagues.

Their analysis included 5,026 women with stage 0-II breast cancer diagnosed from January 2013 to December 2015 and enrolled in the Individualized Cancer Care (iCan Care) study. That study started enrolling 1 month before a U.S. Supreme Court decision on gene patents, which led to lower costs for multiple-gene sequencing tests for breast cancer risk, Dr. Kurian and her coinvestigators said.

Overall, about one-quarter of women in the study had genetic testing, and that did not change over time. What did change over time was the number of women undergoing multiple-gene testing: In 2013, only 25.6% underwent multiple-gene sequencing, versus 74.4% for BRCA1/2-only testing; by 2015, those figures flipped to 66.5% and 33.5%, respectively.

Multiple-gene sequencing increased detection of pathogenic variants in women at average pretest risk (4.2% versus 2.2% for BRCA1/2-only testing), according to the reported data. Detection was increased in women at high pretest risk due to young age, triple-negative breast cancer, or other factors (12% versus 7.8%).

 

 


Prophylactic mastectomy was most strongly associated with detection of pathogenic BRCA1/2 variants, according to Dr. Kurian and her coinvestigators. More women with those variants strongly considered the procedure and had it recommended by their surgeons, and ultimately, significantly more underwent the procedure (79.0% versus 37.6% for other pathogenic variants; P less than .001).

While those mastectomy outcomes were reassuring, Dr. Kurian and her colleagues said, their research uncovered two “important limitations” to multiple-gene sequencing that should be addressed.

They found that testing was done post surgically in 32.5% of women who had multiple-gene sequencing, compared with 19.9% of women who had BRCA1/2-only testing. Postsurgical testing is “too late” and limits its use to make decisions about surgical prevention of second cancers, they said.

They also found racial disparities in detection of variants of unknown significance (VUS). In particular, VUS were detected in 23.7% of white patients, compared with 44.5% of black patients and 50.9% of Asian patients. That’s because most of the genes were first sequenced in white patients, the investigators noted.
 

 


In previous experience with BRCA1/2 testing, extensive VUS reclassification occurred after broader testing within the population over 2 decades.

“It is a crucial priority to resolve persistent racial/ethnic disparities in genetic information, particularly as increasingly comprehensive sequencing tests enter clinical practice,” the investigators wrote.

Dr. Kurian reported that Stanford University received research funding from Myriad Genetics for an unrelated project. No other conflicts of interest were reported.

SOURCE: Kurian AW et al. JAMA Oncol. 2018 May 10. doi: 10.1001/jamaoncol.2018.0644.

 

The introduction of multiple-gene sequencing led to a substantial increase in detection of pathogenic variants in a study of women with breast cancer treated in community practice, results of one retrospective study show.

Multiple-gene sequencing rapidly replaced BRCA1/2 only testing over a 2-year period in the study, driven in part by technological advances and regulatory changes that made comprehensive low-cost genetic testing more accessible, investigators wrote. The report was published in JAMA Oncology.

That quick uptake increased detection of genetic variants that could change care, with no associated increase in prophylactic mastectomy over that same time period, said Allison W. Kurian, MD, of Stanford (Calif.) University, and her coinvestigators.

“The greater yield of clinically relevant information with multiple-gene sequencing offers a major potential advantage over more limited BRCA1/2-only tests,” noted Dr. Kurian and her colleagues.

Their analysis included 5,026 women with stage 0-II breast cancer diagnosed from January 2013 to December 2015 and enrolled in the Individualized Cancer Care (iCan Care) study. That study started enrolling 1 month before a U.S. Supreme Court decision on gene patents, which led to lower costs for multiple-gene sequencing tests for breast cancer risk, Dr. Kurian and her coinvestigators said.

Overall, about one-quarter of women in the study had genetic testing, and that did not change over time. What did change over time was the number of women undergoing multiple-gene testing: In 2013, only 25.6% underwent multiple-gene sequencing, versus 74.4% for BRCA1/2-only testing; by 2015, those figures flipped to 66.5% and 33.5%, respectively.

Multiple-gene sequencing increased detection of pathogenic variants in women at average pretest risk (4.2% versus 2.2% for BRCA1/2-only testing), according to the reported data. Detection was increased in women at high pretest risk due to young age, triple-negative breast cancer, or other factors (12% versus 7.8%).

 

 


Prophylactic mastectomy was most strongly associated with detection of pathogenic BRCA1/2 variants, according to Dr. Kurian and her coinvestigators. More women with those variants strongly considered the procedure and had it recommended by their surgeons, and ultimately, significantly more underwent the procedure (79.0% versus 37.6% for other pathogenic variants; P less than .001).

While those mastectomy outcomes were reassuring, Dr. Kurian and her colleagues said, their research uncovered two “important limitations” to multiple-gene sequencing that should be addressed.

They found that testing was done post surgically in 32.5% of women who had multiple-gene sequencing, compared with 19.9% of women who had BRCA1/2-only testing. Postsurgical testing is “too late” and limits its use to make decisions about surgical prevention of second cancers, they said.

They also found racial disparities in detection of variants of unknown significance (VUS). In particular, VUS were detected in 23.7% of white patients, compared with 44.5% of black patients and 50.9% of Asian patients. That’s because most of the genes were first sequenced in white patients, the investigators noted.
 

 


In previous experience with BRCA1/2 testing, extensive VUS reclassification occurred after broader testing within the population over 2 decades.

“It is a crucial priority to resolve persistent racial/ethnic disparities in genetic information, particularly as increasingly comprehensive sequencing tests enter clinical practice,” the investigators wrote.

Dr. Kurian reported that Stanford University received research funding from Myriad Genetics for an unrelated project. No other conflicts of interest were reported.

SOURCE: Kurian AW et al. JAMA Oncol. 2018 May 10. doi: 10.1001/jamaoncol.2018.0644.

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Key clinical point: For breast cancer patients in community practice, multiple-gene sequencing has rapidly replaced BRCA1/2-only testing, increasing detection of pathogenic variants with no associated increase in prophylactic mastectomy.

Major finding: The rate of pathogenic variant detection was substantially increased with multiple-gene sequencing versus BRCA1/2 only testing for higher-risk patients (12% versus 7.8%) and average risk patients (4.2% versus 2.2%).

Study details: A population-based retrospective cohort study of 5,026 patients with breast cancer diagnosed from January 2013 to December 2015.

Disclosures: Stanford University received research funding from Myriad Genetics for an unrelated project. No other conflicts of interest were reported.

Source: Kurian AW et al. JAMA Oncol. 2018 May 10. doi: 10.1001/jamaoncol.2018.0644.

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Universal depression screening for adolescents not without controversy

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When 14-year-old Ryan saw his pediatrician for his annual physical this past August, he was asked a few quick questions about whether he was having any problems, if he was feeling depressed or anxious, and if there was anything he wanted to discuss. Ryan said no to each question, then the doctor examined him, reminded him to get a flu shot, and signed off on the forms he needed to play team sports in high school. The doctor assured Ryan’s mother that he was healthy, and the visit was over. Next August, Ryan’s exam will likely include a more detailed look at his mental health.

In February 2018, the American Academy of Pediatrics updated its guidelines on screening for depression in adolescents in primary care settings. The guidelines address the problem of undiagnosed and untreated psychiatric illness in children over the age of 10 years, the shortage of available mental health professionals, and techniques primary care physicians might use to address psychiatric needs in adolescents. The AAP guidelines include a new recommendation for universal screening with an assessment tool: “Adolescent patients ages 12 years and older should be screened annually for depression [MDD or depressive disorders] with a formal self-report screening tool either on paper or electronically.”

KatarzynaBialasiewicz/Thinkstock
Howard Liu, MD, is a child and adolescent psychiatrist and the interim chair of psychiatry at the University of Nebraska, Omaha, and director of the Behavioral Health Education Center of Nebraska. “I applaud the AAP for recommending universal depression screening for teenagers, as there has been a rising incidence of teen suicide, especially among female adolescents,” he said. “However, when teens screen positive, we must invest in the child mental health infrastructure to support pediatricians. This includes therapists integrated into primary care practices and prescribers with the capacity to take new patients or practice collaborative care.”

Dr. Liu noted that some of his patients drive 4-5 hours each way to see him in Omaha, then spend the night before making the return trip. “There is a dire shortage of pediatric mental health services in every state. This shifts the responsibility for care to pediatricians, teachers, and parents who often lack the resources to keep kids safe and well. It’s an unconscionable gap in care.”

Dr. Howard Liu
Timothy F. Doran, MD, is chair of pediatrics at the Greater Baltimore Medical Center in Towson, Md., and a past president of the Maryland Chapter of the AAP. “I absolutely think every teenager should be assessed for depression,” he said. With his own patients, he asks open-ended questions about their mental health, then more specific questions about mood, depression, anxiety, sleep, appetite, and libido. If the teen indicates there are problems, he then uses a PHQ-9 to get a sense of whether the depression is mild, moderate, or severe. Dr. Doran estimates that he diagnoses depression in 5%-10% of the adolescents he screens. Baltimore is a metropolitan area with two psychiatry training programs, and Dr. Doran has developed relationships with mental health professionals who will see his patients. If he prescribes an antidepressant, most of those patients will also see a psychotherapist. He notes that it can be more difficult to find resources for children with Medicaid who do not have the resources of some of the families he treats.

Dr. Doran’s practice has not yet implemented the use of a written screening tool for all adolescents. He anticipates doing this soon because of the new guidelines, but he was not enthusiastic about the prospect. “I think I’m catching the kids with depression, and having every child fill out a questionnaire will be an added burden. We are already loaded down with administrative tasks and screening requirements.” Of note, in Dr. Doran’s 35 years in clinical practice, no child under his care has died of suicide.

Dr. Allen Frances
Allen Frances, MD, offers a different take on the new guidelines. Dr. Frances was the chairman of the DSM-IV task force and is the author of “Saving Normal: An Insider’s Revolt Against Out-of-Control Psychiatric Diagnosis, DSM-5, Big Pharma, and the Medicalization of Ordinary Life” (New York: HarperCollins, 2014). Dr. Frances has used his Twitter feed to express his objections to the new guidelines for universal depression screening for teenagers. “Universal mental health screening of children sounds virtuous but is a big mistake. Massive overdiagnosis results in 1) Too much ineffective/unsafe #medication; 2) Needless #stigma; 3) Wasting precious resources. Instead, provide easy access to treatment for kids who really need it.” He goes on to tweet about unintended consequences of universal screening, including the concern that screening may identify teens with normal transient sadness or substance-induced mood changes as being clinically depressed. In Twitter lingo, Dr. Frances continues: “‘Early-warning signs of mental illness in kids are often false alarms leading to unneeded #medication/#stigma. Also, we don’t provide adequate psych care for kids who desperately need it. It makes no sense to create new fake patients when we are neglecting the real ones we already have.”

 

 


Dr. Dinah Miller
It will be interesting to see what happens when Ryan goes for a physical next year. Will the pediatrician devote time to a screening form to document psychiatric symptoms? Will that divert time and attention away from concerns that might be more important to Ryan or his parents? Will he be handed an iPad in the waiting room or emailed a link to a portal before the session so that he can fill out the form on his own? If so, will the doctor remember to check the assessment tool and address mental health concerns that Ryan identifies? It may well prove to be a mixed bag, but let’s hope that universal screening tools open the door for more young people to have their mental health concerns addressed in comprehensive and appropriate ways.

Dr. Miller is the coauthor of “Committed: The Battle Over Involuntary Psychiatric Care,” (Baltimore: Johns Hopkins University Press, 2016).

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When 14-year-old Ryan saw his pediatrician for his annual physical this past August, he was asked a few quick questions about whether he was having any problems, if he was feeling depressed or anxious, and if there was anything he wanted to discuss. Ryan said no to each question, then the doctor examined him, reminded him to get a flu shot, and signed off on the forms he needed to play team sports in high school. The doctor assured Ryan’s mother that he was healthy, and the visit was over. Next August, Ryan’s exam will likely include a more detailed look at his mental health.

In February 2018, the American Academy of Pediatrics updated its guidelines on screening for depression in adolescents in primary care settings. The guidelines address the problem of undiagnosed and untreated psychiatric illness in children over the age of 10 years, the shortage of available mental health professionals, and techniques primary care physicians might use to address psychiatric needs in adolescents. The AAP guidelines include a new recommendation for universal screening with an assessment tool: “Adolescent patients ages 12 years and older should be screened annually for depression [MDD or depressive disorders] with a formal self-report screening tool either on paper or electronically.”

KatarzynaBialasiewicz/Thinkstock
Howard Liu, MD, is a child and adolescent psychiatrist and the interim chair of psychiatry at the University of Nebraska, Omaha, and director of the Behavioral Health Education Center of Nebraska. “I applaud the AAP for recommending universal depression screening for teenagers, as there has been a rising incidence of teen suicide, especially among female adolescents,” he said. “However, when teens screen positive, we must invest in the child mental health infrastructure to support pediatricians. This includes therapists integrated into primary care practices and prescribers with the capacity to take new patients or practice collaborative care.”

Dr. Liu noted that some of his patients drive 4-5 hours each way to see him in Omaha, then spend the night before making the return trip. “There is a dire shortage of pediatric mental health services in every state. This shifts the responsibility for care to pediatricians, teachers, and parents who often lack the resources to keep kids safe and well. It’s an unconscionable gap in care.”

Dr. Howard Liu
Timothy F. Doran, MD, is chair of pediatrics at the Greater Baltimore Medical Center in Towson, Md., and a past president of the Maryland Chapter of the AAP. “I absolutely think every teenager should be assessed for depression,” he said. With his own patients, he asks open-ended questions about their mental health, then more specific questions about mood, depression, anxiety, sleep, appetite, and libido. If the teen indicates there are problems, he then uses a PHQ-9 to get a sense of whether the depression is mild, moderate, or severe. Dr. Doran estimates that he diagnoses depression in 5%-10% of the adolescents he screens. Baltimore is a metropolitan area with two psychiatry training programs, and Dr. Doran has developed relationships with mental health professionals who will see his patients. If he prescribes an antidepressant, most of those patients will also see a psychotherapist. He notes that it can be more difficult to find resources for children with Medicaid who do not have the resources of some of the families he treats.

Dr. Doran’s practice has not yet implemented the use of a written screening tool for all adolescents. He anticipates doing this soon because of the new guidelines, but he was not enthusiastic about the prospect. “I think I’m catching the kids with depression, and having every child fill out a questionnaire will be an added burden. We are already loaded down with administrative tasks and screening requirements.” Of note, in Dr. Doran’s 35 years in clinical practice, no child under his care has died of suicide.

Dr. Allen Frances
Allen Frances, MD, offers a different take on the new guidelines. Dr. Frances was the chairman of the DSM-IV task force and is the author of “Saving Normal: An Insider’s Revolt Against Out-of-Control Psychiatric Diagnosis, DSM-5, Big Pharma, and the Medicalization of Ordinary Life” (New York: HarperCollins, 2014). Dr. Frances has used his Twitter feed to express his objections to the new guidelines for universal depression screening for teenagers. “Universal mental health screening of children sounds virtuous but is a big mistake. Massive overdiagnosis results in 1) Too much ineffective/unsafe #medication; 2) Needless #stigma; 3) Wasting precious resources. Instead, provide easy access to treatment for kids who really need it.” He goes on to tweet about unintended consequences of universal screening, including the concern that screening may identify teens with normal transient sadness or substance-induced mood changes as being clinically depressed. In Twitter lingo, Dr. Frances continues: “‘Early-warning signs of mental illness in kids are often false alarms leading to unneeded #medication/#stigma. Also, we don’t provide adequate psych care for kids who desperately need it. It makes no sense to create new fake patients when we are neglecting the real ones we already have.”

 

 


Dr. Dinah Miller
It will be interesting to see what happens when Ryan goes for a physical next year. Will the pediatrician devote time to a screening form to document psychiatric symptoms? Will that divert time and attention away from concerns that might be more important to Ryan or his parents? Will he be handed an iPad in the waiting room or emailed a link to a portal before the session so that he can fill out the form on his own? If so, will the doctor remember to check the assessment tool and address mental health concerns that Ryan identifies? It may well prove to be a mixed bag, but let’s hope that universal screening tools open the door for more young people to have their mental health concerns addressed in comprehensive and appropriate ways.

Dr. Miller is the coauthor of “Committed: The Battle Over Involuntary Psychiatric Care,” (Baltimore: Johns Hopkins University Press, 2016).

 

When 14-year-old Ryan saw his pediatrician for his annual physical this past August, he was asked a few quick questions about whether he was having any problems, if he was feeling depressed or anxious, and if there was anything he wanted to discuss. Ryan said no to each question, then the doctor examined him, reminded him to get a flu shot, and signed off on the forms he needed to play team sports in high school. The doctor assured Ryan’s mother that he was healthy, and the visit was over. Next August, Ryan’s exam will likely include a more detailed look at his mental health.

In February 2018, the American Academy of Pediatrics updated its guidelines on screening for depression in adolescents in primary care settings. The guidelines address the problem of undiagnosed and untreated psychiatric illness in children over the age of 10 years, the shortage of available mental health professionals, and techniques primary care physicians might use to address psychiatric needs in adolescents. The AAP guidelines include a new recommendation for universal screening with an assessment tool: “Adolescent patients ages 12 years and older should be screened annually for depression [MDD or depressive disorders] with a formal self-report screening tool either on paper or electronically.”

KatarzynaBialasiewicz/Thinkstock
Howard Liu, MD, is a child and adolescent psychiatrist and the interim chair of psychiatry at the University of Nebraska, Omaha, and director of the Behavioral Health Education Center of Nebraska. “I applaud the AAP for recommending universal depression screening for teenagers, as there has been a rising incidence of teen suicide, especially among female adolescents,” he said. “However, when teens screen positive, we must invest in the child mental health infrastructure to support pediatricians. This includes therapists integrated into primary care practices and prescribers with the capacity to take new patients or practice collaborative care.”

Dr. Liu noted that some of his patients drive 4-5 hours each way to see him in Omaha, then spend the night before making the return trip. “There is a dire shortage of pediatric mental health services in every state. This shifts the responsibility for care to pediatricians, teachers, and parents who often lack the resources to keep kids safe and well. It’s an unconscionable gap in care.”

Dr. Howard Liu
Timothy F. Doran, MD, is chair of pediatrics at the Greater Baltimore Medical Center in Towson, Md., and a past president of the Maryland Chapter of the AAP. “I absolutely think every teenager should be assessed for depression,” he said. With his own patients, he asks open-ended questions about their mental health, then more specific questions about mood, depression, anxiety, sleep, appetite, and libido. If the teen indicates there are problems, he then uses a PHQ-9 to get a sense of whether the depression is mild, moderate, or severe. Dr. Doran estimates that he diagnoses depression in 5%-10% of the adolescents he screens. Baltimore is a metropolitan area with two psychiatry training programs, and Dr. Doran has developed relationships with mental health professionals who will see his patients. If he prescribes an antidepressant, most of those patients will also see a psychotherapist. He notes that it can be more difficult to find resources for children with Medicaid who do not have the resources of some of the families he treats.

Dr. Doran’s practice has not yet implemented the use of a written screening tool for all adolescents. He anticipates doing this soon because of the new guidelines, but he was not enthusiastic about the prospect. “I think I’m catching the kids with depression, and having every child fill out a questionnaire will be an added burden. We are already loaded down with administrative tasks and screening requirements.” Of note, in Dr. Doran’s 35 years in clinical practice, no child under his care has died of suicide.

Dr. Allen Frances
Allen Frances, MD, offers a different take on the new guidelines. Dr. Frances was the chairman of the DSM-IV task force and is the author of “Saving Normal: An Insider’s Revolt Against Out-of-Control Psychiatric Diagnosis, DSM-5, Big Pharma, and the Medicalization of Ordinary Life” (New York: HarperCollins, 2014). Dr. Frances has used his Twitter feed to express his objections to the new guidelines for universal depression screening for teenagers. “Universal mental health screening of children sounds virtuous but is a big mistake. Massive overdiagnosis results in 1) Too much ineffective/unsafe #medication; 2) Needless #stigma; 3) Wasting precious resources. Instead, provide easy access to treatment for kids who really need it.” He goes on to tweet about unintended consequences of universal screening, including the concern that screening may identify teens with normal transient sadness or substance-induced mood changes as being clinically depressed. In Twitter lingo, Dr. Frances continues: “‘Early-warning signs of mental illness in kids are often false alarms leading to unneeded #medication/#stigma. Also, we don’t provide adequate psych care for kids who desperately need it. It makes no sense to create new fake patients when we are neglecting the real ones we already have.”

 

 


Dr. Dinah Miller
It will be interesting to see what happens when Ryan goes for a physical next year. Will the pediatrician devote time to a screening form to document psychiatric symptoms? Will that divert time and attention away from concerns that might be more important to Ryan or his parents? Will he be handed an iPad in the waiting room or emailed a link to a portal before the session so that he can fill out the form on his own? If so, will the doctor remember to check the assessment tool and address mental health concerns that Ryan identifies? It may well prove to be a mixed bag, but let’s hope that universal screening tools open the door for more young people to have their mental health concerns addressed in comprehensive and appropriate ways.

Dr. Miller is the coauthor of “Committed: The Battle Over Involuntary Psychiatric Care,” (Baltimore: Johns Hopkins University Press, 2016).

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Impacting careers, impacting patient care

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Thank you for all you do to champion lung health. Your donation supports projects, such as grant funding, which are boosting patient outcomes, improving community health, and advancing the research that continues to enhance the journey for those facing pulmonary illnesses. Each year, your generosity funds more than $550,000 in clinical research and community service grants, allowing CHEST members to develop and implement their ideas through securing preliminary data support, distinguishing themselves among their colleagues, and advancing chest medicine toward medical breakthroughs.

One such story of the advancements being made in communities around the world begins in New York City.

Kids in urban settings are disproportionately affected by asthma. Although we know that being active is good for respiratory health, in an urban setting, children may be breathing in more pollutants. In inner city neighborhoods playgrounds are often next to major highways or industrial areas. These recreational areas may be increasing the risk of developing pulmonary diseases. This is a prime example of why researchers like Dr. Stephanie Lovinsky-Desir are working to find a solution to champion lunch health.

Dr. Lovinsky-Desir is a pediatric pulmonologist based at Columbia University and the recipient of the CHEST Diversity and Young Investigator Award in 2014 for her project on Urban Tree Canopy Exposure, DNA Methylation, and Allergies in Pediatric Asthma. The grant helped launch her into the research that she is most passionate about – asthma and health disparities in urban populations.

As Stephanie can attest, junior faculty often struggle to find funding for their research, especially when focusing on disparities, diversity, and socioeconomic factors that affect public health. “A lot of people can’t take the risk to pursue higher-risk careers like research, because they don’t have seed funding that allows them to dive into bigger awards or research grants.”

She made it her mission to find funding at the beginning of her research, so she could establish her reputation as a researcher and continue to receive further funding. Her plan began to fall into place when she applied for, and won, the CHEST Diversity and Young Investigator Award. Dr. Lovinsky believes the CHEST Foundation grant is what launched her research. “Much of my success in getting grant funding is because I was awarded grants in the past! Once you start getting them and conducting research that produces meaningful results, you keep getting more, and it really starts to snowball. The CHEST Foundation award was the first award I as a Principal Investigator —my idea, my metrics. I feel so proud to have accomplished this.”

The findings she concluded from her CHEST diversity grant research allowed her to modify her study and receive the following awards: an award through her institution, the National Institute of Health KL2 award, and multiple awards including an NIH K01, a children’s scholar award, and the Harold Amos Medical Faculty Development Award. Stephanie is excited for her future research after recently receiving a very competitive score from her NIHK. She believes the CHEST Foundation award jump started her research career, and these other successes have resulted from it. “It’s more than a research project. We are building a research program.” Her current research involves exploring epigenetic mechanisms, particularly DNA methylation, in pediatric and adult allergic asthmatics, as well as understanding the effects of environmental pollutants on asthma, activity, and obesity.

 

 


Though Dr. Lovinsky’s career as a researcher grew from the foundation grant, she says, “The benefit of this award specifically was the gateway to the CHEST Foundation and all of the other opportunities within CHEST.” She is actively involved in the Diversity and Inclusion Task Force and brings many ideas to the table for the future of the CHEST Foundation. “I am committed to being involved with CHEST because of how much the organization has impacted my career. I enjoy giving back by participating in the task force.” Her clinical research and involvement in CHEST demonstrates the direct impact your generous support has on physicians, patients, and lung health.

Thank you for making important research like this possible. Your generosity is the catalyst for change in a world where lung diseases are ranking as one of the top causes of death for men and women everywhere. You’re improving patient outcomes every day, and we thank you from the bottom of our hearts.

Your continued support will make it possible for the next generation of researchers to launch their careers. You can be a Champion for Lung Health and DONATE today through a new gift to the CHEST Foundation. We can meet our goals for the health professionals, patients, and caregivers we serve with your much appreciated and essential support.

To donate:

 

 

Web: chestfoundation.org/donate

Phone:224/521-9527

Again, thank you for all you do to improve patient outcomes. You are the lung health champions that patients and families count on to positively impact lung health.


Lisa K. Moores, MD, FCCP

President & Trustee

Mike E. Nelson, MD, FCCP

Immediate Past President & Trustee

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Thank you for all you do to champion lung health. Your donation supports projects, such as grant funding, which are boosting patient outcomes, improving community health, and advancing the research that continues to enhance the journey for those facing pulmonary illnesses. Each year, your generosity funds more than $550,000 in clinical research and community service grants, allowing CHEST members to develop and implement their ideas through securing preliminary data support, distinguishing themselves among their colleagues, and advancing chest medicine toward medical breakthroughs.

One such story of the advancements being made in communities around the world begins in New York City.

Kids in urban settings are disproportionately affected by asthma. Although we know that being active is good for respiratory health, in an urban setting, children may be breathing in more pollutants. In inner city neighborhoods playgrounds are often next to major highways or industrial areas. These recreational areas may be increasing the risk of developing pulmonary diseases. This is a prime example of why researchers like Dr. Stephanie Lovinsky-Desir are working to find a solution to champion lunch health.

Dr. Lovinsky-Desir is a pediatric pulmonologist based at Columbia University and the recipient of the CHEST Diversity and Young Investigator Award in 2014 for her project on Urban Tree Canopy Exposure, DNA Methylation, and Allergies in Pediatric Asthma. The grant helped launch her into the research that she is most passionate about – asthma and health disparities in urban populations.

As Stephanie can attest, junior faculty often struggle to find funding for their research, especially when focusing on disparities, diversity, and socioeconomic factors that affect public health. “A lot of people can’t take the risk to pursue higher-risk careers like research, because they don’t have seed funding that allows them to dive into bigger awards or research grants.”

She made it her mission to find funding at the beginning of her research, so she could establish her reputation as a researcher and continue to receive further funding. Her plan began to fall into place when she applied for, and won, the CHEST Diversity and Young Investigator Award. Dr. Lovinsky believes the CHEST Foundation grant is what launched her research. “Much of my success in getting grant funding is because I was awarded grants in the past! Once you start getting them and conducting research that produces meaningful results, you keep getting more, and it really starts to snowball. The CHEST Foundation award was the first award I as a Principal Investigator —my idea, my metrics. I feel so proud to have accomplished this.”

The findings she concluded from her CHEST diversity grant research allowed her to modify her study and receive the following awards: an award through her institution, the National Institute of Health KL2 award, and multiple awards including an NIH K01, a children’s scholar award, and the Harold Amos Medical Faculty Development Award. Stephanie is excited for her future research after recently receiving a very competitive score from her NIHK. She believes the CHEST Foundation award jump started her research career, and these other successes have resulted from it. “It’s more than a research project. We are building a research program.” Her current research involves exploring epigenetic mechanisms, particularly DNA methylation, in pediatric and adult allergic asthmatics, as well as understanding the effects of environmental pollutants on asthma, activity, and obesity.

 

 


Though Dr. Lovinsky’s career as a researcher grew from the foundation grant, she says, “The benefit of this award specifically was the gateway to the CHEST Foundation and all of the other opportunities within CHEST.” She is actively involved in the Diversity and Inclusion Task Force and brings many ideas to the table for the future of the CHEST Foundation. “I am committed to being involved with CHEST because of how much the organization has impacted my career. I enjoy giving back by participating in the task force.” Her clinical research and involvement in CHEST demonstrates the direct impact your generous support has on physicians, patients, and lung health.

Thank you for making important research like this possible. Your generosity is the catalyst for change in a world where lung diseases are ranking as one of the top causes of death for men and women everywhere. You’re improving patient outcomes every day, and we thank you from the bottom of our hearts.

Your continued support will make it possible for the next generation of researchers to launch their careers. You can be a Champion for Lung Health and DONATE today through a new gift to the CHEST Foundation. We can meet our goals for the health professionals, patients, and caregivers we serve with your much appreciated and essential support.

To donate:

 

 

Web: chestfoundation.org/donate

Phone:224/521-9527

Again, thank you for all you do to improve patient outcomes. You are the lung health champions that patients and families count on to positively impact lung health.


Lisa K. Moores, MD, FCCP

President & Trustee

Mike E. Nelson, MD, FCCP

Immediate Past President & Trustee

 

Thank you for all you do to champion lung health. Your donation supports projects, such as grant funding, which are boosting patient outcomes, improving community health, and advancing the research that continues to enhance the journey for those facing pulmonary illnesses. Each year, your generosity funds more than $550,000 in clinical research and community service grants, allowing CHEST members to develop and implement their ideas through securing preliminary data support, distinguishing themselves among their colleagues, and advancing chest medicine toward medical breakthroughs.

One such story of the advancements being made in communities around the world begins in New York City.

Kids in urban settings are disproportionately affected by asthma. Although we know that being active is good for respiratory health, in an urban setting, children may be breathing in more pollutants. In inner city neighborhoods playgrounds are often next to major highways or industrial areas. These recreational areas may be increasing the risk of developing pulmonary diseases. This is a prime example of why researchers like Dr. Stephanie Lovinsky-Desir are working to find a solution to champion lunch health.

Dr. Lovinsky-Desir is a pediatric pulmonologist based at Columbia University and the recipient of the CHEST Diversity and Young Investigator Award in 2014 for her project on Urban Tree Canopy Exposure, DNA Methylation, and Allergies in Pediatric Asthma. The grant helped launch her into the research that she is most passionate about – asthma and health disparities in urban populations.

As Stephanie can attest, junior faculty often struggle to find funding for their research, especially when focusing on disparities, diversity, and socioeconomic factors that affect public health. “A lot of people can’t take the risk to pursue higher-risk careers like research, because they don’t have seed funding that allows them to dive into bigger awards or research grants.”

She made it her mission to find funding at the beginning of her research, so she could establish her reputation as a researcher and continue to receive further funding. Her plan began to fall into place when she applied for, and won, the CHEST Diversity and Young Investigator Award. Dr. Lovinsky believes the CHEST Foundation grant is what launched her research. “Much of my success in getting grant funding is because I was awarded grants in the past! Once you start getting them and conducting research that produces meaningful results, you keep getting more, and it really starts to snowball. The CHEST Foundation award was the first award I as a Principal Investigator —my idea, my metrics. I feel so proud to have accomplished this.”

The findings she concluded from her CHEST diversity grant research allowed her to modify her study and receive the following awards: an award through her institution, the National Institute of Health KL2 award, and multiple awards including an NIH K01, a children’s scholar award, and the Harold Amos Medical Faculty Development Award. Stephanie is excited for her future research after recently receiving a very competitive score from her NIHK. She believes the CHEST Foundation award jump started her research career, and these other successes have resulted from it. “It’s more than a research project. We are building a research program.” Her current research involves exploring epigenetic mechanisms, particularly DNA methylation, in pediatric and adult allergic asthmatics, as well as understanding the effects of environmental pollutants on asthma, activity, and obesity.

 

 


Though Dr. Lovinsky’s career as a researcher grew from the foundation grant, she says, “The benefit of this award specifically was the gateway to the CHEST Foundation and all of the other opportunities within CHEST.” She is actively involved in the Diversity and Inclusion Task Force and brings many ideas to the table for the future of the CHEST Foundation. “I am committed to being involved with CHEST because of how much the organization has impacted my career. I enjoy giving back by participating in the task force.” Her clinical research and involvement in CHEST demonstrates the direct impact your generous support has on physicians, patients, and lung health.

Thank you for making important research like this possible. Your generosity is the catalyst for change in a world where lung diseases are ranking as one of the top causes of death for men and women everywhere. You’re improving patient outcomes every day, and we thank you from the bottom of our hearts.

Your continued support will make it possible for the next generation of researchers to launch their careers. You can be a Champion for Lung Health and DONATE today through a new gift to the CHEST Foundation. We can meet our goals for the health professionals, patients, and caregivers we serve with your much appreciated and essential support.

To donate:

 

 

Web: chestfoundation.org/donate

Phone:224/521-9527

Again, thank you for all you do to improve patient outcomes. You are the lung health champions that patients and families count on to positively impact lung health.


Lisa K. Moores, MD, FCCP

President & Trustee

Mike E. Nelson, MD, FCCP

Immediate Past President & Trustee

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AACN releases expert consensus statement on teleICU nursing practice

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Tue, 10/23/2018 - 16:09

 

To remain at the forefront of expanding evidence-based practices in all aspects of critical care, facilities must include teleICUs.

In 2013, the American Association of Critical-Care Nurses (AACN) first defined standards for the emerging telenursing practice in the ICU and has recently published an update, AACN TeleICU Nursing Practice: An Expert Consensus Statement Supporting High Acuity, Progressive and Critical Care.1

The new consensus statement, which creates a framework for implementing, evaluating, and improving teleICU nursing practice, addresses the new findings in this fast-growing area of health care. It also establishes a model for achieving excellence and optimal patient care outcomes through the following:

• Shared knowledge and goals

• Mutual respect

• Skilled communication

• True collaboration

• Authentic leadership

• Optimized technology

• Practice excellence

A 12-person task force, including teleICU nurse leaders, contributed to the statement and brought a fresh perspective to this area of practice.


Task force co-chair Pat Herr, clinical integration director of eCARE ICU at Avera Health, says it was important to harness the energy and lessons learned from experienced teleICU leaders.

“TeleICUs continue to evolve to meet the needs of patients and health systems,” Herr adds. “New technology options and new partnership models are available, and nurse leaders play an important part in using these tools to improve patient care.”

The earliest teleICU design concepts employed a physician-only model of care, but it quickly became clear that critical-care nursing was a necessary component. Today, the most effective teleICU models implement collaborative care that includes physicians, nurses, information technology, and administrative support personnel.Opportunities in teleICU are one way to retain knowledgeable nurses, who can bridge clinical expertise gaps and provide an additional layer of skilled critical care. TeleICU care ensures delivery of both optimal patient outcomes and timely knowledge to support physicians, nurses, and the entire bedside care team.

Task force member Lisa-Mae Williams, operations director of telehealth and eICU at Baptist Health South Florida, says telemedicine doesn’t mean fewer jobs for bedside nurses; it’s an extra set of eyes to surveil vitals and support a clinical workforce that may be stretched thin.


“At the bedside, when teleICU came to my unit, I was very skeptical,” Williams recalls. “But after seeing for myself what those extra nurses brought to the table – the available technology and time they had to assess trends and really delve into what’s going on – it turned out to be the best tool to care for our patients.”

In addition to knowledge gaps, nurse turnover is on the rise, according to the “2017 Survey of Registered Nurses: Viewpoints on Leadership, Nursing, Shortages and Their Profession” from AMN Healthcare, San Diego.2 The survey also finds that more than one in four nurses plan to retire within a year, and 73% of baby boomers expect to retire in 3 years or less.

The shortfall is already more pronounced in rural hospitals facing staffing challenges and in specialty areas where additional education, training, and experience are critical to improve patient safety and outcomes.

The expertise and dynamic, front-line viewpoint of teleICU experts has resulted in a comprehensive, patient-centric update. Their experience delivering both bedside and remote care was instrumental in developing valuable clinical scenarios. The scenarios in the statement are genuine examples of how each key recommendation is implemented by physicians and bedside and teleICU nurses to provide continuity of care; identify high-risk patients; and decrease mortality rates by filling gaps in monitoring and staff expertise.

 

 


As a leader in the delivery of evidence-based practices, AACN offers CCRN-E specialty certification3 for nurses who primarily provide acute or critical care for adult patients in a teleICU setting, which is connected to the bedside via audiovisual communication and computer systems. Visit www.aacn.org > Certification > Get Certified > CCRN-E Adult to learn more.

The expert consensus statement is available for AACN members to download or to purchase a hard copy.4

References

1. https://www.aacn.org/nursing-excellence/standards/aacn-teleicu-nursing-consensus-statement

2. https://www.amnhealthcare.com/uploadedFiles/MainSite/Content/Campaigns/AMN%20Healthcare%202017%20RN%20Survey%20-%20Full%20Report.pdf 3. https://www.aacn.org/certification/get-certified/ccrn-e-adult

4. https://www.aacn.org/nursing-excellence/standards/aacn-teleicu-nursing-consensus-statement

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To remain at the forefront of expanding evidence-based practices in all aspects of critical care, facilities must include teleICUs.

In 2013, the American Association of Critical-Care Nurses (AACN) first defined standards for the emerging telenursing practice in the ICU and has recently published an update, AACN TeleICU Nursing Practice: An Expert Consensus Statement Supporting High Acuity, Progressive and Critical Care.1

The new consensus statement, which creates a framework for implementing, evaluating, and improving teleICU nursing practice, addresses the new findings in this fast-growing area of health care. It also establishes a model for achieving excellence and optimal patient care outcomes through the following:

• Shared knowledge and goals

• Mutual respect

• Skilled communication

• True collaboration

• Authentic leadership

• Optimized technology

• Practice excellence

A 12-person task force, including teleICU nurse leaders, contributed to the statement and brought a fresh perspective to this area of practice.


Task force co-chair Pat Herr, clinical integration director of eCARE ICU at Avera Health, says it was important to harness the energy and lessons learned from experienced teleICU leaders.

“TeleICUs continue to evolve to meet the needs of patients and health systems,” Herr adds. “New technology options and new partnership models are available, and nurse leaders play an important part in using these tools to improve patient care.”

The earliest teleICU design concepts employed a physician-only model of care, but it quickly became clear that critical-care nursing was a necessary component. Today, the most effective teleICU models implement collaborative care that includes physicians, nurses, information technology, and administrative support personnel.Opportunities in teleICU are one way to retain knowledgeable nurses, who can bridge clinical expertise gaps and provide an additional layer of skilled critical care. TeleICU care ensures delivery of both optimal patient outcomes and timely knowledge to support physicians, nurses, and the entire bedside care team.

Task force member Lisa-Mae Williams, operations director of telehealth and eICU at Baptist Health South Florida, says telemedicine doesn’t mean fewer jobs for bedside nurses; it’s an extra set of eyes to surveil vitals and support a clinical workforce that may be stretched thin.


“At the bedside, when teleICU came to my unit, I was very skeptical,” Williams recalls. “But after seeing for myself what those extra nurses brought to the table – the available technology and time they had to assess trends and really delve into what’s going on – it turned out to be the best tool to care for our patients.”

In addition to knowledge gaps, nurse turnover is on the rise, according to the “2017 Survey of Registered Nurses: Viewpoints on Leadership, Nursing, Shortages and Their Profession” from AMN Healthcare, San Diego.2 The survey also finds that more than one in four nurses plan to retire within a year, and 73% of baby boomers expect to retire in 3 years or less.

The shortfall is already more pronounced in rural hospitals facing staffing challenges and in specialty areas where additional education, training, and experience are critical to improve patient safety and outcomes.

The expertise and dynamic, front-line viewpoint of teleICU experts has resulted in a comprehensive, patient-centric update. Their experience delivering both bedside and remote care was instrumental in developing valuable clinical scenarios. The scenarios in the statement are genuine examples of how each key recommendation is implemented by physicians and bedside and teleICU nurses to provide continuity of care; identify high-risk patients; and decrease mortality rates by filling gaps in monitoring and staff expertise.

 

 


As a leader in the delivery of evidence-based practices, AACN offers CCRN-E specialty certification3 for nurses who primarily provide acute or critical care for adult patients in a teleICU setting, which is connected to the bedside via audiovisual communication and computer systems. Visit www.aacn.org > Certification > Get Certified > CCRN-E Adult to learn more.

The expert consensus statement is available for AACN members to download or to purchase a hard copy.4

References

1. https://www.aacn.org/nursing-excellence/standards/aacn-teleicu-nursing-consensus-statement

2. https://www.amnhealthcare.com/uploadedFiles/MainSite/Content/Campaigns/AMN%20Healthcare%202017%20RN%20Survey%20-%20Full%20Report.pdf 3. https://www.aacn.org/certification/get-certified/ccrn-e-adult

4. https://www.aacn.org/nursing-excellence/standards/aacn-teleicu-nursing-consensus-statement

 

To remain at the forefront of expanding evidence-based practices in all aspects of critical care, facilities must include teleICUs.

In 2013, the American Association of Critical-Care Nurses (AACN) first defined standards for the emerging telenursing practice in the ICU and has recently published an update, AACN TeleICU Nursing Practice: An Expert Consensus Statement Supporting High Acuity, Progressive and Critical Care.1

The new consensus statement, which creates a framework for implementing, evaluating, and improving teleICU nursing practice, addresses the new findings in this fast-growing area of health care. It also establishes a model for achieving excellence and optimal patient care outcomes through the following:

• Shared knowledge and goals

• Mutual respect

• Skilled communication

• True collaboration

• Authentic leadership

• Optimized technology

• Practice excellence

A 12-person task force, including teleICU nurse leaders, contributed to the statement and brought a fresh perspective to this area of practice.


Task force co-chair Pat Herr, clinical integration director of eCARE ICU at Avera Health, says it was important to harness the energy and lessons learned from experienced teleICU leaders.

“TeleICUs continue to evolve to meet the needs of patients and health systems,” Herr adds. “New technology options and new partnership models are available, and nurse leaders play an important part in using these tools to improve patient care.”

The earliest teleICU design concepts employed a physician-only model of care, but it quickly became clear that critical-care nursing was a necessary component. Today, the most effective teleICU models implement collaborative care that includes physicians, nurses, information technology, and administrative support personnel.Opportunities in teleICU are one way to retain knowledgeable nurses, who can bridge clinical expertise gaps and provide an additional layer of skilled critical care. TeleICU care ensures delivery of both optimal patient outcomes and timely knowledge to support physicians, nurses, and the entire bedside care team.

Task force member Lisa-Mae Williams, operations director of telehealth and eICU at Baptist Health South Florida, says telemedicine doesn’t mean fewer jobs for bedside nurses; it’s an extra set of eyes to surveil vitals and support a clinical workforce that may be stretched thin.


“At the bedside, when teleICU came to my unit, I was very skeptical,” Williams recalls. “But after seeing for myself what those extra nurses brought to the table – the available technology and time they had to assess trends and really delve into what’s going on – it turned out to be the best tool to care for our patients.”

In addition to knowledge gaps, nurse turnover is on the rise, according to the “2017 Survey of Registered Nurses: Viewpoints on Leadership, Nursing, Shortages and Their Profession” from AMN Healthcare, San Diego.2 The survey also finds that more than one in four nurses plan to retire within a year, and 73% of baby boomers expect to retire in 3 years or less.

The shortfall is already more pronounced in rural hospitals facing staffing challenges and in specialty areas where additional education, training, and experience are critical to improve patient safety and outcomes.

The expertise and dynamic, front-line viewpoint of teleICU experts has resulted in a comprehensive, patient-centric update. Their experience delivering both bedside and remote care was instrumental in developing valuable clinical scenarios. The scenarios in the statement are genuine examples of how each key recommendation is implemented by physicians and bedside and teleICU nurses to provide continuity of care; identify high-risk patients; and decrease mortality rates by filling gaps in monitoring and staff expertise.

 

 


As a leader in the delivery of evidence-based practices, AACN offers CCRN-E specialty certification3 for nurses who primarily provide acute or critical care for adult patients in a teleICU setting, which is connected to the bedside via audiovisual communication and computer systems. Visit www.aacn.org > Certification > Get Certified > CCRN-E Adult to learn more.

The expert consensus statement is available for AACN members to download or to purchase a hard copy.4

References

1. https://www.aacn.org/nursing-excellence/standards/aacn-teleicu-nursing-consensus-statement

2. https://www.amnhealthcare.com/uploadedFiles/MainSite/Content/Campaigns/AMN%20Healthcare%202017%20RN%20Survey%20-%20Full%20Report.pdf 3. https://www.aacn.org/certification/get-certified/ccrn-e-adult

4. https://www.aacn.org/nursing-excellence/standards/aacn-teleicu-nursing-consensus-statement

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Update: FDA workshop on medical devices for SDB

Article Type
Changed
Tue, 10/23/2018 - 16:09

 

Drs. Neil Freedman and Barbara Phillips represented CHEST at an FDA workshop on April 16 on “Study Design Considerations for Devices Including Digital Health Technologies for Sleep-Disordered Breathing (SDB) in Adults. The other organizational participants were The American Academy of Dental Sleep Medicine; The American Academy of Neurology; the American Academy of Otolaryngology, Head and Neck Surgery; The American Academy of Sleep Medicine; and The American Sleep Apnea Association. Here are the questions that the FDA asked the panelists:

1. FDA is seeking to promote innovation and expedite the clinical development of devices intended for the diagnosis and treatment of sleep-disordered breathing (SDB). How should the following conditions (including their severity, eg, mild, moderate, severe, if appropriate) be defined for the purpose of creating appropriate inclusion/exclusion criteria for a clinical study for SDB devices?

a. Apnea

b. Hypopnea

c. Sleep-Disordered Breathing (SDB)

d. Obstructive Sleep Apnea Syndrome (OSAS)

e. Central Sleep Apnea Syndrome (CSAS)

f. Primary Snoring

 

 

2. Polysomnography (PSG) has been widely accepted as the “gold standard” test for the diagnosis of OSA and primary snoring. However, home sleep apnea testing (HSAT) has emerged in recent years as an alternative or complementary diagnostic tool for SDB.

a. Can HSAT be used for establishing a baseline diagnosis and for the collection of clinical performance data for device trials for OSA, CSA, or primary snoring? If so, what are the recommended parameters that should be collected by an HSAT (eg, nasal pressure, oximetry, chest and abdominal respiratory inductance plethysmography)?

b. What constitutes a technically adequate test (either PSG or HSAT, if appropriate) for establishing a baseline diagnosis of SDB for device studies (eg, number of hours, number of nights)?

 

 

3. FDA has received an increasing number of premarket applications for devices intended to treat SDB. How should studies for the various technologies (eg, intra-oral appliances, externally worn devices, electrosurgical devices for tissue reduction, and passive or active implantable devices of the upper airway) be designed with respect to the following factors (please consider whether your recommendations would vary if the device was an implant vs an externally worn device):

a. What is the most appropriate control group (eg, comparison to baseline measures, randomization to a concurrent control group)?

b. What is the minimum duration of the study? For implants and surgical procedures, how long after the intervention should the effectiveness endpoint be assessed?

c. What objective parameter or combination of parameters should be used for the primary effectiveness endpoints (eg, AHI, ODI, T90, or other non-PSG/HSAT parameters)?


d. What would be a clinically meaningful difference for the above primary effectiveness endpoint(s) between/among study arms or within a study arm?

e. What patient-reported outcomes (PROs) are appropriate in the evaluation of SDB devices?

 

 

4. What are the safety and effectiveness concerns when a digital health device provides a diagnosis and monitoring of SDB?

a. What factors are important in developing a reference database (eg, demographics, validation)?b. What are the important safety and effectiveness concerns for SDB digital health devices used in the following settings:

i. A physician office or sleep center environment?

ii. A nonclinical environment?

iii. Prescription vs OTC use?

There was significant discussion and quite a bit of controversy. Among the recommendations to the FDA were that home testing is adequate and acceptable for clinical trials, that the ODI4 is more predictive and reliable than the AHI, and that the syndrome of OSAHS includes symptoms, one of the most important of which is sleepiness. It was acknowledged that digital health devices have the potential to greatly increase access to diagnosis, but access to treatment will need to be addressed, as well. I think this was a very important meeting, and the outcome will likely impact our members. The ultimate goal is to publish a paper about recommended techniques, outcomes, and inclusion characteristics/definitions to be used in clinical trials for new devices to diagnose or treat sleep apnea.

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Drs. Neil Freedman and Barbara Phillips represented CHEST at an FDA workshop on April 16 on “Study Design Considerations for Devices Including Digital Health Technologies for Sleep-Disordered Breathing (SDB) in Adults. The other organizational participants were The American Academy of Dental Sleep Medicine; The American Academy of Neurology; the American Academy of Otolaryngology, Head and Neck Surgery; The American Academy of Sleep Medicine; and The American Sleep Apnea Association. Here are the questions that the FDA asked the panelists:

1. FDA is seeking to promote innovation and expedite the clinical development of devices intended for the diagnosis and treatment of sleep-disordered breathing (SDB). How should the following conditions (including their severity, eg, mild, moderate, severe, if appropriate) be defined for the purpose of creating appropriate inclusion/exclusion criteria for a clinical study for SDB devices?

a. Apnea

b. Hypopnea

c. Sleep-Disordered Breathing (SDB)

d. Obstructive Sleep Apnea Syndrome (OSAS)

e. Central Sleep Apnea Syndrome (CSAS)

f. Primary Snoring

 

 

2. Polysomnography (PSG) has been widely accepted as the “gold standard” test for the diagnosis of OSA and primary snoring. However, home sleep apnea testing (HSAT) has emerged in recent years as an alternative or complementary diagnostic tool for SDB.

a. Can HSAT be used for establishing a baseline diagnosis and for the collection of clinical performance data for device trials for OSA, CSA, or primary snoring? If so, what are the recommended parameters that should be collected by an HSAT (eg, nasal pressure, oximetry, chest and abdominal respiratory inductance plethysmography)?

b. What constitutes a technically adequate test (either PSG or HSAT, if appropriate) for establishing a baseline diagnosis of SDB for device studies (eg, number of hours, number of nights)?

 

 

3. FDA has received an increasing number of premarket applications for devices intended to treat SDB. How should studies for the various technologies (eg, intra-oral appliances, externally worn devices, electrosurgical devices for tissue reduction, and passive or active implantable devices of the upper airway) be designed with respect to the following factors (please consider whether your recommendations would vary if the device was an implant vs an externally worn device):

a. What is the most appropriate control group (eg, comparison to baseline measures, randomization to a concurrent control group)?

b. What is the minimum duration of the study? For implants and surgical procedures, how long after the intervention should the effectiveness endpoint be assessed?

c. What objective parameter or combination of parameters should be used for the primary effectiveness endpoints (eg, AHI, ODI, T90, or other non-PSG/HSAT parameters)?


d. What would be a clinically meaningful difference for the above primary effectiveness endpoint(s) between/among study arms or within a study arm?

e. What patient-reported outcomes (PROs) are appropriate in the evaluation of SDB devices?

 

 

4. What are the safety and effectiveness concerns when a digital health device provides a diagnosis and monitoring of SDB?

a. What factors are important in developing a reference database (eg, demographics, validation)?b. What are the important safety and effectiveness concerns for SDB digital health devices used in the following settings:

i. A physician office or sleep center environment?

ii. A nonclinical environment?

iii. Prescription vs OTC use?

There was significant discussion and quite a bit of controversy. Among the recommendations to the FDA were that home testing is adequate and acceptable for clinical trials, that the ODI4 is more predictive and reliable than the AHI, and that the syndrome of OSAHS includes symptoms, one of the most important of which is sleepiness. It was acknowledged that digital health devices have the potential to greatly increase access to diagnosis, but access to treatment will need to be addressed, as well. I think this was a very important meeting, and the outcome will likely impact our members. The ultimate goal is to publish a paper about recommended techniques, outcomes, and inclusion characteristics/definitions to be used in clinical trials for new devices to diagnose or treat sleep apnea.

 

Drs. Neil Freedman and Barbara Phillips represented CHEST at an FDA workshop on April 16 on “Study Design Considerations for Devices Including Digital Health Technologies for Sleep-Disordered Breathing (SDB) in Adults. The other organizational participants were The American Academy of Dental Sleep Medicine; The American Academy of Neurology; the American Academy of Otolaryngology, Head and Neck Surgery; The American Academy of Sleep Medicine; and The American Sleep Apnea Association. Here are the questions that the FDA asked the panelists:

1. FDA is seeking to promote innovation and expedite the clinical development of devices intended for the diagnosis and treatment of sleep-disordered breathing (SDB). How should the following conditions (including their severity, eg, mild, moderate, severe, if appropriate) be defined for the purpose of creating appropriate inclusion/exclusion criteria for a clinical study for SDB devices?

a. Apnea

b. Hypopnea

c. Sleep-Disordered Breathing (SDB)

d. Obstructive Sleep Apnea Syndrome (OSAS)

e. Central Sleep Apnea Syndrome (CSAS)

f. Primary Snoring

 

 

2. Polysomnography (PSG) has been widely accepted as the “gold standard” test for the diagnosis of OSA and primary snoring. However, home sleep apnea testing (HSAT) has emerged in recent years as an alternative or complementary diagnostic tool for SDB.

a. Can HSAT be used for establishing a baseline diagnosis and for the collection of clinical performance data for device trials for OSA, CSA, or primary snoring? If so, what are the recommended parameters that should be collected by an HSAT (eg, nasal pressure, oximetry, chest and abdominal respiratory inductance plethysmography)?

b. What constitutes a technically adequate test (either PSG or HSAT, if appropriate) for establishing a baseline diagnosis of SDB for device studies (eg, number of hours, number of nights)?

 

 

3. FDA has received an increasing number of premarket applications for devices intended to treat SDB. How should studies for the various technologies (eg, intra-oral appliances, externally worn devices, electrosurgical devices for tissue reduction, and passive or active implantable devices of the upper airway) be designed with respect to the following factors (please consider whether your recommendations would vary if the device was an implant vs an externally worn device):

a. What is the most appropriate control group (eg, comparison to baseline measures, randomization to a concurrent control group)?

b. What is the minimum duration of the study? For implants and surgical procedures, how long after the intervention should the effectiveness endpoint be assessed?

c. What objective parameter or combination of parameters should be used for the primary effectiveness endpoints (eg, AHI, ODI, T90, or other non-PSG/HSAT parameters)?


d. What would be a clinically meaningful difference for the above primary effectiveness endpoint(s) between/among study arms or within a study arm?

e. What patient-reported outcomes (PROs) are appropriate in the evaluation of SDB devices?

 

 

4. What are the safety and effectiveness concerns when a digital health device provides a diagnosis and monitoring of SDB?

a. What factors are important in developing a reference database (eg, demographics, validation)?b. What are the important safety and effectiveness concerns for SDB digital health devices used in the following settings:

i. A physician office or sleep center environment?

ii. A nonclinical environment?

iii. Prescription vs OTC use?

There was significant discussion and quite a bit of controversy. Among the recommendations to the FDA were that home testing is adequate and acceptable for clinical trials, that the ODI4 is more predictive and reliable than the AHI, and that the syndrome of OSAHS includes symptoms, one of the most important of which is sleepiness. It was acknowledged that digital health devices have the potential to greatly increase access to diagnosis, but access to treatment will need to be addressed, as well. I think this was a very important meeting, and the outcome will likely impact our members. The ultimate goal is to publish a paper about recommended techniques, outcomes, and inclusion characteristics/definitions to be used in clinical trials for new devices to diagnose or treat sleep apnea.

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COPD-OSA overlap syndrome

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Tue, 10/23/2018 - 16:09

 

Chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) each affect at least 10% of the general adult population and, thus, both disorders together, commonly referred to as the overlap syndrome, could be expected in at least 1% of adults by chance alone. However, there is evidence of important interactions between the disorders that influence the prevalence of the overlap, which have implications for the development of comorbidities,and also for management (McNicholas WT. Chest. 2017; 152[6]:1318). Furthermore, sleep quality is typically poor in COPD, which has been linked to worse pulmonary function and lung hyperinflation and may contribute to daytime fatigue.

Interactions between COPD and OSA that may influence the prevalence of overlap

Previous reports have presented conflicting results regarding the likely association between COPD and OSA, which may partly reflect different definitions of OSA, patient populations, and methodologies of investigation. However, COPD represents a spectrum of clinical phenotypes ranging from the hyperinflated patient with low BMI (predominant emphysema phenotype) to the patient with higher BMI and tendency to right-sided heart failure (predominant chronic bronchitis phenotype). The predominant emphysema phenotype may predispose to a lower likelihood of OSA, and there is recent evidence that lung hyperinflation is protective against the development of OSA by lowering the critical closing pressure of the upper airway during sleep. Furthermore, the degree of emphysema and gas trapping on CT scan of the thorax correlates inversely with apnea-hypopnia index in patients with severe COPD (Krachman SL et al. Ann Am Thorac Soc. 2016;13[7]:1129).

Dr. Walter T. McNicholas

In contrast, the predominant chronic bronchitis phenotype predisposes to a higher likelihood of OSA because of higher BMI and likelihood of right-sided heart failure. Peripheral fluid retention in such patients predisposes to OSA because of the rostral fluid shift that occurs during sleep in the supine position, predisposing to upper airway obstruction by airway narrowing. The COPDGene study reports that the chronic bronchitis phenotype has a higher prevalence of OSA even in the absence of differences in BMI and lung function (Kim V et al. Chest. 2011;140[3]:626). Upper airway inflammation associated with cigarette smoking may also contribute to the development of OSA, and corticosteroid therapy may adversely affect upper airway muscle function. OSA also appears to exacerbate lower airway inflammation in COPD. In practice, most patients with COPD have a mixture of emphysema and chronic bronchitis, and the probability of OSA will represent the balance of these protective and promoting factors in individual patients (Fig 1).

While there is evidence of increased mortality in patients with COPD and OSA alone, a recent report based on the Sleep Heart Health Study somewhat surprisingly found that the incremental contribution of declining lung function to mortality diminished with increasing severity of SDB measured by AHI (Putcha N et al. Am J Respir Crit Care Med. 2016;194[8]:1007). Thus, the epidemiologic relationship of COPD and OSA and related clinical outcomes remains an important research topic comparing different clinical phenotypes.
 

Mechanisms of interaction in the overlap syndrome and implications for comorbidity

COPD and OSA are associated with several overlapping physiological and biological disturbances, including hypoxia and inflammation, which may contribute to cardiovascular and other comorbidities. Thus, the probability should be high that the overlap syndrome will be associated with a greater risk of comorbidity than with either disease alone. Patients with the overlap syndrome demonstrate greater degrees of oxygen desaturation predisposing to pulmonary hypertension, which is especially common in these patients.

COPD and OSA are each associated with systemic inflammation and oxidative stress, and C-reactive protein (CRP) has been identified as a measure of systemic inflammation that is commonly elevated in both disorders, although in OSA, concurrent obesity is an important confounding factor. Systemic inflammation contributes to the development of cardiovascular disease, which is a common complication of both COPD and OSA. Thus, one could expect that cardiovascular disease is particularly prevalent in patients with overlap syndrome, but there are limited data on this relationship, which represents an important research topic.
 

Clinical assessment

Patients with the overlap syndrome present with typical clinical features of each disorder and additional features that reflect the higher prevalence of hypoxemia, hypercapnia, and pulmonary hypertension. Thus, morning headaches reflecting hypercapnia and peripheral edema reflecting right-sided heart failure may be especially common. Screening questionnaires may be helpful in the initial evaluation of likely OSA in patients with COPD, and objective clinical data, including anthropometrics such as age, sex, and BMI, and medical history such as cardiovascular comorbidity, are especially useful in clinical prediction (McNicholas WT. Lancet Respir Med. 2016;4[9]:683). Thus, screening for OSA in patients with COPD should not be complicated, and the widespread failure to do so may reflect a lack of awareness of the possible association by the clinician involved.

 

 

The specific diagnosis of OSA in COPD requires some form of overnight sleep study, and there is a growing move toward ambulatory studies that focus on cardiorespiratory variables. Overnight monitoring of oxygen saturation is especially useful, particularly if linked to special analysis software, and may be sufficient in many cases. Full polysomnography can be reserved for select cases where the diagnosis remains in doubt.
 

Management and outcomes

Nocturnal hypoxemia in patients with COPD benefits from inhaled, long-acting beta-agonist and anticholinergic therapy, and mean nocturnal oxygen saturation is 2% to 3% higher on each medication compared with placebo. Supplemental oxygen may be indicated when nocturnal oxygen desaturation persists despite optimum pharmacotherapy and does not appear to be associated with significant additional risk of hypercapnia.

However, in patients with COPD-OSA overlap, nonnvasive pressure support is the most appropriate management option. In patients with predominant OSA, continuous positive airway pressure therapy (CPAP) is the preferred option, but where COPD is the dominant component, noninvasive ventilation (NIV) in the form of bi-level positive airway pressure (BIPAP) may be more appropriate. Recent reports in severe COPD indicate that NIV targeted to markedly reduce hypercapnia is associated with improved quality of life and prolonged survival (Köhnlein T et al. Lancet Respir Med. 2014;2[9]:698), and patients with COPD with persistent hypercapnia following hospitalization with an acute exacerbation show improved clinical outcomes and survival with continuing home NIV (Murphy PB et al. JAMA. 2017;317[21]:2177).

The recognition of co-existing OSA in patients with COPD has important clinical relevance as the management of patients with overlap syndrome is different from COPD alone, and the long-term survival of patients with overlap syndrome not treated with nocturnal positive airway pressure is significantly inferior to those patients with overlap syndrome appropriately treated (Marin JM et al. Am J Respir Crit Care Med. 2010;182[3]:325).
 

Dr. McNicholas is with the Department of Respiratory and Sleep Medicine, St. Vincent’s University Hospital, Dublin School of Medicine, University College Dublin, Ireland.

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Chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) each affect at least 10% of the general adult population and, thus, both disorders together, commonly referred to as the overlap syndrome, could be expected in at least 1% of adults by chance alone. However, there is evidence of important interactions between the disorders that influence the prevalence of the overlap, which have implications for the development of comorbidities,and also for management (McNicholas WT. Chest. 2017; 152[6]:1318). Furthermore, sleep quality is typically poor in COPD, which has been linked to worse pulmonary function and lung hyperinflation and may contribute to daytime fatigue.

Interactions between COPD and OSA that may influence the prevalence of overlap

Previous reports have presented conflicting results regarding the likely association between COPD and OSA, which may partly reflect different definitions of OSA, patient populations, and methodologies of investigation. However, COPD represents a spectrum of clinical phenotypes ranging from the hyperinflated patient with low BMI (predominant emphysema phenotype) to the patient with higher BMI and tendency to right-sided heart failure (predominant chronic bronchitis phenotype). The predominant emphysema phenotype may predispose to a lower likelihood of OSA, and there is recent evidence that lung hyperinflation is protective against the development of OSA by lowering the critical closing pressure of the upper airway during sleep. Furthermore, the degree of emphysema and gas trapping on CT scan of the thorax correlates inversely with apnea-hypopnia index in patients with severe COPD (Krachman SL et al. Ann Am Thorac Soc. 2016;13[7]:1129).

Dr. Walter T. McNicholas

In contrast, the predominant chronic bronchitis phenotype predisposes to a higher likelihood of OSA because of higher BMI and likelihood of right-sided heart failure. Peripheral fluid retention in such patients predisposes to OSA because of the rostral fluid shift that occurs during sleep in the supine position, predisposing to upper airway obstruction by airway narrowing. The COPDGene study reports that the chronic bronchitis phenotype has a higher prevalence of OSA even in the absence of differences in BMI and lung function (Kim V et al. Chest. 2011;140[3]:626). Upper airway inflammation associated with cigarette smoking may also contribute to the development of OSA, and corticosteroid therapy may adversely affect upper airway muscle function. OSA also appears to exacerbate lower airway inflammation in COPD. In practice, most patients with COPD have a mixture of emphysema and chronic bronchitis, and the probability of OSA will represent the balance of these protective and promoting factors in individual patients (Fig 1).

While there is evidence of increased mortality in patients with COPD and OSA alone, a recent report based on the Sleep Heart Health Study somewhat surprisingly found that the incremental contribution of declining lung function to mortality diminished with increasing severity of SDB measured by AHI (Putcha N et al. Am J Respir Crit Care Med. 2016;194[8]:1007). Thus, the epidemiologic relationship of COPD and OSA and related clinical outcomes remains an important research topic comparing different clinical phenotypes.
 

Mechanisms of interaction in the overlap syndrome and implications for comorbidity

COPD and OSA are associated with several overlapping physiological and biological disturbances, including hypoxia and inflammation, which may contribute to cardiovascular and other comorbidities. Thus, the probability should be high that the overlap syndrome will be associated with a greater risk of comorbidity than with either disease alone. Patients with the overlap syndrome demonstrate greater degrees of oxygen desaturation predisposing to pulmonary hypertension, which is especially common in these patients.

COPD and OSA are each associated with systemic inflammation and oxidative stress, and C-reactive protein (CRP) has been identified as a measure of systemic inflammation that is commonly elevated in both disorders, although in OSA, concurrent obesity is an important confounding factor. Systemic inflammation contributes to the development of cardiovascular disease, which is a common complication of both COPD and OSA. Thus, one could expect that cardiovascular disease is particularly prevalent in patients with overlap syndrome, but there are limited data on this relationship, which represents an important research topic.
 

Clinical assessment

Patients with the overlap syndrome present with typical clinical features of each disorder and additional features that reflect the higher prevalence of hypoxemia, hypercapnia, and pulmonary hypertension. Thus, morning headaches reflecting hypercapnia and peripheral edema reflecting right-sided heart failure may be especially common. Screening questionnaires may be helpful in the initial evaluation of likely OSA in patients with COPD, and objective clinical data, including anthropometrics such as age, sex, and BMI, and medical history such as cardiovascular comorbidity, are especially useful in clinical prediction (McNicholas WT. Lancet Respir Med. 2016;4[9]:683). Thus, screening for OSA in patients with COPD should not be complicated, and the widespread failure to do so may reflect a lack of awareness of the possible association by the clinician involved.

 

 

The specific diagnosis of OSA in COPD requires some form of overnight sleep study, and there is a growing move toward ambulatory studies that focus on cardiorespiratory variables. Overnight monitoring of oxygen saturation is especially useful, particularly if linked to special analysis software, and may be sufficient in many cases. Full polysomnography can be reserved for select cases where the diagnosis remains in doubt.
 

Management and outcomes

Nocturnal hypoxemia in patients with COPD benefits from inhaled, long-acting beta-agonist and anticholinergic therapy, and mean nocturnal oxygen saturation is 2% to 3% higher on each medication compared with placebo. Supplemental oxygen may be indicated when nocturnal oxygen desaturation persists despite optimum pharmacotherapy and does not appear to be associated with significant additional risk of hypercapnia.

However, in patients with COPD-OSA overlap, nonnvasive pressure support is the most appropriate management option. In patients with predominant OSA, continuous positive airway pressure therapy (CPAP) is the preferred option, but where COPD is the dominant component, noninvasive ventilation (NIV) in the form of bi-level positive airway pressure (BIPAP) may be more appropriate. Recent reports in severe COPD indicate that NIV targeted to markedly reduce hypercapnia is associated with improved quality of life and prolonged survival (Köhnlein T et al. Lancet Respir Med. 2014;2[9]:698), and patients with COPD with persistent hypercapnia following hospitalization with an acute exacerbation show improved clinical outcomes and survival with continuing home NIV (Murphy PB et al. JAMA. 2017;317[21]:2177).

The recognition of co-existing OSA in patients with COPD has important clinical relevance as the management of patients with overlap syndrome is different from COPD alone, and the long-term survival of patients with overlap syndrome not treated with nocturnal positive airway pressure is significantly inferior to those patients with overlap syndrome appropriately treated (Marin JM et al. Am J Respir Crit Care Med. 2010;182[3]:325).
 

Dr. McNicholas is with the Department of Respiratory and Sleep Medicine, St. Vincent’s University Hospital, Dublin School of Medicine, University College Dublin, Ireland.

 

Chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) each affect at least 10% of the general adult population and, thus, both disorders together, commonly referred to as the overlap syndrome, could be expected in at least 1% of adults by chance alone. However, there is evidence of important interactions between the disorders that influence the prevalence of the overlap, which have implications for the development of comorbidities,and also for management (McNicholas WT. Chest. 2017; 152[6]:1318). Furthermore, sleep quality is typically poor in COPD, which has been linked to worse pulmonary function and lung hyperinflation and may contribute to daytime fatigue.

Interactions between COPD and OSA that may influence the prevalence of overlap

Previous reports have presented conflicting results regarding the likely association between COPD and OSA, which may partly reflect different definitions of OSA, patient populations, and methodologies of investigation. However, COPD represents a spectrum of clinical phenotypes ranging from the hyperinflated patient with low BMI (predominant emphysema phenotype) to the patient with higher BMI and tendency to right-sided heart failure (predominant chronic bronchitis phenotype). The predominant emphysema phenotype may predispose to a lower likelihood of OSA, and there is recent evidence that lung hyperinflation is protective against the development of OSA by lowering the critical closing pressure of the upper airway during sleep. Furthermore, the degree of emphysema and gas trapping on CT scan of the thorax correlates inversely with apnea-hypopnia index in patients with severe COPD (Krachman SL et al. Ann Am Thorac Soc. 2016;13[7]:1129).

Dr. Walter T. McNicholas

In contrast, the predominant chronic bronchitis phenotype predisposes to a higher likelihood of OSA because of higher BMI and likelihood of right-sided heart failure. Peripheral fluid retention in such patients predisposes to OSA because of the rostral fluid shift that occurs during sleep in the supine position, predisposing to upper airway obstruction by airway narrowing. The COPDGene study reports that the chronic bronchitis phenotype has a higher prevalence of OSA even in the absence of differences in BMI and lung function (Kim V et al. Chest. 2011;140[3]:626). Upper airway inflammation associated with cigarette smoking may also contribute to the development of OSA, and corticosteroid therapy may adversely affect upper airway muscle function. OSA also appears to exacerbate lower airway inflammation in COPD. In practice, most patients with COPD have a mixture of emphysema and chronic bronchitis, and the probability of OSA will represent the balance of these protective and promoting factors in individual patients (Fig 1).

While there is evidence of increased mortality in patients with COPD and OSA alone, a recent report based on the Sleep Heart Health Study somewhat surprisingly found that the incremental contribution of declining lung function to mortality diminished with increasing severity of SDB measured by AHI (Putcha N et al. Am J Respir Crit Care Med. 2016;194[8]:1007). Thus, the epidemiologic relationship of COPD and OSA and related clinical outcomes remains an important research topic comparing different clinical phenotypes.
 

Mechanisms of interaction in the overlap syndrome and implications for comorbidity

COPD and OSA are associated with several overlapping physiological and biological disturbances, including hypoxia and inflammation, which may contribute to cardiovascular and other comorbidities. Thus, the probability should be high that the overlap syndrome will be associated with a greater risk of comorbidity than with either disease alone. Patients with the overlap syndrome demonstrate greater degrees of oxygen desaturation predisposing to pulmonary hypertension, which is especially common in these patients.

COPD and OSA are each associated with systemic inflammation and oxidative stress, and C-reactive protein (CRP) has been identified as a measure of systemic inflammation that is commonly elevated in both disorders, although in OSA, concurrent obesity is an important confounding factor. Systemic inflammation contributes to the development of cardiovascular disease, which is a common complication of both COPD and OSA. Thus, one could expect that cardiovascular disease is particularly prevalent in patients with overlap syndrome, but there are limited data on this relationship, which represents an important research topic.
 

Clinical assessment

Patients with the overlap syndrome present with typical clinical features of each disorder and additional features that reflect the higher prevalence of hypoxemia, hypercapnia, and pulmonary hypertension. Thus, morning headaches reflecting hypercapnia and peripheral edema reflecting right-sided heart failure may be especially common. Screening questionnaires may be helpful in the initial evaluation of likely OSA in patients with COPD, and objective clinical data, including anthropometrics such as age, sex, and BMI, and medical history such as cardiovascular comorbidity, are especially useful in clinical prediction (McNicholas WT. Lancet Respir Med. 2016;4[9]:683). Thus, screening for OSA in patients with COPD should not be complicated, and the widespread failure to do so may reflect a lack of awareness of the possible association by the clinician involved.

 

 

The specific diagnosis of OSA in COPD requires some form of overnight sleep study, and there is a growing move toward ambulatory studies that focus on cardiorespiratory variables. Overnight monitoring of oxygen saturation is especially useful, particularly if linked to special analysis software, and may be sufficient in many cases. Full polysomnography can be reserved for select cases where the diagnosis remains in doubt.
 

Management and outcomes

Nocturnal hypoxemia in patients with COPD benefits from inhaled, long-acting beta-agonist and anticholinergic therapy, and mean nocturnal oxygen saturation is 2% to 3% higher on each medication compared with placebo. Supplemental oxygen may be indicated when nocturnal oxygen desaturation persists despite optimum pharmacotherapy and does not appear to be associated with significant additional risk of hypercapnia.

However, in patients with COPD-OSA overlap, nonnvasive pressure support is the most appropriate management option. In patients with predominant OSA, continuous positive airway pressure therapy (CPAP) is the preferred option, but where COPD is the dominant component, noninvasive ventilation (NIV) in the form of bi-level positive airway pressure (BIPAP) may be more appropriate. Recent reports in severe COPD indicate that NIV targeted to markedly reduce hypercapnia is associated with improved quality of life and prolonged survival (Köhnlein T et al. Lancet Respir Med. 2014;2[9]:698), and patients with COPD with persistent hypercapnia following hospitalization with an acute exacerbation show improved clinical outcomes and survival with continuing home NIV (Murphy PB et al. JAMA. 2017;317[21]:2177).

The recognition of co-existing OSA in patients with COPD has important clinical relevance as the management of patients with overlap syndrome is different from COPD alone, and the long-term survival of patients with overlap syndrome not treated with nocturnal positive airway pressure is significantly inferior to those patients with overlap syndrome appropriately treated (Marin JM et al. Am J Respir Crit Care Med. 2010;182[3]:325).
 

Dr. McNicholas is with the Department of Respiratory and Sleep Medicine, St. Vincent’s University Hospital, Dublin School of Medicine, University College Dublin, Ireland.

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VIDEO: Addressing the opioid epidemic: Psychiatrists are poised to lead

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– Psychiatrists are uniquely equipped to take the lead in providing cost-effective, evidence-based addiction treatment services, according to Lama Bazzi, MD, and Elie Aoun, MD.

As cochairs of a session titled, “Psychiatrists at the Helm of the Opioid Epidemic” at the annual meeting of the American Psychiatric Association, Dr. Bazzi and Dr. Aoun addressed how psychiatrists can take the lead as part of multidisciplinary teams, as well as roles they can play in policy and the criminal justice system to “shift the paradigm in terms of how the general public thinks about addiction.”

They also discussed existing models and some new models they have been working on to address the problem.

“We want to empower psychiatrists to feel that they already have the knowledge base to do what needs to be done, and to just ... put out there different ways that we can brainstorm together to do that,” Dr. Bazzi of Maimonides Medical Center, Brooklyn, N.Y., said in a video interview at the meeting.



She and Dr. Aoun also discussed an ongoing project that involves input from law enforcement and support from the APA; an online training module is being developed to address different mental disorders – including substance use disorders – and other issues that officers face, such as racial biases and disparities.

“The curriculum that we’re working on is going to be symptom based,” said Dr. Aoun, of Columbia University, New York, explaining that this approach is more practical for helping law enforcement officers in dealing with issues involving individuals with mental disorders.

Another project focuses on keeping people with mental disorders out of the criminal justice system, he said.

 

 


“Every step [of the criminal justice process] is an opportunity to intercept people with mental illness and provide them with intervention,” he said, noting that an adaptation of the model for patients with addictions is also in the works.

He and Dr. Bazzi also focused on where psychiatrists, as experts in both mental health and addiction, can fit into the process.

Dr. Bazzi and Dr. Aoun reported having no disclosures.

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– Psychiatrists are uniquely equipped to take the lead in providing cost-effective, evidence-based addiction treatment services, according to Lama Bazzi, MD, and Elie Aoun, MD.

As cochairs of a session titled, “Psychiatrists at the Helm of the Opioid Epidemic” at the annual meeting of the American Psychiatric Association, Dr. Bazzi and Dr. Aoun addressed how psychiatrists can take the lead as part of multidisciplinary teams, as well as roles they can play in policy and the criminal justice system to “shift the paradigm in terms of how the general public thinks about addiction.”

They also discussed existing models and some new models they have been working on to address the problem.

“We want to empower psychiatrists to feel that they already have the knowledge base to do what needs to be done, and to just ... put out there different ways that we can brainstorm together to do that,” Dr. Bazzi of Maimonides Medical Center, Brooklyn, N.Y., said in a video interview at the meeting.



She and Dr. Aoun also discussed an ongoing project that involves input from law enforcement and support from the APA; an online training module is being developed to address different mental disorders – including substance use disorders – and other issues that officers face, such as racial biases and disparities.

“The curriculum that we’re working on is going to be symptom based,” said Dr. Aoun, of Columbia University, New York, explaining that this approach is more practical for helping law enforcement officers in dealing with issues involving individuals with mental disorders.

Another project focuses on keeping people with mental disorders out of the criminal justice system, he said.

 

 


“Every step [of the criminal justice process] is an opportunity to intercept people with mental illness and provide them with intervention,” he said, noting that an adaptation of the model for patients with addictions is also in the works.

He and Dr. Bazzi also focused on where psychiatrists, as experts in both mental health and addiction, can fit into the process.

Dr. Bazzi and Dr. Aoun reported having no disclosures.

– Psychiatrists are uniquely equipped to take the lead in providing cost-effective, evidence-based addiction treatment services, according to Lama Bazzi, MD, and Elie Aoun, MD.

As cochairs of a session titled, “Psychiatrists at the Helm of the Opioid Epidemic” at the annual meeting of the American Psychiatric Association, Dr. Bazzi and Dr. Aoun addressed how psychiatrists can take the lead as part of multidisciplinary teams, as well as roles they can play in policy and the criminal justice system to “shift the paradigm in terms of how the general public thinks about addiction.”

They also discussed existing models and some new models they have been working on to address the problem.

“We want to empower psychiatrists to feel that they already have the knowledge base to do what needs to be done, and to just ... put out there different ways that we can brainstorm together to do that,” Dr. Bazzi of Maimonides Medical Center, Brooklyn, N.Y., said in a video interview at the meeting.



She and Dr. Aoun also discussed an ongoing project that involves input from law enforcement and support from the APA; an online training module is being developed to address different mental disorders – including substance use disorders – and other issues that officers face, such as racial biases and disparities.

“The curriculum that we’re working on is going to be symptom based,” said Dr. Aoun, of Columbia University, New York, explaining that this approach is more practical for helping law enforcement officers in dealing with issues involving individuals with mental disorders.

Another project focuses on keeping people with mental disorders out of the criminal justice system, he said.

 

 


“Every step [of the criminal justice process] is an opportunity to intercept people with mental illness and provide them with intervention,” he said, noting that an adaptation of the model for patients with addictions is also in the works.

He and Dr. Bazzi also focused on where psychiatrists, as experts in both mental health and addiction, can fit into the process.

Dr. Bazzi and Dr. Aoun reported having no disclosures.

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Get social, stay connected with CHEST Twitter chats

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One of the best ways to stay connected with CHEST and up-to-date on the latest news and research is through our social channels. Twitter is a social platform that is constantly growing for the organization. Since 2009, we’ve had the opportunity to connect with over 20,000 individuals and impact millions with just a simple tweet or sharing of information. As a means to inform our highly active audience and bring the conversation to a social space, we’ve utilized the platform to help drive the conversation on various topics. CHEST moderates a public conversation via Twitter (@accpchest) around topics in pulmonary, critical care, and sleep medicine every few weeks.

So, what exactly is a Twitter chat? Twitter chats are conversations that are held on the social platform and linked together by a distinct hashtag. We typically use the hashtag #pulmCC (which stands for pulmonary, critical care) and allow individuals from all across the globe to join in on the conversation and share their input. In addition to being a great networking opportunity, our chat recently began offering MOC points to CHEST members who attend Twitter chats and are eligible to receive participation points. We recently began offering CME credit for some of our chats, as well.

Over the last 6 years, we’ve hosted a wide range of Twitter chat topics, ranging from asthma to lung cancer. Some of those chats focused on the following topics:

This past March, we held our Twitter chat Sepsis: Revisions, Advancements, New Therapies, led by Drs. Chris Carroll, Alex Niven, and Steven Q. Simpson. We had over 4.2 million impressions!

Every Twitter chat serves a different purpose, typically based on the topic and the individuals we believe would be most interested in the topic. These chats help us spark conversations on the latest research, advancements, and potential opportunities within the pulmonary/critical care field. They also provide physicians with a great opportunity to network and get acquainted with the #pulmCC community.

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One of the best ways to stay connected with CHEST and up-to-date on the latest news and research is through our social channels. Twitter is a social platform that is constantly growing for the organization. Since 2009, we’ve had the opportunity to connect with over 20,000 individuals and impact millions with just a simple tweet or sharing of information. As a means to inform our highly active audience and bring the conversation to a social space, we’ve utilized the platform to help drive the conversation on various topics. CHEST moderates a public conversation via Twitter (@accpchest) around topics in pulmonary, critical care, and sleep medicine every few weeks.

So, what exactly is a Twitter chat? Twitter chats are conversations that are held on the social platform and linked together by a distinct hashtag. We typically use the hashtag #pulmCC (which stands for pulmonary, critical care) and allow individuals from all across the globe to join in on the conversation and share their input. In addition to being a great networking opportunity, our chat recently began offering MOC points to CHEST members who attend Twitter chats and are eligible to receive participation points. We recently began offering CME credit for some of our chats, as well.

Over the last 6 years, we’ve hosted a wide range of Twitter chat topics, ranging from asthma to lung cancer. Some of those chats focused on the following topics:

This past March, we held our Twitter chat Sepsis: Revisions, Advancements, New Therapies, led by Drs. Chris Carroll, Alex Niven, and Steven Q. Simpson. We had over 4.2 million impressions!

Every Twitter chat serves a different purpose, typically based on the topic and the individuals we believe would be most interested in the topic. These chats help us spark conversations on the latest research, advancements, and potential opportunities within the pulmonary/critical care field. They also provide physicians with a great opportunity to network and get acquainted with the #pulmCC community.

 

One of the best ways to stay connected with CHEST and up-to-date on the latest news and research is through our social channels. Twitter is a social platform that is constantly growing for the organization. Since 2009, we’ve had the opportunity to connect with over 20,000 individuals and impact millions with just a simple tweet or sharing of information. As a means to inform our highly active audience and bring the conversation to a social space, we’ve utilized the platform to help drive the conversation on various topics. CHEST moderates a public conversation via Twitter (@accpchest) around topics in pulmonary, critical care, and sleep medicine every few weeks.

So, what exactly is a Twitter chat? Twitter chats are conversations that are held on the social platform and linked together by a distinct hashtag. We typically use the hashtag #pulmCC (which stands for pulmonary, critical care) and allow individuals from all across the globe to join in on the conversation and share their input. In addition to being a great networking opportunity, our chat recently began offering MOC points to CHEST members who attend Twitter chats and are eligible to receive participation points. We recently began offering CME credit for some of our chats, as well.

Over the last 6 years, we’ve hosted a wide range of Twitter chat topics, ranging from asthma to lung cancer. Some of those chats focused on the following topics:

This past March, we held our Twitter chat Sepsis: Revisions, Advancements, New Therapies, led by Drs. Chris Carroll, Alex Niven, and Steven Q. Simpson. We had over 4.2 million impressions!

Every Twitter chat serves a different purpose, typically based on the topic and the individuals we believe would be most interested in the topic. These chats help us spark conversations on the latest research, advancements, and potential opportunities within the pulmonary/critical care field. They also provide physicians with a great opportunity to network and get acquainted with the #pulmCC community.

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This Month in the Journal CHEST®

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Editor’s Picks

 

Giants In Chest Medicine

Sonia Buist, MBChB. By Dr. J.A. Krishnan.
 

Editorial

Is Big Tobacco Still Trying to Deceive the Public? This Is No Time to Rest on Our Laurels. By Drs. D. R. McCaffree and N. R. Desai.
 

Original Research

Defining the “Frequent Exacerbator” Phenotype in COPD: A Hypothesis-Free Approach. By Dr. O. Le Rouzic, et al.



Trial Duration and Risk Reduction in Combination Therapy Trials for Pulmonary Arterial Hypertension: A Systematic Review. By Dr. A. C. Lajoie, et al.



Tai Chi and Pulmonary Rehabilitation Compared for Treatment-Naive Patients With COPD: A Randomized Controlled Trial. By Dr. M. I. Polkey, et al.

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Editor’s Picks

 

Giants In Chest Medicine

Sonia Buist, MBChB. By Dr. J.A. Krishnan.
 

Editorial

Is Big Tobacco Still Trying to Deceive the Public? This Is No Time to Rest on Our Laurels. By Drs. D. R. McCaffree and N. R. Desai.
 

Original Research

Defining the “Frequent Exacerbator” Phenotype in COPD: A Hypothesis-Free Approach. By Dr. O. Le Rouzic, et al.



Trial Duration and Risk Reduction in Combination Therapy Trials for Pulmonary Arterial Hypertension: A Systematic Review. By Dr. A. C. Lajoie, et al.



Tai Chi and Pulmonary Rehabilitation Compared for Treatment-Naive Patients With COPD: A Randomized Controlled Trial. By Dr. M. I. Polkey, et al.

 

Giants In Chest Medicine

Sonia Buist, MBChB. By Dr. J.A. Krishnan.
 

Editorial

Is Big Tobacco Still Trying to Deceive the Public? This Is No Time to Rest on Our Laurels. By Drs. D. R. McCaffree and N. R. Desai.
 

Original Research

Defining the “Frequent Exacerbator” Phenotype in COPD: A Hypothesis-Free Approach. By Dr. O. Le Rouzic, et al.



Trial Duration and Risk Reduction in Combination Therapy Trials for Pulmonary Arterial Hypertension: A Systematic Review. By Dr. A. C. Lajoie, et al.



Tai Chi and Pulmonary Rehabilitation Compared for Treatment-Naive Patients With COPD: A Randomized Controlled Trial. By Dr. M. I. Polkey, et al.

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Talc pleurodesis, ICS, cardiopulmonary exercise testing

Article Type
Changed
Tue, 10/23/2018 - 16:09

 

Interventional Chest/Diagnostic Procedures

Review of The AMPLE Trial: is talc making a comeback?

A proposed advantage of indwelling pleural catheters (IPC) is their purported ability to reduce hospitalization time when compared with the more traditional talc pleurodesis procedure. The recently published AMPLE trial was a multicenter randomized trial comparing the impact of IPCs vs talc pleurodesis on hospitalization days in patients with malignant pleural effusions. One-hundred forty-six patients were randomized for pleurodesis to either IPC vs pleurodesis via talc slurry in nine centers in Australia, New Zealand, Singapore, and Hong Kong. Patients were followed for up to 12 months. Secondary outcomes included need for further pleural intervention, breathlessness, quality of life, and adverse events.

Patients randomized to IPC spent on average 2 days less in the hospital (10 vs 12 days), a difference that was statistically significant, though of questionable clinical relevance, and somewhat disappointing in light of a prior prospective study from the same group suggesting a benefit of 6 to 7 days (Fysh. Chest. 2012;142[2]:394. As in previous studies, additional pleural procedures were more common in the talc group, adverse events occurred more frequently with IPC, but breathlessness and quality of life were identical in both groups.

This study raises interesting questions. Clearly, IPCs have been favored over talc pleurodesis in the US in the last decade, primarily because of a perceived benefit in terms of hospitalization time. In the absence of clear advantage of IPC on time spent in the hospital, impact on breathlessness and quality of life, and considering the inconvenience of frequent drainage, co-pay incurred by patients, and increased adverse events with IPC, the pendulum may swing again toward talc pleurodesis.

Christine Argento, MD, FCCP

Fabien Maldonado, MD, FCCP

Steering Committee Members

Pediatric Chest Medicine

Early escalation of inhaled corticosteroids: does it help prevent asthma exacerbations?

Asthma is one of the most common chronic conditions in children. The importance of effective control of asthma to prevent exacerbations is well accepted. Inhaled corticosteroids (ICS) are a preferred component of treatment to improve asthma control in children with persistent asthma; however, exacerbations can still occur and result in significant morbidity. Most patients receive systemic corticosteroids during acute asthma exacerbations. The most recent Global Initiative for Asthma (GINA) guidelines recommend increasing ICS at the first signs of an asthma exacerbation in an effort to lessen the need for systemic corticosteroids (GINA. Global strategy for asthma management and prevention. 2017. http://www.ginasthma.org/).

In a recent issue of the New England Journal of Medicine, Jackson and colleagues at the National Heart, Lung, and Blood Institute AsthmaNet published the results of a randomized, double-blind 48-week trial, which included 254 children between ages 5 and 11 years with mild-moderate asthma. Their objectives were to compare exacerbation rates, time to first exacerbation, acute care visits, and bronchodilator use in children randomized to treatment with either high (5 x baseline ICS dose x 7 days) or low dose inhaled corticosteroids early in a drop to the “yellow zone” (Jackson, et al. N Engl J Med. 2018;378[10]:891).

Time to asthma exacerbations and exacerbations that required treatment with corticosteroids did not significantly differ between the low dose and high dose groups. Unexpectedly, the rate of exacerbations was higher with the high dose compared with the low dose group (0.48 vs 0.37). The children who were in the high dose group received 16% more ICS compared with the low dose group. Although not significant, there was a lower linear growth rate, ~0.23 cm per year seen in this high-dose group than in the low-dose group. Additionally, the use of bronchodilator, symptoms, and the rates of evaluation by a physician (ie, emergency department or urgent care visits) did not significantly differ between the two groups.

This study was specific to school-age children with mild-moderate persistent asthma treated with low dose ICS with a history of good adherence. Overall, this well-designed study helps address a question that many clinicians have regarding escalating ICS in the “yellow zone.” Escalating ICS did not reduce exacerbations at the cost of a lower linear growth rate. When it comes to escalating ICS for asthma exacerbation, more is not better.

In conclusion, in children with mild-to-moderate persistent asthma treated with daily inhaled glucocorticoids, quintupling the dose at the early signs of loss of asthma control did not reduce the rate of severe asthma exacerbations or improve other asthma outcomes and may be associated with diminished linear growth. (Funded by the National Heart, Lung, and Blood Institute; STICS ClinicalTrials.gov number, NCT02066129).

John Bishara, DO

Fellow-in-Training Member

Pulmonary Physiology, Function, and Rehabilitation

 

 

Understanding cardiopulmonary exercise testing

The cardiopulmonary exercise test (CPET) is an underutilized tool for evaluating patients with dyspnea of uncertain etiology. This is often due to the daunting task of trying to make sense of seemingly large amounts of interacting data, along with clinicians not having been taught a systematic approach for interpreting the results. Unlike other typical tests we order that point to a specific laboratory or anatomic radiographic abnormality, narrowing our differential to a few possibilities, one needs a different mindset when interpreting a CPET. This is a study to demonstrate the body’s normal or abnormal physiologic responses to increasing levels of physical stress. Because different conditions can give similar findings, the physiologic abnormalities must be interpreted in the context of the clinical presentation. If the results do not entirely fit the suspected diagnosis, they should be reported in a manner that may help guide the ordering physician down an alternate pathway. This CHEST NetWork has sought ways to reach out to members to promote a better understanding of the utilization of the basics of pulmonary physiology in the management of patients. We created an online two-part video demonstrating a basic systematic approach toward understanding the combinations of findings one often sees when performing a CPET. A comprehensive understanding cannot be shown in a 40-minute video series, but, hopefully, this will give a starting point to make this task easier and more enjoyable.

Zachary Morris, MD, FCCP

Steering Committee Member

Pulmonary Vascular Disease

BMPR2 mutation regulates singular millimetric fibrovascular lesions in bronchial circulation in PAH

Patients with PAH with BMPR2 mutation are younger with worse hemodynamics, ie, higher mean PAP with higher PVR and a lower cardiac index in comparison to the noncarriers. A systematic analysis of pulmonary imaging using CT angiography or magnetic resonance imaging in patients with PAH demonstrated increased bronchial arterial hypertrophy in BMPR2 mutation carriers compared with those without the mutation. Moreover, hemoptysis is more frequently encountered in patients with PAH with BMPR2 mutation and presumably related to bronchial artery remodeling and angiogenesis. French investigators described, in histopathology findings of explanted lungs of 44 patients with PAH (23 carriers of BMPR2 and 21 noncarriers), unusual singular millimetric fibrovascular lesions (SiMFi) in patients with BMPR2 mutations. The SiMFi is a structure of millimetric dimension with fibrovascular characteristics that are extremely rich in collagen and displayed more than one vascular channel. SiMFi did not show a classic glomeruloid pattern with predominant endothelial cell proliferation as seen in plexiform lesions but rather a large conglomerate of hypertrophic vessels. Performing an ink injection experiment in a freshly explanted lung highlighted a patent connection between bronchial/systemic vessels and pulmonary septal veins. SiMFis had an increased amount of bronchial microvessels and showed increased hypertrophy of larger bronchial arteries. SiMFi is directly related to hypertrophy and/or angiogenesis of vasa vasorum/bronchial arteries in the vicinity of the diseased artery. In patients with PAH with BMPR2 mutations, bronchial angiogenesis is more prevalent compared with patients with PAH lacking these mutations. This highlights the role of bronchial arteries in the spectrum of PAH.

Hector Cajigas, MD, FCCP

Sandeep Sahay, MD, FCCP

Steering Committee Members

References

1.Ghigna MR, et al. BMPR2 mutation status influences bronchial vascular changes in pulmonary arterial hypertension. Eur Respir J. 2016;48[6]:1668. Epub 2016 Nov 3.

2. Tio D, et al. Risk factors for hemoptysis in idiopathic and hereditary pulmonary arterial hypertension. PLoS One. 2013;8:e78132.

3. Elliott CG, et al. Relationship of BMPR2 mutations to vasoreactivity in pulmonary arterial hypertension. Circulation. 2006;113[21]:2509.



Thoracic Oncology

We have a lung cancer screening test but we could use it better

The American Lung Association recently demonstrated the majority of current and former smokers don’t know about lung cancer screening (LCS) with low-dose CT scanning.1 Researchers estimate less than 5% of eligible persons received LCS.2 Awareness campaigns targeting patients and health care providers at the local level can improve LCS uptake.3,4 While any new clinical practice has an expected implementation delay, LCS has another implementation barrier: complex eligibility criteria (age 55 – 80 years PLUS 30+ pack-year smoking history PLUS quit time less than 15 years). Electronic health record (EHR) tools might accelerate the adoption curve to identify eligible persons.5 Moreover, assessing and recording a qualitative smoking history is challenging, at best. One center showed 96.2% discordance between EHR smoking history and that obtained during shared decision-making visit for LCS.6 Mostly, the EHR underreported quantitative pack-year history; meaning LCS-eligible patients might fail to be identified by EHR review alone. Another small pilot showed that some patients age 55 – 79 years will update their EHR smoking history using patient portal, but this will not be effective for all patients.7 For current smokers, age alone may be an effective identification strategy, given the average start time for most smokers.8

 

 

Even though current LCS guidelines leave out some individuals at high risk for lung cancer, we must continue efforts to offer this potentially life-saving service to patients now eligible. Using EHR tools may help proactively identify those who are eligible for lung cancer screening.

A bbie Begnaud, MD

NetWork Member

References

1. New Study from American Lung Association’s LUNG FORCE Reveals Low Awareness of Lifesaving Lung Cancer Screening Among Those at Greatest Risk. (2017). http://www.lung.org/about-us/media/press-releases/new-study-lung-cancer-screening.html. Accessed April 19, 2018.

2. Soneji S, et al. Underuse of Chest Radiography Versus Computed Tomography for Lung Cancer Screening. Am J Public Health. 2017;107(8):1248.

3. Cardarelli R, et al. Terminate lung cancer (TLC) study-A mixed-methods population approach to increase lung cancer screening awareness and low-dose computed tomography in Eastern Kentucky. Cancer Epidemiol. 2017;46:1.

4. Jessup, DL, et al. Implementation of digital awareness strategies to engage patients and providers in a lung cancer screening program: retrospective study. J Med Internet Res. 2018;20(2):e52.

5. Comparison of the Electronic Medical Record versus a Shared Decision Making Conversation. Ann Am Thorac Soc. 2018. In press.

6. Modin HE, et al. Pack-year cigarette smoking history for determination of lung cancer screening eligibility. Ann Am Thorac Soc. 2017 Aug;14(8):1320-1325.

7. Begnaud AL, et al. Randomized electronic promotion of lung cancer screening: a pilot. JCO Clinical Cancer Informatics(1), 1-6. doi:10.1200/cci.17.00033

8. The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General. (2014). Atlanta, GA.

Publications
Topics
Sections

 

Interventional Chest/Diagnostic Procedures

Review of The AMPLE Trial: is talc making a comeback?

A proposed advantage of indwelling pleural catheters (IPC) is their purported ability to reduce hospitalization time when compared with the more traditional talc pleurodesis procedure. The recently published AMPLE trial was a multicenter randomized trial comparing the impact of IPCs vs talc pleurodesis on hospitalization days in patients with malignant pleural effusions. One-hundred forty-six patients were randomized for pleurodesis to either IPC vs pleurodesis via talc slurry in nine centers in Australia, New Zealand, Singapore, and Hong Kong. Patients were followed for up to 12 months. Secondary outcomes included need for further pleural intervention, breathlessness, quality of life, and adverse events.

Patients randomized to IPC spent on average 2 days less in the hospital (10 vs 12 days), a difference that was statistically significant, though of questionable clinical relevance, and somewhat disappointing in light of a prior prospective study from the same group suggesting a benefit of 6 to 7 days (Fysh. Chest. 2012;142[2]:394. As in previous studies, additional pleural procedures were more common in the talc group, adverse events occurred more frequently with IPC, but breathlessness and quality of life were identical in both groups.

This study raises interesting questions. Clearly, IPCs have been favored over talc pleurodesis in the US in the last decade, primarily because of a perceived benefit in terms of hospitalization time. In the absence of clear advantage of IPC on time spent in the hospital, impact on breathlessness and quality of life, and considering the inconvenience of frequent drainage, co-pay incurred by patients, and increased adverse events with IPC, the pendulum may swing again toward talc pleurodesis.

Christine Argento, MD, FCCP

Fabien Maldonado, MD, FCCP

Steering Committee Members

Pediatric Chest Medicine

Early escalation of inhaled corticosteroids: does it help prevent asthma exacerbations?

Asthma is one of the most common chronic conditions in children. The importance of effective control of asthma to prevent exacerbations is well accepted. Inhaled corticosteroids (ICS) are a preferred component of treatment to improve asthma control in children with persistent asthma; however, exacerbations can still occur and result in significant morbidity. Most patients receive systemic corticosteroids during acute asthma exacerbations. The most recent Global Initiative for Asthma (GINA) guidelines recommend increasing ICS at the first signs of an asthma exacerbation in an effort to lessen the need for systemic corticosteroids (GINA. Global strategy for asthma management and prevention. 2017. http://www.ginasthma.org/).

In a recent issue of the New England Journal of Medicine, Jackson and colleagues at the National Heart, Lung, and Blood Institute AsthmaNet published the results of a randomized, double-blind 48-week trial, which included 254 children between ages 5 and 11 years with mild-moderate asthma. Their objectives were to compare exacerbation rates, time to first exacerbation, acute care visits, and bronchodilator use in children randomized to treatment with either high (5 x baseline ICS dose x 7 days) or low dose inhaled corticosteroids early in a drop to the “yellow zone” (Jackson, et al. N Engl J Med. 2018;378[10]:891).

Time to asthma exacerbations and exacerbations that required treatment with corticosteroids did not significantly differ between the low dose and high dose groups. Unexpectedly, the rate of exacerbations was higher with the high dose compared with the low dose group (0.48 vs 0.37). The children who were in the high dose group received 16% more ICS compared with the low dose group. Although not significant, there was a lower linear growth rate, ~0.23 cm per year seen in this high-dose group than in the low-dose group. Additionally, the use of bronchodilator, symptoms, and the rates of evaluation by a physician (ie, emergency department or urgent care visits) did not significantly differ between the two groups.

This study was specific to school-age children with mild-moderate persistent asthma treated with low dose ICS with a history of good adherence. Overall, this well-designed study helps address a question that many clinicians have regarding escalating ICS in the “yellow zone.” Escalating ICS did not reduce exacerbations at the cost of a lower linear growth rate. When it comes to escalating ICS for asthma exacerbation, more is not better.

In conclusion, in children with mild-to-moderate persistent asthma treated with daily inhaled glucocorticoids, quintupling the dose at the early signs of loss of asthma control did not reduce the rate of severe asthma exacerbations or improve other asthma outcomes and may be associated with diminished linear growth. (Funded by the National Heart, Lung, and Blood Institute; STICS ClinicalTrials.gov number, NCT02066129).

John Bishara, DO

Fellow-in-Training Member

Pulmonary Physiology, Function, and Rehabilitation

 

 

Understanding cardiopulmonary exercise testing

The cardiopulmonary exercise test (CPET) is an underutilized tool for evaluating patients with dyspnea of uncertain etiology. This is often due to the daunting task of trying to make sense of seemingly large amounts of interacting data, along with clinicians not having been taught a systematic approach for interpreting the results. Unlike other typical tests we order that point to a specific laboratory or anatomic radiographic abnormality, narrowing our differential to a few possibilities, one needs a different mindset when interpreting a CPET. This is a study to demonstrate the body’s normal or abnormal physiologic responses to increasing levels of physical stress. Because different conditions can give similar findings, the physiologic abnormalities must be interpreted in the context of the clinical presentation. If the results do not entirely fit the suspected diagnosis, they should be reported in a manner that may help guide the ordering physician down an alternate pathway. This CHEST NetWork has sought ways to reach out to members to promote a better understanding of the utilization of the basics of pulmonary physiology in the management of patients. We created an online two-part video demonstrating a basic systematic approach toward understanding the combinations of findings one often sees when performing a CPET. A comprehensive understanding cannot be shown in a 40-minute video series, but, hopefully, this will give a starting point to make this task easier and more enjoyable.

Zachary Morris, MD, FCCP

Steering Committee Member

Pulmonary Vascular Disease

BMPR2 mutation regulates singular millimetric fibrovascular lesions in bronchial circulation in PAH

Patients with PAH with BMPR2 mutation are younger with worse hemodynamics, ie, higher mean PAP with higher PVR and a lower cardiac index in comparison to the noncarriers. A systematic analysis of pulmonary imaging using CT angiography or magnetic resonance imaging in patients with PAH demonstrated increased bronchial arterial hypertrophy in BMPR2 mutation carriers compared with those without the mutation. Moreover, hemoptysis is more frequently encountered in patients with PAH with BMPR2 mutation and presumably related to bronchial artery remodeling and angiogenesis. French investigators described, in histopathology findings of explanted lungs of 44 patients with PAH (23 carriers of BMPR2 and 21 noncarriers), unusual singular millimetric fibrovascular lesions (SiMFi) in patients with BMPR2 mutations. The SiMFi is a structure of millimetric dimension with fibrovascular characteristics that are extremely rich in collagen and displayed more than one vascular channel. SiMFi did not show a classic glomeruloid pattern with predominant endothelial cell proliferation as seen in plexiform lesions but rather a large conglomerate of hypertrophic vessels. Performing an ink injection experiment in a freshly explanted lung highlighted a patent connection between bronchial/systemic vessels and pulmonary septal veins. SiMFis had an increased amount of bronchial microvessels and showed increased hypertrophy of larger bronchial arteries. SiMFi is directly related to hypertrophy and/or angiogenesis of vasa vasorum/bronchial arteries in the vicinity of the diseased artery. In patients with PAH with BMPR2 mutations, bronchial angiogenesis is more prevalent compared with patients with PAH lacking these mutations. This highlights the role of bronchial arteries in the spectrum of PAH.

Hector Cajigas, MD, FCCP

Sandeep Sahay, MD, FCCP

Steering Committee Members

References

1.Ghigna MR, et al. BMPR2 mutation status influences bronchial vascular changes in pulmonary arterial hypertension. Eur Respir J. 2016;48[6]:1668. Epub 2016 Nov 3.

2. Tio D, et al. Risk factors for hemoptysis in idiopathic and hereditary pulmonary arterial hypertension. PLoS One. 2013;8:e78132.

3. Elliott CG, et al. Relationship of BMPR2 mutations to vasoreactivity in pulmonary arterial hypertension. Circulation. 2006;113[21]:2509.



Thoracic Oncology

We have a lung cancer screening test but we could use it better

The American Lung Association recently demonstrated the majority of current and former smokers don’t know about lung cancer screening (LCS) with low-dose CT scanning.1 Researchers estimate less than 5% of eligible persons received LCS.2 Awareness campaigns targeting patients and health care providers at the local level can improve LCS uptake.3,4 While any new clinical practice has an expected implementation delay, LCS has another implementation barrier: complex eligibility criteria (age 55 – 80 years PLUS 30+ pack-year smoking history PLUS quit time less than 15 years). Electronic health record (EHR) tools might accelerate the adoption curve to identify eligible persons.5 Moreover, assessing and recording a qualitative smoking history is challenging, at best. One center showed 96.2% discordance between EHR smoking history and that obtained during shared decision-making visit for LCS.6 Mostly, the EHR underreported quantitative pack-year history; meaning LCS-eligible patients might fail to be identified by EHR review alone. Another small pilot showed that some patients age 55 – 79 years will update their EHR smoking history using patient portal, but this will not be effective for all patients.7 For current smokers, age alone may be an effective identification strategy, given the average start time for most smokers.8

 

 

Even though current LCS guidelines leave out some individuals at high risk for lung cancer, we must continue efforts to offer this potentially life-saving service to patients now eligible. Using EHR tools may help proactively identify those who are eligible for lung cancer screening.

A bbie Begnaud, MD

NetWork Member

References

1. New Study from American Lung Association’s LUNG FORCE Reveals Low Awareness of Lifesaving Lung Cancer Screening Among Those at Greatest Risk. (2017). http://www.lung.org/about-us/media/press-releases/new-study-lung-cancer-screening.html. Accessed April 19, 2018.

2. Soneji S, et al. Underuse of Chest Radiography Versus Computed Tomography for Lung Cancer Screening. Am J Public Health. 2017;107(8):1248.

3. Cardarelli R, et al. Terminate lung cancer (TLC) study-A mixed-methods population approach to increase lung cancer screening awareness and low-dose computed tomography in Eastern Kentucky. Cancer Epidemiol. 2017;46:1.

4. Jessup, DL, et al. Implementation of digital awareness strategies to engage patients and providers in a lung cancer screening program: retrospective study. J Med Internet Res. 2018;20(2):e52.

5. Comparison of the Electronic Medical Record versus a Shared Decision Making Conversation. Ann Am Thorac Soc. 2018. In press.

6. Modin HE, et al. Pack-year cigarette smoking history for determination of lung cancer screening eligibility. Ann Am Thorac Soc. 2017 Aug;14(8):1320-1325.

7. Begnaud AL, et al. Randomized electronic promotion of lung cancer screening: a pilot. JCO Clinical Cancer Informatics(1), 1-6. doi:10.1200/cci.17.00033

8. The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General. (2014). Atlanta, GA.

 

Interventional Chest/Diagnostic Procedures

Review of The AMPLE Trial: is talc making a comeback?

A proposed advantage of indwelling pleural catheters (IPC) is their purported ability to reduce hospitalization time when compared with the more traditional talc pleurodesis procedure. The recently published AMPLE trial was a multicenter randomized trial comparing the impact of IPCs vs talc pleurodesis on hospitalization days in patients with malignant pleural effusions. One-hundred forty-six patients were randomized for pleurodesis to either IPC vs pleurodesis via talc slurry in nine centers in Australia, New Zealand, Singapore, and Hong Kong. Patients were followed for up to 12 months. Secondary outcomes included need for further pleural intervention, breathlessness, quality of life, and adverse events.

Patients randomized to IPC spent on average 2 days less in the hospital (10 vs 12 days), a difference that was statistically significant, though of questionable clinical relevance, and somewhat disappointing in light of a prior prospective study from the same group suggesting a benefit of 6 to 7 days (Fysh. Chest. 2012;142[2]:394. As in previous studies, additional pleural procedures were more common in the talc group, adverse events occurred more frequently with IPC, but breathlessness and quality of life were identical in both groups.

This study raises interesting questions. Clearly, IPCs have been favored over talc pleurodesis in the US in the last decade, primarily because of a perceived benefit in terms of hospitalization time. In the absence of clear advantage of IPC on time spent in the hospital, impact on breathlessness and quality of life, and considering the inconvenience of frequent drainage, co-pay incurred by patients, and increased adverse events with IPC, the pendulum may swing again toward talc pleurodesis.

Christine Argento, MD, FCCP

Fabien Maldonado, MD, FCCP

Steering Committee Members

Pediatric Chest Medicine

Early escalation of inhaled corticosteroids: does it help prevent asthma exacerbations?

Asthma is one of the most common chronic conditions in children. The importance of effective control of asthma to prevent exacerbations is well accepted. Inhaled corticosteroids (ICS) are a preferred component of treatment to improve asthma control in children with persistent asthma; however, exacerbations can still occur and result in significant morbidity. Most patients receive systemic corticosteroids during acute asthma exacerbations. The most recent Global Initiative for Asthma (GINA) guidelines recommend increasing ICS at the first signs of an asthma exacerbation in an effort to lessen the need for systemic corticosteroids (GINA. Global strategy for asthma management and prevention. 2017. http://www.ginasthma.org/).

In a recent issue of the New England Journal of Medicine, Jackson and colleagues at the National Heart, Lung, and Blood Institute AsthmaNet published the results of a randomized, double-blind 48-week trial, which included 254 children between ages 5 and 11 years with mild-moderate asthma. Their objectives were to compare exacerbation rates, time to first exacerbation, acute care visits, and bronchodilator use in children randomized to treatment with either high (5 x baseline ICS dose x 7 days) or low dose inhaled corticosteroids early in a drop to the “yellow zone” (Jackson, et al. N Engl J Med. 2018;378[10]:891).

Time to asthma exacerbations and exacerbations that required treatment with corticosteroids did not significantly differ between the low dose and high dose groups. Unexpectedly, the rate of exacerbations was higher with the high dose compared with the low dose group (0.48 vs 0.37). The children who were in the high dose group received 16% more ICS compared with the low dose group. Although not significant, there was a lower linear growth rate, ~0.23 cm per year seen in this high-dose group than in the low-dose group. Additionally, the use of bronchodilator, symptoms, and the rates of evaluation by a physician (ie, emergency department or urgent care visits) did not significantly differ between the two groups.

This study was specific to school-age children with mild-moderate persistent asthma treated with low dose ICS with a history of good adherence. Overall, this well-designed study helps address a question that many clinicians have regarding escalating ICS in the “yellow zone.” Escalating ICS did not reduce exacerbations at the cost of a lower linear growth rate. When it comes to escalating ICS for asthma exacerbation, more is not better.

In conclusion, in children with mild-to-moderate persistent asthma treated with daily inhaled glucocorticoids, quintupling the dose at the early signs of loss of asthma control did not reduce the rate of severe asthma exacerbations or improve other asthma outcomes and may be associated with diminished linear growth. (Funded by the National Heart, Lung, and Blood Institute; STICS ClinicalTrials.gov number, NCT02066129).

John Bishara, DO

Fellow-in-Training Member

Pulmonary Physiology, Function, and Rehabilitation

 

 

Understanding cardiopulmonary exercise testing

The cardiopulmonary exercise test (CPET) is an underutilized tool for evaluating patients with dyspnea of uncertain etiology. This is often due to the daunting task of trying to make sense of seemingly large amounts of interacting data, along with clinicians not having been taught a systematic approach for interpreting the results. Unlike other typical tests we order that point to a specific laboratory or anatomic radiographic abnormality, narrowing our differential to a few possibilities, one needs a different mindset when interpreting a CPET. This is a study to demonstrate the body’s normal or abnormal physiologic responses to increasing levels of physical stress. Because different conditions can give similar findings, the physiologic abnormalities must be interpreted in the context of the clinical presentation. If the results do not entirely fit the suspected diagnosis, they should be reported in a manner that may help guide the ordering physician down an alternate pathway. This CHEST NetWork has sought ways to reach out to members to promote a better understanding of the utilization of the basics of pulmonary physiology in the management of patients. We created an online two-part video demonstrating a basic systematic approach toward understanding the combinations of findings one often sees when performing a CPET. A comprehensive understanding cannot be shown in a 40-minute video series, but, hopefully, this will give a starting point to make this task easier and more enjoyable.

Zachary Morris, MD, FCCP

Steering Committee Member

Pulmonary Vascular Disease

BMPR2 mutation regulates singular millimetric fibrovascular lesions in bronchial circulation in PAH

Patients with PAH with BMPR2 mutation are younger with worse hemodynamics, ie, higher mean PAP with higher PVR and a lower cardiac index in comparison to the noncarriers. A systematic analysis of pulmonary imaging using CT angiography or magnetic resonance imaging in patients with PAH demonstrated increased bronchial arterial hypertrophy in BMPR2 mutation carriers compared with those without the mutation. Moreover, hemoptysis is more frequently encountered in patients with PAH with BMPR2 mutation and presumably related to bronchial artery remodeling and angiogenesis. French investigators described, in histopathology findings of explanted lungs of 44 patients with PAH (23 carriers of BMPR2 and 21 noncarriers), unusual singular millimetric fibrovascular lesions (SiMFi) in patients with BMPR2 mutations. The SiMFi is a structure of millimetric dimension with fibrovascular characteristics that are extremely rich in collagen and displayed more than one vascular channel. SiMFi did not show a classic glomeruloid pattern with predominant endothelial cell proliferation as seen in plexiform lesions but rather a large conglomerate of hypertrophic vessels. Performing an ink injection experiment in a freshly explanted lung highlighted a patent connection between bronchial/systemic vessels and pulmonary septal veins. SiMFis had an increased amount of bronchial microvessels and showed increased hypertrophy of larger bronchial arteries. SiMFi is directly related to hypertrophy and/or angiogenesis of vasa vasorum/bronchial arteries in the vicinity of the diseased artery. In patients with PAH with BMPR2 mutations, bronchial angiogenesis is more prevalent compared with patients with PAH lacking these mutations. This highlights the role of bronchial arteries in the spectrum of PAH.

Hector Cajigas, MD, FCCP

Sandeep Sahay, MD, FCCP

Steering Committee Members

References

1.Ghigna MR, et al. BMPR2 mutation status influences bronchial vascular changes in pulmonary arterial hypertension. Eur Respir J. 2016;48[6]:1668. Epub 2016 Nov 3.

2. Tio D, et al. Risk factors for hemoptysis in idiopathic and hereditary pulmonary arterial hypertension. PLoS One. 2013;8:e78132.

3. Elliott CG, et al. Relationship of BMPR2 mutations to vasoreactivity in pulmonary arterial hypertension. Circulation. 2006;113[21]:2509.



Thoracic Oncology

We have a lung cancer screening test but we could use it better

The American Lung Association recently demonstrated the majority of current and former smokers don’t know about lung cancer screening (LCS) with low-dose CT scanning.1 Researchers estimate less than 5% of eligible persons received LCS.2 Awareness campaigns targeting patients and health care providers at the local level can improve LCS uptake.3,4 While any new clinical practice has an expected implementation delay, LCS has another implementation barrier: complex eligibility criteria (age 55 – 80 years PLUS 30+ pack-year smoking history PLUS quit time less than 15 years). Electronic health record (EHR) tools might accelerate the adoption curve to identify eligible persons.5 Moreover, assessing and recording a qualitative smoking history is challenging, at best. One center showed 96.2% discordance between EHR smoking history and that obtained during shared decision-making visit for LCS.6 Mostly, the EHR underreported quantitative pack-year history; meaning LCS-eligible patients might fail to be identified by EHR review alone. Another small pilot showed that some patients age 55 – 79 years will update their EHR smoking history using patient portal, but this will not be effective for all patients.7 For current smokers, age alone may be an effective identification strategy, given the average start time for most smokers.8

 

 

Even though current LCS guidelines leave out some individuals at high risk for lung cancer, we must continue efforts to offer this potentially life-saving service to patients now eligible. Using EHR tools may help proactively identify those who are eligible for lung cancer screening.

A bbie Begnaud, MD

NetWork Member

References

1. New Study from American Lung Association’s LUNG FORCE Reveals Low Awareness of Lifesaving Lung Cancer Screening Among Those at Greatest Risk. (2017). http://www.lung.org/about-us/media/press-releases/new-study-lung-cancer-screening.html. Accessed April 19, 2018.

2. Soneji S, et al. Underuse of Chest Radiography Versus Computed Tomography for Lung Cancer Screening. Am J Public Health. 2017;107(8):1248.

3. Cardarelli R, et al. Terminate lung cancer (TLC) study-A mixed-methods population approach to increase lung cancer screening awareness and low-dose computed tomography in Eastern Kentucky. Cancer Epidemiol. 2017;46:1.

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