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."

To read the entire article in pdf format, please click on the FILE at left.

To read the entire article in pdf format, please click on the FILE at left.

To read the entire article in pdf format, please click on the FILE at left.

Visitors to my office often ask about the secret to maintaining "such a marvelous" 11-person staff. "You must pay them a fortune," they say.

Yes, they are compensated fairly; but that’s not why they stay. I know for a fact that many of them have turned down higher salaries at big clinics. Staff turnover is essentially nonexistent. (My most junior employee is going on 18 years.)

They remain, I believe, because I welcome their ideas; and I let them know on a regular basis that I notice and appreciate their efforts.

Soliciting employee input is a win-win; it builds loyalty and a sense of community, and you discover better ways to run your office.

I fancy myself an innovative guy, but I can’t think of everything myself. I don’t sit at the reception window; I don’t handle the phones; I don’t put patients in rooms. So, don’t let your staff keep good ideas to themselves. Your staff will only make the effort, however, if they understand that there is something in it for them, other than a token salary raise at year’s end.

The monthly office meeting is a great vehicle for brainstorming. I like my office manager to run them; or more precisely, we like to let them run themselves. We just moderate the discussion, identify problems, and solicit solutions. Usually the answer will come from the dialogue. In addition, we always leave time for airing of any proposals for general improvement of the office as a whole.

By encouraging my employees to propose solutions and suggest better methods and procedures, I demonstrate to them that they have a stake in the success of the office. And when a solution or a new suggestion is staff conceived, the staff has a stake in ensuring that it is implemented and that it works. This method also offers the opportunity to identify and work out minor problems before they become major ones.

Even in this digital age, an essential tool for me at office meetings is a good old-fashioned yellow legal pad, on which I note everything discussed. Each problem identified and each new idea offered is paired with proposed solutions and practical suggestions for implementation, and someone is assigned the responsibility of taking action. Not only does it guarantee that a problem will not continue and a good idea will not die, it also reassures staff that they are not just whistling in the dark when they point out a problem or propose a new office policy.

Some physicians hold meetings away from the office, perhaps at a local restaurant, going on the theory that staff will be more frank when outside of the office. Personally, I have never found my employees reluctant to express themselves in any setting, but if you have, consider that alternative.

Anytime someone comes up with a great idea, or calls attention to a significant issue, I make sure that the person hears – immediately and publicly – the praise that he or she deserves. That goes for all aspects of the office. Whenever I "catch someone doing something right," I note it, and praise that person.

Of course, it is also sometimes necessary to dole out constructive criticism; but as public as praise should be, criticism should be private. And the manner of the criticism is just as important as the setting. I prefer to point out the problem, ask what might have precipitated it, and suggest ways to correct it. After all, nobody is perfect. When you are understanding of your employees’ mistakes, they will be more understanding of yours.

The emphasis, however, is always on praise. When I leave at the end of the day I always thank the staff. If I can’t think of a specific thing to thank them for, I thank them for a good day. Employees thrive on praise, and will go out of their way to earn it.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. To respond to this column, email Dr. Eastern at [email protected].

Visitors to my office often ask about the secret to maintaining "such a marvelous" 11-person staff. "You must pay them a fortune," they say.

Yes, they are compensated fairly; but that’s not why they stay. I know for a fact that many of them have turned down higher salaries at big clinics. Staff turnover is essentially nonexistent. (My most junior employee is going on 18 years.)

They remain, I believe, because I welcome their ideas; and I let them know on a regular basis that I notice and appreciate their efforts.

Soliciting employee input is a win-win; it builds loyalty and a sense of community, and you discover better ways to run your office.

I fancy myself an innovative guy, but I can’t think of everything myself. I don’t sit at the reception window; I don’t handle the phones; I don’t put patients in rooms. So, don’t let your staff keep good ideas to themselves. Your staff will only make the effort, however, if they understand that there is something in it for them, other than a token salary raise at year’s end.

The monthly office meeting is a great vehicle for brainstorming. I like my office manager to run them; or more precisely, we like to let them run themselves. We just moderate the discussion, identify problems, and solicit solutions. Usually the answer will come from the dialogue. In addition, we always leave time for airing of any proposals for general improvement of the office as a whole.

By encouraging my employees to propose solutions and suggest better methods and procedures, I demonstrate to them that they have a stake in the success of the office. And when a solution or a new suggestion is staff conceived, the staff has a stake in ensuring that it is implemented and that it works. This method also offers the opportunity to identify and work out minor problems before they become major ones.

Even in this digital age, an essential tool for me at office meetings is a good old-fashioned yellow legal pad, on which I note everything discussed. Each problem identified and each new idea offered is paired with proposed solutions and practical suggestions for implementation, and someone is assigned the responsibility of taking action. Not only does it guarantee that a problem will not continue and a good idea will not die, it also reassures staff that they are not just whistling in the dark when they point out a problem or propose a new office policy.

Some physicians hold meetings away from the office, perhaps at a local restaurant, going on the theory that staff will be more frank when outside of the office. Personally, I have never found my employees reluctant to express themselves in any setting, but if you have, consider that alternative.

Anytime someone comes up with a great idea, or calls attention to a significant issue, I make sure that the person hears – immediately and publicly – the praise that he or she deserves. That goes for all aspects of the office. Whenever I "catch someone doing something right," I note it, and praise that person.

Of course, it is also sometimes necessary to dole out constructive criticism; but as public as praise should be, criticism should be private. And the manner of the criticism is just as important as the setting. I prefer to point out the problem, ask what might have precipitated it, and suggest ways to correct it. After all, nobody is perfect. When you are understanding of your employees’ mistakes, they will be more understanding of yours.

The emphasis, however, is always on praise. When I leave at the end of the day I always thank the staff. If I can’t think of a specific thing to thank them for, I thank them for a good day. Employees thrive on praise, and will go out of their way to earn it.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. To respond to this column, email Dr. Eastern at [email protected].

Visitors to my office often ask about the secret to maintaining "such a marvelous" 11-person staff. "You must pay them a fortune," they say.

Yes, they are compensated fairly; but that’s not why they stay. I know for a fact that many of them have turned down higher salaries at big clinics. Staff turnover is essentially nonexistent. (My most junior employee is going on 18 years.)

They remain, I believe, because I welcome their ideas; and I let them know on a regular basis that I notice and appreciate their efforts.

Soliciting employee input is a win-win; it builds loyalty and a sense of community, and you discover better ways to run your office.

I fancy myself an innovative guy, but I can’t think of everything myself. I don’t sit at the reception window; I don’t handle the phones; I don’t put patients in rooms. So, don’t let your staff keep good ideas to themselves. Your staff will only make the effort, however, if they understand that there is something in it for them, other than a token salary raise at year’s end.

The monthly office meeting is a great vehicle for brainstorming. I like my office manager to run them; or more precisely, we like to let them run themselves. We just moderate the discussion, identify problems, and solicit solutions. Usually the answer will come from the dialogue. In addition, we always leave time for airing of any proposals for general improvement of the office as a whole.

By encouraging my employees to propose solutions and suggest better methods and procedures, I demonstrate to them that they have a stake in the success of the office. And when a solution or a new suggestion is staff conceived, the staff has a stake in ensuring that it is implemented and that it works. This method also offers the opportunity to identify and work out minor problems before they become major ones.

Even in this digital age, an essential tool for me at office meetings is a good old-fashioned yellow legal pad, on which I note everything discussed. Each problem identified and each new idea offered is paired with proposed solutions and practical suggestions for implementation, and someone is assigned the responsibility of taking action. Not only does it guarantee that a problem will not continue and a good idea will not die, it also reassures staff that they are not just whistling in the dark when they point out a problem or propose a new office policy.

Some physicians hold meetings away from the office, perhaps at a local restaurant, going on the theory that staff will be more frank when outside of the office. Personally, I have never found my employees reluctant to express themselves in any setting, but if you have, consider that alternative.

Anytime someone comes up with a great idea, or calls attention to a significant issue, I make sure that the person hears – immediately and publicly – the praise that he or she deserves. That goes for all aspects of the office. Whenever I "catch someone doing something right," I note it, and praise that person.

Of course, it is also sometimes necessary to dole out constructive criticism; but as public as praise should be, criticism should be private. And the manner of the criticism is just as important as the setting. I prefer to point out the problem, ask what might have precipitated it, and suggest ways to correct it. After all, nobody is perfect. When you are understanding of your employees’ mistakes, they will be more understanding of yours.

The emphasis, however, is always on praise. When I leave at the end of the day I always thank the staff. If I can’t think of a specific thing to thank them for, I thank them for a good day. Employees thrive on praise, and will go out of their way to earn it.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. To respond to this column, email Dr. Eastern at [email protected].

Perceived Social Support as a Predictor of Disease-Specific Quality of Life in Head-and-Neck Cancer Patients

Frank J. Penedo, PhD; Lara Traeger, PhD; Catherine Benedict, MS; Giovana Thomas, MD; Jason R. Dahn, PhD; Madeline Hernandez Krause, MS; and W. Jarrard Goodwin, MD

ABSTRACT

Background: Treatment for head-and-neck cancer (HNC) can lead to severe decrements in disease-specific quality of life (DSQOL) due to disfigurement and disability in speech, eating, and/or breathing. Psychosocial factors such as social support may explain individual variance in DSQOL outcomes.

Objective: The researchers sought to evaluate changes in perceived availability of social support from pretreatment to posttreatment and to determine whether decreases in perceived social support predicted poorer posttreatment DSQOL among HNC patients, controlling for disease-and treatment-related factors.

Methods: Participants (n equals 32) were newly diagnosed with HNC and were awaiting surgery and/or radiation treatment. Measures included the ENRICHD Social Support instrument (ESSI) to assess perceived social support and the Functional Assessment of Cancer Therapy–Head & Neck (FACT-H&N) to assess DSQOL. Paired-samples t-tests and hierarchical regression analyses were conducted to determine relationships between pretreatment and posttreatment perceived social support and DSQOL.

Results: Perceived social support decreased significantly from pre-to posttreatment (F[31] equals –2.71, P less than .01). After adjusting for relevant covariates and pretreatment DSQOL, change in perceived social support remained a significant predictor of posttreatment DSQOL (Beta equals 0.47, P less than .01).

Limitations: This study included a relatively small sample of HNC patients, which limited power to evaluate mechanisms of observed relationships.

Conclusions: Increased social isolation may be a risk factor for poorer physical recovery from, or adjustment to, treatment-related side effects. Social support may be an important target for psychosocial interventions for patients who face challenging treatment side effects.

To read the article, please see the attached pdf file.

Perceived Social Support as a Predictor of Disease-Specific Quality of Life in Head-and-Neck Cancer Patients

Frank J. Penedo, PhD; Lara Traeger, PhD; Catherine Benedict, MS; Giovana Thomas, MD; Jason R. Dahn, PhD; Madeline Hernandez Krause, MS; and W. Jarrard Goodwin, MD

ABSTRACT

Background: Treatment for head-and-neck cancer (HNC) can lead to severe decrements in disease-specific quality of life (DSQOL) due to disfigurement and disability in speech, eating, and/or breathing. Psychosocial factors such as social support may explain individual variance in DSQOL outcomes.

Objective: The researchers sought to evaluate changes in perceived availability of social support from pretreatment to posttreatment and to determine whether decreases in perceived social support predicted poorer posttreatment DSQOL among HNC patients, controlling for disease-and treatment-related factors.

Methods: Participants (n equals 32) were newly diagnosed with HNC and were awaiting surgery and/or radiation treatment. Measures included the ENRICHD Social Support instrument (ESSI) to assess perceived social support and the Functional Assessment of Cancer Therapy–Head & Neck (FACT-H&N) to assess DSQOL. Paired-samples t-tests and hierarchical regression analyses were conducted to determine relationships between pretreatment and posttreatment perceived social support and DSQOL.

Results: Perceived social support decreased significantly from pre-to posttreatment (F[31] equals –2.71, P less than .01). After adjusting for relevant covariates and pretreatment DSQOL, change in perceived social support remained a significant predictor of posttreatment DSQOL (Beta equals 0.47, P less than .01).

Limitations: This study included a relatively small sample of HNC patients, which limited power to evaluate mechanisms of observed relationships.

Conclusions: Increased social isolation may be a risk factor for poorer physical recovery from, or adjustment to, treatment-related side effects. Social support may be an important target for psychosocial interventions for patients who face challenging treatment side effects.

To read the article, please see the attached pdf file.

Perceived Social Support as a Predictor of Disease-Specific Quality of Life in Head-and-Neck Cancer Patients

Frank J. Penedo, PhD; Lara Traeger, PhD; Catherine Benedict, MS; Giovana Thomas, MD; Jason R. Dahn, PhD; Madeline Hernandez Krause, MS; and W. Jarrard Goodwin, MD

ABSTRACT

Background: Treatment for head-and-neck cancer (HNC) can lead to severe decrements in disease-specific quality of life (DSQOL) due to disfigurement and disability in speech, eating, and/or breathing. Psychosocial factors such as social support may explain individual variance in DSQOL outcomes.

Objective: The researchers sought to evaluate changes in perceived availability of social support from pretreatment to posttreatment and to determine whether decreases in perceived social support predicted poorer posttreatment DSQOL among HNC patients, controlling for disease-and treatment-related factors.

Methods: Participants (n equals 32) were newly diagnosed with HNC and were awaiting surgery and/or radiation treatment. Measures included the ENRICHD Social Support instrument (ESSI) to assess perceived social support and the Functional Assessment of Cancer Therapy–Head & Neck (FACT-H&N) to assess DSQOL. Paired-samples t-tests and hierarchical regression analyses were conducted to determine relationships between pretreatment and posttreatment perceived social support and DSQOL.

Results: Perceived social support decreased significantly from pre-to posttreatment (F[31] equals –2.71, P less than .01). After adjusting for relevant covariates and pretreatment DSQOL, change in perceived social support remained a significant predictor of posttreatment DSQOL (Beta equals 0.47, P less than .01).

Limitations: This study included a relatively small sample of HNC patients, which limited power to evaluate mechanisms of observed relationships.

Conclusions: Increased social isolation may be a risk factor for poorer physical recovery from, or adjustment to, treatment-related side effects. Social support may be an important target for psychosocial interventions for patients who face challenging treatment side effects.

To read the article, please see the attached pdf file.

In his intern year, Jordan Messler, MD, SFHM, would walk by Grady Hospital, the venerable Atlanta institution staffed by the Emory University and Morehouse schools of medicine physicians, with little thought of how the building dates to 1892. Then, one day with professor Ruth Parker, MD, he noticed a picture of a century-old hospital in front of the building. The conversation that followed led the Emory student, and later faculty member, down a path into the past.

“I was just missing history right in front of my eyes, and missing the stories, as all my colleagues were,” says Dr. Messler, medical director at Morton Plant Hospital in Clearwater, Fla.

Not anymore.

Dr. Messler is a hospitalist historian. At HM12 in April in San Diego, he led a session titled “The History of Hospitals,” a workshop that took attendees on a guided tour of medicine, from the Egyptian vizier Imhotep to William Osler, often called the father of modern medicine. It took detours at Galen, Christian hospitals, Islamic practices, and medieval medicine. The story was told through paintings, drawings, and hours of Dr. Messler’s “midnight to 2 a.m.” research.

“The humanities is a lost piece at times,” he says. “It certainly can help shape what we do.

“[It] helps us give a different perspective, makes us think about things in a different way, and, hopefully, can add even to the day-to-day work that people still do on the ground. It’s not going to help you treat heart failure in the research sense, but it should help you treat it in how you face your patient and how you face your facility.” (Click here to listen to more of Dr. Messler's interview with The Hospitalist)

Hospitalist J. Scott Dalston, MD, of Amarillo Hospitalist Services in northwest Texas enjoyed the break from the didactic and lecture approaches taken in nearly all of the annual meeting’s other breakout sessions. Perhaps more important, he felt reminded of what made him want to be a physician in the first place.

“Before medical school, you get caught up in the higher reasons for doing medicine, the calling,” he says. “Then, when you get down and dirty on the front lines, you kind of forget about that. This, in a way, reminds you of that.”

Such was the point of the debut “potpourri” track, according to Brendon Shank, SHM’s associate vice president of communications. The track also featured such nonclinical sessions as “Using Art to Improve Your Clinical Observation Skills” and “Professionalism in the Digital Age” in an attempt to round out the meeting.

Dr. Messler says he hopes his dabble into medicine’s beginnings inspires physicians to wrap history into their present practices. He encourages teaching hospitalists to weave historical nuggets into clinical rounds. He suggests residents ask older patients what their hospital experience used to be like. And he pushes all physicians to take the time to invest in their institution’s past.

“Taking a step back, looking at the history of where we are, going through the footsteps of those people who gone before us, gives us a better appreciation for what we do day to day,” he says. “Sometimes by looking backward we know that’s the best way to look forward.”

Richard Quinn is a freelance writer based in New Jersey.

In his intern year, Jordan Messler, MD, SFHM, would walk by Grady Hospital, the venerable Atlanta institution staffed by the Emory University and Morehouse schools of medicine physicians, with little thought of how the building dates to 1892. Then, one day with professor Ruth Parker, MD, he noticed a picture of a century-old hospital in front of the building. The conversation that followed led the Emory student, and later faculty member, down a path into the past.

“I was just missing history right in front of my eyes, and missing the stories, as all my colleagues were,” says Dr. Messler, medical director at Morton Plant Hospital in Clearwater, Fla.

Not anymore.

Dr. Messler is a hospitalist historian. At HM12 in April in San Diego, he led a session titled “The History of Hospitals,” a workshop that took attendees on a guided tour of medicine, from the Egyptian vizier Imhotep to William Osler, often called the father of modern medicine. It took detours at Galen, Christian hospitals, Islamic practices, and medieval medicine. The story was told through paintings, drawings, and hours of Dr. Messler’s “midnight to 2 a.m.” research.

“The humanities is a lost piece at times,” he says. “It certainly can help shape what we do.

“[It] helps us give a different perspective, makes us think about things in a different way, and, hopefully, can add even to the day-to-day work that people still do on the ground. It’s not going to help you treat heart failure in the research sense, but it should help you treat it in how you face your patient and how you face your facility.” (Click here to listen to more of Dr. Messler's interview with The Hospitalist)

Hospitalist J. Scott Dalston, MD, of Amarillo Hospitalist Services in northwest Texas enjoyed the break from the didactic and lecture approaches taken in nearly all of the annual meeting’s other breakout sessions. Perhaps more important, he felt reminded of what made him want to be a physician in the first place.

“Before medical school, you get caught up in the higher reasons for doing medicine, the calling,” he says. “Then, when you get down and dirty on the front lines, you kind of forget about that. This, in a way, reminds you of that.”

Such was the point of the debut “potpourri” track, according to Brendon Shank, SHM’s associate vice president of communications. The track also featured such nonclinical sessions as “Using Art to Improve Your Clinical Observation Skills” and “Professionalism in the Digital Age” in an attempt to round out the meeting.

Dr. Messler says he hopes his dabble into medicine’s beginnings inspires physicians to wrap history into their present practices. He encourages teaching hospitalists to weave historical nuggets into clinical rounds. He suggests residents ask older patients what their hospital experience used to be like. And he pushes all physicians to take the time to invest in their institution’s past.

“Taking a step back, looking at the history of where we are, going through the footsteps of those people who gone before us, gives us a better appreciation for what we do day to day,” he says. “Sometimes by looking backward we know that’s the best way to look forward.”

Richard Quinn is a freelance writer based in New Jersey.

In his intern year, Jordan Messler, MD, SFHM, would walk by Grady Hospital, the venerable Atlanta institution staffed by the Emory University and Morehouse schools of medicine physicians, with little thought of how the building dates to 1892. Then, one day with professor Ruth Parker, MD, he noticed a picture of a century-old hospital in front of the building. The conversation that followed led the Emory student, and later faculty member, down a path into the past.

“I was just missing history right in front of my eyes, and missing the stories, as all my colleagues were,” says Dr. Messler, medical director at Morton Plant Hospital in Clearwater, Fla.

Not anymore.

Dr. Messler is a hospitalist historian. At HM12 in April in San Diego, he led a session titled “The History of Hospitals,” a workshop that took attendees on a guided tour of medicine, from the Egyptian vizier Imhotep to William Osler, often called the father of modern medicine. It took detours at Galen, Christian hospitals, Islamic practices, and medieval medicine. The story was told through paintings, drawings, and hours of Dr. Messler’s “midnight to 2 a.m.” research.

“The humanities is a lost piece at times,” he says. “It certainly can help shape what we do.

“[It] helps us give a different perspective, makes us think about things in a different way, and, hopefully, can add even to the day-to-day work that people still do on the ground. It’s not going to help you treat heart failure in the research sense, but it should help you treat it in how you face your patient and how you face your facility.” (Click here to listen to more of Dr. Messler's interview with The Hospitalist)

Hospitalist J. Scott Dalston, MD, of Amarillo Hospitalist Services in northwest Texas enjoyed the break from the didactic and lecture approaches taken in nearly all of the annual meeting’s other breakout sessions. Perhaps more important, he felt reminded of what made him want to be a physician in the first place.

“Before medical school, you get caught up in the higher reasons for doing medicine, the calling,” he says. “Then, when you get down and dirty on the front lines, you kind of forget about that. This, in a way, reminds you of that.”

Such was the point of the debut “potpourri” track, according to Brendon Shank, SHM’s associate vice president of communications. The track also featured such nonclinical sessions as “Using Art to Improve Your Clinical Observation Skills” and “Professionalism in the Digital Age” in an attempt to round out the meeting.

Dr. Messler says he hopes his dabble into medicine’s beginnings inspires physicians to wrap history into their present practices. He encourages teaching hospitalists to weave historical nuggets into clinical rounds. He suggests residents ask older patients what their hospital experience used to be like. And he pushes all physicians to take the time to invest in their institution’s past.

“Taking a step back, looking at the history of where we are, going through the footsteps of those people who gone before us, gives us a better appreciation for what we do day to day,” he says. “Sometimes by looking backward we know that’s the best way to look forward.”

Richard Quinn is a freelance writer based in New Jersey.