Bone marrow aspirate

showing multiple myeloma

Results of preclinical research indicate chimeric antigen receptor (CAR) T cells are effective against multiple myeloma (MM).

Researchers generated CAR T cells that target CS1, a molecule found on more than 95% of MM cells.

When injected in mice, these T cells could locate and destroy MM cells.

Jianhua Yu, PhD, of The Ohio State University Comprehensive Cancer Center in Columbus, and his colleagues reported these results in Clinical Cancer Research.

“[O]ur study shows that we can modify T lymphocytes to target CS1 and that these cells efficiently destroy human multiple myeloma cells,” Dr Yu said.

“An important possible advantage to this approach is that these therapeutic T cells have the potential to replicate in the body, and, therefore, they might suppress tumor growth and prevent relapse for a prolonged period.”

Dr Yu and his colleagues used cell lines and cells from MM patients to produce CAR T cells targeting CS1. These cells could be expanded in the lab, and they efficiently recognized and eradicated MM cells in vitro and in vivo.

Compared to control T cells, the CAR T cells better recognized MM cells that overexpressed CS1, and they became more activated following the recognition.

In mice, the CAR T cells greatly reduced the tumor burden and prolonged overall survival. All mice that received CAR T cells were alive 44 days after treatment, compared to 29% and 17% of the mice in the study’s 2 control groups.

“Despite current drugs and use of bone marrow transplantation, multiple myeloma is still incurable, and almost all patients eventually relapse,” said study author Craig Hofmeister, MD, MPH, also of The Ohio State University Comprehensive Cancer Center.

“This study presents a novel strategy for treating multiple myeloma, and we hope to bring it to patients as part of a phase 1 clinical trial as soon as possible.”

Bone marrow aspirate

showing multiple myeloma

Results of preclinical research indicate chimeric antigen receptor (CAR) T cells are effective against multiple myeloma (MM).

Researchers generated CAR T cells that target CS1, a molecule found on more than 95% of MM cells.

When injected in mice, these T cells could locate and destroy MM cells.

Jianhua Yu, PhD, of The Ohio State University Comprehensive Cancer Center in Columbus, and his colleagues reported these results in Clinical Cancer Research.

“[O]ur study shows that we can modify T lymphocytes to target CS1 and that these cells efficiently destroy human multiple myeloma cells,” Dr Yu said.

“An important possible advantage to this approach is that these therapeutic T cells have the potential to replicate in the body, and, therefore, they might suppress tumor growth and prevent relapse for a prolonged period.”

Dr Yu and his colleagues used cell lines and cells from MM patients to produce CAR T cells targeting CS1. These cells could be expanded in the lab, and they efficiently recognized and eradicated MM cells in vitro and in vivo.

Compared to control T cells, the CAR T cells better recognized MM cells that overexpressed CS1, and they became more activated following the recognition.

In mice, the CAR T cells greatly reduced the tumor burden and prolonged overall survival. All mice that received CAR T cells were alive 44 days after treatment, compared to 29% and 17% of the mice in the study’s 2 control groups.

“Despite current drugs and use of bone marrow transplantation, multiple myeloma is still incurable, and almost all patients eventually relapse,” said study author Craig Hofmeister, MD, MPH, also of The Ohio State University Comprehensive Cancer Center.

“This study presents a novel strategy for treating multiple myeloma, and we hope to bring it to patients as part of a phase 1 clinical trial as soon as possible.”

Bone marrow aspirate

showing multiple myeloma

Results of preclinical research indicate chimeric antigen receptor (CAR) T cells are effective against multiple myeloma (MM).

Researchers generated CAR T cells that target CS1, a molecule found on more than 95% of MM cells.

When injected in mice, these T cells could locate and destroy MM cells.

Jianhua Yu, PhD, of The Ohio State University Comprehensive Cancer Center in Columbus, and his colleagues reported these results in Clinical Cancer Research.

“[O]ur study shows that we can modify T lymphocytes to target CS1 and that these cells efficiently destroy human multiple myeloma cells,” Dr Yu said.

“An important possible advantage to this approach is that these therapeutic T cells have the potential to replicate in the body, and, therefore, they might suppress tumor growth and prevent relapse for a prolonged period.”

Dr Yu and his colleagues used cell lines and cells from MM patients to produce CAR T cells targeting CS1. These cells could be expanded in the lab, and they efficiently recognized and eradicated MM cells in vitro and in vivo.

Compared to control T cells, the CAR T cells better recognized MM cells that overexpressed CS1, and they became more activated following the recognition.

In mice, the CAR T cells greatly reduced the tumor burden and prolonged overall survival. All mice that received CAR T cells were alive 44 days after treatment, compared to 29% and 17% of the mice in the study’s 2 control groups.

“Despite current drugs and use of bone marrow transplantation, multiple myeloma is still incurable, and almost all patients eventually relapse,” said study author Craig Hofmeister, MD, MPH, also of The Ohio State University Comprehensive Cancer Center.

“This study presents a novel strategy for treating multiple myeloma, and we hope to bring it to patients as part of a phase 1 clinical trial as soon as possible.”

Scientist in the lab

Credit: Darren Baker

After reviewing data from more than 134,000 patients, researchers at the US Food and Drug Administration (FDA) have concluded that dabigatran has a favorable risk-benefit profile.

Their research showed that, compared to warfarin, dabigatran decreased the risk of stroke, death, and intracranial hemorrhage in patients with atrial fibrillation.

On the other hand, dabigatran increased the risk of gastrointestinal bleeding, and the risk of myocardial infarction was similar for the 2 drugs.

This study was part of the FDA’s ongoing review of dabigatran. The agency has been investigating the safety of dabigatran since 2011, following reports of serious bleeding events associated with the drug.

A previous FDA study, announced in 2012, suggested dabigatran does not pose an increased risk of serious bleeding when compared to warfarin. But other studies have provided conflicting results, so the FDA decided to conduct additional research.

This study included information from more than 134,000 Medicare patients, aged 65 years or older. The researchers compared dabigatran and warfarin, evaluating the risk of ischemic stroke, intracranial hemorrhage, major gastrointestinal bleeding, myocardial infarction, and death.

The FDA said this study is based on a much larger and older patient population than those used in the agency’s earlier review of post-market data, and researchers employed a more sophisticated analytical method to capture and analyze the events of concern.

The data showed that, among new users of anticoagulants, dabigatran was associated with a lower risk of ischemic stroke, intracranial hemorrhage, and death, when compared to warfarin.

The incidence rate of ischemic stroke per 1000 person-years was 11.3 among dabigatran users and 13.9 among warfarin users (hazard ratio [HR]=0.80).

The incidence of intracranial hemorrhage was 3.3 and 9.6, respectively (HR=0.34). And the incidence of death was 32.6 and 37.8, respectively (HR=0.86).

The study also showed an increased risk of major gastrointestinal bleeding with the use of dabigatran compared to warfarin. The incidence rate per 1000 person-years was 34.2 and 26.5, respectively (HR=1.28).

The risk of myocardial infarction was similar for the 2 drugs. The incidence rate per 1000 person-years was 15.7 for dabigatran users and 16.9 for warfarin users (HR=0.92).

These results, except with regard to myocardial infarction, are consistent with the clinical trial results that provided the basis for dabigatran’s approval.

The FDA said these findings suggest dabigatran has a favorable risk-benefit profile, so the agency has made no changes to the drug’s current label or recommendations for use.

The FDA is planning to publish detailed data from this study. Until then, some information is available on the agency’s website.

The FDA said it will continue to investigate the reasons for differences in major gastrointestinal bleeding rates for dabigatran and warfarin. And it will continue reviewing anticoagulant use and the risk of bleeding.

Scientist in the lab

Credit: Darren Baker

After reviewing data from more than 134,000 patients, researchers at the US Food and Drug Administration (FDA) have concluded that dabigatran has a favorable risk-benefit profile.

Their research showed that, compared to warfarin, dabigatran decreased the risk of stroke, death, and intracranial hemorrhage in patients with atrial fibrillation.

On the other hand, dabigatran increased the risk of gastrointestinal bleeding, and the risk of myocardial infarction was similar for the 2 drugs.

This study was part of the FDA’s ongoing review of dabigatran. The agency has been investigating the safety of dabigatran since 2011, following reports of serious bleeding events associated with the drug.

A previous FDA study, announced in 2012, suggested dabigatran does not pose an increased risk of serious bleeding when compared to warfarin. But other studies have provided conflicting results, so the FDA decided to conduct additional research.

This study included information from more than 134,000 Medicare patients, aged 65 years or older. The researchers compared dabigatran and warfarin, evaluating the risk of ischemic stroke, intracranial hemorrhage, major gastrointestinal bleeding, myocardial infarction, and death.

The FDA said this study is based on a much larger and older patient population than those used in the agency’s earlier review of post-market data, and researchers employed a more sophisticated analytical method to capture and analyze the events of concern.

The data showed that, among new users of anticoagulants, dabigatran was associated with a lower risk of ischemic stroke, intracranial hemorrhage, and death, when compared to warfarin.

The incidence rate of ischemic stroke per 1000 person-years was 11.3 among dabigatran users and 13.9 among warfarin users (hazard ratio [HR]=0.80).

The incidence of intracranial hemorrhage was 3.3 and 9.6, respectively (HR=0.34). And the incidence of death was 32.6 and 37.8, respectively (HR=0.86).

The study also showed an increased risk of major gastrointestinal bleeding with the use of dabigatran compared to warfarin. The incidence rate per 1000 person-years was 34.2 and 26.5, respectively (HR=1.28).

The risk of myocardial infarction was similar for the 2 drugs. The incidence rate per 1000 person-years was 15.7 for dabigatran users and 16.9 for warfarin users (HR=0.92).

These results, except with regard to myocardial infarction, are consistent with the clinical trial results that provided the basis for dabigatran’s approval.

The FDA said these findings suggest dabigatran has a favorable risk-benefit profile, so the agency has made no changes to the drug’s current label or recommendations for use.

The FDA is planning to publish detailed data from this study. Until then, some information is available on the agency’s website.

The FDA said it will continue to investigate the reasons for differences in major gastrointestinal bleeding rates for dabigatran and warfarin. And it will continue reviewing anticoagulant use and the risk of bleeding.

Scientist in the lab

Credit: Darren Baker

After reviewing data from more than 134,000 patients, researchers at the US Food and Drug Administration (FDA) have concluded that dabigatran has a favorable risk-benefit profile.

Their research showed that, compared to warfarin, dabigatran decreased the risk of stroke, death, and intracranial hemorrhage in patients with atrial fibrillation.

On the other hand, dabigatran increased the risk of gastrointestinal bleeding, and the risk of myocardial infarction was similar for the 2 drugs.

This study was part of the FDA’s ongoing review of dabigatran. The agency has been investigating the safety of dabigatran since 2011, following reports of serious bleeding events associated with the drug.

A previous FDA study, announced in 2012, suggested dabigatran does not pose an increased risk of serious bleeding when compared to warfarin. But other studies have provided conflicting results, so the FDA decided to conduct additional research.

This study included information from more than 134,000 Medicare patients, aged 65 years or older. The researchers compared dabigatran and warfarin, evaluating the risk of ischemic stroke, intracranial hemorrhage, major gastrointestinal bleeding, myocardial infarction, and death.

The FDA said this study is based on a much larger and older patient population than those used in the agency’s earlier review of post-market data, and researchers employed a more sophisticated analytical method to capture and analyze the events of concern.

The data showed that, among new users of anticoagulants, dabigatran was associated with a lower risk of ischemic stroke, intracranial hemorrhage, and death, when compared to warfarin.

The incidence rate of ischemic stroke per 1000 person-years was 11.3 among dabigatran users and 13.9 among warfarin users (hazard ratio [HR]=0.80).

The incidence of intracranial hemorrhage was 3.3 and 9.6, respectively (HR=0.34). And the incidence of death was 32.6 and 37.8, respectively (HR=0.86).

The study also showed an increased risk of major gastrointestinal bleeding with the use of dabigatran compared to warfarin. The incidence rate per 1000 person-years was 34.2 and 26.5, respectively (HR=1.28).

The risk of myocardial infarction was similar for the 2 drugs. The incidence rate per 1000 person-years was 15.7 for dabigatran users and 16.9 for warfarin users (HR=0.92).

These results, except with regard to myocardial infarction, are consistent with the clinical trial results that provided the basis for dabigatran’s approval.

The FDA said these findings suggest dabigatran has a favorable risk-benefit profile, so the agency has made no changes to the drug’s current label or recommendations for use.

The FDA is planning to publish detailed data from this study. Until then, some information is available on the agency’s website.

The FDA said it will continue to investigate the reasons for differences in major gastrointestinal bleeding rates for dabigatran and warfarin. And it will continue reviewing anticoagulant use and the risk of bleeding.

Warfarin tablets

SAN FRANSICO—New research suggests bleeds and thrombosis are not the only adverse effects of improper warfarin dosing.

The study showed an increased risk of dementia among patients with atrial fibrillation whose warfarin doses were outside the therapeutic range for an extended period of time.

Jared Bunch, MD, of the Intermountain Medical Center Heart Institute in Murray, Utah, and his colleagues presented this finding at the 2014 Annual Heart Rhythm Society Scientific Session (PO05-169).

Previous research suggested that patients with atrial fibrillation had an increased risk of developing dementia. But the cause of that association

was unknown.

“[W]e now know that if warfarin doses are consistently too high or too low, one of the long-term consequences can be brain damage,” Dr Bunch said. “This points to the possibility that dementia in atrial fibrillation patients is partly due to small, repetitive clots and/or bleeds in the brain.”

To make this connection, the researchers analyzed data from 2693 atrial fibrillation patients receiving warfarin. The team evaluated the relationship between dementia and the percentage of time that patients’ warfarin doses were within the therapeutic range (international normalized ratio of 2 to 3).

In all, 4.1% of patients (n=111) were diagnosed with dementia. This included senile dementia (n=37, 1.4%), vascular dementia (n=8, 0.3%), and Alzheimer’s dementia (n=66, 2.4%).

The researchers’ analysis (adjusted for the risk of stroke and bleeding) revealed that the more time a patient’s warfarin dosages were outside the therapeutic range, the greater his risk of developing dementia.

Specifically,  patients within the therapeutic range less than 25% of the time were 4.6 times more likely to develop dementia than patients within range more than 75% of the time.

Patients within the therapeutic range 25% to 50% of the time were 4.1 times more likely to develop dementia. And patients within the therapeutic range 51% to 75% of the time were 2.5 times more likely to develop dementia.

“Our results from the study tell us 2 things,” Dr Bunch said. “With careful use of anticoagulation medications, the dementia risk can be reduced.

Patients on warfarin need very close follow-up in specialized anticoagulation centers, if possible, to ensure their blood levels are within the recommended levels more often.”

“Second, these results also point to a potential new long-term consequence of dependency on long-term anticoagulation medications. In this regard, stroke prevention therapies do not require long-term anticoagulation medications, and reducing the use of these drugs will hopefully lower

dementia risk.”

Warfarin tablets

SAN FRANSICO—New research suggests bleeds and thrombosis are not the only adverse effects of improper warfarin dosing.

The study showed an increased risk of dementia among patients with atrial fibrillation whose warfarin doses were outside the therapeutic range for an extended period of time.

Jared Bunch, MD, of the Intermountain Medical Center Heart Institute in Murray, Utah, and his colleagues presented this finding at the 2014 Annual Heart Rhythm Society Scientific Session (PO05-169).

Previous research suggested that patients with atrial fibrillation had an increased risk of developing dementia. But the cause of that association

was unknown.

“[W]e now know that if warfarin doses are consistently too high or too low, one of the long-term consequences can be brain damage,” Dr Bunch said. “This points to the possibility that dementia in atrial fibrillation patients is partly due to small, repetitive clots and/or bleeds in the brain.”

To make this connection, the researchers analyzed data from 2693 atrial fibrillation patients receiving warfarin. The team evaluated the relationship between dementia and the percentage of time that patients’ warfarin doses were within the therapeutic range (international normalized ratio of 2 to 3).

In all, 4.1% of patients (n=111) were diagnosed with dementia. This included senile dementia (n=37, 1.4%), vascular dementia (n=8, 0.3%), and Alzheimer’s dementia (n=66, 2.4%).

The researchers’ analysis (adjusted for the risk of stroke and bleeding) revealed that the more time a patient’s warfarin dosages were outside the therapeutic range, the greater his risk of developing dementia.

Specifically,  patients within the therapeutic range less than 25% of the time were 4.6 times more likely to develop dementia than patients within range more than 75% of the time.

Patients within the therapeutic range 25% to 50% of the time were 4.1 times more likely to develop dementia. And patients within the therapeutic range 51% to 75% of the time were 2.5 times more likely to develop dementia.

“Our results from the study tell us 2 things,” Dr Bunch said. “With careful use of anticoagulation medications, the dementia risk can be reduced.

Patients on warfarin need very close follow-up in specialized anticoagulation centers, if possible, to ensure their blood levels are within the recommended levels more often.”

“Second, these results also point to a potential new long-term consequence of dependency on long-term anticoagulation medications. In this regard, stroke prevention therapies do not require long-term anticoagulation medications, and reducing the use of these drugs will hopefully lower

dementia risk.”

Warfarin tablets

SAN FRANSICO—New research suggests bleeds and thrombosis are not the only adverse effects of improper warfarin dosing.

The study showed an increased risk of dementia among patients with atrial fibrillation whose warfarin doses were outside the therapeutic range for an extended period of time.

Jared Bunch, MD, of the Intermountain Medical Center Heart Institute in Murray, Utah, and his colleagues presented this finding at the 2014 Annual Heart Rhythm Society Scientific Session (PO05-169).

Previous research suggested that patients with atrial fibrillation had an increased risk of developing dementia. But the cause of that association

was unknown.

“[W]e now know that if warfarin doses are consistently too high or too low, one of the long-term consequences can be brain damage,” Dr Bunch said. “This points to the possibility that dementia in atrial fibrillation patients is partly due to small, repetitive clots and/or bleeds in the brain.”

To make this connection, the researchers analyzed data from 2693 atrial fibrillation patients receiving warfarin. The team evaluated the relationship between dementia and the percentage of time that patients’ warfarin doses were within the therapeutic range (international normalized ratio of 2 to 3).

In all, 4.1% of patients (n=111) were diagnosed with dementia. This included senile dementia (n=37, 1.4%), vascular dementia (n=8, 0.3%), and Alzheimer’s dementia (n=66, 2.4%).

The researchers’ analysis (adjusted for the risk of stroke and bleeding) revealed that the more time a patient’s warfarin dosages were outside the therapeutic range, the greater his risk of developing dementia.

Specifically,  patients within the therapeutic range less than 25% of the time were 4.6 times more likely to develop dementia than patients within range more than 75% of the time.

Patients within the therapeutic range 25% to 50% of the time were 4.1 times more likely to develop dementia. And patients within the therapeutic range 51% to 75% of the time were 2.5 times more likely to develop dementia.

“Our results from the study tell us 2 things,” Dr Bunch said. “With careful use of anticoagulation medications, the dementia risk can be reduced.

Patients on warfarin need very close follow-up in specialized anticoagulation centers, if possible, to ensure their blood levels are within the recommended levels more often.”

“Second, these results also point to a potential new long-term consequence of dependency on long-term anticoagulation medications. In this regard, stroke prevention therapies do not require long-term anticoagulation medications, and reducing the use of these drugs will hopefully lower

dementia risk.”

KEYSTONE, COLO. – Surgical treatment of chronic rhinosinusitis has come a long way from the earlier "grab and tear" days, but referring physicians need to understand that not all otolaryngologists are providing state-of-the-art care.

"I am critical of some of my colleagues," Dr. Todd T. Kingdom said at a meeting on allergy and respiratory diseases sponsored by National Jewish Health.

"If I leave you with one message, it’s to set high expectations of your consultants in otolaryngology. You should find colleagues who are interested in sinus disease, who are committed to it, and who are excellent," added Dr. Kingdom, professor and vice chairman of the department of otolaryngology, head and neck surgery, at the University of Colorado, Denver, and immediate past president of the American Rhinologic Society.

One fine source is the pool of graduates of U.S. subspecialty surgical rhinology fellowship programs. Each year, 30 surgeons complete one of these fellowships, he said.

Technical innovations over the past 15 years have driven major advances in endoscopic sinus surgery. Powered microdebriders are used to precisely and efficiently remove hyperplastic mucosal disease and restore mucociliary clearance. Mucosal preservation is now a central tenet. Forward-thinking surgeons place a priority on creating exposure for delivery of topical medications. The procedures are routinely done on an outpatient basis, and they are less invasive than in former times. The outcomes are better, too, with this modern patient-centered, symptom-based approach.

"We have efficient ways now to take care of very severe disease atraumatically," Dr. Kingdom explained.

He emphasized that postoperative care is critical to successful sinus surgery outcomes. "My biggest criticism of my colleagues in otolaryngology is that many of them cut and go. There isn’t an emphasis on postoperative care," he said. "That’s a clear, clear deficiency in our approach.

"My postop schedule is to see patients at 1, 3, and 6 weeks and 3 and 6 months after surgery – and that’s if they’re doing perfectly. My point is you should have your otolaryngologist really fussing over these people. It’s not, ‘Well, it’s been a couple of weeks, you look fine, you can go back to your allergist now, I’ll see you later.’ It shouldn’t be that way," Dr. Kingdom said.

He reported having no financial conflicts of interest.

[email protected]

KEYSTONE, COLO. – Surgical treatment of chronic rhinosinusitis has come a long way from the earlier "grab and tear" days, but referring physicians need to understand that not all otolaryngologists are providing state-of-the-art care.

"I am critical of some of my colleagues," Dr. Todd T. Kingdom said at a meeting on allergy and respiratory diseases sponsored by National Jewish Health.

"If I leave you with one message, it’s to set high expectations of your consultants in otolaryngology. You should find colleagues who are interested in sinus disease, who are committed to it, and who are excellent," added Dr. Kingdom, professor and vice chairman of the department of otolaryngology, head and neck surgery, at the University of Colorado, Denver, and immediate past president of the American Rhinologic Society.

One fine source is the pool of graduates of U.S. subspecialty surgical rhinology fellowship programs. Each year, 30 surgeons complete one of these fellowships, he said.

Technical innovations over the past 15 years have driven major advances in endoscopic sinus surgery. Powered microdebriders are used to precisely and efficiently remove hyperplastic mucosal disease and restore mucociliary clearance. Mucosal preservation is now a central tenet. Forward-thinking surgeons place a priority on creating exposure for delivery of topical medications. The procedures are routinely done on an outpatient basis, and they are less invasive than in former times. The outcomes are better, too, with this modern patient-centered, symptom-based approach.

"We have efficient ways now to take care of very severe disease atraumatically," Dr. Kingdom explained.

He emphasized that postoperative care is critical to successful sinus surgery outcomes. "My biggest criticism of my colleagues in otolaryngology is that many of them cut and go. There isn’t an emphasis on postoperative care," he said. "That’s a clear, clear deficiency in our approach.

"My postop schedule is to see patients at 1, 3, and 6 weeks and 3 and 6 months after surgery – and that’s if they’re doing perfectly. My point is you should have your otolaryngologist really fussing over these people. It’s not, ‘Well, it’s been a couple of weeks, you look fine, you can go back to your allergist now, I’ll see you later.’ It shouldn’t be that way," Dr. Kingdom said.

He reported having no financial conflicts of interest.

[email protected]

KEYSTONE, COLO. – Surgical treatment of chronic rhinosinusitis has come a long way from the earlier "grab and tear" days, but referring physicians need to understand that not all otolaryngologists are providing state-of-the-art care.

"I am critical of some of my colleagues," Dr. Todd T. Kingdom said at a meeting on allergy and respiratory diseases sponsored by National Jewish Health.

"If I leave you with one message, it’s to set high expectations of your consultants in otolaryngology. You should find colleagues who are interested in sinus disease, who are committed to it, and who are excellent," added Dr. Kingdom, professor and vice chairman of the department of otolaryngology, head and neck surgery, at the University of Colorado, Denver, and immediate past president of the American Rhinologic Society.

One fine source is the pool of graduates of U.S. subspecialty surgical rhinology fellowship programs. Each year, 30 surgeons complete one of these fellowships, he said.

Technical innovations over the past 15 years have driven major advances in endoscopic sinus surgery. Powered microdebriders are used to precisely and efficiently remove hyperplastic mucosal disease and restore mucociliary clearance. Mucosal preservation is now a central tenet. Forward-thinking surgeons place a priority on creating exposure for delivery of topical medications. The procedures are routinely done on an outpatient basis, and they are less invasive than in former times. The outcomes are better, too, with this modern patient-centered, symptom-based approach.

"We have efficient ways now to take care of very severe disease atraumatically," Dr. Kingdom explained.

He emphasized that postoperative care is critical to successful sinus surgery outcomes. "My biggest criticism of my colleagues in otolaryngology is that many of them cut and go. There isn’t an emphasis on postoperative care," he said. "That’s a clear, clear deficiency in our approach.

"My postop schedule is to see patients at 1, 3, and 6 weeks and 3 and 6 months after surgery – and that’s if they’re doing perfectly. My point is you should have your otolaryngologist really fussing over these people. It’s not, ‘Well, it’s been a couple of weeks, you look fine, you can go back to your allergist now, I’ll see you later.’ It shouldn’t be that way," Dr. Kingdom said.

He reported having no financial conflicts of interest.

[email protected]

KEYSTONE, COLO. – Just how lousy do patients with medically refractory chronic rhinosinusitis feel in daily life? A lot worse than you might guess.

Patients who elected to undergo endoscopic sinus surgery after failing medical therapy for chronic rhinosinusitis (CRS) rated their own baseline health state on standardized measures as being well below U.S. population norms. Their degree of impairment was similar to the self-rated scores among age- and gender-matched individuals with end-stage renal disease or Parkinson’s disease, according to Dr. Todd T. Kingdom, professor and vice chairman of the department of otolaryngology, head and neck surgery, at the University of Colorado, Denver, and immediate past president of the American Rhinologic Society.

He cited a 5-year study that prospectively followed 232 adults with CRS who elected to undergo endoscopic sinus surgery (ESS) after failing to improve on medical therapy (Laryngoscope 2011;121:2672-8). Their mean presurgical health state utility value – derived using the Short Form 6D via methods routinely employed by health economists – was 0.65, on a scale in which 0 is death and 1.0 is perfect health.

That was worse than the self-rated scores among patients with heart failure or moderate COPD, as reported in other studies, and only slightly better than the self-rated health of patients awaiting hip replacement or liver transplantation. The U.S. population norm was a score of 0.81, Dr. Kingdom noted at a meeting on allergy and respiratory diseases sponsored by National Jewish Health.

When self-rated health status scores were determined again 6 months or longer after ESS, patients who underwent a revision procedure had a statistically and clinically significant 0.06-point improvement on the 0-1 scale, while those with no prior sinus surgery showed an even more robust 0.09-point gain.

Those are markedly larger improvements than documented in other studies following initiation of drug therapy for Parkinson’s disease, for example, or tumor necrosis factor–inhibitor therapy for psoriasis. Of the specific interventions assessed, only total hip replacement and bariatric surgery resulted in greater self-rated gains in health status than ESS.

In this and other studies, a patient’s baseline clinical phenotype didn’t predict the degree of improvement on quality of life measures following ESS, and gender, age, comorbid asthma, or aspirin-exacerbated respiratory disease did not influence how much benefit a patient would receive from ESS.

Patients with baseline self-reported depression, however, were slightly, albeit statistically significantly, less likely than nondepressed patients to experience significant improvement. And patients who presented without nasal polyps showed significantly more improvement in self-reported health status after ESS than did those with polyps.

Dr. Kingdom reported having no financial conflicts of interest.

[email protected]

KEYSTONE, COLO. – Just how lousy do patients with medically refractory chronic rhinosinusitis feel in daily life? A lot worse than you might guess.

Patients who elected to undergo endoscopic sinus surgery after failing medical therapy for chronic rhinosinusitis (CRS) rated their own baseline health state on standardized measures as being well below U.S. population norms. Their degree of impairment was similar to the self-rated scores among age- and gender-matched individuals with end-stage renal disease or Parkinson’s disease, according to Dr. Todd T. Kingdom, professor and vice chairman of the department of otolaryngology, head and neck surgery, at the University of Colorado, Denver, and immediate past president of the American Rhinologic Society.

He cited a 5-year study that prospectively followed 232 adults with CRS who elected to undergo endoscopic sinus surgery (ESS) after failing to improve on medical therapy (Laryngoscope 2011;121:2672-8). Their mean presurgical health state utility value – derived using the Short Form 6D via methods routinely employed by health economists – was 0.65, on a scale in which 0 is death and 1.0 is perfect health.

That was worse than the self-rated scores among patients with heart failure or moderate COPD, as reported in other studies, and only slightly better than the self-rated health of patients awaiting hip replacement or liver transplantation. The U.S. population norm was a score of 0.81, Dr. Kingdom noted at a meeting on allergy and respiratory diseases sponsored by National Jewish Health.

When self-rated health status scores were determined again 6 months or longer after ESS, patients who underwent a revision procedure had a statistically and clinically significant 0.06-point improvement on the 0-1 scale, while those with no prior sinus surgery showed an even more robust 0.09-point gain.

Those are markedly larger improvements than documented in other studies following initiation of drug therapy for Parkinson’s disease, for example, or tumor necrosis factor–inhibitor therapy for psoriasis. Of the specific interventions assessed, only total hip replacement and bariatric surgery resulted in greater self-rated gains in health status than ESS.

In this and other studies, a patient’s baseline clinical phenotype didn’t predict the degree of improvement on quality of life measures following ESS, and gender, age, comorbid asthma, or aspirin-exacerbated respiratory disease did not influence how much benefit a patient would receive from ESS.

Patients with baseline self-reported depression, however, were slightly, albeit statistically significantly, less likely than nondepressed patients to experience significant improvement. And patients who presented without nasal polyps showed significantly more improvement in self-reported health status after ESS than did those with polyps.

Dr. Kingdom reported having no financial conflicts of interest.

[email protected]

KEYSTONE, COLO. – Just how lousy do patients with medically refractory chronic rhinosinusitis feel in daily life? A lot worse than you might guess.

Patients who elected to undergo endoscopic sinus surgery after failing medical therapy for chronic rhinosinusitis (CRS) rated their own baseline health state on standardized measures as being well below U.S. population norms. Their degree of impairment was similar to the self-rated scores among age- and gender-matched individuals with end-stage renal disease or Parkinson’s disease, according to Dr. Todd T. Kingdom, professor and vice chairman of the department of otolaryngology, head and neck surgery, at the University of Colorado, Denver, and immediate past president of the American Rhinologic Society.

He cited a 5-year study that prospectively followed 232 adults with CRS who elected to undergo endoscopic sinus surgery (ESS) after failing to improve on medical therapy (Laryngoscope 2011;121:2672-8). Their mean presurgical health state utility value – derived using the Short Form 6D via methods routinely employed by health economists – was 0.65, on a scale in which 0 is death and 1.0 is perfect health.

That was worse than the self-rated scores among patients with heart failure or moderate COPD, as reported in other studies, and only slightly better than the self-rated health of patients awaiting hip replacement or liver transplantation. The U.S. population norm was a score of 0.81, Dr. Kingdom noted at a meeting on allergy and respiratory diseases sponsored by National Jewish Health.

When self-rated health status scores were determined again 6 months or longer after ESS, patients who underwent a revision procedure had a statistically and clinically significant 0.06-point improvement on the 0-1 scale, while those with no prior sinus surgery showed an even more robust 0.09-point gain.

Those are markedly larger improvements than documented in other studies following initiation of drug therapy for Parkinson’s disease, for example, or tumor necrosis factor–inhibitor therapy for psoriasis. Of the specific interventions assessed, only total hip replacement and bariatric surgery resulted in greater self-rated gains in health status than ESS.

In this and other studies, a patient’s baseline clinical phenotype didn’t predict the degree of improvement on quality of life measures following ESS, and gender, age, comorbid asthma, or aspirin-exacerbated respiratory disease did not influence how much benefit a patient would receive from ESS.

Patients with baseline self-reported depression, however, were slightly, albeit statistically significantly, less likely than nondepressed patients to experience significant improvement. And patients who presented without nasal polyps showed significantly more improvement in self-reported health status after ESS than did those with polyps.

Dr. Kingdom reported having no financial conflicts of interest.

[email protected]

As the economy continues its slow and uneven recovery, economic crime is on the rise, according to many law enforcement officials around the country.

Despite the current bull market, unemployment remains high and money remains tight.

Tight money increases embezzlement temptations, so this is an excellent time to review your bookkeeping procedures and remove any obvious opportunities for theft by your employees.

Embezzlement is more common than you might think. Discovering it is often easy, because most embezzlers are not particularly skillful at what they do, or adept at covering their tracks. But it often goes undetected, sometimes for years, simply because no one is looking for it.

The experience of a friend of mine was all too typical: His bookkeeper wrote sizable checks to herself, disguising them in the ledger as payments to vendors commonly used by his practice. Since she also balanced the checkbook, she got away with it for many months.

"It wasn’t at all clever," he told me. "And I’m somewhat chagrined to admit that it happened to me."

Is it happening to you, too? You won’t know unless you look.

Detecting fraud is an inexact science; there is no textbook approach that one can follow, but a few simple measures can uncover or prevent a large percentage of dishonest behavior:

• Hire honest employees. Check applicants’ references; find out if they are really as good as they look on paper. And for a few dollars, you can screen prospective employees on one of several public information websites to find out whether they have criminal records, or have been sued (or are suing others). My columns on hiring and background checks are in the archives at edermatologynews.com.

• Minimize opportunities for dishonesty. Theft and embezzlement are often products of opportunity, and there are many ways to minimize those opportunities. No one person should be in charge of the entire bookkeeping process. The person who enters charges should not be the one who enters payments. The employee who writes the checks should not balance the checkbook, and so on. Internal audits should occur on a regular basis, and all employees should know that. Your accountant can help with this.

• Reconcile receipts and cash daily. The most common form of embezzlement is simply employees taking cash out of the till. In a typical scenario, a patient pays a $15 copay in cash; the receptionist records the payment as $5 and pockets the rest. Make sure a receipt is generated for every cash transaction, and that someone other than the person accepting cash reconciles the receipts and the cash daily.

• Insist on separate accounting duties. Another common scam – the one to which my friend fell victim – is false invoices. You think you are paying for supplies and services, but the money is going to an employee. Once again, separation of duties is the key to prevention. One employee should enter invoices into the data system, another should issue the check or make the electronic transfer, and a third should match invoices to goods and services received.

• Verify expense reports. False expense reports are another common form of fraud. When an employee asks for reimbursement of expenses, make sure the expenses are real.

• Safeguard your computers. Today’s technology has made embezzlement easier and more tempting. Data are usually concentrated in one place, accounts can be accessed from remote workstations or off-premises servers, and a paper trail is often eliminated. Your computer vendor should be aware of this, and should have safeguards built into your system. Ask about them.

• Look for red flags. Do you have an employee who refuses to take vacations, because someone else will have to look at the books? Does someone insist on approving or entering expenses that are another employee’s responsibility? Is one employee suddenly living beyond his or her means?

• Consider bonding your employees. The mere knowledge that your staff is bonded will frighten off most dishonest applicants, and you will be assured of some measure of recovery should your safeguards fail.

Most embezzlement is not ingenious, or even particularly well concealed. It often sits in full view of physicians who are convinced that theft from within cannot happen to them. It can, and it does, but a little awareness can go a long way toward keeping it from happening to you.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He holds teaching positions at several hospitals and has delivered more than 500 academic speaking presentations. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Skin & Allergy News.

As the economy continues its slow and uneven recovery, economic crime is on the rise, according to many law enforcement officials around the country.

Despite the current bull market, unemployment remains high and money remains tight.

Tight money increases embezzlement temptations, so this is an excellent time to review your bookkeeping procedures and remove any obvious opportunities for theft by your employees.

Embezzlement is more common than you might think. Discovering it is often easy, because most embezzlers are not particularly skillful at what they do, or adept at covering their tracks. But it often goes undetected, sometimes for years, simply because no one is looking for it.

The experience of a friend of mine was all too typical: His bookkeeper wrote sizable checks to herself, disguising them in the ledger as payments to vendors commonly used by his practice. Since she also balanced the checkbook, she got away with it for many months.

"It wasn’t at all clever," he told me. "And I’m somewhat chagrined to admit that it happened to me."

Is it happening to you, too? You won’t know unless you look.

Detecting fraud is an inexact science; there is no textbook approach that one can follow, but a few simple measures can uncover or prevent a large percentage of dishonest behavior:

• Hire honest employees. Check applicants’ references; find out if they are really as good as they look on paper. And for a few dollars, you can screen prospective employees on one of several public information websites to find out whether they have criminal records, or have been sued (or are suing others). My columns on hiring and background checks are in the archives at edermatologynews.com.

• Minimize opportunities for dishonesty. Theft and embezzlement are often products of opportunity, and there are many ways to minimize those opportunities. No one person should be in charge of the entire bookkeeping process. The person who enters charges should not be the one who enters payments. The employee who writes the checks should not balance the checkbook, and so on. Internal audits should occur on a regular basis, and all employees should know that. Your accountant can help with this.

• Reconcile receipts and cash daily. The most common form of embezzlement is simply employees taking cash out of the till. In a typical scenario, a patient pays a $15 copay in cash; the receptionist records the payment as $5 and pockets the rest. Make sure a receipt is generated for every cash transaction, and that someone other than the person accepting cash reconciles the receipts and the cash daily.

• Insist on separate accounting duties. Another common scam – the one to which my friend fell victim – is false invoices. You think you are paying for supplies and services, but the money is going to an employee. Once again, separation of duties is the key to prevention. One employee should enter invoices into the data system, another should issue the check or make the electronic transfer, and a third should match invoices to goods and services received.

• Verify expense reports. False expense reports are another common form of fraud. When an employee asks for reimbursement of expenses, make sure the expenses are real.

• Safeguard your computers. Today’s technology has made embezzlement easier and more tempting. Data are usually concentrated in one place, accounts can be accessed from remote workstations or off-premises servers, and a paper trail is often eliminated. Your computer vendor should be aware of this, and should have safeguards built into your system. Ask about them.

• Look for red flags. Do you have an employee who refuses to take vacations, because someone else will have to look at the books? Does someone insist on approving or entering expenses that are another employee’s responsibility? Is one employee suddenly living beyond his or her means?

• Consider bonding your employees. The mere knowledge that your staff is bonded will frighten off most dishonest applicants, and you will be assured of some measure of recovery should your safeguards fail.

Most embezzlement is not ingenious, or even particularly well concealed. It often sits in full view of physicians who are convinced that theft from within cannot happen to them. It can, and it does, but a little awareness can go a long way toward keeping it from happening to you.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He holds teaching positions at several hospitals and has delivered more than 500 academic speaking presentations. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Skin & Allergy News.

As the economy continues its slow and uneven recovery, economic crime is on the rise, according to many law enforcement officials around the country.

Despite the current bull market, unemployment remains high and money remains tight.

Tight money increases embezzlement temptations, so this is an excellent time to review your bookkeeping procedures and remove any obvious opportunities for theft by your employees.

Embezzlement is more common than you might think. Discovering it is often easy, because most embezzlers are not particularly skillful at what they do, or adept at covering their tracks. But it often goes undetected, sometimes for years, simply because no one is looking for it.

The experience of a friend of mine was all too typical: His bookkeeper wrote sizable checks to herself, disguising them in the ledger as payments to vendors commonly used by his practice. Since she also balanced the checkbook, she got away with it for many months.

"It wasn’t at all clever," he told me. "And I’m somewhat chagrined to admit that it happened to me."

Is it happening to you, too? You won’t know unless you look.

Detecting fraud is an inexact science; there is no textbook approach that one can follow, but a few simple measures can uncover or prevent a large percentage of dishonest behavior:

• Hire honest employees. Check applicants’ references; find out if they are really as good as they look on paper. And for a few dollars, you can screen prospective employees on one of several public information websites to find out whether they have criminal records, or have been sued (or are suing others). My columns on hiring and background checks are in the archives at edermatologynews.com.

• Minimize opportunities for dishonesty. Theft and embezzlement are often products of opportunity, and there are many ways to minimize those opportunities. No one person should be in charge of the entire bookkeeping process. The person who enters charges should not be the one who enters payments. The employee who writes the checks should not balance the checkbook, and so on. Internal audits should occur on a regular basis, and all employees should know that. Your accountant can help with this.

• Reconcile receipts and cash daily. The most common form of embezzlement is simply employees taking cash out of the till. In a typical scenario, a patient pays a $15 copay in cash; the receptionist records the payment as $5 and pockets the rest. Make sure a receipt is generated for every cash transaction, and that someone other than the person accepting cash reconciles the receipts and the cash daily.

• Insist on separate accounting duties. Another common scam – the one to which my friend fell victim – is false invoices. You think you are paying for supplies and services, but the money is going to an employee. Once again, separation of duties is the key to prevention. One employee should enter invoices into the data system, another should issue the check or make the electronic transfer, and a third should match invoices to goods and services received.

• Verify expense reports. False expense reports are another common form of fraud. When an employee asks for reimbursement of expenses, make sure the expenses are real.

• Safeguard your computers. Today’s technology has made embezzlement easier and more tempting. Data are usually concentrated in one place, accounts can be accessed from remote workstations or off-premises servers, and a paper trail is often eliminated. Your computer vendor should be aware of this, and should have safeguards built into your system. Ask about them.

• Look for red flags. Do you have an employee who refuses to take vacations, because someone else will have to look at the books? Does someone insist on approving or entering expenses that are another employee’s responsibility? Is one employee suddenly living beyond his or her means?

• Consider bonding your employees. The mere knowledge that your staff is bonded will frighten off most dishonest applicants, and you will be assured of some measure of recovery should your safeguards fail.

Most embezzlement is not ingenious, or even particularly well concealed. It often sits in full view of physicians who are convinced that theft from within cannot happen to them. It can, and it does, but a little awareness can go a long way toward keeping it from happening to you.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He holds teaching positions at several hospitals and has delivered more than 500 academic speaking presentations. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Skin & Allergy News.

For decades, surgeons have been at the forefront of the palliative care movement. From the historic utilization of palliative operations to relieve suffering to creation of the American College of Surgeons Palliative Care Task Force, surgeons are often first-line palliative care providers in the management of patients with advanced malignancy.

Palliative care involves paying attention to symptom distress, communicating with patients and families about goals of care in relation to prognosis and patient preferences, planning transitions, and engaging family support. Yet, despite a clear and established role, many surgeons are not prepared to effectively provide palliative care, and they are often resistant to the use of specialty palliative care services.

In my own training, I have witnessed apprehension and failure to use palliative care services. In one instance, I was managing an older patient after a complicated sarcoma resection. The patient suffered complications, which kept him hospitalized and returning to the hospital after short periods at a long-term acute care facility. I suggested that we call palliative care for assistance in management of the patient. He had pain, nausea, and poor oral intake, and he was depressed and anxious about his future. I was told "we don’t want the patient believing we were giving up on him."

After 3 weeks of minimal change, my attending relented. In a short time, the patient’s pain and nausea were better controlled, and we were able to have discussions with the patient and his family to clarify goals of care. Some of the symptom management techniques used methods that I had not yet encountered in my training and that seemed foreign and curious. But seeing the response left no question as to their utility. The patient was able to leave the hospital 2 weeks later with the palliative care service coordinating his management with the primary care provider and surgical team. This was a positive resolution to a significant problem. But what really hindered palliative care use?

Roadblocks include the term palliative having a negative connotation, being equated with "failure." Increased use of quality metrics may deincentivize palliative operations. Also, there is poor training and support for surgeons to provide primary palliative care services themselves. Yet, despite these barriers, there are opportunities for surgeons to improve care of patients with advanced malignancy by improving surgeon-patient communication and giving greater emphasis to advanced care planning prior to operative interventions.

As front-line providers for these patients, surgeons are an ideal conduit for delivery and improved use of early palliative care. My practice includes a discussion of advanced care planning with all of my cancer patients. I introduce this as a normal part of every discussion and refer the patient to the primary care provider or our Quality of Life service to facilitate further conversations and documentation. By destigmatizing the discussion for patients and families, a door is opened to an important part of comprehensive quality care. We must understand that diseases progress and complications occur. Failing to provide preemptive support to patients and families is true failure. With a preemptive approach, patients, families, and caregivers have a better understanding of the medical situation, and the latter can more effectively support the patient.

To standardize the role that surgeons routinely play in management of patients with advanced malignancy, efforts must focus on education and research. The role of education is twofold. First, surgical trainees need adequate tools to perform routine palliative care and an understanding of the appropriate timing to refer for specialized services. There have been multiple national efforts focused on teaching palliative care to varied practitioners. But given the aging population and the paucity of specialist palliative care providers, a renewed effort is needed. Second, surgeons must understand the role that palliative care plays and the benefits their patients can derive from it. Surgeons are routinely involved throughout the course of care of patients with malignancy from diagnosis to the end of life. Recognition of palliative care as a skill along the continuum of care already provided will improve outcomes.

Finally, research must focus on both models of use of palliative care and the quality of current practice. Palliative care as it pertains to surgeons is understudied: What teaching formats are most likely to affect clinical practice? What components of palliative care have an impact in surgical practice? What is the optimal timing and venue for providing palliative care in surgical practice? What health care system changes are needed to support surgeons to provide primary palliative care services?

We are uniquely aware of the complexities of care needed for management of patients with advanced malignancies. We are routinely called on to aid in the management of these patients. Surgical educators and researchers should focus their efforts on what is needed to fully integrate palliative care into patient-centered care already provided by trainees and surgeons.

Dr. Johnston is an assistant professor of surgery in the division of surgical oncology at the Medical College of Wisconsin, Milwaukee. He disclosed no conflicts.

For decades, surgeons have been at the forefront of the palliative care movement. From the historic utilization of palliative operations to relieve suffering to creation of the American College of Surgeons Palliative Care Task Force, surgeons are often first-line palliative care providers in the management of patients with advanced malignancy.

Palliative care involves paying attention to symptom distress, communicating with patients and families about goals of care in relation to prognosis and patient preferences, planning transitions, and engaging family support. Yet, despite a clear and established role, many surgeons are not prepared to effectively provide palliative care, and they are often resistant to the use of specialty palliative care services.

In my own training, I have witnessed apprehension and failure to use palliative care services. In one instance, I was managing an older patient after a complicated sarcoma resection. The patient suffered complications, which kept him hospitalized and returning to the hospital after short periods at a long-term acute care facility. I suggested that we call palliative care for assistance in management of the patient. He had pain, nausea, and poor oral intake, and he was depressed and anxious about his future. I was told "we don’t want the patient believing we were giving up on him."

After 3 weeks of minimal change, my attending relented. In a short time, the patient’s pain and nausea were better controlled, and we were able to have discussions with the patient and his family to clarify goals of care. Some of the symptom management techniques used methods that I had not yet encountered in my training and that seemed foreign and curious. But seeing the response left no question as to their utility. The patient was able to leave the hospital 2 weeks later with the palliative care service coordinating his management with the primary care provider and surgical team. This was a positive resolution to a significant problem. But what really hindered palliative care use?

Roadblocks include the term palliative having a negative connotation, being equated with "failure." Increased use of quality metrics may deincentivize palliative operations. Also, there is poor training and support for surgeons to provide primary palliative care services themselves. Yet, despite these barriers, there are opportunities for surgeons to improve care of patients with advanced malignancy by improving surgeon-patient communication and giving greater emphasis to advanced care planning prior to operative interventions.

As front-line providers for these patients, surgeons are an ideal conduit for delivery and improved use of early palliative care. My practice includes a discussion of advanced care planning with all of my cancer patients. I introduce this as a normal part of every discussion and refer the patient to the primary care provider or our Quality of Life service to facilitate further conversations and documentation. By destigmatizing the discussion for patients and families, a door is opened to an important part of comprehensive quality care. We must understand that diseases progress and complications occur. Failing to provide preemptive support to patients and families is true failure. With a preemptive approach, patients, families, and caregivers have a better understanding of the medical situation, and the latter can more effectively support the patient.

To standardize the role that surgeons routinely play in management of patients with advanced malignancy, efforts must focus on education and research. The role of education is twofold. First, surgical trainees need adequate tools to perform routine palliative care and an understanding of the appropriate timing to refer for specialized services. There have been multiple national efforts focused on teaching palliative care to varied practitioners. But given the aging population and the paucity of specialist palliative care providers, a renewed effort is needed. Second, surgeons must understand the role that palliative care plays and the benefits their patients can derive from it. Surgeons are routinely involved throughout the course of care of patients with malignancy from diagnosis to the end of life. Recognition of palliative care as a skill along the continuum of care already provided will improve outcomes.

Finally, research must focus on both models of use of palliative care and the quality of current practice. Palliative care as it pertains to surgeons is understudied: What teaching formats are most likely to affect clinical practice? What components of palliative care have an impact in surgical practice? What is the optimal timing and venue for providing palliative care in surgical practice? What health care system changes are needed to support surgeons to provide primary palliative care services?

We are uniquely aware of the complexities of care needed for management of patients with advanced malignancies. We are routinely called on to aid in the management of these patients. Surgical educators and researchers should focus their efforts on what is needed to fully integrate palliative care into patient-centered care already provided by trainees and surgeons.

Dr. Johnston is an assistant professor of surgery in the division of surgical oncology at the Medical College of Wisconsin, Milwaukee. He disclosed no conflicts.

For decades, surgeons have been at the forefront of the palliative care movement. From the historic utilization of palliative operations to relieve suffering to creation of the American College of Surgeons Palliative Care Task Force, surgeons are often first-line palliative care providers in the management of patients with advanced malignancy.

Palliative care involves paying attention to symptom distress, communicating with patients and families about goals of care in relation to prognosis and patient preferences, planning transitions, and engaging family support. Yet, despite a clear and established role, many surgeons are not prepared to effectively provide palliative care, and they are often resistant to the use of specialty palliative care services.

In my own training, I have witnessed apprehension and failure to use palliative care services. In one instance, I was managing an older patient after a complicated sarcoma resection. The patient suffered complications, which kept him hospitalized and returning to the hospital after short periods at a long-term acute care facility. I suggested that we call palliative care for assistance in management of the patient. He had pain, nausea, and poor oral intake, and he was depressed and anxious about his future. I was told "we don’t want the patient believing we were giving up on him."

After 3 weeks of minimal change, my attending relented. In a short time, the patient’s pain and nausea were better controlled, and we were able to have discussions with the patient and his family to clarify goals of care. Some of the symptom management techniques used methods that I had not yet encountered in my training and that seemed foreign and curious. But seeing the response left no question as to their utility. The patient was able to leave the hospital 2 weeks later with the palliative care service coordinating his management with the primary care provider and surgical team. This was a positive resolution to a significant problem. But what really hindered palliative care use?

Roadblocks include the term palliative having a negative connotation, being equated with "failure." Increased use of quality metrics may deincentivize palliative operations. Also, there is poor training and support for surgeons to provide primary palliative care services themselves. Yet, despite these barriers, there are opportunities for surgeons to improve care of patients with advanced malignancy by improving surgeon-patient communication and giving greater emphasis to advanced care planning prior to operative interventions.

As front-line providers for these patients, surgeons are an ideal conduit for delivery and improved use of early palliative care. My practice includes a discussion of advanced care planning with all of my cancer patients. I introduce this as a normal part of every discussion and refer the patient to the primary care provider or our Quality of Life service to facilitate further conversations and documentation. By destigmatizing the discussion for patients and families, a door is opened to an important part of comprehensive quality care. We must understand that diseases progress and complications occur. Failing to provide preemptive support to patients and families is true failure. With a preemptive approach, patients, families, and caregivers have a better understanding of the medical situation, and the latter can more effectively support the patient.

To standardize the role that surgeons routinely play in management of patients with advanced malignancy, efforts must focus on education and research. The role of education is twofold. First, surgical trainees need adequate tools to perform routine palliative care and an understanding of the appropriate timing to refer for specialized services. There have been multiple national efforts focused on teaching palliative care to varied practitioners. But given the aging population and the paucity of specialist palliative care providers, a renewed effort is needed. Second, surgeons must understand the role that palliative care plays and the benefits their patients can derive from it. Surgeons are routinely involved throughout the course of care of patients with malignancy from diagnosis to the end of life. Recognition of palliative care as a skill along the continuum of care already provided will improve outcomes.

Finally, research must focus on both models of use of palliative care and the quality of current practice. Palliative care as it pertains to surgeons is understudied: What teaching formats are most likely to affect clinical practice? What components of palliative care have an impact in surgical practice? What is the optimal timing and venue for providing palliative care in surgical practice? What health care system changes are needed to support surgeons to provide primary palliative care services?

We are uniquely aware of the complexities of care needed for management of patients with advanced malignancies. We are routinely called on to aid in the management of these patients. Surgical educators and researchers should focus their efforts on what is needed to fully integrate palliative care into patient-centered care already provided by trainees and surgeons.

Dr. Johnston is an assistant professor of surgery in the division of surgical oncology at the Medical College of Wisconsin, Milwaukee. He disclosed no conflicts.

Antihemophilic factor

The US Food and Drug Administration (FDA) has approved a new indication for the recombinant antihemophilic factor VIII product octocog alfa (Kogenate).

It is now approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.

Octocog alfa was already FDA-approved for the control and prevention of bleeding episodes in adults and children with hemophilia A, for perioperative management in adults and children with hemophilia A, as routine prophylaxis in children with hemophilia A, and to reduce the risk of joint damage in children without pre-existing joint damage.

The FDA’s latest approval is based on data from the SPINART study, in which patients were randomized to receive prophylactic octocog alfa or on-demand treatment. The study was sponsored by Bayer Healthcare, the company developing octocog alfa.

“In Bayer’s SPINART study, adult patients with hemophilia A on the prophylactic regimen experienced significantly fewer bleeding events than those using on-demand treatment,” said Marilyn Manco-Johnson, MD, principal investigator of the study and director at of the Mountain States Regional Hemophilia and Thrombosis Center at the University of Colorado at Denver and Health Sciences Center.

Results of the SPINART study were presented at the World Federation of Hemophilia 2012 World Congress and published in The Journal of Thrombosis and Haemostasis.

The study included 84 patients, ages 15 to 50, with hemophilia A. They were randomized to a prophylaxis regimen of 25 IU/kg 3 times per week (n=42) or on-demand treatment (n=42). Escalation by 5 IU/kg (to 30 or 35 IU/kg maximum) was allowed for subjects with 12 or more annual bleeds after 1 and 2 years.

Patients were stratified based on target joints (presence/absence) and the number of bleeding events in the previous 6 months (≥15 vs <15 annualized bleeds).

Patients who received prophylaxis experienced significantly fewer bleeds (P<0.0001) than patients treated on demand, regardless of factors such as age, bleeding history, and the presence or absence of target joints.

The ratio of the mean bleeding frequency was 15.2 (P<0.0001) for on-demand vs prophylaxis, indicating that patients who received on-demand treatment experienced, on average, 15.2 times as many bleeds as patients treated prophylactically.

The mean annualized bleed rates (bleeds/subject/year) were 37 in the on-demand group versus 2 in the prophylaxis group. The median annualized bleed rate in the on-demand group was 33 versus 0 in the prophylaxis group.

Fifty-two percent (22/42) of prophylaxis subjects experienced no bleeding, and 29% (12/42) of prophylaxis subjects experienced 1 to 2 bleeds during the follow-up period.

Adverse events were consistent with the existing safety profile for octocog alfa. The most common adverse reactions (≥4%) were inhibitor formation in previously untreated and minimally treated patients, skin-related hypersensitivity reactions (eg, rash, pruritus), infusion-site reactions (eg, inflammation, pain), and infections associated with a central venous access device.

Serious adverse reactions associated with octocog alfa include systemic hypersensitivity reactions—bronchospastic reactions and/or hypotension and anaphylaxis—and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.

For more details on octocog alfa, see the full prescribing information.

Antihemophilic factor

The US Food and Drug Administration (FDA) has approved a new indication for the recombinant antihemophilic factor VIII product octocog alfa (Kogenate).

It is now approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.

Octocog alfa was already FDA-approved for the control and prevention of bleeding episodes in adults and children with hemophilia A, for perioperative management in adults and children with hemophilia A, as routine prophylaxis in children with hemophilia A, and to reduce the risk of joint damage in children without pre-existing joint damage.

The FDA’s latest approval is based on data from the SPINART study, in which patients were randomized to receive prophylactic octocog alfa or on-demand treatment. The study was sponsored by Bayer Healthcare, the company developing octocog alfa.

“In Bayer’s SPINART study, adult patients with hemophilia A on the prophylactic regimen experienced significantly fewer bleeding events than those using on-demand treatment,” said Marilyn Manco-Johnson, MD, principal investigator of the study and director at of the Mountain States Regional Hemophilia and Thrombosis Center at the University of Colorado at Denver and Health Sciences Center.

Results of the SPINART study were presented at the World Federation of Hemophilia 2012 World Congress and published in The Journal of Thrombosis and Haemostasis.

The study included 84 patients, ages 15 to 50, with hemophilia A. They were randomized to a prophylaxis regimen of 25 IU/kg 3 times per week (n=42) or on-demand treatment (n=42). Escalation by 5 IU/kg (to 30 or 35 IU/kg maximum) was allowed for subjects with 12 or more annual bleeds after 1 and 2 years.

Patients were stratified based on target joints (presence/absence) and the number of bleeding events in the previous 6 months (≥15 vs <15 annualized bleeds).

Patients who received prophylaxis experienced significantly fewer bleeds (P<0.0001) than patients treated on demand, regardless of factors such as age, bleeding history, and the presence or absence of target joints.

The ratio of the mean bleeding frequency was 15.2 (P<0.0001) for on-demand vs prophylaxis, indicating that patients who received on-demand treatment experienced, on average, 15.2 times as many bleeds as patients treated prophylactically.

The mean annualized bleed rates (bleeds/subject/year) were 37 in the on-demand group versus 2 in the prophylaxis group. The median annualized bleed rate in the on-demand group was 33 versus 0 in the prophylaxis group.

Fifty-two percent (22/42) of prophylaxis subjects experienced no bleeding, and 29% (12/42) of prophylaxis subjects experienced 1 to 2 bleeds during the follow-up period.

Adverse events were consistent with the existing safety profile for octocog alfa. The most common adverse reactions (≥4%) were inhibitor formation in previously untreated and minimally treated patients, skin-related hypersensitivity reactions (eg, rash, pruritus), infusion-site reactions (eg, inflammation, pain), and infections associated with a central venous access device.

Serious adverse reactions associated with octocog alfa include systemic hypersensitivity reactions—bronchospastic reactions and/or hypotension and anaphylaxis—and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.

For more details on octocog alfa, see the full prescribing information.

Antihemophilic factor

The US Food and Drug Administration (FDA) has approved a new indication for the recombinant antihemophilic factor VIII product octocog alfa (Kogenate).

It is now approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.

Octocog alfa was already FDA-approved for the control and prevention of bleeding episodes in adults and children with hemophilia A, for perioperative management in adults and children with hemophilia A, as routine prophylaxis in children with hemophilia A, and to reduce the risk of joint damage in children without pre-existing joint damage.

The FDA’s latest approval is based on data from the SPINART study, in which patients were randomized to receive prophylactic octocog alfa or on-demand treatment. The study was sponsored by Bayer Healthcare, the company developing octocog alfa.

“In Bayer’s SPINART study, adult patients with hemophilia A on the prophylactic regimen experienced significantly fewer bleeding events than those using on-demand treatment,” said Marilyn Manco-Johnson, MD, principal investigator of the study and director at of the Mountain States Regional Hemophilia and Thrombosis Center at the University of Colorado at Denver and Health Sciences Center.

Results of the SPINART study were presented at the World Federation of Hemophilia 2012 World Congress and published in The Journal of Thrombosis and Haemostasis.

The study included 84 patients, ages 15 to 50, with hemophilia A. They were randomized to a prophylaxis regimen of 25 IU/kg 3 times per week (n=42) or on-demand treatment (n=42). Escalation by 5 IU/kg (to 30 or 35 IU/kg maximum) was allowed for subjects with 12 or more annual bleeds after 1 and 2 years.

Patients were stratified based on target joints (presence/absence) and the number of bleeding events in the previous 6 months (≥15 vs <15 annualized bleeds).

Patients who received prophylaxis experienced significantly fewer bleeds (P<0.0001) than patients treated on demand, regardless of factors such as age, bleeding history, and the presence or absence of target joints.

The ratio of the mean bleeding frequency was 15.2 (P<0.0001) for on-demand vs prophylaxis, indicating that patients who received on-demand treatment experienced, on average, 15.2 times as many bleeds as patients treated prophylactically.

The mean annualized bleed rates (bleeds/subject/year) were 37 in the on-demand group versus 2 in the prophylaxis group. The median annualized bleed rate in the on-demand group was 33 versus 0 in the prophylaxis group.

Fifty-two percent (22/42) of prophylaxis subjects experienced no bleeding, and 29% (12/42) of prophylaxis subjects experienced 1 to 2 bleeds during the follow-up period.

Adverse events were consistent with the existing safety profile for octocog alfa. The most common adverse reactions (≥4%) were inhibitor formation in previously untreated and minimally treated patients, skin-related hypersensitivity reactions (eg, rash, pruritus), infusion-site reactions (eg, inflammation, pain), and infections associated with a central venous access device.

Serious adverse reactions associated with octocog alfa include systemic hypersensitivity reactions—bronchospastic reactions and/or hypotension and anaphylaxis—and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.

For more details on octocog alfa, see the full prescribing information.