ACS Surgery News

Minnesota and Alabama have joined six other states in enacting a law that aims to expand the practice of telemedicine by streamlining physician licensure. Alabama Gov. Robert Bentley (R) and Minnesota Gov. Mark Dayton (D) on May 19 each signed into law the Interstate Medical Licensure Compact, model legislation developed by the Federation of State Medical Boards (FSMB).

Larry D. Dixon, executive director for the Alabama Board of Medical Examiners, said the law will help ease the physician shortage in rural and other underserved areas.

©Brigitte Wodicka/thinkstockphotos.com

“Now that [eight] states have enacted the compact legislation, we can begin the real work of establishing the compact to ensure patients have access to quality health care services, while maintaining the highest level of patient protections,” Mr. Dixon said in a statement.

The FSMB also announced the creation of a commission that will meet later this year to discuss the management and administration of the compact. Members of the commission will include two voting representatives appointed by each member state. Commissioners will be selected from physicians appointed to a member board, executives of a member board, or members of the public appointed to a member board.

Under the compact legislation approved physicians would be under the jurisdiction of the state medical board in which the patient is located at the time of the medical interaction. State boards of medicine would retain their individual authority for discipline and oversight. Interested physicians would also need to complete a background check including biometric data (such as fingerprints) and pass all components of either the U.S. Medical Licensing Examination or the Comprehensive Osteopathic Medicine Licensing Examination within three attempts.

The model legislation has been introduced in nearly 20 state legislatures. Alabama and Minnesota join Idaho, Montana, South Dakota, Utah, West Virginia, and Wyoming in enacting the law.

agallegos@frontlinemedcom.com

@legal_med

Minnesota and Alabama have joined six other states in enacting a law that aims to expand the practice of telemedicine by streamlining physician licensure. Alabama Gov. Robert Bentley (R) and Minnesota Gov. Mark Dayton (D) on May 19 each signed into law the Interstate Medical Licensure Compact, model legislation developed by the Federation of State Medical Boards (FSMB).

Larry D. Dixon, executive director for the Alabama Board of Medical Examiners, said the law will help ease the physician shortage in rural and other underserved areas.

©Brigitte Wodicka/thinkstockphotos.com

“Now that [eight] states have enacted the compact legislation, we can begin the real work of establishing the compact to ensure patients have access to quality health care services, while maintaining the highest level of patient protections,” Mr. Dixon said in a statement.

The FSMB also announced the creation of a commission that will meet later this year to discuss the management and administration of the compact. Members of the commission will include two voting representatives appointed by each member state. Commissioners will be selected from physicians appointed to a member board, executives of a member board, or members of the public appointed to a member board.

Under the compact legislation approved physicians would be under the jurisdiction of the state medical board in which the patient is located at the time of the medical interaction. State boards of medicine would retain their individual authority for discipline and oversight. Interested physicians would also need to complete a background check including biometric data (such as fingerprints) and pass all components of either the U.S. Medical Licensing Examination or the Comprehensive Osteopathic Medicine Licensing Examination within three attempts.

The model legislation has been introduced in nearly 20 state legislatures. Alabama and Minnesota join Idaho, Montana, South Dakota, Utah, West Virginia, and Wyoming in enacting the law.

agallegos@frontlinemedcom.com

@legal_med

Minnesota and Alabama have joined six other states in enacting a law that aims to expand the practice of telemedicine by streamlining physician licensure. Alabama Gov. Robert Bentley (R) and Minnesota Gov. Mark Dayton (D) on May 19 each signed into law the Interstate Medical Licensure Compact, model legislation developed by the Federation of State Medical Boards (FSMB).

Larry D. Dixon, executive director for the Alabama Board of Medical Examiners, said the law will help ease the physician shortage in rural and other underserved areas.

©Brigitte Wodicka/thinkstockphotos.com

“Now that [eight] states have enacted the compact legislation, we can begin the real work of establishing the compact to ensure patients have access to quality health care services, while maintaining the highest level of patient protections,” Mr. Dixon said in a statement.

The FSMB also announced the creation of a commission that will meet later this year to discuss the management and administration of the compact. Members of the commission will include two voting representatives appointed by each member state. Commissioners will be selected from physicians appointed to a member board, executives of a member board, or members of the public appointed to a member board.

Under the compact legislation approved physicians would be under the jurisdiction of the state medical board in which the patient is located at the time of the medical interaction. State boards of medicine would retain their individual authority for discipline and oversight. Interested physicians would also need to complete a background check including biometric data (such as fingerprints) and pass all components of either the U.S. Medical Licensing Examination or the Comprehensive Osteopathic Medicine Licensing Examination within three attempts.

The model legislation has been introduced in nearly 20 state legislatures. Alabama and Minnesota join Idaho, Montana, South Dakota, Utah, West Virginia, and Wyoming in enacting the law.

agallegos@frontlinemedcom.com

@legal_med

SAN DIEGO – Treating gut failure after bariatric surgery involves meeting patients’ nutritional needs while avoiding a recurrence of morbid obesity, according to Dr. Kareem Abu-Elmagd of the Cleveland Clinic.

Surgeons must be flexible, and should be familiar with a variety of reconstructive techniques to restore patients to nutritional autonomy while minimizing the need for visceral transplantation, he said.

Gut failure is a rare but serious and potentially life-threatening complication of bariatric surgery. When it occurs, the patient can no longer meet nutritional needs autonomously, but rather requires total parenteral nutrition (TPN). Although comprehensive medical management including TPN is necessary when gut failure occurs, reconstructive surgery or visceral transplantation is the only means to allow patients to regain nutritional autonomy.

Dr. Abu-Elmagd reported the results of 2 decades of experience with post–bariatric surgery gut failure at the Cleveland Clinic and the University of Pittsburgh Medical Center at the annual meeting of the American Surgical Association. He and his coinvestigators at the two facilities assessed a total of 131 patients who were referred for gut failure from 1995 to 2015. The number of referrals, said Dr. Abu-Elmagd, has been increasing sharply, with nearly two-thirds of patients referred over the past 5 years.

The study sought to identify the types and causes of gut failures seen, to describe surgical techniques used for repair or transplant, and to track outcomes for patients after surgical repair for gut failure. Of the 131 patients in the study, 100 had a Roux-en-Y or similar combined malabsorptive and restrictive surgery as their primary bariatric procedure. Overall, 85% of patients were female.

Dr. Abu-Elmagd classified gut failure into three major groups: 55 patients (42%) had type I or catastrophic gut loss, which included strangulation and vascular occlusion; 43 patients (33%) had type II gut failure, caused by technical complications such as loss of gut continuity, strictures, and fistulae; and 33 patients (25%) had type III gut failure, caused by dysfunctional syndromes such as dysmotility, restriction, or absorption.

Of the 131 patients referred, 116 went on to have a total of 317 restorative procedures. Most (n = 84, 72%) needed reversal of their primary bariatric procedure. Patients received a total of 198 autologous reconstruction procedures, while 10 intestinal-lengthening procedures and 25 visceral transplantations were performed.

Dr. Abu-Elmagd and his colleagues characterized the reconstruction procedures according to the embryonic origins of the structures repaired. Seventy-eight patients had major reconstruction of the foregut, “the most tedious and technically challenging procedure … to restore normal gut anatomy and physiology,” said Dr. Abu-Elmagd. Three other patients had gastroplasty to restore the foregut, and seven needed to have an alimentary conduit interposed in order to restore normal alimentary flow. Mid- and hindgut reconstructions (n = 110) were essential to maximize absorption and restore nutritional autonomy, he said.

If patients had less than 100 cm of small bowel remaining, they received serial transverse enteroplasty, an intestinal-lengthening procedure. The few patients who needed intestinal, liver-intestine, or multivisceral transplantations had ultrashort gut syndrome and could not be maintained on TPN.

Five-year cumulative survival for those receiving reconstruction or transplantation was 84%, and plateaued at 72% at 10 and 15 years post restoration. For the subset who received transplantation, the 5-year survival was 69%. Among the first 100 surviving surgical patients, 83% retained full nutritional autonomy.

Bariatric surgery, noted discussant Dr. Debra Sudan of Duke University, “is clearly the most effective treatment for obesity and has tremendous impact on comorbidities,” but, since it is an elective procedure, “it’s devastating when complications develop.” She asked what considerations were specific to the bariatric population when dealing with gut failure.

Bariatric patients, said Dr. Abu-Elmegd, have the advantage that they do not have an underlying disease process, and overall they have the ability to adapt and return to more normal gut function very quickly. From a surgical perspective, the solutions must be flexible and tailored to the patient. He said, “Whatever the patient has, you fix it.”

The authors reported no relevant financial disclosures.

SAN DIEGO – Treating gut failure after bariatric surgery involves meeting patients’ nutritional needs while avoiding a recurrence of morbid obesity, according to Dr. Kareem Abu-Elmagd of the Cleveland Clinic.

Surgeons must be flexible, and should be familiar with a variety of reconstructive techniques to restore patients to nutritional autonomy while minimizing the need for visceral transplantation, he said.

Gut failure is a rare but serious and potentially life-threatening complication of bariatric surgery. When it occurs, the patient can no longer meet nutritional needs autonomously, but rather requires total parenteral nutrition (TPN). Although comprehensive medical management including TPN is necessary when gut failure occurs, reconstructive surgery or visceral transplantation is the only means to allow patients to regain nutritional autonomy.

Dr. Abu-Elmagd reported the results of 2 decades of experience with post–bariatric surgery gut failure at the Cleveland Clinic and the University of Pittsburgh Medical Center at the annual meeting of the American Surgical Association. He and his coinvestigators at the two facilities assessed a total of 131 patients who were referred for gut failure from 1995 to 2015. The number of referrals, said Dr. Abu-Elmagd, has been increasing sharply, with nearly two-thirds of patients referred over the past 5 years.

The study sought to identify the types and causes of gut failures seen, to describe surgical techniques used for repair or transplant, and to track outcomes for patients after surgical repair for gut failure. Of the 131 patients in the study, 100 had a Roux-en-Y or similar combined malabsorptive and restrictive surgery as their primary bariatric procedure. Overall, 85% of patients were female.

Dr. Abu-Elmagd classified gut failure into three major groups: 55 patients (42%) had type I or catastrophic gut loss, which included strangulation and vascular occlusion; 43 patients (33%) had type II gut failure, caused by technical complications such as loss of gut continuity, strictures, and fistulae; and 33 patients (25%) had type III gut failure, caused by dysfunctional syndromes such as dysmotility, restriction, or absorption.

Of the 131 patients referred, 116 went on to have a total of 317 restorative procedures. Most (n = 84, 72%) needed reversal of their primary bariatric procedure. Patients received a total of 198 autologous reconstruction procedures, while 10 intestinal-lengthening procedures and 25 visceral transplantations were performed.

Dr. Abu-Elmagd and his colleagues characterized the reconstruction procedures according to the embryonic origins of the structures repaired. Seventy-eight patients had major reconstruction of the foregut, “the most tedious and technically challenging procedure … to restore normal gut anatomy and physiology,” said Dr. Abu-Elmagd. Three other patients had gastroplasty to restore the foregut, and seven needed to have an alimentary conduit interposed in order to restore normal alimentary flow. Mid- and hindgut reconstructions (n = 110) were essential to maximize absorption and restore nutritional autonomy, he said.

If patients had less than 100 cm of small bowel remaining, they received serial transverse enteroplasty, an intestinal-lengthening procedure. The few patients who needed intestinal, liver-intestine, or multivisceral transplantations had ultrashort gut syndrome and could not be maintained on TPN.

Five-year cumulative survival for those receiving reconstruction or transplantation was 84%, and plateaued at 72% at 10 and 15 years post restoration. For the subset who received transplantation, the 5-year survival was 69%. Among the first 100 surviving surgical patients, 83% retained full nutritional autonomy.

Bariatric surgery, noted discussant Dr. Debra Sudan of Duke University, “is clearly the most effective treatment for obesity and has tremendous impact on comorbidities,” but, since it is an elective procedure, “it’s devastating when complications develop.” She asked what considerations were specific to the bariatric population when dealing with gut failure.

Bariatric patients, said Dr. Abu-Elmegd, have the advantage that they do not have an underlying disease process, and overall they have the ability to adapt and return to more normal gut function very quickly. From a surgical perspective, the solutions must be flexible and tailored to the patient. He said, “Whatever the patient has, you fix it.”

The authors reported no relevant financial disclosures.

SAN DIEGO – Treating gut failure after bariatric surgery involves meeting patients’ nutritional needs while avoiding a recurrence of morbid obesity, according to Dr. Kareem Abu-Elmagd of the Cleveland Clinic.

Surgeons must be flexible, and should be familiar with a variety of reconstructive techniques to restore patients to nutritional autonomy while minimizing the need for visceral transplantation, he said.

Gut failure is a rare but serious and potentially life-threatening complication of bariatric surgery. When it occurs, the patient can no longer meet nutritional needs autonomously, but rather requires total parenteral nutrition (TPN). Although comprehensive medical management including TPN is necessary when gut failure occurs, reconstructive surgery or visceral transplantation is the only means to allow patients to regain nutritional autonomy.

Dr. Abu-Elmagd reported the results of 2 decades of experience with post–bariatric surgery gut failure at the Cleveland Clinic and the University of Pittsburgh Medical Center at the annual meeting of the American Surgical Association. He and his coinvestigators at the two facilities assessed a total of 131 patients who were referred for gut failure from 1995 to 2015. The number of referrals, said Dr. Abu-Elmagd, has been increasing sharply, with nearly two-thirds of patients referred over the past 5 years.

The study sought to identify the types and causes of gut failures seen, to describe surgical techniques used for repair or transplant, and to track outcomes for patients after surgical repair for gut failure. Of the 131 patients in the study, 100 had a Roux-en-Y or similar combined malabsorptive and restrictive surgery as their primary bariatric procedure. Overall, 85% of patients were female.

Dr. Abu-Elmagd classified gut failure into three major groups: 55 patients (42%) had type I or catastrophic gut loss, which included strangulation and vascular occlusion; 43 patients (33%) had type II gut failure, caused by technical complications such as loss of gut continuity, strictures, and fistulae; and 33 patients (25%) had type III gut failure, caused by dysfunctional syndromes such as dysmotility, restriction, or absorption.

Of the 131 patients referred, 116 went on to have a total of 317 restorative procedures. Most (n = 84, 72%) needed reversal of their primary bariatric procedure. Patients received a total of 198 autologous reconstruction procedures, while 10 intestinal-lengthening procedures and 25 visceral transplantations were performed.

Dr. Abu-Elmagd and his colleagues characterized the reconstruction procedures according to the embryonic origins of the structures repaired. Seventy-eight patients had major reconstruction of the foregut, “the most tedious and technically challenging procedure … to restore normal gut anatomy and physiology,” said Dr. Abu-Elmagd. Three other patients had gastroplasty to restore the foregut, and seven needed to have an alimentary conduit interposed in order to restore normal alimentary flow. Mid- and hindgut reconstructions (n = 110) were essential to maximize absorption and restore nutritional autonomy, he said.

If patients had less than 100 cm of small bowel remaining, they received serial transverse enteroplasty, an intestinal-lengthening procedure. The few patients who needed intestinal, liver-intestine, or multivisceral transplantations had ultrashort gut syndrome and could not be maintained on TPN.

Five-year cumulative survival for those receiving reconstruction or transplantation was 84%, and plateaued at 72% at 10 and 15 years post restoration. For the subset who received transplantation, the 5-year survival was 69%. Among the first 100 surviving surgical patients, 83% retained full nutritional autonomy.

Bariatric surgery, noted discussant Dr. Debra Sudan of Duke University, “is clearly the most effective treatment for obesity and has tremendous impact on comorbidities,” but, since it is an elective procedure, “it’s devastating when complications develop.” She asked what considerations were specific to the bariatric population when dealing with gut failure.

Bariatric patients, said Dr. Abu-Elmegd, have the advantage that they do not have an underlying disease process, and overall they have the ability to adapt and return to more normal gut function very quickly. From a surgical perspective, the solutions must be flexible and tailored to the patient. He said, “Whatever the patient has, you fix it.”

The authors reported no relevant financial disclosures.

NEW ORLEANS – Long-term active surveillance seems to be a safe and effective way to avoid overtreatment in men with low- and very low-risk prostate cancer, while still offering a very good chance of catching progressive disease.

According to new data presented at the annual meeting of the American Urological Association, less than 3% of men developed metastatic disease or died from prostate cancer over 15 years of follow-up. The men’s risk of progression dramatically declined over time, decreasing by 30% after each annual, unchanged biopsy.

The findings should reassure both physicians and patients, all of whom want to balance the potential side effects of prostate cancer treatment with the risk of progressive disease, said Dr. Stacy Loeb of New York University, New York.

“Physicians in the U.S. have been slow to adopt the practice of active surveillance, which is much more common in other parts of the world,” said Dr. Loeb, who moderated the press briefing where the data were unveiled. She has worked with Swedish researchers, who determined that 84% of men with very low-risk cancers and 66% of those with low-risk cancers are being managed this way. “The question we have to ask is why we have been so slow to adopt this. Hopefully, studies like these, showing so many men free of disease even at 15 years, will encourage greater acceptance in this country.”

The briefing highlighted several studies on active surveillance; two of these were performed on the Johns Hopkins Active Surveillance Program cohort, which has enrolled about 1,300 men since 1995. Most (71%) have very low-risk cancer; the remainder have low-risk cancer.

The Hopkins protocol calls for a clinical exam and prostate specific antigen (PSA) test twice a year, annual prostate biopsy, and imaging every either year, said Dr. Jeffrey Tosoian, a urology resident at the university.

Triggers for treatment include a change in biopsy or patient decision. Changes in PSA and clinical exam alone don’t trigger treatment, but may prompt a stepped-up monitoring schedule or additional diagnostic studies.

The Hopkins cohort is a fairly typical prostate cancer group. The patients’ mean age at diagnosis is about 66 years, and their mean PSA level is 5.2 ng/mL. Mean follow-up time is now 5 years, but Dr. Tosoian also presented 10- and 15-year data.

At 5 years, 36% of the group had converted to some form of treatment. By 10 and 15 years, conversion had occurred in 50% and 56%, respectively. Not surprisingly, the rate of death from any cause increased as patients aged, from 4% by year 5, to 7% and 31% by years 10 and 15.

But the rate of prostate cancer-specific death was very low throughout the study period: 0.15% at year 5 and 1% at years 10 and 15. Over the entire 15 years, less than 1% of the men died from prostate cancer or developed metastatic disease.

These findings were somewhat more positive than those recently reported by a team at Sunnybrook University, Toronto (J. Clin. Oncol. 2015;33:272-7). That surveillance protocol is less stringent than the one at Hopkins, Dr. Tosoian said, with biopsies every 3-5 years, based on clinical findings and PSA levels.

In that cohort of 819 patients with a median follow-up of 6 years, 3% developed metastatic disease by 15 years and 1.5% died from it, but the men were nine times more likely to die from some other cause than their cancer.

“Certainly, our more intensive monitoring at Hopkins was associated with more treatment, but also with lower death and metastatic rates,” Dr. Tosoian said. “So there are still trade-offs in balancing overtreatment, but the real risk of cancer mortality is quite small.”

However, the question of how long must watchful waiting continue remains. Understandably, most men don’t want to commit to years and years of annual prostate biopsies, said Dr. Ridwan Alam, also of Johns Hopkins.

Dr. Alam presented 15-year data on 808 men who were completely compliant with the program (J. Urology 2015;193:1950-5). Restricting the cohort in this way gives a much more accurate prediction; he said up to 18% of men without disease progression will drop out of active surveillance because they find the process onerous, especially the biopsies.

For the first 2 years of follow-up, the rate of disease reclassification was nearly 0% in both low- and very low-risk groups. “But after that, there was a pretty big gap developing between the two, with the low-risk group doing worse,” Dr. Alam said. By 10 years, 60% of the very low-risk group still had no disease progression; that number remained stable throughout the remainder of the study period. Among low-risk men, however, 60% did have a disease stage reclassification by 7 years; by 10 years, nearly 80% had progressed.

Despite that, the overall risk of reclassification declined sharply over time, decreasing by 30% after every stable biopsy. “If a patient reached 7-9 years without a reclassification, his risk of disease by 15 years was virtually 0,” Dr. Alam said. “This may help reassure men and their doctors about the risks of surveillance, and also reduce the dropout rate by giving them a sense of security – a sense that we really can trust the data and make good decisions based on it.”

Neither Dr. Tosoian nor Dr. Alam had any financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

NEW ORLEANS – Long-term active surveillance seems to be a safe and effective way to avoid overtreatment in men with low- and very low-risk prostate cancer, while still offering a very good chance of catching progressive disease.

According to new data presented at the annual meeting of the American Urological Association, less than 3% of men developed metastatic disease or died from prostate cancer over 15 years of follow-up. The men’s risk of progression dramatically declined over time, decreasing by 30% after each annual, unchanged biopsy.

The findings should reassure both physicians and patients, all of whom want to balance the potential side effects of prostate cancer treatment with the risk of progressive disease, said Dr. Stacy Loeb of New York University, New York.

“Physicians in the U.S. have been slow to adopt the practice of active surveillance, which is much more common in other parts of the world,” said Dr. Loeb, who moderated the press briefing where the data were unveiled. She has worked with Swedish researchers, who determined that 84% of men with very low-risk cancers and 66% of those with low-risk cancers are being managed this way. “The question we have to ask is why we have been so slow to adopt this. Hopefully, studies like these, showing so many men free of disease even at 15 years, will encourage greater acceptance in this country.”

The briefing highlighted several studies on active surveillance; two of these were performed on the Johns Hopkins Active Surveillance Program cohort, which has enrolled about 1,300 men since 1995. Most (71%) have very low-risk cancer; the remainder have low-risk cancer.

The Hopkins protocol calls for a clinical exam and prostate specific antigen (PSA) test twice a year, annual prostate biopsy, and imaging every either year, said Dr. Jeffrey Tosoian, a urology resident at the university.

Triggers for treatment include a change in biopsy or patient decision. Changes in PSA and clinical exam alone don’t trigger treatment, but may prompt a stepped-up monitoring schedule or additional diagnostic studies.

The Hopkins cohort is a fairly typical prostate cancer group. The patients’ mean age at diagnosis is about 66 years, and their mean PSA level is 5.2 ng/mL. Mean follow-up time is now 5 years, but Dr. Tosoian also presented 10- and 15-year data.

At 5 years, 36% of the group had converted to some form of treatment. By 10 and 15 years, conversion had occurred in 50% and 56%, respectively. Not surprisingly, the rate of death from any cause increased as patients aged, from 4% by year 5, to 7% and 31% by years 10 and 15.

But the rate of prostate cancer-specific death was very low throughout the study period: 0.15% at year 5 and 1% at years 10 and 15. Over the entire 15 years, less than 1% of the men died from prostate cancer or developed metastatic disease.

These findings were somewhat more positive than those recently reported by a team at Sunnybrook University, Toronto (J. Clin. Oncol. 2015;33:272-7). That surveillance protocol is less stringent than the one at Hopkins, Dr. Tosoian said, with biopsies every 3-5 years, based on clinical findings and PSA levels.

In that cohort of 819 patients with a median follow-up of 6 years, 3% developed metastatic disease by 15 years and 1.5% died from it, but the men were nine times more likely to die from some other cause than their cancer.

“Certainly, our more intensive monitoring at Hopkins was associated with more treatment, but also with lower death and metastatic rates,” Dr. Tosoian said. “So there are still trade-offs in balancing overtreatment, but the real risk of cancer mortality is quite small.”

However, the question of how long must watchful waiting continue remains. Understandably, most men don’t want to commit to years and years of annual prostate biopsies, said Dr. Ridwan Alam, also of Johns Hopkins.

Dr. Alam presented 15-year data on 808 men who were completely compliant with the program (J. Urology 2015;193:1950-5). Restricting the cohort in this way gives a much more accurate prediction; he said up to 18% of men without disease progression will drop out of active surveillance because they find the process onerous, especially the biopsies.

For the first 2 years of follow-up, the rate of disease reclassification was nearly 0% in both low- and very low-risk groups. “But after that, there was a pretty big gap developing between the two, with the low-risk group doing worse,” Dr. Alam said. By 10 years, 60% of the very low-risk group still had no disease progression; that number remained stable throughout the remainder of the study period. Among low-risk men, however, 60% did have a disease stage reclassification by 7 years; by 10 years, nearly 80% had progressed.

Despite that, the overall risk of reclassification declined sharply over time, decreasing by 30% after every stable biopsy. “If a patient reached 7-9 years without a reclassification, his risk of disease by 15 years was virtually 0,” Dr. Alam said. “This may help reassure men and their doctors about the risks of surveillance, and also reduce the dropout rate by giving them a sense of security – a sense that we really can trust the data and make good decisions based on it.”

Neither Dr. Tosoian nor Dr. Alam had any financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

NEW ORLEANS – Long-term active surveillance seems to be a safe and effective way to avoid overtreatment in men with low- and very low-risk prostate cancer, while still offering a very good chance of catching progressive disease.

According to new data presented at the annual meeting of the American Urological Association, less than 3% of men developed metastatic disease or died from prostate cancer over 15 years of follow-up. The men’s risk of progression dramatically declined over time, decreasing by 30% after each annual, unchanged biopsy.

The findings should reassure both physicians and patients, all of whom want to balance the potential side effects of prostate cancer treatment with the risk of progressive disease, said Dr. Stacy Loeb of New York University, New York.

“Physicians in the U.S. have been slow to adopt the practice of active surveillance, which is much more common in other parts of the world,” said Dr. Loeb, who moderated the press briefing where the data were unveiled. She has worked with Swedish researchers, who determined that 84% of men with very low-risk cancers and 66% of those with low-risk cancers are being managed this way. “The question we have to ask is why we have been so slow to adopt this. Hopefully, studies like these, showing so many men free of disease even at 15 years, will encourage greater acceptance in this country.”

The briefing highlighted several studies on active surveillance; two of these were performed on the Johns Hopkins Active Surveillance Program cohort, which has enrolled about 1,300 men since 1995. Most (71%) have very low-risk cancer; the remainder have low-risk cancer.

The Hopkins protocol calls for a clinical exam and prostate specific antigen (PSA) test twice a year, annual prostate biopsy, and imaging every either year, said Dr. Jeffrey Tosoian, a urology resident at the university.

Triggers for treatment include a change in biopsy or patient decision. Changes in PSA and clinical exam alone don’t trigger treatment, but may prompt a stepped-up monitoring schedule or additional diagnostic studies.

The Hopkins cohort is a fairly typical prostate cancer group. The patients’ mean age at diagnosis is about 66 years, and their mean PSA level is 5.2 ng/mL. Mean follow-up time is now 5 years, but Dr. Tosoian also presented 10- and 15-year data.

At 5 years, 36% of the group had converted to some form of treatment. By 10 and 15 years, conversion had occurred in 50% and 56%, respectively. Not surprisingly, the rate of death from any cause increased as patients aged, from 4% by year 5, to 7% and 31% by years 10 and 15.

But the rate of prostate cancer-specific death was very low throughout the study period: 0.15% at year 5 and 1% at years 10 and 15. Over the entire 15 years, less than 1% of the men died from prostate cancer or developed metastatic disease.

These findings were somewhat more positive than those recently reported by a team at Sunnybrook University, Toronto (J. Clin. Oncol. 2015;33:272-7). That surveillance protocol is less stringent than the one at Hopkins, Dr. Tosoian said, with biopsies every 3-5 years, based on clinical findings and PSA levels.

In that cohort of 819 patients with a median follow-up of 6 years, 3% developed metastatic disease by 15 years and 1.5% died from it, but the men were nine times more likely to die from some other cause than their cancer.

“Certainly, our more intensive monitoring at Hopkins was associated with more treatment, but also with lower death and metastatic rates,” Dr. Tosoian said. “So there are still trade-offs in balancing overtreatment, but the real risk of cancer mortality is quite small.”

However, the question of how long must watchful waiting continue remains. Understandably, most men don’t want to commit to years and years of annual prostate biopsies, said Dr. Ridwan Alam, also of Johns Hopkins.

Dr. Alam presented 15-year data on 808 men who were completely compliant with the program (J. Urology 2015;193:1950-5). Restricting the cohort in this way gives a much more accurate prediction; he said up to 18% of men without disease progression will drop out of active surveillance because they find the process onerous, especially the biopsies.

For the first 2 years of follow-up, the rate of disease reclassification was nearly 0% in both low- and very low-risk groups. “But after that, there was a pretty big gap developing between the two, with the low-risk group doing worse,” Dr. Alam said. By 10 years, 60% of the very low-risk group still had no disease progression; that number remained stable throughout the remainder of the study period. Among low-risk men, however, 60% did have a disease stage reclassification by 7 years; by 10 years, nearly 80% had progressed.

Despite that, the overall risk of reclassification declined sharply over time, decreasing by 30% after every stable biopsy. “If a patient reached 7-9 years without a reclassification, his risk of disease by 15 years was virtually 0,” Dr. Alam said. “This may help reassure men and their doctors about the risks of surveillance, and also reduce the dropout rate by giving them a sense of security – a sense that we really can trust the data and make good decisions based on it.”

Neither Dr. Tosoian nor Dr. Alam had any financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

SILVER SPRING, MD. – A Food and Drug Administration advisory panel unanimously agreed that duodenoscopes that are properly cleaned and disinfected based on current recommendations for reprocessing do not provide “reasonable assurance of safety and effectiveness,” at a meeting on May 15.

The Food and Drug Administration held a meeting of the agency’s gastroenterology and urology devices panel on May 14 and 15, to address recent concerns about duodenoscopes and several outbreaks in US hospitals of serious infections associated with these devices, used to perform endoscopic retrograde cholangiopancreatography (ERCP).

“Although the incidence of infections appears to be very low relative to the 500,000 to 600,000 cases of ERCP performed a year, there certainly have been infections traced to scopes despite apparent compliance with recommended guidelines for cleaning and disinfection,” said one of the panelists, Dr. Kenneth McQuaid, chief of gastroenterology, at the Veterans Affairs Medical Center, San Francisco.

More than two-thirds of the panel said that they should start to be sterilized, while others supported the continued use of high-level disinfection, which they believed worked well, if done properly. Most of the panel called for innovations in the design of duodenoscopes that make them easier to clean. However, none of the 16 panelists said that the risks of the duodenoscopes outweighed their benefits and should not be used. Halting the use of ERCP would be “catastrophic,” Dr McQuaid commented, noting that the infection risk is small and the benefits are “incredibly large.”

Elizabeth Mechcatie/Frontline Medical News

Other recommendations included ensuring the competency and proper training of the technicians involved in duodenoscope reprocessing and continuing to include manual cleaning of the devices, a step that was necessary, they said.

The panel did not officially vote on any of the questions.

In February 2015, the FDA issued safety alerts about the association with duodenoscopes and the transmission of multidrug-resistant bacterial infections in patients who had undergone ERCP procedures with duodenoscopes, despite proper cleaning and disinfection of the devices, pointing out to health care professionals that the “complex design” of duodenoscopes “may impede effective reprocessing. Reprocessing is defined by the FDA as “a detailed, multistep process to clean and disinfect or sterilize reusable devices.” In a March 4 update, the agency said that duodenoscope-associated infections had been reported for all three duodenoscope manufacturers in the United States, and on March 26, announced that Olympus had issued new manual reprocessing instructions for its TJF-Q180V duodenoscope, which had been associated with outbreaks, and was being marketed despite not having received clearance by the FDA for marketing (an application for clearance is now under review).

Among the other questions the panel was asked was what information about the risks of infection should be provided to patients before they undergo an ERCP. Dr. Karen Woods, a gastroenterologist at Baylor University, Houston, said that there should be a discussion with patients that there have been infections with highly resistant microorganisms associated with duodenoscopes. They should be informed if infections have occurred at the institution where they will undergo the procedure, and told what is being done about the problem, and this topic should be included in the written informed consent, she added.

From 2010 through 2014, 3,116,900 ERCP procedures were performed in the United States, including 668,800 in 2014, according to the FDA.

Duodenoscope manufacturers were invited to participate in the meeting but did not come, FDA officials said. The panelists had no disclosures related to the content of this meeting.

Any infections possibly related to duodenoscopes should be reported to the manufacturer and the FDA’s MedWatch program at 800-332-1088 or http://www.fda.gov/Safety/MedWatch/HowToReport/ucm2007306.htm.

emechcatie@frontlinemedcom.com

*CORRECTION 5/17/2015: An earlier version of this story misstated the photo caption information.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel unanimously agreed that duodenoscopes that are properly cleaned and disinfected based on current recommendations for reprocessing do not provide “reasonable assurance of safety and effectiveness,” at a meeting on May 15.

The Food and Drug Administration held a meeting of the agency’s gastroenterology and urology devices panel on May 14 and 15, to address recent concerns about duodenoscopes and several outbreaks in US hospitals of serious infections associated with these devices, used to perform endoscopic retrograde cholangiopancreatography (ERCP).

“Although the incidence of infections appears to be very low relative to the 500,000 to 600,000 cases of ERCP performed a year, there certainly have been infections traced to scopes despite apparent compliance with recommended guidelines for cleaning and disinfection,” said one of the panelists, Dr. Kenneth McQuaid, chief of gastroenterology, at the Veterans Affairs Medical Center, San Francisco.

More than two-thirds of the panel said that they should start to be sterilized, while others supported the continued use of high-level disinfection, which they believed worked well, if done properly. Most of the panel called for innovations in the design of duodenoscopes that make them easier to clean. However, none of the 16 panelists said that the risks of the duodenoscopes outweighed their benefits and should not be used. Halting the use of ERCP would be “catastrophic,” Dr McQuaid commented, noting that the infection risk is small and the benefits are “incredibly large.”

Elizabeth Mechcatie/Frontline Medical News

Other recommendations included ensuring the competency and proper training of the technicians involved in duodenoscope reprocessing and continuing to include manual cleaning of the devices, a step that was necessary, they said.

The panel did not officially vote on any of the questions.

In February 2015, the FDA issued safety alerts about the association with duodenoscopes and the transmission of multidrug-resistant bacterial infections in patients who had undergone ERCP procedures with duodenoscopes, despite proper cleaning and disinfection of the devices, pointing out to health care professionals that the “complex design” of duodenoscopes “may impede effective reprocessing. Reprocessing is defined by the FDA as “a detailed, multistep process to clean and disinfect or sterilize reusable devices.” In a March 4 update, the agency said that duodenoscope-associated infections had been reported for all three duodenoscope manufacturers in the United States, and on March 26, announced that Olympus had issued new manual reprocessing instructions for its TJF-Q180V duodenoscope, which had been associated with outbreaks, and was being marketed despite not having received clearance by the FDA for marketing (an application for clearance is now under review).

Among the other questions the panel was asked was what information about the risks of infection should be provided to patients before they undergo an ERCP. Dr. Karen Woods, a gastroenterologist at Baylor University, Houston, said that there should be a discussion with patients that there have been infections with highly resistant microorganisms associated with duodenoscopes. They should be informed if infections have occurred at the institution where they will undergo the procedure, and told what is being done about the problem, and this topic should be included in the written informed consent, she added.

From 2010 through 2014, 3,116,900 ERCP procedures were performed in the United States, including 668,800 in 2014, according to the FDA.

Duodenoscope manufacturers were invited to participate in the meeting but did not come, FDA officials said. The panelists had no disclosures related to the content of this meeting.

Any infections possibly related to duodenoscopes should be reported to the manufacturer and the FDA’s MedWatch program at 800-332-1088 or http://www.fda.gov/Safety/MedWatch/HowToReport/ucm2007306.htm.

emechcatie@frontlinemedcom.com

*CORRECTION 5/17/2015: An earlier version of this story misstated the photo caption information.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel unanimously agreed that duodenoscopes that are properly cleaned and disinfected based on current recommendations for reprocessing do not provide “reasonable assurance of safety and effectiveness,” at a meeting on May 15.

The Food and Drug Administration held a meeting of the agency’s gastroenterology and urology devices panel on May 14 and 15, to address recent concerns about duodenoscopes and several outbreaks in US hospitals of serious infections associated with these devices, used to perform endoscopic retrograde cholangiopancreatography (ERCP).

“Although the incidence of infections appears to be very low relative to the 500,000 to 600,000 cases of ERCP performed a year, there certainly have been infections traced to scopes despite apparent compliance with recommended guidelines for cleaning and disinfection,” said one of the panelists, Dr. Kenneth McQuaid, chief of gastroenterology, at the Veterans Affairs Medical Center, San Francisco.

More than two-thirds of the panel said that they should start to be sterilized, while others supported the continued use of high-level disinfection, which they believed worked well, if done properly. Most of the panel called for innovations in the design of duodenoscopes that make them easier to clean. However, none of the 16 panelists said that the risks of the duodenoscopes outweighed their benefits and should not be used. Halting the use of ERCP would be “catastrophic,” Dr McQuaid commented, noting that the infection risk is small and the benefits are “incredibly large.”

Elizabeth Mechcatie/Frontline Medical News

Other recommendations included ensuring the competency and proper training of the technicians involved in duodenoscope reprocessing and continuing to include manual cleaning of the devices, a step that was necessary, they said.

The panel did not officially vote on any of the questions.

In February 2015, the FDA issued safety alerts about the association with duodenoscopes and the transmission of multidrug-resistant bacterial infections in patients who had undergone ERCP procedures with duodenoscopes, despite proper cleaning and disinfection of the devices, pointing out to health care professionals that the “complex design” of duodenoscopes “may impede effective reprocessing. Reprocessing is defined by the FDA as “a detailed, multistep process to clean and disinfect or sterilize reusable devices.” In a March 4 update, the agency said that duodenoscope-associated infections had been reported for all three duodenoscope manufacturers in the United States, and on March 26, announced that Olympus had issued new manual reprocessing instructions for its TJF-Q180V duodenoscope, which had been associated with outbreaks, and was being marketed despite not having received clearance by the FDA for marketing (an application for clearance is now under review).

Among the other questions the panel was asked was what information about the risks of infection should be provided to patients before they undergo an ERCP. Dr. Karen Woods, a gastroenterologist at Baylor University, Houston, said that there should be a discussion with patients that there have been infections with highly resistant microorganisms associated with duodenoscopes. They should be informed if infections have occurred at the institution where they will undergo the procedure, and told what is being done about the problem, and this topic should be included in the written informed consent, she added.

From 2010 through 2014, 3,116,900 ERCP procedures were performed in the United States, including 668,800 in 2014, according to the FDA.

Duodenoscope manufacturers were invited to participate in the meeting but did not come, FDA officials said. The panelists had no disclosures related to the content of this meeting.

Any infections possibly related to duodenoscopes should be reported to the manufacturer and the FDA’s MedWatch program at 800-332-1088 or http://www.fda.gov/Safety/MedWatch/HowToReport/ucm2007306.htm.

emechcatie@frontlinemedcom.com

*CORRECTION 5/17/2015: An earlier version of this story misstated the photo caption information.

After nearly 15 years of litigation between UnitedHealth Group Inc. and a group of physicians, the health insurance giant agreed to pay $11.5 million to resolve allegations that it incorrectly paid and managed doctors’ billing claims.

UnitedHealth Group and its subsidiaries agreed to spend at least $9 million in enhancements to its provider self-service website to increase efficiency and reduce delays in managing of claims. The additional funds will go toward educational programs for medical society members pertaining to ICD-10-CM coding, CPT coding, medical review audits, appeals, and claims submission and processing. The settlement stems from lawsuits filed in 2001 by the Medical Society of the State of New York, the Connecticut State Medical Society, the North Carolina Medical Society, the Tennessee Medical Association, and several individual physicians.

Daryl Richard, UnitedHealth Group spokesman, said that the insurer was pleased to finally be ending the litigation, and that the company looks forward to new ways of collaborating with doctors.

“Physicians will have simpler and more comprehensive access to claims management information through enhancements we are making to our physician website,” Mr. Richard said in a statement.

Dr. Joseph Maldonado, president of the New York medical society, said the settlement was a significant victory for physicians.

©jsmith/iStockphoto

“This settlement will improve access to information and the ability to adjust claims for all in-network physicians contracting with United and submitting claims, while providing certain benefits to member physicians,” he said in a statement.

The case was part of a series of lawsuits filed in the early 2000s alleging illegal business practices and corruption by Aetna, Cigna, UnitedHealthcare, Healthnet, Humana, PacifiCare, Prudential, and WellPoint. The suits alleged that the defendants engaged in a conspiracy to wrongfully and fraudulently pay doctors less than the amounts to which they were entitled. Several of the cases were consolidated into what is referred to in court documents as “the lead case.”

The medical societies’ litigation was halted pending the outcome of the lead case, according to the UnitedHealth Group settlement documents. Following a 2007 ruling for defendants in the lead case, plaintiffs in the medical societies’ case attempted to revive their litigation, and a lengthy court battle ensued. The parties tried unsuccessfully to negotiate a settlement for years.

Meanwhile, settlements were eventually reached in the lead case with insurers agreeing to change their business practices and reimburse the plaintiff physicians for hundreds of million dollars, according to a summary by the American Medical Association, a plaintiff in one of the original cases. In addition, the settlements required the insurers to disclose their coding edits, adopt certain CPT conventions, and clarify the criteria under which medical procedures will be deemed medically necessary.

In its settlement with the medical societies, UnitedHealth Group denied all allegations in the suit and admitted no wrongdoing. For their part, the medical societies stated the claims have merit, but that they will dismiss the suit following payment of the settlement, according to court documents.

The settlement will offer significant relief in the areas of claims management and claims resolution, said Edith Kallas, a New York–based attorney and legal counsel for plaintiffs.

“We applaud the medical societies and individual physicians for their commitment to obtaining a meaningful resolution of these issues,” she said in a statement.

agallegos@frontlinemedcom.com

On Twitter @legal_med

After nearly 15 years of litigation between UnitedHealth Group Inc. and a group of physicians, the health insurance giant agreed to pay $11.5 million to resolve allegations that it incorrectly paid and managed doctors’ billing claims.

UnitedHealth Group and its subsidiaries agreed to spend at least $9 million in enhancements to its provider self-service website to increase efficiency and reduce delays in managing of claims. The additional funds will go toward educational programs for medical society members pertaining to ICD-10-CM coding, CPT coding, medical review audits, appeals, and claims submission and processing. The settlement stems from lawsuits filed in 2001 by the Medical Society of the State of New York, the Connecticut State Medical Society, the North Carolina Medical Society, the Tennessee Medical Association, and several individual physicians.

Daryl Richard, UnitedHealth Group spokesman, said that the insurer was pleased to finally be ending the litigation, and that the company looks forward to new ways of collaborating with doctors.

“Physicians will have simpler and more comprehensive access to claims management information through enhancements we are making to our physician website,” Mr. Richard said in a statement.

Dr. Joseph Maldonado, president of the New York medical society, said the settlement was a significant victory for physicians.

©jsmith/iStockphoto

“This settlement will improve access to information and the ability to adjust claims for all in-network physicians contracting with United and submitting claims, while providing certain benefits to member physicians,” he said in a statement.

The case was part of a series of lawsuits filed in the early 2000s alleging illegal business practices and corruption by Aetna, Cigna, UnitedHealthcare, Healthnet, Humana, PacifiCare, Prudential, and WellPoint. The suits alleged that the defendants engaged in a conspiracy to wrongfully and fraudulently pay doctors less than the amounts to which they were entitled. Several of the cases were consolidated into what is referred to in court documents as “the lead case.”

The medical societies’ litigation was halted pending the outcome of the lead case, according to the UnitedHealth Group settlement documents. Following a 2007 ruling for defendants in the lead case, plaintiffs in the medical societies’ case attempted to revive their litigation, and a lengthy court battle ensued. The parties tried unsuccessfully to negotiate a settlement for years.

Meanwhile, settlements were eventually reached in the lead case with insurers agreeing to change their business practices and reimburse the plaintiff physicians for hundreds of million dollars, according to a summary by the American Medical Association, a plaintiff in one of the original cases. In addition, the settlements required the insurers to disclose their coding edits, adopt certain CPT conventions, and clarify the criteria under which medical procedures will be deemed medically necessary.

In its settlement with the medical societies, UnitedHealth Group denied all allegations in the suit and admitted no wrongdoing. For their part, the medical societies stated the claims have merit, but that they will dismiss the suit following payment of the settlement, according to court documents.

The settlement will offer significant relief in the areas of claims management and claims resolution, said Edith Kallas, a New York–based attorney and legal counsel for plaintiffs.

“We applaud the medical societies and individual physicians for their commitment to obtaining a meaningful resolution of these issues,” she said in a statement.

agallegos@frontlinemedcom.com

On Twitter @legal_med

After nearly 15 years of litigation between UnitedHealth Group Inc. and a group of physicians, the health insurance giant agreed to pay $11.5 million to resolve allegations that it incorrectly paid and managed doctors’ billing claims.

UnitedHealth Group and its subsidiaries agreed to spend at least $9 million in enhancements to its provider self-service website to increase efficiency and reduce delays in managing of claims. The additional funds will go toward educational programs for medical society members pertaining to ICD-10-CM coding, CPT coding, medical review audits, appeals, and claims submission and processing. The settlement stems from lawsuits filed in 2001 by the Medical Society of the State of New York, the Connecticut State Medical Society, the North Carolina Medical Society, the Tennessee Medical Association, and several individual physicians.

Daryl Richard, UnitedHealth Group spokesman, said that the insurer was pleased to finally be ending the litigation, and that the company looks forward to new ways of collaborating with doctors.

“Physicians will have simpler and more comprehensive access to claims management information through enhancements we are making to our physician website,” Mr. Richard said in a statement.

Dr. Joseph Maldonado, president of the New York medical society, said the settlement was a significant victory for physicians.

©jsmith/iStockphoto

“This settlement will improve access to information and the ability to adjust claims for all in-network physicians contracting with United and submitting claims, while providing certain benefits to member physicians,” he said in a statement.

The case was part of a series of lawsuits filed in the early 2000s alleging illegal business practices and corruption by Aetna, Cigna, UnitedHealthcare, Healthnet, Humana, PacifiCare, Prudential, and WellPoint. The suits alleged that the defendants engaged in a conspiracy to wrongfully and fraudulently pay doctors less than the amounts to which they were entitled. Several of the cases were consolidated into what is referred to in court documents as “the lead case.”

The medical societies’ litigation was halted pending the outcome of the lead case, according to the UnitedHealth Group settlement documents. Following a 2007 ruling for defendants in the lead case, plaintiffs in the medical societies’ case attempted to revive their litigation, and a lengthy court battle ensued. The parties tried unsuccessfully to negotiate a settlement for years.

Meanwhile, settlements were eventually reached in the lead case with insurers agreeing to change their business practices and reimburse the plaintiff physicians for hundreds of million dollars, according to a summary by the American Medical Association, a plaintiff in one of the original cases. In addition, the settlements required the insurers to disclose their coding edits, adopt certain CPT conventions, and clarify the criteria under which medical procedures will be deemed medically necessary.

In its settlement with the medical societies, UnitedHealth Group denied all allegations in the suit and admitted no wrongdoing. For their part, the medical societies stated the claims have merit, but that they will dismiss the suit following payment of the settlement, according to court documents.

The settlement will offer significant relief in the areas of claims management and claims resolution, said Edith Kallas, a New York–based attorney and legal counsel for plaintiffs.

“We applaud the medical societies and individual physicians for their commitment to obtaining a meaningful resolution of these issues,” she said in a statement.

agallegos@frontlinemedcom.com

On Twitter @legal_med

In his most recent bestseller, Being Mortal, Dr. Atul Gawande has again raised social awareness of the inadequacies of our health care system in assisting patients with end-of-life decisions and care. In his treatise, he laments his own lack of training in medical school and residency regarding what he has emphasized should be a key component of any physician’s education.

To some degree, there has been a greater emphasis on palliative care training in our medical schools since Dr. Gawande graduated two decades or so ago. The subject of physician-patient communication, including those difficult discussions that should occur near the end of life, is now incorporated into most medical school curricula. Additionally, palliative care has become a respected and growing subspecialty within both medicine and surgery.* Despite these improvements, still far too many patients die while receiving futile end-of-life care in our nation’s intensive care units and hospital wards rather than in the comfort of their homes surrounded by loved ones. Although referrals have increased, too few patients are afforded the opportunity to utilize hospice care and, those that do, are often referred too late in the course of their terminal disease to obtain full benefit

Why are we not doing better? Two likely contributors include a physician mindset that only cure is success and death represents failure, and unrealistic expectations of patients as to what modern medicine can accomplish. A more fixable and probably more important factor is the failure of doctors to effectively communicate during these highly stressful circumstances. As emphasized by Gawande and from my own experience, the key to negotiating a sensible path in hopeless, end-of-life situations is frequent, reasonable, and realistic consultation with our patients.

Not only are the conversations usually difficult and demanding, but the choices of whether to pursue treatment or remove life-sustaining efforts are frequently not well-defined. While these challenging clinical scenarios are often painted as black and white in the lay press, any physician or surgeon who has cared for such patients realizes that there is a delicate and precarious balance between providing hope, administering appropriate aggressive treatment, and ensuring patient comfort. In a well-intentioned attempt to leave some remnant of hope, we physicians too frequently paint an unrealistic picture for our patients.

Advance patient directives have been promoted as one means for patients to avoid futile, uncomfortable, and unnecessary care during the last stage of their lives. Though I by no means wish to discourage these often useful legal documents, they should not be entered into naively. For example, aggressive life-sustaining care for a patient with extensive metastatic lung cancer is likely inappropriate. On the other hand, short-term ventilator assistance for an elderly unconscious person recovering from an automobile accident may result in many additional years of enjoyable and productive life. Patients need to understand that all grave clinical situations are not equal and that their advance directives should be flexible enough to cover a variety of circumstances.

It has been well established that most patients and families have selective hearing and understanding. Even when the details of a major operation with a greater likelihood of a negative rather than a positive outcome are carefully and clearly presented using lay language, the potential positive outcomes frequently push the more probable adverse consequences into hidden recesses of the brain. In my experience, the more desperate the situation, the more often it is that the possibility of an unsuccessful outcome will be masked or denied by patients or their family members. Even though in my practice I carefully explained the high probability of eventual recurrence when operating on patients with pancreatic cancer, many of them were surprised and some were even quite indignant when this disappointing consequence developed. In my opinion, the most effective means to avoid such misunderstandings is to always have the patient and/or family relate their comprehension of the just-completed conversation. It is then essential to re-emphasize the important details that they suppressed and pushed to the background from your initial explanation.

In these challenging end-of-life moments, what advice should we offer? One question that should almost never be asked of the patient or his/her representative is: “Would you like everything possible done?” Especially for a family member who may take on considerable guilt by answering in the negative, the response will nearly always be “yes” no matter how unlikely a successful outcome. Rather, I believe that recommending only reasonable options, including and possibly emphasizing the choice of comfort therapy alone despite the certainty of death, is our obligation. We should be cognizant of the fact that the decision made by the patient is often highly dependent on how the alternatives are presented by his/her doctor. After clearly presenting the therapeutic options and their likely consequences, it may be helpful to relate what you would do yourself for a loved one in the same circumstances.

As in many other aspects of our lives, a useful guidepost in these situations is the Golden Rule: “Do unto others as you would have done unto yourself.” Interestingly, most probably based on our intimate exposure to numerous unnecessarily complicated and uncomfortable deaths, there is evidence that we physicians choose to die differently than our patients. In a recent essay, Dr. Ken Murray presented data from the John Hopkins Precursors Study that suggested doctors are less likely than their patients to submit themselves to futile end-of-life care. (Murray K: Doctors really do die differently. Zocalopublicsquare.org; accessed March 29, 2015). The proof he presents is from a survey of graduates of Johns Hopkins School of Medicine between 1948 and 1964. It revealed that 65% of them had written their own advance directives in comparison to 20% for the public at large. In addition, only 10% of the graduates would opt for cardiopulmonary resuscitation if they were comatose, compared with 75% of the general population.

I suspect that most surgeons, desiring a dignified death for themselves, are not surprised by these statistics. Therefore, we owe it to our patients to be as compassionate and thoughtful in managing the last stage of their lives as we have traditionally been trained to do in earlier phases when cure was a realistic expectation.

Dr. Rikkers is Editor in Chief of ACS Surgery News.

*Recognizing the importance of end-of-life issues in a surgeon’s education, in 2012 ACS Surgery News initiated a series of articles on various aspects of palliative care.

In his most recent bestseller, Being Mortal, Dr. Atul Gawande has again raised social awareness of the inadequacies of our health care system in assisting patients with end-of-life decisions and care. In his treatise, he laments his own lack of training in medical school and residency regarding what he has emphasized should be a key component of any physician’s education.

To some degree, there has been a greater emphasis on palliative care training in our medical schools since Dr. Gawande graduated two decades or so ago. The subject of physician-patient communication, including those difficult discussions that should occur near the end of life, is now incorporated into most medical school curricula. Additionally, palliative care has become a respected and growing subspecialty within both medicine and surgery.* Despite these improvements, still far too many patients die while receiving futile end-of-life care in our nation’s intensive care units and hospital wards rather than in the comfort of their homes surrounded by loved ones. Although referrals have increased, too few patients are afforded the opportunity to utilize hospice care and, those that do, are often referred too late in the course of their terminal disease to obtain full benefit

Why are we not doing better? Two likely contributors include a physician mindset that only cure is success and death represents failure, and unrealistic expectations of patients as to what modern medicine can accomplish. A more fixable and probably more important factor is the failure of doctors to effectively communicate during these highly stressful circumstances. As emphasized by Gawande and from my own experience, the key to negotiating a sensible path in hopeless, end-of-life situations is frequent, reasonable, and realistic consultation with our patients.

Not only are the conversations usually difficult and demanding, but the choices of whether to pursue treatment or remove life-sustaining efforts are frequently not well-defined. While these challenging clinical scenarios are often painted as black and white in the lay press, any physician or surgeon who has cared for such patients realizes that there is a delicate and precarious balance between providing hope, administering appropriate aggressive treatment, and ensuring patient comfort. In a well-intentioned attempt to leave some remnant of hope, we physicians too frequently paint an unrealistic picture for our patients.

Advance patient directives have been promoted as one means for patients to avoid futile, uncomfortable, and unnecessary care during the last stage of their lives. Though I by no means wish to discourage these often useful legal documents, they should not be entered into naively. For example, aggressive life-sustaining care for a patient with extensive metastatic lung cancer is likely inappropriate. On the other hand, short-term ventilator assistance for an elderly unconscious person recovering from an automobile accident may result in many additional years of enjoyable and productive life. Patients need to understand that all grave clinical situations are not equal and that their advance directives should be flexible enough to cover a variety of circumstances.

It has been well established that most patients and families have selective hearing and understanding. Even when the details of a major operation with a greater likelihood of a negative rather than a positive outcome are carefully and clearly presented using lay language, the potential positive outcomes frequently push the more probable adverse consequences into hidden recesses of the brain. In my experience, the more desperate the situation, the more often it is that the possibility of an unsuccessful outcome will be masked or denied by patients or their family members. Even though in my practice I carefully explained the high probability of eventual recurrence when operating on patients with pancreatic cancer, many of them were surprised and some were even quite indignant when this disappointing consequence developed. In my opinion, the most effective means to avoid such misunderstandings is to always have the patient and/or family relate their comprehension of the just-completed conversation. It is then essential to re-emphasize the important details that they suppressed and pushed to the background from your initial explanation.

In these challenging end-of-life moments, what advice should we offer? One question that should almost never be asked of the patient or his/her representative is: “Would you like everything possible done?” Especially for a family member who may take on considerable guilt by answering in the negative, the response will nearly always be “yes” no matter how unlikely a successful outcome. Rather, I believe that recommending only reasonable options, including and possibly emphasizing the choice of comfort therapy alone despite the certainty of death, is our obligation. We should be cognizant of the fact that the decision made by the patient is often highly dependent on how the alternatives are presented by his/her doctor. After clearly presenting the therapeutic options and their likely consequences, it may be helpful to relate what you would do yourself for a loved one in the same circumstances.

As in many other aspects of our lives, a useful guidepost in these situations is the Golden Rule: “Do unto others as you would have done unto yourself.” Interestingly, most probably based on our intimate exposure to numerous unnecessarily complicated and uncomfortable deaths, there is evidence that we physicians choose to die differently than our patients. In a recent essay, Dr. Ken Murray presented data from the John Hopkins Precursors Study that suggested doctors are less likely than their patients to submit themselves to futile end-of-life care. (Murray K: Doctors really do die differently. Zocalopublicsquare.org; accessed March 29, 2015). The proof he presents is from a survey of graduates of Johns Hopkins School of Medicine between 1948 and 1964. It revealed that 65% of them had written their own advance directives in comparison to 20% for the public at large. In addition, only 10% of the graduates would opt for cardiopulmonary resuscitation if they were comatose, compared with 75% of the general population.

I suspect that most surgeons, desiring a dignified death for themselves, are not surprised by these statistics. Therefore, we owe it to our patients to be as compassionate and thoughtful in managing the last stage of their lives as we have traditionally been trained to do in earlier phases when cure was a realistic expectation.

Dr. Rikkers is Editor in Chief of ACS Surgery News.

*Recognizing the importance of end-of-life issues in a surgeon’s education, in 2012 ACS Surgery News initiated a series of articles on various aspects of palliative care.

In his most recent bestseller, Being Mortal, Dr. Atul Gawande has again raised social awareness of the inadequacies of our health care system in assisting patients with end-of-life decisions and care. In his treatise, he laments his own lack of training in medical school and residency regarding what he has emphasized should be a key component of any physician’s education.

To some degree, there has been a greater emphasis on palliative care training in our medical schools since Dr. Gawande graduated two decades or so ago. The subject of physician-patient communication, including those difficult discussions that should occur near the end of life, is now incorporated into most medical school curricula. Additionally, palliative care has become a respected and growing subspecialty within both medicine and surgery.* Despite these improvements, still far too many patients die while receiving futile end-of-life care in our nation’s intensive care units and hospital wards rather than in the comfort of their homes surrounded by loved ones. Although referrals have increased, too few patients are afforded the opportunity to utilize hospice care and, those that do, are often referred too late in the course of their terminal disease to obtain full benefit

Why are we not doing better? Two likely contributors include a physician mindset that only cure is success and death represents failure, and unrealistic expectations of patients as to what modern medicine can accomplish. A more fixable and probably more important factor is the failure of doctors to effectively communicate during these highly stressful circumstances. As emphasized by Gawande and from my own experience, the key to negotiating a sensible path in hopeless, end-of-life situations is frequent, reasonable, and realistic consultation with our patients.

Not only are the conversations usually difficult and demanding, but the choices of whether to pursue treatment or remove life-sustaining efforts are frequently not well-defined. While these challenging clinical scenarios are often painted as black and white in the lay press, any physician or surgeon who has cared for such patients realizes that there is a delicate and precarious balance between providing hope, administering appropriate aggressive treatment, and ensuring patient comfort. In a well-intentioned attempt to leave some remnant of hope, we physicians too frequently paint an unrealistic picture for our patients.

Advance patient directives have been promoted as one means for patients to avoid futile, uncomfortable, and unnecessary care during the last stage of their lives. Though I by no means wish to discourage these often useful legal documents, they should not be entered into naively. For example, aggressive life-sustaining care for a patient with extensive metastatic lung cancer is likely inappropriate. On the other hand, short-term ventilator assistance for an elderly unconscious person recovering from an automobile accident may result in many additional years of enjoyable and productive life. Patients need to understand that all grave clinical situations are not equal and that their advance directives should be flexible enough to cover a variety of circumstances.

It has been well established that most patients and families have selective hearing and understanding. Even when the details of a major operation with a greater likelihood of a negative rather than a positive outcome are carefully and clearly presented using lay language, the potential positive outcomes frequently push the more probable adverse consequences into hidden recesses of the brain. In my experience, the more desperate the situation, the more often it is that the possibility of an unsuccessful outcome will be masked or denied by patients or their family members. Even though in my practice I carefully explained the high probability of eventual recurrence when operating on patients with pancreatic cancer, many of them were surprised and some were even quite indignant when this disappointing consequence developed. In my opinion, the most effective means to avoid such misunderstandings is to always have the patient and/or family relate their comprehension of the just-completed conversation. It is then essential to re-emphasize the important details that they suppressed and pushed to the background from your initial explanation.

In these challenging end-of-life moments, what advice should we offer? One question that should almost never be asked of the patient or his/her representative is: “Would you like everything possible done?” Especially for a family member who may take on considerable guilt by answering in the negative, the response will nearly always be “yes” no matter how unlikely a successful outcome. Rather, I believe that recommending only reasonable options, including and possibly emphasizing the choice of comfort therapy alone despite the certainty of death, is our obligation. We should be cognizant of the fact that the decision made by the patient is often highly dependent on how the alternatives are presented by his/her doctor. After clearly presenting the therapeutic options and their likely consequences, it may be helpful to relate what you would do yourself for a loved one in the same circumstances.

As in many other aspects of our lives, a useful guidepost in these situations is the Golden Rule: “Do unto others as you would have done unto yourself.” Interestingly, most probably based on our intimate exposure to numerous unnecessarily complicated and uncomfortable deaths, there is evidence that we physicians choose to die differently than our patients. In a recent essay, Dr. Ken Murray presented data from the John Hopkins Precursors Study that suggested doctors are less likely than their patients to submit themselves to futile end-of-life care. (Murray K: Doctors really do die differently. Zocalopublicsquare.org; accessed March 29, 2015). The proof he presents is from a survey of graduates of Johns Hopkins School of Medicine between 1948 and 1964. It revealed that 65% of them had written their own advance directives in comparison to 20% for the public at large. In addition, only 10% of the graduates would opt for cardiopulmonary resuscitation if they were comatose, compared with 75% of the general population.

I suspect that most surgeons, desiring a dignified death for themselves, are not surprised by these statistics. Therefore, we owe it to our patients to be as compassionate and thoughtful in managing the last stage of their lives as we have traditionally been trained to do in earlier phases when cure was a realistic expectation.

Dr. Rikkers is Editor in Chief of ACS Surgery News.

*Recognizing the importance of end-of-life issues in a surgeon’s education, in 2012 ACS Surgery News initiated a series of articles on various aspects of palliative care.