Management of recurrent non-small cell lung cancer (NSCLC) is a clinical challenge. Around one third of patients who are diagnosed with NSCLC will experience a localregional or advanced stage recurrence. The median time to recurrence from initial diagnosis is 11.5 months. The median age of initial diagnosis of NSCLC is 71 years of age, patients with recurrent disease tend therefore to be even older. Treatment is a challenge, as this elderly patient population tends to have multiple comorbidities, polypharmacy and socioeconomic factors, that have not been accounted for in clinical trials in patients that define our current treatment recommendations. This case-based review outlines some of these challenges and outlines the need for further research.

*For a PDF of the full article, click in the link to the left of this introduction.

Management of recurrent non-small cell lung cancer (NSCLC) is a clinical challenge. Around one third of patients who are diagnosed with NSCLC will experience a localregional or advanced stage recurrence. The median time to recurrence from initial diagnosis is 11.5 months. The median age of initial diagnosis of NSCLC is 71 years of age, patients with recurrent disease tend therefore to be even older. Treatment is a challenge, as this elderly patient population tends to have multiple comorbidities, polypharmacy and socioeconomic factors, that have not been accounted for in clinical trials in patients that define our current treatment recommendations. This case-based review outlines some of these challenges and outlines the need for further research.

*For a PDF of the full article, click in the link to the left of this introduction.

Management of recurrent non-small cell lung cancer (NSCLC) is a clinical challenge. Around one third of patients who are diagnosed with NSCLC will experience a localregional or advanced stage recurrence. The median time to recurrence from initial diagnosis is 11.5 months. The median age of initial diagnosis of NSCLC is 71 years of age, patients with recurrent disease tend therefore to be even older. Treatment is a challenge, as this elderly patient population tends to have multiple comorbidities, polypharmacy and socioeconomic factors, that have not been accounted for in clinical trials in patients that define our current treatment recommendations. This case-based review outlines some of these challenges and outlines the need for further research.

*For a PDF of the full article, click in the link to the left of this introduction.

BOSTON – Children who present to a primary care practice following a head or facial injury must be carefully evaluated for signs and symptoms of concussion, and those with concussion should be advised to give their brains a break, recommended a pediatric injury specialist at the annual meeting of the Pediatric Academic Societies.

Cognitive rest involves limiting "cognitive activity to a level that does not elicit symptoms." For children, this means forgoing computers, video games, texting/social media, reading for school and/or homework, and avoiding noisy or busy environments.

"The primary focus of pediatric concussion management should be return to cognitive activities and then return to the playing field," Dr. Kristy B. Arbogast said.

A review of records from a large pediatric primary care network showed that 25% of patients with concussion symptoms did not have concussion mentioned in the medical assessment or diagnosis, and nearly half of children in a random sample presented for reevaluation of concussion or persistent concussion symptoms, said Dr. Arbogast, an emergency physician and director of the Pediatric Injury Prevention Program at Children’s Hospital of Philadelphia.

"So-called ‘mild’ traumatic brain injuries are often far from mild. They lead to poor neurological outcomes that can adversely affect a child’s quality of life," she said.

Children with concussion make an estimated 144,000 emergency department visits annually in the United States. As children’s participation in year-round sports has increased, their risk of mild traumatic brain injury (TBI) has also increased, Dr. Arbogast noted.

Concussions among professional athletes receive considerable attention in the popular press, where the stories center on physical recovery and returning to the game. But for school kids, who are at significant risk for learning disabilities, memory problems, and emotional or behavioral changes after a TBI, the focus should be on physical and cognitive rest, she said.

Dr. Arbogast and her colleagues reviewed the concussion management and return-to-school practices of pediatric primary care providers by reviewing records from their hospital’s primary care network.

They looked for data on children aged 5-18 years with any presentation of mild TBI based on ICD-9 codes for skull fracture, concussion, intracranial injury, head injury (unspecified), or facial fracture. The children received initial or continuing care during the study period of July 2010 through June 2011.

The researchers included children who presented with one or more injury characteristics such as amnesia, loss of consciousness, cognitive symptoms (decline in school performance, report of being "in a fog"), emotional symptoms, and physical symptoms or exam findings including eye-tracking problems, headache, nausea/vomiting, poor balance, sleep disturbances, slow reaction times, or visual disturbance. Children with moderate or severe head trauma were excluded from the study.

The investigators randomly selected a sample of 193 patients who met all of the criteria. In all, 51% had a sports-related injury, 8% had previously had a concussion, and 6% had sustained a loss of consciousness.

There was no mention of concussion in the medical assessment or diagnosis of 25% of the sample. Of 94 children who presented for reevaluation of concussion, 33% reported a decline in school performance, 13% said they felt like they were "in a fog," 12% reported vision problems, 12% reported fatigue, and 11% had concentration problems (some reported more than one symptom).

When the authors looked at the written instructions primary care providers gave to the patients, they found that while 54% received return-to-play instructions, only 34% received return-to-school instructions, suggesting that in many cases the practitioners may have failed to recognize the importance of cognitive rest, Dr. Arbogast said. The remaining 12% of patients did not have written instructions documented.

She recommended that clinicians caring for children with suspected concussion ask about all symptoms individually in a systematic fashion, and prescribe a return-to-school protocol with a stepwise approach. The protocol includes a return to the previous step if an action elicits the return of symptoms, sending a standardized letter to notify the child’s school of the plan, and training the child’s parent or guardian to oversee the child’s progression from one step to the next.

The study was funded by the Children’s Hospital of Philadelphia and the University of Pennsylvania, also in Philadelphia. Dr. Arbogast and coinvestigators reported having no conflicts of interest to disclose.

BOSTON – Children who present to a primary care practice following a head or facial injury must be carefully evaluated for signs and symptoms of concussion, and those with concussion should be advised to give their brains a break, recommended a pediatric injury specialist at the annual meeting of the Pediatric Academic Societies.

Cognitive rest involves limiting "cognitive activity to a level that does not elicit symptoms." For children, this means forgoing computers, video games, texting/social media, reading for school and/or homework, and avoiding noisy or busy environments.

"The primary focus of pediatric concussion management should be return to cognitive activities and then return to the playing field," Dr. Kristy B. Arbogast said.

A review of records from a large pediatric primary care network showed that 25% of patients with concussion symptoms did not have concussion mentioned in the medical assessment or diagnosis, and nearly half of children in a random sample presented for reevaluation of concussion or persistent concussion symptoms, said Dr. Arbogast, an emergency physician and director of the Pediatric Injury Prevention Program at Children’s Hospital of Philadelphia.

"So-called ‘mild’ traumatic brain injuries are often far from mild. They lead to poor neurological outcomes that can adversely affect a child’s quality of life," she said.

Children with concussion make an estimated 144,000 emergency department visits annually in the United States. As children’s participation in year-round sports has increased, their risk of mild traumatic brain injury (TBI) has also increased, Dr. Arbogast noted.

Concussions among professional athletes receive considerable attention in the popular press, where the stories center on physical recovery and returning to the game. But for school kids, who are at significant risk for learning disabilities, memory problems, and emotional or behavioral changes after a TBI, the focus should be on physical and cognitive rest, she said.

Dr. Arbogast and her colleagues reviewed the concussion management and return-to-school practices of pediatric primary care providers by reviewing records from their hospital’s primary care network.

They looked for data on children aged 5-18 years with any presentation of mild TBI based on ICD-9 codes for skull fracture, concussion, intracranial injury, head injury (unspecified), or facial fracture. The children received initial or continuing care during the study period of July 2010 through June 2011.

The researchers included children who presented with one or more injury characteristics such as amnesia, loss of consciousness, cognitive symptoms (decline in school performance, report of being "in a fog"), emotional symptoms, and physical symptoms or exam findings including eye-tracking problems, headache, nausea/vomiting, poor balance, sleep disturbances, slow reaction times, or visual disturbance. Children with moderate or severe head trauma were excluded from the study.

The investigators randomly selected a sample of 193 patients who met all of the criteria. In all, 51% had a sports-related injury, 8% had previously had a concussion, and 6% had sustained a loss of consciousness.

There was no mention of concussion in the medical assessment or diagnosis of 25% of the sample. Of 94 children who presented for reevaluation of concussion, 33% reported a decline in school performance, 13% said they felt like they were "in a fog," 12% reported vision problems, 12% reported fatigue, and 11% had concentration problems (some reported more than one symptom).

When the authors looked at the written instructions primary care providers gave to the patients, they found that while 54% received return-to-play instructions, only 34% received return-to-school instructions, suggesting that in many cases the practitioners may have failed to recognize the importance of cognitive rest, Dr. Arbogast said. The remaining 12% of patients did not have written instructions documented.

She recommended that clinicians caring for children with suspected concussion ask about all symptoms individually in a systematic fashion, and prescribe a return-to-school protocol with a stepwise approach. The protocol includes a return to the previous step if an action elicits the return of symptoms, sending a standardized letter to notify the child’s school of the plan, and training the child’s parent or guardian to oversee the child’s progression from one step to the next.

The study was funded by the Children’s Hospital of Philadelphia and the University of Pennsylvania, also in Philadelphia. Dr. Arbogast and coinvestigators reported having no conflicts of interest to disclose.

BOSTON – Children who present to a primary care practice following a head or facial injury must be carefully evaluated for signs and symptoms of concussion, and those with concussion should be advised to give their brains a break, recommended a pediatric injury specialist at the annual meeting of the Pediatric Academic Societies.

Cognitive rest involves limiting "cognitive activity to a level that does not elicit symptoms." For children, this means forgoing computers, video games, texting/social media, reading for school and/or homework, and avoiding noisy or busy environments.

"The primary focus of pediatric concussion management should be return to cognitive activities and then return to the playing field," Dr. Kristy B. Arbogast said.

A review of records from a large pediatric primary care network showed that 25% of patients with concussion symptoms did not have concussion mentioned in the medical assessment or diagnosis, and nearly half of children in a random sample presented for reevaluation of concussion or persistent concussion symptoms, said Dr. Arbogast, an emergency physician and director of the Pediatric Injury Prevention Program at Children’s Hospital of Philadelphia.

"So-called ‘mild’ traumatic brain injuries are often far from mild. They lead to poor neurological outcomes that can adversely affect a child’s quality of life," she said.

Children with concussion make an estimated 144,000 emergency department visits annually in the United States. As children’s participation in year-round sports has increased, their risk of mild traumatic brain injury (TBI) has also increased, Dr. Arbogast noted.

Concussions among professional athletes receive considerable attention in the popular press, where the stories center on physical recovery and returning to the game. But for school kids, who are at significant risk for learning disabilities, memory problems, and emotional or behavioral changes after a TBI, the focus should be on physical and cognitive rest, she said.

Dr. Arbogast and her colleagues reviewed the concussion management and return-to-school practices of pediatric primary care providers by reviewing records from their hospital’s primary care network.

They looked for data on children aged 5-18 years with any presentation of mild TBI based on ICD-9 codes for skull fracture, concussion, intracranial injury, head injury (unspecified), or facial fracture. The children received initial or continuing care during the study period of July 2010 through June 2011.

The researchers included children who presented with one or more injury characteristics such as amnesia, loss of consciousness, cognitive symptoms (decline in school performance, report of being "in a fog"), emotional symptoms, and physical symptoms or exam findings including eye-tracking problems, headache, nausea/vomiting, poor balance, sleep disturbances, slow reaction times, or visual disturbance. Children with moderate or severe head trauma were excluded from the study.

The investigators randomly selected a sample of 193 patients who met all of the criteria. In all, 51% had a sports-related injury, 8% had previously had a concussion, and 6% had sustained a loss of consciousness.

There was no mention of concussion in the medical assessment or diagnosis of 25% of the sample. Of 94 children who presented for reevaluation of concussion, 33% reported a decline in school performance, 13% said they felt like they were "in a fog," 12% reported vision problems, 12% reported fatigue, and 11% had concentration problems (some reported more than one symptom).

When the authors looked at the written instructions primary care providers gave to the patients, they found that while 54% received return-to-play instructions, only 34% received return-to-school instructions, suggesting that in many cases the practitioners may have failed to recognize the importance of cognitive rest, Dr. Arbogast said. The remaining 12% of patients did not have written instructions documented.

She recommended that clinicians caring for children with suspected concussion ask about all symptoms individually in a systematic fashion, and prescribe a return-to-school protocol with a stepwise approach. The protocol includes a return to the previous step if an action elicits the return of symptoms, sending a standardized letter to notify the child’s school of the plan, and training the child’s parent or guardian to oversee the child’s progression from one step to the next.

The study was funded by the Children’s Hospital of Philadelphia and the University of Pennsylvania, also in Philadelphia. Dr. Arbogast and coinvestigators reported having no conflicts of interest to disclose.

ABSTRACT

Background: Little is known about how young adults (YAs) cope with cancer or about the relationship between coping and psychological distress in YAs with advanced cancer.

Objectives: The goals of this study were to identify coping strategies
used by YAs with advanced cancer and examine the relationship between
these coping strategies and psychological distress.

Methods: Using structured clinical interviews with 53 YAs (aged 20–40 years) with advanced cancer, researchers assessed coping methods, depression, anxiety, and grief. A principal components factor analysis identified underlying coping factors. Regression analyses examined the relationship between these coping factors and depression, anxiety, and grief.

Results: Six coping factors emerged and were labeled as proactive, distancing, negative expression, support-seeking, respite-seeking, and acceptance coping. Acceptance and support-seeking coping styles were used most frequently. Coping by negative expression was positively associated with severity of grief after researchers controlled for depression, anxiety, and confounding variables. Support-seeking coping was positively associated with anxiety after researchers controlled for depression and grief.

Limitations: This study was limited by a cross-sectional design, small sample size, and focus on YAs with advanced cancer.

Conclusions: YAs with advanced cancer utilize a range of coping responses that are uniquely related to psychological distress.

To read this article, click on the FILES link at left.

ABSTRACT

Background: Little is known about how young adults (YAs) cope with cancer or about the relationship between coping and psychological distress in YAs with advanced cancer.

Objectives: The goals of this study were to identify coping strategies
used by YAs with advanced cancer and examine the relationship between
these coping strategies and psychological distress.

Methods: Using structured clinical interviews with 53 YAs (aged 20–40 years) with advanced cancer, researchers assessed coping methods, depression, anxiety, and grief. A principal components factor analysis identified underlying coping factors. Regression analyses examined the relationship between these coping factors and depression, anxiety, and grief.

Results: Six coping factors emerged and were labeled as proactive, distancing, negative expression, support-seeking, respite-seeking, and acceptance coping. Acceptance and support-seeking coping styles were used most frequently. Coping by negative expression was positively associated with severity of grief after researchers controlled for depression, anxiety, and confounding variables. Support-seeking coping was positively associated with anxiety after researchers controlled for depression and grief.

Limitations: This study was limited by a cross-sectional design, small sample size, and focus on YAs with advanced cancer.

Conclusions: YAs with advanced cancer utilize a range of coping responses that are uniquely related to psychological distress.

To read this article, click on the FILES link at left.

ABSTRACT

Background: Little is known about how young adults (YAs) cope with cancer or about the relationship between coping and psychological distress in YAs with advanced cancer.

Objectives: The goals of this study were to identify coping strategies
used by YAs with advanced cancer and examine the relationship between
these coping strategies and psychological distress.

Methods: Using structured clinical interviews with 53 YAs (aged 20–40 years) with advanced cancer, researchers assessed coping methods, depression, anxiety, and grief. A principal components factor analysis identified underlying coping factors. Regression analyses examined the relationship between these coping factors and depression, anxiety, and grief.

Results: Six coping factors emerged and were labeled as proactive, distancing, negative expression, support-seeking, respite-seeking, and acceptance coping. Acceptance and support-seeking coping styles were used most frequently. Coping by negative expression was positively associated with severity of grief after researchers controlled for depression, anxiety, and confounding variables. Support-seeking coping was positively associated with anxiety after researchers controlled for depression and grief.

Limitations: This study was limited by a cross-sectional design, small sample size, and focus on YAs with advanced cancer.

Conclusions: YAs with advanced cancer utilize a range of coping responses that are uniquely related to psychological distress.

To read this article, click on the FILES link at left.

ABSTRACT

Background: Breast cancer survivors receive routine medical follow-up but are screened less frequently to detect symptom severity and interference with function in daily life.

Objectives: Among breast cancer survivors, we describe the usual and worst severity of 5 common symptoms and the extent to which these symptoms interfere with general activity and enjoyment of life, we determine the associations among symptoms and the interference items, and we explore associations of interference with function and the most prevalent symptoms.

Methods: The cross-sectional, descriptive 1-page Breast Cancer Survivor Symptom Survey was mailed to breast cancer survivors identified in a clinical database (ONCOBASE). In total, 184/457 (40.3%) surveys were returned and 162 (35.4%) were used. Participants recorded usual and worst severity of 5 symptoms (fatigue, disturbed sleep, pain, distress, and numbness/tingling) and symptom interference with general activity and enjoyment of life during the past 7 days.

Results: Participants reported usual symptom severity as mild and highest for sleep disturbance, followed by fatigue, distress, numbness/tingling, and pain. Participants recorded worst sleep disturbance and fatigue as moderately severe. Higher pain and fatigue were associated with all other symptoms, whereas disturbed sleep and distress were related to all except numbness/tingling. All symptoms interfered with general activity and enjoyment of life. Pain and numbness/tingling were associated with lower function and disturbed sleep, and made a unique contribution to fatigue.

Limitations: Limitations of the study include relatively low response and use of a modification of an established scale.

Conclusion: Symptoms often coexisted and contributed to interference with daily function. Pain was most consistently associated with interference with function and severity of other symptoms.

To read this study, please click on the Link to the left of this abstract.

ABSTRACT

Background: Breast cancer survivors receive routine medical follow-up but are screened less frequently to detect symptom severity and interference with function in daily life.

Objectives: Among breast cancer survivors, we describe the usual and worst severity of 5 common symptoms and the extent to which these symptoms interfere with general activity and enjoyment of life, we determine the associations among symptoms and the interference items, and we explore associations of interference with function and the most prevalent symptoms.

Methods: The cross-sectional, descriptive 1-page Breast Cancer Survivor Symptom Survey was mailed to breast cancer survivors identified in a clinical database (ONCOBASE). In total, 184/457 (40.3%) surveys were returned and 162 (35.4%) were used. Participants recorded usual and worst severity of 5 symptoms (fatigue, disturbed sleep, pain, distress, and numbness/tingling) and symptom interference with general activity and enjoyment of life during the past 7 days.

Results: Participants reported usual symptom severity as mild and highest for sleep disturbance, followed by fatigue, distress, numbness/tingling, and pain. Participants recorded worst sleep disturbance and fatigue as moderately severe. Higher pain and fatigue were associated with all other symptoms, whereas disturbed sleep and distress were related to all except numbness/tingling. All symptoms interfered with general activity and enjoyment of life. Pain and numbness/tingling were associated with lower function and disturbed sleep, and made a unique contribution to fatigue.

Limitations: Limitations of the study include relatively low response and use of a modification of an established scale.

Conclusion: Symptoms often coexisted and contributed to interference with daily function. Pain was most consistently associated with interference with function and severity of other symptoms.

To read this study, please click on the Link to the left of this abstract.

ABSTRACT

Background: Breast cancer survivors receive routine medical follow-up but are screened less frequently to detect symptom severity and interference with function in daily life.

Objectives: Among breast cancer survivors, we describe the usual and worst severity of 5 common symptoms and the extent to which these symptoms interfere with general activity and enjoyment of life, we determine the associations among symptoms and the interference items, and we explore associations of interference with function and the most prevalent symptoms.

Methods: The cross-sectional, descriptive 1-page Breast Cancer Survivor Symptom Survey was mailed to breast cancer survivors identified in a clinical database (ONCOBASE). In total, 184/457 (40.3%) surveys were returned and 162 (35.4%) were used. Participants recorded usual and worst severity of 5 symptoms (fatigue, disturbed sleep, pain, distress, and numbness/tingling) and symptom interference with general activity and enjoyment of life during the past 7 days.

Results: Participants reported usual symptom severity as mild and highest for sleep disturbance, followed by fatigue, distress, numbness/tingling, and pain. Participants recorded worst sleep disturbance and fatigue as moderately severe. Higher pain and fatigue were associated with all other symptoms, whereas disturbed sleep and distress were related to all except numbness/tingling. All symptoms interfered with general activity and enjoyment of life. Pain and numbness/tingling were associated with lower function and disturbed sleep, and made a unique contribution to fatigue.

Limitations: Limitations of the study include relatively low response and use of a modification of an established scale.

Conclusion: Symptoms often coexisted and contributed to interference with daily function. Pain was most consistently associated with interference with function and severity of other symptoms.

To read this study, please click on the Link to the left of this abstract.

LAS VEGAS -- Drug-eluting stents placed below the knee worked well to revascularize critically ischemic limbs in a study of 20 patients. Within a mean 10 months’ follow-up, wounds in 17 of the 20 patients in the study (85%) were healed after stenting, and 16 patients (80%) reported pain relief. Only two needed subsequent amputations.

"Stents are just emerging for below the knee. We certainly have one of the early, large-volume [series], with reasonable follow-up," said Dr. Michael Wilderman, a vascular surgeon at Hackensack (N.J.) University Medical Center.

Before they were stented, the patients had, on average, Rutherford stage 4.9 disease, indicating pain at rest and ischemic toe or foot ulcers. The majority had already lost some tissue, and seven (35%) had cellulitis.

Diabetes, hypertension, heart disease, and other comorbidities – plus an average age of 79 years – were found to make open repair too risky, according to Dr. Wilderman, who spoke at the annual meeting of the Society for Clinical Vascular Surgery.

The 25 lesions, in 22 limbs, were located in the below-knee popliteal artery, tibioperoneal trunk, anterior tibial artery, peroneal artery, and posterior tibial artery. Five lesions threatened distal reversed saphenous vein grafts.

The researchers placed everolimus-eluting stents (average diameter, 3 mm) using standard percutaneous techniques. The lesions they addressed were short, and thus could be adequately covered with a 3-cm stent.

Complications were minimal: One patient had a groin hematoma, and another had a puncture-site pseudoaneurysm.

"Initially, we were not planning to stent the first couple we did. We were just going to balloon and see what happens, because that’s what everyone else does," Dr. Wilderman said.

However, because the vessels did not look good angiographically, his team put a stent in and the patients did well. "We found that if we had a short, focal [lesion] that we could stent, we would just stent it," he explained.

Because drug-eluting stents work well for coronary arteries, and tibial arteries share similar histology and luminal diameters, it made sense to try them for below-the-knee ischemia, he said.

Asked for comment, Dr. George Meier, chief of vascular surgery at the University of Cincinnati, noted that coronary drug-eluting stents have been used off label below the knee before. "It’s something we occasionally do in recurrent lesions when we have nothing else to do. The difficulty is following it out long enough to see if it makes an impact," he said.

Dr. Wilderman and Dr. Meier reported that they had no relevant financial disclosures.

LAS VEGAS -- Drug-eluting stents placed below the knee worked well to revascularize critically ischemic limbs in a study of 20 patients. Within a mean 10 months’ follow-up, wounds in 17 of the 20 patients in the study (85%) were healed after stenting, and 16 patients (80%) reported pain relief. Only two needed subsequent amputations.

"Stents are just emerging for below the knee. We certainly have one of the early, large-volume [series], with reasonable follow-up," said Dr. Michael Wilderman, a vascular surgeon at Hackensack (N.J.) University Medical Center.

Before they were stented, the patients had, on average, Rutherford stage 4.9 disease, indicating pain at rest and ischemic toe or foot ulcers. The majority had already lost some tissue, and seven (35%) had cellulitis.

Diabetes, hypertension, heart disease, and other comorbidities – plus an average age of 79 years – were found to make open repair too risky, according to Dr. Wilderman, who spoke at the annual meeting of the Society for Clinical Vascular Surgery.

The 25 lesions, in 22 limbs, were located in the below-knee popliteal artery, tibioperoneal trunk, anterior tibial artery, peroneal artery, and posterior tibial artery. Five lesions threatened distal reversed saphenous vein grafts.

The researchers placed everolimus-eluting stents (average diameter, 3 mm) using standard percutaneous techniques. The lesions they addressed were short, and thus could be adequately covered with a 3-cm stent.

Complications were minimal: One patient had a groin hematoma, and another had a puncture-site pseudoaneurysm.

"Initially, we were not planning to stent the first couple we did. We were just going to balloon and see what happens, because that’s what everyone else does," Dr. Wilderman said.

However, because the vessels did not look good angiographically, his team put a stent in and the patients did well. "We found that if we had a short, focal [lesion] that we could stent, we would just stent it," he explained.

Because drug-eluting stents work well for coronary arteries, and tibial arteries share similar histology and luminal diameters, it made sense to try them for below-the-knee ischemia, he said.

Asked for comment, Dr. George Meier, chief of vascular surgery at the University of Cincinnati, noted that coronary drug-eluting stents have been used off label below the knee before. "It’s something we occasionally do in recurrent lesions when we have nothing else to do. The difficulty is following it out long enough to see if it makes an impact," he said.

Dr. Wilderman and Dr. Meier reported that they had no relevant financial disclosures.

LAS VEGAS -- Drug-eluting stents placed below the knee worked well to revascularize critically ischemic limbs in a study of 20 patients. Within a mean 10 months’ follow-up, wounds in 17 of the 20 patients in the study (85%) were healed after stenting, and 16 patients (80%) reported pain relief. Only two needed subsequent amputations.

"Stents are just emerging for below the knee. We certainly have one of the early, large-volume [series], with reasonable follow-up," said Dr. Michael Wilderman, a vascular surgeon at Hackensack (N.J.) University Medical Center.

Before they were stented, the patients had, on average, Rutherford stage 4.9 disease, indicating pain at rest and ischemic toe or foot ulcers. The majority had already lost some tissue, and seven (35%) had cellulitis.

Diabetes, hypertension, heart disease, and other comorbidities – plus an average age of 79 years – were found to make open repair too risky, according to Dr. Wilderman, who spoke at the annual meeting of the Society for Clinical Vascular Surgery.

The 25 lesions, in 22 limbs, were located in the below-knee popliteal artery, tibioperoneal trunk, anterior tibial artery, peroneal artery, and posterior tibial artery. Five lesions threatened distal reversed saphenous vein grafts.

The researchers placed everolimus-eluting stents (average diameter, 3 mm) using standard percutaneous techniques. The lesions they addressed were short, and thus could be adequately covered with a 3-cm stent.

Complications were minimal: One patient had a groin hematoma, and another had a puncture-site pseudoaneurysm.

"Initially, we were not planning to stent the first couple we did. We were just going to balloon and see what happens, because that’s what everyone else does," Dr. Wilderman said.

However, because the vessels did not look good angiographically, his team put a stent in and the patients did well. "We found that if we had a short, focal [lesion] that we could stent, we would just stent it," he explained.

Because drug-eluting stents work well for coronary arteries, and tibial arteries share similar histology and luminal diameters, it made sense to try them for below-the-knee ischemia, he said.

Asked for comment, Dr. George Meier, chief of vascular surgery at the University of Cincinnati, noted that coronary drug-eluting stents have been used off label below the knee before. "It’s something we occasionally do in recurrent lesions when we have nothing else to do. The difficulty is following it out long enough to see if it makes an impact," he said.

Dr. Wilderman and Dr. Meier reported that they had no relevant financial disclosures.

Endovascular lower-extremity revascularization by vascular specialists resulted in more transfusions and ICU use, as well as a longer hospital stay, more repeat revascularization procedures and amputations, and higher costs, compared with the same procedures performed by interventional radiologists, according to the results of a large database analysis of the Medicare 5% Standard Analytical Files.

Dr. Abdul M. Zafar of the Vascular Disease Research Center, Brown University Alpert Medical School, Providence, and his colleagues extracted claims for endovascularlower extremity revascularization (ELER) index procedures using Current Procedural Terminology (CPT) codes in the years 2005 through 2007.

They recorded the unique IDs of the 15,455 patients who underwent these procedures and for whom an inpatient or outpatient claim corresponding to the index procedure claim was available. This comprised all claims for percutaneous angioplasty, atherectomy, and stent implantation of lower extremity arteries.

The self-designated specialty code of the physician performing the procedure was used to determine specialist type: vascular surgeons (VS), interventional radiologists (IR); interventional cardiologists (IC); and "other."

After excluding patients who might have undergone hybrid procedures and those who underwent thrombolysis procedures in the same year as the index procedure, the final sample of 14,608 patients was analyzed for the following outcomes: length of hospital stay; use of intensive care unit (ICU) services; transfusions; in-hospital mortality; and repeat intervention (defined as any ELER, open lower-extremity revascularization, or amputation of the lower extremity).

The researchers built risk-adjusted logistic regression models by using maximum-likelihood estimates to compare various patient outcomes across different specialties, and they used a linear regression model employing ordinary least squares to analyze length of stay. Cost analysis was performed using a linear regression model based on the least-squares approach. All models were adjusted for age, sex, race, admission type (emergency or ambulatory), and other comorbidities using the Elixhauser comorbidities software available from the Agency for Healthcare Research and Quality. Other regression models that included the International Classification of Disease-9 code for disease severity were developed, but were less predictive and had lower R² values, according to the authors. All logistic regression models passed the goodness-of-fit test at the 99% confidence level. In addition, linear regression models were also found to be satisfactory at the same level, according to the authors.

Within the study, there were 3,565 index procedures done by IRs; 5,489 by ICs; 5,358 by VSs; and 196 performed by "other" specialties (J. Vasc. Interven. Radiol 2012;23:3-9).

Dr. Zafar and his colleagues reported that VS outcomes were significantly worse than when the procedures were performed by an IR or IC. IRs had a 32% lower likelihood of ICU use (P less than .001) and a 37% lower likelihood of repeat lower-extremity revascularization or amputation (P less than .001) compared with VS. "Although statistical significance was not reached, both transfusion use and in-hospital mortality were 19% less likely after IRs performed procedures compared with VSs (P = .113 and P =.351, respectively)."

"Vascular surgeons were the only specialists with post-index procedure length of stay exceeding 3 days, significantly longer than observed for other specialties. The adjusted average 1-year costs per index procedure were 9% greater for vascular surgeons than for interventional radiologists ($19,012 vs. $17,640)," they said.

"The reasons for worse outcomes among VSs are not known, but may be related to insufficient training in catheter-based interventions as a result of the extensive time learning and practicing open surgical procedure compared with IRs and ICs, whose focus is catheter interventions," they said. "Medicare data indicate that patients who need lower-extremity endovascular revascularization services experience shorter hospital stays, require less transfusions and ICU services, have lower in-hospital mortality rates, and have much less chance of a subsequent revascularization or amputation within one year if treated by an IR rather than a VS," they concluded.

The study was supported by a grant from the Society of Interventional Radiology and internal funds from the Vascular Disease Research Center. One authors received research funding from Cordis/Johnson&Johnson, and Abbott Vascular and consulting for Microvention/Terumo.

Endovascular lower-extremity revascularization by vascular specialists resulted in more transfusions and ICU use, as well as a longer hospital stay, more repeat revascularization procedures and amputations, and higher costs, compared with the same procedures performed by interventional radiologists, according to the results of a large database analysis of the Medicare 5% Standard Analytical Files.

Dr. Abdul M. Zafar of the Vascular Disease Research Center, Brown University Alpert Medical School, Providence, and his colleagues extracted claims for endovascularlower extremity revascularization (ELER) index procedures using Current Procedural Terminology (CPT) codes in the years 2005 through 2007.

They recorded the unique IDs of the 15,455 patients who underwent these procedures and for whom an inpatient or outpatient claim corresponding to the index procedure claim was available. This comprised all claims for percutaneous angioplasty, atherectomy, and stent implantation of lower extremity arteries.

The self-designated specialty code of the physician performing the procedure was used to determine specialist type: vascular surgeons (VS), interventional radiologists (IR); interventional cardiologists (IC); and "other."

After excluding patients who might have undergone hybrid procedures and those who underwent thrombolysis procedures in the same year as the index procedure, the final sample of 14,608 patients was analyzed for the following outcomes: length of hospital stay; use of intensive care unit (ICU) services; transfusions; in-hospital mortality; and repeat intervention (defined as any ELER, open lower-extremity revascularization, or amputation of the lower extremity).

The researchers built risk-adjusted logistic regression models by using maximum-likelihood estimates to compare various patient outcomes across different specialties, and they used a linear regression model employing ordinary least squares to analyze length of stay. Cost analysis was performed using a linear regression model based on the least-squares approach. All models were adjusted for age, sex, race, admission type (emergency or ambulatory), and other comorbidities using the Elixhauser comorbidities software available from the Agency for Healthcare Research and Quality. Other regression models that included the International Classification of Disease-9 code for disease severity were developed, but were less predictive and had lower R² values, according to the authors. All logistic regression models passed the goodness-of-fit test at the 99% confidence level. In addition, linear regression models were also found to be satisfactory at the same level, according to the authors.

Within the study, there were 3,565 index procedures done by IRs; 5,489 by ICs; 5,358 by VSs; and 196 performed by "other" specialties (J. Vasc. Interven. Radiol 2012;23:3-9).

Dr. Zafar and his colleagues reported that VS outcomes were significantly worse than when the procedures were performed by an IR or IC. IRs had a 32% lower likelihood of ICU use (P less than .001) and a 37% lower likelihood of repeat lower-extremity revascularization or amputation (P less than .001) compared with VS. "Although statistical significance was not reached, both transfusion use and in-hospital mortality were 19% less likely after IRs performed procedures compared with VSs (P = .113 and P =.351, respectively)."

"Vascular surgeons were the only specialists with post-index procedure length of stay exceeding 3 days, significantly longer than observed for other specialties. The adjusted average 1-year costs per index procedure were 9% greater for vascular surgeons than for interventional radiologists ($19,012 vs. $17,640)," they said.

"The reasons for worse outcomes among VSs are not known, but may be related to insufficient training in catheter-based interventions as a result of the extensive time learning and practicing open surgical procedure compared with IRs and ICs, whose focus is catheter interventions," they said. "Medicare data indicate that patients who need lower-extremity endovascular revascularization services experience shorter hospital stays, require less transfusions and ICU services, have lower in-hospital mortality rates, and have much less chance of a subsequent revascularization or amputation within one year if treated by an IR rather than a VS," they concluded.

The study was supported by a grant from the Society of Interventional Radiology and internal funds from the Vascular Disease Research Center. One authors received research funding from Cordis/Johnson&Johnson, and Abbott Vascular and consulting for Microvention/Terumo.

Endovascular lower-extremity revascularization by vascular specialists resulted in more transfusions and ICU use, as well as a longer hospital stay, more repeat revascularization procedures and amputations, and higher costs, compared with the same procedures performed by interventional radiologists, according to the results of a large database analysis of the Medicare 5% Standard Analytical Files.

Dr. Abdul M. Zafar of the Vascular Disease Research Center, Brown University Alpert Medical School, Providence, and his colleagues extracted claims for endovascularlower extremity revascularization (ELER) index procedures using Current Procedural Terminology (CPT) codes in the years 2005 through 2007.

They recorded the unique IDs of the 15,455 patients who underwent these procedures and for whom an inpatient or outpatient claim corresponding to the index procedure claim was available. This comprised all claims for percutaneous angioplasty, atherectomy, and stent implantation of lower extremity arteries.

The self-designated specialty code of the physician performing the procedure was used to determine specialist type: vascular surgeons (VS), interventional radiologists (IR); interventional cardiologists (IC); and "other."

After excluding patients who might have undergone hybrid procedures and those who underwent thrombolysis procedures in the same year as the index procedure, the final sample of 14,608 patients was analyzed for the following outcomes: length of hospital stay; use of intensive care unit (ICU) services; transfusions; in-hospital mortality; and repeat intervention (defined as any ELER, open lower-extremity revascularization, or amputation of the lower extremity).

The researchers built risk-adjusted logistic regression models by using maximum-likelihood estimates to compare various patient outcomes across different specialties, and they used a linear regression model employing ordinary least squares to analyze length of stay. Cost analysis was performed using a linear regression model based on the least-squares approach. All models were adjusted for age, sex, race, admission type (emergency or ambulatory), and other comorbidities using the Elixhauser comorbidities software available from the Agency for Healthcare Research and Quality. Other regression models that included the International Classification of Disease-9 code for disease severity were developed, but were less predictive and had lower R² values, according to the authors. All logistic regression models passed the goodness-of-fit test at the 99% confidence level. In addition, linear regression models were also found to be satisfactory at the same level, according to the authors.

Within the study, there were 3,565 index procedures done by IRs; 5,489 by ICs; 5,358 by VSs; and 196 performed by "other" specialties (J. Vasc. Interven. Radiol 2012;23:3-9).

Dr. Zafar and his colleagues reported that VS outcomes were significantly worse than when the procedures were performed by an IR or IC. IRs had a 32% lower likelihood of ICU use (P less than .001) and a 37% lower likelihood of repeat lower-extremity revascularization or amputation (P less than .001) compared with VS. "Although statistical significance was not reached, both transfusion use and in-hospital mortality were 19% less likely after IRs performed procedures compared with VSs (P = .113 and P =.351, respectively)."

"Vascular surgeons were the only specialists with post-index procedure length of stay exceeding 3 days, significantly longer than observed for other specialties. The adjusted average 1-year costs per index procedure were 9% greater for vascular surgeons than for interventional radiologists ($19,012 vs. $17,640)," they said.

"The reasons for worse outcomes among VSs are not known, but may be related to insufficient training in catheter-based interventions as a result of the extensive time learning and practicing open surgical procedure compared with IRs and ICs, whose focus is catheter interventions," they said. "Medicare data indicate that patients who need lower-extremity endovascular revascularization services experience shorter hospital stays, require less transfusions and ICU services, have lower in-hospital mortality rates, and have much less chance of a subsequent revascularization or amputation within one year if treated by an IR rather than a VS," they concluded.

The study was supported by a grant from the Society of Interventional Radiology and internal funds from the Vascular Disease Research Center. One authors received research funding from Cordis/Johnson&Johnson, and Abbott Vascular and consulting for Microvention/Terumo.

The Affordable Care Act (ACA) has the laudable goals of extending health care insurance coverage and reducing overall health care costs. However, hidden in the over 2,400 pages of this bill are a number of provisions, many as yet unrecognized, which will have detrimental effects on our national economy, multiple parts of the health care industry, as well as most medical practitioners. 

One of the most onerous aspects of the ACA is the Sunshine Act, which is intended to bring transparency to any and all financial relationships between industry and physicians. This ACA provision mandates that everything a drug company or medical device maker provides to a physician must be disclosed and, after September 30, 2013, it must be published in detail on the Internet.

These disclosures must include pens, thumb drives, shirts and meals, as well as grants for research or travel to present data at meetings and consultant fees for proctoring cases in which new devices are used by physicians unfamiliar with them.

The purpose of this provision is to expose any financial bias or conflict of interest which might increase costs or influence and thereby corrupt research findings, medical education and ultimately medical practice.

On its face governmental involvement in this area might seem justified by the facts that such financial conflicts might lead to care which is unnecessary or harmful to patients (the public), and that government and the taxpayer are largely paying the bills.

Moreover, there have been a few flagrant abuses of the industry-doctor financial relationship in which conflicts of interest have risen to the level of gross commercialism with physicians receiving outlandish sums for providing fraudulent data or promoting drugs or products in a way unjustified by the scientific evidence. So the goal of providing more transparency to the financial relationships between industry and doctors seems a reasonable one.

Don't be fooled. The Sunshine Act's specifics are anything but reasonable. Doctors' judgments and actions are clearly not going to be corrupted by a pen, a thumb drive, or a meal.

It is also reasonable that physicians be compensated fairly for the time spent away from their practice in providing consultant services, participating in educational activities or conducting industry sponsored research, some of which produces valid and important scientific data unobtainable without industry support.

The JUPITER trial is one such example, proving the value of statins in decreasing strokes and myocardial infarctions in high-risk patients with normal lipid profiles. To lump funds received from industry for such meritorious activities together with excessive financial rewards for unjustified promotional activity, as the Sunshine Act's reporting will do, is unfair.

Doctors should not be presumed to be corrupt just because they are paid for legitimate services -- just as are all other professionals.

In addition, the Sunshine Act will require industry to expend many millions of dollars in tedious record keeping and documentation of multiple miniscule details. This plus the implication of taint will discourage relationships between industry and physicians which will have many detrimental effects on medical education and more importantly on U.S. medical innovation.

The latter is already lagging far behind that in other parts of the developed world because of stringent FDA requirements. All these unintended consequences of the Sunshine Act will have a profound negative effect on patient care in our country and thus be harmful to the U.S. public at large.

There are two possible solutions to the problems resulting from the Sunshine Act in its present form. The first is to remove the negativism and unfairness of its reporting requirement by several modifications. The requirement of reporting small and trivial items like pens, thumb drives and meals should be eliminated.

Reporting of only substantial sums in excess of $10,000 or $25,000 should be required. This would decrease markedly the administrative burden of Sunshine reporting.

Moreover, it should be mandated that all funds received from industry by a physician not be listed as a lump sum, but be qualified by the time involved and the type of service rendered.

Just because a physician receives a large payment does not mean it is evil, a bribe, or unjustified. In all other fields, excellence, creativity, knowledge, contribution, and time commitment are rewarded financially, and this should be the case in the industry-doctor relationship arena as well.

A second solution to fix the Sunshine Act and make it fair is to apply all its provisions to Members of Congress and all other elected and non-elected employees of our Federal Government.

After all, just like medical practitioners and those in the health care industry, our federal officials -- and employees -- actions impact on the well-being of our society, and all these individuals in government are paid by the taxpayers.

So let's be fair and apply the same Sunshine Act reporting requirements to those in government to avoid corruption of their actions by unfair and opaque conflicts of interest.

Thus, the Sunshine Act should be fixed. More importantly ,the transparency of its requirements should be allowed to shine on Congress and other federal employees who are paid by the public to support its interests.

If these two corrective actions cannot be taken, the Sunshine Act should be done away with entirely.

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist. 

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

The Affordable Care Act (ACA) has the laudable goals of extending health care insurance coverage and reducing overall health care costs. However, hidden in the over 2,400 pages of this bill are a number of provisions, many as yet unrecognized, which will have detrimental effects on our national economy, multiple parts of the health care industry, as well as most medical practitioners. 

One of the most onerous aspects of the ACA is the Sunshine Act, which is intended to bring transparency to any and all financial relationships between industry and physicians. This ACA provision mandates that everything a drug company or medical device maker provides to a physician must be disclosed and, after September 30, 2013, it must be published in detail on the Internet.

These disclosures must include pens, thumb drives, shirts and meals, as well as grants for research or travel to present data at meetings and consultant fees for proctoring cases in which new devices are used by physicians unfamiliar with them.

The purpose of this provision is to expose any financial bias or conflict of interest which might increase costs or influence and thereby corrupt research findings, medical education and ultimately medical practice.

On its face governmental involvement in this area might seem justified by the facts that such financial conflicts might lead to care which is unnecessary or harmful to patients (the public), and that government and the taxpayer are largely paying the bills.

Moreover, there have been a few flagrant abuses of the industry-doctor financial relationship in which conflicts of interest have risen to the level of gross commercialism with physicians receiving outlandish sums for providing fraudulent data or promoting drugs or products in a way unjustified by the scientific evidence. So the goal of providing more transparency to the financial relationships between industry and doctors seems a reasonable one.

Don't be fooled. The Sunshine Act's specifics are anything but reasonable. Doctors' judgments and actions are clearly not going to be corrupted by a pen, a thumb drive, or a meal.

It is also reasonable that physicians be compensated fairly for the time spent away from their practice in providing consultant services, participating in educational activities or conducting industry sponsored research, some of which produces valid and important scientific data unobtainable without industry support.

The JUPITER trial is one such example, proving the value of statins in decreasing strokes and myocardial infarctions in high-risk patients with normal lipid profiles. To lump funds received from industry for such meritorious activities together with excessive financial rewards for unjustified promotional activity, as the Sunshine Act's reporting will do, is unfair.

Doctors should not be presumed to be corrupt just because they are paid for legitimate services -- just as are all other professionals.

In addition, the Sunshine Act will require industry to expend many millions of dollars in tedious record keeping and documentation of multiple miniscule details. This plus the implication of taint will discourage relationships between industry and physicians which will have many detrimental effects on medical education and more importantly on U.S. medical innovation.

The latter is already lagging far behind that in other parts of the developed world because of stringent FDA requirements. All these unintended consequences of the Sunshine Act will have a profound negative effect on patient care in our country and thus be harmful to the U.S. public at large.

There are two possible solutions to the problems resulting from the Sunshine Act in its present form. The first is to remove the negativism and unfairness of its reporting requirement by several modifications. The requirement of reporting small and trivial items like pens, thumb drives and meals should be eliminated.

Reporting of only substantial sums in excess of $10,000 or $25,000 should be required. This would decrease markedly the administrative burden of Sunshine reporting.

Moreover, it should be mandated that all funds received from industry by a physician not be listed as a lump sum, but be qualified by the time involved and the type of service rendered.

Just because a physician receives a large payment does not mean it is evil, a bribe, or unjustified. In all other fields, excellence, creativity, knowledge, contribution, and time commitment are rewarded financially, and this should be the case in the industry-doctor relationship arena as well.

A second solution to fix the Sunshine Act and make it fair is to apply all its provisions to Members of Congress and all other elected and non-elected employees of our Federal Government.

After all, just like medical practitioners and those in the health care industry, our federal officials -- and employees -- actions impact on the well-being of our society, and all these individuals in government are paid by the taxpayers.

So let's be fair and apply the same Sunshine Act reporting requirements to those in government to avoid corruption of their actions by unfair and opaque conflicts of interest.

Thus, the Sunshine Act should be fixed. More importantly ,the transparency of its requirements should be allowed to shine on Congress and other federal employees who are paid by the public to support its interests.

If these two corrective actions cannot be taken, the Sunshine Act should be done away with entirely.

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist. 

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

The Affordable Care Act (ACA) has the laudable goals of extending health care insurance coverage and reducing overall health care costs. However, hidden in the over 2,400 pages of this bill are a number of provisions, many as yet unrecognized, which will have detrimental effects on our national economy, multiple parts of the health care industry, as well as most medical practitioners. 

One of the most onerous aspects of the ACA is the Sunshine Act, which is intended to bring transparency to any and all financial relationships between industry and physicians. This ACA provision mandates that everything a drug company or medical device maker provides to a physician must be disclosed and, after September 30, 2013, it must be published in detail on the Internet.

These disclosures must include pens, thumb drives, shirts and meals, as well as grants for research or travel to present data at meetings and consultant fees for proctoring cases in which new devices are used by physicians unfamiliar with them.

The purpose of this provision is to expose any financial bias or conflict of interest which might increase costs or influence and thereby corrupt research findings, medical education and ultimately medical practice.

On its face governmental involvement in this area might seem justified by the facts that such financial conflicts might lead to care which is unnecessary or harmful to patients (the public), and that government and the taxpayer are largely paying the bills.

Moreover, there have been a few flagrant abuses of the industry-doctor financial relationship in which conflicts of interest have risen to the level of gross commercialism with physicians receiving outlandish sums for providing fraudulent data or promoting drugs or products in a way unjustified by the scientific evidence. So the goal of providing more transparency to the financial relationships between industry and doctors seems a reasonable one.

Don't be fooled. The Sunshine Act's specifics are anything but reasonable. Doctors' judgments and actions are clearly not going to be corrupted by a pen, a thumb drive, or a meal.

It is also reasonable that physicians be compensated fairly for the time spent away from their practice in providing consultant services, participating in educational activities or conducting industry sponsored research, some of which produces valid and important scientific data unobtainable without industry support.

The JUPITER trial is one such example, proving the value of statins in decreasing strokes and myocardial infarctions in high-risk patients with normal lipid profiles. To lump funds received from industry for such meritorious activities together with excessive financial rewards for unjustified promotional activity, as the Sunshine Act's reporting will do, is unfair.

Doctors should not be presumed to be corrupt just because they are paid for legitimate services -- just as are all other professionals.

In addition, the Sunshine Act will require industry to expend many millions of dollars in tedious record keeping and documentation of multiple miniscule details. This plus the implication of taint will discourage relationships between industry and physicians which will have many detrimental effects on medical education and more importantly on U.S. medical innovation.

The latter is already lagging far behind that in other parts of the developed world because of stringent FDA requirements. All these unintended consequences of the Sunshine Act will have a profound negative effect on patient care in our country and thus be harmful to the U.S. public at large.

There are two possible solutions to the problems resulting from the Sunshine Act in its present form. The first is to remove the negativism and unfairness of its reporting requirement by several modifications. The requirement of reporting small and trivial items like pens, thumb drives and meals should be eliminated.

Reporting of only substantial sums in excess of $10,000 or $25,000 should be required. This would decrease markedly the administrative burden of Sunshine reporting.

Moreover, it should be mandated that all funds received from industry by a physician not be listed as a lump sum, but be qualified by the time involved and the type of service rendered.

Just because a physician receives a large payment does not mean it is evil, a bribe, or unjustified. In all other fields, excellence, creativity, knowledge, contribution, and time commitment are rewarded financially, and this should be the case in the industry-doctor relationship arena as well.

A second solution to fix the Sunshine Act and make it fair is to apply all its provisions to Members of Congress and all other elected and non-elected employees of our Federal Government.

After all, just like medical practitioners and those in the health care industry, our federal officials -- and employees -- actions impact on the well-being of our society, and all these individuals in government are paid by the taxpayers.

So let's be fair and apply the same Sunshine Act reporting requirements to those in government to avoid corruption of their actions by unfair and opaque conflicts of interest.

Thus, the Sunshine Act should be fixed. More importantly ,the transparency of its requirements should be allowed to shine on Congress and other federal employees who are paid by the public to support its interests.

If these two corrective actions cannot be taken, the Sunshine Act should be done away with entirely.

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist. 

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

SILVER SPRING, MD. – Lack of data on patients with refractory gout has scuttled for now any recommendation to approve the interleukin-1 inhibitor rilonacept.*

The Food and Drug Administration’s Arthritis Advisory Committee voted 11 to 0 that the safety and efficacy data on rilonacept did not support its approval for the prevention of gout flares during the initiation of uric acid-lowering therapy in adults with gout.

Although most panelists agreed there was evidence that the treatment was effective in reducing gout flares, they said the effect was modest, and that they would be reluctant to use it as a first-line treatment. They said that it would be useful for patients who are intolerant or refractory to NSAIDs and/or colchicine, but added that these types of patients comprised only a small group of patients in the 16 week pivotal trials, and that this length of time was not enough to evaluate safety because it was likely that the treatment would be used for longer periods of time.

Rilonacept, marketed as Arcalyst, was approved by the FDA in 2008 for the chronic treatment of familial cold autoinflammatory syndrome and Muckle-Wells syndrome (or cryopyrin-associated periodic syndromes), rare genetic disorders. Preclinical and clinical data indicate that interleukin-1 (IL-1) plays a role in triggering gout flares during the initiation of uric acid–lowering therapy, according to Regeneron Pharmaceuticals, which makes the drug. The dose for which Regeneron was seeking approval was a loading dose of 160 mg followed by a weekly dose of 80 mg for 16 weeks.

The manufacturer presented data to the FDA panel from two studies of almost 500 largely middle-aged men with moderate to severe gout. Their gout’s severity was characterized by a serum uric acid level of at least 7.5 mg/dL and at least two gout flares during the previous year. Patients were randomized to a dose of 80 mg subcutaneously, a dose of 160 mg administered once a week (after a 320-mg loading dose) given subcutaneously, or placebo. At the same time, all the participants initiated uric acid–lowering treatment with allopurinol. The prophylactic use of NSAIDs, glucocorticoids, or colchicine was not allowed. One study was conducted in the United States and Canada; the other was conducted in Germany, India, Indonesia, South Africa, and Taiwan.

Over a period of 16 weeks, treatment with the 80-mg dose was associated with a statistically significant reduction in the mean number of gout flares – the primary end point – compared with placebo. Those on the 80-mg dose had a mean of 0.29-0.35 gout flares per patient, compared with a mean of about one gout flare per patient on placebo, with no significant differences between the two rilonacept doses. In the two studies, 19% and almost 26% of those on the 80-mg dose had at least one gout flare, compared with almost half of those on placebo. Several panelists raised the issue of whether it was worth exposing patients to a biologic therapy when they had a 50% chance of not having a flare.

In a pooled database of the two pivotal studies and two other gout studies comparing the effectiveness of the 160-mg dose of rilonacept in about 1,000 patients to placebo in almost 400 patients, no significant increase in serious infections was observed in patients treated for 16 weeks. However, six malignancies were diagnosed during treatment with rilonacept, compared with none among those on placebo. FDA reviewers noted that while this number was low and the types of malignancies were not unusual for the typical gout patient, the lack of any malignancies among those on placebo and the biologic plausibility for an increased malignancy risk with a biologic immunosuppressant was a concern and suggested it would be useful to have data on a period longer than 16 weeks.

Although most panelists agreed there was evidence that the treatment was effective in reducing gout flares, they said the effect was modest, and that they would be reluctant to use it as a first-line treatment. They said that it would be useful for patients who are intolerant or refractory to NSAIDs and/or colchicine, but added that these types of patients comprised only a small group of patients in the pivotal trial, and that 16 weeks was not long enough to evaluate safety because it was likely that the treatment would be used for longer periods of time.

Several panel members questioned why the company did not compare rilonacept to an active control, such as colchicine, which is one of the main drugs used to prevent gout flares during the initiation of uric acid–lowering therapy.

The FDA usually follows the recommendations of its advisory panels. The panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver but not at this meeting.

*Correction, 5/9/2012: A previous version of this story misstated the panelists' concern about the drug's potential to cause cancer.

SILVER SPRING, MD. – Lack of data on patients with refractory gout has scuttled for now any recommendation to approve the interleukin-1 inhibitor rilonacept.*

The Food and Drug Administration’s Arthritis Advisory Committee voted 11 to 0 that the safety and efficacy data on rilonacept did not support its approval for the prevention of gout flares during the initiation of uric acid-lowering therapy in adults with gout.

Although most panelists agreed there was evidence that the treatment was effective in reducing gout flares, they said the effect was modest, and that they would be reluctant to use it as a first-line treatment. They said that it would be useful for patients who are intolerant or refractory to NSAIDs and/or colchicine, but added that these types of patients comprised only a small group of patients in the 16 week pivotal trials, and that this length of time was not enough to evaluate safety because it was likely that the treatment would be used for longer periods of time.

Rilonacept, marketed as Arcalyst, was approved by the FDA in 2008 for the chronic treatment of familial cold autoinflammatory syndrome and Muckle-Wells syndrome (or cryopyrin-associated periodic syndromes), rare genetic disorders. Preclinical and clinical data indicate that interleukin-1 (IL-1) plays a role in triggering gout flares during the initiation of uric acid–lowering therapy, according to Regeneron Pharmaceuticals, which makes the drug. The dose for which Regeneron was seeking approval was a loading dose of 160 mg followed by a weekly dose of 80 mg for 16 weeks.

The manufacturer presented data to the FDA panel from two studies of almost 500 largely middle-aged men with moderate to severe gout. Their gout’s severity was characterized by a serum uric acid level of at least 7.5 mg/dL and at least two gout flares during the previous year. Patients were randomized to a dose of 80 mg subcutaneously, a dose of 160 mg administered once a week (after a 320-mg loading dose) given subcutaneously, or placebo. At the same time, all the participants initiated uric acid–lowering treatment with allopurinol. The prophylactic use of NSAIDs, glucocorticoids, or colchicine was not allowed. One study was conducted in the United States and Canada; the other was conducted in Germany, India, Indonesia, South Africa, and Taiwan.

Over a period of 16 weeks, treatment with the 80-mg dose was associated with a statistically significant reduction in the mean number of gout flares – the primary end point – compared with placebo. Those on the 80-mg dose had a mean of 0.29-0.35 gout flares per patient, compared with a mean of about one gout flare per patient on placebo, with no significant differences between the two rilonacept doses. In the two studies, 19% and almost 26% of those on the 80-mg dose had at least one gout flare, compared with almost half of those on placebo. Several panelists raised the issue of whether it was worth exposing patients to a biologic therapy when they had a 50% chance of not having a flare.

In a pooled database of the two pivotal studies and two other gout studies comparing the effectiveness of the 160-mg dose of rilonacept in about 1,000 patients to placebo in almost 400 patients, no significant increase in serious infections was observed in patients treated for 16 weeks. However, six malignancies were diagnosed during treatment with rilonacept, compared with none among those on placebo. FDA reviewers noted that while this number was low and the types of malignancies were not unusual for the typical gout patient, the lack of any malignancies among those on placebo and the biologic plausibility for an increased malignancy risk with a biologic immunosuppressant was a concern and suggested it would be useful to have data on a period longer than 16 weeks.

Although most panelists agreed there was evidence that the treatment was effective in reducing gout flares, they said the effect was modest, and that they would be reluctant to use it as a first-line treatment. They said that it would be useful for patients who are intolerant or refractory to NSAIDs and/or colchicine, but added that these types of patients comprised only a small group of patients in the pivotal trial, and that 16 weeks was not long enough to evaluate safety because it was likely that the treatment would be used for longer periods of time.

Several panel members questioned why the company did not compare rilonacept to an active control, such as colchicine, which is one of the main drugs used to prevent gout flares during the initiation of uric acid–lowering therapy.

The FDA usually follows the recommendations of its advisory panels. The panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver but not at this meeting.

*Correction, 5/9/2012: A previous version of this story misstated the panelists' concern about the drug's potential to cause cancer.

SILVER SPRING, MD. – Lack of data on patients with refractory gout has scuttled for now any recommendation to approve the interleukin-1 inhibitor rilonacept.*

The Food and Drug Administration’s Arthritis Advisory Committee voted 11 to 0 that the safety and efficacy data on rilonacept did not support its approval for the prevention of gout flares during the initiation of uric acid-lowering therapy in adults with gout.

Although most panelists agreed there was evidence that the treatment was effective in reducing gout flares, they said the effect was modest, and that they would be reluctant to use it as a first-line treatment. They said that it would be useful for patients who are intolerant or refractory to NSAIDs and/or colchicine, but added that these types of patients comprised only a small group of patients in the 16 week pivotal trials, and that this length of time was not enough to evaluate safety because it was likely that the treatment would be used for longer periods of time.

Rilonacept, marketed as Arcalyst, was approved by the FDA in 2008 for the chronic treatment of familial cold autoinflammatory syndrome and Muckle-Wells syndrome (or cryopyrin-associated periodic syndromes), rare genetic disorders. Preclinical and clinical data indicate that interleukin-1 (IL-1) plays a role in triggering gout flares during the initiation of uric acid–lowering therapy, according to Regeneron Pharmaceuticals, which makes the drug. The dose for which Regeneron was seeking approval was a loading dose of 160 mg followed by a weekly dose of 80 mg for 16 weeks.

The manufacturer presented data to the FDA panel from two studies of almost 500 largely middle-aged men with moderate to severe gout. Their gout’s severity was characterized by a serum uric acid level of at least 7.5 mg/dL and at least two gout flares during the previous year. Patients were randomized to a dose of 80 mg subcutaneously, a dose of 160 mg administered once a week (after a 320-mg loading dose) given subcutaneously, or placebo. At the same time, all the participants initiated uric acid–lowering treatment with allopurinol. The prophylactic use of NSAIDs, glucocorticoids, or colchicine was not allowed. One study was conducted in the United States and Canada; the other was conducted in Germany, India, Indonesia, South Africa, and Taiwan.

Over a period of 16 weeks, treatment with the 80-mg dose was associated with a statistically significant reduction in the mean number of gout flares – the primary end point – compared with placebo. Those on the 80-mg dose had a mean of 0.29-0.35 gout flares per patient, compared with a mean of about one gout flare per patient on placebo, with no significant differences between the two rilonacept doses. In the two studies, 19% and almost 26% of those on the 80-mg dose had at least one gout flare, compared with almost half of those on placebo. Several panelists raised the issue of whether it was worth exposing patients to a biologic therapy when they had a 50% chance of not having a flare.

In a pooled database of the two pivotal studies and two other gout studies comparing the effectiveness of the 160-mg dose of rilonacept in about 1,000 patients to placebo in almost 400 patients, no significant increase in serious infections was observed in patients treated for 16 weeks. However, six malignancies were diagnosed during treatment with rilonacept, compared with none among those on placebo. FDA reviewers noted that while this number was low and the types of malignancies were not unusual for the typical gout patient, the lack of any malignancies among those on placebo and the biologic plausibility for an increased malignancy risk with a biologic immunosuppressant was a concern and suggested it would be useful to have data on a period longer than 16 weeks.

Although most panelists agreed there was evidence that the treatment was effective in reducing gout flares, they said the effect was modest, and that they would be reluctant to use it as a first-line treatment. They said that it would be useful for patients who are intolerant or refractory to NSAIDs and/or colchicine, but added that these types of patients comprised only a small group of patients in the pivotal trial, and that 16 weeks was not long enough to evaluate safety because it was likely that the treatment would be used for longer periods of time.

Several panel members questioned why the company did not compare rilonacept to an active control, such as colchicine, which is one of the main drugs used to prevent gout flares during the initiation of uric acid–lowering therapy.

The FDA usually follows the recommendations of its advisory panels. The panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver but not at this meeting.

*Correction, 5/9/2012: A previous version of this story misstated the panelists' concern about the drug's potential to cause cancer.

Hospitalists should be aware of the privacy perils of social media, according to a lawyer helping to develop a webinar that will focus on the legal implications of healthcare workers' use of social media platforms.

"The idea that everyone has something important to say in 140 characters or less these days just seems to be part of a growing culture that doesn't consider the publication of private information to be an intrusion," says Gregory McNeer Jr., principal of Stratford Consulting in Winston-Salem, N.C. "There is a bit of a disconnect—whether it's with doctors, or patients, or nurses, or technicians, or whomever—as to what their obligations are under the law."

McNeer is partnering with law firm Maguire Woods and mobile technology firm Novarus Healthcare to host the online conference, called "HIPAA and Social Media: Strategies for Protecting Patient Privacy in a HITECH World." The intent, he says, is to raise awareness of the potential privacy pitfalls social media pose for physicians, and to guide session participants through the nuances of the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act—measures focused on the protection of patient information.

McNeer says physicians who "vent about a bad day" could inadvertently release patient information that could draw regulatory attention. He points to several instances nationwide in which healthcare professionals have faced consequences for talking about patients on Facebook or posting X-rays online.

"We have a clear channel for unauthorized dissemination of protected healthcare information," he says. "Once somebody has tweeted something, the horse is out of the barn. But do you have a tool that will give you notification of the breach within 24 hours? Or do you wait until the lawsuit shows up?"

The webinar is at 1 p.m. May 30; email McNeer for more information or to register.

Hospitalists should be aware of the privacy perils of social media, according to a lawyer helping to develop a webinar that will focus on the legal implications of healthcare workers' use of social media platforms.

"The idea that everyone has something important to say in 140 characters or less these days just seems to be part of a growing culture that doesn't consider the publication of private information to be an intrusion," says Gregory McNeer Jr., principal of Stratford Consulting in Winston-Salem, N.C. "There is a bit of a disconnect—whether it's with doctors, or patients, or nurses, or technicians, or whomever—as to what their obligations are under the law."

McNeer is partnering with law firm Maguire Woods and mobile technology firm Novarus Healthcare to host the online conference, called "HIPAA and Social Media: Strategies for Protecting Patient Privacy in a HITECH World." The intent, he says, is to raise awareness of the potential privacy pitfalls social media pose for physicians, and to guide session participants through the nuances of the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act—measures focused on the protection of patient information.

McNeer says physicians who "vent about a bad day" could inadvertently release patient information that could draw regulatory attention. He points to several instances nationwide in which healthcare professionals have faced consequences for talking about patients on Facebook or posting X-rays online.

"We have a clear channel for unauthorized dissemination of protected healthcare information," he says. "Once somebody has tweeted something, the horse is out of the barn. But do you have a tool that will give you notification of the breach within 24 hours? Or do you wait until the lawsuit shows up?"

The webinar is at 1 p.m. May 30; email McNeer for more information or to register.

Hospitalists should be aware of the privacy perils of social media, according to a lawyer helping to develop a webinar that will focus on the legal implications of healthcare workers' use of social media platforms.

"The idea that everyone has something important to say in 140 characters or less these days just seems to be part of a growing culture that doesn't consider the publication of private information to be an intrusion," says Gregory McNeer Jr., principal of Stratford Consulting in Winston-Salem, N.C. "There is a bit of a disconnect—whether it's with doctors, or patients, or nurses, or technicians, or whomever—as to what their obligations are under the law."

McNeer is partnering with law firm Maguire Woods and mobile technology firm Novarus Healthcare to host the online conference, called "HIPAA and Social Media: Strategies for Protecting Patient Privacy in a HITECH World." The intent, he says, is to raise awareness of the potential privacy pitfalls social media pose for physicians, and to guide session participants through the nuances of the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act—measures focused on the protection of patient information.

McNeer says physicians who "vent about a bad day" could inadvertently release patient information that could draw regulatory attention. He points to several instances nationwide in which healthcare professionals have faced consequences for talking about patients on Facebook or posting X-rays online.

"We have a clear channel for unauthorized dissemination of protected healthcare information," he says. "Once somebody has tweeted something, the horse is out of the barn. But do you have a tool that will give you notification of the breach within 24 hours? Or do you wait until the lawsuit shows up?"

The webinar is at 1 p.m. May 30; email McNeer for more information or to register.

A major review of the medical literature from 1978 to 2009 on the overuse of health services found the topic understudied, with limited data except in a few areas, such as antibiotic use for upper respiratory infections.

Overuse of medical services—services with no benefit or for which harm outweighs the benefit—needs more attention and more investment, says Deborah Korenstein, MD, of Mount Sinai School of Medicine in New York, the review's lead author. Until that happens, she says, it will be premature for health policy makers to talk about cost savings to be accrued under healthcare reform from reductions in overuse and waste.

Dr. Korenstein sees opportunities for hospitalists to initiate studies of health resource usage, costs, and opportunities for improving efficiency, making these part of their hospitals' quality initiatives.

"People in healthcare have talked about overuse without understanding what it means, how common it is, and how intractable it can be to remedy," she says, adding it's a difficult subject to study, without recognized standards for measuring overuse. "Some situations are clearly inappropriate—for example, antibiotics for colds. That doesn’t mean they’re easy to get rid of."

The main finding: there is very little evidence on overuse, Dr. Korenstein says. For people on the front lines of healthcare, she recommends mindfulness to the issue.

"Challenge yourself to think about what you're doing and why," she says. "Resist doing interventions just because you can."

A major review of the medical literature from 1978 to 2009 on the overuse of health services found the topic understudied, with limited data except in a few areas, such as antibiotic use for upper respiratory infections.

Overuse of medical services—services with no benefit or for which harm outweighs the benefit—needs more attention and more investment, says Deborah Korenstein, MD, of Mount Sinai School of Medicine in New York, the review's lead author. Until that happens, she says, it will be premature for health policy makers to talk about cost savings to be accrued under healthcare reform from reductions in overuse and waste.

Dr. Korenstein sees opportunities for hospitalists to initiate studies of health resource usage, costs, and opportunities for improving efficiency, making these part of their hospitals' quality initiatives.

"People in healthcare have talked about overuse without understanding what it means, how common it is, and how intractable it can be to remedy," she says, adding it's a difficult subject to study, without recognized standards for measuring overuse. "Some situations are clearly inappropriate—for example, antibiotics for colds. That doesn’t mean they’re easy to get rid of."

The main finding: there is very little evidence on overuse, Dr. Korenstein says. For people on the front lines of healthcare, she recommends mindfulness to the issue.

"Challenge yourself to think about what you're doing and why," she says. "Resist doing interventions just because you can."

A major review of the medical literature from 1978 to 2009 on the overuse of health services found the topic understudied, with limited data except in a few areas, such as antibiotic use for upper respiratory infections.

Overuse of medical services—services with no benefit or for which harm outweighs the benefit—needs more attention and more investment, says Deborah Korenstein, MD, of Mount Sinai School of Medicine in New York, the review's lead author. Until that happens, she says, it will be premature for health policy makers to talk about cost savings to be accrued under healthcare reform from reductions in overuse and waste.

Dr. Korenstein sees opportunities for hospitalists to initiate studies of health resource usage, costs, and opportunities for improving efficiency, making these part of their hospitals' quality initiatives.

"People in healthcare have talked about overuse without understanding what it means, how common it is, and how intractable it can be to remedy," she says, adding it's a difficult subject to study, without recognized standards for measuring overuse. "Some situations are clearly inappropriate—for example, antibiotics for colds. That doesn’t mean they’re easy to get rid of."

The main finding: there is very little evidence on overuse, Dr. Korenstein says. For people on the front lines of healthcare, she recommends mindfulness to the issue.

"Challenge yourself to think about what you're doing and why," she says. "Resist doing interventions just because you can."