All Content

NEW YORK - About a third of heart failure patients have anemia and most also have iron deficiency, according to UK researchers.

This observational analysis, Dr. John G.F. Cleland told Reuters Health by email, "shows that iron deficiency is very common in patients with heart failure and often leads to anemia and that the prevalence of both iron deficiency and anemia are both highly sensitive to the criteria used to define them."

In a June 29 online paper in JAMA Cardiology, Dr. Cleland, of the University of Hull, and colleagues report that they came to this conclusion after studying data on more than 4,400 patients seen at a local clinic over a 10-year period. All were referred because of suspected heart failure, and their median age was 73 years.

Data collected included hemoglobin, serum iron, transferrin saturation, and serum ferritin concentrations.

Overall, 1,237 patients (27.8%) had anemia, with a higher prevalence (33.3%) in patients who met the criteria for heart failure with or without left ventricular systolic dysfunction (LVSD).

Depending on the definition used, iron deficiency was present in 270 (43.2%) to 425 (68.0%) patients with anemia. This was the case in 260 (14.7%) to 624 (35.3%) of those without anemia.

Lower concentrations of hemoglobin (hazard ratio 0.92) and serum iron (HR 0.98) were independently associated with higher all-cause and cardiovascular mortality in multivariable analyses.

Moreover, said Dr. Cleland, "Serum iron and transferrin saturation were highly correlated (raising the question of the need to measure both) and both were strongly related to anemia. In contrast, serum ferritin, the most widely (supposed) measure of iron deficiency, was more strongly related to measures of inflammation than anemia."

"Lower concentrations of hemoglobin and serum iron and lower transferrin saturation," he stressed, "were associated with a higher mortality. In contrast, lower serum ferritin was associated with a better prognosis, probably because it is more a measure of inflammation than of iron deficiency."

Dr. Cleland concluded, "Serum ferritin is a poor measure of iron deficiency in patients with heart failure. Many patients with normal serum ferritin (defined by many as greater than 100 ng/mL) have iron deficiency. Clinical trials of intravenous iron for patients with heart failure should be aware of this issue to ensure they enroll appropriate patients."

The National Heart Service, Vifor Pharma, and Amgen supported this research. Dr. Cleland reported research support from Vifor and Amgen.

SOURCE: http://bit.ly/29ukoX4

JAMA Cardiol 2016.

NEW YORK - About a third of heart failure patients have anemia and most also have iron deficiency, according to UK researchers.

This observational analysis, Dr. John G.F. Cleland told Reuters Health by email, "shows that iron deficiency is very common in patients with heart failure and often leads to anemia and that the prevalence of both iron deficiency and anemia are both highly sensitive to the criteria used to define them."

In a June 29 online paper in JAMA Cardiology, Dr. Cleland, of the University of Hull, and colleagues report that they came to this conclusion after studying data on more than 4,400 patients seen at a local clinic over a 10-year period. All were referred because of suspected heart failure, and their median age was 73 years.

Data collected included hemoglobin, serum iron, transferrin saturation, and serum ferritin concentrations.

Overall, 1,237 patients (27.8%) had anemia, with a higher prevalence (33.3%) in patients who met the criteria for heart failure with or without left ventricular systolic dysfunction (LVSD).

Depending on the definition used, iron deficiency was present in 270 (43.2%) to 425 (68.0%) patients with anemia. This was the case in 260 (14.7%) to 624 (35.3%) of those without anemia.

Lower concentrations of hemoglobin (hazard ratio 0.92) and serum iron (HR 0.98) were independently associated with higher all-cause and cardiovascular mortality in multivariable analyses.

Moreover, said Dr. Cleland, "Serum iron and transferrin saturation were highly correlated (raising the question of the need to measure both) and both were strongly related to anemia. In contrast, serum ferritin, the most widely (supposed) measure of iron deficiency, was more strongly related to measures of inflammation than anemia."

"Lower concentrations of hemoglobin and serum iron and lower transferrin saturation," he stressed, "were associated with a higher mortality. In contrast, lower serum ferritin was associated with a better prognosis, probably because it is more a measure of inflammation than of iron deficiency."

Dr. Cleland concluded, "Serum ferritin is a poor measure of iron deficiency in patients with heart failure. Many patients with normal serum ferritin (defined by many as greater than 100 ng/mL) have iron deficiency. Clinical trials of intravenous iron for patients with heart failure should be aware of this issue to ensure they enroll appropriate patients."

The National Heart Service, Vifor Pharma, and Amgen supported this research. Dr. Cleland reported research support from Vifor and Amgen.

SOURCE: http://bit.ly/29ukoX4

JAMA Cardiol 2016.

NEW YORK - About a third of heart failure patients have anemia and most also have iron deficiency, according to UK researchers.

This observational analysis, Dr. John G.F. Cleland told Reuters Health by email, "shows that iron deficiency is very common in patients with heart failure and often leads to anemia and that the prevalence of both iron deficiency and anemia are both highly sensitive to the criteria used to define them."

In a June 29 online paper in JAMA Cardiology, Dr. Cleland, of the University of Hull, and colleagues report that they came to this conclusion after studying data on more than 4,400 patients seen at a local clinic over a 10-year period. All were referred because of suspected heart failure, and their median age was 73 years.

Data collected included hemoglobin, serum iron, transferrin saturation, and serum ferritin concentrations.

Overall, 1,237 patients (27.8%) had anemia, with a higher prevalence (33.3%) in patients who met the criteria for heart failure with or without left ventricular systolic dysfunction (LVSD).

Depending on the definition used, iron deficiency was present in 270 (43.2%) to 425 (68.0%) patients with anemia. This was the case in 260 (14.7%) to 624 (35.3%) of those without anemia.

Lower concentrations of hemoglobin (hazard ratio 0.92) and serum iron (HR 0.98) were independently associated with higher all-cause and cardiovascular mortality in multivariable analyses.

Moreover, said Dr. Cleland, "Serum iron and transferrin saturation were highly correlated (raising the question of the need to measure both) and both were strongly related to anemia. In contrast, serum ferritin, the most widely (supposed) measure of iron deficiency, was more strongly related to measures of inflammation than anemia."

"Lower concentrations of hemoglobin and serum iron and lower transferrin saturation," he stressed, "were associated with a higher mortality. In contrast, lower serum ferritin was associated with a better prognosis, probably because it is more a measure of inflammation than of iron deficiency."

Dr. Cleland concluded, "Serum ferritin is a poor measure of iron deficiency in patients with heart failure. Many patients with normal serum ferritin (defined by many as greater than 100 ng/mL) have iron deficiency. Clinical trials of intravenous iron for patients with heart failure should be aware of this issue to ensure they enroll appropriate patients."

The National Heart Service, Vifor Pharma, and Amgen supported this research. Dr. Cleland reported research support from Vifor and Amgen.

SOURCE: http://bit.ly/29ukoX4

JAMA Cardiol 2016.

NEW YORK - Long-term use of the bisphosphonate alendronate substantially lowers the risk of hip fracture without increasing the risk of atypical fractures of the subtrochanteric femur or femoral shaft, according to a Danish study.

"These findings support an acceptable balance between benefit and risk with treatment with alendronate in terms of fracture outcomes, even for over 10 years of continuous use," the authors conclude in the BMJ online June 28.

Placebo-controlled trials have shown a reduction in hip fracture risk with alendronate treatment for three years in older women with osteoporosis, but observational studies have suggested that atypical femur fractures are more common in long-term users of bisphosphonates.

To investigate further, researchers analyzed data from Danish practice registries on nearly 62,000 alendronate users. A total of 1,428 people sustained a fracture of the subtrochanteric femur or femoral shaft (ST/FS), an incidence rate of 3.4 per 1,000 person years, and 6,784 sustained a hip fracture (incidence rate 16.2 per 1,000 person years).

"Long-term adherent use of alendronate in excess of 10 dose years was associated with an adjusted 30% lower risk of hip fracture and no increase in the risk of fractures of the subtrochanteric femur or femoral shaft," the investigators report in their paper.

"In addition, we have shown that even in the worst case scenario (assuming 100% of subtrochanteric and femoral shaft fractures are atypical and secondary to bisphosphonate use and making no allowance for the higher prevalence of comorbid conditions in these patients) the number of atypical femur fractures remains too low to offset the benefits on hip fracture in patients with long-term alendronate use up to 10 years," they say.

"Safety concerns have probably limited the adherence to anti-osteoporosis therapies," Dr. Daniel Preto-Alhambra, University of Oxford, Nuffield Orthopaedics Centre in the United Kingdom, who worked on the study, told Reuters Health by email.

"Our findings support a good risk-benefit for this treatment in terms of femur fracture risk reduction, even when prescribed for 10 years and over. These data should reassure physicians and patients on the bone-related risk-benefits of alendronate therapy," he added.

The study had no commercial funding. Several authors made disclosure statements.

SOURCE: http://bit.ly/29y33NQ

BMJ 2016.

NEW YORK - Long-term use of the bisphosphonate alendronate substantially lowers the risk of hip fracture without increasing the risk of atypical fractures of the subtrochanteric femur or femoral shaft, according to a Danish study.

"These findings support an acceptable balance between benefit and risk with treatment with alendronate in terms of fracture outcomes, even for over 10 years of continuous use," the authors conclude in the BMJ online June 28.

Placebo-controlled trials have shown a reduction in hip fracture risk with alendronate treatment for three years in older women with osteoporosis, but observational studies have suggested that atypical femur fractures are more common in long-term users of bisphosphonates.

To investigate further, researchers analyzed data from Danish practice registries on nearly 62,000 alendronate users. A total of 1,428 people sustained a fracture of the subtrochanteric femur or femoral shaft (ST/FS), an incidence rate of 3.4 per 1,000 person years, and 6,784 sustained a hip fracture (incidence rate 16.2 per 1,000 person years).

"Long-term adherent use of alendronate in excess of 10 dose years was associated with an adjusted 30% lower risk of hip fracture and no increase in the risk of fractures of the subtrochanteric femur or femoral shaft," the investigators report in their paper.

"In addition, we have shown that even in the worst case scenario (assuming 100% of subtrochanteric and femoral shaft fractures are atypical and secondary to bisphosphonate use and making no allowance for the higher prevalence of comorbid conditions in these patients) the number of atypical femur fractures remains too low to offset the benefits on hip fracture in patients with long-term alendronate use up to 10 years," they say.

"Safety concerns have probably limited the adherence to anti-osteoporosis therapies," Dr. Daniel Preto-Alhambra, University of Oxford, Nuffield Orthopaedics Centre in the United Kingdom, who worked on the study, told Reuters Health by email.

"Our findings support a good risk-benefit for this treatment in terms of femur fracture risk reduction, even when prescribed for 10 years and over. These data should reassure physicians and patients on the bone-related risk-benefits of alendronate therapy," he added.

The study had no commercial funding. Several authors made disclosure statements.

SOURCE: http://bit.ly/29y33NQ

BMJ 2016.

NEW YORK - Long-term use of the bisphosphonate alendronate substantially lowers the risk of hip fracture without increasing the risk of atypical fractures of the subtrochanteric femur or femoral shaft, according to a Danish study.

"These findings support an acceptable balance between benefit and risk with treatment with alendronate in terms of fracture outcomes, even for over 10 years of continuous use," the authors conclude in the BMJ online June 28.

Placebo-controlled trials have shown a reduction in hip fracture risk with alendronate treatment for three years in older women with osteoporosis, but observational studies have suggested that atypical femur fractures are more common in long-term users of bisphosphonates.

To investigate further, researchers analyzed data from Danish practice registries on nearly 62,000 alendronate users. A total of 1,428 people sustained a fracture of the subtrochanteric femur or femoral shaft (ST/FS), an incidence rate of 3.4 per 1,000 person years, and 6,784 sustained a hip fracture (incidence rate 16.2 per 1,000 person years).

"Long-term adherent use of alendronate in excess of 10 dose years was associated with an adjusted 30% lower risk of hip fracture and no increase in the risk of fractures of the subtrochanteric femur or femoral shaft," the investigators report in their paper.

"In addition, we have shown that even in the worst case scenario (assuming 100% of subtrochanteric and femoral shaft fractures are atypical and secondary to bisphosphonate use and making no allowance for the higher prevalence of comorbid conditions in these patients) the number of atypical femur fractures remains too low to offset the benefits on hip fracture in patients with long-term alendronate use up to 10 years," they say.

"Safety concerns have probably limited the adherence to anti-osteoporosis therapies," Dr. Daniel Preto-Alhambra, University of Oxford, Nuffield Orthopaedics Centre in the United Kingdom, who worked on the study, told Reuters Health by email.

"Our findings support a good risk-benefit for this treatment in terms of femur fracture risk reduction, even when prescribed for 10 years and over. These data should reassure physicians and patients on the bone-related risk-benefits of alendronate therapy," he added.

The study had no commercial funding. Several authors made disclosure statements.

SOURCE: http://bit.ly/29y33NQ

BMJ 2016.

CHICAGO - Medicare enrollees are moving in greater numbers than ever to the program's managed care option as a way to save money. But the tradeoff is much less ability to use their preferred doctors and hospitals.

Seniors can choose between traditional fee-for-service Medicare - which is accepted by most healthcare providers - or a Medicare Advantage plan. The latter encompasses health maintenance organizations (HMOs) or preferred provider organizations (PPOs), which control costs by creating healthcare provider networks that enrollees must use.

In theory, prospective Advantage enrollees can review lists of in-network providers before opting into a plan. But a new study by the Kaiser Family Foundation (KFF) finds that provider data often is very difficult to review, can be out of date and frequently contain inaccurate information.

KFF's review also found shortcomings in the quality of providers in some Medicare Advantage provider networks. One out of every five plans did not include a regional academic medical center - institutions which usually offer the highest quality care and top specialists. And only 40 percent of Advantage provider networks included top-quality cancer centers, as indicated by membership in the National Cancer Institute's network.

NCI-designated cancer centers offer cutting-edge treatments and tend to have greater access to clinical trials. They are especially important for patients with rare and advanced cancers, or other complicating conditions, said Gretchen Jacobson, KFF's associate director of the program on Medicare policy and co-author of the study.

The upshot: Medicare Advantage may be just fine if you are healthy, but problems may crop up if your healthcare needs become more complex and you have very specific healthcare provider preferences.

This year, 31 percent of Medicare enrollees are in Advantage plans, up from 11 percent in 2010. That number is expected to hit 41 percent by 2026, according to a forecast by the Congressional Budget Office.

When you sign up for Advantage, your Part B premium goes to the insurance company providing the plan. The largest providers are UnitedHealthcare, Humana Inc and Blue Cross Blue Shield.

One often hears critics claim that healthcare providers are bailing out of traditional Medicare in large numbers - but that is not actually the case. Last year, 14 percent of Medicare enrollees who were seeking a new primary care doctor reported major problems in finding a physician who would treat them, according to survey data from the Medicare Payment Advisory Commission, an independent congressional agency. Among those seeking a new specialist, 6 percent reported major problems. In both cases, that represents 1 percent of the total Medicare population.

ADVANTAGES, PITFALLS

Advantage plans often offer extra benefits, such as health club memberships, vision care and some limited dental care. Cost-sharing is often lower, and many plans provide prescription drug coverage with no extra premium. "It can be very attractive to many seniors who are living on a fixed budget," Jacobson said.

The trade-off is limited provider networks - and the challenges prospective enrollees face in determining who they are allowed to see for healthcare, and who is off-limits. KFF reviewed 409 Advantage plans, including 307 HMOs and 102 PPOs. Researchers found provider directories often were riddled with errors, omissions and outdated information.

"There's no reason in this era of technology why this needs to be as difficult as it is," Jacobson said. "People should be able to simply tell the system who their doctors are, the illnesses they have, and get a recommendation for a plan that will work for them."

KFF also found that Advantage provider network quality differs significantly. For example, Los Angeles has three NCI-designated cancer centers. Most of the Advantage plans there do not include any of them, but one plan includes all three.

A report last year by the U.S. Government Accountability Office found that the Centers for Medicare & Medicaid Services (CMS), which runs Medicare, needs to improve its oversight of Advantage plans to assure that provider networks are robust. The report also criticized CMS for doing too little to assess the accuracy of Advantage plan provider lists.

Even when Advantage enrollees are able to confirm participation by their healthcare providers, there is no guarantee that will continue. Advantage plans are free to add or drop health providers during the course of an enrollment season.

That became an especially hot issue in 2014 when UnitedHealthcare dropped providers who covered thousands of the insurer's patients, including the prominent Yale-New Haven Hospital system.

Democrats in Congress have proposed legislation that would prohibit Advantage plans from dropping providers without cause during the middle of an enrollment year.

Under current rules, plans must provide 30 days' notice to enrollees when providers are dropped. Enrollees who lose access to a provider can make a midyear plan change only under very limited circumstances. "You can do it only if you are receiving ongoing care from a provider that is terminated," Jacobson said. "Otherwise you need to wait until the next open enrollment period."

The annual enrollment period for Advantage and Part D prescription drug plans are held from Oct. 15 to Dec. 7 each year. At that point, a beneficiary could switch to a different Advantage plan, or shift back to traditional Medicare. But a serious diagnosis in January would leave you hamstrung until the following year.

Said Jacobson: "It can be a roll of the dice."

(The opinions expressed here are those of the author, a columnist for Reuters.)

CHICAGO - Medicare enrollees are moving in greater numbers than ever to the program's managed care option as a way to save money. But the tradeoff is much less ability to use their preferred doctors and hospitals.

Seniors can choose between traditional fee-for-service Medicare - which is accepted by most healthcare providers - or a Medicare Advantage plan. The latter encompasses health maintenance organizations (HMOs) or preferred provider organizations (PPOs), which control costs by creating healthcare provider networks that enrollees must use.

In theory, prospective Advantage enrollees can review lists of in-network providers before opting into a plan. But a new study by the Kaiser Family Foundation (KFF) finds that provider data often is very difficult to review, can be out of date and frequently contain inaccurate information.

KFF's review also found shortcomings in the quality of providers in some Medicare Advantage provider networks. One out of every five plans did not include a regional academic medical center - institutions which usually offer the highest quality care and top specialists. And only 40 percent of Advantage provider networks included top-quality cancer centers, as indicated by membership in the National Cancer Institute's network.

NCI-designated cancer centers offer cutting-edge treatments and tend to have greater access to clinical trials. They are especially important for patients with rare and advanced cancers, or other complicating conditions, said Gretchen Jacobson, KFF's associate director of the program on Medicare policy and co-author of the study.

The upshot: Medicare Advantage may be just fine if you are healthy, but problems may crop up if your healthcare needs become more complex and you have very specific healthcare provider preferences.

This year, 31 percent of Medicare enrollees are in Advantage plans, up from 11 percent in 2010. That number is expected to hit 41 percent by 2026, according to a forecast by the Congressional Budget Office.

When you sign up for Advantage, your Part B premium goes to the insurance company providing the plan. The largest providers are UnitedHealthcare, Humana Inc and Blue Cross Blue Shield.

One often hears critics claim that healthcare providers are bailing out of traditional Medicare in large numbers - but that is not actually the case. Last year, 14 percent of Medicare enrollees who were seeking a new primary care doctor reported major problems in finding a physician who would treat them, according to survey data from the Medicare Payment Advisory Commission, an independent congressional agency. Among those seeking a new specialist, 6 percent reported major problems. In both cases, that represents 1 percent of the total Medicare population.

ADVANTAGES, PITFALLS

Advantage plans often offer extra benefits, such as health club memberships, vision care and some limited dental care. Cost-sharing is often lower, and many plans provide prescription drug coverage with no extra premium. "It can be very attractive to many seniors who are living on a fixed budget," Jacobson said.

The trade-off is limited provider networks - and the challenges prospective enrollees face in determining who they are allowed to see for healthcare, and who is off-limits. KFF reviewed 409 Advantage plans, including 307 HMOs and 102 PPOs. Researchers found provider directories often were riddled with errors, omissions and outdated information.

"There's no reason in this era of technology why this needs to be as difficult as it is," Jacobson said. "People should be able to simply tell the system who their doctors are, the illnesses they have, and get a recommendation for a plan that will work for them."

KFF also found that Advantage provider network quality differs significantly. For example, Los Angeles has three NCI-designated cancer centers. Most of the Advantage plans there do not include any of them, but one plan includes all three.

A report last year by the U.S. Government Accountability Office found that the Centers for Medicare & Medicaid Services (CMS), which runs Medicare, needs to improve its oversight of Advantage plans to assure that provider networks are robust. The report also criticized CMS for doing too little to assess the accuracy of Advantage plan provider lists.

Even when Advantage enrollees are able to confirm participation by their healthcare providers, there is no guarantee that will continue. Advantage plans are free to add or drop health providers during the course of an enrollment season.

That became an especially hot issue in 2014 when UnitedHealthcare dropped providers who covered thousands of the insurer's patients, including the prominent Yale-New Haven Hospital system.

Democrats in Congress have proposed legislation that would prohibit Advantage plans from dropping providers without cause during the middle of an enrollment year.

Under current rules, plans must provide 30 days' notice to enrollees when providers are dropped. Enrollees who lose access to a provider can make a midyear plan change only under very limited circumstances. "You can do it only if you are receiving ongoing care from a provider that is terminated," Jacobson said. "Otherwise you need to wait until the next open enrollment period."

The annual enrollment period for Advantage and Part D prescription drug plans are held from Oct. 15 to Dec. 7 each year. At that point, a beneficiary could switch to a different Advantage plan, or shift back to traditional Medicare. But a serious diagnosis in January would leave you hamstrung until the following year.

Said Jacobson: "It can be a roll of the dice."

(The opinions expressed here are those of the author, a columnist for Reuters.)

CHICAGO - Medicare enrollees are moving in greater numbers than ever to the program's managed care option as a way to save money. But the tradeoff is much less ability to use their preferred doctors and hospitals.

Seniors can choose between traditional fee-for-service Medicare - which is accepted by most healthcare providers - or a Medicare Advantage plan. The latter encompasses health maintenance organizations (HMOs) or preferred provider organizations (PPOs), which control costs by creating healthcare provider networks that enrollees must use.

In theory, prospective Advantage enrollees can review lists of in-network providers before opting into a plan. But a new study by the Kaiser Family Foundation (KFF) finds that provider data often is very difficult to review, can be out of date and frequently contain inaccurate information.

KFF's review also found shortcomings in the quality of providers in some Medicare Advantage provider networks. One out of every five plans did not include a regional academic medical center - institutions which usually offer the highest quality care and top specialists. And only 40 percent of Advantage provider networks included top-quality cancer centers, as indicated by membership in the National Cancer Institute's network.

NCI-designated cancer centers offer cutting-edge treatments and tend to have greater access to clinical trials. They are especially important for patients with rare and advanced cancers, or other complicating conditions, said Gretchen Jacobson, KFF's associate director of the program on Medicare policy and co-author of the study.

The upshot: Medicare Advantage may be just fine if you are healthy, but problems may crop up if your healthcare needs become more complex and you have very specific healthcare provider preferences.

This year, 31 percent of Medicare enrollees are in Advantage plans, up from 11 percent in 2010. That number is expected to hit 41 percent by 2026, according to a forecast by the Congressional Budget Office.

When you sign up for Advantage, your Part B premium goes to the insurance company providing the plan. The largest providers are UnitedHealthcare, Humana Inc and Blue Cross Blue Shield.

One often hears critics claim that healthcare providers are bailing out of traditional Medicare in large numbers - but that is not actually the case. Last year, 14 percent of Medicare enrollees who were seeking a new primary care doctor reported major problems in finding a physician who would treat them, according to survey data from the Medicare Payment Advisory Commission, an independent congressional agency. Among those seeking a new specialist, 6 percent reported major problems. In both cases, that represents 1 percent of the total Medicare population.

ADVANTAGES, PITFALLS

Advantage plans often offer extra benefits, such as health club memberships, vision care and some limited dental care. Cost-sharing is often lower, and many plans provide prescription drug coverage with no extra premium. "It can be very attractive to many seniors who are living on a fixed budget," Jacobson said.

The trade-off is limited provider networks - and the challenges prospective enrollees face in determining who they are allowed to see for healthcare, and who is off-limits. KFF reviewed 409 Advantage plans, including 307 HMOs and 102 PPOs. Researchers found provider directories often were riddled with errors, omissions and outdated information.

"There's no reason in this era of technology why this needs to be as difficult as it is," Jacobson said. "People should be able to simply tell the system who their doctors are, the illnesses they have, and get a recommendation for a plan that will work for them."

KFF also found that Advantage provider network quality differs significantly. For example, Los Angeles has three NCI-designated cancer centers. Most of the Advantage plans there do not include any of them, but one plan includes all three.

A report last year by the U.S. Government Accountability Office found that the Centers for Medicare & Medicaid Services (CMS), which runs Medicare, needs to improve its oversight of Advantage plans to assure that provider networks are robust. The report also criticized CMS for doing too little to assess the accuracy of Advantage plan provider lists.

Even when Advantage enrollees are able to confirm participation by their healthcare providers, there is no guarantee that will continue. Advantage plans are free to add or drop health providers during the course of an enrollment season.

That became an especially hot issue in 2014 when UnitedHealthcare dropped providers who covered thousands of the insurer's patients, including the prominent Yale-New Haven Hospital system.

Democrats in Congress have proposed legislation that would prohibit Advantage plans from dropping providers without cause during the middle of an enrollment year.

Under current rules, plans must provide 30 days' notice to enrollees when providers are dropped. Enrollees who lose access to a provider can make a midyear plan change only under very limited circumstances. "You can do it only if you are receiving ongoing care from a provider that is terminated," Jacobson said. "Otherwise you need to wait until the next open enrollment period."

The annual enrollment period for Advantage and Part D prescription drug plans are held from Oct. 15 to Dec. 7 each year. At that point, a beneficiary could switch to a different Advantage plan, or shift back to traditional Medicare. But a serious diagnosis in January would leave you hamstrung until the following year.

Said Jacobson: "It can be a roll of the dice."

(The opinions expressed here are those of the author, a columnist for Reuters.)

WASHINGTON - The White House announced on Wednesday measures aimed at advancing President Barack Obama's precision medicine initiative, including plans to speed the development of tests used to identify genetic mutations and guide medical treatment.

The U.S. Food and Drug Administration said it planned to issue a proposal to create performance standards to guide development of next generation sequencing (NGS) tests. These tests scan a person's DNA and identify genetic differences that could be responsible for a patient's symptoms.

The standards would be designed to assess how accurately a test identifies a genetic variant. The developer would certify that it had met those standards. Currently the FDA itself determines the test's accuracy.

"We believe that the use of standards is the best way to allow regulation to keep pace with the evolution of NGS technology," Dr. Robert Califf told reporters on a conference call.

A second FDA proposal would allow test developers to use data from publicly accessible genetic databases, not just their own data, to demonstrate that the test accurately predicts disease. Califf said the approach could potentially get rid of the need for the FDA to review the tests before they reach the market.

"Taken together, these guidances will foster innovation, assure the quality and reliability of NGS-based tests and promote their adoption into clinical practice," he said.

The FDA's action is part of a broader government initiative to promote the development of individually tailored medicines. Obama introduced the initiative in his State of the Union address last year, saying he wanted the United States to lead a new era of medicine, "one that delivers the right treatment at the right time."

As part of the project, the National Institutes of Health will invest $55 million to build the infrastructure needed to collect genetic data from more than 1 million volunteers, its director, Dr. Francis Collins, said on the conference call.

Collins said it will take three to four years to assemble the desired amount of genetic material, which will then be available to researchers to help develop drugs for cancer and other disease. Anyone, he said, can participate.

"This is about all of us," he said. "Participants will be true partners, not subjects, not patients." Data sharing, he added, will be "swift."

WASHINGTON - The White House announced on Wednesday measures aimed at advancing President Barack Obama's precision medicine initiative, including plans to speed the development of tests used to identify genetic mutations and guide medical treatment.

The U.S. Food and Drug Administration said it planned to issue a proposal to create performance standards to guide development of next generation sequencing (NGS) tests. These tests scan a person's DNA and identify genetic differences that could be responsible for a patient's symptoms.

The standards would be designed to assess how accurately a test identifies a genetic variant. The developer would certify that it had met those standards. Currently the FDA itself determines the test's accuracy.

"We believe that the use of standards is the best way to allow regulation to keep pace with the evolution of NGS technology," Dr. Robert Califf told reporters on a conference call.

A second FDA proposal would allow test developers to use data from publicly accessible genetic databases, not just their own data, to demonstrate that the test accurately predicts disease. Califf said the approach could potentially get rid of the need for the FDA to review the tests before they reach the market.

"Taken together, these guidances will foster innovation, assure the quality and reliability of NGS-based tests and promote their adoption into clinical practice," he said.

The FDA's action is part of a broader government initiative to promote the development of individually tailored medicines. Obama introduced the initiative in his State of the Union address last year, saying he wanted the United States to lead a new era of medicine, "one that delivers the right treatment at the right time."

As part of the project, the National Institutes of Health will invest $55 million to build the infrastructure needed to collect genetic data from more than 1 million volunteers, its director, Dr. Francis Collins, said on the conference call.

Collins said it will take three to four years to assemble the desired amount of genetic material, which will then be available to researchers to help develop drugs for cancer and other disease. Anyone, he said, can participate.

"This is about all of us," he said. "Participants will be true partners, not subjects, not patients." Data sharing, he added, will be "swift."

WASHINGTON - The White House announced on Wednesday measures aimed at advancing President Barack Obama's precision medicine initiative, including plans to speed the development of tests used to identify genetic mutations and guide medical treatment.

The U.S. Food and Drug Administration said it planned to issue a proposal to create performance standards to guide development of next generation sequencing (NGS) tests. These tests scan a person's DNA and identify genetic differences that could be responsible for a patient's symptoms.

The standards would be designed to assess how accurately a test identifies a genetic variant. The developer would certify that it had met those standards. Currently the FDA itself determines the test's accuracy.

"We believe that the use of standards is the best way to allow regulation to keep pace with the evolution of NGS technology," Dr. Robert Califf told reporters on a conference call.

A second FDA proposal would allow test developers to use data from publicly accessible genetic databases, not just their own data, to demonstrate that the test accurately predicts disease. Califf said the approach could potentially get rid of the need for the FDA to review the tests before they reach the market.

"Taken together, these guidances will foster innovation, assure the quality and reliability of NGS-based tests and promote their adoption into clinical practice," he said.

The FDA's action is part of a broader government initiative to promote the development of individually tailored medicines. Obama introduced the initiative in his State of the Union address last year, saying he wanted the United States to lead a new era of medicine, "one that delivers the right treatment at the right time."

As part of the project, the National Institutes of Health will invest $55 million to build the infrastructure needed to collect genetic data from more than 1 million volunteers, its director, Dr. Francis Collins, said on the conference call.

Collins said it will take three to four years to assemble the desired amount of genetic material, which will then be available to researchers to help develop drugs for cancer and other disease. Anyone, he said, can participate.

"This is about all of us," he said. "Participants will be true partners, not subjects, not patients." Data sharing, he added, will be "swift."

Physicians wrote significantly fewer prescriptions for painkillers and other medications for elderly and disabled patients who had legal access to medical marijuana, a new study finds.

In fact, Medicare saved more than $165 million in 2013 on prescription drugs in the District of Columbia and 17 states that allowed cannabis to be used as medicine, researchers calculated. If every state in the nation legalized medical marijuana, the study forecast that the federal program would save more than $468 million a year on pharmaceuticals for disabled Americans and those 65 and older.

No health insurance, including Medicare, will reimburse for the cost of marijuana. Although medical cannabis is legal today in 25 states and the District of Columbia, federal law continues to prohibit its prescription in all circumstances.

The new study, published July 6 in Health Affairs, was the first to ask if there's any evidence that medical marijuana is being used as medicine, said senior author W. David Bradford in a phone interview. The answer is yes, said Bradford, a health economist and a professor at the University of Georgia in Athens.

"When states turned on medical marijuana laws, we did see a rather substantial turn away from FDA-approved medicine," he said.

Researchers analyzed Medicare data from 2010 through 2013 for drugs approved by the U.S. Food and Drug Administration (FDA) to treat nine ailments - from pain to depression and nausea - for which marijuana might be an alternative remedy.

They expected to see fewer prescriptions for FDA-approved drugs that might treat the same conditions as cannabis. Indeed, except for glaucoma, doctors wrote fewer prescriptions for all nine ailments after medical marijuana laws took effect, the study found.

The number of Medicare prescriptions significantly dropped for drugs that treat pain, depression, anxiety, nausea, psychoses, seizures and sleep disorders.

For pain, the annual number of daily doses prescribed per physician fell by more than 11 percent.

"The results show that marijuana might be beneficial with diverting people away from opioids," Bradford said.

A 2014 study found that opioid overdose death rates were on average nearly 25 percent lower in states where medical marijuana was legal compared to states where it remained illegal. Chronic or severe pain is considered a primary indicator for medical marijuana in most states where it is legal.

Nearly two million Americans either abused or were dependent on prescription opioids in 2014, according to the U.S. Centers for Disease Control and Prevention (CDC). Since 1999, more than 165,000 Americans have died from prescription opioid overdoses.

Addiction psychiatrist Dr. Kevin Hill questioned whether medical marijuana patients might in some cases be getting inferior or incorrect treatment, and if so, whether the resulting extra healthcare costs would overshadow the Medicare drug savings. Hill, a professor at Harvard Medical School in Boston, was not involved in the new study.

"Fewer opioid prescriptions in medical marijuana states might be a good thing, but I am concerned about the overall quality of care delivered in medical marijuana specialty clinics," he told Reuters Health in an email.

He criticized the implementation of medical marijuana laws in many states as often leading to "medical care that is of poor quality."

Part of the problem stems from a dearth of research into the efficacy of medical marijuana.

Although California became the first state to legalize medical marijuana in 1996, federal law enacted by Congress in 1970 continues to put cannabis in the same category as heroin, Schedule 1 of the Comprehensive Drug Abuse Prevention and Control Act, and finds it has no medicinal value. Consequently, research has been severely limited.

Sheigla Murphy, a medical sociologist who was not involved in the current study, praised it as a major contribution to the literature on the role of medical marijuana in older adults.

Murphy directs the Center for Substance Abuse Studies in San Francisco and has done prior research on marijuana and baby boomers. She said some older adults prefer marijuana to painkillers and sleeping pills.

"It fits with the problems of older age, problems with sleeping, depression, arthritis, worn-out body parts that begin to hurt. Marijuana can relieve these without the side effects of grogginess and worrying about addiction," she said.

"As we're trying to reduce the number of pain medications, I think marijuana would be a welcome addition to the pharmacopeia," she said. "The one thing we know is no one has ever died of it."

SOURCE: http://bit.ly/1lx2GBv

Health Affairs 2016.

Physicians wrote significantly fewer prescriptions for painkillers and other medications for elderly and disabled patients who had legal access to medical marijuana, a new study finds.

In fact, Medicare saved more than $165 million in 2013 on prescription drugs in the District of Columbia and 17 states that allowed cannabis to be used as medicine, researchers calculated. If every state in the nation legalized medical marijuana, the study forecast that the federal program would save more than $468 million a year on pharmaceuticals for disabled Americans and those 65 and older.

No health insurance, including Medicare, will reimburse for the cost of marijuana. Although medical cannabis is legal today in 25 states and the District of Columbia, federal law continues to prohibit its prescription in all circumstances.

The new study, published July 6 in Health Affairs, was the first to ask if there's any evidence that medical marijuana is being used as medicine, said senior author W. David Bradford in a phone interview. The answer is yes, said Bradford, a health economist and a professor at the University of Georgia in Athens.

"When states turned on medical marijuana laws, we did see a rather substantial turn away from FDA-approved medicine," he said.

Researchers analyzed Medicare data from 2010 through 2013 for drugs approved by the U.S. Food and Drug Administration (FDA) to treat nine ailments - from pain to depression and nausea - for which marijuana might be an alternative remedy.

They expected to see fewer prescriptions for FDA-approved drugs that might treat the same conditions as cannabis. Indeed, except for glaucoma, doctors wrote fewer prescriptions for all nine ailments after medical marijuana laws took effect, the study found.

The number of Medicare prescriptions significantly dropped for drugs that treat pain, depression, anxiety, nausea, psychoses, seizures and sleep disorders.

For pain, the annual number of daily doses prescribed per physician fell by more than 11 percent.

"The results show that marijuana might be beneficial with diverting people away from opioids," Bradford said.

A 2014 study found that opioid overdose death rates were on average nearly 25 percent lower in states where medical marijuana was legal compared to states where it remained illegal. Chronic or severe pain is considered a primary indicator for medical marijuana in most states where it is legal.

Nearly two million Americans either abused or were dependent on prescription opioids in 2014, according to the U.S. Centers for Disease Control and Prevention (CDC). Since 1999, more than 165,000 Americans have died from prescription opioid overdoses.

Addiction psychiatrist Dr. Kevin Hill questioned whether medical marijuana patients might in some cases be getting inferior or incorrect treatment, and if so, whether the resulting extra healthcare costs would overshadow the Medicare drug savings. Hill, a professor at Harvard Medical School in Boston, was not involved in the new study.

"Fewer opioid prescriptions in medical marijuana states might be a good thing, but I am concerned about the overall quality of care delivered in medical marijuana specialty clinics," he told Reuters Health in an email.

He criticized the implementation of medical marijuana laws in many states as often leading to "medical care that is of poor quality."

Part of the problem stems from a dearth of research into the efficacy of medical marijuana.

Although California became the first state to legalize medical marijuana in 1996, federal law enacted by Congress in 1970 continues to put cannabis in the same category as heroin, Schedule 1 of the Comprehensive Drug Abuse Prevention and Control Act, and finds it has no medicinal value. Consequently, research has been severely limited.

Sheigla Murphy, a medical sociologist who was not involved in the current study, praised it as a major contribution to the literature on the role of medical marijuana in older adults.

Murphy directs the Center for Substance Abuse Studies in San Francisco and has done prior research on marijuana and baby boomers. She said some older adults prefer marijuana to painkillers and sleeping pills.

"It fits with the problems of older age, problems with sleeping, depression, arthritis, worn-out body parts that begin to hurt. Marijuana can relieve these without the side effects of grogginess and worrying about addiction," she said.

"As we're trying to reduce the number of pain medications, I think marijuana would be a welcome addition to the pharmacopeia," she said. "The one thing we know is no one has ever died of it."

SOURCE: http://bit.ly/1lx2GBv

Health Affairs 2016.

Physicians wrote significantly fewer prescriptions for painkillers and other medications for elderly and disabled patients who had legal access to medical marijuana, a new study finds.

In fact, Medicare saved more than $165 million in 2013 on prescription drugs in the District of Columbia and 17 states that allowed cannabis to be used as medicine, researchers calculated. If every state in the nation legalized medical marijuana, the study forecast that the federal program would save more than $468 million a year on pharmaceuticals for disabled Americans and those 65 and older.

No health insurance, including Medicare, will reimburse for the cost of marijuana. Although medical cannabis is legal today in 25 states and the District of Columbia, federal law continues to prohibit its prescription in all circumstances.

The new study, published July 6 in Health Affairs, was the first to ask if there's any evidence that medical marijuana is being used as medicine, said senior author W. David Bradford in a phone interview. The answer is yes, said Bradford, a health economist and a professor at the University of Georgia in Athens.

"When states turned on medical marijuana laws, we did see a rather substantial turn away from FDA-approved medicine," he said.

Researchers analyzed Medicare data from 2010 through 2013 for drugs approved by the U.S. Food and Drug Administration (FDA) to treat nine ailments - from pain to depression and nausea - for which marijuana might be an alternative remedy.

They expected to see fewer prescriptions for FDA-approved drugs that might treat the same conditions as cannabis. Indeed, except for glaucoma, doctors wrote fewer prescriptions for all nine ailments after medical marijuana laws took effect, the study found.

The number of Medicare prescriptions significantly dropped for drugs that treat pain, depression, anxiety, nausea, psychoses, seizures and sleep disorders.

For pain, the annual number of daily doses prescribed per physician fell by more than 11 percent.

"The results show that marijuana might be beneficial with diverting people away from opioids," Bradford said.

A 2014 study found that opioid overdose death rates were on average nearly 25 percent lower in states where medical marijuana was legal compared to states where it remained illegal. Chronic or severe pain is considered a primary indicator for medical marijuana in most states where it is legal.

Nearly two million Americans either abused or were dependent on prescription opioids in 2014, according to the U.S. Centers for Disease Control and Prevention (CDC). Since 1999, more than 165,000 Americans have died from prescription opioid overdoses.

Addiction psychiatrist Dr. Kevin Hill questioned whether medical marijuana patients might in some cases be getting inferior or incorrect treatment, and if so, whether the resulting extra healthcare costs would overshadow the Medicare drug savings. Hill, a professor at Harvard Medical School in Boston, was not involved in the new study.

"Fewer opioid prescriptions in medical marijuana states might be a good thing, but I am concerned about the overall quality of care delivered in medical marijuana specialty clinics," he told Reuters Health in an email.

He criticized the implementation of medical marijuana laws in many states as often leading to "medical care that is of poor quality."

Part of the problem stems from a dearth of research into the efficacy of medical marijuana.

Although California became the first state to legalize medical marijuana in 1996, federal law enacted by Congress in 1970 continues to put cannabis in the same category as heroin, Schedule 1 of the Comprehensive Drug Abuse Prevention and Control Act, and finds it has no medicinal value. Consequently, research has been severely limited.

Sheigla Murphy, a medical sociologist who was not involved in the current study, praised it as a major contribution to the literature on the role of medical marijuana in older adults.

Murphy directs the Center for Substance Abuse Studies in San Francisco and has done prior research on marijuana and baby boomers. She said some older adults prefer marijuana to painkillers and sleeping pills.

"It fits with the problems of older age, problems with sleeping, depression, arthritis, worn-out body parts that begin to hurt. Marijuana can relieve these without the side effects of grogginess and worrying about addiction," she said.

"As we're trying to reduce the number of pain medications, I think marijuana would be a welcome addition to the pharmacopeia," she said. "The one thing we know is no one has ever died of it."

SOURCE: http://bit.ly/1lx2GBv

Health Affairs 2016.

NEW YORK - After a decade of follow-up in the Prostate Cancer Research International Active Surveillance (PRIAS) study, researchers have confirmed that active surveillance is a safe treatment option for men with low-risk prostate cancer.

"However," they say, "some changes could be made to the follow-up protocol to safely increase the number of men who remain on active surveillance."

Dr. Leonard P. Bokhorst of Erasmus University Medical Center in Rotterdam, the Netherlands, and colleagues analyzed data on more than 5,000 men in 18 countries followed in PRIAS, including 622 who were followed more than five years and 107 were followed more than 7.5 years.

The median age at diagnosis was 65.9 years.

Original inclusion criteria included Gleason score 3+3 or lower, stage cT2c or lower, and prostate-specific antigen (PSA) 10 ng/ml or lower. PSA tests were scheduled every three months and digital rectal examinations were scheduled every six months during the first two years of study, then less often later. Criteria to recommend starting active treatment include Gleason score higher than 3+3, more than two positive cores, and stage higher than cT2.

Median PSA for the study population was 5.7 ng/ml. Most men (69%) had one positive biopsy core, with Gleason score of 3+3 (99%) and a clinical stage of T1c (88%).

Almost 3,400 men received at least one repeat biopsy during follow-up and some received up to five biopsies.

Overall, 1,768 men discontinued active surveillance during follow-up, 1,102 due to protocol-based reclassification. Other reasons for discontinuations included anxiety, switch to watchful waiting, death, and loss to follow-up. Two-thirds (67%) of the men were treated with either radical prostatectomy or radiation therapy after discontinuation. Only 3% received hormonal therapy.

Almost half (48%) of the patients were still on active surveillance after five years and 27% were on active surveillance at 10 years, the researchers reported online June 19 in European Urology.

The team had pathology data on 360 men who had radical prostatectomy. Of the men who switched to treatment because of protocol-based reclassification, 82 (30%) had favorable pathological outcomes, 85 (34%) had intermediate outcomes, and 100 (36%) had unfavorable outcomes.

Mortality from prostate cancer was less than 1% during follow-up.

Because of the higher rate of unfavorable treatment outcomes, the researchers recommended a change in the PRIAS protocol.

"Instead of an immediate switch to active treatment if more than two cores are positive, men should receive further investigation to confirm higher risk disease," the researchers write. They recommend examination by magnetic resonance imaging because its negative predictive value for Gleason upgrading is near 100%.

They concluded, "Criteria used to recommend a switch to active treatment do not seem selective enough to avoid unnecessary switches to active treatment."

Dr. Bokhorst did not respond to a request for comment.

The Prostate Cancer Research Foundation, Rotterdam, supports the PRIAS study. The authors made no disclosures.

SOURCE: http://bit.ly/28Q5Cd3

Eur Urol 2016.

NEW YORK - After a decade of follow-up in the Prostate Cancer Research International Active Surveillance (PRIAS) study, researchers have confirmed that active surveillance is a safe treatment option for men with low-risk prostate cancer.

"However," they say, "some changes could be made to the follow-up protocol to safely increase the number of men who remain on active surveillance."

Dr. Leonard P. Bokhorst of Erasmus University Medical Center in Rotterdam, the Netherlands, and colleagues analyzed data on more than 5,000 men in 18 countries followed in PRIAS, including 622 who were followed more than five years and 107 were followed more than 7.5 years.

The median age at diagnosis was 65.9 years.

Original inclusion criteria included Gleason score 3+3 or lower, stage cT2c or lower, and prostate-specific antigen (PSA) 10 ng/ml or lower. PSA tests were scheduled every three months and digital rectal examinations were scheduled every six months during the first two years of study, then less often later. Criteria to recommend starting active treatment include Gleason score higher than 3+3, more than two positive cores, and stage higher than cT2.

Median PSA for the study population was 5.7 ng/ml. Most men (69%) had one positive biopsy core, with Gleason score of 3+3 (99%) and a clinical stage of T1c (88%).

Almost 3,400 men received at least one repeat biopsy during follow-up and some received up to five biopsies.

Overall, 1,768 men discontinued active surveillance during follow-up, 1,102 due to protocol-based reclassification. Other reasons for discontinuations included anxiety, switch to watchful waiting, death, and loss to follow-up. Two-thirds (67%) of the men were treated with either radical prostatectomy or radiation therapy after discontinuation. Only 3% received hormonal therapy.

Almost half (48%) of the patients were still on active surveillance after five years and 27% were on active surveillance at 10 years, the researchers reported online June 19 in European Urology.

The team had pathology data on 360 men who had radical prostatectomy. Of the men who switched to treatment because of protocol-based reclassification, 82 (30%) had favorable pathological outcomes, 85 (34%) had intermediate outcomes, and 100 (36%) had unfavorable outcomes.

Mortality from prostate cancer was less than 1% during follow-up.

Because of the higher rate of unfavorable treatment outcomes, the researchers recommended a change in the PRIAS protocol.

"Instead of an immediate switch to active treatment if more than two cores are positive, men should receive further investigation to confirm higher risk disease," the researchers write. They recommend examination by magnetic resonance imaging because its negative predictive value for Gleason upgrading is near 100%.

They concluded, "Criteria used to recommend a switch to active treatment do not seem selective enough to avoid unnecessary switches to active treatment."

Dr. Bokhorst did not respond to a request for comment.

The Prostate Cancer Research Foundation, Rotterdam, supports the PRIAS study. The authors made no disclosures.

SOURCE: http://bit.ly/28Q5Cd3

Eur Urol 2016.

NEW YORK - After a decade of follow-up in the Prostate Cancer Research International Active Surveillance (PRIAS) study, researchers have confirmed that active surveillance is a safe treatment option for men with low-risk prostate cancer.

"However," they say, "some changes could be made to the follow-up protocol to safely increase the number of men who remain on active surveillance."

Dr. Leonard P. Bokhorst of Erasmus University Medical Center in Rotterdam, the Netherlands, and colleagues analyzed data on more than 5,000 men in 18 countries followed in PRIAS, including 622 who were followed more than five years and 107 were followed more than 7.5 years.

The median age at diagnosis was 65.9 years.

Original inclusion criteria included Gleason score 3+3 or lower, stage cT2c or lower, and prostate-specific antigen (PSA) 10 ng/ml or lower. PSA tests were scheduled every three months and digital rectal examinations were scheduled every six months during the first two years of study, then less often later. Criteria to recommend starting active treatment include Gleason score higher than 3+3, more than two positive cores, and stage higher than cT2.

Median PSA for the study population was 5.7 ng/ml. Most men (69%) had one positive biopsy core, with Gleason score of 3+3 (99%) and a clinical stage of T1c (88%).

Almost 3,400 men received at least one repeat biopsy during follow-up and some received up to five biopsies.

Overall, 1,768 men discontinued active surveillance during follow-up, 1,102 due to protocol-based reclassification. Other reasons for discontinuations included anxiety, switch to watchful waiting, death, and loss to follow-up. Two-thirds (67%) of the men were treated with either radical prostatectomy or radiation therapy after discontinuation. Only 3% received hormonal therapy.

Almost half (48%) of the patients were still on active surveillance after five years and 27% were on active surveillance at 10 years, the researchers reported online June 19 in European Urology.

The team had pathology data on 360 men who had radical prostatectomy. Of the men who switched to treatment because of protocol-based reclassification, 82 (30%) had favorable pathological outcomes, 85 (34%) had intermediate outcomes, and 100 (36%) had unfavorable outcomes.

Mortality from prostate cancer was less than 1% during follow-up.

Because of the higher rate of unfavorable treatment outcomes, the researchers recommended a change in the PRIAS protocol.

"Instead of an immediate switch to active treatment if more than two cores are positive, men should receive further investigation to confirm higher risk disease," the researchers write. They recommend examination by magnetic resonance imaging because its negative predictive value for Gleason upgrading is near 100%.

They concluded, "Criteria used to recommend a switch to active treatment do not seem selective enough to avoid unnecessary switches to active treatment."

Dr. Bokhorst did not respond to a request for comment.

The Prostate Cancer Research Foundation, Rotterdam, supports the PRIAS study. The authors made no disclosures.

SOURCE: http://bit.ly/28Q5Cd3

Eur Urol 2016.

NEW YORK - Progression of the coronary artery calcification (CAC) score over time predicts the risk of cardiovascular disease, but it performs no better than the most recent CAC score, according to findings from the Cooper Center Longitudinal Study (CCLS).

"I must admit that I expected to find that the change in CAC was going to provide a lot of information about cardiovascular events, and was quite surprised when it didn't add much," Dr. Benjamin D. Levine from Cooper Clinic and University of Texas Southwestern Medical Center, Dallas, Texas told Reuters Health by email. "I was then also surprised when Dr. Andre Paixao, one of our cardiology fellows at the time (now at Emory), suggested that we look at the last CAC score as the best measure for risk attributable to CAC, and he turned out to be right!"

CAC correlates with overall atherosclerotic plaque and predicts incident coronary heart disease (CHD) events, CHD mortality, and total mortality, but only a few studies have evaluated the implications of CAC progression.

Dr. Levine and colleagues used CCLS data from 5,933 participants free of cardiovascular disease (CVD) at baseline to evaluate the relative contributions of baseline CAC score, follow-up CAC score, and CAC progression rates to the risk of incident CVD events.

At baseline, 2,870 (48%) individuals had CAC. These individuals were older, more likely to be on statin therapy, and had higher systolic blood pressure and lower cardiorespiratory fitness, according to the June 29th JACC Cardiovascular Imaging online report.

Individuals with detectable CAC at baseline had significantly higher total CVD event rates than those without detectable CAC (7.70 vs 1.44 per 1,000 person-years, respectively), as well as hard CVD event rates, i.e., CVD death, nonfatal myocardial infarction, or nonfatal atherosclerotic stroke (2.68 vs 1.14 per 1,000 person-years, respectively).

Rates of total CVD and CHD events increased across quartiles of CAC progression, but there was no independent association between CAC progression and CVD outcomes after adjustment for the follow-up CAC score.

"These findings greatly simplify the interpretation of CAC scores over time," Dr. Levine said. "Because it is so difficult to quantify 'change' (a score that goes from 1 to 2 is 100% change, but from 101 to 102 is 1% change), it has been hard for clinicians to wrap their minds around the additional risk information that is contained in follow up scores. Since it is not the calcium we are worried about anyway (calcified plaque generally doesn't rupture - it is the company it keeps that is important), what matters is the overall atherosclerotic burden, as reflected by the absolute CAC score. How fast it changes doesn't matter at all!"

"Don't worry about complicated formulas for quantifying change in CAC," Dr. Levine said. "Just use the latest score to calculate the risk associated with CAC. Now that new calculators are available (and some new ones coming from our work in this space), only the latest CAC score is needed to assess risk."

In an editorial, Dr. Prediman K. Shah from Cedars Sinai Hart Institute in Los Angeles writes, "So change in CAC score may be bad, indifferent, or possibly even good depending on what causes the change: progression of underlying atherosclerosis (potentially bad) versus increased density of calcification indicating a plaque stabilizing response (potentially good)."

Dr. Shah continues. "How to distinguish potential contributors to change in CAC score remains an important and at this time an unanswered question."

"Addition of other variables that incorporate regions of change, change in regional density and other volumetric aspect of CAC change, extracoronary calcification, and epicardial fat volume may improve the value and relevance of change in CAC score," Dr. Shah said. "Further studies are needed to address these issues."

Dr. Joseph Yeboah from Wake Forest Baptist Health, Winston-Salem, North Carolina, who has also researched the association between CAC scores and cardiovascular disease risk, told Reuters Health by email, "This happens to be the first study to show that CAC progression is not informative for CVD risk assessment. At the very best, this study makes the data mixed, which is not surprising given the challenge of using a change in a variable (CAC progression) as a predictor. Some researchers have suggested that CAC density progression instead of CAC score progression may be more appropriate."

"In my opinion, these results will have very little influence on how CAC is used presently for CVD risk assessment," he said. "To my knowledge, there is presently no guideline or recommendation regarding the use of CAC progression for CVD risk assessment. This is because of the inherent challenges in assessing CAC progression and the paucity of data."

"The ACC/AHA guidelines clearly recommend the use of CAC, not CAC progression," Dr. Yeboah concluded. "The take away message here is that physicians should not use CAC progression for CVD risk assessment. More research is needed to fully understand CAC progression."

SOURCE: http://bit.ly/29rOdFM and http://bit.ly/29olMIA

J Am Coll Cardiol Imag 2016.

NEW YORK - Progression of the coronary artery calcification (CAC) score over time predicts the risk of cardiovascular disease, but it performs no better than the most recent CAC score, according to findings from the Cooper Center Longitudinal Study (CCLS).

"I must admit that I expected to find that the change in CAC was going to provide a lot of information about cardiovascular events, and was quite surprised when it didn't add much," Dr. Benjamin D. Levine from Cooper Clinic and University of Texas Southwestern Medical Center, Dallas, Texas told Reuters Health by email. "I was then also surprised when Dr. Andre Paixao, one of our cardiology fellows at the time (now at Emory), suggested that we look at the last CAC score as the best measure for risk attributable to CAC, and he turned out to be right!"

CAC correlates with overall atherosclerotic plaque and predicts incident coronary heart disease (CHD) events, CHD mortality, and total mortality, but only a few studies have evaluated the implications of CAC progression.

Dr. Levine and colleagues used CCLS data from 5,933 participants free of cardiovascular disease (CVD) at baseline to evaluate the relative contributions of baseline CAC score, follow-up CAC score, and CAC progression rates to the risk of incident CVD events.

At baseline, 2,870 (48%) individuals had CAC. These individuals were older, more likely to be on statin therapy, and had higher systolic blood pressure and lower cardiorespiratory fitness, according to the June 29th JACC Cardiovascular Imaging online report.

Individuals with detectable CAC at baseline had significantly higher total CVD event rates than those without detectable CAC (7.70 vs 1.44 per 1,000 person-years, respectively), as well as hard CVD event rates, i.e., CVD death, nonfatal myocardial infarction, or nonfatal atherosclerotic stroke (2.68 vs 1.14 per 1,000 person-years, respectively).

Rates of total CVD and CHD events increased across quartiles of CAC progression, but there was no independent association between CAC progression and CVD outcomes after adjustment for the follow-up CAC score.

"These findings greatly simplify the interpretation of CAC scores over time," Dr. Levine said. "Because it is so difficult to quantify 'change' (a score that goes from 1 to 2 is 100% change, but from 101 to 102 is 1% change), it has been hard for clinicians to wrap their minds around the additional risk information that is contained in follow up scores. Since it is not the calcium we are worried about anyway (calcified plaque generally doesn't rupture - it is the company it keeps that is important), what matters is the overall atherosclerotic burden, as reflected by the absolute CAC score. How fast it changes doesn't matter at all!"

"Don't worry about complicated formulas for quantifying change in CAC," Dr. Levine said. "Just use the latest score to calculate the risk associated with CAC. Now that new calculators are available (and some new ones coming from our work in this space), only the latest CAC score is needed to assess risk."

In an editorial, Dr. Prediman K. Shah from Cedars Sinai Hart Institute in Los Angeles writes, "So change in CAC score may be bad, indifferent, or possibly even good depending on what causes the change: progression of underlying atherosclerosis (potentially bad) versus increased density of calcification indicating a plaque stabilizing response (potentially good)."

Dr. Shah continues. "How to distinguish potential contributors to change in CAC score remains an important and at this time an unanswered question."

"Addition of other variables that incorporate regions of change, change in regional density and other volumetric aspect of CAC change, extracoronary calcification, and epicardial fat volume may improve the value and relevance of change in CAC score," Dr. Shah said. "Further studies are needed to address these issues."

Dr. Joseph Yeboah from Wake Forest Baptist Health, Winston-Salem, North Carolina, who has also researched the association between CAC scores and cardiovascular disease risk, told Reuters Health by email, "This happens to be the first study to show that CAC progression is not informative for CVD risk assessment. At the very best, this study makes the data mixed, which is not surprising given the challenge of using a change in a variable (CAC progression) as a predictor. Some researchers have suggested that CAC density progression instead of CAC score progression may be more appropriate."

"In my opinion, these results will have very little influence on how CAC is used presently for CVD risk assessment," he said. "To my knowledge, there is presently no guideline or recommendation regarding the use of CAC progression for CVD risk assessment. This is because of the inherent challenges in assessing CAC progression and the paucity of data."

"The ACC/AHA guidelines clearly recommend the use of CAC, not CAC progression," Dr. Yeboah concluded. "The take away message here is that physicians should not use CAC progression for CVD risk assessment. More research is needed to fully understand CAC progression."

SOURCE: http://bit.ly/29rOdFM and http://bit.ly/29olMIA

J Am Coll Cardiol Imag 2016.

NEW YORK - Progression of the coronary artery calcification (CAC) score over time predicts the risk of cardiovascular disease, but it performs no better than the most recent CAC score, according to findings from the Cooper Center Longitudinal Study (CCLS).

"I must admit that I expected to find that the change in CAC was going to provide a lot of information about cardiovascular events, and was quite surprised when it didn't add much," Dr. Benjamin D. Levine from Cooper Clinic and University of Texas Southwestern Medical Center, Dallas, Texas told Reuters Health by email. "I was then also surprised when Dr. Andre Paixao, one of our cardiology fellows at the time (now at Emory), suggested that we look at the last CAC score as the best measure for risk attributable to CAC, and he turned out to be right!"

CAC correlates with overall atherosclerotic plaque and predicts incident coronary heart disease (CHD) events, CHD mortality, and total mortality, but only a few studies have evaluated the implications of CAC progression.

Dr. Levine and colleagues used CCLS data from 5,933 participants free of cardiovascular disease (CVD) at baseline to evaluate the relative contributions of baseline CAC score, follow-up CAC score, and CAC progression rates to the risk of incident CVD events.

At baseline, 2,870 (48%) individuals had CAC. These individuals were older, more likely to be on statin therapy, and had higher systolic blood pressure and lower cardiorespiratory fitness, according to the June 29th JACC Cardiovascular Imaging online report.

Individuals with detectable CAC at baseline had significantly higher total CVD event rates than those without detectable CAC (7.70 vs 1.44 per 1,000 person-years, respectively), as well as hard CVD event rates, i.e., CVD death, nonfatal myocardial infarction, or nonfatal atherosclerotic stroke (2.68 vs 1.14 per 1,000 person-years, respectively).

Rates of total CVD and CHD events increased across quartiles of CAC progression, but there was no independent association between CAC progression and CVD outcomes after adjustment for the follow-up CAC score.

"These findings greatly simplify the interpretation of CAC scores over time," Dr. Levine said. "Because it is so difficult to quantify 'change' (a score that goes from 1 to 2 is 100% change, but from 101 to 102 is 1% change), it has been hard for clinicians to wrap their minds around the additional risk information that is contained in follow up scores. Since it is not the calcium we are worried about anyway (calcified plaque generally doesn't rupture - it is the company it keeps that is important), what matters is the overall atherosclerotic burden, as reflected by the absolute CAC score. How fast it changes doesn't matter at all!"

"Don't worry about complicated formulas for quantifying change in CAC," Dr. Levine said. "Just use the latest score to calculate the risk associated with CAC. Now that new calculators are available (and some new ones coming from our work in this space), only the latest CAC score is needed to assess risk."

In an editorial, Dr. Prediman K. Shah from Cedars Sinai Hart Institute in Los Angeles writes, "So change in CAC score may be bad, indifferent, or possibly even good depending on what causes the change: progression of underlying atherosclerosis (potentially bad) versus increased density of calcification indicating a plaque stabilizing response (potentially good)."

Dr. Shah continues. "How to distinguish potential contributors to change in CAC score remains an important and at this time an unanswered question."

"Addition of other variables that incorporate regions of change, change in regional density and other volumetric aspect of CAC change, extracoronary calcification, and epicardial fat volume may improve the value and relevance of change in CAC score," Dr. Shah said. "Further studies are needed to address these issues."

Dr. Joseph Yeboah from Wake Forest Baptist Health, Winston-Salem, North Carolina, who has also researched the association between CAC scores and cardiovascular disease risk, told Reuters Health by email, "This happens to be the first study to show that CAC progression is not informative for CVD risk assessment. At the very best, this study makes the data mixed, which is not surprising given the challenge of using a change in a variable (CAC progression) as a predictor. Some researchers have suggested that CAC density progression instead of CAC score progression may be more appropriate."

"In my opinion, these results will have very little influence on how CAC is used presently for CVD risk assessment," he said. "To my knowledge, there is presently no guideline or recommendation regarding the use of CAC progression for CVD risk assessment. This is because of the inherent challenges in assessing CAC progression and the paucity of data."

"The ACC/AHA guidelines clearly recommend the use of CAC, not CAC progression," Dr. Yeboah concluded. "The take away message here is that physicians should not use CAC progression for CVD risk assessment. More research is needed to fully understand CAC progression."

SOURCE: http://bit.ly/29rOdFM and http://bit.ly/29olMIA

J Am Coll Cardiol Imag 2016.

The Maker Movement, the 21st century's upgrade of do-it-yourself that includes 3D printers and "the Internet of Things," is showing up in hospitals in interesting ways. Clinical teams confronted with a nagging issue on the wards can work together to design and prototype physical-product solutions. Two Beth Israel Deaconess hospitalists talk about the Maker Movement, and how they've turned it into a team-based, near real-time collaborative process for addressing quality improvement challenges.

The Maker Movement, the 21st century's upgrade of do-it-yourself that includes 3D printers and "the Internet of Things," is showing up in hospitals in interesting ways. Clinical teams confronted with a nagging issue on the wards can work together to design and prototype physical-product solutions. Two Beth Israel Deaconess hospitalists talk about the Maker Movement, and how they've turned it into a team-based, near real-time collaborative process for addressing quality improvement challenges.

The Maker Movement, the 21st century's upgrade of do-it-yourself that includes 3D printers and "the Internet of Things," is showing up in hospitals in interesting ways. Clinical teams confronted with a nagging issue on the wards can work together to design and prototype physical-product solutions. Two Beth Israel Deaconess hospitalists talk about the Maker Movement, and how they've turned it into a team-based, near real-time collaborative process for addressing quality improvement challenges.

Dive into the most current evidence-based topics in hospital medicine, and earn up to 36 AAPA Category 1 CME credits at the same time. You’ll also have great opportunities to network with practitioners from around the country. During the course, you will:

• Learn the most current evidence-based clinical practice for key topics in hospital medicine

• Augment your knowledge base to enhance your existing hospital medicine practice

• Expand your knowledge to transition into hospital medicine practice

• Network with other practitioners from across the country

Learn more at www.aapa.org/bootcamp.

Dive into the most current evidence-based topics in hospital medicine, and earn up to 36 AAPA Category 1 CME credits at the same time. You’ll also have great opportunities to network with practitioners from around the country. During the course, you will:

• Learn the most current evidence-based clinical practice for key topics in hospital medicine

• Augment your knowledge base to enhance your existing hospital medicine practice

• Expand your knowledge to transition into hospital medicine practice

• Network with other practitioners from across the country

Learn more at www.aapa.org/bootcamp.

Dive into the most current evidence-based topics in hospital medicine, and earn up to 36 AAPA Category 1 CME credits at the same time. You’ll also have great opportunities to network with practitioners from around the country. During the course, you will:

• Learn the most current evidence-based clinical practice for key topics in hospital medicine

• Augment your knowledge base to enhance your existing hospital medicine practice

• Expand your knowledge to transition into hospital medicine practice

• Network with other practitioners from across the country

Learn more at www.aapa.org/bootcamp.

• Mandalay Bay Beach: The 43-story “seaside” resort boasts the spectacular 11-acre Mandalay Bay Beach, complete with 2,700 tons of real sand. Three pools, an exciting wave pool, and a quarter-mile lazy river provide a refreshing escape from the desert heat.
• Dining: With more than 20 diverse restaurants featuring eight celebrity chefs, Mandalay Bay features cuisine of all types and a world of flavors.
• Entertainment: Dance the night away at the Eyecandy Sound Lounge, or take in the spectacular Cirque du Soleil show.

For reservations, call 877-632-9001 and ask for SHM’s room block. Or reserve your room online at www.hospitalmedicine2017.org/hotel.

• Mandalay Bay Beach: The 43-story “seaside” resort boasts the spectacular 11-acre Mandalay Bay Beach, complete with 2,700 tons of real sand. Three pools, an exciting wave pool, and a quarter-mile lazy river provide a refreshing escape from the desert heat.
• Dining: With more than 20 diverse restaurants featuring eight celebrity chefs, Mandalay Bay features cuisine of all types and a world of flavors.
• Entertainment: Dance the night away at the Eyecandy Sound Lounge, or take in the spectacular Cirque du Soleil show.

For reservations, call 877-632-9001 and ask for SHM’s room block. Or reserve your room online at www.hospitalmedicine2017.org/hotel.

• Mandalay Bay Beach: The 43-story “seaside” resort boasts the spectacular 11-acre Mandalay Bay Beach, complete with 2,700 tons of real sand. Three pools, an exciting wave pool, and a quarter-mile lazy river provide a refreshing escape from the desert heat.
• Dining: With more than 20 diverse restaurants featuring eight celebrity chefs, Mandalay Bay features cuisine of all types and a world of flavors.
• Entertainment: Dance the night away at the Eyecandy Sound Lounge, or take in the spectacular Cirque du Soleil show.

For reservations, call 877-632-9001 and ask for SHM’s room block. Or reserve your room online at www.hospitalmedicine2017.org/hotel.