The impact of a nurse practitioner-led symptom clinic on emergency department use in cancer patients

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Background Emergency department (ED) use and hospitalization is distressing to cancer patients and drives up the cost of health care. A growing body of evidence demonstrates that more than half of those visits may be avoidable.

Objective To examine the impact of a nurse practitioner (NP)-led, physician-supervised, outpatient symptom management clinic on ED use.

Methods We conducted a retrospective review of ED encounters to quantify the frequency of ED use by oncology patients at a community cancer institute 6 months before (October 2012-March 2013) and after (April-September 2013) the initiation of an NP-staffed symptom management clinic.

Results The highest use of the ED and supportive clinic was among patients with advanced cancer, most commonly with lung or breast cancer, who were receiving cytotoxic chemotherapy. Uncontrolled symptoms of shortness of breath, pain, weakness, fever, nausea, vomiting, and diarrhea commonly led to ED visits. Despite instituting the NP-staffed symptom management clinic to manage those symptoms, there was a 17.9% increase in ED use. However, of the patients seen by the NP, 95% may have avoided hospitalization.

Limitations Retrospective study

Conclusions Our study identifies a high-risk population of patients who use the ED frequently. NP-led clinics could aggressively manage the symptom burden of these patients and potentially reduce ED visits as other studies have demonstrated. Although our study did not directly demonstrate this, we have identified weaknesses of care delivery in our clinic that could be optimized. In addition, we have demonstrated that the majority of patients seen for acute symptoms by an NP avoided an ED visit. 

 

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Background Emergency department (ED) use and hospitalization is distressing to cancer patients and drives up the cost of health care. A growing body of evidence demonstrates that more than half of those visits may be avoidable.

Objective To examine the impact of a nurse practitioner (NP)-led, physician-supervised, outpatient symptom management clinic on ED use.

Methods We conducted a retrospective review of ED encounters to quantify the frequency of ED use by oncology patients at a community cancer institute 6 months before (October 2012-March 2013) and after (April-September 2013) the initiation of an NP-staffed symptom management clinic.

Results The highest use of the ED and supportive clinic was among patients with advanced cancer, most commonly with lung or breast cancer, who were receiving cytotoxic chemotherapy. Uncontrolled symptoms of shortness of breath, pain, weakness, fever, nausea, vomiting, and diarrhea commonly led to ED visits. Despite instituting the NP-staffed symptom management clinic to manage those symptoms, there was a 17.9% increase in ED use. However, of the patients seen by the NP, 95% may have avoided hospitalization.

Limitations Retrospective study

Conclusions Our study identifies a high-risk population of patients who use the ED frequently. NP-led clinics could aggressively manage the symptom burden of these patients and potentially reduce ED visits as other studies have demonstrated. Although our study did not directly demonstrate this, we have identified weaknesses of care delivery in our clinic that could be optimized. In addition, we have demonstrated that the majority of patients seen for acute symptoms by an NP avoided an ED visit. 

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Background Emergency department (ED) use and hospitalization is distressing to cancer patients and drives up the cost of health care. A growing body of evidence demonstrates that more than half of those visits may be avoidable.

Objective To examine the impact of a nurse practitioner (NP)-led, physician-supervised, outpatient symptom management clinic on ED use.

Methods We conducted a retrospective review of ED encounters to quantify the frequency of ED use by oncology patients at a community cancer institute 6 months before (October 2012-March 2013) and after (April-September 2013) the initiation of an NP-staffed symptom management clinic.

Results The highest use of the ED and supportive clinic was among patients with advanced cancer, most commonly with lung or breast cancer, who were receiving cytotoxic chemotherapy. Uncontrolled symptoms of shortness of breath, pain, weakness, fever, nausea, vomiting, and diarrhea commonly led to ED visits. Despite instituting the NP-staffed symptom management clinic to manage those symptoms, there was a 17.9% increase in ED use. However, of the patients seen by the NP, 95% may have avoided hospitalization.

Limitations Retrospective study

Conclusions Our study identifies a high-risk population of patients who use the ED frequently. NP-led clinics could aggressively manage the symptom burden of these patients and potentially reduce ED visits as other studies have demonstrated. Although our study did not directly demonstrate this, we have identified weaknesses of care delivery in our clinic that could be optimized. In addition, we have demonstrated that the majority of patients seen for acute symptoms by an NP avoided an ED visit. 

 

Click on the PDF icon at the top of this introduction to read the full article.

 
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Hereditary breast and ovarian cancer: risk assessment in minority women and provider knowledge gaps

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Hereditary breast and ovarian cancer: risk assessment in minority women and provider knowledge gaps
Background The Georgia Breast Cancer Genomics Project identified minority and underserved women at high risk for hereditary breast and ovarian cancer based on family history. Education, web-based screening, genetic counseling, and testing were provided in public health and primary care settings in accordance with evidence-based recommendations and guidelines.
Objectives To assess risk of hereditary breast and ovarian cancer (HBOC) among minority and underserved women, provide genetic services according to evidence-based guidelines, and evaluate provider knowledge of HBOC.
Methods The Georgia Department of Public Health established this project through a cooperative agreement with the Centers for Disease Control and Prevention. HBOC screening and genetic services were provided in 13 public health centers and federally qualified health centers. Staff received training on genetics and risk assessment using the Breast Cancer Genetics Referral Screening Tool (B-RST). Providers and medical residents were surveyed on their knowledge of HBOC. Young women with breast cancer were surveyed on receipt of genetic services. 
Results More than 5,400 women were successfully screened; 79% identified as racial/ethnic minorities. 5% of women screened positive on the B-RST, which is consistent with HBOC prevalence; 79% agreed to follow up. 23% met criteria for increased risk of BRCA 1/2 mutation and received genetic counseling and testing. Surveys revealed profound gaps in knowledge among physicians and medical residents and lack of delivery of evidence-based genetic services to survivors. 
Conclusions The genomics project demonstrated the efficacy of population-based screening to identify high-risk women before they receive a diagnosis of cancer. A high percentage of women who screened positive also completed genetic counseling and testing. Access to the benefits of HBOC management to prevent cancer and decrease mortality among minority and underserved women depends on improvements in knowledge of genetics and evidence-based practice by providers. 
Funding/sponsorship This project was funded through a cooperative agreement from the Centers for Disease Control and Prevention to the Georgia Department of Public Health from 2011-2014.


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Background The Georgia Breast Cancer Genomics Project identified minority and underserved women at high risk for hereditary breast and ovarian cancer based on family history. Education, web-based screening, genetic counseling, and testing were provided in public health and primary care settings in accordance with evidence-based recommendations and guidelines.
Objectives To assess risk of hereditary breast and ovarian cancer (HBOC) among minority and underserved women, provide genetic services according to evidence-based guidelines, and evaluate provider knowledge of HBOC.
Methods The Georgia Department of Public Health established this project through a cooperative agreement with the Centers for Disease Control and Prevention. HBOC screening and genetic services were provided in 13 public health centers and federally qualified health centers. Staff received training on genetics and risk assessment using the Breast Cancer Genetics Referral Screening Tool (B-RST). Providers and medical residents were surveyed on their knowledge of HBOC. Young women with breast cancer were surveyed on receipt of genetic services. 
Results More than 5,400 women were successfully screened; 79% identified as racial/ethnic minorities. 5% of women screened positive on the B-RST, which is consistent with HBOC prevalence; 79% agreed to follow up. 23% met criteria for increased risk of BRCA 1/2 mutation and received genetic counseling and testing. Surveys revealed profound gaps in knowledge among physicians and medical residents and lack of delivery of evidence-based genetic services to survivors. 
Conclusions The genomics project demonstrated the efficacy of population-based screening to identify high-risk women before they receive a diagnosis of cancer. A high percentage of women who screened positive also completed genetic counseling and testing. Access to the benefits of HBOC management to prevent cancer and decrease mortality among minority and underserved women depends on improvements in knowledge of genetics and evidence-based practice by providers. 
Funding/sponsorship This project was funded through a cooperative agreement from the Centers for Disease Control and Prevention to the Georgia Department of Public Health from 2011-2014.


Click on the PDF icon at the top of this introduction to read the full article. 

 

Background The Georgia Breast Cancer Genomics Project identified minority and underserved women at high risk for hereditary breast and ovarian cancer based on family history. Education, web-based screening, genetic counseling, and testing were provided in public health and primary care settings in accordance with evidence-based recommendations and guidelines.
Objectives To assess risk of hereditary breast and ovarian cancer (HBOC) among minority and underserved women, provide genetic services according to evidence-based guidelines, and evaluate provider knowledge of HBOC.
Methods The Georgia Department of Public Health established this project through a cooperative agreement with the Centers for Disease Control and Prevention. HBOC screening and genetic services were provided in 13 public health centers and federally qualified health centers. Staff received training on genetics and risk assessment using the Breast Cancer Genetics Referral Screening Tool (B-RST). Providers and medical residents were surveyed on their knowledge of HBOC. Young women with breast cancer were surveyed on receipt of genetic services. 
Results More than 5,400 women were successfully screened; 79% identified as racial/ethnic minorities. 5% of women screened positive on the B-RST, which is consistent with HBOC prevalence; 79% agreed to follow up. 23% met criteria for increased risk of BRCA 1/2 mutation and received genetic counseling and testing. Surveys revealed profound gaps in knowledge among physicians and medical residents and lack of delivery of evidence-based genetic services to survivors. 
Conclusions The genomics project demonstrated the efficacy of population-based screening to identify high-risk women before they receive a diagnosis of cancer. A high percentage of women who screened positive also completed genetic counseling and testing. Access to the benefits of HBOC management to prevent cancer and decrease mortality among minority and underserved women depends on improvements in knowledge of genetics and evidence-based practice by providers. 
Funding/sponsorship This project was funded through a cooperative agreement from the Centers for Disease Control and Prevention to the Georgia Department of Public Health from 2011-2014.


Click on the PDF icon at the top of this introduction to read the full article. 

 

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HBV/HIV coinfection a significant risk factor for inpatient mortality

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HBV/HIV coinfection a significant risk factor for inpatient mortality

Patients coinfected with hepatitis B virus and HIV are at greater risk for in-hospital mortality, particularly in liver-related admissions, compared with HBV monoinfection, according to a study in the Journal of Viral Hepatitis.

Researchers at Massachusetts General Hospital, Boston, identified patients in the 2011 U.S. Nationwide Inpatient Sample who had been hospitalized with HBV or HIV monoinfection or HBV/HIV coinfection using ICD-9-CM codes. A total of 72,584 discharges with HBV monoinfection, 133,880 discharges with HIV monoinfection and 8,156 discharges with HBV/HIV coinfection were included. The researchers then compared liver-related hospital admissions among the three groups and performed multivariable logistic regression to identify independent predictors of in-hospital mortality, length of stay, and total charges.

CDC/Dr. Erskine Palmer

According to Raymond T. Chung, MD, director of hepatology at Massachusetts General Hospital, and his coauthors, this study is the first to examine outcomes of HBV/HIV coinfection among hospitalized patients, a “group that represents those with advanced disease and vulnerable to poor outcomes and high health care utilization.” (J Viral Hepat. 2016 Jun 13. doi: 10.1111/jvh.12555)

Patients in the study with HBV monoinfection tended to be older than those with HIV monoinfection or HBV/HIV coinfection. Of those aged 51-65 years, 42% had HBV monoinfection, 34% had HIV monoinfection, and 31% had HBV/HIV coinfection (P less than .001). Males were overrepresented in the HBV/HIV coinfection group (77%), compared with those with HBV monoinfection (57%), and HIV monoinfection (67%). Additionally, the investigators found that patients with HBV monoinfection were more likely to be white (42%) than were those with HIV monoinfection (26%) or HBV/HIV coinfection (27%).

Dr. Chung and his colleagues found that HBV/HIV coinfection was associated with significantly higher adjusted in-hospital mortality, compared with patients with HBV monoinfection (adjusted odds ratio, 1.67; 95% confidence interval, 1.30-2.15), but not compared with HIV monoinfection (aOR, 1.22; 95% CI, 0.96-1.54).

“Interestingly, [the] increase in risk of mortality was primarily observed in liver-related admissions … and not infectious-related hospitalizations,” Dr. Chung and his coauthors said.

The overall adjusted hospital length of stay (LOS;1.53 days; 95% CI, 0.93-2.13; less than .001) and total hospitalization charges ($17,595; 95% CI 11,120-24,069; P less than .0001) were higher in the coinfected group, compared with the HBV monoinfection group – even after adjustment for comorbidity- and disease-related complications, the authors wrote. LOS and total charges also were higher in the coinfected group, compared with the HIV monoinfection group (+0.62 days; P = .034; $8,840; P = .005).

While HBV/HIV coinfection by itself was not associated with higher in-hospital mortality, the presence of HBV along with cirrhosis or complications of portal hypertension was associated with three times greater in-hospital mortality in patients with HIV, compared with those without such complications (odds ratio, 3.00; 95% CI, 1.80-5.02). Researchers also found that LOS (0.62 days; 95% CI, 0.05-1.20; P = .034) and hospitalization cost ($8,840; 95% CI, 2,604-15,077; P = .005) were increased in patients with HBV/HIV coinfection, compared with HIV monoinfection.

“Overall health care utilization from HBV/HIV coinfection is … higher than for either infection alone and higher than the national average for all hospitalizations, emphasizing the health care burden from these illnesses,” the authors concluded.

Three study coauthors were supported in part by grants from the National Institutes of Health, while one coauthor was supported by a career development award from the American Gastroenterological Association and by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Chung reported no financial conflict of interests. One coauthor reported participation on scientific advisory boards of AbbVie and Cubist pharmaceuticals.

[email protected]

On Twitter @richpizzi

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Patients coinfected with hepatitis B virus and HIV are at greater risk for in-hospital mortality, particularly in liver-related admissions, compared with HBV monoinfection, according to a study in the Journal of Viral Hepatitis.

Researchers at Massachusetts General Hospital, Boston, identified patients in the 2011 U.S. Nationwide Inpatient Sample who had been hospitalized with HBV or HIV monoinfection or HBV/HIV coinfection using ICD-9-CM codes. A total of 72,584 discharges with HBV monoinfection, 133,880 discharges with HIV monoinfection and 8,156 discharges with HBV/HIV coinfection were included. The researchers then compared liver-related hospital admissions among the three groups and performed multivariable logistic regression to identify independent predictors of in-hospital mortality, length of stay, and total charges.

CDC/Dr. Erskine Palmer

According to Raymond T. Chung, MD, director of hepatology at Massachusetts General Hospital, and his coauthors, this study is the first to examine outcomes of HBV/HIV coinfection among hospitalized patients, a “group that represents those with advanced disease and vulnerable to poor outcomes and high health care utilization.” (J Viral Hepat. 2016 Jun 13. doi: 10.1111/jvh.12555)

Patients in the study with HBV monoinfection tended to be older than those with HIV monoinfection or HBV/HIV coinfection. Of those aged 51-65 years, 42% had HBV monoinfection, 34% had HIV monoinfection, and 31% had HBV/HIV coinfection (P less than .001). Males were overrepresented in the HBV/HIV coinfection group (77%), compared with those with HBV monoinfection (57%), and HIV monoinfection (67%). Additionally, the investigators found that patients with HBV monoinfection were more likely to be white (42%) than were those with HIV monoinfection (26%) or HBV/HIV coinfection (27%).

Dr. Chung and his colleagues found that HBV/HIV coinfection was associated with significantly higher adjusted in-hospital mortality, compared with patients with HBV monoinfection (adjusted odds ratio, 1.67; 95% confidence interval, 1.30-2.15), but not compared with HIV monoinfection (aOR, 1.22; 95% CI, 0.96-1.54).

“Interestingly, [the] increase in risk of mortality was primarily observed in liver-related admissions … and not infectious-related hospitalizations,” Dr. Chung and his coauthors said.

The overall adjusted hospital length of stay (LOS;1.53 days; 95% CI, 0.93-2.13; less than .001) and total hospitalization charges ($17,595; 95% CI 11,120-24,069; P less than .0001) were higher in the coinfected group, compared with the HBV monoinfection group – even after adjustment for comorbidity- and disease-related complications, the authors wrote. LOS and total charges also were higher in the coinfected group, compared with the HIV monoinfection group (+0.62 days; P = .034; $8,840; P = .005).

While HBV/HIV coinfection by itself was not associated with higher in-hospital mortality, the presence of HBV along with cirrhosis or complications of portal hypertension was associated with three times greater in-hospital mortality in patients with HIV, compared with those without such complications (odds ratio, 3.00; 95% CI, 1.80-5.02). Researchers also found that LOS (0.62 days; 95% CI, 0.05-1.20; P = .034) and hospitalization cost ($8,840; 95% CI, 2,604-15,077; P = .005) were increased in patients with HBV/HIV coinfection, compared with HIV monoinfection.

“Overall health care utilization from HBV/HIV coinfection is … higher than for either infection alone and higher than the national average for all hospitalizations, emphasizing the health care burden from these illnesses,” the authors concluded.

Three study coauthors were supported in part by grants from the National Institutes of Health, while one coauthor was supported by a career development award from the American Gastroenterological Association and by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Chung reported no financial conflict of interests. One coauthor reported participation on scientific advisory boards of AbbVie and Cubist pharmaceuticals.

[email protected]

On Twitter @richpizzi

Patients coinfected with hepatitis B virus and HIV are at greater risk for in-hospital mortality, particularly in liver-related admissions, compared with HBV monoinfection, according to a study in the Journal of Viral Hepatitis.

Researchers at Massachusetts General Hospital, Boston, identified patients in the 2011 U.S. Nationwide Inpatient Sample who had been hospitalized with HBV or HIV monoinfection or HBV/HIV coinfection using ICD-9-CM codes. A total of 72,584 discharges with HBV monoinfection, 133,880 discharges with HIV monoinfection and 8,156 discharges with HBV/HIV coinfection were included. The researchers then compared liver-related hospital admissions among the three groups and performed multivariable logistic regression to identify independent predictors of in-hospital mortality, length of stay, and total charges.

CDC/Dr. Erskine Palmer

According to Raymond T. Chung, MD, director of hepatology at Massachusetts General Hospital, and his coauthors, this study is the first to examine outcomes of HBV/HIV coinfection among hospitalized patients, a “group that represents those with advanced disease and vulnerable to poor outcomes and high health care utilization.” (J Viral Hepat. 2016 Jun 13. doi: 10.1111/jvh.12555)

Patients in the study with HBV monoinfection tended to be older than those with HIV monoinfection or HBV/HIV coinfection. Of those aged 51-65 years, 42% had HBV monoinfection, 34% had HIV monoinfection, and 31% had HBV/HIV coinfection (P less than .001). Males were overrepresented in the HBV/HIV coinfection group (77%), compared with those with HBV monoinfection (57%), and HIV monoinfection (67%). Additionally, the investigators found that patients with HBV monoinfection were more likely to be white (42%) than were those with HIV monoinfection (26%) or HBV/HIV coinfection (27%).

Dr. Chung and his colleagues found that HBV/HIV coinfection was associated with significantly higher adjusted in-hospital mortality, compared with patients with HBV monoinfection (adjusted odds ratio, 1.67; 95% confidence interval, 1.30-2.15), but not compared with HIV monoinfection (aOR, 1.22; 95% CI, 0.96-1.54).

“Interestingly, [the] increase in risk of mortality was primarily observed in liver-related admissions … and not infectious-related hospitalizations,” Dr. Chung and his coauthors said.

The overall adjusted hospital length of stay (LOS;1.53 days; 95% CI, 0.93-2.13; less than .001) and total hospitalization charges ($17,595; 95% CI 11,120-24,069; P less than .0001) were higher in the coinfected group, compared with the HBV monoinfection group – even after adjustment for comorbidity- and disease-related complications, the authors wrote. LOS and total charges also were higher in the coinfected group, compared with the HIV monoinfection group (+0.62 days; P = .034; $8,840; P = .005).

While HBV/HIV coinfection by itself was not associated with higher in-hospital mortality, the presence of HBV along with cirrhosis or complications of portal hypertension was associated with three times greater in-hospital mortality in patients with HIV, compared with those without such complications (odds ratio, 3.00; 95% CI, 1.80-5.02). Researchers also found that LOS (0.62 days; 95% CI, 0.05-1.20; P = .034) and hospitalization cost ($8,840; 95% CI, 2,604-15,077; P = .005) were increased in patients with HBV/HIV coinfection, compared with HIV monoinfection.

“Overall health care utilization from HBV/HIV coinfection is … higher than for either infection alone and higher than the national average for all hospitalizations, emphasizing the health care burden from these illnesses,” the authors concluded.

Three study coauthors were supported in part by grants from the National Institutes of Health, while one coauthor was supported by a career development award from the American Gastroenterological Association and by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Chung reported no financial conflict of interests. One coauthor reported participation on scientific advisory boards of AbbVie and Cubist pharmaceuticals.

[email protected]

On Twitter @richpizzi

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FROM THE JOURNAL OF VIRAL HEPATITIS

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Key clinical point: Patients coinfected with HBV and HIV are at greater risk for in-hospital mortality, particularly in liver-related admissions, compared with HBV monoinfection.

Major finding: HBV/HIV coinfection was associated with significantly higher adjusted in-hospital mortality, compared with patients with HBV monoinfection, but not when compared with HIV monoinfection.

Data source: Comparison study of patient discharges from the 2011 U.S. Nationwide Inpatient Sample: 72,584 discharges with HBV monoinfection, 133,880 discharges with HIV monoinfection and 8,156 discharges with HBV/HIV coinfection.

Disclosures: Three study coauthors were supported in part by grants from the National Institutes of Health, while one coauthor was supported by a career development award from the American Gastroenterological Association and by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Chung reported no financial conflict of interests. One coauthor reported participation on scientific advisory boards of AbbVie and Cubist pharmaceuticals.

New Guideline for Stroke Rehabilitation

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New Guideline for Stroke Rehabilitation

The American Heart Association/American Stroke Association has issued its first guideline on adult stroke rehabilitation. Published in the June issue of Stroke, the guideline calls for intensive, multidisciplinary treatment in an inpatient rehabilitation facility.

“Previous guidelines have focused on the medical issues involved in the initial management of stroke, but many people survive a stroke with some level of disability. There is increasing evidence that rehabilitation can have a big impact on the survivors’ quality of life, so the time is right to review the evidence in this complex field and highlight effective and important aspects of rehabilitation,” said Carolee J. Winstein, PhD, PT, lead author of the guideline and Professor of Biokinesiology and Physical Therapy at the University of Southern California in Los Angeles.

Carolee J. Winstein, PhD, PT

The American Stroke Association strongly recommends that stroke patients be treated at an inpatient rehabilitation facility whenever possible, rather than at a skilled nursing facility. While in an inpatient rehabilitation facility, a patient participates in at least three hours of rehabilitation per day with physical therapists, occupational therapists, and speech therapists. Nurses are continuously available, and doctors typically visit daily.

“There is considerable evidence that patients benefit from the team approach in a facility that understands the importance of rehabilitation during the early period after a stroke,” said Dr. Winstein.

According to Dr. Winstein and her coauthors, caregivers should advocate for discharge to an inpatient rehabilitation facility and insist that a stroke survivor not be discharged from the hospital until he or she has participated in a structured program on preventing falls. This program should include education about changes to make the home safer (eg, removing throw rugs and improving lighting), minimizing the fall risk resulting from the side effects of medication, and safely using assistive devices such as wheelchairs, walkers, and canes.

“This recommendation will probably change medical practice. Even the top stroke centers may not have a formal falls-prevention program, but it is very important because a high percentage of patients end up falling after a stroke,” Dr. Winstein said.

The guideline also recommends the following measures:

• Intense mobility-task training after stroke for all survivors with walking limitations to relearn activities such as climbing stairs

• An individually tailored exercise program that allows survivors to safely continue to improve their cardiovascular fitness through proper exercise and physical activity after formal rehabilitation is complete

• An enriched environment (which might include a computer, books, music, and games) to increase engagement and cognitive activities during rehabilitation

• Speech therapy for those with difficulty speaking following a stroke

• Eye exercises for survivors with difficulty focusing on near objects

• A balance training program for survivors with poor balance, or who are at risk for falls.

“For a person to fulfill his or her full potential after stroke, there needs to be a coordinated effort and ongoing communication between a team of professionals, as well as the patient, family, and caregivers,” Dr. Winstein said.

References

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Winstein CJ, Stein J, Arena R, et al. Guidelines for adult stroke rehabilitation and recovery: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2016;47(6):e98-e169.

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The American Heart Association/American Stroke Association has issued its first guideline on adult stroke rehabilitation. Published in the June issue of Stroke, the guideline calls for intensive, multidisciplinary treatment in an inpatient rehabilitation facility.

“Previous guidelines have focused on the medical issues involved in the initial management of stroke, but many people survive a stroke with some level of disability. There is increasing evidence that rehabilitation can have a big impact on the survivors’ quality of life, so the time is right to review the evidence in this complex field and highlight effective and important aspects of rehabilitation,” said Carolee J. Winstein, PhD, PT, lead author of the guideline and Professor of Biokinesiology and Physical Therapy at the University of Southern California in Los Angeles.

Carolee J. Winstein, PhD, PT

The American Stroke Association strongly recommends that stroke patients be treated at an inpatient rehabilitation facility whenever possible, rather than at a skilled nursing facility. While in an inpatient rehabilitation facility, a patient participates in at least three hours of rehabilitation per day with physical therapists, occupational therapists, and speech therapists. Nurses are continuously available, and doctors typically visit daily.

“There is considerable evidence that patients benefit from the team approach in a facility that understands the importance of rehabilitation during the early period after a stroke,” said Dr. Winstein.

According to Dr. Winstein and her coauthors, caregivers should advocate for discharge to an inpatient rehabilitation facility and insist that a stroke survivor not be discharged from the hospital until he or she has participated in a structured program on preventing falls. This program should include education about changes to make the home safer (eg, removing throw rugs and improving lighting), minimizing the fall risk resulting from the side effects of medication, and safely using assistive devices such as wheelchairs, walkers, and canes.

“This recommendation will probably change medical practice. Even the top stroke centers may not have a formal falls-prevention program, but it is very important because a high percentage of patients end up falling after a stroke,” Dr. Winstein said.

The guideline also recommends the following measures:

• Intense mobility-task training after stroke for all survivors with walking limitations to relearn activities such as climbing stairs

• An individually tailored exercise program that allows survivors to safely continue to improve their cardiovascular fitness through proper exercise and physical activity after formal rehabilitation is complete

• An enriched environment (which might include a computer, books, music, and games) to increase engagement and cognitive activities during rehabilitation

• Speech therapy for those with difficulty speaking following a stroke

• Eye exercises for survivors with difficulty focusing on near objects

• A balance training program for survivors with poor balance, or who are at risk for falls.

“For a person to fulfill his or her full potential after stroke, there needs to be a coordinated effort and ongoing communication between a team of professionals, as well as the patient, family, and caregivers,” Dr. Winstein said.

The American Heart Association/American Stroke Association has issued its first guideline on adult stroke rehabilitation. Published in the June issue of Stroke, the guideline calls for intensive, multidisciplinary treatment in an inpatient rehabilitation facility.

“Previous guidelines have focused on the medical issues involved in the initial management of stroke, but many people survive a stroke with some level of disability. There is increasing evidence that rehabilitation can have a big impact on the survivors’ quality of life, so the time is right to review the evidence in this complex field and highlight effective and important aspects of rehabilitation,” said Carolee J. Winstein, PhD, PT, lead author of the guideline and Professor of Biokinesiology and Physical Therapy at the University of Southern California in Los Angeles.

Carolee J. Winstein, PhD, PT

The American Stroke Association strongly recommends that stroke patients be treated at an inpatient rehabilitation facility whenever possible, rather than at a skilled nursing facility. While in an inpatient rehabilitation facility, a patient participates in at least three hours of rehabilitation per day with physical therapists, occupational therapists, and speech therapists. Nurses are continuously available, and doctors typically visit daily.

“There is considerable evidence that patients benefit from the team approach in a facility that understands the importance of rehabilitation during the early period after a stroke,” said Dr. Winstein.

According to Dr. Winstein and her coauthors, caregivers should advocate for discharge to an inpatient rehabilitation facility and insist that a stroke survivor not be discharged from the hospital until he or she has participated in a structured program on preventing falls. This program should include education about changes to make the home safer (eg, removing throw rugs and improving lighting), minimizing the fall risk resulting from the side effects of medication, and safely using assistive devices such as wheelchairs, walkers, and canes.

“This recommendation will probably change medical practice. Even the top stroke centers may not have a formal falls-prevention program, but it is very important because a high percentage of patients end up falling after a stroke,” Dr. Winstein said.

The guideline also recommends the following measures:

• Intense mobility-task training after stroke for all survivors with walking limitations to relearn activities such as climbing stairs

• An individually tailored exercise program that allows survivors to safely continue to improve their cardiovascular fitness through proper exercise and physical activity after formal rehabilitation is complete

• An enriched environment (which might include a computer, books, music, and games) to increase engagement and cognitive activities during rehabilitation

• Speech therapy for those with difficulty speaking following a stroke

• Eye exercises for survivors with difficulty focusing on near objects

• A balance training program for survivors with poor balance, or who are at risk for falls.

“For a person to fulfill his or her full potential after stroke, there needs to be a coordinated effort and ongoing communication between a team of professionals, as well as the patient, family, and caregivers,” Dr. Winstein said.

References

Suggested Reading
Winstein CJ, Stein J, Arena R, et al. Guidelines for adult stroke rehabilitation and recovery: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2016;47(6):e98-e169.

References

Suggested Reading
Winstein CJ, Stein J, Arena R, et al. Guidelines for adult stroke rehabilitation and recovery: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2016;47(6):e98-e169.

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Quality versus queasy: neurokinin 1 receptor antagonist use in moderately emetogenic chemotherapy

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Background The American Society of Clinical Oncology (ASCO) launched the Quality Oncology Practice Initiative (QOPI) program in 2010 to promote quality cancer care. The association has subsequently influenced the use of neurokinin 1 (NK-1) receptor antagonists through articles published in peer-reviewed publications and its Choosing Wisely campaign.

Objective To explore the rationale behind the use of NK-1 receptor antagonists in clinical practice.

Methods We distributed an anonymous 12-question online survey to 650 medical oncologists in 5 states, inquiring about their use of these agents. A total of 155 responses were analyzed.

Results QOPI-certified physicians were significantly more likely than noncertified physicians to use NK-1 receptor antagonists with moderately emetogenic regimens, including weekly cisplatin for head and neck cancer (82.6% vs 27.0%, respectively; P < .001), cervical and bladder cancer (81.4% vs 32.7%, P < .001), and with CHOP (cyclophosphamide, hydroxydaunorubicin, oncovin, prednisone) with or without rituximab in lymphoma (81.4 vs 17.3%, P < .001). The majority of QOPI-certified physicians reported using these agents for the sole purpose of maintaining QOPI certification (80.0%-86.0%). Certified physicians were also significantly more likely to appropriately prescribe NK-1 antagonists with highly emetogenic chemotherapy.

Limitations Responder bias; short survey that precludes detailed analysis; small sample size may limit generalizability to the field of medical oncology.

Conclusion Our data demonstrate that providers in QOPI-certified practices are significantly more likely than those in noncertified practices to prescribe NK-1 receptor antagonists. Certified physicians report that satisfying ASCO-QOPI requirements is their primary motivation for offering these agents.

 

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neurokinin 1 receptor antagonists, NK-1, emetogenic regimens, cisplatin, CHOP, cyclophosphamide, hydroxydaunorubicin, oncovin, prednisone, rituximab, lymphoma, bladder cancer, head and neck cancer, cervical cancer, Quality Oncology Practice Initiative, QOPI
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Background The American Society of Clinical Oncology (ASCO) launched the Quality Oncology Practice Initiative (QOPI) program in 2010 to promote quality cancer care. The association has subsequently influenced the use of neurokinin 1 (NK-1) receptor antagonists through articles published in peer-reviewed publications and its Choosing Wisely campaign.

Objective To explore the rationale behind the use of NK-1 receptor antagonists in clinical practice.

Methods We distributed an anonymous 12-question online survey to 650 medical oncologists in 5 states, inquiring about their use of these agents. A total of 155 responses were analyzed.

Results QOPI-certified physicians were significantly more likely than noncertified physicians to use NK-1 receptor antagonists with moderately emetogenic regimens, including weekly cisplatin for head and neck cancer (82.6% vs 27.0%, respectively; P < .001), cervical and bladder cancer (81.4% vs 32.7%, P < .001), and with CHOP (cyclophosphamide, hydroxydaunorubicin, oncovin, prednisone) with or without rituximab in lymphoma (81.4 vs 17.3%, P < .001). The majority of QOPI-certified physicians reported using these agents for the sole purpose of maintaining QOPI certification (80.0%-86.0%). Certified physicians were also significantly more likely to appropriately prescribe NK-1 antagonists with highly emetogenic chemotherapy.

Limitations Responder bias; short survey that precludes detailed analysis; small sample size may limit generalizability to the field of medical oncology.

Conclusion Our data demonstrate that providers in QOPI-certified practices are significantly more likely than those in noncertified practices to prescribe NK-1 receptor antagonists. Certified physicians report that satisfying ASCO-QOPI requirements is their primary motivation for offering these agents.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Background The American Society of Clinical Oncology (ASCO) launched the Quality Oncology Practice Initiative (QOPI) program in 2010 to promote quality cancer care. The association has subsequently influenced the use of neurokinin 1 (NK-1) receptor antagonists through articles published in peer-reviewed publications and its Choosing Wisely campaign.

Objective To explore the rationale behind the use of NK-1 receptor antagonists in clinical practice.

Methods We distributed an anonymous 12-question online survey to 650 medical oncologists in 5 states, inquiring about their use of these agents. A total of 155 responses were analyzed.

Results QOPI-certified physicians were significantly more likely than noncertified physicians to use NK-1 receptor antagonists with moderately emetogenic regimens, including weekly cisplatin for head and neck cancer (82.6% vs 27.0%, respectively; P < .001), cervical and bladder cancer (81.4% vs 32.7%, P < .001), and with CHOP (cyclophosphamide, hydroxydaunorubicin, oncovin, prednisone) with or without rituximab in lymphoma (81.4 vs 17.3%, P < .001). The majority of QOPI-certified physicians reported using these agents for the sole purpose of maintaining QOPI certification (80.0%-86.0%). Certified physicians were also significantly more likely to appropriately prescribe NK-1 antagonists with highly emetogenic chemotherapy.

Limitations Responder bias; short survey that precludes detailed analysis; small sample size may limit generalizability to the field of medical oncology.

Conclusion Our data demonstrate that providers in QOPI-certified practices are significantly more likely than those in noncertified practices to prescribe NK-1 receptor antagonists. Certified physicians report that satisfying ASCO-QOPI requirements is their primary motivation for offering these agents.

 

Click on the PDF icon at the top of this introduction to read the full article.

 
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neurokinin 1 receptor antagonists, NK-1, emetogenic regimens, cisplatin, CHOP, cyclophosphamide, hydroxydaunorubicin, oncovin, prednisone, rituximab, lymphoma, bladder cancer, head and neck cancer, cervical cancer, Quality Oncology Practice Initiative, QOPI
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neurokinin 1 receptor antagonists, NK-1, emetogenic regimens, cisplatin, CHOP, cyclophosphamide, hydroxydaunorubicin, oncovin, prednisone, rituximab, lymphoma, bladder cancer, head and neck cancer, cervical cancer, Quality Oncology Practice Initiative, QOPI
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Long-term community-based results of breast-conserving therapy in early-stage breast cancer

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Long-term community-based results of breast-conserving therapy in early-stage breast cancer

Background Multicenter clinical trials conducted primarily at academic centers have shown that breast-conserving therapy (BCT) and mastectomy lead to equivalent overall survival (OS) for women with early-stage breast cancer.

Objective To determine rates of BCT and OS after conservation therapy in a large urban community practice, compare them with national rates, and identify risk factors for survival.

Methods We identified 1,172 T1-2, N0 breast cancer patients diagnosed during 1997-2007 in our hospital tumor registry and compared the rates of BCT and adjuvant radiotherapy with a similar population in the SEER [Surveillance, Epidemiology, and End Results] database (N = 232,898) for the same treatment period. Cox proportional hazards models were used to assess the influence of age at diagnosis, tumor grade, biomarker status, margin status, and receipt of hormones, radiation, or chemotherapy on OS after BCT.

Results The rate of breast-conserving surgery (BCS) was higher in our practice compared with the national average (90.9% and 66.4%, respectively). The rate of adjuvant radiation after BCS in our practice was 93.7%; survival estimates were higher for patients treated with adjuvant radiation across all age groups, compared with the national estimates (92.5% and 72.9%). Younger age and receipt of radiation were associated with improved survival.

Limitations Retrospective study design; confounding factors such as comorbidities were not considered.

Conclusions We had high rates of BCT and adjuvant radiation in early-stage breast cancer patients in our community practice, which resulted in excellent survival rates that compared favorably with those in large academic centers and emphasizes the role of appropriate use of adjuvant radiation.

Funding Vantage Oncology

 

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Background Multicenter clinical trials conducted primarily at academic centers have shown that breast-conserving therapy (BCT) and mastectomy lead to equivalent overall survival (OS) for women with early-stage breast cancer.

Objective To determine rates of BCT and OS after conservation therapy in a large urban community practice, compare them with national rates, and identify risk factors for survival.

Methods We identified 1,172 T1-2, N0 breast cancer patients diagnosed during 1997-2007 in our hospital tumor registry and compared the rates of BCT and adjuvant radiotherapy with a similar population in the SEER [Surveillance, Epidemiology, and End Results] database (N = 232,898) for the same treatment period. Cox proportional hazards models were used to assess the influence of age at diagnosis, tumor grade, biomarker status, margin status, and receipt of hormones, radiation, or chemotherapy on OS after BCT.

Results The rate of breast-conserving surgery (BCS) was higher in our practice compared with the national average (90.9% and 66.4%, respectively). The rate of adjuvant radiation after BCS in our practice was 93.7%; survival estimates were higher for patients treated with adjuvant radiation across all age groups, compared with the national estimates (92.5% and 72.9%). Younger age and receipt of radiation were associated with improved survival.

Limitations Retrospective study design; confounding factors such as comorbidities were not considered.

Conclusions We had high rates of BCT and adjuvant radiation in early-stage breast cancer patients in our community practice, which resulted in excellent survival rates that compared favorably with those in large academic centers and emphasizes the role of appropriate use of adjuvant radiation.

Funding Vantage Oncology

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Background Multicenter clinical trials conducted primarily at academic centers have shown that breast-conserving therapy (BCT) and mastectomy lead to equivalent overall survival (OS) for women with early-stage breast cancer.

Objective To determine rates of BCT and OS after conservation therapy in a large urban community practice, compare them with national rates, and identify risk factors for survival.

Methods We identified 1,172 T1-2, N0 breast cancer patients diagnosed during 1997-2007 in our hospital tumor registry and compared the rates of BCT and adjuvant radiotherapy with a similar population in the SEER [Surveillance, Epidemiology, and End Results] database (N = 232,898) for the same treatment period. Cox proportional hazards models were used to assess the influence of age at diagnosis, tumor grade, biomarker status, margin status, and receipt of hormones, radiation, or chemotherapy on OS after BCT.

Results The rate of breast-conserving surgery (BCS) was higher in our practice compared with the national average (90.9% and 66.4%, respectively). The rate of adjuvant radiation after BCS in our practice was 93.7%; survival estimates were higher for patients treated with adjuvant radiation across all age groups, compared with the national estimates (92.5% and 72.9%). Younger age and receipt of radiation were associated with improved survival.

Limitations Retrospective study design; confounding factors such as comorbidities were not considered.

Conclusions We had high rates of BCT and adjuvant radiation in early-stage breast cancer patients in our community practice, which resulted in excellent survival rates that compared favorably with those in large academic centers and emphasizes the role of appropriate use of adjuvant radiation.

Funding Vantage Oncology

 

Click on the PDF icon at the top of this introduction to read the full article.

 

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Tool kit improves communication after an adverse event

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Tool kit improves communication after an adverse event

The Communication and Optimal Resolution tool kit, offered by the Agency for Healthcare Research and Quality, helps hospitals, health systems, and clinicians respond to patients who are harmed by the care they receive, Andy Bindman, MD, AHRQ director, said in a blog post.

The tool kit is a new addition to AHRQ’s suite of patient safety tools and training materials.

Poor communication can lead to life-and-death mistakes, which can then become legal issues, said Dr. Bindman. The Communication and Optimal Resolution (CANDOR) tool kit uses time as a key factor by disclosing harm to patients and families as soon as it happens.

“It has been estimated that medical errors are the third-leading cause of death in the United States and that the majority of clinicians have experience with a medical error that resulted in harm to a patient. Often these ‘mistakes’ are not the result of poorly trained individuals but the result of the faulty systems we sometimes work in,” Dr. Bindman noted.

“It is also important for us to engage with colleagues to reflect on the mistake and explore the root causes of how it happened. This helps us to learn from the situation and take steps to minimize the chances of a similar mistake happening again to another patient,” he said.

Funding for CANDOR was provided by the AHRQ’s $23 million Patient Safety and Medical Liability grant initiative, launched in 2009. The initiative is the largest federal investment in research linking improved patient safety to reduced medical liability, according to Dr. Bindman.

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The Communication and Optimal Resolution tool kit, offered by the Agency for Healthcare Research and Quality, helps hospitals, health systems, and clinicians respond to patients who are harmed by the care they receive, Andy Bindman, MD, AHRQ director, said in a blog post.

The tool kit is a new addition to AHRQ’s suite of patient safety tools and training materials.

Poor communication can lead to life-and-death mistakes, which can then become legal issues, said Dr. Bindman. The Communication and Optimal Resolution (CANDOR) tool kit uses time as a key factor by disclosing harm to patients and families as soon as it happens.

“It has been estimated that medical errors are the third-leading cause of death in the United States and that the majority of clinicians have experience with a medical error that resulted in harm to a patient. Often these ‘mistakes’ are not the result of poorly trained individuals but the result of the faulty systems we sometimes work in,” Dr. Bindman noted.

“It is also important for us to engage with colleagues to reflect on the mistake and explore the root causes of how it happened. This helps us to learn from the situation and take steps to minimize the chances of a similar mistake happening again to another patient,” he said.

Funding for CANDOR was provided by the AHRQ’s $23 million Patient Safety and Medical Liability grant initiative, launched in 2009. The initiative is the largest federal investment in research linking improved patient safety to reduced medical liability, according to Dr. Bindman.

[email protected]

The Communication and Optimal Resolution tool kit, offered by the Agency for Healthcare Research and Quality, helps hospitals, health systems, and clinicians respond to patients who are harmed by the care they receive, Andy Bindman, MD, AHRQ director, said in a blog post.

The tool kit is a new addition to AHRQ’s suite of patient safety tools and training materials.

Poor communication can lead to life-and-death mistakes, which can then become legal issues, said Dr. Bindman. The Communication and Optimal Resolution (CANDOR) tool kit uses time as a key factor by disclosing harm to patients and families as soon as it happens.

“It has been estimated that medical errors are the third-leading cause of death in the United States and that the majority of clinicians have experience with a medical error that resulted in harm to a patient. Often these ‘mistakes’ are not the result of poorly trained individuals but the result of the faulty systems we sometimes work in,” Dr. Bindman noted.

“It is also important for us to engage with colleagues to reflect on the mistake and explore the root causes of how it happened. This helps us to learn from the situation and take steps to minimize the chances of a similar mistake happening again to another patient,” he said.

Funding for CANDOR was provided by the AHRQ’s $23 million Patient Safety and Medical Liability grant initiative, launched in 2009. The initiative is the largest federal investment in research linking improved patient safety to reduced medical liability, according to Dr. Bindman.

[email protected]

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Insomnia in Young Men Boosts Cardiovascular and Cerebrovascular Risk

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Insomnia in Young Men Boosts Cardiovascular and Cerebrovascular Risk

DENVER – Young to early middle-aged men with insomnia symptoms are at increased risk for cardiovascular and cerebrovascular events, according to an analysis from the landmark CARDIA study.

“We found that younger to mid-life men with difficulty initiating sleep or with more than one insomnia symptom were at greater risk for incident cardiovascular disease events. And despite the fact that women in general seemed to be more prone to report those sleep difficulties, those that did were not at increased risk,” Megan E. Petrov, PhD, reported at the annual meeting of the Associated Professional Sleep Societies.

©KatarzynaBialasiewicz/ Thinkstock

It is well established that insomnia in older adults is associated with increased cardiovascular risk. For example, a meta-analysis of 13 prospective studies with more than 123,000 subjects concluded that insomnia was associated with a 45% increased risk of fatal and nonfatal cardiovascular events (Eur J Prev Cardiol. 2014 Jan;21[1]:57-64). But those studies typically involved older individuals, which makes cause and effect more difficult to determine because so many chronic conditions become more prevalent with advancing age, noted Dr. Petrov of Arizona State University in Phoenix.

“We wanted to see if insomnia is truly an early risk factor in the pathogenesis of cardiovascular disease and stroke,” she said.

To do so, she and her coinvestigators turned to the CARDIA database. CARDIA (the Coronary Artery Risk Development in Young Adults study), is a National Heart, Lung, and Blood Institute–sponsored prospective, epidemiologic study.

She reported on 2,950 non-Hispanic black or white participants aged 33-45 and free of any history of cardiovascular disease in 2000-2001, when they answered questions about insomnia symptoms. Difficulty in initiating sleep was reported by 16.3% of men and 20.7% of women. Difficulty maintaining sleep was a problem for 9.3% of men and 14.5% of women. And 20.6% of men and 20.1% of women reported frequent early morning awakening.

During a mean 11.5 years of prospective follow-up, 4.1% of men and 2.3% of women had a fatal or nonfatal MI, stroke, transient ischemic attack, heart failure, peripheral vascular disease, or hospitalization for an acute coronary syndrome.

In a multivariate logistic regression analysis fully adjusted for demographics, socioeconomic status, body mass index, blood pressure, diabetes, depression, health behaviors, medications, thyroid disease, and kidney problems, men who reported difficulty in getting to sleep had a 2.64-fold increased risk of one of these adverse outcomes. That was the only insomnia symptom associated with significantly increased risk. However, men but not women who reported having more than one insomnia symptom had a 39% increased risk of a cardiovascular event for each additional symptom.

Prior studies have shown that insomnia is associated with cardiac sympathetic hyperactivation. That observation suggests a plausible mechanism for increased cardiovascular and cerebrovascular risk, but it doesn’t explain why that risk was confined to young men in CARDIA. One possibility is that because of gender-related differences in perception, men tend to report having insomnia symptoms only when the insomnia is more severe, Dr. Petrov suggested.

The strengths of the CARDIA study are that all cardiovascular endpoints had to be physician certified, and the study includes a large black population. A study limitation is the relatively small number of cardiovascular events, as to be expected in a younger population. Thus, confirmation of the new findings in another large data set will be important, she noted.

As a next step in her research, Dr. Petrov said she plans to drill down in the CARDIA data to see if race modified the impact of insomnia symptoms on cardiovascular outcomes. Black participants reported all insomnia symptoms more frequently than did whites. For example, difficulty initiating sleep was reported by 25.7% of blacks, compared with just 13.5% of whites, and early morning awakening was twice as prevalent among the black participants.

Also, CARDIA participants provided self-reported sleep duration data. It will be illuminating to see if sleep duration had a modifying effect upon the insomnia/cardiovascular risk association observed in men, she said.

Dr. Petrov reported having no relevant financial conflicts.

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DENVER – Young to early middle-aged men with insomnia symptoms are at increased risk for cardiovascular and cerebrovascular events, according to an analysis from the landmark CARDIA study.

“We found that younger to mid-life men with difficulty initiating sleep or with more than one insomnia symptom were at greater risk for incident cardiovascular disease events. And despite the fact that women in general seemed to be more prone to report those sleep difficulties, those that did were not at increased risk,” Megan E. Petrov, PhD, reported at the annual meeting of the Associated Professional Sleep Societies.

©KatarzynaBialasiewicz/ Thinkstock

It is well established that insomnia in older adults is associated with increased cardiovascular risk. For example, a meta-analysis of 13 prospective studies with more than 123,000 subjects concluded that insomnia was associated with a 45% increased risk of fatal and nonfatal cardiovascular events (Eur J Prev Cardiol. 2014 Jan;21[1]:57-64). But those studies typically involved older individuals, which makes cause and effect more difficult to determine because so many chronic conditions become more prevalent with advancing age, noted Dr. Petrov of Arizona State University in Phoenix.

“We wanted to see if insomnia is truly an early risk factor in the pathogenesis of cardiovascular disease and stroke,” she said.

To do so, she and her coinvestigators turned to the CARDIA database. CARDIA (the Coronary Artery Risk Development in Young Adults study), is a National Heart, Lung, and Blood Institute–sponsored prospective, epidemiologic study.

She reported on 2,950 non-Hispanic black or white participants aged 33-45 and free of any history of cardiovascular disease in 2000-2001, when they answered questions about insomnia symptoms. Difficulty in initiating sleep was reported by 16.3% of men and 20.7% of women. Difficulty maintaining sleep was a problem for 9.3% of men and 14.5% of women. And 20.6% of men and 20.1% of women reported frequent early morning awakening.

During a mean 11.5 years of prospective follow-up, 4.1% of men and 2.3% of women had a fatal or nonfatal MI, stroke, transient ischemic attack, heart failure, peripheral vascular disease, or hospitalization for an acute coronary syndrome.

In a multivariate logistic regression analysis fully adjusted for demographics, socioeconomic status, body mass index, blood pressure, diabetes, depression, health behaviors, medications, thyroid disease, and kidney problems, men who reported difficulty in getting to sleep had a 2.64-fold increased risk of one of these adverse outcomes. That was the only insomnia symptom associated with significantly increased risk. However, men but not women who reported having more than one insomnia symptom had a 39% increased risk of a cardiovascular event for each additional symptom.

Prior studies have shown that insomnia is associated with cardiac sympathetic hyperactivation. That observation suggests a plausible mechanism for increased cardiovascular and cerebrovascular risk, but it doesn’t explain why that risk was confined to young men in CARDIA. One possibility is that because of gender-related differences in perception, men tend to report having insomnia symptoms only when the insomnia is more severe, Dr. Petrov suggested.

The strengths of the CARDIA study are that all cardiovascular endpoints had to be physician certified, and the study includes a large black population. A study limitation is the relatively small number of cardiovascular events, as to be expected in a younger population. Thus, confirmation of the new findings in another large data set will be important, she noted.

As a next step in her research, Dr. Petrov said she plans to drill down in the CARDIA data to see if race modified the impact of insomnia symptoms on cardiovascular outcomes. Black participants reported all insomnia symptoms more frequently than did whites. For example, difficulty initiating sleep was reported by 25.7% of blacks, compared with just 13.5% of whites, and early morning awakening was twice as prevalent among the black participants.

Also, CARDIA participants provided self-reported sleep duration data. It will be illuminating to see if sleep duration had a modifying effect upon the insomnia/cardiovascular risk association observed in men, she said.

Dr. Petrov reported having no relevant financial conflicts.

DENVER – Young to early middle-aged men with insomnia symptoms are at increased risk for cardiovascular and cerebrovascular events, according to an analysis from the landmark CARDIA study.

“We found that younger to mid-life men with difficulty initiating sleep or with more than one insomnia symptom were at greater risk for incident cardiovascular disease events. And despite the fact that women in general seemed to be more prone to report those sleep difficulties, those that did were not at increased risk,” Megan E. Petrov, PhD, reported at the annual meeting of the Associated Professional Sleep Societies.

©KatarzynaBialasiewicz/ Thinkstock

It is well established that insomnia in older adults is associated with increased cardiovascular risk. For example, a meta-analysis of 13 prospective studies with more than 123,000 subjects concluded that insomnia was associated with a 45% increased risk of fatal and nonfatal cardiovascular events (Eur J Prev Cardiol. 2014 Jan;21[1]:57-64). But those studies typically involved older individuals, which makes cause and effect more difficult to determine because so many chronic conditions become more prevalent with advancing age, noted Dr. Petrov of Arizona State University in Phoenix.

“We wanted to see if insomnia is truly an early risk factor in the pathogenesis of cardiovascular disease and stroke,” she said.

To do so, she and her coinvestigators turned to the CARDIA database. CARDIA (the Coronary Artery Risk Development in Young Adults study), is a National Heart, Lung, and Blood Institute–sponsored prospective, epidemiologic study.

She reported on 2,950 non-Hispanic black or white participants aged 33-45 and free of any history of cardiovascular disease in 2000-2001, when they answered questions about insomnia symptoms. Difficulty in initiating sleep was reported by 16.3% of men and 20.7% of women. Difficulty maintaining sleep was a problem for 9.3% of men and 14.5% of women. And 20.6% of men and 20.1% of women reported frequent early morning awakening.

During a mean 11.5 years of prospective follow-up, 4.1% of men and 2.3% of women had a fatal or nonfatal MI, stroke, transient ischemic attack, heart failure, peripheral vascular disease, or hospitalization for an acute coronary syndrome.

In a multivariate logistic regression analysis fully adjusted for demographics, socioeconomic status, body mass index, blood pressure, diabetes, depression, health behaviors, medications, thyroid disease, and kidney problems, men who reported difficulty in getting to sleep had a 2.64-fold increased risk of one of these adverse outcomes. That was the only insomnia symptom associated with significantly increased risk. However, men but not women who reported having more than one insomnia symptom had a 39% increased risk of a cardiovascular event for each additional symptom.

Prior studies have shown that insomnia is associated with cardiac sympathetic hyperactivation. That observation suggests a plausible mechanism for increased cardiovascular and cerebrovascular risk, but it doesn’t explain why that risk was confined to young men in CARDIA. One possibility is that because of gender-related differences in perception, men tend to report having insomnia symptoms only when the insomnia is more severe, Dr. Petrov suggested.

The strengths of the CARDIA study are that all cardiovascular endpoints had to be physician certified, and the study includes a large black population. A study limitation is the relatively small number of cardiovascular events, as to be expected in a younger population. Thus, confirmation of the new findings in another large data set will be important, she noted.

As a next step in her research, Dr. Petrov said she plans to drill down in the CARDIA data to see if race modified the impact of insomnia symptoms on cardiovascular outcomes. Black participants reported all insomnia symptoms more frequently than did whites. For example, difficulty initiating sleep was reported by 25.7% of blacks, compared with just 13.5% of whites, and early morning awakening was twice as prevalent among the black participants.

Also, CARDIA participants provided self-reported sleep duration data. It will be illuminating to see if sleep duration had a modifying effect upon the insomnia/cardiovascular risk association observed in men, she said.

Dr. Petrov reported having no relevant financial conflicts.

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Insomnia in young men boosts cardiovascular and cerebrovascular risk

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Insomnia in young men boosts cardiovascular and cerebrovascular risk

DENVER – Young to early middle-aged men with insomnia symptoms are at increased risk for cardiovascular and cerebrovascular events, according to an analysis from the landmark CARDIA study.

“We found that younger to mid-life men with difficulty initiating sleep or with more than one insomnia symptom were at greater risk for incident cardiovascular disease events. And despite the fact that women in general seemed to be more prone to report those sleep difficulties, those that did were not at increased risk,” Megan E. Petrov, PhD, reported at the annual meeting of the Associated Professional Sleep Societies.

©KatarzynaBialasiewicz/ Thinkstock

It is well established that insomnia in older adults is associated with increased cardiovascular risk. For example, a meta-analysis of 13 prospective studies with more than 123,000 subjects concluded that insomnia was associated with a 45% increased risk of fatal and nonfatal cardiovascular events (Eur J Prev Cardiol. 2014 Jan;21[1]:57-64). But those studies typically involved older individuals, which makes cause and effect more difficult to determine because so many chronic conditions become more prevalent with advancing age, noted Dr. Petrov of Arizona State University in Phoenix.

“We wanted to see if insomnia is truly an early risk factor in the pathogenesis of cardiovascular disease and stroke,” she said.

To do so, she and her coinvestigators turned to the CARDIA database. CARDIA (the Coronary Artery Risk Development in Young Adults study), is a National Heart, Lung, and Blood Institute–sponsored prospective, epidemiologic study.

She reported on 2,950 non-Hispanic black or white participants aged 33-45 and free of any history of cardiovascular disease in 2000-2001, when they answered questions about insomnia symptoms. Difficulty in initiating sleep was reported by 16.3% of men and 20.7% of women. Difficulty maintaining sleep was a problem for 9.3% of men and 14.5% of women. And 20.6% of men and 20.1% of women reported frequent early morning awakening.

During a mean 11.5 years of prospective follow-up, 4.1% of men and 2.3% of women had a fatal or nonfatal MI, stroke, transient ischemic attack, heart failure, peripheral vascular disease, or hospitalization for an acute coronary syndrome.

In a multivariate logistic regression analysis fully adjusted for demographics, socioeconomic status, body mass index, blood pressure, diabetes, depression, health behaviors, medications, thyroid disease, and kidney problems, men who reported difficulty in getting to sleep had a 2.64-fold increased risk of one of these adverse outcomes. That was the only insomnia symptom associated with significantly increased risk. However, men but not women who reported having more than one insomnia symptom had a 39% increased risk of a cardiovascular event for each additional symptom.

Prior studies have shown that insomnia is associated with cardiac sympathetic hyperactivation. That observation suggests a plausible mechanism for increased cardiovascular and cerebrovascular risk, but it doesn’t explain why that risk was confined to young men in CARDIA. One possibility is that because of gender-related differences in perception, men tend to report having insomnia symptoms only when the insomnia is more severe, Dr. Petrov suggested.

The strengths of the CARDIA study are that all cardiovascular endpoints had to be physician certified, and the study includes a large black population. A study limitation is the relatively small number of cardiovascular events, as to be expected in a younger population. Thus, confirmation of the new findings in another large data set will be important, she noted.

As a next step in her research, Dr. Petrov said she plans to drill down in the CARDIA data to see if race modified the impact of insomnia symptoms on cardiovascular outcomes. Black participants reported all insomnia symptoms more frequently than did whites. For example, difficulty initiating sleep was reported by 25.7% of blacks, compared with just 13.5% of whites, and early morning awakening was twice as prevalent among the black participants.

Also, CARDIA participants provided self-reported sleep duration data. It will be illuminating to see if sleep duration had a modifying effect upon the insomnia/cardiovascular risk association observed in men, she said.

Dr. Petrov reported having no relevant financial conflicts.

[email protected]

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DENVER – Young to early middle-aged men with insomnia symptoms are at increased risk for cardiovascular and cerebrovascular events, according to an analysis from the landmark CARDIA study.

“We found that younger to mid-life men with difficulty initiating sleep or with more than one insomnia symptom were at greater risk for incident cardiovascular disease events. And despite the fact that women in general seemed to be more prone to report those sleep difficulties, those that did were not at increased risk,” Megan E. Petrov, PhD, reported at the annual meeting of the Associated Professional Sleep Societies.

©KatarzynaBialasiewicz/ Thinkstock

It is well established that insomnia in older adults is associated with increased cardiovascular risk. For example, a meta-analysis of 13 prospective studies with more than 123,000 subjects concluded that insomnia was associated with a 45% increased risk of fatal and nonfatal cardiovascular events (Eur J Prev Cardiol. 2014 Jan;21[1]:57-64). But those studies typically involved older individuals, which makes cause and effect more difficult to determine because so many chronic conditions become more prevalent with advancing age, noted Dr. Petrov of Arizona State University in Phoenix.

“We wanted to see if insomnia is truly an early risk factor in the pathogenesis of cardiovascular disease and stroke,” she said.

To do so, she and her coinvestigators turned to the CARDIA database. CARDIA (the Coronary Artery Risk Development in Young Adults study), is a National Heart, Lung, and Blood Institute–sponsored prospective, epidemiologic study.

She reported on 2,950 non-Hispanic black or white participants aged 33-45 and free of any history of cardiovascular disease in 2000-2001, when they answered questions about insomnia symptoms. Difficulty in initiating sleep was reported by 16.3% of men and 20.7% of women. Difficulty maintaining sleep was a problem for 9.3% of men and 14.5% of women. And 20.6% of men and 20.1% of women reported frequent early morning awakening.

During a mean 11.5 years of prospective follow-up, 4.1% of men and 2.3% of women had a fatal or nonfatal MI, stroke, transient ischemic attack, heart failure, peripheral vascular disease, or hospitalization for an acute coronary syndrome.

In a multivariate logistic regression analysis fully adjusted for demographics, socioeconomic status, body mass index, blood pressure, diabetes, depression, health behaviors, medications, thyroid disease, and kidney problems, men who reported difficulty in getting to sleep had a 2.64-fold increased risk of one of these adverse outcomes. That was the only insomnia symptom associated with significantly increased risk. However, men but not women who reported having more than one insomnia symptom had a 39% increased risk of a cardiovascular event for each additional symptom.

Prior studies have shown that insomnia is associated with cardiac sympathetic hyperactivation. That observation suggests a plausible mechanism for increased cardiovascular and cerebrovascular risk, but it doesn’t explain why that risk was confined to young men in CARDIA. One possibility is that because of gender-related differences in perception, men tend to report having insomnia symptoms only when the insomnia is more severe, Dr. Petrov suggested.

The strengths of the CARDIA study are that all cardiovascular endpoints had to be physician certified, and the study includes a large black population. A study limitation is the relatively small number of cardiovascular events, as to be expected in a younger population. Thus, confirmation of the new findings in another large data set will be important, she noted.

As a next step in her research, Dr. Petrov said she plans to drill down in the CARDIA data to see if race modified the impact of insomnia symptoms on cardiovascular outcomes. Black participants reported all insomnia symptoms more frequently than did whites. For example, difficulty initiating sleep was reported by 25.7% of blacks, compared with just 13.5% of whites, and early morning awakening was twice as prevalent among the black participants.

Also, CARDIA participants provided self-reported sleep duration data. It will be illuminating to see if sleep duration had a modifying effect upon the insomnia/cardiovascular risk association observed in men, she said.

Dr. Petrov reported having no relevant financial conflicts.

[email protected]

DENVER – Young to early middle-aged men with insomnia symptoms are at increased risk for cardiovascular and cerebrovascular events, according to an analysis from the landmark CARDIA study.

“We found that younger to mid-life men with difficulty initiating sleep or with more than one insomnia symptom were at greater risk for incident cardiovascular disease events. And despite the fact that women in general seemed to be more prone to report those sleep difficulties, those that did were not at increased risk,” Megan E. Petrov, PhD, reported at the annual meeting of the Associated Professional Sleep Societies.

©KatarzynaBialasiewicz/ Thinkstock

It is well established that insomnia in older adults is associated with increased cardiovascular risk. For example, a meta-analysis of 13 prospective studies with more than 123,000 subjects concluded that insomnia was associated with a 45% increased risk of fatal and nonfatal cardiovascular events (Eur J Prev Cardiol. 2014 Jan;21[1]:57-64). But those studies typically involved older individuals, which makes cause and effect more difficult to determine because so many chronic conditions become more prevalent with advancing age, noted Dr. Petrov of Arizona State University in Phoenix.

“We wanted to see if insomnia is truly an early risk factor in the pathogenesis of cardiovascular disease and stroke,” she said.

To do so, she and her coinvestigators turned to the CARDIA database. CARDIA (the Coronary Artery Risk Development in Young Adults study), is a National Heart, Lung, and Blood Institute–sponsored prospective, epidemiologic study.

She reported on 2,950 non-Hispanic black or white participants aged 33-45 and free of any history of cardiovascular disease in 2000-2001, when they answered questions about insomnia symptoms. Difficulty in initiating sleep was reported by 16.3% of men and 20.7% of women. Difficulty maintaining sleep was a problem for 9.3% of men and 14.5% of women. And 20.6% of men and 20.1% of women reported frequent early morning awakening.

During a mean 11.5 years of prospective follow-up, 4.1% of men and 2.3% of women had a fatal or nonfatal MI, stroke, transient ischemic attack, heart failure, peripheral vascular disease, or hospitalization for an acute coronary syndrome.

In a multivariate logistic regression analysis fully adjusted for demographics, socioeconomic status, body mass index, blood pressure, diabetes, depression, health behaviors, medications, thyroid disease, and kidney problems, men who reported difficulty in getting to sleep had a 2.64-fold increased risk of one of these adverse outcomes. That was the only insomnia symptom associated with significantly increased risk. However, men but not women who reported having more than one insomnia symptom had a 39% increased risk of a cardiovascular event for each additional symptom.

Prior studies have shown that insomnia is associated with cardiac sympathetic hyperactivation. That observation suggests a plausible mechanism for increased cardiovascular and cerebrovascular risk, but it doesn’t explain why that risk was confined to young men in CARDIA. One possibility is that because of gender-related differences in perception, men tend to report having insomnia symptoms only when the insomnia is more severe, Dr. Petrov suggested.

The strengths of the CARDIA study are that all cardiovascular endpoints had to be physician certified, and the study includes a large black population. A study limitation is the relatively small number of cardiovascular events, as to be expected in a younger population. Thus, confirmation of the new findings in another large data set will be important, she noted.

As a next step in her research, Dr. Petrov said she plans to drill down in the CARDIA data to see if race modified the impact of insomnia symptoms on cardiovascular outcomes. Black participants reported all insomnia symptoms more frequently than did whites. For example, difficulty initiating sleep was reported by 25.7% of blacks, compared with just 13.5% of whites, and early morning awakening was twice as prevalent among the black participants.

Also, CARDIA participants provided self-reported sleep duration data. It will be illuminating to see if sleep duration had a modifying effect upon the insomnia/cardiovascular risk association observed in men, she said.

Dr. Petrov reported having no relevant financial conflicts.

[email protected]

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Key clinical point: Insomnia symptoms are associated with increased cardiovascular and cerebrovascular event rates in young to middle-aged men.

Major finding: Men aged 33-45 who reported frequent difficulty in falling asleep were at an adjusted 2.64-fold increased risk of a major cardiovascular or cerebrovascular event during subsequent follow-up.

Data source: The prospective, epidemiologic CARDIA study including 2,950 black or white subjects aged 33-45 at enrollment who were followed for a mean of 11.5 years.

Disclosures: The CARDIA study is supported by the National Institutes of Health. The presenter reported having no relevant financial conflicts.

Protein-Based Risk Score Improves Prediction of Cardiovascular Events

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Protein-Based Risk Score Improves Prediction of Cardiovascular Events

NEW YORK - A new protein-based risk score outperforms the Framingham model for predicting cardiovascular outcomes in patients with stable coronary heart disease.

"Patients who carry the diagnosis of stable coronary heart disease have been viewed traditionally as a homogeneous population within which all individuals tend to be treated similarly," Dr. Peter Ganz, from the University of California, San Francisco, told Reuters Health by email.

"Instead, we found that individuals who all carried the same clinical diagnosis of stable coronary heart disease had a risk of adverse events (heart attacks, strokes, heart failure, and death) that varied by as much as 10-fold, as revealed by analysis of the levels of nine proteins in their blood," he said.

Dr. Ganz and colleagues sought to derive and validate a score to predict the risk of cardiovascular outcomes among patients with coronary heart disease, using modified aptamers to measure 1,130 proteins in plasma samples.

Aptamers are small nucleic acids that can form secondary and tertiary structures capable of specifically binding proteins and thus can be considered the chemical equivalent of antibodies.

The researchers' unbiased statistical approach identified nine proteins, from which they derived a risk score that reflects the probability of a cardiovascular event occurring within four years.

In both the derivation and validation cohorts, participants had four-year cumulative event rates of 60% to 80% in the highest risk score decile and less than 10% in the lowest risk score decile, according to the June 21 JAMA report.

Compared with the Framingham model, the protein-based risk score showed an absolute increase of 12% in average risk for participants with events compared with participants without events.

The protein-based risk score was within two percentage points of the observed event rate in the external validation cohort.

Moreover, the protein-based risk score changed more than the Framingham model among participants approaching new events, and the protein-based risk score at follow-up was a stronger predictor of subsequent outcomes than the preceding baseline risk score.

"We may now be able to tell individual patients with coronary heart disease, 'You are at a very high risk, medium risk, or a very low risk,' and they may opt to be treated differently from other patients with the same diagnosis," Dr. Ganz said.

"In addition to the results described in the JAMA paper that apply to patients with coronary heart disease, we have an ongoing discovery program to identify proteins that can predict the risk of cardiovascular disease in additional patient populations, including lower-risk individuals who appear healthy but may actually be at high risk of coronary heart disease due to high cholesterol, high blood pressure, diabetes, or smoking, or among individuals who may be at high risk due to kidney disease or HIV infection," Dr. Ganz said.

"Although more accurate risk prediction is always welcome, clinicians more readily embrace measuring a prognostic biomarker or calculating a risk score if the results could alter therapeutic decision making," writes Dr. Marc S. Sabatine from Brigham and Women's Hospital, Boston, in an accompanying editorial.

"To that end, it would be interesting to apply these arrays to samples from patients in randomized clinical trials of therapies," he said. "If a gradient of treatment benefit existed, such data would make measurement of the relevant proteins in clinical practice more compelling (which, for the current list, is impractical). Furthermore, part of the long-term value of this sort of proteomics work may come from exploring the basic pathways that underline some of the novel associations described."

Dr. Matthew Sherwood, from Duke University Medical Center, Durham, North Carolina, who recently described multimarker risk stratification in patients with acute myocardial infarction, told Reuters Health by email, "While the results are impressive, their scope is limited. Since the population studied is already at high risk for further cardiovascular events, more refined risk stratification may not have significant clinical import. These patients have indications for treatment of CAD at present, thus changes in medical management are unlikely."

 

 

"Our ability to use proteomic signatures to predict cardiovascular risk continues to expand, and may become available to a broad cohort of patients in the future," Dr. Sherwood said. "The clinical utility of these platforms remains uncertain, and further investigation is needed to determine if proteomic based risk scores could help to modify therapeutic management in lower risk populations."

SomaLogic provided funding for protein assays and employed two coauthors. Four coauthors and the editorialist reported disclosures.

SOURCE: http://bit.ly/28L6oEy and http://bit.ly/28NgaJg

JAMA 2016.

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NEW YORK - A new protein-based risk score outperforms the Framingham model for predicting cardiovascular outcomes in patients with stable coronary heart disease.

"Patients who carry the diagnosis of stable coronary heart disease have been viewed traditionally as a homogeneous population within which all individuals tend to be treated similarly," Dr. Peter Ganz, from the University of California, San Francisco, told Reuters Health by email.

"Instead, we found that individuals who all carried the same clinical diagnosis of stable coronary heart disease had a risk of adverse events (heart attacks, strokes, heart failure, and death) that varied by as much as 10-fold, as revealed by analysis of the levels of nine proteins in their blood," he said.

Dr. Ganz and colleagues sought to derive and validate a score to predict the risk of cardiovascular outcomes among patients with coronary heart disease, using modified aptamers to measure 1,130 proteins in plasma samples.

Aptamers are small nucleic acids that can form secondary and tertiary structures capable of specifically binding proteins and thus can be considered the chemical equivalent of antibodies.

The researchers' unbiased statistical approach identified nine proteins, from which they derived a risk score that reflects the probability of a cardiovascular event occurring within four years.

In both the derivation and validation cohorts, participants had four-year cumulative event rates of 60% to 80% in the highest risk score decile and less than 10% in the lowest risk score decile, according to the June 21 JAMA report.

Compared with the Framingham model, the protein-based risk score showed an absolute increase of 12% in average risk for participants with events compared with participants without events.

The protein-based risk score was within two percentage points of the observed event rate in the external validation cohort.

Moreover, the protein-based risk score changed more than the Framingham model among participants approaching new events, and the protein-based risk score at follow-up was a stronger predictor of subsequent outcomes than the preceding baseline risk score.

"We may now be able to tell individual patients with coronary heart disease, 'You are at a very high risk, medium risk, or a very low risk,' and they may opt to be treated differently from other patients with the same diagnosis," Dr. Ganz said.

"In addition to the results described in the JAMA paper that apply to patients with coronary heart disease, we have an ongoing discovery program to identify proteins that can predict the risk of cardiovascular disease in additional patient populations, including lower-risk individuals who appear healthy but may actually be at high risk of coronary heart disease due to high cholesterol, high blood pressure, diabetes, or smoking, or among individuals who may be at high risk due to kidney disease or HIV infection," Dr. Ganz said.

"Although more accurate risk prediction is always welcome, clinicians more readily embrace measuring a prognostic biomarker or calculating a risk score if the results could alter therapeutic decision making," writes Dr. Marc S. Sabatine from Brigham and Women's Hospital, Boston, in an accompanying editorial.

"To that end, it would be interesting to apply these arrays to samples from patients in randomized clinical trials of therapies," he said. "If a gradient of treatment benefit existed, such data would make measurement of the relevant proteins in clinical practice more compelling (which, for the current list, is impractical). Furthermore, part of the long-term value of this sort of proteomics work may come from exploring the basic pathways that underline some of the novel associations described."

Dr. Matthew Sherwood, from Duke University Medical Center, Durham, North Carolina, who recently described multimarker risk stratification in patients with acute myocardial infarction, told Reuters Health by email, "While the results are impressive, their scope is limited. Since the population studied is already at high risk for further cardiovascular events, more refined risk stratification may not have significant clinical import. These patients have indications for treatment of CAD at present, thus changes in medical management are unlikely."

 

 

"Our ability to use proteomic signatures to predict cardiovascular risk continues to expand, and may become available to a broad cohort of patients in the future," Dr. Sherwood said. "The clinical utility of these platforms remains uncertain, and further investigation is needed to determine if proteomic based risk scores could help to modify therapeutic management in lower risk populations."

SomaLogic provided funding for protein assays and employed two coauthors. Four coauthors and the editorialist reported disclosures.

SOURCE: http://bit.ly/28L6oEy and http://bit.ly/28NgaJg

JAMA 2016.

NEW YORK - A new protein-based risk score outperforms the Framingham model for predicting cardiovascular outcomes in patients with stable coronary heart disease.

"Patients who carry the diagnosis of stable coronary heart disease have been viewed traditionally as a homogeneous population within which all individuals tend to be treated similarly," Dr. Peter Ganz, from the University of California, San Francisco, told Reuters Health by email.

"Instead, we found that individuals who all carried the same clinical diagnosis of stable coronary heart disease had a risk of adverse events (heart attacks, strokes, heart failure, and death) that varied by as much as 10-fold, as revealed by analysis of the levels of nine proteins in their blood," he said.

Dr. Ganz and colleagues sought to derive and validate a score to predict the risk of cardiovascular outcomes among patients with coronary heart disease, using modified aptamers to measure 1,130 proteins in plasma samples.

Aptamers are small nucleic acids that can form secondary and tertiary structures capable of specifically binding proteins and thus can be considered the chemical equivalent of antibodies.

The researchers' unbiased statistical approach identified nine proteins, from which they derived a risk score that reflects the probability of a cardiovascular event occurring within four years.

In both the derivation and validation cohorts, participants had four-year cumulative event rates of 60% to 80% in the highest risk score decile and less than 10% in the lowest risk score decile, according to the June 21 JAMA report.

Compared with the Framingham model, the protein-based risk score showed an absolute increase of 12% in average risk for participants with events compared with participants without events.

The protein-based risk score was within two percentage points of the observed event rate in the external validation cohort.

Moreover, the protein-based risk score changed more than the Framingham model among participants approaching new events, and the protein-based risk score at follow-up was a stronger predictor of subsequent outcomes than the preceding baseline risk score.

"We may now be able to tell individual patients with coronary heart disease, 'You are at a very high risk, medium risk, or a very low risk,' and they may opt to be treated differently from other patients with the same diagnosis," Dr. Ganz said.

"In addition to the results described in the JAMA paper that apply to patients with coronary heart disease, we have an ongoing discovery program to identify proteins that can predict the risk of cardiovascular disease in additional patient populations, including lower-risk individuals who appear healthy but may actually be at high risk of coronary heart disease due to high cholesterol, high blood pressure, diabetes, or smoking, or among individuals who may be at high risk due to kidney disease or HIV infection," Dr. Ganz said.

"Although more accurate risk prediction is always welcome, clinicians more readily embrace measuring a prognostic biomarker or calculating a risk score if the results could alter therapeutic decision making," writes Dr. Marc S. Sabatine from Brigham and Women's Hospital, Boston, in an accompanying editorial.

"To that end, it would be interesting to apply these arrays to samples from patients in randomized clinical trials of therapies," he said. "If a gradient of treatment benefit existed, such data would make measurement of the relevant proteins in clinical practice more compelling (which, for the current list, is impractical). Furthermore, part of the long-term value of this sort of proteomics work may come from exploring the basic pathways that underline some of the novel associations described."

Dr. Matthew Sherwood, from Duke University Medical Center, Durham, North Carolina, who recently described multimarker risk stratification in patients with acute myocardial infarction, told Reuters Health by email, "While the results are impressive, their scope is limited. Since the population studied is already at high risk for further cardiovascular events, more refined risk stratification may not have significant clinical import. These patients have indications for treatment of CAD at present, thus changes in medical management are unlikely."

 

 

"Our ability to use proteomic signatures to predict cardiovascular risk continues to expand, and may become available to a broad cohort of patients in the future," Dr. Sherwood said. "The clinical utility of these platforms remains uncertain, and further investigation is needed to determine if proteomic based risk scores could help to modify therapeutic management in lower risk populations."

SomaLogic provided funding for protein assays and employed two coauthors. Four coauthors and the editorialist reported disclosures.

SOURCE: http://bit.ly/28L6oEy and http://bit.ly/28NgaJg

JAMA 2016.

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