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American College of Surgeons (ACS): Annual Clinical Congress
Long-term data show laparoscopic Roux-en-Y still safer, cheaper than open
WASHINGTON – Fifteen years after having a Roux-en-Y gastric bypass, patients who had laparoscopic surgery were more likely to still be alive, without long-term complications and with a much smaller surgery-related medical bill than those who had open surgery.
Laparoscopic surgery conferred a 44% decrease in the chance of death from any cause, and a 20% decrease in the risk of having a long-term complication related to bariatric surgery, Dr. Anna Weiss reported at the annual clinical congress of the American College of Surgeons.
Her population-based study of 135,000 patients is one of the largest and longest of its kind, allowing it to pick up long-term outcomes trends that have not been detailed before, said Dr. Weiss of the University of California, San Diego.
The study used data from the California Office of Statewide Health Planning and Development. The database assigns every patient a unique identification number and tracks every hospital admission for that patient. Dr. Weiss looked at health outcomes for patients who underwent an open or laparoscopic Roux-en-Y gastric bypass anytime from 1995 to 2009.
The study’s primary outcome was all-cause mortality. Secondary outcomes included the incidence of gallbladder disease, cholecystectomy, marginal ulcer, and reoperation. It also examined the cost of the index surgery and subsequent costs related to the surgery.
She found a significant, time-bound association with the frequency of laparoscopic bypass. In 1995, less than 5% of the procedures were performed laparoscopically. By 2000, that had risen to about 20%. Thereafter, the frequency rose sharply. By 2009, just over 90% of Roux-en-Y procedures were minimally invasive.
About 80% of the patients were women; about 72% were white. They ranged widely in age, with more than 2,000 being 80 years or older at the time of surgery. But, Dr. Weiss said, the majority, about 70%, were aged 30-60 years.
Comorbidities were common and included prior gallbladder disease (20%), hypertension (51%), hyperlipidemia (31%), and diabetes (28%).
Most patients (67%) stayed in the hospital no more than 3 days. However, significantly more patients with laparoscopic surgery had these short stays (90% vs. 44% of the open-surgery group). Significantly more patients in the open-surgery group stayed 4-6 days (33% vs. 8%) and 7 or more days (22% vs. 2%).
Most of the patients had private insurance (80%). Medicare insured 10% and Medi-Cal, 6%. The remainder were self-pay. Significantly more laparoscopic procedures were performed at Centers of Excellence (76% vs. 59% of open procedures).
Overall, the rates of marginal ulcer and reoperations were low (1% each). However, Dr. Weiss noted, other outcomes were much more common, including gallbladder complications (22%) and cholecystectomies (13%). Long-term complications were significantly more common in the open group (10% vs. less than 5%).
By the end of the follow-up period, overall all-cause mortality was 11%. It was significantly less in the laparoscopic group than in the open group (about 5% vs. 20%).
Laparoscopic surgery carried a significantly smaller price tag than open surgery. The mean cost of the index operation was $56,170 for laparoscopic surgery, compared with a mean of $87,026 for open surgery. Over the entire follow-up period, patients who had open surgery racked up about $31,000 more in costs related directly to the procedure. However, Dr. Weiss noted, the standard deviation of lifetime costs ranged from $208,153 for an open procedure vs. $84,299 for a laparoscopic procedure.
Despite these differences, publicly insured patients were much more likely to have had open surgery. Patients with Medicare were significantly more likely to have an open than a laparoscopic procedure (15% vs. 6%), as were patients with Medi-Cal (7% vs. 4%). Patients with private insurance were significantly more likely to have laparoscopic surgery (86% vs. 74%).
In a multivariate analysis, several factors were significantly associated with outcome. Female gender reduced the risk of death by more than 30%. Younger age also portended better outcomes. Compared with patients in their 20s, those in their 50s were three times as likely to have died; those in their 60s, six times as likely, and those in their 70s, almost nine times as likely. The few patients who had surgery in their 80s were 10 times as likely to die as the youngest. However, several commentators pointed out during discussion that age-related all-cause mortality is not a surprising finding in a longitudinal study.
Insurance was also significantly related to outcome. Dr. Weiss used the self-pay group as her reference group. Compared with these patients, Medicare and Medi-Cal patients were twice as likely to have died by the study’s end. "Interestingly, they were no more likely to have long-term complications. However, when they did, these were more serious complications, possibly indicating that overall those with public insurance could have been a sicker group" at baseline.
Longer length of stay was also a significant predictor of mortality, with patients staying a week or longer five times more likely to have died by the end of follow-up than the reference group of those staying 4-6 days. "Interestingly, we also found that patients who stayed 3 days or less were 73% more likely to have died." This probably represented patients who had serious perioperative complications, she suggested.
Having either surgery at a Center of Excellence reduced the risk of mortality by 25%, she added.
Dr. Weiss had no financial disclosures.
WASHINGTON – Fifteen years after having a Roux-en-Y gastric bypass, patients who had laparoscopic surgery were more likely to still be alive, without long-term complications and with a much smaller surgery-related medical bill than those who had open surgery.
Laparoscopic surgery conferred a 44% decrease in the chance of death from any cause, and a 20% decrease in the risk of having a long-term complication related to bariatric surgery, Dr. Anna Weiss reported at the annual clinical congress of the American College of Surgeons.
Her population-based study of 135,000 patients is one of the largest and longest of its kind, allowing it to pick up long-term outcomes trends that have not been detailed before, said Dr. Weiss of the University of California, San Diego.
The study used data from the California Office of Statewide Health Planning and Development. The database assigns every patient a unique identification number and tracks every hospital admission for that patient. Dr. Weiss looked at health outcomes for patients who underwent an open or laparoscopic Roux-en-Y gastric bypass anytime from 1995 to 2009.
The study’s primary outcome was all-cause mortality. Secondary outcomes included the incidence of gallbladder disease, cholecystectomy, marginal ulcer, and reoperation. It also examined the cost of the index surgery and subsequent costs related to the surgery.
She found a significant, time-bound association with the frequency of laparoscopic bypass. In 1995, less than 5% of the procedures were performed laparoscopically. By 2000, that had risen to about 20%. Thereafter, the frequency rose sharply. By 2009, just over 90% of Roux-en-Y procedures were minimally invasive.
About 80% of the patients were women; about 72% were white. They ranged widely in age, with more than 2,000 being 80 years or older at the time of surgery. But, Dr. Weiss said, the majority, about 70%, were aged 30-60 years.
Comorbidities were common and included prior gallbladder disease (20%), hypertension (51%), hyperlipidemia (31%), and diabetes (28%).
Most patients (67%) stayed in the hospital no more than 3 days. However, significantly more patients with laparoscopic surgery had these short stays (90% vs. 44% of the open-surgery group). Significantly more patients in the open-surgery group stayed 4-6 days (33% vs. 8%) and 7 or more days (22% vs. 2%).
Most of the patients had private insurance (80%). Medicare insured 10% and Medi-Cal, 6%. The remainder were self-pay. Significantly more laparoscopic procedures were performed at Centers of Excellence (76% vs. 59% of open procedures).
Overall, the rates of marginal ulcer and reoperations were low (1% each). However, Dr. Weiss noted, other outcomes were much more common, including gallbladder complications (22%) and cholecystectomies (13%). Long-term complications were significantly more common in the open group (10% vs. less than 5%).
By the end of the follow-up period, overall all-cause mortality was 11%. It was significantly less in the laparoscopic group than in the open group (about 5% vs. 20%).
Laparoscopic surgery carried a significantly smaller price tag than open surgery. The mean cost of the index operation was $56,170 for laparoscopic surgery, compared with a mean of $87,026 for open surgery. Over the entire follow-up period, patients who had open surgery racked up about $31,000 more in costs related directly to the procedure. However, Dr. Weiss noted, the standard deviation of lifetime costs ranged from $208,153 for an open procedure vs. $84,299 for a laparoscopic procedure.
Despite these differences, publicly insured patients were much more likely to have had open surgery. Patients with Medicare were significantly more likely to have an open than a laparoscopic procedure (15% vs. 6%), as were patients with Medi-Cal (7% vs. 4%). Patients with private insurance were significantly more likely to have laparoscopic surgery (86% vs. 74%).
In a multivariate analysis, several factors were significantly associated with outcome. Female gender reduced the risk of death by more than 30%. Younger age also portended better outcomes. Compared with patients in their 20s, those in their 50s were three times as likely to have died; those in their 60s, six times as likely, and those in their 70s, almost nine times as likely. The few patients who had surgery in their 80s were 10 times as likely to die as the youngest. However, several commentators pointed out during discussion that age-related all-cause mortality is not a surprising finding in a longitudinal study.
Insurance was also significantly related to outcome. Dr. Weiss used the self-pay group as her reference group. Compared with these patients, Medicare and Medi-Cal patients were twice as likely to have died by the study’s end. "Interestingly, they were no more likely to have long-term complications. However, when they did, these were more serious complications, possibly indicating that overall those with public insurance could have been a sicker group" at baseline.
Longer length of stay was also a significant predictor of mortality, with patients staying a week or longer five times more likely to have died by the end of follow-up than the reference group of those staying 4-6 days. "Interestingly, we also found that patients who stayed 3 days or less were 73% more likely to have died." This probably represented patients who had serious perioperative complications, she suggested.
Having either surgery at a Center of Excellence reduced the risk of mortality by 25%, she added.
Dr. Weiss had no financial disclosures.
WASHINGTON – Fifteen years after having a Roux-en-Y gastric bypass, patients who had laparoscopic surgery were more likely to still be alive, without long-term complications and with a much smaller surgery-related medical bill than those who had open surgery.
Laparoscopic surgery conferred a 44% decrease in the chance of death from any cause, and a 20% decrease in the risk of having a long-term complication related to bariatric surgery, Dr. Anna Weiss reported at the annual clinical congress of the American College of Surgeons.
Her population-based study of 135,000 patients is one of the largest and longest of its kind, allowing it to pick up long-term outcomes trends that have not been detailed before, said Dr. Weiss of the University of California, San Diego.
The study used data from the California Office of Statewide Health Planning and Development. The database assigns every patient a unique identification number and tracks every hospital admission for that patient. Dr. Weiss looked at health outcomes for patients who underwent an open or laparoscopic Roux-en-Y gastric bypass anytime from 1995 to 2009.
The study’s primary outcome was all-cause mortality. Secondary outcomes included the incidence of gallbladder disease, cholecystectomy, marginal ulcer, and reoperation. It also examined the cost of the index surgery and subsequent costs related to the surgery.
She found a significant, time-bound association with the frequency of laparoscopic bypass. In 1995, less than 5% of the procedures were performed laparoscopically. By 2000, that had risen to about 20%. Thereafter, the frequency rose sharply. By 2009, just over 90% of Roux-en-Y procedures were minimally invasive.
About 80% of the patients were women; about 72% were white. They ranged widely in age, with more than 2,000 being 80 years or older at the time of surgery. But, Dr. Weiss said, the majority, about 70%, were aged 30-60 years.
Comorbidities were common and included prior gallbladder disease (20%), hypertension (51%), hyperlipidemia (31%), and diabetes (28%).
Most patients (67%) stayed in the hospital no more than 3 days. However, significantly more patients with laparoscopic surgery had these short stays (90% vs. 44% of the open-surgery group). Significantly more patients in the open-surgery group stayed 4-6 days (33% vs. 8%) and 7 or more days (22% vs. 2%).
Most of the patients had private insurance (80%). Medicare insured 10% and Medi-Cal, 6%. The remainder were self-pay. Significantly more laparoscopic procedures were performed at Centers of Excellence (76% vs. 59% of open procedures).
Overall, the rates of marginal ulcer and reoperations were low (1% each). However, Dr. Weiss noted, other outcomes were much more common, including gallbladder complications (22%) and cholecystectomies (13%). Long-term complications were significantly more common in the open group (10% vs. less than 5%).
By the end of the follow-up period, overall all-cause mortality was 11%. It was significantly less in the laparoscopic group than in the open group (about 5% vs. 20%).
Laparoscopic surgery carried a significantly smaller price tag than open surgery. The mean cost of the index operation was $56,170 for laparoscopic surgery, compared with a mean of $87,026 for open surgery. Over the entire follow-up period, patients who had open surgery racked up about $31,000 more in costs related directly to the procedure. However, Dr. Weiss noted, the standard deviation of lifetime costs ranged from $208,153 for an open procedure vs. $84,299 for a laparoscopic procedure.
Despite these differences, publicly insured patients were much more likely to have had open surgery. Patients with Medicare were significantly more likely to have an open than a laparoscopic procedure (15% vs. 6%), as were patients with Medi-Cal (7% vs. 4%). Patients with private insurance were significantly more likely to have laparoscopic surgery (86% vs. 74%).
In a multivariate analysis, several factors were significantly associated with outcome. Female gender reduced the risk of death by more than 30%. Younger age also portended better outcomes. Compared with patients in their 20s, those in their 50s were three times as likely to have died; those in their 60s, six times as likely, and those in their 70s, almost nine times as likely. The few patients who had surgery in their 80s were 10 times as likely to die as the youngest. However, several commentators pointed out during discussion that age-related all-cause mortality is not a surprising finding in a longitudinal study.
Insurance was also significantly related to outcome. Dr. Weiss used the self-pay group as her reference group. Compared with these patients, Medicare and Medi-Cal patients were twice as likely to have died by the study’s end. "Interestingly, they were no more likely to have long-term complications. However, when they did, these were more serious complications, possibly indicating that overall those with public insurance could have been a sicker group" at baseline.
Longer length of stay was also a significant predictor of mortality, with patients staying a week or longer five times more likely to have died by the end of follow-up than the reference group of those staying 4-6 days. "Interestingly, we also found that patients who stayed 3 days or less were 73% more likely to have died." This probably represented patients who had serious perioperative complications, she suggested.
Having either surgery at a Center of Excellence reduced the risk of mortality by 25%, she added.
Dr. Weiss had no financial disclosures.
AT THE ACS CLINICAL CONGRESS
Major finding: After up to 15 years of follow-up, patients who had laparoscopic gastric bypass were 44% less likely to have died and 20% less likely to have a long-term surgical complication than patients who had an open procedure.
Data source: The longitudinal study comprised data on 135,000 patients treated from 1995 to 2009.
Disclosures: Dr. Weiss had no financial disclosures.
Surgeons appeal for change to emergency response protocols
WASHINGTON – A first step to limiting loss of life in mass shooting events is to train law enforcement officers to manage hemorrhaging and ultimately to extend that training to all citizens, a collaborative panel of medical, military, and law enforcement leaders has concluded.
Communities must insist that hemostatic control become a core law-enforcement skill. Rapid hemostatic control has now been shown in several analyses to be critical to the survival of mass-shooting victims, panel members said at the annual clinical congress of the American College of Surgeons.
"Tourniquets don’t belong on an ambulance. They belong in a policeman’s pocket," said Dr. Norman E. McSwain, a panel member and medical director of PreHospital Trauma Life Support, New Orleans.
"If you give these [law-enforcement] officers the training and the equipment, they will absolutely utilize it and you will see an immediate return on your investment. They will make you proud," added Dr. Alexander Eastman, another panel member who also is interim chief of trauma at Parkland Memorial Hospital in Dallas and a lieutenant on the Dallas Police Department SWAT team.
The recommendation discussed by panelists at the meeting is just one from a collaborative committee that included, among others, high-level representatives from the Department of Defense (DOD), the Federal Bureau of Investigation (FBI), and the Federal Emergency Management Agency (FEMA).
According to Dr. Lenworth M. Jacobs, trauma director and chief academic officer for Hartford (Conn.) Hospital, the committee grew out of the "profound effect" he experienced in reviewing the autopsies of the 26 Sandy Hook Elementary School shooting victims in Newtown. The number of dead was over three times greater than the number of injured victims in that attack and the medical examiner on the case asked Dr. Jacobs to help determine why the survival rate was so low.
Dr. Jacobs, a regent with the American College of Surgeons (ACS), approached the ACS Board of Regents about an initiative to develop community responses to mass shootings, because he felt "something good had to come out of" that tragic event. In response, the board tasked Dr. Jacobs and Dr. Michael Rotondo, who chairs the ACS committee on trauma, with forming a consortium of leaders to help communities better prepare for the worst in an era when civilians have access to military-grade weaponry and explosive devices.
The committee met in Hartford in April 2013 and drafted the Hartford Consensus, based on the group’s shared belief that community leaders should approach mass-casualty events like the combat situations they closely resemble. "We need to shift the paradigm and draw from the military to improve survivability in the field," said Dr. David Stuart Wade, chief medical officer for the FBI.
The committee turned to the DOD’s protocols for Tactical Combat Casualty Care. Predicated on a tightly integrated response to an attack, including the "buddy system" of attending to a fellow soldier’s wounds, the protocols were found to have helped reduce the incidence of preventable deaths from extremity hemorrhage to just 2.6% over the course of a decade (J. Trauma Acute Care Surg. 2012;73:S431-7).
In a subsequent interview, Dr. McSwain cited another study (J. Emerg. Med. 2011;41:590-7) that influenced the committee, showing that greater survival rates in 499 soldiers wounded in battle were associated with the prehospital application of tourniquets (89% vs. 78% hospital), particularly when applied before the onset of shock (96% vs. 4% after).
The group also created the THREAT response model for civilian agencies, taking the three current discrete stages of mass casualty–event response in America – threat suppression, medical assessment, and transport – and overlapping them so that definitive care starts immediately to minimize casualties. THREAT stands for Threat suppression, Hemorrhage control, Rapid Evacuation, Assess patient, Transport to trauma center.
Referring to how law enforcement, emergency medical personnel, and other municipal agencies currently are segmented, with each agency acting according to its own objectives, command structures, and vocabularies, Dr. Eastman said that the THREAT model "is 100% a new paradigm" that can make all municipal disaster responses, regardless of the nature of the tragedy, more efficient. "The Hartford Consensus is designed to make these groups, that previously might not have worked well together, become more integrated than ever," he said.
The committee met again in July to draft the Hartford Consensus II, a call to action for local communities across the country to adapt the THREAT model to their current mass casualty–event response plans or to develop a TREAT-based plan if they don’t have one already. "Failing to plan is planning to fail," Dr. Rotondo said during the panel presentation, of which he was the comoderator. "Think the unthinkable and begin to think how you would respond," he said, advising the audience to "practice what you’ve planned. Go deep into your resources."
The Hartford Consensus II also recommends that tourniquets and other medical equipment be prepositioned in appropriate public locations, similar to how automatic external defibrillators are, and that the public be taught how to use them.
In response to questions about training the public, including school teachers, how to protect themselves and others from an active shooter, Dr. Jacobs responded that the best thing to do is to "run, hide, fight." He stated that the time necessary to hide was typically only 15 minutes before the situation is under control.
"I can tell you that a military-grade bullet, shot at point-blank range into anybody, but especially little people, is devastating," Dr. Jacobs said. The weapon used in the Sandy Hook shooting was a military-style semiautomatic Bushmaster .223 rifle. "While you don’t really want to take on an AK-47 or a Bushmaster," Dr. Jacobs said that if it were necessary to confront the shooter, "be as aggressive as possible."
Surgeons can play a part in ensuring the Hartford Consensus is adopted nationally, said Dr. Wade, by becoming "energized" and meeting with their respective local authorities to discuss ways to protect their communities.
"Be a good citizen," Dr. Rotondo told the audience, suggesting they communicate with other hospitals in their hometowns and develop strong relationships with their local leaders to help prepare for such a disaster. He also mentioned that the ACS committee on trauma is available to the surgical community to help activate change.
The committee’s next step, said Dr. Jacobs, is to work with the entertainment industry to start incorporating the THREAT model into movies and television shows so that a measured response to the type of violence that has become a fact of American life can be modeled for the citizenry.
WASHINGTON – A first step to limiting loss of life in mass shooting events is to train law enforcement officers to manage hemorrhaging and ultimately to extend that training to all citizens, a collaborative panel of medical, military, and law enforcement leaders has concluded.
Communities must insist that hemostatic control become a core law-enforcement skill. Rapid hemostatic control has now been shown in several analyses to be critical to the survival of mass-shooting victims, panel members said at the annual clinical congress of the American College of Surgeons.
"Tourniquets don’t belong on an ambulance. They belong in a policeman’s pocket," said Dr. Norman E. McSwain, a panel member and medical director of PreHospital Trauma Life Support, New Orleans.
"If you give these [law-enforcement] officers the training and the equipment, they will absolutely utilize it and you will see an immediate return on your investment. They will make you proud," added Dr. Alexander Eastman, another panel member who also is interim chief of trauma at Parkland Memorial Hospital in Dallas and a lieutenant on the Dallas Police Department SWAT team.
The recommendation discussed by panelists at the meeting is just one from a collaborative committee that included, among others, high-level representatives from the Department of Defense (DOD), the Federal Bureau of Investigation (FBI), and the Federal Emergency Management Agency (FEMA).
According to Dr. Lenworth M. Jacobs, trauma director and chief academic officer for Hartford (Conn.) Hospital, the committee grew out of the "profound effect" he experienced in reviewing the autopsies of the 26 Sandy Hook Elementary School shooting victims in Newtown. The number of dead was over three times greater than the number of injured victims in that attack and the medical examiner on the case asked Dr. Jacobs to help determine why the survival rate was so low.
Dr. Jacobs, a regent with the American College of Surgeons (ACS), approached the ACS Board of Regents about an initiative to develop community responses to mass shootings, because he felt "something good had to come out of" that tragic event. In response, the board tasked Dr. Jacobs and Dr. Michael Rotondo, who chairs the ACS committee on trauma, with forming a consortium of leaders to help communities better prepare for the worst in an era when civilians have access to military-grade weaponry and explosive devices.
The committee met in Hartford in April 2013 and drafted the Hartford Consensus, based on the group’s shared belief that community leaders should approach mass-casualty events like the combat situations they closely resemble. "We need to shift the paradigm and draw from the military to improve survivability in the field," said Dr. David Stuart Wade, chief medical officer for the FBI.
The committee turned to the DOD’s protocols for Tactical Combat Casualty Care. Predicated on a tightly integrated response to an attack, including the "buddy system" of attending to a fellow soldier’s wounds, the protocols were found to have helped reduce the incidence of preventable deaths from extremity hemorrhage to just 2.6% over the course of a decade (J. Trauma Acute Care Surg. 2012;73:S431-7).
In a subsequent interview, Dr. McSwain cited another study (J. Emerg. Med. 2011;41:590-7) that influenced the committee, showing that greater survival rates in 499 soldiers wounded in battle were associated with the prehospital application of tourniquets (89% vs. 78% hospital), particularly when applied before the onset of shock (96% vs. 4% after).
The group also created the THREAT response model for civilian agencies, taking the three current discrete stages of mass casualty–event response in America – threat suppression, medical assessment, and transport – and overlapping them so that definitive care starts immediately to minimize casualties. THREAT stands for Threat suppression, Hemorrhage control, Rapid Evacuation, Assess patient, Transport to trauma center.
Referring to how law enforcement, emergency medical personnel, and other municipal agencies currently are segmented, with each agency acting according to its own objectives, command structures, and vocabularies, Dr. Eastman said that the THREAT model "is 100% a new paradigm" that can make all municipal disaster responses, regardless of the nature of the tragedy, more efficient. "The Hartford Consensus is designed to make these groups, that previously might not have worked well together, become more integrated than ever," he said.
The committee met again in July to draft the Hartford Consensus II, a call to action for local communities across the country to adapt the THREAT model to their current mass casualty–event response plans or to develop a TREAT-based plan if they don’t have one already. "Failing to plan is planning to fail," Dr. Rotondo said during the panel presentation, of which he was the comoderator. "Think the unthinkable and begin to think how you would respond," he said, advising the audience to "practice what you’ve planned. Go deep into your resources."
The Hartford Consensus II also recommends that tourniquets and other medical equipment be prepositioned in appropriate public locations, similar to how automatic external defibrillators are, and that the public be taught how to use them.
In response to questions about training the public, including school teachers, how to protect themselves and others from an active shooter, Dr. Jacobs responded that the best thing to do is to "run, hide, fight." He stated that the time necessary to hide was typically only 15 minutes before the situation is under control.
"I can tell you that a military-grade bullet, shot at point-blank range into anybody, but especially little people, is devastating," Dr. Jacobs said. The weapon used in the Sandy Hook shooting was a military-style semiautomatic Bushmaster .223 rifle. "While you don’t really want to take on an AK-47 or a Bushmaster," Dr. Jacobs said that if it were necessary to confront the shooter, "be as aggressive as possible."
Surgeons can play a part in ensuring the Hartford Consensus is adopted nationally, said Dr. Wade, by becoming "energized" and meeting with their respective local authorities to discuss ways to protect their communities.
"Be a good citizen," Dr. Rotondo told the audience, suggesting they communicate with other hospitals in their hometowns and develop strong relationships with their local leaders to help prepare for such a disaster. He also mentioned that the ACS committee on trauma is available to the surgical community to help activate change.
The committee’s next step, said Dr. Jacobs, is to work with the entertainment industry to start incorporating the THREAT model into movies and television shows so that a measured response to the type of violence that has become a fact of American life can be modeled for the citizenry.
WASHINGTON – A first step to limiting loss of life in mass shooting events is to train law enforcement officers to manage hemorrhaging and ultimately to extend that training to all citizens, a collaborative panel of medical, military, and law enforcement leaders has concluded.
Communities must insist that hemostatic control become a core law-enforcement skill. Rapid hemostatic control has now been shown in several analyses to be critical to the survival of mass-shooting victims, panel members said at the annual clinical congress of the American College of Surgeons.
"Tourniquets don’t belong on an ambulance. They belong in a policeman’s pocket," said Dr. Norman E. McSwain, a panel member and medical director of PreHospital Trauma Life Support, New Orleans.
"If you give these [law-enforcement] officers the training and the equipment, they will absolutely utilize it and you will see an immediate return on your investment. They will make you proud," added Dr. Alexander Eastman, another panel member who also is interim chief of trauma at Parkland Memorial Hospital in Dallas and a lieutenant on the Dallas Police Department SWAT team.
The recommendation discussed by panelists at the meeting is just one from a collaborative committee that included, among others, high-level representatives from the Department of Defense (DOD), the Federal Bureau of Investigation (FBI), and the Federal Emergency Management Agency (FEMA).
According to Dr. Lenworth M. Jacobs, trauma director and chief academic officer for Hartford (Conn.) Hospital, the committee grew out of the "profound effect" he experienced in reviewing the autopsies of the 26 Sandy Hook Elementary School shooting victims in Newtown. The number of dead was over three times greater than the number of injured victims in that attack and the medical examiner on the case asked Dr. Jacobs to help determine why the survival rate was so low.
Dr. Jacobs, a regent with the American College of Surgeons (ACS), approached the ACS Board of Regents about an initiative to develop community responses to mass shootings, because he felt "something good had to come out of" that tragic event. In response, the board tasked Dr. Jacobs and Dr. Michael Rotondo, who chairs the ACS committee on trauma, with forming a consortium of leaders to help communities better prepare for the worst in an era when civilians have access to military-grade weaponry and explosive devices.
The committee met in Hartford in April 2013 and drafted the Hartford Consensus, based on the group’s shared belief that community leaders should approach mass-casualty events like the combat situations they closely resemble. "We need to shift the paradigm and draw from the military to improve survivability in the field," said Dr. David Stuart Wade, chief medical officer for the FBI.
The committee turned to the DOD’s protocols for Tactical Combat Casualty Care. Predicated on a tightly integrated response to an attack, including the "buddy system" of attending to a fellow soldier’s wounds, the protocols were found to have helped reduce the incidence of preventable deaths from extremity hemorrhage to just 2.6% over the course of a decade (J. Trauma Acute Care Surg. 2012;73:S431-7).
In a subsequent interview, Dr. McSwain cited another study (J. Emerg. Med. 2011;41:590-7) that influenced the committee, showing that greater survival rates in 499 soldiers wounded in battle were associated with the prehospital application of tourniquets (89% vs. 78% hospital), particularly when applied before the onset of shock (96% vs. 4% after).
The group also created the THREAT response model for civilian agencies, taking the three current discrete stages of mass casualty–event response in America – threat suppression, medical assessment, and transport – and overlapping them so that definitive care starts immediately to minimize casualties. THREAT stands for Threat suppression, Hemorrhage control, Rapid Evacuation, Assess patient, Transport to trauma center.
Referring to how law enforcement, emergency medical personnel, and other municipal agencies currently are segmented, with each agency acting according to its own objectives, command structures, and vocabularies, Dr. Eastman said that the THREAT model "is 100% a new paradigm" that can make all municipal disaster responses, regardless of the nature of the tragedy, more efficient. "The Hartford Consensus is designed to make these groups, that previously might not have worked well together, become more integrated than ever," he said.
The committee met again in July to draft the Hartford Consensus II, a call to action for local communities across the country to adapt the THREAT model to their current mass casualty–event response plans or to develop a TREAT-based plan if they don’t have one already. "Failing to plan is planning to fail," Dr. Rotondo said during the panel presentation, of which he was the comoderator. "Think the unthinkable and begin to think how you would respond," he said, advising the audience to "practice what you’ve planned. Go deep into your resources."
The Hartford Consensus II also recommends that tourniquets and other medical equipment be prepositioned in appropriate public locations, similar to how automatic external defibrillators are, and that the public be taught how to use them.
In response to questions about training the public, including school teachers, how to protect themselves and others from an active shooter, Dr. Jacobs responded that the best thing to do is to "run, hide, fight." He stated that the time necessary to hide was typically only 15 minutes before the situation is under control.
"I can tell you that a military-grade bullet, shot at point-blank range into anybody, but especially little people, is devastating," Dr. Jacobs said. The weapon used in the Sandy Hook shooting was a military-style semiautomatic Bushmaster .223 rifle. "While you don’t really want to take on an AK-47 or a Bushmaster," Dr. Jacobs said that if it were necessary to confront the shooter, "be as aggressive as possible."
Surgeons can play a part in ensuring the Hartford Consensus is adopted nationally, said Dr. Wade, by becoming "energized" and meeting with their respective local authorities to discuss ways to protect their communities.
"Be a good citizen," Dr. Rotondo told the audience, suggesting they communicate with other hospitals in their hometowns and develop strong relationships with their local leaders to help prepare for such a disaster. He also mentioned that the ACS committee on trauma is available to the surgical community to help activate change.
The committee’s next step, said Dr. Jacobs, is to work with the entertainment industry to start incorporating the THREAT model into movies and television shows so that a measured response to the type of violence that has become a fact of American life can be modeled for the citizenry.
AT THE ACS CLINICAL CONGRESS
Major finding: The primary cause of death for mass casualty events is hemorrhaging.
Data source: The Hartford Consensus, published in the American College of Surgeons Bulletin.
Disclosures: The Joint Committee to Create a National Policy to Enhance Survivability from Mass-Casualty Shooting Events sponsored this study. The doctors did not disclose any other relevant disclosures.
Gastric bypass induces diabetes remission in obese patients
WASHINGTON – Gastric bypass surgery resulted in significantly more weight loss and also improved measures of glycemic control significantly more than did other forms of bariatric surgery, Dr. John Morton reported at the annual clinical congress of the American College of Surgeons.
However, he noted, while remission did correlate with weight loss in patients who had gastric banding or sleeving, it appeared to be independent of weight loss in those who had the bypass surgery. While he didn’t speculate on the reasons for this finding, he did affirm his belief that gastric bypass is the best option for most obese patients with comorbid diabetes.
"I feel very comfortable recommending it" for these patients, said Dr. Morton of the Stanford (Calif.) University. "There are, of course, other clinical conditions to consider when deciding [among] bypass, banding, and sleeve, but if the only consideration is around diabetes, I’m 100% comfortable in recommending it for obese diabetics."
He presented the 1-year follow-up data on 1,792 obese patients who underwent bariatric surgery. Of these, 1,364 had a Roux-en-Y bypass; 264 had a sleeve gastrectomy; and 164 had adjustable gastric banding.
The patients were a mean of about 46 years old. Body mass index was statistically, but not clinically, different between the groups (bypass 47 kg/m2; band 44 kg/m2; sleeve 44 kg/m2). Waist circumference ranged from 51 to 53 inches. About 75% of the group was female and more than half, white.
Overall, about one-third of each group had type 2 diabetes. Most were taking only oral medications. About 5% took only insulin, and about a quarter took both oral agents and insulin. At baseline, the mean HbA1c was more than 7% in each group. The mean fasting insulin was 36 microU/mL in the bypass group, 28 microU/mL in the band group, and 32 microU/mL in the sleeve group.
By 12 months after surgery, patients with diabetes who had bypass had lost the most weight – a mean of 71% of their excess body weight, compared with 38% in the banding group and 50% in the sleeve group.
Those who had the bypass surgery also experienced the biggest change in their HbA1c – dropping almost 16% to a mean of 5.8%. Patients in the other two groups experienced a mean drop of 10%, resulting in HbA1c levels of right around 6%.
Fasting insulin levels also improved significantly more in the bypass group, falling from a baseline mean of 56 microU/mL to 7.8 microU/mL – a decrease of 68%. In the band group, the level fell from 28 microU/mL to 12 microU/mL – a 52% decrease. In the sleeve group, levels fell from 32 microU/mL to 10 microU/mL – a 61% decrease.
"Fasting insulin is also considered an independent marker of cardiac risk," Dr. Morton added, indicating that the risk of cardiovascular problems would fall along with insulin levels.
Blood glucose improved significantly more in the bypass group, falling from a baseline mean of 149 mg/dL to 101 mg/dL – a 22% change. In the band group, the level fell from 140 mg/dL to 125 mg/dL (8%) and in the sleeve group, from 130 mg/dL to 118 mg/dL (5.6%).
A multivariate analysis controlled for surgery type, sex, body mass index, race, age, and insurance status. Of these factors, surgery type was the strongest predictor, with bypass patients three times more likely to achieve that goal than those undergoing banding or sleeve placement.
Dr. Morton did not present his complication data. However, during the discussion period, he said the three procedures were similarly safe. The gastric sleeve group had a higher leak rate than did the other groups, but that remained less than 1%. Readmission rates were comparable, he said, but he did not provide that number.
"Any time you consider this, it has to be a risk/benefit analysis," he said. "It’s our philosophy that for obese patients with severe diabetes, we approach them first with the bypass because it has the most proven track record over time."
Dr. Morton has up to 7 years of data on some of the patients, and said he is now analyzing that. But when questioned about durability, he agreed that diabetes can recur in the rather common scenario of a patient regaining weight. "At the end of the day, though, what’s important is that the obese patient with diabetes gets treatment. All three surgeries demonstrated some improvement, and I believe that any surgery is better than no surgery at all."
Dr. Morton has received research support from Covidien.
WASHINGTON – Gastric bypass surgery resulted in significantly more weight loss and also improved measures of glycemic control significantly more than did other forms of bariatric surgery, Dr. John Morton reported at the annual clinical congress of the American College of Surgeons.
However, he noted, while remission did correlate with weight loss in patients who had gastric banding or sleeving, it appeared to be independent of weight loss in those who had the bypass surgery. While he didn’t speculate on the reasons for this finding, he did affirm his belief that gastric bypass is the best option for most obese patients with comorbid diabetes.
"I feel very comfortable recommending it" for these patients, said Dr. Morton of the Stanford (Calif.) University. "There are, of course, other clinical conditions to consider when deciding [among] bypass, banding, and sleeve, but if the only consideration is around diabetes, I’m 100% comfortable in recommending it for obese diabetics."
He presented the 1-year follow-up data on 1,792 obese patients who underwent bariatric surgery. Of these, 1,364 had a Roux-en-Y bypass; 264 had a sleeve gastrectomy; and 164 had adjustable gastric banding.
The patients were a mean of about 46 years old. Body mass index was statistically, but not clinically, different between the groups (bypass 47 kg/m2; band 44 kg/m2; sleeve 44 kg/m2). Waist circumference ranged from 51 to 53 inches. About 75% of the group was female and more than half, white.
Overall, about one-third of each group had type 2 diabetes. Most were taking only oral medications. About 5% took only insulin, and about a quarter took both oral agents and insulin. At baseline, the mean HbA1c was more than 7% in each group. The mean fasting insulin was 36 microU/mL in the bypass group, 28 microU/mL in the band group, and 32 microU/mL in the sleeve group.
By 12 months after surgery, patients with diabetes who had bypass had lost the most weight – a mean of 71% of their excess body weight, compared with 38% in the banding group and 50% in the sleeve group.
Those who had the bypass surgery also experienced the biggest change in their HbA1c – dropping almost 16% to a mean of 5.8%. Patients in the other two groups experienced a mean drop of 10%, resulting in HbA1c levels of right around 6%.
Fasting insulin levels also improved significantly more in the bypass group, falling from a baseline mean of 56 microU/mL to 7.8 microU/mL – a decrease of 68%. In the band group, the level fell from 28 microU/mL to 12 microU/mL – a 52% decrease. In the sleeve group, levels fell from 32 microU/mL to 10 microU/mL – a 61% decrease.
"Fasting insulin is also considered an independent marker of cardiac risk," Dr. Morton added, indicating that the risk of cardiovascular problems would fall along with insulin levels.
Blood glucose improved significantly more in the bypass group, falling from a baseline mean of 149 mg/dL to 101 mg/dL – a 22% change. In the band group, the level fell from 140 mg/dL to 125 mg/dL (8%) and in the sleeve group, from 130 mg/dL to 118 mg/dL (5.6%).
A multivariate analysis controlled for surgery type, sex, body mass index, race, age, and insurance status. Of these factors, surgery type was the strongest predictor, with bypass patients three times more likely to achieve that goal than those undergoing banding or sleeve placement.
Dr. Morton did not present his complication data. However, during the discussion period, he said the three procedures were similarly safe. The gastric sleeve group had a higher leak rate than did the other groups, but that remained less than 1%. Readmission rates were comparable, he said, but he did not provide that number.
"Any time you consider this, it has to be a risk/benefit analysis," he said. "It’s our philosophy that for obese patients with severe diabetes, we approach them first with the bypass because it has the most proven track record over time."
Dr. Morton has up to 7 years of data on some of the patients, and said he is now analyzing that. But when questioned about durability, he agreed that diabetes can recur in the rather common scenario of a patient regaining weight. "At the end of the day, though, what’s important is that the obese patient with diabetes gets treatment. All three surgeries demonstrated some improvement, and I believe that any surgery is better than no surgery at all."
Dr. Morton has received research support from Covidien.
WASHINGTON – Gastric bypass surgery resulted in significantly more weight loss and also improved measures of glycemic control significantly more than did other forms of bariatric surgery, Dr. John Morton reported at the annual clinical congress of the American College of Surgeons.
However, he noted, while remission did correlate with weight loss in patients who had gastric banding or sleeving, it appeared to be independent of weight loss in those who had the bypass surgery. While he didn’t speculate on the reasons for this finding, he did affirm his belief that gastric bypass is the best option for most obese patients with comorbid diabetes.
"I feel very comfortable recommending it" for these patients, said Dr. Morton of the Stanford (Calif.) University. "There are, of course, other clinical conditions to consider when deciding [among] bypass, banding, and sleeve, but if the only consideration is around diabetes, I’m 100% comfortable in recommending it for obese diabetics."
He presented the 1-year follow-up data on 1,792 obese patients who underwent bariatric surgery. Of these, 1,364 had a Roux-en-Y bypass; 264 had a sleeve gastrectomy; and 164 had adjustable gastric banding.
The patients were a mean of about 46 years old. Body mass index was statistically, but not clinically, different between the groups (bypass 47 kg/m2; band 44 kg/m2; sleeve 44 kg/m2). Waist circumference ranged from 51 to 53 inches. About 75% of the group was female and more than half, white.
Overall, about one-third of each group had type 2 diabetes. Most were taking only oral medications. About 5% took only insulin, and about a quarter took both oral agents and insulin. At baseline, the mean HbA1c was more than 7% in each group. The mean fasting insulin was 36 microU/mL in the bypass group, 28 microU/mL in the band group, and 32 microU/mL in the sleeve group.
By 12 months after surgery, patients with diabetes who had bypass had lost the most weight – a mean of 71% of their excess body weight, compared with 38% in the banding group and 50% in the sleeve group.
Those who had the bypass surgery also experienced the biggest change in their HbA1c – dropping almost 16% to a mean of 5.8%. Patients in the other two groups experienced a mean drop of 10%, resulting in HbA1c levels of right around 6%.
Fasting insulin levels also improved significantly more in the bypass group, falling from a baseline mean of 56 microU/mL to 7.8 microU/mL – a decrease of 68%. In the band group, the level fell from 28 microU/mL to 12 microU/mL – a 52% decrease. In the sleeve group, levels fell from 32 microU/mL to 10 microU/mL – a 61% decrease.
"Fasting insulin is also considered an independent marker of cardiac risk," Dr. Morton added, indicating that the risk of cardiovascular problems would fall along with insulin levels.
Blood glucose improved significantly more in the bypass group, falling from a baseline mean of 149 mg/dL to 101 mg/dL – a 22% change. In the band group, the level fell from 140 mg/dL to 125 mg/dL (8%) and in the sleeve group, from 130 mg/dL to 118 mg/dL (5.6%).
A multivariate analysis controlled for surgery type, sex, body mass index, race, age, and insurance status. Of these factors, surgery type was the strongest predictor, with bypass patients three times more likely to achieve that goal than those undergoing banding or sleeve placement.
Dr. Morton did not present his complication data. However, during the discussion period, he said the three procedures were similarly safe. The gastric sleeve group had a higher leak rate than did the other groups, but that remained less than 1%. Readmission rates were comparable, he said, but he did not provide that number.
"Any time you consider this, it has to be a risk/benefit analysis," he said. "It’s our philosophy that for obese patients with severe diabetes, we approach them first with the bypass because it has the most proven track record over time."
Dr. Morton has up to 7 years of data on some of the patients, and said he is now analyzing that. But when questioned about durability, he agreed that diabetes can recur in the rather common scenario of a patient regaining weight. "At the end of the day, though, what’s important is that the obese patient with diabetes gets treatment. All three surgeries demonstrated some improvement, and I believe that any surgery is better than no surgery at all."
Dr. Morton has received research support from Covidien.
AT THE ACS CLINICAL CONGRESS
Major finding: Obese patients with diabetes lost significantly more weight and had significantly better glycemic control after gastric bypass than after gastric banding or sleeve gastrectomy.
Data source: The 1-year follow-up study contained data on 1,792 patients.
Disclosures: Dr. Morton has received research support from Covidien.
Surgeons call for change in mass casualty response
WASHINGTON – In the aftermath of the Sandy Hook Elementary School shootings, Dr. Lenworth Jacobs, a regent of the American College of Surgeons (ACS) and vice president of academic affairs at Hartford (Conn.) Hospital, was called to examine the autopsies of the victims. What he saw affected him so profoundly that he asked the ACS how surgeons might help communities to respond to such chaotic tragedies and minimize the enormous loss of life that occurs.
The resulting Hartford Consensus – a document created by members of the ACS, the FBI, and various law enforcement and military organizations that calls for a new paradigm in emergency response – was presented at the annual clinical congress of the American College of Surgeons.
WASHINGTON – In the aftermath of the Sandy Hook Elementary School shootings, Dr. Lenworth Jacobs, a regent of the American College of Surgeons (ACS) and vice president of academic affairs at Hartford (Conn.) Hospital, was called to examine the autopsies of the victims. What he saw affected him so profoundly that he asked the ACS how surgeons might help communities to respond to such chaotic tragedies and minimize the enormous loss of life that occurs.
The resulting Hartford Consensus – a document created by members of the ACS, the FBI, and various law enforcement and military organizations that calls for a new paradigm in emergency response – was presented at the annual clinical congress of the American College of Surgeons.
WASHINGTON – In the aftermath of the Sandy Hook Elementary School shootings, Dr. Lenworth Jacobs, a regent of the American College of Surgeons (ACS) and vice president of academic affairs at Hartford (Conn.) Hospital, was called to examine the autopsies of the victims. What he saw affected him so profoundly that he asked the ACS how surgeons might help communities to respond to such chaotic tragedies and minimize the enormous loss of life that occurs.
The resulting Hartford Consensus – a document created by members of the ACS, the FBI, and various law enforcement and military organizations that calls for a new paradigm in emergency response – was presented at the annual clinical congress of the American College of Surgeons.
AT THE ACS CLINICAL CONGRESS
VTE rate does not accurately measure quality of care
Postoperative venous thromboembolism rates may not be an effective way of measuring hospital quality, according to Dr. Karl Y. Bilimoria and his colleagues.
The investigators calculated patient-level rates of venous thromboembolism as well as rates of imaging for VTE using data from the American Hospital Association and Medicare Compare from 2009-2010 from nearly 1 million patients discharged from 2,786 hospitals after a major surgery.
They sought to determine the association between hospital adherence to VTE reduction protocols (Surgical Care Improvement Project for VTE or SCIP-VTE-2) and risk-adjusted rates of VTE as measured by Patient Safety Indicator 12 (PSI-12) from the Agency for Healthcare Research and Quality. They also looked at how overall hospital quality scores correlated with VTE prophylaxis and risk-adjusted VTE scores.
Their findings were presented at the annual clinical congress of the American College of Surgeons and simultaneously published Oct. 7 in JAMA (2013 Oct. 7 [doi:10.1001/jama.2013.280048]).
Hospitals that adhered consistently to VTE reduction protocols paradoxically had higher PSI-12 scores, although not significantly so (P = .03). Hospitals with higher overall quality scores also adhered to VTE reduction protocols at a higher rate (93.3% in the lowest quartile vs. 95.5% in the highest) and had significantly higher risk-adjusted VTE event scores (P less than .001).
"Most important, hospital VTE rates were associated with the intensity of detecting VTE with imaging studies," the investigators said. Mean VTE diagnostic imaging rates ranged from 32/1,000 in the lowest quartile to 167/1,000 in the highest.
Hospitals with the lowest imaging rates diagnosed 5.0 VTEs per 1,000 discharges, compared with hospitals with the highest imaging rates diagnosing 13.5 VTEs per 1,000 discharges.
In effect, PSI-12 scores the use of VTE imaging by hospitals instead of the quality of care provided, the investigators said. Further, surveillance bias impedes quality performance improvements; thus, decision making becomes more difficult for "patients seeking to identify a high-quality hospital."
In an accompanying editorial, Dr. Edwin H. Livingston, deputy editor of JAMA, noted that hypervigilance of VTEs might further worsen care in that "the very high compliance rate with VTE prophylaxis might result from many patients receiving treatments from which they are not likely to benefit. This is because current process measures were based on older guidelines that overestimated the benefits of VTE prophylaxis" (JAMA 2013 Oct. 7 [doi:10.1001/jama.2013.280049]).
For that reason, Dr. Livingston recommended that public reporting of VTEs be "reconsidered or curtailed because few hospitals have sufficient numbers of patients to show statistically significant effects of prophylactic measures on VTE rates."
The study was funded by the AHRQ and Northwestern University. Dr. Bilimoria has received honoraria from hospitals, professional societies, and continuing medical education companies for presentation on quality improvement.
Measuring outcomes in general and safety events in particular is a complex proposition. This is particularly true when using patient safety indicators (PSIs) and hospital-acquired conditions (HACs) as outcome metrics to compare performance across organizations.
 |
| Dr. Robert Pendleton |
In addition to the usual challenging nuances such as severity of illness adjustment, these indicators rely on accurate documentation and coding and as the Agency for Healthcare Research and Quality states: PSIs identify "potential in-hospital complications and adverse events following surgeries, procedures, and childbirth."
This is well meaning when an analytic team uses these metrics as part of a comprehensive quality and patient safety program to identify potential internal improvement opportunities. However, there are real limitations when using these metrics as outcomes that are tied to public reporting initiatives, payment incentives, and rankings.
The study in this weeks JAMA by Bilimoria and colleagues highlights another limitation of some of these metrics- that of surveillance bias. Using PSI-12 (postoperative venous thromboembolism) risk-adjusted VTE rates were shown to correlate positively with intensity of imaging use (surveillance) and inversely with other measures of quality such as structure or process.
Thus, those with the highest VTE rates did everything right, but also looked for events more often.
This finding complicates the use of PSI-12 as an indicator to compare outcomes across healthcare systems. However, when used as an internal driver in the context of other local metrics of quality and safety, the original intent of PSI-12 as an indicator of potential hospital complications does not change.
This highlights the importance of health care systems in
understanding the strengths and limitations of quality and safety metrics and
in developing the analytic capabilities to turn data points into real
opportunities to deliver better care, rather than going down the proverbial
rabbit hole.
Yet, regulatory agencies should also recognize that using imperfect metrics as a part of payment-reform initiatives needs to be done with extreme caution or there will be unintended consequences that do not lead to our collective goal of exceptional value in healthcare for our patients.
Dr. Robert Pendleton is chief medical quality officer for University of Utah Health Care, Salt Lake City.
Measuring outcomes in general and safety events in particular is a complex proposition. This is particularly true when using patient safety indicators (PSIs) and hospital-acquired conditions (HACs) as outcome metrics to compare performance across organizations.
|
| Dr. Robert Pendleton |
In addition to the usual challenging nuances such as severity of illness adjustment, these indicators rely on accurate documentation and coding and as the Agency for Healthcare Research and Quality states: PSIs identify "potential in-hospital complications and adverse events following surgeries, procedures, and childbirth."
This is well meaning when an analytic team uses these metrics as part of a comprehensive quality and patient safety program to identify potential internal improvement opportunities. However, there are real limitations when using these metrics as outcomes that are tied to public reporting initiatives, payment incentives, and rankings.
The study in this weeks JAMA by Bilimoria and colleagues highlights another limitation of some of these metrics- that of surveillance bias. Using PSI-12 (postoperative venous thromboembolism) risk-adjusted VTE rates were shown to correlate positively with intensity of imaging use (surveillance) and inversely with other measures of quality such as structure or process.
Thus, those with the highest VTE rates did everything right, but also looked for events more often.
This finding complicates the use of PSI-12 as an indicator to compare outcomes across healthcare systems. However, when used as an internal driver in the context of other local metrics of quality and safety, the original intent of PSI-12 as an indicator of potential hospital complications does not change.
This highlights the importance of health care systems in
understanding the strengths and limitations of quality and safety metrics and
in developing the analytic capabilities to turn data points into real
opportunities to deliver better care, rather than going down the proverbial
rabbit hole.
Yet, regulatory agencies should also recognize that using imperfect metrics as a part of payment-reform initiatives needs to be done with extreme caution or there will be unintended consequences that do not lead to our collective goal of exceptional value in healthcare for our patients.
Dr. Robert Pendleton is chief medical quality officer for University of Utah Health Care, Salt Lake City.
Measuring outcomes in general and safety events in particular is a complex proposition. This is particularly true when using patient safety indicators (PSIs) and hospital-acquired conditions (HACs) as outcome metrics to compare performance across organizations.
|
| Dr. Robert Pendleton |
In addition to the usual challenging nuances such as severity of illness adjustment, these indicators rely on accurate documentation and coding and as the Agency for Healthcare Research and Quality states: PSIs identify "potential in-hospital complications and adverse events following surgeries, procedures, and childbirth."
This is well meaning when an analytic team uses these metrics as part of a comprehensive quality and patient safety program to identify potential internal improvement opportunities. However, there are real limitations when using these metrics as outcomes that are tied to public reporting initiatives, payment incentives, and rankings.
The study in this weeks JAMA by Bilimoria and colleagues highlights another limitation of some of these metrics- that of surveillance bias. Using PSI-12 (postoperative venous thromboembolism) risk-adjusted VTE rates were shown to correlate positively with intensity of imaging use (surveillance) and inversely with other measures of quality such as structure or process.
Thus, those with the highest VTE rates did everything right, but also looked for events more often.
This finding complicates the use of PSI-12 as an indicator to compare outcomes across healthcare systems. However, when used as an internal driver in the context of other local metrics of quality and safety, the original intent of PSI-12 as an indicator of potential hospital complications does not change.
This highlights the importance of health care systems in
understanding the strengths and limitations of quality and safety metrics and
in developing the analytic capabilities to turn data points into real
opportunities to deliver better care, rather than going down the proverbial
rabbit hole.
Yet, regulatory agencies should also recognize that using imperfect metrics as a part of payment-reform initiatives needs to be done with extreme caution or there will be unintended consequences that do not lead to our collective goal of exceptional value in healthcare for our patients.
Dr. Robert Pendleton is chief medical quality officer for University of Utah Health Care, Salt Lake City.
Postoperative venous thromboembolism rates may not be an effective way of measuring hospital quality, according to Dr. Karl Y. Bilimoria and his colleagues.
The investigators calculated patient-level rates of venous thromboembolism as well as rates of imaging for VTE using data from the American Hospital Association and Medicare Compare from 2009-2010 from nearly 1 million patients discharged from 2,786 hospitals after a major surgery.
They sought to determine the association between hospital adherence to VTE reduction protocols (Surgical Care Improvement Project for VTE or SCIP-VTE-2) and risk-adjusted rates of VTE as measured by Patient Safety Indicator 12 (PSI-12) from the Agency for Healthcare Research and Quality. They also looked at how overall hospital quality scores correlated with VTE prophylaxis and risk-adjusted VTE scores.
Their findings were presented at the annual clinical congress of the American College of Surgeons and simultaneously published Oct. 7 in JAMA (2013 Oct. 7 [doi:10.1001/jama.2013.280048]).
Hospitals that adhered consistently to VTE reduction protocols paradoxically had higher PSI-12 scores, although not significantly so (P = .03). Hospitals with higher overall quality scores also adhered to VTE reduction protocols at a higher rate (93.3% in the lowest quartile vs. 95.5% in the highest) and had significantly higher risk-adjusted VTE event scores (P less than .001).
"Most important, hospital VTE rates were associated with the intensity of detecting VTE with imaging studies," the investigators said. Mean VTE diagnostic imaging rates ranged from 32/1,000 in the lowest quartile to 167/1,000 in the highest.
Hospitals with the lowest imaging rates diagnosed 5.0 VTEs per 1,000 discharges, compared with hospitals with the highest imaging rates diagnosing 13.5 VTEs per 1,000 discharges.
In effect, PSI-12 scores the use of VTE imaging by hospitals instead of the quality of care provided, the investigators said. Further, surveillance bias impedes quality performance improvements; thus, decision making becomes more difficult for "patients seeking to identify a high-quality hospital."
In an accompanying editorial, Dr. Edwin H. Livingston, deputy editor of JAMA, noted that hypervigilance of VTEs might further worsen care in that "the very high compliance rate with VTE prophylaxis might result from many patients receiving treatments from which they are not likely to benefit. This is because current process measures were based on older guidelines that overestimated the benefits of VTE prophylaxis" (JAMA 2013 Oct. 7 [doi:10.1001/jama.2013.280049]).
For that reason, Dr. Livingston recommended that public reporting of VTEs be "reconsidered or curtailed because few hospitals have sufficient numbers of patients to show statistically significant effects of prophylactic measures on VTE rates."
The study was funded by the AHRQ and Northwestern University. Dr. Bilimoria has received honoraria from hospitals, professional societies, and continuing medical education companies for presentation on quality improvement.
Postoperative venous thromboembolism rates may not be an effective way of measuring hospital quality, according to Dr. Karl Y. Bilimoria and his colleagues.
The investigators calculated patient-level rates of venous thromboembolism as well as rates of imaging for VTE using data from the American Hospital Association and Medicare Compare from 2009-2010 from nearly 1 million patients discharged from 2,786 hospitals after a major surgery.
They sought to determine the association between hospital adherence to VTE reduction protocols (Surgical Care Improvement Project for VTE or SCIP-VTE-2) and risk-adjusted rates of VTE as measured by Patient Safety Indicator 12 (PSI-12) from the Agency for Healthcare Research and Quality. They also looked at how overall hospital quality scores correlated with VTE prophylaxis and risk-adjusted VTE scores.
Their findings were presented at the annual clinical congress of the American College of Surgeons and simultaneously published Oct. 7 in JAMA (2013 Oct. 7 [doi:10.1001/jama.2013.280048]).
Hospitals that adhered consistently to VTE reduction protocols paradoxically had higher PSI-12 scores, although not significantly so (P = .03). Hospitals with higher overall quality scores also adhered to VTE reduction protocols at a higher rate (93.3% in the lowest quartile vs. 95.5% in the highest) and had significantly higher risk-adjusted VTE event scores (P less than .001).
"Most important, hospital VTE rates were associated with the intensity of detecting VTE with imaging studies," the investigators said. Mean VTE diagnostic imaging rates ranged from 32/1,000 in the lowest quartile to 167/1,000 in the highest.
Hospitals with the lowest imaging rates diagnosed 5.0 VTEs per 1,000 discharges, compared with hospitals with the highest imaging rates diagnosing 13.5 VTEs per 1,000 discharges.
In effect, PSI-12 scores the use of VTE imaging by hospitals instead of the quality of care provided, the investigators said. Further, surveillance bias impedes quality performance improvements; thus, decision making becomes more difficult for "patients seeking to identify a high-quality hospital."
In an accompanying editorial, Dr. Edwin H. Livingston, deputy editor of JAMA, noted that hypervigilance of VTEs might further worsen care in that "the very high compliance rate with VTE prophylaxis might result from many patients receiving treatments from which they are not likely to benefit. This is because current process measures were based on older guidelines that overestimated the benefits of VTE prophylaxis" (JAMA 2013 Oct. 7 [doi:10.1001/jama.2013.280049]).
For that reason, Dr. Livingston recommended that public reporting of VTEs be "reconsidered or curtailed because few hospitals have sufficient numbers of patients to show statistically significant effects of prophylactic measures on VTE rates."
The study was funded by the AHRQ and Northwestern University. Dr. Bilimoria has received honoraria from hospitals, professional societies, and continuing medical education companies for presentation on quality improvement.
FROM THE ACS CLINICAL CONGRESS
Major finding: Hospitals that adhered consistently to VTE reduction protocols had higher rates of VTE, although not significantly so (P = .03).
Data source: Study of hospital risk-adjusted VTE prophylaxis adherence rates to postoperative VTE event rates in 2,786 hospitals.
Disclosures: The study was funded by the AHRQ and Northwestern University. Dr. Bilimoria has received honoraria from hospitals, professional societies, and continuing medical education companies for presentation on quality improvement.
False-negative rate for sentinel nodes high after neoadjuvant chemotherapy
The false-negative rate of sentinel lymph node results was almost 13% after neoadjuvant chemotherapy, in a study of women initially presenting with biopsy-proven node-positive breast cancer, which is above the acceptable threshold, a study has shown.
Considering the threshold for a false-negative rate is 10%, "changes in approach and patient selection that result in greater sensitivity would be necessary" to support the use of sentinel lymph node (SLN) surgery "as an alternative" to axillary lymph node dissection in this population of patients with breast cancer, concluded Dr. Judy Boughey of the department of surgery, Mayo Clinic, Rochester, Minn., and her associates in the Alliance for Clinical Trials in Oncology.
The investigators also found that false-negative SLN biopsy results were significantly lower when two mapping agents were used; the false-negative rate was also significantly lower when at least three sentinel lymph nodes were sampled. The results of the study were presented at the annual clinical congress of the American Congress of Surgeons and simultaneously published online on Oct. 7, 2013, in JAMA (doi:10.1001/jama.2013.278932).
The phase II study addressed the false-negative rate of SLN biopsy after neoadjuvant chemotherapy, in women who initially presented with pathologically confirmed node-positive disease. The study enrolled 701 women from July 2009 to June 2011, at 136 institutions. The women had clinical stage T0 through T4, N1 through N2, M0 breast cancer; most (663) had cN1 disease (disease in movable axillary lymph nodes) and 38 had cN2 disease (disease in fixed or matted axillary lymph nodes). After chemotherapy was completed, the patients had surgery, involving SLN biopsy and axillary lymph node dissection.
Of the 701 women, 687 underwent both SLN biopsy and axillary lymph node dissection, 2 had only SLN biopsy, and 12 had axillary lymph node dissection only. Most of the 689 women who underwent SLN biopsy had the procedure performed with blue dye and radiolabeled colloid (79%), 116 (16.8%) had radiolabeled colloid only, and 28 (4.1%) had blue dye only.
Of the 689 women who had SLN biopsy, at least one SLN was detected in 639 (almost 93%). Among the 651 women with cN1 disease, at least one SLN was detected in 605 women (93%); and among the 38 women with cN2 disease, at least one SNL was detected in 34 (89.5%).
In 525 of the patients with cN1 disease, at least two SLNs were excised and axillary lymph node dissection was completed. There was no residual node disease found in 215 of these patients, for a nodal pathologic complete response rate of 41%.
Of the remaining 310 patients, nodal disease was found in the sentinel lymph nodes in 108 patients (20.6%), and in both axillary and sentinel nodes in 163 patients (31.1%).
Residual node disease was found in the axillary lymph nodes of only 39 (7.4%) of the patients. Therefore, the results of the SLN biopsy results were false negative in 39 of the 310 patients, for a false negative rate of 12.6%.
While the study results "suggest that surgeons cannot reliably detect all axillary lymph node metastases in patients with cN1 breast cancer following chemotherapy" with SLN procedures, "we did identify important factors influencing the likelihood of a false-negative SLN," the authors said. The false-negative rate for the SLN biopsy results was significantly decreased when both blue dye and radiolabeled colloid were used as mapping agents, and when at least three sentinel lymph nodes were biopsied.
When both blue dye and radiolabeled colloid were used, the false-negative rate was 10.8%, compared with 20.3% when only one agent was used. "Using two mapping agents with different molecule sizes and transit times is an important surgical standard that should be adhered to for SLN surgery after chemotherapy," they said, noting that after chemotherapy, "the axilla often has more fibrosis, making evaluation of lymphatic drainage and surgical dissection more challenging."
And when at least three SLNs were examined, the false negative rate was 9.1%, compared with 21.1% when two were sampled. "As the accuracy of any sampling test is dependent on the amount of material sampled, these results are not surprising," they said, noting that this has been found in other studies.
SLN is less invasive than axillary dissection and is considered a reliable way to check for axillary nodal disease in women who present with node-negative disease, but the use of SLN biopsy after neoadjuvant chemotherapy in women with cN1 disease "has been questioned," because the false-negative rate for this approach in this population has ranged from 7% to 25% in small studies, the only data available on this approach, according to the authors.
The study was supported by a grant from the National Cancer Institute to the American College of Surgeons Oncology Group (ACOSOG). The patients were in the ACOSOG Z1071 trial. Four of the authors reported having grants from the National Institutes of Health or Komen Foundation, having contracts with Galena BioPharma, or having been paid for lectures from LifeCell. The remaining 17 authors said they had no relevant financial disclosures.
"[T]he appropriateness of SLN biopsy in this setting remains uncertain," although the study provides important information, according to Dr. Monica Morrow and Dr. Chau Dang. The increasing number of targeted therapies for breast cancer has enabled physicians to "move away from the ‘one size fits all’ approach." As a result, "the prognostic information obtained from residual nodal disease after neoadjuvant therapy is likely to become increasingly important in determining the need for additional therapy." If true, "research in ways to improve the performance of the SLN biopsy after neoadjuvant therapy is needed for this approach to become a viable management strategy."
Dr. Morrow and Dr. Dang of Memorial Sloan-Kettering Cancer Center in New York made their remarks in an editorial accompanying the article (JAMA 2013 Oct. 7 [doi:10.l001/jama.2013.7844]). Dr. Dang disclosed having received grant funding from Genentech. Dr. Morrow said she had no relevant financial disclosures.
"[T]he appropriateness of SLN biopsy in this setting remains uncertain," although the study provides important information, according to Dr. Monica Morrow and Dr. Chau Dang. The increasing number of targeted therapies for breast cancer has enabled physicians to "move away from the ‘one size fits all’ approach." As a result, "the prognostic information obtained from residual nodal disease after neoadjuvant therapy is likely to become increasingly important in determining the need for additional therapy." If true, "research in ways to improve the performance of the SLN biopsy after neoadjuvant therapy is needed for this approach to become a viable management strategy."
Dr. Morrow and Dr. Dang of Memorial Sloan-Kettering Cancer Center in New York made their remarks in an editorial accompanying the article (JAMA 2013 Oct. 7 [doi:10.l001/jama.2013.7844]). Dr. Dang disclosed having received grant funding from Genentech. Dr. Morrow said she had no relevant financial disclosures.
"[T]he appropriateness of SLN biopsy in this setting remains uncertain," although the study provides important information, according to Dr. Monica Morrow and Dr. Chau Dang. The increasing number of targeted therapies for breast cancer has enabled physicians to "move away from the ‘one size fits all’ approach." As a result, "the prognostic information obtained from residual nodal disease after neoadjuvant therapy is likely to become increasingly important in determining the need for additional therapy." If true, "research in ways to improve the performance of the SLN biopsy after neoadjuvant therapy is needed for this approach to become a viable management strategy."
Dr. Morrow and Dr. Dang of Memorial Sloan-Kettering Cancer Center in New York made their remarks in an editorial accompanying the article (JAMA 2013 Oct. 7 [doi:10.l001/jama.2013.7844]). Dr. Dang disclosed having received grant funding from Genentech. Dr. Morrow said she had no relevant financial disclosures.
The false-negative rate of sentinel lymph node results was almost 13% after neoadjuvant chemotherapy, in a study of women initially presenting with biopsy-proven node-positive breast cancer, which is above the acceptable threshold, a study has shown.
Considering the threshold for a false-negative rate is 10%, "changes in approach and patient selection that result in greater sensitivity would be necessary" to support the use of sentinel lymph node (SLN) surgery "as an alternative" to axillary lymph node dissection in this population of patients with breast cancer, concluded Dr. Judy Boughey of the department of surgery, Mayo Clinic, Rochester, Minn., and her associates in the Alliance for Clinical Trials in Oncology.
The investigators also found that false-negative SLN biopsy results were significantly lower when two mapping agents were used; the false-negative rate was also significantly lower when at least three sentinel lymph nodes were sampled. The results of the study were presented at the annual clinical congress of the American Congress of Surgeons and simultaneously published online on Oct. 7, 2013, in JAMA (doi:10.1001/jama.2013.278932).
The phase II study addressed the false-negative rate of SLN biopsy after neoadjuvant chemotherapy, in women who initially presented with pathologically confirmed node-positive disease. The study enrolled 701 women from July 2009 to June 2011, at 136 institutions. The women had clinical stage T0 through T4, N1 through N2, M0 breast cancer; most (663) had cN1 disease (disease in movable axillary lymph nodes) and 38 had cN2 disease (disease in fixed or matted axillary lymph nodes). After chemotherapy was completed, the patients had surgery, involving SLN biopsy and axillary lymph node dissection.
Of the 701 women, 687 underwent both SLN biopsy and axillary lymph node dissection, 2 had only SLN biopsy, and 12 had axillary lymph node dissection only. Most of the 689 women who underwent SLN biopsy had the procedure performed with blue dye and radiolabeled colloid (79%), 116 (16.8%) had radiolabeled colloid only, and 28 (4.1%) had blue dye only.
Of the 689 women who had SLN biopsy, at least one SLN was detected in 639 (almost 93%). Among the 651 women with cN1 disease, at least one SLN was detected in 605 women (93%); and among the 38 women with cN2 disease, at least one SNL was detected in 34 (89.5%).
In 525 of the patients with cN1 disease, at least two SLNs were excised and axillary lymph node dissection was completed. There was no residual node disease found in 215 of these patients, for a nodal pathologic complete response rate of 41%.
Of the remaining 310 patients, nodal disease was found in the sentinel lymph nodes in 108 patients (20.6%), and in both axillary and sentinel nodes in 163 patients (31.1%).
Residual node disease was found in the axillary lymph nodes of only 39 (7.4%) of the patients. Therefore, the results of the SLN biopsy results were false negative in 39 of the 310 patients, for a false negative rate of 12.6%.
While the study results "suggest that surgeons cannot reliably detect all axillary lymph node metastases in patients with cN1 breast cancer following chemotherapy" with SLN procedures, "we did identify important factors influencing the likelihood of a false-negative SLN," the authors said. The false-negative rate for the SLN biopsy results was significantly decreased when both blue dye and radiolabeled colloid were used as mapping agents, and when at least three sentinel lymph nodes were biopsied.
When both blue dye and radiolabeled colloid were used, the false-negative rate was 10.8%, compared with 20.3% when only one agent was used. "Using two mapping agents with different molecule sizes and transit times is an important surgical standard that should be adhered to for SLN surgery after chemotherapy," they said, noting that after chemotherapy, "the axilla often has more fibrosis, making evaluation of lymphatic drainage and surgical dissection more challenging."
And when at least three SLNs were examined, the false negative rate was 9.1%, compared with 21.1% when two were sampled. "As the accuracy of any sampling test is dependent on the amount of material sampled, these results are not surprising," they said, noting that this has been found in other studies.
SLN is less invasive than axillary dissection and is considered a reliable way to check for axillary nodal disease in women who present with node-negative disease, but the use of SLN biopsy after neoadjuvant chemotherapy in women with cN1 disease "has been questioned," because the false-negative rate for this approach in this population has ranged from 7% to 25% in small studies, the only data available on this approach, according to the authors.
The study was supported by a grant from the National Cancer Institute to the American College of Surgeons Oncology Group (ACOSOG). The patients were in the ACOSOG Z1071 trial. Four of the authors reported having grants from the National Institutes of Health or Komen Foundation, having contracts with Galena BioPharma, or having been paid for lectures from LifeCell. The remaining 17 authors said they had no relevant financial disclosures.
The false-negative rate of sentinel lymph node results was almost 13% after neoadjuvant chemotherapy, in a study of women initially presenting with biopsy-proven node-positive breast cancer, which is above the acceptable threshold, a study has shown.
Considering the threshold for a false-negative rate is 10%, "changes in approach and patient selection that result in greater sensitivity would be necessary" to support the use of sentinel lymph node (SLN) surgery "as an alternative" to axillary lymph node dissection in this population of patients with breast cancer, concluded Dr. Judy Boughey of the department of surgery, Mayo Clinic, Rochester, Minn., and her associates in the Alliance for Clinical Trials in Oncology.
The investigators also found that false-negative SLN biopsy results were significantly lower when two mapping agents were used; the false-negative rate was also significantly lower when at least three sentinel lymph nodes were sampled. The results of the study were presented at the annual clinical congress of the American Congress of Surgeons and simultaneously published online on Oct. 7, 2013, in JAMA (doi:10.1001/jama.2013.278932).
The phase II study addressed the false-negative rate of SLN biopsy after neoadjuvant chemotherapy, in women who initially presented with pathologically confirmed node-positive disease. The study enrolled 701 women from July 2009 to June 2011, at 136 institutions. The women had clinical stage T0 through T4, N1 through N2, M0 breast cancer; most (663) had cN1 disease (disease in movable axillary lymph nodes) and 38 had cN2 disease (disease in fixed or matted axillary lymph nodes). After chemotherapy was completed, the patients had surgery, involving SLN biopsy and axillary lymph node dissection.
Of the 701 women, 687 underwent both SLN biopsy and axillary lymph node dissection, 2 had only SLN biopsy, and 12 had axillary lymph node dissection only. Most of the 689 women who underwent SLN biopsy had the procedure performed with blue dye and radiolabeled colloid (79%), 116 (16.8%) had radiolabeled colloid only, and 28 (4.1%) had blue dye only.
Of the 689 women who had SLN biopsy, at least one SLN was detected in 639 (almost 93%). Among the 651 women with cN1 disease, at least one SLN was detected in 605 women (93%); and among the 38 women with cN2 disease, at least one SNL was detected in 34 (89.5%).
In 525 of the patients with cN1 disease, at least two SLNs were excised and axillary lymph node dissection was completed. There was no residual node disease found in 215 of these patients, for a nodal pathologic complete response rate of 41%.
Of the remaining 310 patients, nodal disease was found in the sentinel lymph nodes in 108 patients (20.6%), and in both axillary and sentinel nodes in 163 patients (31.1%).
Residual node disease was found in the axillary lymph nodes of only 39 (7.4%) of the patients. Therefore, the results of the SLN biopsy results were false negative in 39 of the 310 patients, for a false negative rate of 12.6%.
While the study results "suggest that surgeons cannot reliably detect all axillary lymph node metastases in patients with cN1 breast cancer following chemotherapy" with SLN procedures, "we did identify important factors influencing the likelihood of a false-negative SLN," the authors said. The false-negative rate for the SLN biopsy results was significantly decreased when both blue dye and radiolabeled colloid were used as mapping agents, and when at least three sentinel lymph nodes were biopsied.
When both blue dye and radiolabeled colloid were used, the false-negative rate was 10.8%, compared with 20.3% when only one agent was used. "Using two mapping agents with different molecule sizes and transit times is an important surgical standard that should be adhered to for SLN surgery after chemotherapy," they said, noting that after chemotherapy, "the axilla often has more fibrosis, making evaluation of lymphatic drainage and surgical dissection more challenging."
And when at least three SLNs were examined, the false negative rate was 9.1%, compared with 21.1% when two were sampled. "As the accuracy of any sampling test is dependent on the amount of material sampled, these results are not surprising," they said, noting that this has been found in other studies.
SLN is less invasive than axillary dissection and is considered a reliable way to check for axillary nodal disease in women who present with node-negative disease, but the use of SLN biopsy after neoadjuvant chemotherapy in women with cN1 disease "has been questioned," because the false-negative rate for this approach in this population has ranged from 7% to 25% in small studies, the only data available on this approach, according to the authors.
The study was supported by a grant from the National Cancer Institute to the American College of Surgeons Oncology Group (ACOSOG). The patients were in the ACOSOG Z1071 trial. Four of the authors reported having grants from the National Institutes of Health or Komen Foundation, having contracts with Galena BioPharma, or having been paid for lectures from LifeCell. The remaining 17 authors said they had no relevant financial disclosures.
FROM THE ACS CLINICAL CONGRESS
Major finding: Sentinel lymph node findings had a false-negative rate of 12.6% among women with cN1 breast cancer, after neoadjuvant chemotherapy, above the acceptable threshold of 10%, but the false-negative rate dropped below this level when a dual mapping technique was used and when more than two sentinel nodes were biopsied.
Data source: A prospective, phase II multicenter study that evaluated the false-negative rate of sentinel lymph node surgery in more than 700 women with clinically node-positive breast cancer treated with chemotherapy before surgery.
Disclosures: The study was supported by a grant from the National Cancer Institute to the American College of Surgeons Oncology Group. Four authors reported having received grants from the National Institutes of Health or the Komen Foundation, having contracts with Galena BioPharma, or having been paid for lectures by LifeCell. The remaining authors said they had no relevant financial disclosures.
