An improved version of a neurostimulator device for treating gastroparesis has been approved by the Food and Drug Administration, according to the manufacturer.

In a Jan. 23 press release, Medtronic said that the FDA had approved a new version of the Enterra neurostimulator device, which has been available since 2000. It was approved as a treatment for chronic, intractable (drug refractory) nausea and vomiting associated with gastroparesis related to diabetes or of idiopathic etiology in patients aged 18-70 years, under a Humanitarian Device Exemption.

The programmable device – a battery-powered neurostimulator implanted under the skin in the lower abdominal region – “uses mild electrical pulses to stimulate the antrum portion of the stomach muscle wall,” which “may reduce the symptoms of nausea and the number of vomiting episodes related to gastroparesis,” according to the Medtronic website. The improvements of the new version – the Enterra II system – include new programming software and an indicator that alerts the clinician and patient when the device needs to be replaced; the battery lasts from 5 to 10 years. In addition, it does not have a magnetic activation switch, so it is more compatible with electromagnetic interference, according to the website.

A humanitarian use device “is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year,” according to the FDA. For approval, the company submits a humanitarian device exemption application, which does not require submission of effectiveness data, but “must contain sufficient information for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.”

The Medtronic release points out that use of the gastric electrical stimulation therapy at a medical center requires approval from the center’s Institutional Review Board.

[email protected]

An improved version of a neurostimulator device for treating gastroparesis has been approved by the Food and Drug Administration, according to the manufacturer.

In a Jan. 23 press release, Medtronic said that the FDA had approved a new version of the Enterra neurostimulator device, which has been available since 2000. It was approved as a treatment for chronic, intractable (drug refractory) nausea and vomiting associated with gastroparesis related to diabetes or of idiopathic etiology in patients aged 18-70 years, under a Humanitarian Device Exemption.

The programmable device – a battery-powered neurostimulator implanted under the skin in the lower abdominal region – “uses mild electrical pulses to stimulate the antrum portion of the stomach muscle wall,” which “may reduce the symptoms of nausea and the number of vomiting episodes related to gastroparesis,” according to the Medtronic website. The improvements of the new version – the Enterra II system – include new programming software and an indicator that alerts the clinician and patient when the device needs to be replaced; the battery lasts from 5 to 10 years. In addition, it does not have a magnetic activation switch, so it is more compatible with electromagnetic interference, according to the website.

A humanitarian use device “is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year,” according to the FDA. For approval, the company submits a humanitarian device exemption application, which does not require submission of effectiveness data, but “must contain sufficient information for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.”

The Medtronic release points out that use of the gastric electrical stimulation therapy at a medical center requires approval from the center’s Institutional Review Board.

[email protected]

An improved version of a neurostimulator device for treating gastroparesis has been approved by the Food and Drug Administration, according to the manufacturer.

In a Jan. 23 press release, Medtronic said that the FDA had approved a new version of the Enterra neurostimulator device, which has been available since 2000. It was approved as a treatment for chronic, intractable (drug refractory) nausea and vomiting associated with gastroparesis related to diabetes or of idiopathic etiology in patients aged 18-70 years, under a Humanitarian Device Exemption.

The programmable device – a battery-powered neurostimulator implanted under the skin in the lower abdominal region – “uses mild electrical pulses to stimulate the antrum portion of the stomach muscle wall,” which “may reduce the symptoms of nausea and the number of vomiting episodes related to gastroparesis,” according to the Medtronic website. The improvements of the new version – the Enterra II system – include new programming software and an indicator that alerts the clinician and patient when the device needs to be replaced; the battery lasts from 5 to 10 years. In addition, it does not have a magnetic activation switch, so it is more compatible with electromagnetic interference, according to the website.

A humanitarian use device “is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year,” according to the FDA. For approval, the company submits a humanitarian device exemption application, which does not require submission of effectiveness data, but “must contain sufficient information for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.”

The Medtronic release points out that use of the gastric electrical stimulation therapy at a medical center requires approval from the center’s Institutional Review Board.

[email protected]

Updates have been issued to guidelines on diagnosing and treating interstitial cystitis and bladder pain by the American Urological Association.

The basic assessment should include a careful history, physical examination, and laboratory examination to rule in symptoms that characterize interstitial cystitis/bladder pain syndrome (and rule out other disorders). Baseline voiding symptoms and pain levels should be obtained in order to measure subsequent treatment effects.

Overall management should initially focus on conservative therapies including patient education, behavior modification, and stress management. Treatment, including pain management, is determined by symptom severity, clinician judgment, and patient preferences.

Second-line treatments include manual physical therapy techniques, oral medications (amitriptyline, cimetidine, hydroxyzine, or pentosan polysulfate), and intravesical treatments (dimethyl sulfoxide, heparin, or lidocaine). Third-line treatments are cystoscopy under anesthesia with short-duration, low-pressure hydrodistension, fulguration, and injection of triamcinolone, the guidelines state.

Find the full guideline sat the Agency for Healthcare Research and Quality website.

Updates have been issued to guidelines on diagnosing and treating interstitial cystitis and bladder pain by the American Urological Association.

The basic assessment should include a careful history, physical examination, and laboratory examination to rule in symptoms that characterize interstitial cystitis/bladder pain syndrome (and rule out other disorders). Baseline voiding symptoms and pain levels should be obtained in order to measure subsequent treatment effects.

Overall management should initially focus on conservative therapies including patient education, behavior modification, and stress management. Treatment, including pain management, is determined by symptom severity, clinician judgment, and patient preferences.

Second-line treatments include manual physical therapy techniques, oral medications (amitriptyline, cimetidine, hydroxyzine, or pentosan polysulfate), and intravesical treatments (dimethyl sulfoxide, heparin, or lidocaine). Third-line treatments are cystoscopy under anesthesia with short-duration, low-pressure hydrodistension, fulguration, and injection of triamcinolone, the guidelines state.

Find the full guideline sat the Agency for Healthcare Research and Quality website.

Updates have been issued to guidelines on diagnosing and treating interstitial cystitis and bladder pain by the American Urological Association.

The basic assessment should include a careful history, physical examination, and laboratory examination to rule in symptoms that characterize interstitial cystitis/bladder pain syndrome (and rule out other disorders). Baseline voiding symptoms and pain levels should be obtained in order to measure subsequent treatment effects.

Overall management should initially focus on conservative therapies including patient education, behavior modification, and stress management. Treatment, including pain management, is determined by symptom severity, clinician judgment, and patient preferences.

Second-line treatments include manual physical therapy techniques, oral medications (amitriptyline, cimetidine, hydroxyzine, or pentosan polysulfate), and intravesical treatments (dimethyl sulfoxide, heparin, or lidocaine). Third-line treatments are cystoscopy under anesthesia with short-duration, low-pressure hydrodistension, fulguration, and injection of triamcinolone, the guidelines state.

Find the full guideline sat the Agency for Healthcare Research and Quality website.

LAKE BUENA VISTA, FLA. – Academic surgeons earn an average of 10% or $1.3 million less in gross income across their lifetime than surgeons in private practice, an analysis shows.

Some surgical specialties fare better than others, with academic neurosurgeons having the largest reduction in gross income at $4.2 million (-24.2%), while academic pediatric surgeons earn $238,376 more (1.53%) than their private practice counterparts. They were the only ones to do so.

Several academic surgical specialties did not make the 10% average including trauma surgeons whose lifetime earnings were down 12% or $2.4 million, vascular surgeons at 13.8% or $1.7 million, and surgical oncologists at 12.2% or $1.3 million.

Patrice Wendling/Frontline Medical Group

“The concern that we have is that the academic surgeons are where the education of the future lies,” lead study author Dr. Joseph Martin Lopez said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma (EAST).

Every year a new class of surgeons is faced with the question of academic practice or private practice, but they are also struggling with increasing student loan debt and longer training as more surgical residents elect to enter fellowship rather than general practice. This growing financial liability coupled with declining physician reimbursement could rapidly shift physician practices and thus threaten the fiscal viability of certain surgical fields or academic surgical careers.

“The more financially irresponsible you make it to become an academic surgeon, the more we put at risk our current mode of training,” Dr. Lopez of Wake Forest University in Winston-Salem, N.C., said.

To account for additional factors outside gross income, the investigators ran the numbers using a second analysis, a net present value calculation, however, and came up with roughly the same salary gap to contend with.

Net present value (NPV) calculations are commonly used in business to calculate the profitability of an investment and also have been used in the medical field to gauge return on investment for various careers. The NPV calculation accounts for positive and negative cash flows over the entire length of a career, using in this case, a 5% discount rate and adjusting for inflation, Dr. Lopez explained.

Both the lifetime gross income and 5% NPV calculation used data from the Medical Group Management Association’s 2012 physician salary report, the 2012 Association of American Medical Colleges physician salary report, and the AAMC database for residency and fellow salary.

The NPV assumed a career length of 37-39 years, based on a retirement age of 65 years for all specialties. Positive cash flows included annual salary less federal income tax. Negative cash flows included the average principal for student loans, according to the AAMC, and interest at 5%, the average for the three largest student loan lenders in 2014, he said. Student loan repayment was calculated for a fixed-rate loan to be paid over 25 years beginning after residency or any required fellowship.

The average reduction in 5% NPV across surgical specialties for an academic surgeon versus a privately employed surgeon was 12.8% or $246,499, Dr. Lopez said.

Once again, academic neurosurgeons had the largest reduction in 5% NPV at 25.5% or a loss of $619,681, followed closely by trauma surgeons (23% or $381,179) and surgical oncologists (16.3% or $256,373). Academic pediatric surgeons had the smallest reduction in 5% NPV at 4.2% or $88,827.

During a discussion of the provocative poster, attendees questioned whether it was fair to say that private surgeons make more money without acknowledging the risk they face, compared with surgeons employed in an academic setting.

Dr. Lopez countered that increasingly, even private surgeons are no longer truly private surgeons.

“More and more surgical groups are being bought up by hospitals, and even the private surgical groups are being bought up by hospitals, which does stabilize your income to some extent,” he said. “We all still have RVU goals to meet and RVU incentives that make it so you can get paid a little more, but it’s something that’s a consideration. It is a risk-reward to be a private surgeon. Depending on how your contract is structured or how your group decides to pay the partners, it may be that if you don’t take very much call or take that many cases, you’ll end up on the short end of the stick.”

Dr. Ben L. Zarzaur, a general surgeon at Indiana University in Indianapolis who comoderated the poster discussion, pointed out that market pressures unaccounted for in the model can dramatically influence a surgeon’s salary over a lifetime.

Dr. Lopez agreed, citing how the increasing number of stent placements by cardiologists, for example, has impacted the bottom line of cardiothoracic surgeons. The NPV calculation was specifically used, however, because it gets at market forces such as inflation and return on investment, not addressed by gross income figures alone.

Finally, Dr. Zarzaur turned and asked the relatively young crowd what they would do if offered $600,000 a year, but had to work 110 hours a week or could get $250,000 and work only 40 hours a week. Most responded that they’d choose the former to repay their student loans and then switch to the lower-paying position. Responders made much of job satisfaction, work-life balance, and the ability of surgeons in academic practice to take time away from clinical work to conduct research, their ready access to continuing medical education, and their ability to educate the next generation of surgeons.

“Any time we see this academic-private disparity, you have to think about these secondary gains,” Dr. Zarzaur said. “This is really interesting work. It gets into why we choose what we do, why we’d take $600,000, work 110 hours a week, and get our rear ends kicked. The flip side is, if I saw this, why would you ever go into academics? But people still choose to do it. I’m in academics so there’s a bias, but we choose to do it anyway up to a point. I don’t know where that point is, but up to a point we do.”

[email protected]

LAKE BUENA VISTA, FLA. – Academic surgeons earn an average of 10% or $1.3 million less in gross income across their lifetime than surgeons in private practice, an analysis shows.

Some surgical specialties fare better than others, with academic neurosurgeons having the largest reduction in gross income at $4.2 million (-24.2%), while academic pediatric surgeons earn $238,376 more (1.53%) than their private practice counterparts. They were the only ones to do so.

Several academic surgical specialties did not make the 10% average including trauma surgeons whose lifetime earnings were down 12% or $2.4 million, vascular surgeons at 13.8% or $1.7 million, and surgical oncologists at 12.2% or $1.3 million.

Patrice Wendling/Frontline Medical Group

“The concern that we have is that the academic surgeons are where the education of the future lies,” lead study author Dr. Joseph Martin Lopez said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma (EAST).

Every year a new class of surgeons is faced with the question of academic practice or private practice, but they are also struggling with increasing student loan debt and longer training as more surgical residents elect to enter fellowship rather than general practice. This growing financial liability coupled with declining physician reimbursement could rapidly shift physician practices and thus threaten the fiscal viability of certain surgical fields or academic surgical careers.

“The more financially irresponsible you make it to become an academic surgeon, the more we put at risk our current mode of training,” Dr. Lopez of Wake Forest University in Winston-Salem, N.C., said.

To account for additional factors outside gross income, the investigators ran the numbers using a second analysis, a net present value calculation, however, and came up with roughly the same salary gap to contend with.

Net present value (NPV) calculations are commonly used in business to calculate the profitability of an investment and also have been used in the medical field to gauge return on investment for various careers. The NPV calculation accounts for positive and negative cash flows over the entire length of a career, using in this case, a 5% discount rate and adjusting for inflation, Dr. Lopez explained.

Both the lifetime gross income and 5% NPV calculation used data from the Medical Group Management Association’s 2012 physician salary report, the 2012 Association of American Medical Colleges physician salary report, and the AAMC database for residency and fellow salary.

The NPV assumed a career length of 37-39 years, based on a retirement age of 65 years for all specialties. Positive cash flows included annual salary less federal income tax. Negative cash flows included the average principal for student loans, according to the AAMC, and interest at 5%, the average for the three largest student loan lenders in 2014, he said. Student loan repayment was calculated for a fixed-rate loan to be paid over 25 years beginning after residency or any required fellowship.

The average reduction in 5% NPV across surgical specialties for an academic surgeon versus a privately employed surgeon was 12.8% or $246,499, Dr. Lopez said.

Once again, academic neurosurgeons had the largest reduction in 5% NPV at 25.5% or a loss of $619,681, followed closely by trauma surgeons (23% or $381,179) and surgical oncologists (16.3% or $256,373). Academic pediatric surgeons had the smallest reduction in 5% NPV at 4.2% or $88,827.

During a discussion of the provocative poster, attendees questioned whether it was fair to say that private surgeons make more money without acknowledging the risk they face, compared with surgeons employed in an academic setting.

Dr. Lopez countered that increasingly, even private surgeons are no longer truly private surgeons.

“More and more surgical groups are being bought up by hospitals, and even the private surgical groups are being bought up by hospitals, which does stabilize your income to some extent,” he said. “We all still have RVU goals to meet and RVU incentives that make it so you can get paid a little more, but it’s something that’s a consideration. It is a risk-reward to be a private surgeon. Depending on how your contract is structured or how your group decides to pay the partners, it may be that if you don’t take very much call or take that many cases, you’ll end up on the short end of the stick.”

Dr. Ben L. Zarzaur, a general surgeon at Indiana University in Indianapolis who comoderated the poster discussion, pointed out that market pressures unaccounted for in the model can dramatically influence a surgeon’s salary over a lifetime.

Dr. Lopez agreed, citing how the increasing number of stent placements by cardiologists, for example, has impacted the bottom line of cardiothoracic surgeons. The NPV calculation was specifically used, however, because it gets at market forces such as inflation and return on investment, not addressed by gross income figures alone.

Finally, Dr. Zarzaur turned and asked the relatively young crowd what they would do if offered $600,000 a year, but had to work 110 hours a week or could get $250,000 and work only 40 hours a week. Most responded that they’d choose the former to repay their student loans and then switch to the lower-paying position. Responders made much of job satisfaction, work-life balance, and the ability of surgeons in academic practice to take time away from clinical work to conduct research, their ready access to continuing medical education, and their ability to educate the next generation of surgeons.

“Any time we see this academic-private disparity, you have to think about these secondary gains,” Dr. Zarzaur said. “This is really interesting work. It gets into why we choose what we do, why we’d take $600,000, work 110 hours a week, and get our rear ends kicked. The flip side is, if I saw this, why would you ever go into academics? But people still choose to do it. I’m in academics so there’s a bias, but we choose to do it anyway up to a point. I don’t know where that point is, but up to a point we do.”

[email protected]

LAKE BUENA VISTA, FLA. – Academic surgeons earn an average of 10% or $1.3 million less in gross income across their lifetime than surgeons in private practice, an analysis shows.

Some surgical specialties fare better than others, with academic neurosurgeons having the largest reduction in gross income at $4.2 million (-24.2%), while academic pediatric surgeons earn $238,376 more (1.53%) than their private practice counterparts. They were the only ones to do so.

Several academic surgical specialties did not make the 10% average including trauma surgeons whose lifetime earnings were down 12% or $2.4 million, vascular surgeons at 13.8% or $1.7 million, and surgical oncologists at 12.2% or $1.3 million.

Patrice Wendling/Frontline Medical Group

“The concern that we have is that the academic surgeons are where the education of the future lies,” lead study author Dr. Joseph Martin Lopez said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma (EAST).

Every year a new class of surgeons is faced with the question of academic practice or private practice, but they are also struggling with increasing student loan debt and longer training as more surgical residents elect to enter fellowship rather than general practice. This growing financial liability coupled with declining physician reimbursement could rapidly shift physician practices and thus threaten the fiscal viability of certain surgical fields or academic surgical careers.

“The more financially irresponsible you make it to become an academic surgeon, the more we put at risk our current mode of training,” Dr. Lopez of Wake Forest University in Winston-Salem, N.C., said.

To account for additional factors outside gross income, the investigators ran the numbers using a second analysis, a net present value calculation, however, and came up with roughly the same salary gap to contend with.

Net present value (NPV) calculations are commonly used in business to calculate the profitability of an investment and also have been used in the medical field to gauge return on investment for various careers. The NPV calculation accounts for positive and negative cash flows over the entire length of a career, using in this case, a 5% discount rate and adjusting for inflation, Dr. Lopez explained.

Both the lifetime gross income and 5% NPV calculation used data from the Medical Group Management Association’s 2012 physician salary report, the 2012 Association of American Medical Colleges physician salary report, and the AAMC database for residency and fellow salary.

The NPV assumed a career length of 37-39 years, based on a retirement age of 65 years for all specialties. Positive cash flows included annual salary less federal income tax. Negative cash flows included the average principal for student loans, according to the AAMC, and interest at 5%, the average for the three largest student loan lenders in 2014, he said. Student loan repayment was calculated for a fixed-rate loan to be paid over 25 years beginning after residency or any required fellowship.

The average reduction in 5% NPV across surgical specialties for an academic surgeon versus a privately employed surgeon was 12.8% or $246,499, Dr. Lopez said.

Once again, academic neurosurgeons had the largest reduction in 5% NPV at 25.5% or a loss of $619,681, followed closely by trauma surgeons (23% or $381,179) and surgical oncologists (16.3% or $256,373). Academic pediatric surgeons had the smallest reduction in 5% NPV at 4.2% or $88,827.

During a discussion of the provocative poster, attendees questioned whether it was fair to say that private surgeons make more money without acknowledging the risk they face, compared with surgeons employed in an academic setting.

Dr. Lopez countered that increasingly, even private surgeons are no longer truly private surgeons.

“More and more surgical groups are being bought up by hospitals, and even the private surgical groups are being bought up by hospitals, which does stabilize your income to some extent,” he said. “We all still have RVU goals to meet and RVU incentives that make it so you can get paid a little more, but it’s something that’s a consideration. It is a risk-reward to be a private surgeon. Depending on how your contract is structured or how your group decides to pay the partners, it may be that if you don’t take very much call or take that many cases, you’ll end up on the short end of the stick.”

Dr. Ben L. Zarzaur, a general surgeon at Indiana University in Indianapolis who comoderated the poster discussion, pointed out that market pressures unaccounted for in the model can dramatically influence a surgeon’s salary over a lifetime.

Dr. Lopez agreed, citing how the increasing number of stent placements by cardiologists, for example, has impacted the bottom line of cardiothoracic surgeons. The NPV calculation was specifically used, however, because it gets at market forces such as inflation and return on investment, not addressed by gross income figures alone.

Finally, Dr. Zarzaur turned and asked the relatively young crowd what they would do if offered $600,000 a year, but had to work 110 hours a week or could get $250,000 and work only 40 hours a week. Most responded that they’d choose the former to repay their student loans and then switch to the lower-paying position. Responders made much of job satisfaction, work-life balance, and the ability of surgeons in academic practice to take time away from clinical work to conduct research, their ready access to continuing medical education, and their ability to educate the next generation of surgeons.

“Any time we see this academic-private disparity, you have to think about these secondary gains,” Dr. Zarzaur said. “This is really interesting work. It gets into why we choose what we do, why we’d take $600,000, work 110 hours a week, and get our rear ends kicked. The flip side is, if I saw this, why would you ever go into academics? But people still choose to do it. I’m in academics so there’s a bias, but we choose to do it anyway up to a point. I don’t know where that point is, but up to a point we do.”

[email protected]

Some things make my job much harder than it should be. One of them is prior authorizations.

At the start of every year, insurers release a new formulary, so prior authorizations are often required, even drugs that patients have been on for a long time. Everyday I spend anywhere from 10 to 30 minutes filling out prior authorization paperwork.

Sometimes, it’s not too difficult. If someone is getting a biologic for the first time, it usually means they’ve had an inadequate response to methotrexate. The form makes sure we’ve checked the patient’s TB status. Sometimes, it asks about a history of heart failure. These are reasonable questions designed to protect the patient.

Frequently, though, the questionnaires are more onerous, and for less altruistic motives. A prior authorization for celecoxib (Celebrex) requires that I list at least two other prescription NSAIDs that the patient has been on. I can guarantee that I do not know that information off the top of my head, so this requires some digging into the chart. If it’s a patient whose care I’ve assumed from someone else, or whose chart is several volumes thick, I won’t even know where to begin. Even worse is the pregabalin (Lyrica) prior authorization that asks about previous use of tricyclic antidepressants, cyclobenzaprine, SSRIs, gabapentin. When were they on these agents and for how long? What was the outcome of each failed medication?

These two examples do not ensure patient safety. They simply go directly to what the insurer’s bottom line is. They benefit no one but the insurer, and create lots of problems for everyone who has to abide by the insurer’s rules.

The worst of it, this year, has to be prior authorization for injectable methotrexate. I have recently run into a lot of problems with this one. For one patient who had been on weekly adalimumab (Humira) and subcutaneous methotrexate, I was asked to justify the combination with a journal article or two, because mechanistically the insurers reject methotrexate as having any role in therapy for patients already on weekly adalimumab, antidrug antibodies notwithstanding. I had inherited this patient from another rheumatologist, and she’d been on this regimen for over a decade; it was infuriating and frustrating to be asked to justify a regimen that the patient had not had problems with for the previous 10 years and that was working fine for her.

For another patient, I was asked to fax a letter to the pharmacy stating why the drug was necessary. Then I was asked to fax another letter to the insurer’s benefits manager. A day later, I was informed that there was no process of appeal for medications that were not on formulary. None whatsoever. The letters that they had asked me to write had no bearing and meant nothing to them. This was the very definition of a complete waste of time.

If I wanted the patient to be on subcutaneous methotrexate, the patient would have to pay out of pocket for the drug. I got on the phone with someone whose job was to repeatedly tell me that I had no options. She couldn’t direct me to anyone higher up than her. I understand that this automaton would have no intelligent answers for me, but I asked rhetorically if etanercept would be covered. She said yes. I then asked rhetorically if she knew how much more the biologic agent would cost the insurance company. I cut her off as she was about to look up the price of the drug.

I can think of hundreds of ways in which I could make better use of my time instead of playing a game I am forced to play against my will, a game that is shrouded in layers of bureaucracy over which I have very little control and has no benefit to my patients. There are days when the game is enough to make me want to throw in the towel.

Dr. Chan practices rheumatology in Pawtucket, R.I.

Some things make my job much harder than it should be. One of them is prior authorizations.

At the start of every year, insurers release a new formulary, so prior authorizations are often required, even drugs that patients have been on for a long time. Everyday I spend anywhere from 10 to 30 minutes filling out prior authorization paperwork.

Sometimes, it’s not too difficult. If someone is getting a biologic for the first time, it usually means they’ve had an inadequate response to methotrexate. The form makes sure we’ve checked the patient’s TB status. Sometimes, it asks about a history of heart failure. These are reasonable questions designed to protect the patient.

Frequently, though, the questionnaires are more onerous, and for less altruistic motives. A prior authorization for celecoxib (Celebrex) requires that I list at least two other prescription NSAIDs that the patient has been on. I can guarantee that I do not know that information off the top of my head, so this requires some digging into the chart. If it’s a patient whose care I’ve assumed from someone else, or whose chart is several volumes thick, I won’t even know where to begin. Even worse is the pregabalin (Lyrica) prior authorization that asks about previous use of tricyclic antidepressants, cyclobenzaprine, SSRIs, gabapentin. When were they on these agents and for how long? What was the outcome of each failed medication?

These two examples do not ensure patient safety. They simply go directly to what the insurer’s bottom line is. They benefit no one but the insurer, and create lots of problems for everyone who has to abide by the insurer’s rules.

The worst of it, this year, has to be prior authorization for injectable methotrexate. I have recently run into a lot of problems with this one. For one patient who had been on weekly adalimumab (Humira) and subcutaneous methotrexate, I was asked to justify the combination with a journal article or two, because mechanistically the insurers reject methotrexate as having any role in therapy for patients already on weekly adalimumab, antidrug antibodies notwithstanding. I had inherited this patient from another rheumatologist, and she’d been on this regimen for over a decade; it was infuriating and frustrating to be asked to justify a regimen that the patient had not had problems with for the previous 10 years and that was working fine for her.

For another patient, I was asked to fax a letter to the pharmacy stating why the drug was necessary. Then I was asked to fax another letter to the insurer’s benefits manager. A day later, I was informed that there was no process of appeal for medications that were not on formulary. None whatsoever. The letters that they had asked me to write had no bearing and meant nothing to them. This was the very definition of a complete waste of time.

If I wanted the patient to be on subcutaneous methotrexate, the patient would have to pay out of pocket for the drug. I got on the phone with someone whose job was to repeatedly tell me that I had no options. She couldn’t direct me to anyone higher up than her. I understand that this automaton would have no intelligent answers for me, but I asked rhetorically if etanercept would be covered. She said yes. I then asked rhetorically if she knew how much more the biologic agent would cost the insurance company. I cut her off as she was about to look up the price of the drug.

I can think of hundreds of ways in which I could make better use of my time instead of playing a game I am forced to play against my will, a game that is shrouded in layers of bureaucracy over which I have very little control and has no benefit to my patients. There are days when the game is enough to make me want to throw in the towel.

Dr. Chan practices rheumatology in Pawtucket, R.I.

Some things make my job much harder than it should be. One of them is prior authorizations.

At the start of every year, insurers release a new formulary, so prior authorizations are often required, even drugs that patients have been on for a long time. Everyday I spend anywhere from 10 to 30 minutes filling out prior authorization paperwork.

Sometimes, it’s not too difficult. If someone is getting a biologic for the first time, it usually means they’ve had an inadequate response to methotrexate. The form makes sure we’ve checked the patient’s TB status. Sometimes, it asks about a history of heart failure. These are reasonable questions designed to protect the patient.

Frequently, though, the questionnaires are more onerous, and for less altruistic motives. A prior authorization for celecoxib (Celebrex) requires that I list at least two other prescription NSAIDs that the patient has been on. I can guarantee that I do not know that information off the top of my head, so this requires some digging into the chart. If it’s a patient whose care I’ve assumed from someone else, or whose chart is several volumes thick, I won’t even know where to begin. Even worse is the pregabalin (Lyrica) prior authorization that asks about previous use of tricyclic antidepressants, cyclobenzaprine, SSRIs, gabapentin. When were they on these agents and for how long? What was the outcome of each failed medication?

These two examples do not ensure patient safety. They simply go directly to what the insurer’s bottom line is. They benefit no one but the insurer, and create lots of problems for everyone who has to abide by the insurer’s rules.

The worst of it, this year, has to be prior authorization for injectable methotrexate. I have recently run into a lot of problems with this one. For one patient who had been on weekly adalimumab (Humira) and subcutaneous methotrexate, I was asked to justify the combination with a journal article or two, because mechanistically the insurers reject methotrexate as having any role in therapy for patients already on weekly adalimumab, antidrug antibodies notwithstanding. I had inherited this patient from another rheumatologist, and she’d been on this regimen for over a decade; it was infuriating and frustrating to be asked to justify a regimen that the patient had not had problems with for the previous 10 years and that was working fine for her.

For another patient, I was asked to fax a letter to the pharmacy stating why the drug was necessary. Then I was asked to fax another letter to the insurer’s benefits manager. A day later, I was informed that there was no process of appeal for medications that were not on formulary. None whatsoever. The letters that they had asked me to write had no bearing and meant nothing to them. This was the very definition of a complete waste of time.

If I wanted the patient to be on subcutaneous methotrexate, the patient would have to pay out of pocket for the drug. I got on the phone with someone whose job was to repeatedly tell me that I had no options. She couldn’t direct me to anyone higher up than her. I understand that this automaton would have no intelligent answers for me, but I asked rhetorically if etanercept would be covered. She said yes. I then asked rhetorically if she knew how much more the biologic agent would cost the insurance company. I cut her off as she was about to look up the price of the drug.

I can think of hundreds of ways in which I could make better use of my time instead of playing a game I am forced to play against my will, a game that is shrouded in layers of bureaucracy over which I have very little control and has no benefit to my patients. There are days when the game is enough to make me want to throw in the towel.

Dr. Chan practices rheumatology in Pawtucket, R.I.

A Canadian guideline on screening, assessment, and care of anxiety and depressive symptoms in adults with cancer has been adapted for the United States by the American Society of Clinical Oncology.

It is recommended that all patients with cancer be evaluated for symptoms of depression and anxiety at periodic times across the trajectory of care. Assessment should be performed using validated, published measures and procedures. Depending on levels of symptoms and supplementary information, differing treatment pathways are recommended. Failure to identify and treat anxiety and depression increases the risk for poor quality of life and potential disease-related morbidity and mortality, according to ASCO.

The full guideline can be found on the Agency for Healthcare Research and Quality website.

A Canadian guideline on screening, assessment, and care of anxiety and depressive symptoms in adults with cancer has been adapted for the United States by the American Society of Clinical Oncology.

It is recommended that all patients with cancer be evaluated for symptoms of depression and anxiety at periodic times across the trajectory of care. Assessment should be performed using validated, published measures and procedures. Depending on levels of symptoms and supplementary information, differing treatment pathways are recommended. Failure to identify and treat anxiety and depression increases the risk for poor quality of life and potential disease-related morbidity and mortality, according to ASCO.

The full guideline can be found on the Agency for Healthcare Research and Quality website.

A Canadian guideline on screening, assessment, and care of anxiety and depressive symptoms in adults with cancer has been adapted for the United States by the American Society of Clinical Oncology.

It is recommended that all patients with cancer be evaluated for symptoms of depression and anxiety at periodic times across the trajectory of care. Assessment should be performed using validated, published measures and procedures. Depending on levels of symptoms and supplementary information, differing treatment pathways are recommended. Failure to identify and treat anxiety and depression increases the risk for poor quality of life and potential disease-related morbidity and mortality, according to ASCO.

The full guideline can be found on the Agency for Healthcare Research and Quality website.

A new guideline on identifying optimal chemotherapy and targeted therapy for women with human epidermal growth factor 2–negative or unknown advanced breast cancer has been released by the American Society of Clinical Oncology.

Endocrine therapy is preferable to chemotherapy as first-line treatment for patients with estrogen receptor–positive metastatic breast cancer unless improvement is medically necessary. Single-agent is preferable to combination chemotherapy, and longer planned duration improves outcome but must be balanced against toxicity. There is no single optimal first-line or subsequent-line chemotherapy, and choice of treatment will be determined by multiple factors including prior therapy, toxicity, performance status, comorbid conditions, and patient preference. The role of bevacizumab remains controversial. Other targeted therapies have not been shown to enhance chemotherapy outcomes in HER2-negative breast cancer, the researchers said.

The full guideline can be found on the Agency for Healthcare Research and Quality website.

A new guideline on identifying optimal chemotherapy and targeted therapy for women with human epidermal growth factor 2–negative or unknown advanced breast cancer has been released by the American Society of Clinical Oncology.

Endocrine therapy is preferable to chemotherapy as first-line treatment for patients with estrogen receptor–positive metastatic breast cancer unless improvement is medically necessary. Single-agent is preferable to combination chemotherapy, and longer planned duration improves outcome but must be balanced against toxicity. There is no single optimal first-line or subsequent-line chemotherapy, and choice of treatment will be determined by multiple factors including prior therapy, toxicity, performance status, comorbid conditions, and patient preference. The role of bevacizumab remains controversial. Other targeted therapies have not been shown to enhance chemotherapy outcomes in HER2-negative breast cancer, the researchers said.

The full guideline can be found on the Agency for Healthcare Research and Quality website.

A new guideline on identifying optimal chemotherapy and targeted therapy for women with human epidermal growth factor 2–negative or unknown advanced breast cancer has been released by the American Society of Clinical Oncology.

Endocrine therapy is preferable to chemotherapy as first-line treatment for patients with estrogen receptor–positive metastatic breast cancer unless improvement is medically necessary. Single-agent is preferable to combination chemotherapy, and longer planned duration improves outcome but must be balanced against toxicity. There is no single optimal first-line or subsequent-line chemotherapy, and choice of treatment will be determined by multiple factors including prior therapy, toxicity, performance status, comorbid conditions, and patient preference. The role of bevacizumab remains controversial. Other targeted therapies have not been shown to enhance chemotherapy outcomes in HER2-negative breast cancer, the researchers said.

The full guideline can be found on the Agency for Healthcare Research and Quality website.

The human papillomavirus (HPV) vaccination is not associated with the development of multiple sclerosis (MS) or other demyelinating diseases, according to a study published January 6 in JAMA. Researchers examined Danish and Swedish girls and women between ages 10 and 44. Participants were followed up from 2006 to 2013. A total of 3,983,824 girls and women were eligible for inclusion in this study. Of these individuals, 789,082 were vaccinated, and 1,927,581 HPV vaccine doses were administered. At follow-up, 4,322 cases of MS and 3,300 cases of other demyelinating diseases were identified, of which 73 and 90, respectively, occurred within the risk period of two years following vaccination. “These findings do not support concerns about a causal relationship between HPV vaccination and demyelinating diseases,” the researchers stated.

No evidence of disease activity (NEDA) is a difficult outcome for patients with multiple sclerosis (MS) to sustain in the long term, even with treatment, according to a study published online ahead of print December 22 in JAMA Neurology. Researchers investigated the sustainability of NEDA over seven years in a group of 219 patients with MS. Patients had seven years of follow-up that included yearly brain MRI and biannual clinic visits. Investigators found that of 215 patients, 99 (46%) had NEDA for clinical and MRI measures at one year. At two years, 60 of 218 patients (27.5%) maintained NEDA, and 17 of 216 patients (7.9%) sustained NEDA after seven years. There was no difference in NEDA status for patients with early MS, compared with patients with more established disease.

Pharnext announced the proof of concept of its pleotherapy research and development approach based on a proprietary network pharmacology platform that identifies synergistic combinations of drugs already approved for other diseases. According to two reports published online December 10, 2014, in the Orphanet Journal of Rare Diseases, Pharnext’s lead pleodrug, PXT-3003, has shown positive results in preclinical and phase 2 clinical studies. The first paper shows consistent and synergistic preclinical data for PXT-3003 in two Charcot–Marie–Tooth disease type 1A (CMT 1A) rodent models. The second paper presents positive phase 2 results of PXT-3003 in 80 patients with mild to moderate CMT 1A.

Patients with acute ischemic stroke admitted to tertiary stroke centers during July had similar outcomes to patients admitted during other months, despite receiving slightly less frequent thrombolysis and stroke unit care, according to a study published online ahead of print December 19 in the Journal of Stroke and Cerebrovascular Diseases. Researchers examined 10,319 patients with acute ischemic stroke between July 1, 2003 and March 31, 2008. The research team evaluated referrals to long-term care facilities, length of hospital stay, hospital readmissions or emergency department visits within 30 days of hospital discharge, and hospital readmissions within 30 days from discharge due to stroke. “Ischemic stroke patients admitted in July were less likely to receive clot-busting drugs or be admitted to stroke units, but ultimately patients did just as well regardless of the month,” stated the investigators.

Insomnia symptoms are an important factor for explaining the mechanism by which alcohol use increases suicide risk, according to a study published December 15 in the Journal of Clinical Sleep Medicine. The study included 375 undergraduate students at a large, public university in the southeastern United States. Participants completed an online questionnaire that examined insomnia symptoms, nightmares, alcohol use, and suicide risk. Alcohol use was significantly associated with suicide risk among women. In addition, further analysis revealed that insomnia symptoms explained a significant proportion of the relationship between alcohol and suicide risk. Investigators found no direct effect of alcohol use on suicide risk in men, but they observed a significant indirect effect of alcohol use increasing suicide risk through insomnia symptoms.

The virtual supermarket (VSM) application correctly identifies 87.30% of patients with mild cognitive impairment (MCI), a level of diagnostic accuracy similar to that of standardized neuropsychologic tests, according to a study published online ahead of print November 25 in the Journal of Alzheimer’s Disease. Two groups, one of healthy older adults and one of patients with MCI, were recruited from day centers for people with cognitive disorders. Participants used the VSM application and underwent a battery of neuropsychologic tests. The VSM application accurately distinguished between patients with MCI and healthy older adults, but it was unable to differentiate between MCI subtypes. Overall, the VSM application is a valid method of screening for MCI in an older adult population, but it cannot be used for MCI subtype assessment.

—Kimberly D. Williams

The human papillomavirus (HPV) vaccination is not associated with the development of multiple sclerosis (MS) or other demyelinating diseases, according to a study published January 6 in JAMA. Researchers examined Danish and Swedish girls and women between ages 10 and 44. Participants were followed up from 2006 to 2013. A total of 3,983,824 girls and women were eligible for inclusion in this study. Of these individuals, 789,082 were vaccinated, and 1,927,581 HPV vaccine doses were administered. At follow-up, 4,322 cases of MS and 3,300 cases of other demyelinating diseases were identified, of which 73 and 90, respectively, occurred within the risk period of two years following vaccination. “These findings do not support concerns about a causal relationship between HPV vaccination and demyelinating diseases,” the researchers stated.

No evidence of disease activity (NEDA) is a difficult outcome for patients with multiple sclerosis (MS) to sustain in the long term, even with treatment, according to a study published online ahead of print December 22 in JAMA Neurology. Researchers investigated the sustainability of NEDA over seven years in a group of 219 patients with MS. Patients had seven years of follow-up that included yearly brain MRI and biannual clinic visits. Investigators found that of 215 patients, 99 (46%) had NEDA for clinical and MRI measures at one year. At two years, 60 of 218 patients (27.5%) maintained NEDA, and 17 of 216 patients (7.9%) sustained NEDA after seven years. There was no difference in NEDA status for patients with early MS, compared with patients with more established disease.

Pharnext announced the proof of concept of its pleotherapy research and development approach based on a proprietary network pharmacology platform that identifies synergistic combinations of drugs already approved for other diseases. According to two reports published online December 10, 2014, in the Orphanet Journal of Rare Diseases, Pharnext’s lead pleodrug, PXT-3003, has shown positive results in preclinical and phase 2 clinical studies. The first paper shows consistent and synergistic preclinical data for PXT-3003 in two Charcot–Marie–Tooth disease type 1A (CMT 1A) rodent models. The second paper presents positive phase 2 results of PXT-3003 in 80 patients with mild to moderate CMT 1A.

Patients with acute ischemic stroke admitted to tertiary stroke centers during July had similar outcomes to patients admitted during other months, despite receiving slightly less frequent thrombolysis and stroke unit care, according to a study published online ahead of print December 19 in the Journal of Stroke and Cerebrovascular Diseases. Researchers examined 10,319 patients with acute ischemic stroke between July 1, 2003 and March 31, 2008. The research team evaluated referrals to long-term care facilities, length of hospital stay, hospital readmissions or emergency department visits within 30 days of hospital discharge, and hospital readmissions within 30 days from discharge due to stroke. “Ischemic stroke patients admitted in July were less likely to receive clot-busting drugs or be admitted to stroke units, but ultimately patients did just as well regardless of the month,” stated the investigators.

Insomnia symptoms are an important factor for explaining the mechanism by which alcohol use increases suicide risk, according to a study published December 15 in the Journal of Clinical Sleep Medicine. The study included 375 undergraduate students at a large, public university in the southeastern United States. Participants completed an online questionnaire that examined insomnia symptoms, nightmares, alcohol use, and suicide risk. Alcohol use was significantly associated with suicide risk among women. In addition, further analysis revealed that insomnia symptoms explained a significant proportion of the relationship between alcohol and suicide risk. Investigators found no direct effect of alcohol use on suicide risk in men, but they observed a significant indirect effect of alcohol use increasing suicide risk through insomnia symptoms.

The virtual supermarket (VSM) application correctly identifies 87.30% of patients with mild cognitive impairment (MCI), a level of diagnostic accuracy similar to that of standardized neuropsychologic tests, according to a study published online ahead of print November 25 in the Journal of Alzheimer’s Disease. Two groups, one of healthy older adults and one of patients with MCI, were recruited from day centers for people with cognitive disorders. Participants used the VSM application and underwent a battery of neuropsychologic tests. The VSM application accurately distinguished between patients with MCI and healthy older adults, but it was unable to differentiate between MCI subtypes. Overall, the VSM application is a valid method of screening for MCI in an older adult population, but it cannot be used for MCI subtype assessment.

—Kimberly D. Williams

The human papillomavirus (HPV) vaccination is not associated with the development of multiple sclerosis (MS) or other demyelinating diseases, according to a study published January 6 in JAMA. Researchers examined Danish and Swedish girls and women between ages 10 and 44. Participants were followed up from 2006 to 2013. A total of 3,983,824 girls and women were eligible for inclusion in this study. Of these individuals, 789,082 were vaccinated, and 1,927,581 HPV vaccine doses were administered. At follow-up, 4,322 cases of MS and 3,300 cases of other demyelinating diseases were identified, of which 73 and 90, respectively, occurred within the risk period of two years following vaccination. “These findings do not support concerns about a causal relationship between HPV vaccination and demyelinating diseases,” the researchers stated.

No evidence of disease activity (NEDA) is a difficult outcome for patients with multiple sclerosis (MS) to sustain in the long term, even with treatment, according to a study published online ahead of print December 22 in JAMA Neurology. Researchers investigated the sustainability of NEDA over seven years in a group of 219 patients with MS. Patients had seven years of follow-up that included yearly brain MRI and biannual clinic visits. Investigators found that of 215 patients, 99 (46%) had NEDA for clinical and MRI measures at one year. At two years, 60 of 218 patients (27.5%) maintained NEDA, and 17 of 216 patients (7.9%) sustained NEDA after seven years. There was no difference in NEDA status for patients with early MS, compared with patients with more established disease.

Pharnext announced the proof of concept of its pleotherapy research and development approach based on a proprietary network pharmacology platform that identifies synergistic combinations of drugs already approved for other diseases. According to two reports published online December 10, 2014, in the Orphanet Journal of Rare Diseases, Pharnext’s lead pleodrug, PXT-3003, has shown positive results in preclinical and phase 2 clinical studies. The first paper shows consistent and synergistic preclinical data for PXT-3003 in two Charcot–Marie–Tooth disease type 1A (CMT 1A) rodent models. The second paper presents positive phase 2 results of PXT-3003 in 80 patients with mild to moderate CMT 1A.

Patients with acute ischemic stroke admitted to tertiary stroke centers during July had similar outcomes to patients admitted during other months, despite receiving slightly less frequent thrombolysis and stroke unit care, according to a study published online ahead of print December 19 in the Journal of Stroke and Cerebrovascular Diseases. Researchers examined 10,319 patients with acute ischemic stroke between July 1, 2003 and March 31, 2008. The research team evaluated referrals to long-term care facilities, length of hospital stay, hospital readmissions or emergency department visits within 30 days of hospital discharge, and hospital readmissions within 30 days from discharge due to stroke. “Ischemic stroke patients admitted in July were less likely to receive clot-busting drugs or be admitted to stroke units, but ultimately patients did just as well regardless of the month,” stated the investigators.

Insomnia symptoms are an important factor for explaining the mechanism by which alcohol use increases suicide risk, according to a study published December 15 in the Journal of Clinical Sleep Medicine. The study included 375 undergraduate students at a large, public university in the southeastern United States. Participants completed an online questionnaire that examined insomnia symptoms, nightmares, alcohol use, and suicide risk. Alcohol use was significantly associated with suicide risk among women. In addition, further analysis revealed that insomnia symptoms explained a significant proportion of the relationship between alcohol and suicide risk. Investigators found no direct effect of alcohol use on suicide risk in men, but they observed a significant indirect effect of alcohol use increasing suicide risk through insomnia symptoms.

The virtual supermarket (VSM) application correctly identifies 87.30% of patients with mild cognitive impairment (MCI), a level of diagnostic accuracy similar to that of standardized neuropsychologic tests, according to a study published online ahead of print November 25 in the Journal of Alzheimer’s Disease. Two groups, one of healthy older adults and one of patients with MCI, were recruited from day centers for people with cognitive disorders. Participants used the VSM application and underwent a battery of neuropsychologic tests. The VSM application accurately distinguished between patients with MCI and healthy older adults, but it was unable to differentiate between MCI subtypes. Overall, the VSM application is a valid method of screening for MCI in an older adult population, but it cannot be used for MCI subtype assessment.

—Kimberly D. Williams

SCOTTSDALE, Ariz.– “It’s surprising to me today, when I go proctor or watch a case, how people don’t understand the impact of radiation,” Dr. Mark A. Farber, professor of surgery and radiology at the University of North Carolina, Chapel Hill, said at the Southern Association for Vascular Surgery annual meeting. “Many times, I see people’s hands underneath the machine and on the fluoroscopy image.”

This flouting of the so-called ALARA (as low as reasonably achievable) principle happens in part because the number of complex procedures performed by vascular surgeons is increasing, despite what presenter Dr. Melissa Kirkwood, a vascular surgeon at the University of Texas Southwestern Medical Center, Dallas, told the audience is a lack of training in radiation dose terminology and basic safety principles. Yet, practicing excellent radiation safety protocols is “paramount” according to Dr. Farber who, along with Dr. Kirkwood, shared insights on how to minimize dose to both patients and vascular specialists, whether it be from primary, leakage, or scatter radiation.

Table up, detector down

Minimizing the air gap by as little as 100 mm – from 700 mm to 600 mm, for example – can reduce the dose of radiation from 17%-29%, whereas a 
10-cm increase in the air gap can result in as much as a 20%-38% increase in the radiation skin dose. This is essentially the application of the inverse square law, according to Dr. Kirkwood.

Dr. Farber said that some of the newer, more advanced machines have sensors that automatically detect where the collector should be in relation to the patient, but if your machine doesn’t have these “bells and whistles … remember that the skin dose decreases as the air gap decreases.”

Another advantage to using new imaging systems, according to Dr. Farber, is that they allow the use of pulsed fluoroscopy for as few as 2 or 3 pulses/sec. The selected pulse rate determines the number of fluoroscopic image frames that are generated by the machine per second. This is significant when the dose savings are essential and when performing simpler procedures, he said. “If you go from 7.5 frames down to 3 frames/sec, you can decrease the exposure for both you and your patient.”

Use between 15 and 30 pulses/sec for critical procedures where precision is crucial, but reducing the rate to 7.5 pulses/sec may result in as much as 70% less of a skin dose.

Add radiation barriers

Don’t assume that the lead shielding is doing the job. “It’s important that you keep up on this and have it tested regularly,” said Dr. Farber, who recently discovered his thyroid shield was cracked and needed to be replaced. Also, consider the lead shielding of your staff, which, even if it is not used as frequently as the physician’s, can suffer from improper handling. “They fold it or crinkle it up and drop it on the floor. This can lead to problems,” he said. And be sure to remember leaded glasses, lead drapes for the sides of the table, and leaded ceiling-mounted or standing shields.

For extra protection, Dr. Farber recommended the use of disposable protective drapes with cut-outs that allow access to the patient while helping to reduce the amount of scatter radiation exposure to the operator’s limbs. At a tally of anywhere from 1 to 10 mGy/hour, scatter radiation emanating from the patient is a particular risk to the operator’s legs from the knees down, said Dr. Kirkwood, “depending on how tall you are.”

Using the disposable drapes also can result in a 12-fold decrease in the amount of scatter on the eyes, a 25-fold decrease in thyroid exposure to scatter, and a 29-fold decrease in the hands being exposed. “They can be cumbersome at times, I admit,” Dr. Farber said. “But there is no substitute for using protective drapes.”

Leaded aprons also help cut radiation transmission rates, even if they are not foolproof. Wearing two-piece leaded apron systems can help cut down the body strain from the weight of the aprons; however, Dr. Farber said that, at his institution, they use a suspended body shield system operated by a boom so there is no physical stress on the clinician. Because the weightless system also provides additional protection for the specialist’s head and limbs, Dr. Farber said that the hefty price tag is justified. “The way I sold it to the hospital was I told them I could stop doing procedures, or they could get me one of these systems so I could do more procedures,” he said, adding he is having a weightless system installed on each side of the table. “They’ll get their money’s worth by the fact that you’re not over your exposure limit.”

And finally, don’t forget to protect the anesthesiologist! A standing shield that gives broad coverage area should suffice, Dr. Farber said.

Alter the intensifier position

Altering the angle can help ensure that one area of the patient’s body isn’t being overexposed to radiation. Since previously irradiated skin reacts abnormally when re-exposed to radiation because the regeneration and repair of the dermis can take up to several weeks after the initial insult, the timing of the intervals between exposures is critical, said Dr. Kirkwood, adding that the Joint Commission recommended that all doses of fluoroscopically guided interventions performed within the past 6-12 months should be considered when assessing potential skin injury risk.

Use collimation

Making it tighter, for example, can help improve image quality and reduce the radiation dose to both the patient and the operator, as can varying the acquisition rates.

Exit the room during DSA

During digital subtraction angiography, Dr. Farber said to “get away from the table if you can! It’s a huge dose you don’t need to be exposed to if you don’t need to be right next to the machine.” Dr. Kirkwood agreed: “Angiography is 10-100 times more dose than fluoroscopy.”

Reduce magnification

Using a larger monitor allows the operator to see more detail without increasing the magnification, which also increases the dose in the amount of the diameter over the diameter squared. “By not magnifying up [from a field of view of 14 to 28], you will save yourself a factor of at least 4,” Dr. Farber said. “And the actual dose may be even less.”

Optimize imaging

Today’s advanced imaging systems make it easy to produce many high-quality images – CT scans and ultrasounds – that allow a more comprehensive picture. Having various image sources on screen at once is “practice changing” because it can help clinicians see more possibilities for “how to do the case,” said Dr. Farber. “I’ve never heard anyone say, ’Well, I wish I didn’t have that extra imaging next to me.’ ”

Save images

But once you get it, don’t forget to keep it. “Many times you do an acquisition, you move the machine, and you realize you forget to save the image and now you’ve got to go back and do it all over again,” Dr. Farber lamented. But by once again making technology your friend, with functions that allow auto-return to previous positions, among other auto-commands, you can save the needed information and reduce any unnecessary dose exposure for both yourself and the patient, he said.

Protect your eyes

Cataracts are still all too common in the field, according to Dr. Farber. “It’s important that you have side shields on your glasses to cut down on the amount of radiation that comes in and around the glasses.” Eschew glasses that don’t overtly hug your face.

Geometric differences

Don’t forget that, if you’re standing on the side of the imaging source, the scattering effect will be greater than if you’re on the side of the image receptor. Once again, an understanding of the inverse square law can be protective, according to Dr. Kirkwood: “As x-rays exit the source, there is an exponential decrease in the number of x-rays per unit area as the distance from the source increases.”

“It’s simple stuff,” concluded Dr. Farber. “If you get in the habit of doing these things you will cut down your radiation exposure.”

Neither Dr. Farber nor Dr. Kirkwood had any relevant disclosures.

[email protected]
On Twitter @whitneymcknight

SCOTTSDALE, Ariz.– “It’s surprising to me today, when I go proctor or watch a case, how people don’t understand the impact of radiation,” Dr. Mark A. Farber, professor of surgery and radiology at the University of North Carolina, Chapel Hill, said at the Southern Association for Vascular Surgery annual meeting. “Many times, I see people’s hands underneath the machine and on the fluoroscopy image.”

This flouting of the so-called ALARA (as low as reasonably achievable) principle happens in part because the number of complex procedures performed by vascular surgeons is increasing, despite what presenter Dr. Melissa Kirkwood, a vascular surgeon at the University of Texas Southwestern Medical Center, Dallas, told the audience is a lack of training in radiation dose terminology and basic safety principles. Yet, practicing excellent radiation safety protocols is “paramount” according to Dr. Farber who, along with Dr. Kirkwood, shared insights on how to minimize dose to both patients and vascular specialists, whether it be from primary, leakage, or scatter radiation.

Table up, detector down

Minimizing the air gap by as little as 100 mm – from 700 mm to 600 mm, for example – can reduce the dose of radiation from 17%-29%, whereas a 
10-cm increase in the air gap can result in as much as a 20%-38% increase in the radiation skin dose. This is essentially the application of the inverse square law, according to Dr. Kirkwood.

Dr. Farber said that some of the newer, more advanced machines have sensors that automatically detect where the collector should be in relation to the patient, but if your machine doesn’t have these “bells and whistles … remember that the skin dose decreases as the air gap decreases.”

Another advantage to using new imaging systems, according to Dr. Farber, is that they allow the use of pulsed fluoroscopy for as few as 2 or 3 pulses/sec. The selected pulse rate determines the number of fluoroscopic image frames that are generated by the machine per second. This is significant when the dose savings are essential and when performing simpler procedures, he said. “If you go from 7.5 frames down to 3 frames/sec, you can decrease the exposure for both you and your patient.”

Use between 15 and 30 pulses/sec for critical procedures where precision is crucial, but reducing the rate to 7.5 pulses/sec may result in as much as 70% less of a skin dose.

Add radiation barriers

Don’t assume that the lead shielding is doing the job. “It’s important that you keep up on this and have it tested regularly,” said Dr. Farber, who recently discovered his thyroid shield was cracked and needed to be replaced. Also, consider the lead shielding of your staff, which, even if it is not used as frequently as the physician’s, can suffer from improper handling. “They fold it or crinkle it up and drop it on the floor. This can lead to problems,” he said. And be sure to remember leaded glasses, lead drapes for the sides of the table, and leaded ceiling-mounted or standing shields.

For extra protection, Dr. Farber recommended the use of disposable protective drapes with cut-outs that allow access to the patient while helping to reduce the amount of scatter radiation exposure to the operator’s limbs. At a tally of anywhere from 1 to 10 mGy/hour, scatter radiation emanating from the patient is a particular risk to the operator’s legs from the knees down, said Dr. Kirkwood, “depending on how tall you are.”

Using the disposable drapes also can result in a 12-fold decrease in the amount of scatter on the eyes, a 25-fold decrease in thyroid exposure to scatter, and a 29-fold decrease in the hands being exposed. “They can be cumbersome at times, I admit,” Dr. Farber said. “But there is no substitute for using protective drapes.”

Leaded aprons also help cut radiation transmission rates, even if they are not foolproof. Wearing two-piece leaded apron systems can help cut down the body strain from the weight of the aprons; however, Dr. Farber said that, at his institution, they use a suspended body shield system operated by a boom so there is no physical stress on the clinician. Because the weightless system also provides additional protection for the specialist’s head and limbs, Dr. Farber said that the hefty price tag is justified. “The way I sold it to the hospital was I told them I could stop doing procedures, or they could get me one of these systems so I could do more procedures,” he said, adding he is having a weightless system installed on each side of the table. “They’ll get their money’s worth by the fact that you’re not over your exposure limit.”

And finally, don’t forget to protect the anesthesiologist! A standing shield that gives broad coverage area should suffice, Dr. Farber said.

Alter the intensifier position

Altering the angle can help ensure that one area of the patient’s body isn’t being overexposed to radiation. Since previously irradiated skin reacts abnormally when re-exposed to radiation because the regeneration and repair of the dermis can take up to several weeks after the initial insult, the timing of the intervals between exposures is critical, said Dr. Kirkwood, adding that the Joint Commission recommended that all doses of fluoroscopically guided interventions performed within the past 6-12 months should be considered when assessing potential skin injury risk.

Use collimation

Making it tighter, for example, can help improve image quality and reduce the radiation dose to both the patient and the operator, as can varying the acquisition rates.

Exit the room during DSA

During digital subtraction angiography, Dr. Farber said to “get away from the table if you can! It’s a huge dose you don’t need to be exposed to if you don’t need to be right next to the machine.” Dr. Kirkwood agreed: “Angiography is 10-100 times more dose than fluoroscopy.”

Reduce magnification

Using a larger monitor allows the operator to see more detail without increasing the magnification, which also increases the dose in the amount of the diameter over the diameter squared. “By not magnifying up [from a field of view of 14 to 28], you will save yourself a factor of at least 4,” Dr. Farber said. “And the actual dose may be even less.”

Optimize imaging

Today’s advanced imaging systems make it easy to produce many high-quality images – CT scans and ultrasounds – that allow a more comprehensive picture. Having various image sources on screen at once is “practice changing” because it can help clinicians see more possibilities for “how to do the case,” said Dr. Farber. “I’ve never heard anyone say, ’Well, I wish I didn’t have that extra imaging next to me.’ ”

Save images

But once you get it, don’t forget to keep it. “Many times you do an acquisition, you move the machine, and you realize you forget to save the image and now you’ve got to go back and do it all over again,” Dr. Farber lamented. But by once again making technology your friend, with functions that allow auto-return to previous positions, among other auto-commands, you can save the needed information and reduce any unnecessary dose exposure for both yourself and the patient, he said.

Protect your eyes

Cataracts are still all too common in the field, according to Dr. Farber. “It’s important that you have side shields on your glasses to cut down on the amount of radiation that comes in and around the glasses.” Eschew glasses that don’t overtly hug your face.

Geometric differences

Don’t forget that, if you’re standing on the side of the imaging source, the scattering effect will be greater than if you’re on the side of the image receptor. Once again, an understanding of the inverse square law can be protective, according to Dr. Kirkwood: “As x-rays exit the source, there is an exponential decrease in the number of x-rays per unit area as the distance from the source increases.”

“It’s simple stuff,” concluded Dr. Farber. “If you get in the habit of doing these things you will cut down your radiation exposure.”

Neither Dr. Farber nor Dr. Kirkwood had any relevant disclosures.

[email protected]
On Twitter @whitneymcknight

SCOTTSDALE, Ariz.– “It’s surprising to me today, when I go proctor or watch a case, how people don’t understand the impact of radiation,” Dr. Mark A. Farber, professor of surgery and radiology at the University of North Carolina, Chapel Hill, said at the Southern Association for Vascular Surgery annual meeting. “Many times, I see people’s hands underneath the machine and on the fluoroscopy image.”

This flouting of the so-called ALARA (as low as reasonably achievable) principle happens in part because the number of complex procedures performed by vascular surgeons is increasing, despite what presenter Dr. Melissa Kirkwood, a vascular surgeon at the University of Texas Southwestern Medical Center, Dallas, told the audience is a lack of training in radiation dose terminology and basic safety principles. Yet, practicing excellent radiation safety protocols is “paramount” according to Dr. Farber who, along with Dr. Kirkwood, shared insights on how to minimize dose to both patients and vascular specialists, whether it be from primary, leakage, or scatter radiation.

Table up, detector down

Minimizing the air gap by as little as 100 mm – from 700 mm to 600 mm, for example – can reduce the dose of radiation from 17%-29%, whereas a 
10-cm increase in the air gap can result in as much as a 20%-38% increase in the radiation skin dose. This is essentially the application of the inverse square law, according to Dr. Kirkwood.

Dr. Farber said that some of the newer, more advanced machines have sensors that automatically detect where the collector should be in relation to the patient, but if your machine doesn’t have these “bells and whistles … remember that the skin dose decreases as the air gap decreases.”

Another advantage to using new imaging systems, according to Dr. Farber, is that they allow the use of pulsed fluoroscopy for as few as 2 or 3 pulses/sec. The selected pulse rate determines the number of fluoroscopic image frames that are generated by the machine per second. This is significant when the dose savings are essential and when performing simpler procedures, he said. “If you go from 7.5 frames down to 3 frames/sec, you can decrease the exposure for both you and your patient.”

Use between 15 and 30 pulses/sec for critical procedures where precision is crucial, but reducing the rate to 7.5 pulses/sec may result in as much as 70% less of a skin dose.

Add radiation barriers

Don’t assume that the lead shielding is doing the job. “It’s important that you keep up on this and have it tested regularly,” said Dr. Farber, who recently discovered his thyroid shield was cracked and needed to be replaced. Also, consider the lead shielding of your staff, which, even if it is not used as frequently as the physician’s, can suffer from improper handling. “They fold it or crinkle it up and drop it on the floor. This can lead to problems,” he said. And be sure to remember leaded glasses, lead drapes for the sides of the table, and leaded ceiling-mounted or standing shields.

For extra protection, Dr. Farber recommended the use of disposable protective drapes with cut-outs that allow access to the patient while helping to reduce the amount of scatter radiation exposure to the operator’s limbs. At a tally of anywhere from 1 to 10 mGy/hour, scatter radiation emanating from the patient is a particular risk to the operator’s legs from the knees down, said Dr. Kirkwood, “depending on how tall you are.”

Using the disposable drapes also can result in a 12-fold decrease in the amount of scatter on the eyes, a 25-fold decrease in thyroid exposure to scatter, and a 29-fold decrease in the hands being exposed. “They can be cumbersome at times, I admit,” Dr. Farber said. “But there is no substitute for using protective drapes.”

Leaded aprons also help cut radiation transmission rates, even if they are not foolproof. Wearing two-piece leaded apron systems can help cut down the body strain from the weight of the aprons; however, Dr. Farber said that, at his institution, they use a suspended body shield system operated by a boom so there is no physical stress on the clinician. Because the weightless system also provides additional protection for the specialist’s head and limbs, Dr. Farber said that the hefty price tag is justified. “The way I sold it to the hospital was I told them I could stop doing procedures, or they could get me one of these systems so I could do more procedures,” he said, adding he is having a weightless system installed on each side of the table. “They’ll get their money’s worth by the fact that you’re not over your exposure limit.”

And finally, don’t forget to protect the anesthesiologist! A standing shield that gives broad coverage area should suffice, Dr. Farber said.

Alter the intensifier position

Altering the angle can help ensure that one area of the patient’s body isn’t being overexposed to radiation. Since previously irradiated skin reacts abnormally when re-exposed to radiation because the regeneration and repair of the dermis can take up to several weeks after the initial insult, the timing of the intervals between exposures is critical, said Dr. Kirkwood, adding that the Joint Commission recommended that all doses of fluoroscopically guided interventions performed within the past 6-12 months should be considered when assessing potential skin injury risk.

Use collimation

Making it tighter, for example, can help improve image quality and reduce the radiation dose to both the patient and the operator, as can varying the acquisition rates.

Exit the room during DSA

During digital subtraction angiography, Dr. Farber said to “get away from the table if you can! It’s a huge dose you don’t need to be exposed to if you don’t need to be right next to the machine.” Dr. Kirkwood agreed: “Angiography is 10-100 times more dose than fluoroscopy.”

Reduce magnification

Using a larger monitor allows the operator to see more detail without increasing the magnification, which also increases the dose in the amount of the diameter over the diameter squared. “By not magnifying up [from a field of view of 14 to 28], you will save yourself a factor of at least 4,” Dr. Farber said. “And the actual dose may be even less.”

Optimize imaging

Today’s advanced imaging systems make it easy to produce many high-quality images – CT scans and ultrasounds – that allow a more comprehensive picture. Having various image sources on screen at once is “practice changing” because it can help clinicians see more possibilities for “how to do the case,” said Dr. Farber. “I’ve never heard anyone say, ’Well, I wish I didn’t have that extra imaging next to me.’ ”

Save images

But once you get it, don’t forget to keep it. “Many times you do an acquisition, you move the machine, and you realize you forget to save the image and now you’ve got to go back and do it all over again,” Dr. Farber lamented. But by once again making technology your friend, with functions that allow auto-return to previous positions, among other auto-commands, you can save the needed information and reduce any unnecessary dose exposure for both yourself and the patient, he said.

Protect your eyes

Cataracts are still all too common in the field, according to Dr. Farber. “It’s important that you have side shields on your glasses to cut down on the amount of radiation that comes in and around the glasses.” Eschew glasses that don’t overtly hug your face.

Geometric differences

Don’t forget that, if you’re standing on the side of the imaging source, the scattering effect will be greater than if you’re on the side of the image receptor. Once again, an understanding of the inverse square law can be protective, according to Dr. Kirkwood: “As x-rays exit the source, there is an exponential decrease in the number of x-rays per unit area as the distance from the source increases.”

“It’s simple stuff,” concluded Dr. Farber. “If you get in the habit of doing these things you will cut down your radiation exposure.”

Neither Dr. Farber nor Dr. Kirkwood had any relevant disclosures.

[email protected]
On Twitter @whitneymcknight

CORONADO, CALIF. – About half of patients decide to undergo head and neck surgery even before meeting their surgeon, and concerns about cost of the procedure weigh heavily on their minds, results from a pilot study demonstrated.

In an effort to determine which factors influence patient decision making about elective surgery in otolaryngology, lead study author Dr. Maya G. Sardesai and her associates surveyed 48 consecutive adults who underwent head and neck surgery performed by one of six surgeons at Harborview Medical Center, Seattle, between March and September 2014.

The effort “rose from an observation in her clinical practice that, despite similar degrees of disease burden and similar counseling, patients sometimes show widely divergent degrees of enthusiasm for elective procedures,” Dr. Sardesai of the department of otolaryngology-head and neck surgery at the medical center said at the Triological Society’s Combined Sections Meeting. “This prompted the question: What information influences decision making in this setting?”

Current guidelines emphasize discussing the risks and benefits of surgery in the informed consent process, she continued, “but some studies of decision making in this setting have suggested that other factors might also influence decisions, such as family advice, social perception, and cost. There’s limited data in the otolaryngology literature about this, even though there’s a preponderance of quality-of-life surgery with low but potentially significant risks.”

With input from patients and surgeons, the researchers created a 35-question survey and administered it in the surgeon’s office, with questions that centered around the timing of the procedure, advice of others, sources of information, and their approach to decision making. More than half of patients (56%) were undergoing tonsillectomy, followed by a nasal procedure (48%), palate procedure (44%), midline glossectomy (35%), hyoid suspension (4%), genioglossus advancement (4%), laryngeal procedure (2%), and other (6%). (The numbers exceeded 100% because some patients underwent more than one procedure.)

Nearly half of subjects (49%) reported making their decision to pursue surgery even before their surgical consultation or meeting their surgeon. The researchers then divided the cohort into patients who had decided to pursue surgery before or after meeting their surgeon. Among those who made the decision before meeting the surgeon, 64% rated information they received from their primary care provider as very important, while 100% rated information they received from the surgeon as very important. These percentages were similar among patients who made the decision after meeting the surgeon (43% and 96%, respectively).

Patients who made their decision to pursue surgery after meeting their surgeon also were more likely to weigh information received from the Internet as more important, compared with patients who made their decision before meeting their surgeon (38% vs. 20%). “This difference was not statistically significant,” Dr. Sardesai said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. “All patients felt that Internet information seemed important.”

Patients in both groups weighed concerns about symptoms as very important (in the range of 83%), which rated “highly if not more than concerns about the risks with or without surgery (70%).” Finally, she and her associates found that 49% of patients in both groups considered the cost of medical bills as very important, “which is an interesting finding, because our current consent process doesn’t include much discussion about monetary costs of treatment.”

Overall, the findings suggest that otolaryngologists and head and neck surgeons should reach out to referring providers “to ensure that they are well informed about the indications, benefits, limitation, and risks of head and neck surgeries,” Dr. Sardesai concluded. “This may also enhance opportunities for shared and collaborative decision making. If decisions are being made prior to consultation, it begs the question about whether there are potential surgery candidates who defer surgical consultation altogether, and thus may be missing opportunities for better care. As otolaryngologists, we should also take an active role in providing and curating information from the Internet, since this is currently likely an increasingly important source of information for patients.”

She acknowledged certain limitations of the study, including its small sample size and the potential for recall bias. In addition, the survey “was administered in a surgeon’s office, which might bias patients to overemphasize the role of the surgeon,” she said. “Our future plans are to administer an enhanced version of the survey to broader [practice settings] to better understand these differences.”

Dr. Sardesai reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF. – About half of patients decide to undergo head and neck surgery even before meeting their surgeon, and concerns about cost of the procedure weigh heavily on their minds, results from a pilot study demonstrated.

In an effort to determine which factors influence patient decision making about elective surgery in otolaryngology, lead study author Dr. Maya G. Sardesai and her associates surveyed 48 consecutive adults who underwent head and neck surgery performed by one of six surgeons at Harborview Medical Center, Seattle, between March and September 2014.

The effort “rose from an observation in her clinical practice that, despite similar degrees of disease burden and similar counseling, patients sometimes show widely divergent degrees of enthusiasm for elective procedures,” Dr. Sardesai of the department of otolaryngology-head and neck surgery at the medical center said at the Triological Society’s Combined Sections Meeting. “This prompted the question: What information influences decision making in this setting?”

Current guidelines emphasize discussing the risks and benefits of surgery in the informed consent process, she continued, “but some studies of decision making in this setting have suggested that other factors might also influence decisions, such as family advice, social perception, and cost. There’s limited data in the otolaryngology literature about this, even though there’s a preponderance of quality-of-life surgery with low but potentially significant risks.”

With input from patients and surgeons, the researchers created a 35-question survey and administered it in the surgeon’s office, with questions that centered around the timing of the procedure, advice of others, sources of information, and their approach to decision making. More than half of patients (56%) were undergoing tonsillectomy, followed by a nasal procedure (48%), palate procedure (44%), midline glossectomy (35%), hyoid suspension (4%), genioglossus advancement (4%), laryngeal procedure (2%), and other (6%). (The numbers exceeded 100% because some patients underwent more than one procedure.)

Nearly half of subjects (49%) reported making their decision to pursue surgery even before their surgical consultation or meeting their surgeon. The researchers then divided the cohort into patients who had decided to pursue surgery before or after meeting their surgeon. Among those who made the decision before meeting the surgeon, 64% rated information they received from their primary care provider as very important, while 100% rated information they received from the surgeon as very important. These percentages were similar among patients who made the decision after meeting the surgeon (43% and 96%, respectively).

Patients who made their decision to pursue surgery after meeting their surgeon also were more likely to weigh information received from the Internet as more important, compared with patients who made their decision before meeting their surgeon (38% vs. 20%). “This difference was not statistically significant,” Dr. Sardesai said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. “All patients felt that Internet information seemed important.”

Patients in both groups weighed concerns about symptoms as very important (in the range of 83%), which rated “highly if not more than concerns about the risks with or without surgery (70%).” Finally, she and her associates found that 49% of patients in both groups considered the cost of medical bills as very important, “which is an interesting finding, because our current consent process doesn’t include much discussion about monetary costs of treatment.”

Overall, the findings suggest that otolaryngologists and head and neck surgeons should reach out to referring providers “to ensure that they are well informed about the indications, benefits, limitation, and risks of head and neck surgeries,” Dr. Sardesai concluded. “This may also enhance opportunities for shared and collaborative decision making. If decisions are being made prior to consultation, it begs the question about whether there are potential surgery candidates who defer surgical consultation altogether, and thus may be missing opportunities for better care. As otolaryngologists, we should also take an active role in providing and curating information from the Internet, since this is currently likely an increasingly important source of information for patients.”

She acknowledged certain limitations of the study, including its small sample size and the potential for recall bias. In addition, the survey “was administered in a surgeon’s office, which might bias patients to overemphasize the role of the surgeon,” she said. “Our future plans are to administer an enhanced version of the survey to broader [practice settings] to better understand these differences.”

Dr. Sardesai reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF. – About half of patients decide to undergo head and neck surgery even before meeting their surgeon, and concerns about cost of the procedure weigh heavily on their minds, results from a pilot study demonstrated.

In an effort to determine which factors influence patient decision making about elective surgery in otolaryngology, lead study author Dr. Maya G. Sardesai and her associates surveyed 48 consecutive adults who underwent head and neck surgery performed by one of six surgeons at Harborview Medical Center, Seattle, between March and September 2014.

The effort “rose from an observation in her clinical practice that, despite similar degrees of disease burden and similar counseling, patients sometimes show widely divergent degrees of enthusiasm for elective procedures,” Dr. Sardesai of the department of otolaryngology-head and neck surgery at the medical center said at the Triological Society’s Combined Sections Meeting. “This prompted the question: What information influences decision making in this setting?”

Current guidelines emphasize discussing the risks and benefits of surgery in the informed consent process, she continued, “but some studies of decision making in this setting have suggested that other factors might also influence decisions, such as family advice, social perception, and cost. There’s limited data in the otolaryngology literature about this, even though there’s a preponderance of quality-of-life surgery with low but potentially significant risks.”

With input from patients and surgeons, the researchers created a 35-question survey and administered it in the surgeon’s office, with questions that centered around the timing of the procedure, advice of others, sources of information, and their approach to decision making. More than half of patients (56%) were undergoing tonsillectomy, followed by a nasal procedure (48%), palate procedure (44%), midline glossectomy (35%), hyoid suspension (4%), genioglossus advancement (4%), laryngeal procedure (2%), and other (6%). (The numbers exceeded 100% because some patients underwent more than one procedure.)

Nearly half of subjects (49%) reported making their decision to pursue surgery even before their surgical consultation or meeting their surgeon. The researchers then divided the cohort into patients who had decided to pursue surgery before or after meeting their surgeon. Among those who made the decision before meeting the surgeon, 64% rated information they received from their primary care provider as very important, while 100% rated information they received from the surgeon as very important. These percentages were similar among patients who made the decision after meeting the surgeon (43% and 96%, respectively).

Patients who made their decision to pursue surgery after meeting their surgeon also were more likely to weigh information received from the Internet as more important, compared with patients who made their decision before meeting their surgeon (38% vs. 20%). “This difference was not statistically significant,” Dr. Sardesai said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. “All patients felt that Internet information seemed important.”

Patients in both groups weighed concerns about symptoms as very important (in the range of 83%), which rated “highly if not more than concerns about the risks with or without surgery (70%).” Finally, she and her associates found that 49% of patients in both groups considered the cost of medical bills as very important, “which is an interesting finding, because our current consent process doesn’t include much discussion about monetary costs of treatment.”

Overall, the findings suggest that otolaryngologists and head and neck surgeons should reach out to referring providers “to ensure that they are well informed about the indications, benefits, limitation, and risks of head and neck surgeries,” Dr. Sardesai concluded. “This may also enhance opportunities for shared and collaborative decision making. If decisions are being made prior to consultation, it begs the question about whether there are potential surgery candidates who defer surgical consultation altogether, and thus may be missing opportunities for better care. As otolaryngologists, we should also take an active role in providing and curating information from the Internet, since this is currently likely an increasingly important source of information for patients.”

She acknowledged certain limitations of the study, including its small sample size and the potential for recall bias. In addition, the survey “was administered in a surgeon’s office, which might bias patients to overemphasize the role of the surgeon,” she said. “Our future plans are to administer an enhanced version of the survey to broader [practice settings] to better understand these differences.”

Dr. Sardesai reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

Yuankai Shi, MD, PhD

Photo by Larry Young

SAN FRANCISCO—The histone deacetylase (HDAC) inhibitor chidamide is effective and well-tolerated in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), results of the phase 2 CHIPEL trial suggest.

The study showed that chidamide can elicit higher response rates than those previously observed with the folate analog metabolic inhibitor pralatrexate and the HDAC inhibitor romidepsin.

Chidamide also prolonged survival and posed a lower risk of toxicity compared to pralatrexate and romidepsin.

Yuankai Shi, MD, PhD, of the Chinese Academy of Medical Science & Peking Union Medical College in  Beijing, China, presented these results at the 7th Annual T-cell Lymphoma Forum. The trial is sponsored by Chipscreen Biosciences Ltd.

He noted that the CHIPEL study was split into two parts: an exploratory trial and a pivotal trial.

Exploratory trial

The exploratory trial included 19 patients who had a median age of 51 and were a median of 1.41 years from diagnosis. Seventeen patients had PTCL unspecified (PTCL-U), and 2 had other subtypes of PTCL.

The patients received chidamide at 30 mg (n=9) or 50 mg (n=10) twice a week for 2 weeks of a 3-week cycle. The overall response rate was 26% (n=5), and 16% of patients (n=3) had a complete response (CR) or unconfirmed CR (CRu).

Pivotal trial

The pivotal trial included 83 patients who had a median age of 53 and were a median of 1.06 years from diagnosis.

The patients had PTCL-U (29.1%, n=23), nasal NK/T-cell lymphoma (20.3%, n=16), anaplastic large-cell lymphoma (ALCL, 20.3%, n=16), angioimmunoblastic T-cell lymphoma (AITL, 11.4%, n=9), enteropathy-type T-cell lymphoma (2.5%, n=2), CD4-positive PTCL (1.3%, n=1), Lennert-type PTCL (1.3%, n=1), transformed mycosis fungoides (1.3%, n=1), and other subtypes of PTCL (12.7%, n=10).

These patients received chidamide at 30 mg twice a week without a drug-free holiday.

The overall response rate was 29% (n=23) according to investigators and 28% (n=22) according to an independent review committee. Fourteen percent of patients (n=11) had a CR/CRu, according to both sources.

The median progression-free survival was 2.1 months for all patients, 14 months for patients who achieved CR/CRus, 7.7 months in patients with partial responses, and 2.5 months in patients with stable disease.

The median overall survival was 21.4 months in all patients and not reached in patients who had a CR/CRu, partial response, or stable disease.

Overall safety

Of all 102 patients (in both the pivotal and exploratory analyses), 80% had at least one adverse event (AE), 37% had grade 3 or higher AEs, 17% had AEs leading to treatment discontinuation, and 8% had severe AEs.

The most common AEs were thrombocytopenia (50%), leukopenia (37%), neutropenia (19%), fatigue (11%), and fever (11%).

Twenty-four percent of patients had grade 3 or higher thrombocytopenia, 13% had grade 3 or higher leukopenia, and 10% had grade 3 or higher neutropenia.

Chidamide vs other agents

Dr Shi compared response rates with chidamide in the pivotal trial to those previously observed with pralatrexate (O’Connor et al, JCO 2011) and romidepsin (Coiffier et al, J Hematol Oncol 2014).

In patients with PTCL-U, response rates were similar for all 3 drugs (≈30%). In ALCL, the response rate with chidamide was higher (≈50%) than with pralatrexate (≈30%) or romidepsin (≈25%). And in AITL, the response rate with chidamide was higher (≈45%) than with pralatrexate (≈8%) or romidepsin (≈30%).

Chidamide also conferred better overall survival than pralatrexate, romidepsin, and other treatments from previous studies.

The median overall survival was 6.5 months with chemotherapy (Mak et al, JCO 2013), 14.5 months with pralatrexate (O’Connor et al, JCO 2011), 11.3 months with romidepsin (Coiffier et al, J Hematol Oncol 2014), 7.9 months with belinostat (Hyon-Zu Lee, Clinical Review 2009), and 21.4 months with chidamide.

Finally, Dr Shi compared the rates of AEs observed in the chidamide pivotal trial to AEs observed in the pralatrexate and romidepsin trials.

At least one AE occurred in 100% of patients treated with pralatrexate, 96% of patients on romidepsin, and 82% of patients on chidamide. Grade 3 or higher AEs occurred in 74%, 66%, and 39% of patients, respectively. And at least one severe AE occurred in 44%, 46%, and 8% of patients, respectively.

The favorable results observed with chidamide support the Chinese Food and Drug Administration’s December decision to approve the drug (under the brand name Epidaza) for use in patients with PTCL.

Yuankai Shi, MD, PhD

Photo by Larry Young

SAN FRANCISCO—The histone deacetylase (HDAC) inhibitor chidamide is effective and well-tolerated in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), results of the phase 2 CHIPEL trial suggest.

The study showed that chidamide can elicit higher response rates than those previously observed with the folate analog metabolic inhibitor pralatrexate and the HDAC inhibitor romidepsin.

Chidamide also prolonged survival and posed a lower risk of toxicity compared to pralatrexate and romidepsin.

Yuankai Shi, MD, PhD, of the Chinese Academy of Medical Science & Peking Union Medical College in  Beijing, China, presented these results at the 7th Annual T-cell Lymphoma Forum. The trial is sponsored by Chipscreen Biosciences Ltd.

He noted that the CHIPEL study was split into two parts: an exploratory trial and a pivotal trial.

Exploratory trial

The exploratory trial included 19 patients who had a median age of 51 and were a median of 1.41 years from diagnosis. Seventeen patients had PTCL unspecified (PTCL-U), and 2 had other subtypes of PTCL.

The patients received chidamide at 30 mg (n=9) or 50 mg (n=10) twice a week for 2 weeks of a 3-week cycle. The overall response rate was 26% (n=5), and 16% of patients (n=3) had a complete response (CR) or unconfirmed CR (CRu).

Pivotal trial

The pivotal trial included 83 patients who had a median age of 53 and were a median of 1.06 years from diagnosis.

The patients had PTCL-U (29.1%, n=23), nasal NK/T-cell lymphoma (20.3%, n=16), anaplastic large-cell lymphoma (ALCL, 20.3%, n=16), angioimmunoblastic T-cell lymphoma (AITL, 11.4%, n=9), enteropathy-type T-cell lymphoma (2.5%, n=2), CD4-positive PTCL (1.3%, n=1), Lennert-type PTCL (1.3%, n=1), transformed mycosis fungoides (1.3%, n=1), and other subtypes of PTCL (12.7%, n=10).

These patients received chidamide at 30 mg twice a week without a drug-free holiday.

The overall response rate was 29% (n=23) according to investigators and 28% (n=22) according to an independent review committee. Fourteen percent of patients (n=11) had a CR/CRu, according to both sources.

The median progression-free survival was 2.1 months for all patients, 14 months for patients who achieved CR/CRus, 7.7 months in patients with partial responses, and 2.5 months in patients with stable disease.

The median overall survival was 21.4 months in all patients and not reached in patients who had a CR/CRu, partial response, or stable disease.

Overall safety

Of all 102 patients (in both the pivotal and exploratory analyses), 80% had at least one adverse event (AE), 37% had grade 3 or higher AEs, 17% had AEs leading to treatment discontinuation, and 8% had severe AEs.

The most common AEs were thrombocytopenia (50%), leukopenia (37%), neutropenia (19%), fatigue (11%), and fever (11%).

Twenty-four percent of patients had grade 3 or higher thrombocytopenia, 13% had grade 3 or higher leukopenia, and 10% had grade 3 or higher neutropenia.

Chidamide vs other agents

Dr Shi compared response rates with chidamide in the pivotal trial to those previously observed with pralatrexate (O’Connor et al, JCO 2011) and romidepsin (Coiffier et al, J Hematol Oncol 2014).

In patients with PTCL-U, response rates were similar for all 3 drugs (≈30%). In ALCL, the response rate with chidamide was higher (≈50%) than with pralatrexate (≈30%) or romidepsin (≈25%). And in AITL, the response rate with chidamide was higher (≈45%) than with pralatrexate (≈8%) or romidepsin (≈30%).

Chidamide also conferred better overall survival than pralatrexate, romidepsin, and other treatments from previous studies.

The median overall survival was 6.5 months with chemotherapy (Mak et al, JCO 2013), 14.5 months with pralatrexate (O’Connor et al, JCO 2011), 11.3 months with romidepsin (Coiffier et al, J Hematol Oncol 2014), 7.9 months with belinostat (Hyon-Zu Lee, Clinical Review 2009), and 21.4 months with chidamide.

Finally, Dr Shi compared the rates of AEs observed in the chidamide pivotal trial to AEs observed in the pralatrexate and romidepsin trials.

At least one AE occurred in 100% of patients treated with pralatrexate, 96% of patients on romidepsin, and 82% of patients on chidamide. Grade 3 or higher AEs occurred in 74%, 66%, and 39% of patients, respectively. And at least one severe AE occurred in 44%, 46%, and 8% of patients, respectively.

The favorable results observed with chidamide support the Chinese Food and Drug Administration’s December decision to approve the drug (under the brand name Epidaza) for use in patients with PTCL.

Yuankai Shi, MD, PhD

Photo by Larry Young

SAN FRANCISCO—The histone deacetylase (HDAC) inhibitor chidamide is effective and well-tolerated in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), results of the phase 2 CHIPEL trial suggest.

The study showed that chidamide can elicit higher response rates than those previously observed with the folate analog metabolic inhibitor pralatrexate and the HDAC inhibitor romidepsin.

Chidamide also prolonged survival and posed a lower risk of toxicity compared to pralatrexate and romidepsin.

Yuankai Shi, MD, PhD, of the Chinese Academy of Medical Science & Peking Union Medical College in  Beijing, China, presented these results at the 7th Annual T-cell Lymphoma Forum. The trial is sponsored by Chipscreen Biosciences Ltd.

He noted that the CHIPEL study was split into two parts: an exploratory trial and a pivotal trial.

Exploratory trial

The exploratory trial included 19 patients who had a median age of 51 and were a median of 1.41 years from diagnosis. Seventeen patients had PTCL unspecified (PTCL-U), and 2 had other subtypes of PTCL.

The patients received chidamide at 30 mg (n=9) or 50 mg (n=10) twice a week for 2 weeks of a 3-week cycle. The overall response rate was 26% (n=5), and 16% of patients (n=3) had a complete response (CR) or unconfirmed CR (CRu).

Pivotal trial

The pivotal trial included 83 patients who had a median age of 53 and were a median of 1.06 years from diagnosis.

The patients had PTCL-U (29.1%, n=23), nasal NK/T-cell lymphoma (20.3%, n=16), anaplastic large-cell lymphoma (ALCL, 20.3%, n=16), angioimmunoblastic T-cell lymphoma (AITL, 11.4%, n=9), enteropathy-type T-cell lymphoma (2.5%, n=2), CD4-positive PTCL (1.3%, n=1), Lennert-type PTCL (1.3%, n=1), transformed mycosis fungoides (1.3%, n=1), and other subtypes of PTCL (12.7%, n=10).

These patients received chidamide at 30 mg twice a week without a drug-free holiday.

The overall response rate was 29% (n=23) according to investigators and 28% (n=22) according to an independent review committee. Fourteen percent of patients (n=11) had a CR/CRu, according to both sources.

The median progression-free survival was 2.1 months for all patients, 14 months for patients who achieved CR/CRus, 7.7 months in patients with partial responses, and 2.5 months in patients with stable disease.

The median overall survival was 21.4 months in all patients and not reached in patients who had a CR/CRu, partial response, or stable disease.

Overall safety

Of all 102 patients (in both the pivotal and exploratory analyses), 80% had at least one adverse event (AE), 37% had grade 3 or higher AEs, 17% had AEs leading to treatment discontinuation, and 8% had severe AEs.

The most common AEs were thrombocytopenia (50%), leukopenia (37%), neutropenia (19%), fatigue (11%), and fever (11%).

Twenty-four percent of patients had grade 3 or higher thrombocytopenia, 13% had grade 3 or higher leukopenia, and 10% had grade 3 or higher neutropenia.

Chidamide vs other agents

Dr Shi compared response rates with chidamide in the pivotal trial to those previously observed with pralatrexate (O’Connor et al, JCO 2011) and romidepsin (Coiffier et al, J Hematol Oncol 2014).

In patients with PTCL-U, response rates were similar for all 3 drugs (≈30%). In ALCL, the response rate with chidamide was higher (≈50%) than with pralatrexate (≈30%) or romidepsin (≈25%). And in AITL, the response rate with chidamide was higher (≈45%) than with pralatrexate (≈8%) or romidepsin (≈30%).

Chidamide also conferred better overall survival than pralatrexate, romidepsin, and other treatments from previous studies.

The median overall survival was 6.5 months with chemotherapy (Mak et al, JCO 2013), 14.5 months with pralatrexate (O’Connor et al, JCO 2011), 11.3 months with romidepsin (Coiffier et al, J Hematol Oncol 2014), 7.9 months with belinostat (Hyon-Zu Lee, Clinical Review 2009), and 21.4 months with chidamide.

Finally, Dr Shi compared the rates of AEs observed in the chidamide pivotal trial to AEs observed in the pralatrexate and romidepsin trials.

At least one AE occurred in 100% of patients treated with pralatrexate, 96% of patients on romidepsin, and 82% of patients on chidamide. Grade 3 or higher AEs occurred in 74%, 66%, and 39% of patients, respectively. And at least one severe AE occurred in 44%, 46%, and 8% of patients, respectively.

The favorable results observed with chidamide support the Chinese Food and Drug Administration’s December decision to approve the drug (under the brand name Epidaza) for use in patients with PTCL.