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FDA approves peramivir, first IV flu antiviral
Peramivir, an intravenously administered neuraminidase inhibitor, has been approved for treating acute uncomplicated influenza in adults aged 18 years and older, who “have shown symptoms of flu for no more than two days,” the Food and Drug Administration announced on Dec. 22.*
It is administered as a single IV dose, and will be marketed as Rapivab, by BioCryst Pharmaceuticals.
“Rapivab is the third neuraminidase inhibitor approved by the FDA to treat flu infection, but the first approved as an IV formulation,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. The drug inhibits the viral neuraminidase, which releases virus particles from infected cells.
“The availability of a single-dose, intravenous option for the treatment of acute uncomplicated flu allows health care professionals and patients to have a choice based on an individual patient’s needs,” he added.
Approval was based on a study of 297 people with confirmed influenza, randomized to 300 mg or 600 mg of peramivir, or placebo.
“Overall, participants receiving Rapivab 600 mg had their combined influenza symptoms alleviated 21 hours sooner, on average, than those receiving placebo, which is consistent with other drugs in the same class,” and those on the 600 mg dose “also recovered to normal temperature approximately 12 hours sooner compared to placebo,” the statement said. These findings were confirmed in supportive studies, but “efficacy could not be established in patients with serious influenza requiring hospitalization,” the statement added.
Diarrhea was among the common adverse events associated with peramivir; rare, serious adverse events included serious skin or hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme, according to the FDA.
The two previously approved neuraminidase inhibitors are oseltamivir (Tamiflu), which is administered orally, and zanamivir (Relenza), which is inhaled.
*Correction, 12/23/2014: An earlier version of this story misstated the date Peramivir was approved.
Peramivir, an intravenously administered neuraminidase inhibitor, has been approved for treating acute uncomplicated influenza in adults aged 18 years and older, who “have shown symptoms of flu for no more than two days,” the Food and Drug Administration announced on Dec. 22.*
It is administered as a single IV dose, and will be marketed as Rapivab, by BioCryst Pharmaceuticals.
“Rapivab is the third neuraminidase inhibitor approved by the FDA to treat flu infection, but the first approved as an IV formulation,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. The drug inhibits the viral neuraminidase, which releases virus particles from infected cells.
“The availability of a single-dose, intravenous option for the treatment of acute uncomplicated flu allows health care professionals and patients to have a choice based on an individual patient’s needs,” he added.
Approval was based on a study of 297 people with confirmed influenza, randomized to 300 mg or 600 mg of peramivir, or placebo.
“Overall, participants receiving Rapivab 600 mg had their combined influenza symptoms alleviated 21 hours sooner, on average, than those receiving placebo, which is consistent with other drugs in the same class,” and those on the 600 mg dose “also recovered to normal temperature approximately 12 hours sooner compared to placebo,” the statement said. These findings were confirmed in supportive studies, but “efficacy could not be established in patients with serious influenza requiring hospitalization,” the statement added.
Diarrhea was among the common adverse events associated with peramivir; rare, serious adverse events included serious skin or hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme, according to the FDA.
The two previously approved neuraminidase inhibitors are oseltamivir (Tamiflu), which is administered orally, and zanamivir (Relenza), which is inhaled.
*Correction, 12/23/2014: An earlier version of this story misstated the date Peramivir was approved.
Peramivir, an intravenously administered neuraminidase inhibitor, has been approved for treating acute uncomplicated influenza in adults aged 18 years and older, who “have shown symptoms of flu for no more than two days,” the Food and Drug Administration announced on Dec. 22.*
It is administered as a single IV dose, and will be marketed as Rapivab, by BioCryst Pharmaceuticals.
“Rapivab is the third neuraminidase inhibitor approved by the FDA to treat flu infection, but the first approved as an IV formulation,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. The drug inhibits the viral neuraminidase, which releases virus particles from infected cells.
“The availability of a single-dose, intravenous option for the treatment of acute uncomplicated flu allows health care professionals and patients to have a choice based on an individual patient’s needs,” he added.
Approval was based on a study of 297 people with confirmed influenza, randomized to 300 mg or 600 mg of peramivir, or placebo.
“Overall, participants receiving Rapivab 600 mg had their combined influenza symptoms alleviated 21 hours sooner, on average, than those receiving placebo, which is consistent with other drugs in the same class,” and those on the 600 mg dose “also recovered to normal temperature approximately 12 hours sooner compared to placebo,” the statement said. These findings were confirmed in supportive studies, but “efficacy could not be established in patients with serious influenza requiring hospitalization,” the statement added.
Diarrhea was among the common adverse events associated with peramivir; rare, serious adverse events included serious skin or hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme, according to the FDA.
The two previously approved neuraminidase inhibitors are oseltamivir (Tamiflu), which is administered orally, and zanamivir (Relenza), which is inhaled.
*Correction, 12/23/2014: An earlier version of this story misstated the date Peramivir was approved.
Robotic thyroidectomy outcomes better in high-volume centers
CORONADO, CALIF. – Robotic thyroid surgery performed at the highest-volume center had a lower complication rate and shorter hospital stays than did the other hospitals in the study, results from a study of national data showed.
The Food and Drug Administration suspended its approval of robotic thyroidectomy in October 2011, citing risks and lack of adequate safety and outcomes research. The researchers observed a drop in the number of robotic thyroidectomies performed in the United States after the FDA issued its restriction in 2011. “That move appears to have made a pretty large impact on the projected growth of this procedure,” Dr. Hinson said at the annual meeting of the American Thyroid Association.
In Korea, where the procedure gained recognition in the early 2000s, “a lot of people cite cultural factors, such as aversion to neck scars, lean body habitus, and low body mass index make the procedure more feasible, so it’s a very popular approach there,” said Dr. Hinson, a research fellow at the University of Arkansas for Medical Sciences, Little Rock. In addition, until recently, there were financial incentives to do thyroid surgery with robotic assistance in the Korean health care system. “That said, in the United States, the cultural forces are distinct, our patients are larger and heavier on average, and most patients don’t have a strong aversion to a neck scar. The procedure is paid the same with or without the robot, but takes on average three times as long with the robot. Surgeons have such great results with open techniques that it’s very hard to make an argument that robotic surgery improves outcomes that much.”
In what is believed to be the largest study of its kind in the United States, Dr. Hinson and his associates evaluated data from the University HealthSystem Consortium (UHC) and an additional academic center which did not participate in the UHC discharge database. The study included 484 patients who underwent robotic thyroidectomy in the United States between 2009 and 2013. Data were compiled from discharge summaries at 110 university medical centers and another 140 of their affiliated hospitals. The researchers collected data on age, gender, race, insurance, comorbidities, complications, discharge status, length of stay, and ICU admission.
Dr. Hinson and his associates found that, compared with outpatients, inpatients had significantly greater numbers of comorbidities and complications. The most common comorbidity was hypertension (12 cases), followed by chronic pulmonary disease (8 cases) and diabetes with complications and comorbidities (6 cases). The median hospital length of stay was 1 day for inpatients, and 57% of outpatients stayed overnight. In addition, 8% of inpatients required an ICU stay, while 99% of outpatients and 97% of inpatients were discharged to home. The highest-volume institution in the data set performed most of the outpatient cases and had a lower rate of complications. “That makes sense,” Dr. Hinson said. “If you’re proficient, you’re more likely to have learned how to avoid complications.
“The approach to the neck has largely been unchanged over the last 100 years,” he said. While several other surgical fields have found highly successful and popular niches for endoscopic and/or robotic technology, the uses for these services has been largely limited in head and neck surgery. The da Vinci system was largely created with abdominal surgery in mind. As surgical techniques and robotic technology develop, systemic applications for this technology, previously unrecognized, may emerge. A lot of academic centers were/are hopeful that robotic thyroid surgery may provide the gateway for advancement of such techniques in the head and neck region.”
He reported having no financial disclosures.
On Twitter @dougbrunk
CORONADO, CALIF. – Robotic thyroid surgery performed at the highest-volume center had a lower complication rate and shorter hospital stays than did the other hospitals in the study, results from a study of national data showed.
The Food and Drug Administration suspended its approval of robotic thyroidectomy in October 2011, citing risks and lack of adequate safety and outcomes research. The researchers observed a drop in the number of robotic thyroidectomies performed in the United States after the FDA issued its restriction in 2011. “That move appears to have made a pretty large impact on the projected growth of this procedure,” Dr. Hinson said at the annual meeting of the American Thyroid Association.
In Korea, where the procedure gained recognition in the early 2000s, “a lot of people cite cultural factors, such as aversion to neck scars, lean body habitus, and low body mass index make the procedure more feasible, so it’s a very popular approach there,” said Dr. Hinson, a research fellow at the University of Arkansas for Medical Sciences, Little Rock. In addition, until recently, there were financial incentives to do thyroid surgery with robotic assistance in the Korean health care system. “That said, in the United States, the cultural forces are distinct, our patients are larger and heavier on average, and most patients don’t have a strong aversion to a neck scar. The procedure is paid the same with or without the robot, but takes on average three times as long with the robot. Surgeons have such great results with open techniques that it’s very hard to make an argument that robotic surgery improves outcomes that much.”
In what is believed to be the largest study of its kind in the United States, Dr. Hinson and his associates evaluated data from the University HealthSystem Consortium (UHC) and an additional academic center which did not participate in the UHC discharge database. The study included 484 patients who underwent robotic thyroidectomy in the United States between 2009 and 2013. Data were compiled from discharge summaries at 110 university medical centers and another 140 of their affiliated hospitals. The researchers collected data on age, gender, race, insurance, comorbidities, complications, discharge status, length of stay, and ICU admission.
Dr. Hinson and his associates found that, compared with outpatients, inpatients had significantly greater numbers of comorbidities and complications. The most common comorbidity was hypertension (12 cases), followed by chronic pulmonary disease (8 cases) and diabetes with complications and comorbidities (6 cases). The median hospital length of stay was 1 day for inpatients, and 57% of outpatients stayed overnight. In addition, 8% of inpatients required an ICU stay, while 99% of outpatients and 97% of inpatients were discharged to home. The highest-volume institution in the data set performed most of the outpatient cases and had a lower rate of complications. “That makes sense,” Dr. Hinson said. “If you’re proficient, you’re more likely to have learned how to avoid complications.
“The approach to the neck has largely been unchanged over the last 100 years,” he said. While several other surgical fields have found highly successful and popular niches for endoscopic and/or robotic technology, the uses for these services has been largely limited in head and neck surgery. The da Vinci system was largely created with abdominal surgery in mind. As surgical techniques and robotic technology develop, systemic applications for this technology, previously unrecognized, may emerge. A lot of academic centers were/are hopeful that robotic thyroid surgery may provide the gateway for advancement of such techniques in the head and neck region.”
He reported having no financial disclosures.
On Twitter @dougbrunk
CORONADO, CALIF. – Robotic thyroid surgery performed at the highest-volume center had a lower complication rate and shorter hospital stays than did the other hospitals in the study, results from a study of national data showed.
The Food and Drug Administration suspended its approval of robotic thyroidectomy in October 2011, citing risks and lack of adequate safety and outcomes research. The researchers observed a drop in the number of robotic thyroidectomies performed in the United States after the FDA issued its restriction in 2011. “That move appears to have made a pretty large impact on the projected growth of this procedure,” Dr. Hinson said at the annual meeting of the American Thyroid Association.
In Korea, where the procedure gained recognition in the early 2000s, “a lot of people cite cultural factors, such as aversion to neck scars, lean body habitus, and low body mass index make the procedure more feasible, so it’s a very popular approach there,” said Dr. Hinson, a research fellow at the University of Arkansas for Medical Sciences, Little Rock. In addition, until recently, there were financial incentives to do thyroid surgery with robotic assistance in the Korean health care system. “That said, in the United States, the cultural forces are distinct, our patients are larger and heavier on average, and most patients don’t have a strong aversion to a neck scar. The procedure is paid the same with or without the robot, but takes on average three times as long with the robot. Surgeons have such great results with open techniques that it’s very hard to make an argument that robotic surgery improves outcomes that much.”
In what is believed to be the largest study of its kind in the United States, Dr. Hinson and his associates evaluated data from the University HealthSystem Consortium (UHC) and an additional academic center which did not participate in the UHC discharge database. The study included 484 patients who underwent robotic thyroidectomy in the United States between 2009 and 2013. Data were compiled from discharge summaries at 110 university medical centers and another 140 of their affiliated hospitals. The researchers collected data on age, gender, race, insurance, comorbidities, complications, discharge status, length of stay, and ICU admission.
Dr. Hinson and his associates found that, compared with outpatients, inpatients had significantly greater numbers of comorbidities and complications. The most common comorbidity was hypertension (12 cases), followed by chronic pulmonary disease (8 cases) and diabetes with complications and comorbidities (6 cases). The median hospital length of stay was 1 day for inpatients, and 57% of outpatients stayed overnight. In addition, 8% of inpatients required an ICU stay, while 99% of outpatients and 97% of inpatients were discharged to home. The highest-volume institution in the data set performed most of the outpatient cases and had a lower rate of complications. “That makes sense,” Dr. Hinson said. “If you’re proficient, you’re more likely to have learned how to avoid complications.
“The approach to the neck has largely been unchanged over the last 100 years,” he said. While several other surgical fields have found highly successful and popular niches for endoscopic and/or robotic technology, the uses for these services has been largely limited in head and neck surgery. The da Vinci system was largely created with abdominal surgery in mind. As surgical techniques and robotic technology develop, systemic applications for this technology, previously unrecognized, may emerge. A lot of academic centers were/are hopeful that robotic thyroid surgery may provide the gateway for advancement of such techniques in the head and neck region.”
He reported having no financial disclosures.
On Twitter @dougbrunk
AT THE ATA ANNUAL MEETING
Key clinical point: Robotic thyroid surgery performed by higher-volume surgeons is associated with lower complications and shorter hospital stays.
Major finding: Compared with outpatients, inpatients had a significantly greater number of comorbidities (P < .001) and complications (P =.005). In addition, the highest-volume institution in the data set performed most of the outpatient cases and had a lower rate of complications.
Data source: A study of 484 patients from the University HealthSystem Consortium who underwent robotic thyroidectomy in the United States between 2009 and 2013.
Disclosures:Dr. Hinson reported having no financial disclosures.
Survey: Med students disdain private practice
Almost three-quarters of medical students are aiming for future employment in a large health system or hospital, while just 10% want to work in a solo or partnership practice, according to a survey from Epocrates.
Last year, the numbers were 70% and 17%, respectively.
One cause: Students are not being trained in the business of medicine, said Dr. Anne Meneghetti, executive director of medical information at Epocrates.
“More than half of them are dissatisfied with the training they received in med school on practice management and ownership,” Dr. Meneghetti said in an interview. “The majority feel unprepared to do the billing and coding and other administrative practice functions in this highly regulated environment.”
That finding also plays into another concern future physicians have – work-life balance. A total of 60% of the survey respondents cited that as top concern, moving ahead of being a good physician, which was identified by 50%. In 2013, being a good physician was identified at the top concern by 55% of those surveyed, with work-life balance coming in at 51%.
“Given the choice between a reasonable lifestyle in a large organization versus the hassles of business ownership in this highly regulated field, the choice is really easy for most of them,” Dr. Meneghetti said. “There’s a lot more security and predictability in these larger enterprise settings.”
Nearly all students surveyed “feel it is important to work with extended care teams (which can include registered nurses, physician assistants, specialists, and medical staff)” in order to deliver high quality care and ensure financial success as a physician, according to the report. Two-thirds (66%) said they “feel they are being prepared to tackle the task of care coordination, while 20% feel their training is merely adequate.”
“Younger physicians seem to instinctively know what the entire medical community is realizing – that medicine is a team experience,” Dr. Meneghetti said.
Despite that, the survey found that 65% of medical students feel they don’t know enough about accountable care organizations, down from 72% in the previous year, with 39% unsure about the purpose or structure of ACOs.
The Ninth Future Physicians of America survey report represents the responses of 1,462 medical students surveyed between late August and early September.
Almost three-quarters of medical students are aiming for future employment in a large health system or hospital, while just 10% want to work in a solo or partnership practice, according to a survey from Epocrates.
Last year, the numbers were 70% and 17%, respectively.
One cause: Students are not being trained in the business of medicine, said Dr. Anne Meneghetti, executive director of medical information at Epocrates.
“More than half of them are dissatisfied with the training they received in med school on practice management and ownership,” Dr. Meneghetti said in an interview. “The majority feel unprepared to do the billing and coding and other administrative practice functions in this highly regulated environment.”
That finding also plays into another concern future physicians have – work-life balance. A total of 60% of the survey respondents cited that as top concern, moving ahead of being a good physician, which was identified by 50%. In 2013, being a good physician was identified at the top concern by 55% of those surveyed, with work-life balance coming in at 51%.
“Given the choice between a reasonable lifestyle in a large organization versus the hassles of business ownership in this highly regulated field, the choice is really easy for most of them,” Dr. Meneghetti said. “There’s a lot more security and predictability in these larger enterprise settings.”
Nearly all students surveyed “feel it is important to work with extended care teams (which can include registered nurses, physician assistants, specialists, and medical staff)” in order to deliver high quality care and ensure financial success as a physician, according to the report. Two-thirds (66%) said they “feel they are being prepared to tackle the task of care coordination, while 20% feel their training is merely adequate.”
“Younger physicians seem to instinctively know what the entire medical community is realizing – that medicine is a team experience,” Dr. Meneghetti said.
Despite that, the survey found that 65% of medical students feel they don’t know enough about accountable care organizations, down from 72% in the previous year, with 39% unsure about the purpose or structure of ACOs.
The Ninth Future Physicians of America survey report represents the responses of 1,462 medical students surveyed between late August and early September.
Almost three-quarters of medical students are aiming for future employment in a large health system or hospital, while just 10% want to work in a solo or partnership practice, according to a survey from Epocrates.
Last year, the numbers were 70% and 17%, respectively.
One cause: Students are not being trained in the business of medicine, said Dr. Anne Meneghetti, executive director of medical information at Epocrates.
“More than half of them are dissatisfied with the training they received in med school on practice management and ownership,” Dr. Meneghetti said in an interview. “The majority feel unprepared to do the billing and coding and other administrative practice functions in this highly regulated environment.”
That finding also plays into another concern future physicians have – work-life balance. A total of 60% of the survey respondents cited that as top concern, moving ahead of being a good physician, which was identified by 50%. In 2013, being a good physician was identified at the top concern by 55% of those surveyed, with work-life balance coming in at 51%.
“Given the choice between a reasonable lifestyle in a large organization versus the hassles of business ownership in this highly regulated field, the choice is really easy for most of them,” Dr. Meneghetti said. “There’s a lot more security and predictability in these larger enterprise settings.”
Nearly all students surveyed “feel it is important to work with extended care teams (which can include registered nurses, physician assistants, specialists, and medical staff)” in order to deliver high quality care and ensure financial success as a physician, according to the report. Two-thirds (66%) said they “feel they are being prepared to tackle the task of care coordination, while 20% feel their training is merely adequate.”
“Younger physicians seem to instinctively know what the entire medical community is realizing – that medicine is a team experience,” Dr. Meneghetti said.
Despite that, the survey found that 65% of medical students feel they don’t know enough about accountable care organizations, down from 72% in the previous year, with 39% unsure about the purpose or structure of ACOs.
The Ninth Future Physicians of America survey report represents the responses of 1,462 medical students surveyed between late August and early September.
Happy holidays from Medicare: 250,000 docs to get meaningful use penalty
About 257,000 doctors and other medical professionals, or about 50% of those eligible to participate in the electronic health record incentive program, are about to get a holiday “gift” from Medicare: a 1% reduction in Medicare pay.
The reduction will come from 2015 Medicare payments to doctors who failed to meet meaningful use requirements during a 2013 reporting period or did not receive a hardship exemption, according to the Centers for Medicare & Medicaid Services
The penalties apply to those who have not met Stage 1 of the meaningful use criteria, and given how few have attested to meeting Stage 2 so far, the number of doctors and providers being penalized could go significantly higher.
“It speaks to how hard it is” to meet the meaningful use criteria, commented Dr. Neil Skolnik, a family physician in Jenkintown, Penn. “What it’s creating is a lot of disgruntlement among physicians who aren’t meeting [meaningful use]. ... People really resent that. They are burdened by working hard to make the [EHR] work in their office and then getting a penalty. Even though they have the [EHR], they’re not meeting all the criteria. It’s a big deal. It’s really hard on people.”
Physicians continue to press CMS to reduce the 2015 attestation period for meeting meaningful use Stage 2 to 90 days, down from the current full-year requirement.
In a Dec. 15 letter to federal officials, the American College of Cardiology said it remains “unconvinced that significant numbers of [eligible professionals] and [eligible hospitals] will be able to meet the current requirements of reporting for a full year in 2015 and urge CMS and [the Office of the National Coordinator for Heath Information Technology] to adjust the 2015 reporting period to the 90 days originally afforded to [eligible professionals] and [eligible hospitals] for 2014.”
The cardiologists added that by pushing for a full-year attestation period, “CMS and ONC are setting EPs and EHs up for failure. ... It is simply too much to expect them to ... meet a full year reporting requirement, especially when coupled with implementation of the penalty phase of the federal EHR Incentive program, the value-based payment program, the Physician Quality Reporting System penalties, and ICD-10 implementation.”
About 257,000 doctors and other medical professionals, or about 50% of those eligible to participate in the electronic health record incentive program, are about to get a holiday “gift” from Medicare: a 1% reduction in Medicare pay.
The reduction will come from 2015 Medicare payments to doctors who failed to meet meaningful use requirements during a 2013 reporting period or did not receive a hardship exemption, according to the Centers for Medicare & Medicaid Services
The penalties apply to those who have not met Stage 1 of the meaningful use criteria, and given how few have attested to meeting Stage 2 so far, the number of doctors and providers being penalized could go significantly higher.
“It speaks to how hard it is” to meet the meaningful use criteria, commented Dr. Neil Skolnik, a family physician in Jenkintown, Penn. “What it’s creating is a lot of disgruntlement among physicians who aren’t meeting [meaningful use]. ... People really resent that. They are burdened by working hard to make the [EHR] work in their office and then getting a penalty. Even though they have the [EHR], they’re not meeting all the criteria. It’s a big deal. It’s really hard on people.”
Physicians continue to press CMS to reduce the 2015 attestation period for meeting meaningful use Stage 2 to 90 days, down from the current full-year requirement.
In a Dec. 15 letter to federal officials, the American College of Cardiology said it remains “unconvinced that significant numbers of [eligible professionals] and [eligible hospitals] will be able to meet the current requirements of reporting for a full year in 2015 and urge CMS and [the Office of the National Coordinator for Heath Information Technology] to adjust the 2015 reporting period to the 90 days originally afforded to [eligible professionals] and [eligible hospitals] for 2014.”
The cardiologists added that by pushing for a full-year attestation period, “CMS and ONC are setting EPs and EHs up for failure. ... It is simply too much to expect them to ... meet a full year reporting requirement, especially when coupled with implementation of the penalty phase of the federal EHR Incentive program, the value-based payment program, the Physician Quality Reporting System penalties, and ICD-10 implementation.”
About 257,000 doctors and other medical professionals, or about 50% of those eligible to participate in the electronic health record incentive program, are about to get a holiday “gift” from Medicare: a 1% reduction in Medicare pay.
The reduction will come from 2015 Medicare payments to doctors who failed to meet meaningful use requirements during a 2013 reporting period or did not receive a hardship exemption, according to the Centers for Medicare & Medicaid Services
The penalties apply to those who have not met Stage 1 of the meaningful use criteria, and given how few have attested to meeting Stage 2 so far, the number of doctors and providers being penalized could go significantly higher.
“It speaks to how hard it is” to meet the meaningful use criteria, commented Dr. Neil Skolnik, a family physician in Jenkintown, Penn. “What it’s creating is a lot of disgruntlement among physicians who aren’t meeting [meaningful use]. ... People really resent that. They are burdened by working hard to make the [EHR] work in their office and then getting a penalty. Even though they have the [EHR], they’re not meeting all the criteria. It’s a big deal. It’s really hard on people.”
Physicians continue to press CMS to reduce the 2015 attestation period for meeting meaningful use Stage 2 to 90 days, down from the current full-year requirement.
In a Dec. 15 letter to federal officials, the American College of Cardiology said it remains “unconvinced that significant numbers of [eligible professionals] and [eligible hospitals] will be able to meet the current requirements of reporting for a full year in 2015 and urge CMS and [the Office of the National Coordinator for Heath Information Technology] to adjust the 2015 reporting period to the 90 days originally afforded to [eligible professionals] and [eligible hospitals] for 2014.”
The cardiologists added that by pushing for a full-year attestation period, “CMS and ONC are setting EPs and EHs up for failure. ... It is simply too much to expect them to ... meet a full year reporting requirement, especially when coupled with implementation of the penalty phase of the federal EHR Incentive program, the value-based payment program, the Physician Quality Reporting System penalties, and ICD-10 implementation.”
Genetic test predicts 10-year risk of DCIS recurrence
SAN ANTONIO – A genetic assay specific for ductal cancer in situ accurately predicted 10-year recurrence risk in women who underwent breast-conserving surgery as treatment for the disease.
Women whom the test identified as having a high recurrence risk were 68% more likely to have an ipsilateral recurrence of either ductal cancer in situ (DCIS) or invasive breast cancer, Dr. Eileen Rakovitch said at the San Antonio Breast Cancer Symposium. These results suggest that the Oncotype DX DCIS Score could be used as a risk stratification biomarker, said Dr. Rakovitch, a radiation oncologist at Sunnybrook Health Sciences Centre, Toronto.
“We hope this will enable both clinicians and patients to understand their individual risk of progression, and to weigh the risks and benefits of available treatment. This might reduce the problems of overtreating women at low risk and undertreating women at high risk of recurrence.”
The Oncotype DX DCIS is a multigene expression assay that identifies 12 of the 21 genes included in the Oncotype DX Recurrence Score; seven of these are cancer specific and five are reference genes. It stratifies women into three 10-year risk groups according to increasing score (1-100): low-risk (less than 39), intermediate risk (39-54), and high-risk (55 and higher).
It was previously validated in a retrospective analysis of 327 selected cases, all of which were estrogen receptor–positive. In that study, all women had DCIS treatment by breast-conserving surgery alone. Tumors had to be 2.5 cm or less with nuclear grades 1 or 2; or at least 1 cm with a nuclear grade 3. Negative surgical margins of at least 3 cm were also required. In that population, after adjustment for tamoxifen use, the intermediate- and high-risk groups faced more than a doubling of the 10-year ipsilateral local recurrence risk (HR 2.31) compared to the low-risk group.
The study Dr. Rakovitch reported investigated the score’s validity in a cohort with mixed hormone receptor status, and in the subgroup of women with only ER-positive tumors.
The cohort was drawn from several Canadian health care databases that linked diagnosis, treatment, and outcome. Cases were verified by chart reviews of each stage of care. The women were treated from 1994 to 2003 and followed for a mean of 10 years. The final diagnosis was DCIS, and they were treated only with breast-conserving surgery.
Most (81%) were at least 50 years old. About half had an intermediate nuclear grade; it was low in 10% and high in the remainder. Necrosis was present in 61% of the tumors; 63% were solid and 20%, multifocal. Tumor size data were missing in about half; of those with data, 25% were 10 mm or smaller and the remainder larger than 10 mm.
Over the follow-up period, there were 100 recurrences (44 DCIS and 56 invasive cancers). The overall 10-year recurrence risk was 10%. The groups diverged significantly in risk. It was 28% in the high-risk and 33% in the intermediate-risk groups – not significantly different. But both those were significantly higher than the 13% risk in the low-risk group. These results were remarkably similar to those of the earlier validity study in women with ER-positive tumors.
Risk was further stratified by whether the recurrence was local or invasive and the results were similarly significantly different. For invasive local recurrence, the risks were 15.5%, 21%, and 8% for the high-, intermediate-, and low-risk groups. For local recurrence, the risks were 13.7%, 14% and 5.4%, respectively.
A multivariate analysis controlled for age at diagnosis, tumor subtype, and multifocality – none of these were significantly related to the risk of recurrence.
Funding for the study was provided by grants from the Canadian Cancer Society Research Institute and a research grant from Genomic Health, which makes the test. Dr. Rakovitch had no conflicts of interest.
On Twitter @alz_gal
SAN ANTONIO – A genetic assay specific for ductal cancer in situ accurately predicted 10-year recurrence risk in women who underwent breast-conserving surgery as treatment for the disease.
Women whom the test identified as having a high recurrence risk were 68% more likely to have an ipsilateral recurrence of either ductal cancer in situ (DCIS) or invasive breast cancer, Dr. Eileen Rakovitch said at the San Antonio Breast Cancer Symposium. These results suggest that the Oncotype DX DCIS Score could be used as a risk stratification biomarker, said Dr. Rakovitch, a radiation oncologist at Sunnybrook Health Sciences Centre, Toronto.
“We hope this will enable both clinicians and patients to understand their individual risk of progression, and to weigh the risks and benefits of available treatment. This might reduce the problems of overtreating women at low risk and undertreating women at high risk of recurrence.”
The Oncotype DX DCIS is a multigene expression assay that identifies 12 of the 21 genes included in the Oncotype DX Recurrence Score; seven of these are cancer specific and five are reference genes. It stratifies women into three 10-year risk groups according to increasing score (1-100): low-risk (less than 39), intermediate risk (39-54), and high-risk (55 and higher).
It was previously validated in a retrospective analysis of 327 selected cases, all of which were estrogen receptor–positive. In that study, all women had DCIS treatment by breast-conserving surgery alone. Tumors had to be 2.5 cm or less with nuclear grades 1 or 2; or at least 1 cm with a nuclear grade 3. Negative surgical margins of at least 3 cm were also required. In that population, after adjustment for tamoxifen use, the intermediate- and high-risk groups faced more than a doubling of the 10-year ipsilateral local recurrence risk (HR 2.31) compared to the low-risk group.
The study Dr. Rakovitch reported investigated the score’s validity in a cohort with mixed hormone receptor status, and in the subgroup of women with only ER-positive tumors.
The cohort was drawn from several Canadian health care databases that linked diagnosis, treatment, and outcome. Cases were verified by chart reviews of each stage of care. The women were treated from 1994 to 2003 and followed for a mean of 10 years. The final diagnosis was DCIS, and they were treated only with breast-conserving surgery.
Most (81%) were at least 50 years old. About half had an intermediate nuclear grade; it was low in 10% and high in the remainder. Necrosis was present in 61% of the tumors; 63% were solid and 20%, multifocal. Tumor size data were missing in about half; of those with data, 25% were 10 mm or smaller and the remainder larger than 10 mm.
Over the follow-up period, there were 100 recurrences (44 DCIS and 56 invasive cancers). The overall 10-year recurrence risk was 10%. The groups diverged significantly in risk. It was 28% in the high-risk and 33% in the intermediate-risk groups – not significantly different. But both those were significantly higher than the 13% risk in the low-risk group. These results were remarkably similar to those of the earlier validity study in women with ER-positive tumors.
Risk was further stratified by whether the recurrence was local or invasive and the results were similarly significantly different. For invasive local recurrence, the risks were 15.5%, 21%, and 8% for the high-, intermediate-, and low-risk groups. For local recurrence, the risks were 13.7%, 14% and 5.4%, respectively.
A multivariate analysis controlled for age at diagnosis, tumor subtype, and multifocality – none of these were significantly related to the risk of recurrence.
Funding for the study was provided by grants from the Canadian Cancer Society Research Institute and a research grant from Genomic Health, which makes the test. Dr. Rakovitch had no conflicts of interest.
On Twitter @alz_gal
SAN ANTONIO – A genetic assay specific for ductal cancer in situ accurately predicted 10-year recurrence risk in women who underwent breast-conserving surgery as treatment for the disease.
Women whom the test identified as having a high recurrence risk were 68% more likely to have an ipsilateral recurrence of either ductal cancer in situ (DCIS) or invasive breast cancer, Dr. Eileen Rakovitch said at the San Antonio Breast Cancer Symposium. These results suggest that the Oncotype DX DCIS Score could be used as a risk stratification biomarker, said Dr. Rakovitch, a radiation oncologist at Sunnybrook Health Sciences Centre, Toronto.
“We hope this will enable both clinicians and patients to understand their individual risk of progression, and to weigh the risks and benefits of available treatment. This might reduce the problems of overtreating women at low risk and undertreating women at high risk of recurrence.”
The Oncotype DX DCIS is a multigene expression assay that identifies 12 of the 21 genes included in the Oncotype DX Recurrence Score; seven of these are cancer specific and five are reference genes. It stratifies women into three 10-year risk groups according to increasing score (1-100): low-risk (less than 39), intermediate risk (39-54), and high-risk (55 and higher).
It was previously validated in a retrospective analysis of 327 selected cases, all of which were estrogen receptor–positive. In that study, all women had DCIS treatment by breast-conserving surgery alone. Tumors had to be 2.5 cm or less with nuclear grades 1 or 2; or at least 1 cm with a nuclear grade 3. Negative surgical margins of at least 3 cm were also required. In that population, after adjustment for tamoxifen use, the intermediate- and high-risk groups faced more than a doubling of the 10-year ipsilateral local recurrence risk (HR 2.31) compared to the low-risk group.
The study Dr. Rakovitch reported investigated the score’s validity in a cohort with mixed hormone receptor status, and in the subgroup of women with only ER-positive tumors.
The cohort was drawn from several Canadian health care databases that linked diagnosis, treatment, and outcome. Cases were verified by chart reviews of each stage of care. The women were treated from 1994 to 2003 and followed for a mean of 10 years. The final diagnosis was DCIS, and they were treated only with breast-conserving surgery.
Most (81%) were at least 50 years old. About half had an intermediate nuclear grade; it was low in 10% and high in the remainder. Necrosis was present in 61% of the tumors; 63% were solid and 20%, multifocal. Tumor size data were missing in about half; of those with data, 25% were 10 mm or smaller and the remainder larger than 10 mm.
Over the follow-up period, there were 100 recurrences (44 DCIS and 56 invasive cancers). The overall 10-year recurrence risk was 10%. The groups diverged significantly in risk. It was 28% in the high-risk and 33% in the intermediate-risk groups – not significantly different. But both those were significantly higher than the 13% risk in the low-risk group. These results were remarkably similar to those of the earlier validity study in women with ER-positive tumors.
Risk was further stratified by whether the recurrence was local or invasive and the results were similarly significantly different. For invasive local recurrence, the risks were 15.5%, 21%, and 8% for the high-, intermediate-, and low-risk groups. For local recurrence, the risks were 13.7%, 14% and 5.4%, respectively.
A multivariate analysis controlled for age at diagnosis, tumor subtype, and multifocality – none of these were significantly related to the risk of recurrence.
Funding for the study was provided by grants from the Canadian Cancer Society Research Institute and a research grant from Genomic Health, which makes the test. Dr. Rakovitch had no conflicts of interest.
On Twitter @alz_gal
AT SABCS 2014
Key clinical point: A genetic assay can accurately predict the 10-year risk of local recurrence in women with ductal carcinoma in situ.
Major finding: Women with the highest risk as graded by Oncotype DCIS Score were 68% more likely to develop recurrence than were those in the lowest risk group.
Data source: The retrospective validation study comprised 257 women with DCIS who were treated with breast-conserving surgery alone.
Disclosures:Funding was provided by the Canadian Cancer Society Research Institute and a research grant from Genomic Health, which makes the test. Dr. Rakovitch had no conflicts of interest.
Survey: Hospitals that listen to their patients make fewer errors
Hospital patients who are treated with respect by staff are less likely to experience a preventable medical error, according to a study conducted by Consumer Reports.
About a quarter of the 1,200 patients who responded to the Consumer Reports survey felt hospital staff did not treat them as adults who were involved in their own care. A third of patients felt their wishes for treatments were not respected, with a similar number reporting that hospital staff would interrupt them. Around 20% said they were not treated fairly and experienced discrimination.
Overall, patients who were unhappy with how they were treated at the hospital were two and a half times more likely to experience some sort of preventable error, such as a drug error, rehospitalization, or a hospital-acquired disease than those who were happy with their treatment. Around 440,000 deaths are attributed to medical errors every year.
“We encourage patients to speak up when they feel that their wishes are not being heard. This survey validates that doing so might actually save your life,” Lisa McGiffert, manager of Consumer Reports’ Safe Patient Project, said in a written statement.
The full report, “How Not to Get Sick(er) in the Hospital,” which includes ratings of almost 2,600 U.S. hospitals, is featured in the February 2015 issue of Consumer Reports, and at ConsumerReports.org.
Hospital patients who are treated with respect by staff are less likely to experience a preventable medical error, according to a study conducted by Consumer Reports.
About a quarter of the 1,200 patients who responded to the Consumer Reports survey felt hospital staff did not treat them as adults who were involved in their own care. A third of patients felt their wishes for treatments were not respected, with a similar number reporting that hospital staff would interrupt them. Around 20% said they were not treated fairly and experienced discrimination.
Overall, patients who were unhappy with how they were treated at the hospital were two and a half times more likely to experience some sort of preventable error, such as a drug error, rehospitalization, or a hospital-acquired disease than those who were happy with their treatment. Around 440,000 deaths are attributed to medical errors every year.
“We encourage patients to speak up when they feel that their wishes are not being heard. This survey validates that doing so might actually save your life,” Lisa McGiffert, manager of Consumer Reports’ Safe Patient Project, said in a written statement.
The full report, “How Not to Get Sick(er) in the Hospital,” which includes ratings of almost 2,600 U.S. hospitals, is featured in the February 2015 issue of Consumer Reports, and at ConsumerReports.org.
Hospital patients who are treated with respect by staff are less likely to experience a preventable medical error, according to a study conducted by Consumer Reports.
About a quarter of the 1,200 patients who responded to the Consumer Reports survey felt hospital staff did not treat them as adults who were involved in their own care. A third of patients felt their wishes for treatments were not respected, with a similar number reporting that hospital staff would interrupt them. Around 20% said they were not treated fairly and experienced discrimination.
Overall, patients who were unhappy with how they were treated at the hospital were two and a half times more likely to experience some sort of preventable error, such as a drug error, rehospitalization, or a hospital-acquired disease than those who were happy with their treatment. Around 440,000 deaths are attributed to medical errors every year.
“We encourage patients to speak up when they feel that their wishes are not being heard. This survey validates that doing so might actually save your life,” Lisa McGiffert, manager of Consumer Reports’ Safe Patient Project, said in a written statement.
The full report, “How Not to Get Sick(er) in the Hospital,” which includes ratings of almost 2,600 U.S. hospitals, is featured in the February 2015 issue of Consumer Reports, and at ConsumerReports.org.
Senate confirms Murthy as Surgeon General
Boston hospitalist Dr. Vivek Murthy was confirmed Dec. 15 as the 19th U.S. Surgeon General, by a 51-43 vote of the U.S. Senate.
“Being ‘America’s doctor’ requires many of the same traits required of hospitalists: leadership, sharp clinical skills, and the ability to engage with patients,” Dr. Burke Kealey, president of the Society of Hospital Medicine, said in a statement. “Like hospitalists in thousands of hospitals across the country, I am confident Dr. Murthy will become an agent of change to improve delivery of care in our country.”
“As a practicing physician, Dr. Murthy brings extensive clinical expertise caring for patients and training hundreds of medical residents,” Dr. Robert L. Wergin, president of the American Academy of Family Physicians, said in a statement. “Dr. Murthy demonstrates a clear and thoughtful understanding of how important it is to transform our health care system from one focused on sick care to one based on wellness, good health practices, and early intervention.”
Dr. Murthy was nominated by President Obama in November 2013 and got fairly light treatment at a Senate confirmation hearing in February 2014. But Republican senators refused to entertain a confirmation vote for a variety of reasons, with Dr. Murthy’s advocacy on gun violence being cited most often. They also objected to his activist role in the passage of the Affordable Care Act while president of Doctors for America and his campaigning for Mr. Obama in the 2008 presidential election.
“The majority of his career has not been spent as a doctor treating patients, but as an activist,” said Sen. John Barrasso (R-Wyo.) in a speech before the confirmation vote.
But Sen. Dick Durbin (D-Ill.) called Dr. Murthy an outstanding physician and a public health expert, and noted that he had received the backing of some 100 health-related organizations earlier this year, including the American College of Physicians, the AAFP, the American Academy of Pediatrics, the American Cancer Society, the American Hospital Association, the American Diabetes Association, and many others.
Sen. Mark Kirk (Ill.) was the only Republican to vote to confirm Dr. Murthy, while three Democrats voted against him: Sen. Joe Donnelly (Ind.), Sen. Heidi Heitkamp (N.D.), and Sen. Joe Manchin (W.Va.). There were 6 abstentions.
The ACP reiterated its support for Dr. Murthy, citing a Feburary letter to two Senate committee chairmen in which college leaders called Dr. Murthy “a strong advocate for the provision of health insurance coverage to all Americans and ... a proven leader who can build coalitions among diverse individuals to ensure better health for our communities.”
The ACP statement also highlighted Dr. Murthy’s extensive public health experience, including serving on the U.S. Presidential Advisory Council on Prevention, Health Promotion, and Integrative and Public Health; cofounding VISIONS Worldwide in 1995, a nonprofit organization focused on HIV/AIDS education in India and the U.S.; and cofounding TrialNetworks, aimed at optimizing the quality and efficiency of clinical trials.
The nation has been without a confirmed surgeon general since Dr. Regina M. Benjamin retired in 2013.
On Twitter @aliciaault
Boston hospitalist Dr. Vivek Murthy was confirmed Dec. 15 as the 19th U.S. Surgeon General, by a 51-43 vote of the U.S. Senate.
“Being ‘America’s doctor’ requires many of the same traits required of hospitalists: leadership, sharp clinical skills, and the ability to engage with patients,” Dr. Burke Kealey, president of the Society of Hospital Medicine, said in a statement. “Like hospitalists in thousands of hospitals across the country, I am confident Dr. Murthy will become an agent of change to improve delivery of care in our country.”
“As a practicing physician, Dr. Murthy brings extensive clinical expertise caring for patients and training hundreds of medical residents,” Dr. Robert L. Wergin, president of the American Academy of Family Physicians, said in a statement. “Dr. Murthy demonstrates a clear and thoughtful understanding of how important it is to transform our health care system from one focused on sick care to one based on wellness, good health practices, and early intervention.”
Dr. Murthy was nominated by President Obama in November 2013 and got fairly light treatment at a Senate confirmation hearing in February 2014. But Republican senators refused to entertain a confirmation vote for a variety of reasons, with Dr. Murthy’s advocacy on gun violence being cited most often. They also objected to his activist role in the passage of the Affordable Care Act while president of Doctors for America and his campaigning for Mr. Obama in the 2008 presidential election.
“The majority of his career has not been spent as a doctor treating patients, but as an activist,” said Sen. John Barrasso (R-Wyo.) in a speech before the confirmation vote.
But Sen. Dick Durbin (D-Ill.) called Dr. Murthy an outstanding physician and a public health expert, and noted that he had received the backing of some 100 health-related organizations earlier this year, including the American College of Physicians, the AAFP, the American Academy of Pediatrics, the American Cancer Society, the American Hospital Association, the American Diabetes Association, and many others.
Sen. Mark Kirk (Ill.) was the only Republican to vote to confirm Dr. Murthy, while three Democrats voted against him: Sen. Joe Donnelly (Ind.), Sen. Heidi Heitkamp (N.D.), and Sen. Joe Manchin (W.Va.). There were 6 abstentions.
The ACP reiterated its support for Dr. Murthy, citing a Feburary letter to two Senate committee chairmen in which college leaders called Dr. Murthy “a strong advocate for the provision of health insurance coverage to all Americans and ... a proven leader who can build coalitions among diverse individuals to ensure better health for our communities.”
The ACP statement also highlighted Dr. Murthy’s extensive public health experience, including serving on the U.S. Presidential Advisory Council on Prevention, Health Promotion, and Integrative and Public Health; cofounding VISIONS Worldwide in 1995, a nonprofit organization focused on HIV/AIDS education in India and the U.S.; and cofounding TrialNetworks, aimed at optimizing the quality and efficiency of clinical trials.
The nation has been without a confirmed surgeon general since Dr. Regina M. Benjamin retired in 2013.
On Twitter @aliciaault
Boston hospitalist Dr. Vivek Murthy was confirmed Dec. 15 as the 19th U.S. Surgeon General, by a 51-43 vote of the U.S. Senate.
“Being ‘America’s doctor’ requires many of the same traits required of hospitalists: leadership, sharp clinical skills, and the ability to engage with patients,” Dr. Burke Kealey, president of the Society of Hospital Medicine, said in a statement. “Like hospitalists in thousands of hospitals across the country, I am confident Dr. Murthy will become an agent of change to improve delivery of care in our country.”
“As a practicing physician, Dr. Murthy brings extensive clinical expertise caring for patients and training hundreds of medical residents,” Dr. Robert L. Wergin, president of the American Academy of Family Physicians, said in a statement. “Dr. Murthy demonstrates a clear and thoughtful understanding of how important it is to transform our health care system from one focused on sick care to one based on wellness, good health practices, and early intervention.”
Dr. Murthy was nominated by President Obama in November 2013 and got fairly light treatment at a Senate confirmation hearing in February 2014. But Republican senators refused to entertain a confirmation vote for a variety of reasons, with Dr. Murthy’s advocacy on gun violence being cited most often. They also objected to his activist role in the passage of the Affordable Care Act while president of Doctors for America and his campaigning for Mr. Obama in the 2008 presidential election.
“The majority of his career has not been spent as a doctor treating patients, but as an activist,” said Sen. John Barrasso (R-Wyo.) in a speech before the confirmation vote.
But Sen. Dick Durbin (D-Ill.) called Dr. Murthy an outstanding physician and a public health expert, and noted that he had received the backing of some 100 health-related organizations earlier this year, including the American College of Physicians, the AAFP, the American Academy of Pediatrics, the American Cancer Society, the American Hospital Association, the American Diabetes Association, and many others.
Sen. Mark Kirk (Ill.) was the only Republican to vote to confirm Dr. Murthy, while three Democrats voted against him: Sen. Joe Donnelly (Ind.), Sen. Heidi Heitkamp (N.D.), and Sen. Joe Manchin (W.Va.). There were 6 abstentions.
The ACP reiterated its support for Dr. Murthy, citing a Feburary letter to two Senate committee chairmen in which college leaders called Dr. Murthy “a strong advocate for the provision of health insurance coverage to all Americans and ... a proven leader who can build coalitions among diverse individuals to ensure better health for our communities.”
The ACP statement also highlighted Dr. Murthy’s extensive public health experience, including serving on the U.S. Presidential Advisory Council on Prevention, Health Promotion, and Integrative and Public Health; cofounding VISIONS Worldwide in 1995, a nonprofit organization focused on HIV/AIDS education in India and the U.S.; and cofounding TrialNetworks, aimed at optimizing the quality and efficiency of clinical trials.
The nation has been without a confirmed surgeon general since Dr. Regina M. Benjamin retired in 2013.
On Twitter @aliciaault
Successful AVF creation a national challenge
CORONADO, CALIF.– Clinicians have a ways to go before they reach the National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative Guidelines for vascular access, a recent analysis of national data suggest.
Part of the challenge is because the incidence of renal disease continues to grow over time, Dr. Mark R. Nehler said at the annual meeting of the Western Vascular Society. “The elderly population is growing, and the need for access is growing,” said Dr. Nehler, chief of the section of vascular surgery and endovascular therapy and podiatry at the University of Colorado Anschutz Medical Campus, Aurora. “There’s also large geographic variation in how patients are being treated, and a large percentage of patients do not see a nephrologist before they’re put on dialysis.”
The 2010 targets set by the Kidney Disease Outcomes Quality Initiative Guidelines recommend that clinicians create an arteriovenous fistula (AVF) in 50% of new-onset and 67% of existing hemodialysis patients, respectively, and to use catheters in fewer than 10% of hemodialysis patients. “Over time, the recommendations have become catheter-last rather than fistula-first,” Dr. Nehler said.
According to 2014 incidence data Dr. Nehler presented from Fistula First, a coalition that focuses on increasing the use of AV fistulas and decreasing the use of tunneled dialysis catheters, clinicians are using AVFs in new-onset hemodialysis patients only 20% of the time, 75% are still using catheters, and 5% are using grafts. “If you look at the incidence data for access, we’re not meeting the guidelines,” Dr. Nehler commented. “A fair amount of them have fistulas maturing, but we’re nowhere close to the 50% of patients starting dialysis using a fistula.”
Prevalence data from Fistula First is more on target, with 64% of patients using an AVF, but 19% of patients are using a catheter for prevalent access, “so there’s still some work to be done, but these numbers continue to get better.” States doing a good job implementing the guidelines include Colorado, New Mexico, New Hampshire, Washington, and Utah. “Some of the worst performers are in the South and in the East,” Dr. Nehler said. “When you look at the types of patients that don’t do well with fistulas, you realize that it probably has as much to do with the types of patients [clinicians are] taking care of as it has to do with any particular skill set of the surgeons involved.”
He characterized the rate of fistula maturation as “fairly sobering, where you can see a failure rate of 40%-45%, based on results from randomized trials,” he said. “Failure rate has been associated with advanced age, vein size, forearm AVFs especially in diabetics and in nonwhite patients.”
Dr. Nehler reported having no financial disclosures.
On Twitter @dougbrunk
CORONADO, CALIF.– Clinicians have a ways to go before they reach the National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative Guidelines for vascular access, a recent analysis of national data suggest.
Part of the challenge is because the incidence of renal disease continues to grow over time, Dr. Mark R. Nehler said at the annual meeting of the Western Vascular Society. “The elderly population is growing, and the need for access is growing,” said Dr. Nehler, chief of the section of vascular surgery and endovascular therapy and podiatry at the University of Colorado Anschutz Medical Campus, Aurora. “There’s also large geographic variation in how patients are being treated, and a large percentage of patients do not see a nephrologist before they’re put on dialysis.”
The 2010 targets set by the Kidney Disease Outcomes Quality Initiative Guidelines recommend that clinicians create an arteriovenous fistula (AVF) in 50% of new-onset and 67% of existing hemodialysis patients, respectively, and to use catheters in fewer than 10% of hemodialysis patients. “Over time, the recommendations have become catheter-last rather than fistula-first,” Dr. Nehler said.
According to 2014 incidence data Dr. Nehler presented from Fistula First, a coalition that focuses on increasing the use of AV fistulas and decreasing the use of tunneled dialysis catheters, clinicians are using AVFs in new-onset hemodialysis patients only 20% of the time, 75% are still using catheters, and 5% are using grafts. “If you look at the incidence data for access, we’re not meeting the guidelines,” Dr. Nehler commented. “A fair amount of them have fistulas maturing, but we’re nowhere close to the 50% of patients starting dialysis using a fistula.”
Prevalence data from Fistula First is more on target, with 64% of patients using an AVF, but 19% of patients are using a catheter for prevalent access, “so there’s still some work to be done, but these numbers continue to get better.” States doing a good job implementing the guidelines include Colorado, New Mexico, New Hampshire, Washington, and Utah. “Some of the worst performers are in the South and in the East,” Dr. Nehler said. “When you look at the types of patients that don’t do well with fistulas, you realize that it probably has as much to do with the types of patients [clinicians are] taking care of as it has to do with any particular skill set of the surgeons involved.”
He characterized the rate of fistula maturation as “fairly sobering, where you can see a failure rate of 40%-45%, based on results from randomized trials,” he said. “Failure rate has been associated with advanced age, vein size, forearm AVFs especially in diabetics and in nonwhite patients.”
Dr. Nehler reported having no financial disclosures.
On Twitter @dougbrunk
CORONADO, CALIF.– Clinicians have a ways to go before they reach the National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative Guidelines for vascular access, a recent analysis of national data suggest.
Part of the challenge is because the incidence of renal disease continues to grow over time, Dr. Mark R. Nehler said at the annual meeting of the Western Vascular Society. “The elderly population is growing, and the need for access is growing,” said Dr. Nehler, chief of the section of vascular surgery and endovascular therapy and podiatry at the University of Colorado Anschutz Medical Campus, Aurora. “There’s also large geographic variation in how patients are being treated, and a large percentage of patients do not see a nephrologist before they’re put on dialysis.”
The 2010 targets set by the Kidney Disease Outcomes Quality Initiative Guidelines recommend that clinicians create an arteriovenous fistula (AVF) in 50% of new-onset and 67% of existing hemodialysis patients, respectively, and to use catheters in fewer than 10% of hemodialysis patients. “Over time, the recommendations have become catheter-last rather than fistula-first,” Dr. Nehler said.
According to 2014 incidence data Dr. Nehler presented from Fistula First, a coalition that focuses on increasing the use of AV fistulas and decreasing the use of tunneled dialysis catheters, clinicians are using AVFs in new-onset hemodialysis patients only 20% of the time, 75% are still using catheters, and 5% are using grafts. “If you look at the incidence data for access, we’re not meeting the guidelines,” Dr. Nehler commented. “A fair amount of them have fistulas maturing, but we’re nowhere close to the 50% of patients starting dialysis using a fistula.”
Prevalence data from Fistula First is more on target, with 64% of patients using an AVF, but 19% of patients are using a catheter for prevalent access, “so there’s still some work to be done, but these numbers continue to get better.” States doing a good job implementing the guidelines include Colorado, New Mexico, New Hampshire, Washington, and Utah. “Some of the worst performers are in the South and in the East,” Dr. Nehler said. “When you look at the types of patients that don’t do well with fistulas, you realize that it probably has as much to do with the types of patients [clinicians are] taking care of as it has to do with any particular skill set of the surgeons involved.”
He characterized the rate of fistula maturation as “fairly sobering, where you can see a failure rate of 40%-45%, based on results from randomized trials,” he said. “Failure rate has been associated with advanced age, vein size, forearm AVFs especially in diabetics and in nonwhite patients.”
Dr. Nehler reported having no financial disclosures.
On Twitter @dougbrunk
EXPERT ANALYSIS AT THE WESTERN VASCULAR SOCIETY ANNUAL MEETING
Prostate cancer surveillance appears safe through 15 years
Active surveillance appears to be safe through 15 years of follow-up for men who have low-risk prostate cancer, according to a report published online Dec. 15 in the Journal of Clinical Oncology.
In extended follow-up of a prospective cohort study begun in 1995, 993 men (current median age, 68 years; range, 41-89 years) with low-risk prostate cancer were assessed. Active surveillance consisted of PSA testing every 3 months for the first 2 years after diagnosis and then every 6 months thereafter, with repeat biopsy at 1 year and then every 3-4 years until the age of 80. These study participants were offered radical intervention only if the disease showed signs of progression, said Dr. Laurence Klotz of Sunnybrook Health Sciences Centre, University of Toronto, and his associates.
A total of 149 patients died, 819 were alive, and 25 were lost to follow-up. Only 15 men (1.5%) died from prostate cancer, and an additional 13 men with confirmed metastases either are alive (9 patients) or died from other causes (4 patients). Overall, the risk of dying from another cause was nearly 10 times greater than that for dying from prostate cancer (HR, 9.2). Even among men younger than 70, who had lower competing risks of death from other causes than older men, the risk of death from another cause was almost six times greater than that for death from prostate cancer (HR, 5.8), the investigators said (J. Clin. Oncol. 2014 Dec. 15 [doi:10.1200/JCO.2014.55.1192]).
The rate of patients who developed PSA failure during follow-up was 2.8% at 5 years and 10.2% at 10 years after diagnosis. These outcomes are consistent with those in low-risk patients managed with initial definitive intervention such as radiotherapy and surgery, Dr. Klotz and his associates added.
This study was supported by the Prostate Cancer Research Foundation of Canada. Dr. Klotz and his associates reported having no financial conflicts of interest.
This report from Dr. Klotz and his associates gives us the longest follow-up to date in one of the largest extant active surveillance cohorts.
The overall rate of metastasis was 2.8%. Before proponents of immediate definitive treatment argue that this rate is too high, they should note that it is not dissimilar from the risk of lethal disease among men who receive such immediate definitive treatment for low-risk tumors.
Dr. Matthew R. Cooperberg is with the University of California, San Francisco, and the Helen Diller Family Comprehensive Cancer Center. He reported receiving research funding from Genomic Health, Myriad Genetics, and GenomeDx Biosciences. Dr. Cooperberg made these remarks in an editorial accompanying the report (J. Clin. Oncol. 2014 Dec. 15 [doi:10.1200/jco.2014.59.2329]).
This report from Dr. Klotz and his associates gives us the longest follow-up to date in one of the largest extant active surveillance cohorts.
The overall rate of metastasis was 2.8%. Before proponents of immediate definitive treatment argue that this rate is too high, they should note that it is not dissimilar from the risk of lethal disease among men who receive such immediate definitive treatment for low-risk tumors.
Dr. Matthew R. Cooperberg is with the University of California, San Francisco, and the Helen Diller Family Comprehensive Cancer Center. He reported receiving research funding from Genomic Health, Myriad Genetics, and GenomeDx Biosciences. Dr. Cooperberg made these remarks in an editorial accompanying the report (J. Clin. Oncol. 2014 Dec. 15 [doi:10.1200/jco.2014.59.2329]).
This report from Dr. Klotz and his associates gives us the longest follow-up to date in one of the largest extant active surveillance cohorts.
The overall rate of metastasis was 2.8%. Before proponents of immediate definitive treatment argue that this rate is too high, they should note that it is not dissimilar from the risk of lethal disease among men who receive such immediate definitive treatment for low-risk tumors.
Dr. Matthew R. Cooperberg is with the University of California, San Francisco, and the Helen Diller Family Comprehensive Cancer Center. He reported receiving research funding from Genomic Health, Myriad Genetics, and GenomeDx Biosciences. Dr. Cooperberg made these remarks in an editorial accompanying the report (J. Clin. Oncol. 2014 Dec. 15 [doi:10.1200/jco.2014.59.2329]).
Active surveillance appears to be safe through 15 years of follow-up for men who have low-risk prostate cancer, according to a report published online Dec. 15 in the Journal of Clinical Oncology.
In extended follow-up of a prospective cohort study begun in 1995, 993 men (current median age, 68 years; range, 41-89 years) with low-risk prostate cancer were assessed. Active surveillance consisted of PSA testing every 3 months for the first 2 years after diagnosis and then every 6 months thereafter, with repeat biopsy at 1 year and then every 3-4 years until the age of 80. These study participants were offered radical intervention only if the disease showed signs of progression, said Dr. Laurence Klotz of Sunnybrook Health Sciences Centre, University of Toronto, and his associates.
A total of 149 patients died, 819 were alive, and 25 were lost to follow-up. Only 15 men (1.5%) died from prostate cancer, and an additional 13 men with confirmed metastases either are alive (9 patients) or died from other causes (4 patients). Overall, the risk of dying from another cause was nearly 10 times greater than that for dying from prostate cancer (HR, 9.2). Even among men younger than 70, who had lower competing risks of death from other causes than older men, the risk of death from another cause was almost six times greater than that for death from prostate cancer (HR, 5.8), the investigators said (J. Clin. Oncol. 2014 Dec. 15 [doi:10.1200/JCO.2014.55.1192]).
The rate of patients who developed PSA failure during follow-up was 2.8% at 5 years and 10.2% at 10 years after diagnosis. These outcomes are consistent with those in low-risk patients managed with initial definitive intervention such as radiotherapy and surgery, Dr. Klotz and his associates added.
This study was supported by the Prostate Cancer Research Foundation of Canada. Dr. Klotz and his associates reported having no financial conflicts of interest.
Active surveillance appears to be safe through 15 years of follow-up for men who have low-risk prostate cancer, according to a report published online Dec. 15 in the Journal of Clinical Oncology.
In extended follow-up of a prospective cohort study begun in 1995, 993 men (current median age, 68 years; range, 41-89 years) with low-risk prostate cancer were assessed. Active surveillance consisted of PSA testing every 3 months for the first 2 years after diagnosis and then every 6 months thereafter, with repeat biopsy at 1 year and then every 3-4 years until the age of 80. These study participants were offered radical intervention only if the disease showed signs of progression, said Dr. Laurence Klotz of Sunnybrook Health Sciences Centre, University of Toronto, and his associates.
A total of 149 patients died, 819 were alive, and 25 were lost to follow-up. Only 15 men (1.5%) died from prostate cancer, and an additional 13 men with confirmed metastases either are alive (9 patients) or died from other causes (4 patients). Overall, the risk of dying from another cause was nearly 10 times greater than that for dying from prostate cancer (HR, 9.2). Even among men younger than 70, who had lower competing risks of death from other causes than older men, the risk of death from another cause was almost six times greater than that for death from prostate cancer (HR, 5.8), the investigators said (J. Clin. Oncol. 2014 Dec. 15 [doi:10.1200/JCO.2014.55.1192]).
The rate of patients who developed PSA failure during follow-up was 2.8% at 5 years and 10.2% at 10 years after diagnosis. These outcomes are consistent with those in low-risk patients managed with initial definitive intervention such as radiotherapy and surgery, Dr. Klotz and his associates added.
This study was supported by the Prostate Cancer Research Foundation of Canada. Dr. Klotz and his associates reported having no financial conflicts of interest.
Key clinical point: Active surveillance for low-risk prostate cancer appears safe through 15 years of follow-up.
Major finding: Only 1.5% of men died from prostate cancer during follow-up, and the risk of dying from another cause was nearly 10 times greater than that for dying from prostate cancer (HR, 9.2).
Data source: Extended (15-year) follow-up of a cohort of 993 men with low-risk prostate cancer who only underwent treatment if the disease showed signs of progression.
Disclosures: This study was supported by the Prostate Cancer Research Foundation of Canada. Dr. Klotz and his associates reported having no financial conflicts of interest.
Proposal would enable medical decision making by same-sex spouses
Under a new federal proposal, physicians could more easily provide sensitive medical information about patients to same-sex spouses and follow the treatment wishes of same-sex partners when a patient is incapacitated.
The proposal from the Centers for Medicare & Medicaid Services is aimed at making program requirements more consistent with the U.S. Supreme Court’s decision in United States v. Windsor and would apply to mental health, hospital, laboratory, hospice, long-term care, and ambulatory surgical center services.
The proposed rules allow for smoother communication among physicians, patients, and same-sex spouses and reduce frustration for all parties when it comes to medical decision making, said Dr. Harvey J. Makadon, director of the National LGBT Health Education Center at the Fenway Institute, Boston, and a professor of medicine at Harvard Medical School.
“The proposed rules essentially recognize the reality that same-sex individuals can now get married and that their spouses need to be treated in the same way that all spouses are treated in terms of being involved in health care decision making,” Dr. Makadon said in an interview. “Rules like this make life easier for clinicians, who are in a better position not only to respect [same-sex relationships], but to feel like the CMS supports their ability to involve the appropriate loved ones in a patient’s care.”
In Windsor, the Supreme Court in 2013 held that Section 3 of the Defense of Marriage Act (DOMA) was unconstitutional because it violated the Fifth Amendment. DOMA had stated that, within government programs, the word “marriage” meant only a legal union between one man and one woman and the word “spouse” could refer only to a husband or wife of the opposite sex. Since the decision, the government has started approving some Medicare enrollments for same-sex spouses, including care under Medicare Part A and skilled nursing services under Medicare Advantage.
The CMS proposal, announced Dec. 11, would revise language within the Medicare and Medicare programs to recognize marriages between individuals of the same sex who were lawfully married under state law, regardless of where the couple now resides or the jurisdiction in which a health provider is located. The regulations would mandate that same-sex partners be afforded treatment equal to that afforded to opposite-sex spouses if the marriage is valid in the jurisdiction in which it was celebrated.
Specifically, CMS wants program language to reflect that hospitals, ambulatory surgical centers, and community mental health centers must inform recognized same-sex spouses of a patient’s rights in advance of care decisions when necessary. Current language requires health providers in such care environments to inform patients or, when appropriate, legal representatives, of a patient’s rights in advance of furnishing or discontinuing care. Additionally, the agency suggests adding same-sex spouses to the definition of “representative” for purposes of authorizing or terminating medical care or revoking hospice care on behalf of a terminally ill patient.
Same-sex spouses also would more easily access laboratory test results in certain circumstances. Current CMS language requires that legal representatives be notified about blood screenings and infectious disease results if patients are deemed incompetent. In such instances, recognized same-sex spouses now would be included in the definition of legal representative, according to the proposal.
The proposed rules are a significant step in the federal government’s efforts to ensure that programs treat married same-sex couples equal to their opposite-sex counterparts, as mandated by Windsor, said Hector Vargas, executive director of GLMA: Health Professionals Advancing LGBT Equality (formally known as the Gay and Lesbian Medical Association).
“While facilities and providers should already treat all married couples equally, the regulation removes any doubt about this for Medicare- and Medicaid-participating facilities and providers,” Mr. Vargas said in an interview.
The proposed rules were published Dec. 12 in the Federal Register. Comments on the latest proposal can be submitted to www.regulations.gov until Feb. 10, 2015.
On Twitter @legal_med
Under a new federal proposal, physicians could more easily provide sensitive medical information about patients to same-sex spouses and follow the treatment wishes of same-sex partners when a patient is incapacitated.
The proposal from the Centers for Medicare & Medicaid Services is aimed at making program requirements more consistent with the U.S. Supreme Court’s decision in United States v. Windsor and would apply to mental health, hospital, laboratory, hospice, long-term care, and ambulatory surgical center services.
The proposed rules allow for smoother communication among physicians, patients, and same-sex spouses and reduce frustration for all parties when it comes to medical decision making, said Dr. Harvey J. Makadon, director of the National LGBT Health Education Center at the Fenway Institute, Boston, and a professor of medicine at Harvard Medical School.
“The proposed rules essentially recognize the reality that same-sex individuals can now get married and that their spouses need to be treated in the same way that all spouses are treated in terms of being involved in health care decision making,” Dr. Makadon said in an interview. “Rules like this make life easier for clinicians, who are in a better position not only to respect [same-sex relationships], but to feel like the CMS supports their ability to involve the appropriate loved ones in a patient’s care.”
In Windsor, the Supreme Court in 2013 held that Section 3 of the Defense of Marriage Act (DOMA) was unconstitutional because it violated the Fifth Amendment. DOMA had stated that, within government programs, the word “marriage” meant only a legal union between one man and one woman and the word “spouse” could refer only to a husband or wife of the opposite sex. Since the decision, the government has started approving some Medicare enrollments for same-sex spouses, including care under Medicare Part A and skilled nursing services under Medicare Advantage.
The CMS proposal, announced Dec. 11, would revise language within the Medicare and Medicare programs to recognize marriages between individuals of the same sex who were lawfully married under state law, regardless of where the couple now resides or the jurisdiction in which a health provider is located. The regulations would mandate that same-sex partners be afforded treatment equal to that afforded to opposite-sex spouses if the marriage is valid in the jurisdiction in which it was celebrated.
Specifically, CMS wants program language to reflect that hospitals, ambulatory surgical centers, and community mental health centers must inform recognized same-sex spouses of a patient’s rights in advance of care decisions when necessary. Current language requires health providers in such care environments to inform patients or, when appropriate, legal representatives, of a patient’s rights in advance of furnishing or discontinuing care. Additionally, the agency suggests adding same-sex spouses to the definition of “representative” for purposes of authorizing or terminating medical care or revoking hospice care on behalf of a terminally ill patient.
Same-sex spouses also would more easily access laboratory test results in certain circumstances. Current CMS language requires that legal representatives be notified about blood screenings and infectious disease results if patients are deemed incompetent. In such instances, recognized same-sex spouses now would be included in the definition of legal representative, according to the proposal.
The proposed rules are a significant step in the federal government’s efforts to ensure that programs treat married same-sex couples equal to their opposite-sex counterparts, as mandated by Windsor, said Hector Vargas, executive director of GLMA: Health Professionals Advancing LGBT Equality (formally known as the Gay and Lesbian Medical Association).
“While facilities and providers should already treat all married couples equally, the regulation removes any doubt about this for Medicare- and Medicaid-participating facilities and providers,” Mr. Vargas said in an interview.
The proposed rules were published Dec. 12 in the Federal Register. Comments on the latest proposal can be submitted to www.regulations.gov until Feb. 10, 2015.
On Twitter @legal_med
Under a new federal proposal, physicians could more easily provide sensitive medical information about patients to same-sex spouses and follow the treatment wishes of same-sex partners when a patient is incapacitated.
The proposal from the Centers for Medicare & Medicaid Services is aimed at making program requirements more consistent with the U.S. Supreme Court’s decision in United States v. Windsor and would apply to mental health, hospital, laboratory, hospice, long-term care, and ambulatory surgical center services.
The proposed rules allow for smoother communication among physicians, patients, and same-sex spouses and reduce frustration for all parties when it comes to medical decision making, said Dr. Harvey J. Makadon, director of the National LGBT Health Education Center at the Fenway Institute, Boston, and a professor of medicine at Harvard Medical School.
“The proposed rules essentially recognize the reality that same-sex individuals can now get married and that their spouses need to be treated in the same way that all spouses are treated in terms of being involved in health care decision making,” Dr. Makadon said in an interview. “Rules like this make life easier for clinicians, who are in a better position not only to respect [same-sex relationships], but to feel like the CMS supports their ability to involve the appropriate loved ones in a patient’s care.”
In Windsor, the Supreme Court in 2013 held that Section 3 of the Defense of Marriage Act (DOMA) was unconstitutional because it violated the Fifth Amendment. DOMA had stated that, within government programs, the word “marriage” meant only a legal union between one man and one woman and the word “spouse” could refer only to a husband or wife of the opposite sex. Since the decision, the government has started approving some Medicare enrollments for same-sex spouses, including care under Medicare Part A and skilled nursing services under Medicare Advantage.
The CMS proposal, announced Dec. 11, would revise language within the Medicare and Medicare programs to recognize marriages between individuals of the same sex who were lawfully married under state law, regardless of where the couple now resides or the jurisdiction in which a health provider is located. The regulations would mandate that same-sex partners be afforded treatment equal to that afforded to opposite-sex spouses if the marriage is valid in the jurisdiction in which it was celebrated.
Specifically, CMS wants program language to reflect that hospitals, ambulatory surgical centers, and community mental health centers must inform recognized same-sex spouses of a patient’s rights in advance of care decisions when necessary. Current language requires health providers in such care environments to inform patients or, when appropriate, legal representatives, of a patient’s rights in advance of furnishing or discontinuing care. Additionally, the agency suggests adding same-sex spouses to the definition of “representative” for purposes of authorizing or terminating medical care or revoking hospice care on behalf of a terminally ill patient.
Same-sex spouses also would more easily access laboratory test results in certain circumstances. Current CMS language requires that legal representatives be notified about blood screenings and infectious disease results if patients are deemed incompetent. In such instances, recognized same-sex spouses now would be included in the definition of legal representative, according to the proposal.
The proposed rules are a significant step in the federal government’s efforts to ensure that programs treat married same-sex couples equal to their opposite-sex counterparts, as mandated by Windsor, said Hector Vargas, executive director of GLMA: Health Professionals Advancing LGBT Equality (formally known as the Gay and Lesbian Medical Association).
“While facilities and providers should already treat all married couples equally, the regulation removes any doubt about this for Medicare- and Medicaid-participating facilities and providers,” Mr. Vargas said in an interview.
The proposed rules were published Dec. 12 in the Federal Register. Comments on the latest proposal can be submitted to www.regulations.gov until Feb. 10, 2015.
On Twitter @legal_med
