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OR staff perception of safety linked to better surgical outcomes
PHILADELPHIA – No large-scale study has evaluated the culture of operating room safety and 30-day postoperative death, but a statewide evaluation of South Carolina hospitals found that those in which operating-room personnel perceived a high degree of safety reported lower all-cause 30-day postoperative mortality rates.
“Reducing postoperative death rates and improving patient safety require that, in addition to technical competence, surgeons lead surgical teams in ways that foster the creation of a culture in operating rooms where personnel feel respected and invited to speak up on behalf of patient safety,” George Molina, MD, MPH, said at the annual meeting of the American Surgical Association. Dr. Molina is with Brigham and Women’s Hospital, Harvard T.H. Chan School of Public Health, and Massachusetts General Hospital, Boston.
The study drew on a statewide quality and safety program of the South Carolina Hospital Association known as Safe Surgery 2015, one component of which was a survey sent to operating-room (OR) personnel to measure baseline culture of surgical safety. The survey evaluated five teamwork factors: mutual respect, clinical leadership, assertiveness, coordination, and effective communication. The overall response rate of OR staff at 31 surveyed hospitals was 38.1% with 1,793 completed surveys, with a physicians response rate of 29%.
The researchers analyzed statewide claims data of nearly all surgery in the state (except for operations at Veterans Affairs, military and Shriners’ centers) and a state-level death registry to identify patients who died within 30 days after an inpatient operation. The unadjusted median 30-day postoperative death rate at the 31 participating hospitals was 3.2%, Dr. Molina said.
The study evaluated the association between hospital-level mean scores for each survey statement and postoperative death, and used machine learning to adjust for potential confounders. The analysis also took into account hospital-level variables such as patient gender, Charlson Comorbidity Index, primary payer status, and procedure type.
“Among the factors that make up the teamwork dimension, respect, leadership and assertiveness on behalf of patient safety were significantly associated with lower 30-day postoperative death rates,” Dr. Molina said. “For every one-point increase on a seven-point Likert scale and the hospital level mean score for respect, clinical leadership, and assertiveness among all survey respondents, there were associated decreases in postoperative mortality following surgery, ranging from 14% to 29%.”
Of the five teamwork variables, assertiveness had the lowest relative risk, 0.71 (P = .01), whereas communication had the highest, 0.98 (P = .77).
Dr. Molina noted a number of limitations to the study, such as the inability to generalize findings from a single state and the use of cross-sectional data, which precludes a causal link between culture and mortality. “Postoperative mortality is most likely due to multiple factors that take place not only in the operating room, but also during the course of preoperative and postoperative course,” he said.
In his discussion, Justin Dimick, MD, of the University of Michigan, Ann Arbor, asked Dr. Molina what interventions beyond OR checklists are available to improve safety culture.
“It’s not a matter of changing perceptions but actually changing behaviors and then actually improving the culture,” Dr. Molina said. OR team training that includes simulated emergency response is one such intervention. Other strategies he offered: “Working on communication, in particular closed-loop communication among health care providers working in the operating room, and then also quality and safety programs such as Safe Surgery 2015.”
Dr. Molina reported no financial disclosures. Dr. Dimick is cofounder of Arbor Metrix and receives royalties.
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is anticipated to be published in the Annals of Surgery pending editorial review.
PHILADELPHIA – No large-scale study has evaluated the culture of operating room safety and 30-day postoperative death, but a statewide evaluation of South Carolina hospitals found that those in which operating-room personnel perceived a high degree of safety reported lower all-cause 30-day postoperative mortality rates.
“Reducing postoperative death rates and improving patient safety require that, in addition to technical competence, surgeons lead surgical teams in ways that foster the creation of a culture in operating rooms where personnel feel respected and invited to speak up on behalf of patient safety,” George Molina, MD, MPH, said at the annual meeting of the American Surgical Association. Dr. Molina is with Brigham and Women’s Hospital, Harvard T.H. Chan School of Public Health, and Massachusetts General Hospital, Boston.
The study drew on a statewide quality and safety program of the South Carolina Hospital Association known as Safe Surgery 2015, one component of which was a survey sent to operating-room (OR) personnel to measure baseline culture of surgical safety. The survey evaluated five teamwork factors: mutual respect, clinical leadership, assertiveness, coordination, and effective communication. The overall response rate of OR staff at 31 surveyed hospitals was 38.1% with 1,793 completed surveys, with a physicians response rate of 29%.
The researchers analyzed statewide claims data of nearly all surgery in the state (except for operations at Veterans Affairs, military and Shriners’ centers) and a state-level death registry to identify patients who died within 30 days after an inpatient operation. The unadjusted median 30-day postoperative death rate at the 31 participating hospitals was 3.2%, Dr. Molina said.
The study evaluated the association between hospital-level mean scores for each survey statement and postoperative death, and used machine learning to adjust for potential confounders. The analysis also took into account hospital-level variables such as patient gender, Charlson Comorbidity Index, primary payer status, and procedure type.
“Among the factors that make up the teamwork dimension, respect, leadership and assertiveness on behalf of patient safety were significantly associated with lower 30-day postoperative death rates,” Dr. Molina said. “For every one-point increase on a seven-point Likert scale and the hospital level mean score for respect, clinical leadership, and assertiveness among all survey respondents, there were associated decreases in postoperative mortality following surgery, ranging from 14% to 29%.”
Of the five teamwork variables, assertiveness had the lowest relative risk, 0.71 (P = .01), whereas communication had the highest, 0.98 (P = .77).
Dr. Molina noted a number of limitations to the study, such as the inability to generalize findings from a single state and the use of cross-sectional data, which precludes a causal link between culture and mortality. “Postoperative mortality is most likely due to multiple factors that take place not only in the operating room, but also during the course of preoperative and postoperative course,” he said.
In his discussion, Justin Dimick, MD, of the University of Michigan, Ann Arbor, asked Dr. Molina what interventions beyond OR checklists are available to improve safety culture.
“It’s not a matter of changing perceptions but actually changing behaviors and then actually improving the culture,” Dr. Molina said. OR team training that includes simulated emergency response is one such intervention. Other strategies he offered: “Working on communication, in particular closed-loop communication among health care providers working in the operating room, and then also quality and safety programs such as Safe Surgery 2015.”
Dr. Molina reported no financial disclosures. Dr. Dimick is cofounder of Arbor Metrix and receives royalties.
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is anticipated to be published in the Annals of Surgery pending editorial review.
PHILADELPHIA – No large-scale study has evaluated the culture of operating room safety and 30-day postoperative death, but a statewide evaluation of South Carolina hospitals found that those in which operating-room personnel perceived a high degree of safety reported lower all-cause 30-day postoperative mortality rates.
“Reducing postoperative death rates and improving patient safety require that, in addition to technical competence, surgeons lead surgical teams in ways that foster the creation of a culture in operating rooms where personnel feel respected and invited to speak up on behalf of patient safety,” George Molina, MD, MPH, said at the annual meeting of the American Surgical Association. Dr. Molina is with Brigham and Women’s Hospital, Harvard T.H. Chan School of Public Health, and Massachusetts General Hospital, Boston.
The study drew on a statewide quality and safety program of the South Carolina Hospital Association known as Safe Surgery 2015, one component of which was a survey sent to operating-room (OR) personnel to measure baseline culture of surgical safety. The survey evaluated five teamwork factors: mutual respect, clinical leadership, assertiveness, coordination, and effective communication. The overall response rate of OR staff at 31 surveyed hospitals was 38.1% with 1,793 completed surveys, with a physicians response rate of 29%.
The researchers analyzed statewide claims data of nearly all surgery in the state (except for operations at Veterans Affairs, military and Shriners’ centers) and a state-level death registry to identify patients who died within 30 days after an inpatient operation. The unadjusted median 30-day postoperative death rate at the 31 participating hospitals was 3.2%, Dr. Molina said.
The study evaluated the association between hospital-level mean scores for each survey statement and postoperative death, and used machine learning to adjust for potential confounders. The analysis also took into account hospital-level variables such as patient gender, Charlson Comorbidity Index, primary payer status, and procedure type.
“Among the factors that make up the teamwork dimension, respect, leadership and assertiveness on behalf of patient safety were significantly associated with lower 30-day postoperative death rates,” Dr. Molina said. “For every one-point increase on a seven-point Likert scale and the hospital level mean score for respect, clinical leadership, and assertiveness among all survey respondents, there were associated decreases in postoperative mortality following surgery, ranging from 14% to 29%.”
Of the five teamwork variables, assertiveness had the lowest relative risk, 0.71 (P = .01), whereas communication had the highest, 0.98 (P = .77).
Dr. Molina noted a number of limitations to the study, such as the inability to generalize findings from a single state and the use of cross-sectional data, which precludes a causal link between culture and mortality. “Postoperative mortality is most likely due to multiple factors that take place not only in the operating room, but also during the course of preoperative and postoperative course,” he said.
In his discussion, Justin Dimick, MD, of the University of Michigan, Ann Arbor, asked Dr. Molina what interventions beyond OR checklists are available to improve safety culture.
“It’s not a matter of changing perceptions but actually changing behaviors and then actually improving the culture,” Dr. Molina said. OR team training that includes simulated emergency response is one such intervention. Other strategies he offered: “Working on communication, in particular closed-loop communication among health care providers working in the operating room, and then also quality and safety programs such as Safe Surgery 2015.”
Dr. Molina reported no financial disclosures. Dr. Dimick is cofounder of Arbor Metrix and receives royalties.
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is anticipated to be published in the Annals of Surgery pending editorial review.
Key clinical point: Perceptions of safety among operating room personnel may influence postoperative death rates.
Major finding: Higher scores for key teamwork variables were associated with decreases in postoperative hospital death rates ranging from 14% to 29%.
Data source: Survey responses of 1,793 operating room personnel at 31 member hospitals of the South Carolina Hospital Association.
Disclosures: Dr. Molina reported no financial disclosures. Dr. Dimick is cofounder of Arbor Metrix and receives royalties.
Choice of lap vs. open SBO surgery still hinges on patient selection
PHILADELPHIA – In surgery for small-bowel obstruction, laparoscopy is more likely to result in bowel injury than is open surgery but with ultimately better outcomes overall. This means that surgeons should proceed with “considerable caution” when performing minimally invasive surgery in the small bowel, researchers at University of Toronto reported during the annual meeting of the American Surgical Association.
In explaining the rationale for the study, Dr. Behman said, “Several studies have shown that over the last several years [that] the utilization of laparoscopic techniques for adhesive small-bowel obstruction has become increasingly common. However, these procedures have some inherent challenges.” Those technical challenges include introducing the trocar into an abdomen filled with distended bowel, trying to manipulate the distended bowel with laparoscopic bowel graspers, and the potentially ischemic bowel wall, he said.
The University of Toronto researchers performed a population-based retrospective cohort study of 8,584 patients in the Ministry of Health Ontario database from 2005 to 2014. The primary outcome was a composite, consisting of bowel repair, including operative billing codes for either via intraoperative enterotomy or suture repair of the intestine, or bowel resection. Secondary outcomes were serious complications and 30-day mortality.
During the study period, the share of SBO procedures performed laparoscopically increased from 4% in 2005 to 14.3% in 2014, Dr. Behman said.
“Patients in the laparoscopic group were slightly younger, had a lower overall comorbidity burden, and tended to be treated at larger hospitals and hospitals without teaching designations,” Dr. Behman said. Specifically, the average age of the 673 patients who had laparoscopy was 63 years vs. 67 years for the 7,911 open-procedure patients. As for comorbidities, 9% and 50% in the laparoscopic group were healthy and low users and high and very high users, respectively, vs. 7% and 57% of the open-procedure group.
The incidence of any bowel intervention was 53.5% in the laparoscopic group vs. 42% in the open group, Dr. Behman said. After a multivariable regression analysis, the researchers determined the following factors raised a patient’s odds of having a bowel intervention: older age; female sex; having had an after-hours procedure; and having had the procedure earlier in the study period. “However, even after [the researchers adjusted] for all of these covariates, the variable in our model that was most significantly associated with a bowel intervention was having had a laparoscopic procedure, with an odds ratio of 1.6,” Dr. Behman said.
When analyzing secondary outcomes, the researchers found that laparoscopy was associated with a lower risk of 30-day mortality (OR, 0.6) and serious complication (OR, 0.8). “So, there does appear to be a direct trade-off with laparoscopy probably having better clinical outcomes, but also being a risk factor for bowel intervention,” Dr. Behman said. So the researchers preformed a secondary analysis that divided the cohort into four subgroups: laparoscopy with and without bowel intervention; and open surgery with and without bowel intervention.
“The next question we wanted to ask was, in patients that are at high risk of a laparoscopic bowel injury, is an open approach or early conversion to open beneficial?” Dr. Behman said. “To put this another way, is it more important to avoid a bowel intervention or to avoid the morbidity associated with an open procedure?”
The secondary analysis confirmed that laparoscopic patients had lower rates of serious complications: in those without bowel intervention, 5% for laparoscopy vs. 10% for open; and in those who had a bowel intervention, 15% for laparoscopy vs. 22% for open. However, those who had an open procedure without a bowel intervention had lower complication rates than did those who had a laparoscopic operation with a bowel intervention, Dr. Behman said, “suggesting that perhaps the bowel intervention is a greater driver of serious complications than having an open procedure.”
These findings can inform patient selection, Dr. Behman added. “In light of the fact that laparoscopic approaches are likely associated with a greater risk of bowel intervention, appropriate caution should accompany these procedures,” he said. “In patients who are at high risk for a bowel intervention, an open approach or early conversion to a laparotomy should be considered.”
In his discussion of the study, Lawrence Diebel, MD, FACS, of Wayne State University, Detroit, asked if the study accounted for timing of surgery, the etiology of laparoscopic-related bowel interventions, and if serosal tears were included as bowel injuries. Dr. Behman said that the study did include timing of surgery in the initial analysis and found it to be a nonfactor. However, the database did not specify the causes for bowel resections or reasons for conversions.
Dr. Behman and Dr. Diebel reported having no financial disclosures
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is to be published in the Annals of Surgery pending editorial review.
PHILADELPHIA – In surgery for small-bowel obstruction, laparoscopy is more likely to result in bowel injury than is open surgery but with ultimately better outcomes overall. This means that surgeons should proceed with “considerable caution” when performing minimally invasive surgery in the small bowel, researchers at University of Toronto reported during the annual meeting of the American Surgical Association.
In explaining the rationale for the study, Dr. Behman said, “Several studies have shown that over the last several years [that] the utilization of laparoscopic techniques for adhesive small-bowel obstruction has become increasingly common. However, these procedures have some inherent challenges.” Those technical challenges include introducing the trocar into an abdomen filled with distended bowel, trying to manipulate the distended bowel with laparoscopic bowel graspers, and the potentially ischemic bowel wall, he said.
The University of Toronto researchers performed a population-based retrospective cohort study of 8,584 patients in the Ministry of Health Ontario database from 2005 to 2014. The primary outcome was a composite, consisting of bowel repair, including operative billing codes for either via intraoperative enterotomy or suture repair of the intestine, or bowel resection. Secondary outcomes were serious complications and 30-day mortality.
During the study period, the share of SBO procedures performed laparoscopically increased from 4% in 2005 to 14.3% in 2014, Dr. Behman said.
“Patients in the laparoscopic group were slightly younger, had a lower overall comorbidity burden, and tended to be treated at larger hospitals and hospitals without teaching designations,” Dr. Behman said. Specifically, the average age of the 673 patients who had laparoscopy was 63 years vs. 67 years for the 7,911 open-procedure patients. As for comorbidities, 9% and 50% in the laparoscopic group were healthy and low users and high and very high users, respectively, vs. 7% and 57% of the open-procedure group.
The incidence of any bowel intervention was 53.5% in the laparoscopic group vs. 42% in the open group, Dr. Behman said. After a multivariable regression analysis, the researchers determined the following factors raised a patient’s odds of having a bowel intervention: older age; female sex; having had an after-hours procedure; and having had the procedure earlier in the study period. “However, even after [the researchers adjusted] for all of these covariates, the variable in our model that was most significantly associated with a bowel intervention was having had a laparoscopic procedure, with an odds ratio of 1.6,” Dr. Behman said.
When analyzing secondary outcomes, the researchers found that laparoscopy was associated with a lower risk of 30-day mortality (OR, 0.6) and serious complication (OR, 0.8). “So, there does appear to be a direct trade-off with laparoscopy probably having better clinical outcomes, but also being a risk factor for bowel intervention,” Dr. Behman said. So the researchers preformed a secondary analysis that divided the cohort into four subgroups: laparoscopy with and without bowel intervention; and open surgery with and without bowel intervention.
“The next question we wanted to ask was, in patients that are at high risk of a laparoscopic bowel injury, is an open approach or early conversion to open beneficial?” Dr. Behman said. “To put this another way, is it more important to avoid a bowel intervention or to avoid the morbidity associated with an open procedure?”
The secondary analysis confirmed that laparoscopic patients had lower rates of serious complications: in those without bowel intervention, 5% for laparoscopy vs. 10% for open; and in those who had a bowel intervention, 15% for laparoscopy vs. 22% for open. However, those who had an open procedure without a bowel intervention had lower complication rates than did those who had a laparoscopic operation with a bowel intervention, Dr. Behman said, “suggesting that perhaps the bowel intervention is a greater driver of serious complications than having an open procedure.”
These findings can inform patient selection, Dr. Behman added. “In light of the fact that laparoscopic approaches are likely associated with a greater risk of bowel intervention, appropriate caution should accompany these procedures,” he said. “In patients who are at high risk for a bowel intervention, an open approach or early conversion to a laparotomy should be considered.”
In his discussion of the study, Lawrence Diebel, MD, FACS, of Wayne State University, Detroit, asked if the study accounted for timing of surgery, the etiology of laparoscopic-related bowel interventions, and if serosal tears were included as bowel injuries. Dr. Behman said that the study did include timing of surgery in the initial analysis and found it to be a nonfactor. However, the database did not specify the causes for bowel resections or reasons for conversions.
Dr. Behman and Dr. Diebel reported having no financial disclosures
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is to be published in the Annals of Surgery pending editorial review.
PHILADELPHIA – In surgery for small-bowel obstruction, laparoscopy is more likely to result in bowel injury than is open surgery but with ultimately better outcomes overall. This means that surgeons should proceed with “considerable caution” when performing minimally invasive surgery in the small bowel, researchers at University of Toronto reported during the annual meeting of the American Surgical Association.
In explaining the rationale for the study, Dr. Behman said, “Several studies have shown that over the last several years [that] the utilization of laparoscopic techniques for adhesive small-bowel obstruction has become increasingly common. However, these procedures have some inherent challenges.” Those technical challenges include introducing the trocar into an abdomen filled with distended bowel, trying to manipulate the distended bowel with laparoscopic bowel graspers, and the potentially ischemic bowel wall, he said.
The University of Toronto researchers performed a population-based retrospective cohort study of 8,584 patients in the Ministry of Health Ontario database from 2005 to 2014. The primary outcome was a composite, consisting of bowel repair, including operative billing codes for either via intraoperative enterotomy or suture repair of the intestine, or bowel resection. Secondary outcomes were serious complications and 30-day mortality.
During the study period, the share of SBO procedures performed laparoscopically increased from 4% in 2005 to 14.3% in 2014, Dr. Behman said.
“Patients in the laparoscopic group were slightly younger, had a lower overall comorbidity burden, and tended to be treated at larger hospitals and hospitals without teaching designations,” Dr. Behman said. Specifically, the average age of the 673 patients who had laparoscopy was 63 years vs. 67 years for the 7,911 open-procedure patients. As for comorbidities, 9% and 50% in the laparoscopic group were healthy and low users and high and very high users, respectively, vs. 7% and 57% of the open-procedure group.
The incidence of any bowel intervention was 53.5% in the laparoscopic group vs. 42% in the open group, Dr. Behman said. After a multivariable regression analysis, the researchers determined the following factors raised a patient’s odds of having a bowel intervention: older age; female sex; having had an after-hours procedure; and having had the procedure earlier in the study period. “However, even after [the researchers adjusted] for all of these covariates, the variable in our model that was most significantly associated with a bowel intervention was having had a laparoscopic procedure, with an odds ratio of 1.6,” Dr. Behman said.
When analyzing secondary outcomes, the researchers found that laparoscopy was associated with a lower risk of 30-day mortality (OR, 0.6) and serious complication (OR, 0.8). “So, there does appear to be a direct trade-off with laparoscopy probably having better clinical outcomes, but also being a risk factor for bowel intervention,” Dr. Behman said. So the researchers preformed a secondary analysis that divided the cohort into four subgroups: laparoscopy with and without bowel intervention; and open surgery with and without bowel intervention.
“The next question we wanted to ask was, in patients that are at high risk of a laparoscopic bowel injury, is an open approach or early conversion to open beneficial?” Dr. Behman said. “To put this another way, is it more important to avoid a bowel intervention or to avoid the morbidity associated with an open procedure?”
The secondary analysis confirmed that laparoscopic patients had lower rates of serious complications: in those without bowel intervention, 5% for laparoscopy vs. 10% for open; and in those who had a bowel intervention, 15% for laparoscopy vs. 22% for open. However, those who had an open procedure without a bowel intervention had lower complication rates than did those who had a laparoscopic operation with a bowel intervention, Dr. Behman said, “suggesting that perhaps the bowel intervention is a greater driver of serious complications than having an open procedure.”
These findings can inform patient selection, Dr. Behman added. “In light of the fact that laparoscopic approaches are likely associated with a greater risk of bowel intervention, appropriate caution should accompany these procedures,” he said. “In patients who are at high risk for a bowel intervention, an open approach or early conversion to a laparotomy should be considered.”
In his discussion of the study, Lawrence Diebel, MD, FACS, of Wayne State University, Detroit, asked if the study accounted for timing of surgery, the etiology of laparoscopic-related bowel interventions, and if serosal tears were included as bowel injuries. Dr. Behman said that the study did include timing of surgery in the initial analysis and found it to be a nonfactor. However, the database did not specify the causes for bowel resections or reasons for conversions.
Dr. Behman and Dr. Diebel reported having no financial disclosures
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is to be published in the Annals of Surgery pending editorial review.
AT THE ASA ANNUAL MEETING
Key clinical point: Laparoscopic surgery for SBO is associated with a greater risk of bowel intervention.
Major finding: The incidence of bowel intervention was 53.5% vs. 43.4% in laparoscopic and open procedures, respectively.
Data source: Review of 8,584 procedures for SBO in the Ministry of Health Ontario database performed from 2005 to 2014.
Disclosures: Dr. Behman and Dr. Diebel reported having no financial disclosures.
Low-income uninsured trauma patients at risk for ruinous medical costs
Almost three-quarters of uninsured adults admitted for traumatic injury are at risk of catastrophic health expenditures (CHEs), according to a large retrospective study from a national patient database.
Since enactment of the Affordable Care Act in 2010, the number of uninsured individuals has dropped substantially, but there remains a large population of younger adults, many from low-income areas, who still are not covered. The Centers for Disease Control and Prevention reported in 2015 that 12.8% of individuals aged 18-64 years were uninsured. The financial impact of a traumatic injury is likely to be significant for those paying out of pocket, but the question of who is at risk and to what degree is understudied, according to John W. Scott, MD, of Brigham and Women’s Hospital, Boston, and his colleagues.
“Defining populations at risk of financial catastrophe after medical expense is a necessary step towards elucidating the effect of health care reforms intended to increase access to healthcare through insurance expansion,” they wrote in the Annals of Surgery (2017 Apr 7. doi: 10.1097/SLA.0000000000002254).
Dr. Scott and his colleagues analyzed trauma diagnoses in adults aged 18-64 years from Nationwide Inpatient Sample 2007-2011. They used the U.S. Census data to estimate post-subsistence income (income remaining after paying for food) and hospital charges for trauma diagnoses. The sample of 117,502 patient encounters was weighted to represent 579,683 trauma patients in the national database.
CHEs were defined conservatively as expenses that exceed 40% of a patient’s post-subsistence income; they also applied a lower threshold of CHEs – 10% of a patient’s entire income – without accounting for subsistence needs.
The investigators wanted to look at who was at greatest risk for CHEs and used the Census data to sort trauma patients by residential zip code to identify the distribution of income in the sample.
Costs to trauma patients varied by injury severity score (ISS) and by income quartile. Patients in the 25th income quartile paid less for their treatment, even accounting for ISS, but despite this difference, poorer patients were at a much greater risk for CHEs.
The median charge for all of these uninsured trauma patients was $27,420. Those trauma patients in the 25th percentile of income were charged an average of $15,196, while those in 75th quartile were charged $49,696. The difference in costs also was evident when comparing patients in different ISS categories: for ISS 9-15, median trauma costs for the lower-quartile patients was $31,095, but costs for the upper quartile patients was $52,639.
With cost, income, and injury severity data, the investigators found that overall the proportion of adults aged 18-64 years at risk for CHEs was 70.8% (95% confidence interval, 70.7%-71.1%). Subpopulations (ethnicity/race, age, sex) were within a few percentage point of each other.
Risk of CHEs varied widely by income quartile and ISS. Uninsured trauma patients in the highest income quartile had a 52.9% risk of CHEs, compared with 77.5% of those in the lowest-income quartile. Overall, 81.8% of patients with ISS greater than 24 were at risk for CHEs. In addition, the study found that patients treated at large or urban teaching hospitals – those most likely to handle the most-severely injured patients – were at a heightened risk for CHEs.
When the investigators conducted the same analysis with a lower threshold of CHEs (10% of income, not including subsistence expenses), the overall risk for uninsured trauma patients for catastrophic health expenses was more than 90%.
“Trauma patients are at particularly high risk for CHE because trauma disproportionately affects uninsured patients with little disposable income and because trauma injuries commonly affect multiple organ systems and incur expensive, multispecialty care,” Dr. Scott and his colleagues wrote. “Large unpaid medical debts may have longstanding impacts on patients’ financial well-being, affecting credit ratings and overall financial solvency. These financial stresses may be further compounded by an inability to return to work caused by injury.”
Dr. Scott and his coauthors added that having health insurance does not entirely eliminate the risk for CHEs and that individuals in the lower income brackets covered by employer-based plans or Medicaid had difficulty paying medical bills.
Only hospital costs were examined, which may not reflect forgiven debts, the investigators noted. In addition, the costs may be underreported because they do not include physician charges, postacute care, home health care, or rehabilitation. Incomes were estimated by zip code analysis, which may misclassify some individuals.
“Efforts are needed to ensure that the lifesaving care provided by our highly coordinated trauma systems do not have the unintended consequence of curing patients into destitution,” Dr. Scott and his colleagues wrote
The authors declared no conflicts of interest.
Almost three-quarters of uninsured adults admitted for traumatic injury are at risk of catastrophic health expenditures (CHEs), according to a large retrospective study from a national patient database.
Since enactment of the Affordable Care Act in 2010, the number of uninsured individuals has dropped substantially, but there remains a large population of younger adults, many from low-income areas, who still are not covered. The Centers for Disease Control and Prevention reported in 2015 that 12.8% of individuals aged 18-64 years were uninsured. The financial impact of a traumatic injury is likely to be significant for those paying out of pocket, but the question of who is at risk and to what degree is understudied, according to John W. Scott, MD, of Brigham and Women’s Hospital, Boston, and his colleagues.
“Defining populations at risk of financial catastrophe after medical expense is a necessary step towards elucidating the effect of health care reforms intended to increase access to healthcare through insurance expansion,” they wrote in the Annals of Surgery (2017 Apr 7. doi: 10.1097/SLA.0000000000002254).
Dr. Scott and his colleagues analyzed trauma diagnoses in adults aged 18-64 years from Nationwide Inpatient Sample 2007-2011. They used the U.S. Census data to estimate post-subsistence income (income remaining after paying for food) and hospital charges for trauma diagnoses. The sample of 117,502 patient encounters was weighted to represent 579,683 trauma patients in the national database.
CHEs were defined conservatively as expenses that exceed 40% of a patient’s post-subsistence income; they also applied a lower threshold of CHEs – 10% of a patient’s entire income – without accounting for subsistence needs.
The investigators wanted to look at who was at greatest risk for CHEs and used the Census data to sort trauma patients by residential zip code to identify the distribution of income in the sample.
Costs to trauma patients varied by injury severity score (ISS) and by income quartile. Patients in the 25th income quartile paid less for their treatment, even accounting for ISS, but despite this difference, poorer patients were at a much greater risk for CHEs.
The median charge for all of these uninsured trauma patients was $27,420. Those trauma patients in the 25th percentile of income were charged an average of $15,196, while those in 75th quartile were charged $49,696. The difference in costs also was evident when comparing patients in different ISS categories: for ISS 9-15, median trauma costs for the lower-quartile patients was $31,095, but costs for the upper quartile patients was $52,639.
With cost, income, and injury severity data, the investigators found that overall the proportion of adults aged 18-64 years at risk for CHEs was 70.8% (95% confidence interval, 70.7%-71.1%). Subpopulations (ethnicity/race, age, sex) were within a few percentage point of each other.
Risk of CHEs varied widely by income quartile and ISS. Uninsured trauma patients in the highest income quartile had a 52.9% risk of CHEs, compared with 77.5% of those in the lowest-income quartile. Overall, 81.8% of patients with ISS greater than 24 were at risk for CHEs. In addition, the study found that patients treated at large or urban teaching hospitals – those most likely to handle the most-severely injured patients – were at a heightened risk for CHEs.
When the investigators conducted the same analysis with a lower threshold of CHEs (10% of income, not including subsistence expenses), the overall risk for uninsured trauma patients for catastrophic health expenses was more than 90%.
“Trauma patients are at particularly high risk for CHE because trauma disproportionately affects uninsured patients with little disposable income and because trauma injuries commonly affect multiple organ systems and incur expensive, multispecialty care,” Dr. Scott and his colleagues wrote. “Large unpaid medical debts may have longstanding impacts on patients’ financial well-being, affecting credit ratings and overall financial solvency. These financial stresses may be further compounded by an inability to return to work caused by injury.”
Dr. Scott and his coauthors added that having health insurance does not entirely eliminate the risk for CHEs and that individuals in the lower income brackets covered by employer-based plans or Medicaid had difficulty paying medical bills.
Only hospital costs were examined, which may not reflect forgiven debts, the investigators noted. In addition, the costs may be underreported because they do not include physician charges, postacute care, home health care, or rehabilitation. Incomes were estimated by zip code analysis, which may misclassify some individuals.
“Efforts are needed to ensure that the lifesaving care provided by our highly coordinated trauma systems do not have the unintended consequence of curing patients into destitution,” Dr. Scott and his colleagues wrote
The authors declared no conflicts of interest.
Almost three-quarters of uninsured adults admitted for traumatic injury are at risk of catastrophic health expenditures (CHEs), according to a large retrospective study from a national patient database.
Since enactment of the Affordable Care Act in 2010, the number of uninsured individuals has dropped substantially, but there remains a large population of younger adults, many from low-income areas, who still are not covered. The Centers for Disease Control and Prevention reported in 2015 that 12.8% of individuals aged 18-64 years were uninsured. The financial impact of a traumatic injury is likely to be significant for those paying out of pocket, but the question of who is at risk and to what degree is understudied, according to John W. Scott, MD, of Brigham and Women’s Hospital, Boston, and his colleagues.
“Defining populations at risk of financial catastrophe after medical expense is a necessary step towards elucidating the effect of health care reforms intended to increase access to healthcare through insurance expansion,” they wrote in the Annals of Surgery (2017 Apr 7. doi: 10.1097/SLA.0000000000002254).
Dr. Scott and his colleagues analyzed trauma diagnoses in adults aged 18-64 years from Nationwide Inpatient Sample 2007-2011. They used the U.S. Census data to estimate post-subsistence income (income remaining after paying for food) and hospital charges for trauma diagnoses. The sample of 117,502 patient encounters was weighted to represent 579,683 trauma patients in the national database.
CHEs were defined conservatively as expenses that exceed 40% of a patient’s post-subsistence income; they also applied a lower threshold of CHEs – 10% of a patient’s entire income – without accounting for subsistence needs.
The investigators wanted to look at who was at greatest risk for CHEs and used the Census data to sort trauma patients by residential zip code to identify the distribution of income in the sample.
Costs to trauma patients varied by injury severity score (ISS) and by income quartile. Patients in the 25th income quartile paid less for their treatment, even accounting for ISS, but despite this difference, poorer patients were at a much greater risk for CHEs.
The median charge for all of these uninsured trauma patients was $27,420. Those trauma patients in the 25th percentile of income were charged an average of $15,196, while those in 75th quartile were charged $49,696. The difference in costs also was evident when comparing patients in different ISS categories: for ISS 9-15, median trauma costs for the lower-quartile patients was $31,095, but costs for the upper quartile patients was $52,639.
With cost, income, and injury severity data, the investigators found that overall the proportion of adults aged 18-64 years at risk for CHEs was 70.8% (95% confidence interval, 70.7%-71.1%). Subpopulations (ethnicity/race, age, sex) were within a few percentage point of each other.
Risk of CHEs varied widely by income quartile and ISS. Uninsured trauma patients in the highest income quartile had a 52.9% risk of CHEs, compared with 77.5% of those in the lowest-income quartile. Overall, 81.8% of patients with ISS greater than 24 were at risk for CHEs. In addition, the study found that patients treated at large or urban teaching hospitals – those most likely to handle the most-severely injured patients – were at a heightened risk for CHEs.
When the investigators conducted the same analysis with a lower threshold of CHEs (10% of income, not including subsistence expenses), the overall risk for uninsured trauma patients for catastrophic health expenses was more than 90%.
“Trauma patients are at particularly high risk for CHE because trauma disproportionately affects uninsured patients with little disposable income and because trauma injuries commonly affect multiple organ systems and incur expensive, multispecialty care,” Dr. Scott and his colleagues wrote. “Large unpaid medical debts may have longstanding impacts on patients’ financial well-being, affecting credit ratings and overall financial solvency. These financial stresses may be further compounded by an inability to return to work caused by injury.”
Dr. Scott and his coauthors added that having health insurance does not entirely eliminate the risk for CHEs and that individuals in the lower income brackets covered by employer-based plans or Medicaid had difficulty paying medical bills.
Only hospital costs were examined, which may not reflect forgiven debts, the investigators noted. In addition, the costs may be underreported because they do not include physician charges, postacute care, home health care, or rehabilitation. Incomes were estimated by zip code analysis, which may misclassify some individuals.
“Efforts are needed to ensure that the lifesaving care provided by our highly coordinated trauma systems do not have the unintended consequence of curing patients into destitution,” Dr. Scott and his colleagues wrote
The authors declared no conflicts of interest.
FROM ANNALS OF SURGERY
Postop pain may be a predictor for readmission
PHILADELPHIA – How a patient reacts to postoperative pain and how the pain progresses or regresses can be key predictors for 30-day hospital readmissions and emergency department visits after hospital discharge, according to an analysis of more than 200,000 operations in a national database.
The study sample included 211,213 operations in the Veterans Affairs Surgical Quality Improvement Program during 2008-2014, 45% of which were orthopedic in nature, 37% general, and 18% vascular. The overall 30-day unplanned readmission rate was 10.8% and the 30-day ED utilization rate was 14.2%, Dr. Hawn said.
The study identified six distinct postoperative inpatient pain trajectories based on postop pain scores: persistently low (4.5%); mild to low (9%); persistently mild (15.3%); moderate to low (12.1%); persistently moderate (40.2%); and persistently high (18.9%). One of the study objectives, Dr. Hawn said, “was to see if we could identify patterns of postoperative pain trajectories in a surgical cohort, and to describe these subpopulations by their trajectories, and then to determine whether there was an association with postdischarge health care utilization.” The hypothesis was that inpatient postoperative pain trajectory would be associated with 30-day readmission and ED visits as well as postop complications, Dr. Hawn added.
Patients with high pain trajectories had highest rates of postdischarge readmission and ED visits, 14.4% and 16.3%, respectively, Dr. Hawn said.
“Patients in the low-pain categories were more likely to undergo general and vascular procedures compared to orthopedic procedures in the high-pain categories,” Dr. Hawn said. “In the low-pain categories, they were older and less likely to be female. They were less likely to have independent functional status whereas patients in the high-pain category had a 26% prevalence of preoperative diagnosis of depression.”
Those in the high-pain category had a 1.5 times greater risk of an unplanned readmission and a 4 times greater risk in pain-related readmission, according to an odds ratio analysis of the data.
“As for the prevalence of our outcomes, 10.7% had an unplanned readmission. A total of 1.5% from the overall cohort had a pain-related readmission, 8.6% had an emergency visit within 30 days of discharge that did not result in a readmission, and 4.4% had at least one postdischarge complication,” Dr. Hawn said.
In his discussion, Clifford Y. Ko, MD, FACS, of the University of California, Los Angeles, asked what was the take-home for surgeons managing patients postoperatively in the era of the opioid epidemic. “For these types of patients, we need to get our colleagues, the pain specialists, involved much earlier,” Dr. Hawn said. “We need to rethink that strategy of treating the pain-score number. And I think there’s been so much national attention to this that we will stop focusing on that number as a measure of quality of care and patient satisfaction. Those are some trends we’ll see in the future.”
Neither Dr. Hawn nor Dr. Ko reported any financial disclosures
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is anticipated to be published in the Annals of Surgery pending editorial review.
PHILADELPHIA – How a patient reacts to postoperative pain and how the pain progresses or regresses can be key predictors for 30-day hospital readmissions and emergency department visits after hospital discharge, according to an analysis of more than 200,000 operations in a national database.
The study sample included 211,213 operations in the Veterans Affairs Surgical Quality Improvement Program during 2008-2014, 45% of which were orthopedic in nature, 37% general, and 18% vascular. The overall 30-day unplanned readmission rate was 10.8% and the 30-day ED utilization rate was 14.2%, Dr. Hawn said.
The study identified six distinct postoperative inpatient pain trajectories based on postop pain scores: persistently low (4.5%); mild to low (9%); persistently mild (15.3%); moderate to low (12.1%); persistently moderate (40.2%); and persistently high (18.9%). One of the study objectives, Dr. Hawn said, “was to see if we could identify patterns of postoperative pain trajectories in a surgical cohort, and to describe these subpopulations by their trajectories, and then to determine whether there was an association with postdischarge health care utilization.” The hypothesis was that inpatient postoperative pain trajectory would be associated with 30-day readmission and ED visits as well as postop complications, Dr. Hawn added.
Patients with high pain trajectories had highest rates of postdischarge readmission and ED visits, 14.4% and 16.3%, respectively, Dr. Hawn said.
“Patients in the low-pain categories were more likely to undergo general and vascular procedures compared to orthopedic procedures in the high-pain categories,” Dr. Hawn said. “In the low-pain categories, they were older and less likely to be female. They were less likely to have independent functional status whereas patients in the high-pain category had a 26% prevalence of preoperative diagnosis of depression.”
Those in the high-pain category had a 1.5 times greater risk of an unplanned readmission and a 4 times greater risk in pain-related readmission, according to an odds ratio analysis of the data.
“As for the prevalence of our outcomes, 10.7% had an unplanned readmission. A total of 1.5% from the overall cohort had a pain-related readmission, 8.6% had an emergency visit within 30 days of discharge that did not result in a readmission, and 4.4% had at least one postdischarge complication,” Dr. Hawn said.
In his discussion, Clifford Y. Ko, MD, FACS, of the University of California, Los Angeles, asked what was the take-home for surgeons managing patients postoperatively in the era of the opioid epidemic. “For these types of patients, we need to get our colleagues, the pain specialists, involved much earlier,” Dr. Hawn said. “We need to rethink that strategy of treating the pain-score number. And I think there’s been so much national attention to this that we will stop focusing on that number as a measure of quality of care and patient satisfaction. Those are some trends we’ll see in the future.”
Neither Dr. Hawn nor Dr. Ko reported any financial disclosures
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is anticipated to be published in the Annals of Surgery pending editorial review.
PHILADELPHIA – How a patient reacts to postoperative pain and how the pain progresses or regresses can be key predictors for 30-day hospital readmissions and emergency department visits after hospital discharge, according to an analysis of more than 200,000 operations in a national database.
The study sample included 211,213 operations in the Veterans Affairs Surgical Quality Improvement Program during 2008-2014, 45% of which were orthopedic in nature, 37% general, and 18% vascular. The overall 30-day unplanned readmission rate was 10.8% and the 30-day ED utilization rate was 14.2%, Dr. Hawn said.
The study identified six distinct postoperative inpatient pain trajectories based on postop pain scores: persistently low (4.5%); mild to low (9%); persistently mild (15.3%); moderate to low (12.1%); persistently moderate (40.2%); and persistently high (18.9%). One of the study objectives, Dr. Hawn said, “was to see if we could identify patterns of postoperative pain trajectories in a surgical cohort, and to describe these subpopulations by their trajectories, and then to determine whether there was an association with postdischarge health care utilization.” The hypothesis was that inpatient postoperative pain trajectory would be associated with 30-day readmission and ED visits as well as postop complications, Dr. Hawn added.
Patients with high pain trajectories had highest rates of postdischarge readmission and ED visits, 14.4% and 16.3%, respectively, Dr. Hawn said.
“Patients in the low-pain categories were more likely to undergo general and vascular procedures compared to orthopedic procedures in the high-pain categories,” Dr. Hawn said. “In the low-pain categories, they were older and less likely to be female. They were less likely to have independent functional status whereas patients in the high-pain category had a 26% prevalence of preoperative diagnosis of depression.”
Those in the high-pain category had a 1.5 times greater risk of an unplanned readmission and a 4 times greater risk in pain-related readmission, according to an odds ratio analysis of the data.
“As for the prevalence of our outcomes, 10.7% had an unplanned readmission. A total of 1.5% from the overall cohort had a pain-related readmission, 8.6% had an emergency visit within 30 days of discharge that did not result in a readmission, and 4.4% had at least one postdischarge complication,” Dr. Hawn said.
In his discussion, Clifford Y. Ko, MD, FACS, of the University of California, Los Angeles, asked what was the take-home for surgeons managing patients postoperatively in the era of the opioid epidemic. “For these types of patients, we need to get our colleagues, the pain specialists, involved much earlier,” Dr. Hawn said. “We need to rethink that strategy of treating the pain-score number. And I think there’s been so much national attention to this that we will stop focusing on that number as a measure of quality of care and patient satisfaction. Those are some trends we’ll see in the future.”
Neither Dr. Hawn nor Dr. Ko reported any financial disclosures
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is anticipated to be published in the Annals of Surgery pending editorial review.
AT THE ASA ANNUAL
Key clinical point: A higher trajectory of postoperative pain scores may be a predictor of 30-day readmission and emergency department utilization.
Major finding: Patients with high pain trajectories had the highest rates of post-discharge readmission and emergency department visits, 14.4% and 16.3%, respectively.
Data source: Retrospective cohort study of Veterans Affairs’ data on operations on 211,213 operations performed during 2008-2014.
Disclosures: Dr. Hawn and her coauthors reported having no financial disclosures.
Drainage may be nonfactor after distal pancreatectomy outcomes
PHILADELPHIA – A randomized multicenter trial that compared patients who had distal pancreatectomy with and without routine peritoneal drainage found no appreciable difference in the complication rates between the two groups, the lead investigator reported at the annual meeting of the American Surgical Association here.
The trial randomized 202 patients to the intraperitoneal drainage group and 197 to the nondrainage group. The groups were well matched in terms of patients who dropped out because of metastatic disease or other reason, as well as demographics and operative data. “They were equally matched for laparoscopic vs. open, equally matched for vascular resection, equally matched for pancreatic texture and duct size, equally matched for method of transection, equally matched for operative time and blood loss and equally matched for surgical pathology,” Dr. Van Buren said.
The primary outcome was frequency of grade 2 complications or greater, which occurred in 44% (76) of the drainage group and 42% (72) of the nondrainage group (P = .804). “Similarly, the groups were equal for grade 3 severe complications as well as median complication severity and median number of complications,” Dr. Van Buren said. The rates of complications of grade 3 or greater were 29% (51) for the drainage group and 26% (44) for the nondrainage group (P = .477). Ninety-day mortality also was similar between the two groups: None died in the drainage group and two (1%) died in the nondrainage group (P = .24).
Drilling down into types of complications, Dr. Van Buren added that rates were similar across the board. “There was no difference in clinically relevant postoperative pancreatic fistula between the drain and no-drain group,” he said. “There was no difference in intra-abdominal abscess, no difference in the rates of postoperative imaging, no difference in the rates of postoperative percutaneous drain placements, and there was no difference in readmission or reoperation.”
One outcome that was noticeably different between the two groups was intra-abdominal fluid collections, reported in 9% (15) of the drainage group and 22% (38) of the nondrainage group (P = .0004). “However,” Dr. Van Buren said, “these were asymptomatic.”
In his discussion of the presentation, Charles Yeo, MD, FACS, of Thomas Jefferson University, Philadelphia, said that “the scope and the rigor of this study are impressive and quite laudable” but raised a number of questions, including concerns about the two deaths in the nondrainage group in the context of two other trials: a smaller multicenter trial, coauthored by Dr. Van Buren, that compared postoperative use of drains and nondrainage in pancreaticoduodenectomy but was halted because of eight deaths in the nondrainage group (Ann Surg. 2014;259:605-12); and the German PANDRA trial reported at last year’s ASA meeting that found nondrainage after pancreaticoduodenectomy to be superior to drainage in terms of reintervention and fistula rates.
Dr. Van Buren replied that the first study from Baylor – referenced by Dr. Yeo – involved “well-balanced groups, and they were equally matched and had minimal dropout throughout.” Because of that, the finding that drain placement for the pancreaticoduodenectomy “was definitive,” whereas the PANDRA trial was subject to some criticisms. The screening and randomization processes in PANDRA have been criticized because 3,200 patients were eligible for enrollment, suggesting a screening bias, Dr. Van Buren said. In addition, drains were placed in 21% of patients who were allocated to the no-drain group, suggesting surgeons deviated from the protocol in higher-risk situations, resulting in additional selection bias. This implies PANDRA was more of a selective draining trial, he said.
Dr. Van Buren and Dr. Yeo reported having no financial disclosures.
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is to be published in Annals of Surgery pending editorial review.
PHILADELPHIA – A randomized multicenter trial that compared patients who had distal pancreatectomy with and without routine peritoneal drainage found no appreciable difference in the complication rates between the two groups, the lead investigator reported at the annual meeting of the American Surgical Association here.
The trial randomized 202 patients to the intraperitoneal drainage group and 197 to the nondrainage group. The groups were well matched in terms of patients who dropped out because of metastatic disease or other reason, as well as demographics and operative data. “They were equally matched for laparoscopic vs. open, equally matched for vascular resection, equally matched for pancreatic texture and duct size, equally matched for method of transection, equally matched for operative time and blood loss and equally matched for surgical pathology,” Dr. Van Buren said.
The primary outcome was frequency of grade 2 complications or greater, which occurred in 44% (76) of the drainage group and 42% (72) of the nondrainage group (P = .804). “Similarly, the groups were equal for grade 3 severe complications as well as median complication severity and median number of complications,” Dr. Van Buren said. The rates of complications of grade 3 or greater were 29% (51) for the drainage group and 26% (44) for the nondrainage group (P = .477). Ninety-day mortality also was similar between the two groups: None died in the drainage group and two (1%) died in the nondrainage group (P = .24).
Drilling down into types of complications, Dr. Van Buren added that rates were similar across the board. “There was no difference in clinically relevant postoperative pancreatic fistula between the drain and no-drain group,” he said. “There was no difference in intra-abdominal abscess, no difference in the rates of postoperative imaging, no difference in the rates of postoperative percutaneous drain placements, and there was no difference in readmission or reoperation.”
One outcome that was noticeably different between the two groups was intra-abdominal fluid collections, reported in 9% (15) of the drainage group and 22% (38) of the nondrainage group (P = .0004). “However,” Dr. Van Buren said, “these were asymptomatic.”
In his discussion of the presentation, Charles Yeo, MD, FACS, of Thomas Jefferson University, Philadelphia, said that “the scope and the rigor of this study are impressive and quite laudable” but raised a number of questions, including concerns about the two deaths in the nondrainage group in the context of two other trials: a smaller multicenter trial, coauthored by Dr. Van Buren, that compared postoperative use of drains and nondrainage in pancreaticoduodenectomy but was halted because of eight deaths in the nondrainage group (Ann Surg. 2014;259:605-12); and the German PANDRA trial reported at last year’s ASA meeting that found nondrainage after pancreaticoduodenectomy to be superior to drainage in terms of reintervention and fistula rates.
Dr. Van Buren replied that the first study from Baylor – referenced by Dr. Yeo – involved “well-balanced groups, and they were equally matched and had minimal dropout throughout.” Because of that, the finding that drain placement for the pancreaticoduodenectomy “was definitive,” whereas the PANDRA trial was subject to some criticisms. The screening and randomization processes in PANDRA have been criticized because 3,200 patients were eligible for enrollment, suggesting a screening bias, Dr. Van Buren said. In addition, drains were placed in 21% of patients who were allocated to the no-drain group, suggesting surgeons deviated from the protocol in higher-risk situations, resulting in additional selection bias. This implies PANDRA was more of a selective draining trial, he said.
Dr. Van Buren and Dr. Yeo reported having no financial disclosures.
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is to be published in Annals of Surgery pending editorial review.
PHILADELPHIA – A randomized multicenter trial that compared patients who had distal pancreatectomy with and without routine peritoneal drainage found no appreciable difference in the complication rates between the two groups, the lead investigator reported at the annual meeting of the American Surgical Association here.
The trial randomized 202 patients to the intraperitoneal drainage group and 197 to the nondrainage group. The groups were well matched in terms of patients who dropped out because of metastatic disease or other reason, as well as demographics and operative data. “They were equally matched for laparoscopic vs. open, equally matched for vascular resection, equally matched for pancreatic texture and duct size, equally matched for method of transection, equally matched for operative time and blood loss and equally matched for surgical pathology,” Dr. Van Buren said.
The primary outcome was frequency of grade 2 complications or greater, which occurred in 44% (76) of the drainage group and 42% (72) of the nondrainage group (P = .804). “Similarly, the groups were equal for grade 3 severe complications as well as median complication severity and median number of complications,” Dr. Van Buren said. The rates of complications of grade 3 or greater were 29% (51) for the drainage group and 26% (44) for the nondrainage group (P = .477). Ninety-day mortality also was similar between the two groups: None died in the drainage group and two (1%) died in the nondrainage group (P = .24).
Drilling down into types of complications, Dr. Van Buren added that rates were similar across the board. “There was no difference in clinically relevant postoperative pancreatic fistula between the drain and no-drain group,” he said. “There was no difference in intra-abdominal abscess, no difference in the rates of postoperative imaging, no difference in the rates of postoperative percutaneous drain placements, and there was no difference in readmission or reoperation.”
One outcome that was noticeably different between the two groups was intra-abdominal fluid collections, reported in 9% (15) of the drainage group and 22% (38) of the nondrainage group (P = .0004). “However,” Dr. Van Buren said, “these were asymptomatic.”
In his discussion of the presentation, Charles Yeo, MD, FACS, of Thomas Jefferson University, Philadelphia, said that “the scope and the rigor of this study are impressive and quite laudable” but raised a number of questions, including concerns about the two deaths in the nondrainage group in the context of two other trials: a smaller multicenter trial, coauthored by Dr. Van Buren, that compared postoperative use of drains and nondrainage in pancreaticoduodenectomy but was halted because of eight deaths in the nondrainage group (Ann Surg. 2014;259:605-12); and the German PANDRA trial reported at last year’s ASA meeting that found nondrainage after pancreaticoduodenectomy to be superior to drainage in terms of reintervention and fistula rates.
Dr. Van Buren replied that the first study from Baylor – referenced by Dr. Yeo – involved “well-balanced groups, and they were equally matched and had minimal dropout throughout.” Because of that, the finding that drain placement for the pancreaticoduodenectomy “was definitive,” whereas the PANDRA trial was subject to some criticisms. The screening and randomization processes in PANDRA have been criticized because 3,200 patients were eligible for enrollment, suggesting a screening bias, Dr. Van Buren said. In addition, drains were placed in 21% of patients who were allocated to the no-drain group, suggesting surgeons deviated from the protocol in higher-risk situations, resulting in additional selection bias. This implies PANDRA was more of a selective draining trial, he said.
Dr. Van Buren and Dr. Yeo reported having no financial disclosures.
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is to be published in Annals of Surgery pending editorial review.
AT THE ASA ANNUAL
Key clinical point: A randomized clinical trial has provided Level 1 evidence that placement of intraperitoneal drains does not alter clinical outcomes after distal pancreatectomy.
Major finding: No significant difference was found in the rate of complications between those who had drains and those who did not (44% vs. 42% of complications greater than grade 2).
Data source: Randomized trial of 399 patients who underwent distal pancreatectomy at 14 high-volume pancreas centers.
Disclosures: Dr. Van Buren reported having no financial disclosures.
Androgen receptor screening not ready for triple-negative breast cancer
LAS VEGAS – Despite the early promise of antiandrogen therapy, it’s not time yet to routinely screen women with triple-negative breast cancer for androgen receptors, according to Tiffany A. Traina, MD, the head of research into the disease at Memorial Sloan Kettering Cancer Center, New York.
There’s no standardized test for androgen receptors in breast cancer, so people “are doing different kinds of testing.” In the literature, “the range of AR positivity is anywhere from 12% to 79%, which reflects how we are all over the map in methodology; you might just as well throw a dart at the board. I would encourage screening in the context of the ongoing trials,” Dr. Traina said.
More than a decade ago, Memorial Sloan Kettering found a subset of TNBC that had ARs, which was peculiar because the tumors weren’t otherwise responsive to hormones. Androgen exposure increased growth, but the AR antagonist flutamide (Eulexin)blocked it. “It was thought provoking. There are a lot of drugs in the prostate cancer world” such as flutamide that shut down androgens, she said (Oncogene. 2006 Jun 29;25[28]:3994-4008).
Several have been tried, and investigations are ongoing. The work matters because TNBC is a particularly bad diagnosis. Blocking androgens seems to give some women a few more months of life.
Dr. Traina was the senior author in an early proof-of-concept study for AR blockade that involved 26 women with metastatic TNBC who had been through up to eight prior chemotherapy regimens. The women received 150 mg daily of the prostate cancer AR antagonist bicalutamide (Casodex). Disease remained stable in five (19%) for more than 6 months. Median progression-free survival was 12 weeks, which was “not that far off from what you get with [standard] chemotherapies. This was encouraging, and it led to multiple other trials looking at targeted therapies,” she said (Clin Cancer Res. 2013 Oct 1; 19[19]: 5505-12).
Dr. Traina led a phase II investigation of the prostate cancer AR antagonist enzalutamide (Xtandi) in 118 women with advanced AR-positive TNBC. Her team created an androgen-driven gene signature as a potential biomarker of response. Median progression-free survival was 32 weeks in the 56 women (47%) who were positive for the gene signature, but 9 weeks in those who were not. There were two complete responses and five partial responses with enzalutamide. Currently, “we are looking at using enzalutamide for patients with AR-positive TNBC in the early stage after failure of standard therapies,” she said.
French investigators recently reported a 6-month clinical benefit – including one complete response – in 7 (21%) of 34 women with locally advanced or metastatic TNBC who were treated with 1,000 mg daily of abiraterone acetate (Zytiga), an androgen biosynthesis inhibitor approved for prostate cancer (Ann Oncol. 2016 May;27[5]:812-8).
“We still have a ways to go” before AR treatment reaches the clinic for routine breast cancer treatment, “but there’s reason for hope,” Dr. Traina said.
Dr. Traina reported funding, honoraria, and steering committing payments from a number of companies working on or marketing TNBC AR drugs, including Pfizer, Astellas, Innocrin, AstraZeneca, Eisai, and Merck.
LAS VEGAS – Despite the early promise of antiandrogen therapy, it’s not time yet to routinely screen women with triple-negative breast cancer for androgen receptors, according to Tiffany A. Traina, MD, the head of research into the disease at Memorial Sloan Kettering Cancer Center, New York.
There’s no standardized test for androgen receptors in breast cancer, so people “are doing different kinds of testing.” In the literature, “the range of AR positivity is anywhere from 12% to 79%, which reflects how we are all over the map in methodology; you might just as well throw a dart at the board. I would encourage screening in the context of the ongoing trials,” Dr. Traina said.
More than a decade ago, Memorial Sloan Kettering found a subset of TNBC that had ARs, which was peculiar because the tumors weren’t otherwise responsive to hormones. Androgen exposure increased growth, but the AR antagonist flutamide (Eulexin)blocked it. “It was thought provoking. There are a lot of drugs in the prostate cancer world” such as flutamide that shut down androgens, she said (Oncogene. 2006 Jun 29;25[28]:3994-4008).
Several have been tried, and investigations are ongoing. The work matters because TNBC is a particularly bad diagnosis. Blocking androgens seems to give some women a few more months of life.
Dr. Traina was the senior author in an early proof-of-concept study for AR blockade that involved 26 women with metastatic TNBC who had been through up to eight prior chemotherapy regimens. The women received 150 mg daily of the prostate cancer AR antagonist bicalutamide (Casodex). Disease remained stable in five (19%) for more than 6 months. Median progression-free survival was 12 weeks, which was “not that far off from what you get with [standard] chemotherapies. This was encouraging, and it led to multiple other trials looking at targeted therapies,” she said (Clin Cancer Res. 2013 Oct 1; 19[19]: 5505-12).
Dr. Traina led a phase II investigation of the prostate cancer AR antagonist enzalutamide (Xtandi) in 118 women with advanced AR-positive TNBC. Her team created an androgen-driven gene signature as a potential biomarker of response. Median progression-free survival was 32 weeks in the 56 women (47%) who were positive for the gene signature, but 9 weeks in those who were not. There were two complete responses and five partial responses with enzalutamide. Currently, “we are looking at using enzalutamide for patients with AR-positive TNBC in the early stage after failure of standard therapies,” she said.
French investigators recently reported a 6-month clinical benefit – including one complete response – in 7 (21%) of 34 women with locally advanced or metastatic TNBC who were treated with 1,000 mg daily of abiraterone acetate (Zytiga), an androgen biosynthesis inhibitor approved for prostate cancer (Ann Oncol. 2016 May;27[5]:812-8).
“We still have a ways to go” before AR treatment reaches the clinic for routine breast cancer treatment, “but there’s reason for hope,” Dr. Traina said.
Dr. Traina reported funding, honoraria, and steering committing payments from a number of companies working on or marketing TNBC AR drugs, including Pfizer, Astellas, Innocrin, AstraZeneca, Eisai, and Merck.
LAS VEGAS – Despite the early promise of antiandrogen therapy, it’s not time yet to routinely screen women with triple-negative breast cancer for androgen receptors, according to Tiffany A. Traina, MD, the head of research into the disease at Memorial Sloan Kettering Cancer Center, New York.
There’s no standardized test for androgen receptors in breast cancer, so people “are doing different kinds of testing.” In the literature, “the range of AR positivity is anywhere from 12% to 79%, which reflects how we are all over the map in methodology; you might just as well throw a dart at the board. I would encourage screening in the context of the ongoing trials,” Dr. Traina said.
More than a decade ago, Memorial Sloan Kettering found a subset of TNBC that had ARs, which was peculiar because the tumors weren’t otherwise responsive to hormones. Androgen exposure increased growth, but the AR antagonist flutamide (Eulexin)blocked it. “It was thought provoking. There are a lot of drugs in the prostate cancer world” such as flutamide that shut down androgens, she said (Oncogene. 2006 Jun 29;25[28]:3994-4008).
Several have been tried, and investigations are ongoing. The work matters because TNBC is a particularly bad diagnosis. Blocking androgens seems to give some women a few more months of life.
Dr. Traina was the senior author in an early proof-of-concept study for AR blockade that involved 26 women with metastatic TNBC who had been through up to eight prior chemotherapy regimens. The women received 150 mg daily of the prostate cancer AR antagonist bicalutamide (Casodex). Disease remained stable in five (19%) for more than 6 months. Median progression-free survival was 12 weeks, which was “not that far off from what you get with [standard] chemotherapies. This was encouraging, and it led to multiple other trials looking at targeted therapies,” she said (Clin Cancer Res. 2013 Oct 1; 19[19]: 5505-12).
Dr. Traina led a phase II investigation of the prostate cancer AR antagonist enzalutamide (Xtandi) in 118 women with advanced AR-positive TNBC. Her team created an androgen-driven gene signature as a potential biomarker of response. Median progression-free survival was 32 weeks in the 56 women (47%) who were positive for the gene signature, but 9 weeks in those who were not. There were two complete responses and five partial responses with enzalutamide. Currently, “we are looking at using enzalutamide for patients with AR-positive TNBC in the early stage after failure of standard therapies,” she said.
French investigators recently reported a 6-month clinical benefit – including one complete response – in 7 (21%) of 34 women with locally advanced or metastatic TNBC who were treated with 1,000 mg daily of abiraterone acetate (Zytiga), an androgen biosynthesis inhibitor approved for prostate cancer (Ann Oncol. 2016 May;27[5]:812-8).
“We still have a ways to go” before AR treatment reaches the clinic for routine breast cancer treatment, “but there’s reason for hope,” Dr. Traina said.
Dr. Traina reported funding, honoraria, and steering committing payments from a number of companies working on or marketing TNBC AR drugs, including Pfizer, Astellas, Innocrin, AstraZeneca, Eisai, and Merck.
EXPERT ANALYSIS FROM ASBS 2017
Endoscopic weight loss surgery cuts costs, side effects
Obese patients who underwent endoscopic sleeve gastroplasty had significantly fewer complications and shorter hospital stays than did those who had laparoscopic sleeve gastrectomy or laparoscopic band placement, according to results from a study of 278 adults. The data were presented at the annual Digestive Disease Week®.
Overall, 1% of patients who underwent endoscopic sleeve gastroplasty (ESG) experienced adverse events, compared with 8% of those who underwent laparoscopic sleeve gastrectomy (LSG) and 9% of those who underwent laparoscopic band placement (LAGB).
ESG, which reduces gastric volume by use of an endoscopic suturing system of full-thickness sutures through the greater curvature of the stomach, is becoming a popular weight-loss procedure for patients with a body mass index greater than 30 kg/m2 who are poor candidates for laparoscopic surgery or who would prefer a less invasive procedure, according to Reem Z. Sharaiha, MD, of Cornell University, New York.
Dr. Sharaiha and her colleagues randomized 91 patients to ESG, 120 to LSG, and 67 to LAGB. Patient demographic characteristics, including age, gender, and diabetes, were similar among the three groups. However, patients in the LSG group had a higher average BMI than did the LAGB and ESG groups (47.3 kg/m2, 45.7 kg/m2, and 38.8 kg/m2, respectively). In addition, the incidence of hypertension, and hyperlipidemia was significantly higher in each of the surgical groups compared to the ESG group (P less than .01).
The average postprocedure hospital stay was 0.13 days for ESG patients compared with 3.09 days for LSG patients and 1.68 days for LAGB patients. ESG also had the lowest cost of the three procedures, averaging $12,000 for the procedure compared to $22,000 for LSG and $15,000 for LAGB.
After 1 year, patients in the LSG group had the greatest percentage of total body weight loss (29.3%), followed by ESG patients (17.6%), and LAGB patients (14.5%). Rates of leaks, pulmonary embolism events, and 90-day readmission were not significantly different among the groups.
The study results do not imply that ESG will replace either LAGB or LSG for weight loss, Dr. Sharaiha noted, but the results suggest that ESG is a viable option for some patients.
Dr. Sharaiha had no relevant financial conflicts to disclose.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
Obese patients who underwent endoscopic sleeve gastroplasty had significantly fewer complications and shorter hospital stays than did those who had laparoscopic sleeve gastrectomy or laparoscopic band placement, according to results from a study of 278 adults. The data were presented at the annual Digestive Disease Week®.
Overall, 1% of patients who underwent endoscopic sleeve gastroplasty (ESG) experienced adverse events, compared with 8% of those who underwent laparoscopic sleeve gastrectomy (LSG) and 9% of those who underwent laparoscopic band placement (LAGB).
ESG, which reduces gastric volume by use of an endoscopic suturing system of full-thickness sutures through the greater curvature of the stomach, is becoming a popular weight-loss procedure for patients with a body mass index greater than 30 kg/m2 who are poor candidates for laparoscopic surgery or who would prefer a less invasive procedure, according to Reem Z. Sharaiha, MD, of Cornell University, New York.
Dr. Sharaiha and her colleagues randomized 91 patients to ESG, 120 to LSG, and 67 to LAGB. Patient demographic characteristics, including age, gender, and diabetes, were similar among the three groups. However, patients in the LSG group had a higher average BMI than did the LAGB and ESG groups (47.3 kg/m2, 45.7 kg/m2, and 38.8 kg/m2, respectively). In addition, the incidence of hypertension, and hyperlipidemia was significantly higher in each of the surgical groups compared to the ESG group (P less than .01).
The average postprocedure hospital stay was 0.13 days for ESG patients compared with 3.09 days for LSG patients and 1.68 days for LAGB patients. ESG also had the lowest cost of the three procedures, averaging $12,000 for the procedure compared to $22,000 for LSG and $15,000 for LAGB.
After 1 year, patients in the LSG group had the greatest percentage of total body weight loss (29.3%), followed by ESG patients (17.6%), and LAGB patients (14.5%). Rates of leaks, pulmonary embolism events, and 90-day readmission were not significantly different among the groups.
The study results do not imply that ESG will replace either LAGB or LSG for weight loss, Dr. Sharaiha noted, but the results suggest that ESG is a viable option for some patients.
Dr. Sharaiha had no relevant financial conflicts to disclose.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
Obese patients who underwent endoscopic sleeve gastroplasty had significantly fewer complications and shorter hospital stays than did those who had laparoscopic sleeve gastrectomy or laparoscopic band placement, according to results from a study of 278 adults. The data were presented at the annual Digestive Disease Week®.
Overall, 1% of patients who underwent endoscopic sleeve gastroplasty (ESG) experienced adverse events, compared with 8% of those who underwent laparoscopic sleeve gastrectomy (LSG) and 9% of those who underwent laparoscopic band placement (LAGB).
ESG, which reduces gastric volume by use of an endoscopic suturing system of full-thickness sutures through the greater curvature of the stomach, is becoming a popular weight-loss procedure for patients with a body mass index greater than 30 kg/m2 who are poor candidates for laparoscopic surgery or who would prefer a less invasive procedure, according to Reem Z. Sharaiha, MD, of Cornell University, New York.
Dr. Sharaiha and her colleagues randomized 91 patients to ESG, 120 to LSG, and 67 to LAGB. Patient demographic characteristics, including age, gender, and diabetes, were similar among the three groups. However, patients in the LSG group had a higher average BMI than did the LAGB and ESG groups (47.3 kg/m2, 45.7 kg/m2, and 38.8 kg/m2, respectively). In addition, the incidence of hypertension, and hyperlipidemia was significantly higher in each of the surgical groups compared to the ESG group (P less than .01).
The average postprocedure hospital stay was 0.13 days for ESG patients compared with 3.09 days for LSG patients and 1.68 days for LAGB patients. ESG also had the lowest cost of the three procedures, averaging $12,000 for the procedure compared to $22,000 for LSG and $15,000 for LAGB.
After 1 year, patients in the LSG group had the greatest percentage of total body weight loss (29.3%), followed by ESG patients (17.6%), and LAGB patients (14.5%). Rates of leaks, pulmonary embolism events, and 90-day readmission were not significantly different among the groups.
The study results do not imply that ESG will replace either LAGB or LSG for weight loss, Dr. Sharaiha noted, but the results suggest that ESG is a viable option for some patients.
Dr. Sharaiha had no relevant financial conflicts to disclose.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
FROM DDW
Key clinical point: Endoscopic sleeve gastroplasty is a viable option for patients seeking weight loss but wishing to avoid major surgery.
Major finding: After 1 year, 1% of patients who underwent endoscopic sleeve gastroplasty experienced adverse events, compared with 8% of laparoscopic sleeve gastrectomy patients, and 9% of laparoscopic band placement patients.
Data source: A randomized trial of 278 obese adults who underwent one of three weight loss procedures.
Disclosures: Dr. Sharaiha had no relevant financial conflicts to disclose.
Restoring the promise of (really) meaningful use
When we started publishing the EHR Report several years ago, our very first column was a brief overview of a new federal incentive program known as Meaningful Use. At that time, the prospect of receiving thousands of dollars to adopt an electronic health record seemed exciting, and our dream of health care’s digital future appeared to be coming true.
Best of all, we as physicians would be paid to simply embrace it!
Unfortunately, it wasn’t long before that dream (for many at least) devolved into a nightmare. Electronic health records hadn’t been designed to fit into physicians’ long-established work flows, and just weren’t up to the challenge of increasing efficiency. In fact, EHRs quickly became virtual taskmasters, leaving physicians mired in a sea of clicks and slow-moving screens.
Frankly speaking, Meaningful Use hasn’t lived up to its promises. With measures obligating users to fill in a myriad of check-boxes and document often irrelevant information, the program has seemed less like an incentive and more like a penance.
To top it off, the all-or-nothing requirement has meant that – after a year of hard work – providers missing even one goal receive no payments at all, and instead are assessed financial penalties!
All of this has appropriately led physicians to become jaded – not excited – about the digital future.
Thankfully, there is reason for hope: 2017 marks the end of Meaningful Use under Medicare.
What’s new for 2017?
MACRA has a much grander scope and sets an even loftier goal: transforming care delivery to achieve better value and ultimately healthier patients.
Now, in case you’re not already confused by the number of programs cited above, there is one more we need to mention to explain the future of EHR incentives: the Merit-based Incentive Payment System, or MIPS, one of two tracks in the Quality Payment Program.
The majority of Medicare providers will choose this track, which focuses on four major components to determine reimbursement incentives: quality, improvement activities, advancing care information, and cost.
Depending on performance in each of these areas, participants will see a variable payment adjustment (upward or downward) in subsequent years (this is a percentage of Medicare payments that increases annually, beginning with a possible +/– 4% in 2019, to a maximum of +/– 9% in 2022).
Providers under MIPS who choose to attest for this year can select from three levels of participation:
1. Test: submission of only a minimal amount of 2017 data (such as one or two measures) to avoid penalty.
2. Partial: submission of 90 days’ worth of data, which may result in a neutral or positive payment adjustment (and may even earn the max adjustment).
3. Full: submission of a full year of data.
Here’s an example of how this will work: A provider who attests in March 2018 for the full 2017 year and does really well could see up to a 4% incentive bonus on Medicare payments in 2019. A provider who chooses not to attest would receive a penalty of 4%.
It’s worth noting here that MIPS expands upon the inclusion criteria set for Meaningful Use under Medicare. Medicare Part B clinicians are eligible to participate if they bill $30,000 in charges and see at least 100 Medicare patients annually. MIPS also broadens the list of eligible provider types. Physicians, nurse practitioners, physician assistants, clinical nurse specialists, and certified registered nurse anesthetists are all able to attest.
Advancing Care Information
Under MIPS, Meaningful Use is replaced by an initiative called Advancing Care Information, or ACI. In this new incarnation, there are fewer required measures, and they are much less onerous than they were under the former program.
Also, there are a number of optional measures. A provider may choose to attest to these nonrequired metrics to improve his or her chances of achieving the maximum incentive, but it isn’t necessary. There are also bonus measures involving public health registry reporting. These are optional but a sure bet to increase incentives. In all, the ACI component composes 25% of a provider’s final MIPS score.
For 2017, participants are able to choose one of two tracks in the ACI program, depending on their EHR’s certification year. (If you are confused by this or don’t know the status of your product, check with your vendor or go to https://chpl.healthit.gov to figure it out).
Providers with technology certified to the 2015 edition (or a combination of technologies from the 2014 and 2015 editions) can fully attest to the ACI objectives and measures or elect to use the transition objectives and measures. Those with 2014 edition software must choose the transition measures.
We will cover the specific measures in a future column, but for now we’ll note that both tracks are very similar and focus on protecting patient data, encouraging patient access to their own records, and sharing information electronically with other providers.
Rekindling the dream
We are certain that changing legislation won’t solve all of the problems inherent in current EHR systems, but we are always encouraged by any attempt to reduce the documentation burden on physicians. By eschewing thresholds, eliminating the all-or-nothing requirement, and reducing the number of required measures, the ACI program does seem to shift the focus away from volume and toward value.
That alone has the potential to restore our hope of a brighter future, and make our use of electronic health records significantly more meaningful.
Note: To learn more about Quality Payment Program and MIPS, we highly recommend an online resource published by the Centers for Medicare & Medicaid Services that is easy to follow and is full of useful information. It can be found at https://qpp.cms.gov.
Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.
When we started publishing the EHR Report several years ago, our very first column was a brief overview of a new federal incentive program known as Meaningful Use. At that time, the prospect of receiving thousands of dollars to adopt an electronic health record seemed exciting, and our dream of health care’s digital future appeared to be coming true.
Best of all, we as physicians would be paid to simply embrace it!
Unfortunately, it wasn’t long before that dream (for many at least) devolved into a nightmare. Electronic health records hadn’t been designed to fit into physicians’ long-established work flows, and just weren’t up to the challenge of increasing efficiency. In fact, EHRs quickly became virtual taskmasters, leaving physicians mired in a sea of clicks and slow-moving screens.
Frankly speaking, Meaningful Use hasn’t lived up to its promises. With measures obligating users to fill in a myriad of check-boxes and document often irrelevant information, the program has seemed less like an incentive and more like a penance.
To top it off, the all-or-nothing requirement has meant that – after a year of hard work – providers missing even one goal receive no payments at all, and instead are assessed financial penalties!
All of this has appropriately led physicians to become jaded – not excited – about the digital future.
Thankfully, there is reason for hope: 2017 marks the end of Meaningful Use under Medicare.
What’s new for 2017?
MACRA has a much grander scope and sets an even loftier goal: transforming care delivery to achieve better value and ultimately healthier patients.
Now, in case you’re not already confused by the number of programs cited above, there is one more we need to mention to explain the future of EHR incentives: the Merit-based Incentive Payment System, or MIPS, one of two tracks in the Quality Payment Program.
The majority of Medicare providers will choose this track, which focuses on four major components to determine reimbursement incentives: quality, improvement activities, advancing care information, and cost.
Depending on performance in each of these areas, participants will see a variable payment adjustment (upward or downward) in subsequent years (this is a percentage of Medicare payments that increases annually, beginning with a possible +/– 4% in 2019, to a maximum of +/– 9% in 2022).
Providers under MIPS who choose to attest for this year can select from three levels of participation:
1. Test: submission of only a minimal amount of 2017 data (such as one or two measures) to avoid penalty.
2. Partial: submission of 90 days’ worth of data, which may result in a neutral or positive payment adjustment (and may even earn the max adjustment).
3. Full: submission of a full year of data.
Here’s an example of how this will work: A provider who attests in March 2018 for the full 2017 year and does really well could see up to a 4% incentive bonus on Medicare payments in 2019. A provider who chooses not to attest would receive a penalty of 4%.
It’s worth noting here that MIPS expands upon the inclusion criteria set for Meaningful Use under Medicare. Medicare Part B clinicians are eligible to participate if they bill $30,000 in charges and see at least 100 Medicare patients annually. MIPS also broadens the list of eligible provider types. Physicians, nurse practitioners, physician assistants, clinical nurse specialists, and certified registered nurse anesthetists are all able to attest.
Advancing Care Information
Under MIPS, Meaningful Use is replaced by an initiative called Advancing Care Information, or ACI. In this new incarnation, there are fewer required measures, and they are much less onerous than they were under the former program.
Also, there are a number of optional measures. A provider may choose to attest to these nonrequired metrics to improve his or her chances of achieving the maximum incentive, but it isn’t necessary. There are also bonus measures involving public health registry reporting. These are optional but a sure bet to increase incentives. In all, the ACI component composes 25% of a provider’s final MIPS score.
For 2017, participants are able to choose one of two tracks in the ACI program, depending on their EHR’s certification year. (If you are confused by this or don’t know the status of your product, check with your vendor or go to https://chpl.healthit.gov to figure it out).
Providers with technology certified to the 2015 edition (or a combination of technologies from the 2014 and 2015 editions) can fully attest to the ACI objectives and measures or elect to use the transition objectives and measures. Those with 2014 edition software must choose the transition measures.
We will cover the specific measures in a future column, but for now we’ll note that both tracks are very similar and focus on protecting patient data, encouraging patient access to their own records, and sharing information electronically with other providers.
Rekindling the dream
We are certain that changing legislation won’t solve all of the problems inherent in current EHR systems, but we are always encouraged by any attempt to reduce the documentation burden on physicians. By eschewing thresholds, eliminating the all-or-nothing requirement, and reducing the number of required measures, the ACI program does seem to shift the focus away from volume and toward value.
That alone has the potential to restore our hope of a brighter future, and make our use of electronic health records significantly more meaningful.
Note: To learn more about Quality Payment Program and MIPS, we highly recommend an online resource published by the Centers for Medicare & Medicaid Services that is easy to follow and is full of useful information. It can be found at https://qpp.cms.gov.
Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.
When we started publishing the EHR Report several years ago, our very first column was a brief overview of a new federal incentive program known as Meaningful Use. At that time, the prospect of receiving thousands of dollars to adopt an electronic health record seemed exciting, and our dream of health care’s digital future appeared to be coming true.
Best of all, we as physicians would be paid to simply embrace it!
Unfortunately, it wasn’t long before that dream (for many at least) devolved into a nightmare. Electronic health records hadn’t been designed to fit into physicians’ long-established work flows, and just weren’t up to the challenge of increasing efficiency. In fact, EHRs quickly became virtual taskmasters, leaving physicians mired in a sea of clicks and slow-moving screens.
Frankly speaking, Meaningful Use hasn’t lived up to its promises. With measures obligating users to fill in a myriad of check-boxes and document often irrelevant information, the program has seemed less like an incentive and more like a penance.
To top it off, the all-or-nothing requirement has meant that – after a year of hard work – providers missing even one goal receive no payments at all, and instead are assessed financial penalties!
All of this has appropriately led physicians to become jaded – not excited – about the digital future.
Thankfully, there is reason for hope: 2017 marks the end of Meaningful Use under Medicare.
What’s new for 2017?
MACRA has a much grander scope and sets an even loftier goal: transforming care delivery to achieve better value and ultimately healthier patients.
Now, in case you’re not already confused by the number of programs cited above, there is one more we need to mention to explain the future of EHR incentives: the Merit-based Incentive Payment System, or MIPS, one of two tracks in the Quality Payment Program.
The majority of Medicare providers will choose this track, which focuses on four major components to determine reimbursement incentives: quality, improvement activities, advancing care information, and cost.
Depending on performance in each of these areas, participants will see a variable payment adjustment (upward or downward) in subsequent years (this is a percentage of Medicare payments that increases annually, beginning with a possible +/– 4% in 2019, to a maximum of +/– 9% in 2022).
Providers under MIPS who choose to attest for this year can select from three levels of participation:
1. Test: submission of only a minimal amount of 2017 data (such as one or two measures) to avoid penalty.
2. Partial: submission of 90 days’ worth of data, which may result in a neutral or positive payment adjustment (and may even earn the max adjustment).
3. Full: submission of a full year of data.
Here’s an example of how this will work: A provider who attests in March 2018 for the full 2017 year and does really well could see up to a 4% incentive bonus on Medicare payments in 2019. A provider who chooses not to attest would receive a penalty of 4%.
It’s worth noting here that MIPS expands upon the inclusion criteria set for Meaningful Use under Medicare. Medicare Part B clinicians are eligible to participate if they bill $30,000 in charges and see at least 100 Medicare patients annually. MIPS also broadens the list of eligible provider types. Physicians, nurse practitioners, physician assistants, clinical nurse specialists, and certified registered nurse anesthetists are all able to attest.
Advancing Care Information
Under MIPS, Meaningful Use is replaced by an initiative called Advancing Care Information, or ACI. In this new incarnation, there are fewer required measures, and they are much less onerous than they were under the former program.
Also, there are a number of optional measures. A provider may choose to attest to these nonrequired metrics to improve his or her chances of achieving the maximum incentive, but it isn’t necessary. There are also bonus measures involving public health registry reporting. These are optional but a sure bet to increase incentives. In all, the ACI component composes 25% of a provider’s final MIPS score.
For 2017, participants are able to choose one of two tracks in the ACI program, depending on their EHR’s certification year. (If you are confused by this or don’t know the status of your product, check with your vendor or go to https://chpl.healthit.gov to figure it out).
Providers with technology certified to the 2015 edition (or a combination of technologies from the 2014 and 2015 editions) can fully attest to the ACI objectives and measures or elect to use the transition objectives and measures. Those with 2014 edition software must choose the transition measures.
We will cover the specific measures in a future column, but for now we’ll note that both tracks are very similar and focus on protecting patient data, encouraging patient access to their own records, and sharing information electronically with other providers.
Rekindling the dream
We are certain that changing legislation won’t solve all of the problems inherent in current EHR systems, but we are always encouraged by any attempt to reduce the documentation burden on physicians. By eschewing thresholds, eliminating the all-or-nothing requirement, and reducing the number of required measures, the ACI program does seem to shift the focus away from volume and toward value.
That alone has the potential to restore our hope of a brighter future, and make our use of electronic health records significantly more meaningful.
Note: To learn more about Quality Payment Program and MIPS, we highly recommend an online resource published by the Centers for Medicare & Medicaid Services that is easy to follow and is full of useful information. It can be found at https://qpp.cms.gov.
Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.
Breast density is no reason to perform MRI
LAS VEGAS – In women with higher density (HD) breasts, preoperative MRI revealed more abnormalities than were seen in women with lower density (LD) breasts, but there was no difference in the number of secondary cancers detected or long-term recurrence rates.
Breast density is often cited by radiologists as a reason to conduct a preoperative MRI, but the study suggests that it should not be a driving factor. “It’s a real challenge when our radiologists provide us reports that say, ‘Due to increased density, we recommend MRI,’ because it’s really hard to then disregard that. I think this is very important data,” said Judy Boughey, MD, professor of surgery at the Mayo Clinic, Rochester, MN, who moderated the session at the annual meeting of the American Society of Breast Surgeons where the research was presented.
“MRI is a valuable tool, and we’re still trying to figure out who it should be performed in,” said lead author Sarah McLaughlin, MD, of the Mayo Clinic, Jacksonville, FL, in an interview.
The researchers retrospectively analyzed data from 683 women at their institution who underwent preoperative MRI between 2007 and 2011. They grouped them by mammography results into LD (33%; Breast Imaging–Reporting and Data System density, 1 and 2) and HD (67%; BI-RADS density, 3 and 4).
Patients in the HD group more often had ipsilateral MRI findings (42% vs. 31%; P = .005), but ,of those with MRI findings, a similar number of patients in each group needed a second site biopsy (HD 65% vs. LD 67%; P = .78).
In all patients who had an additional MRI finding, the odds of detecting an additional ipsilateral cancer were not statistically significant between HD (32%) and LD (23%; P = .15) patients.
HD patients were also more likely to have abnormalities in the contralateral breast (25% vs. 14%; P = .009), but there were no statistically significant differences in rates of second-site biopsy recommendations or in the percentages of abnormalities that turned out to be cancerous (HD 6% vs. LD 3%; P = 1.0).
Following MRI, 70% of LD patients expressed a preference for breast-conserving surgery, compared with 53% of HD patients (P = .0001).
Over a median 7 years of follow-up, there was no difference in freedom from recurrence rates between the two groups (91% in LD vs. 90% in HD; P = .57).
“To me, it says that you don’t have to order an MRI just because they have cancer in a high density breast. You can feel reassured by your surgical plan and treatment recommendations based on conventional imaging,” said Dr. McLaughlin.
The researchers can’t determine if having an MRI done increased patient worry and potentially led to the higher rate of mastectomies chosen by women in the HD group. “Is that a result of the MRI? I don’t think we can say that, but there’s this whole other discussion piece that goes into it. You definitely see patients who say, ‘But it found these other things, and I’m going to have a mastectomy.’ So, there’s that patient preference and worry piece,” said Dr. McLaughlin.
The study results should offer some reassurance to patients. “There were no differences in local recurrence rates according to density. Maybe the next angle is allaying some of that fear, because the outcomes were the same. It’s really driven more by tumor biology and multimodality therapy,” said Dr. McLaughlin.
The study doesn’t provide the final word on breast density and MRI, according to Dr. Boughey. “I think this is an area that needs to be studied more with a clinical trial. There are several going on in different countries, and this is an area where we need level 1 data. This study does fit with what many other studies have shown, which is that MRI probably doesn’t have as much benefit as patients believe it does, so our role really is to try to help educate patients.”
LAS VEGAS – In women with higher density (HD) breasts, preoperative MRI revealed more abnormalities than were seen in women with lower density (LD) breasts, but there was no difference in the number of secondary cancers detected or long-term recurrence rates.
Breast density is often cited by radiologists as a reason to conduct a preoperative MRI, but the study suggests that it should not be a driving factor. “It’s a real challenge when our radiologists provide us reports that say, ‘Due to increased density, we recommend MRI,’ because it’s really hard to then disregard that. I think this is very important data,” said Judy Boughey, MD, professor of surgery at the Mayo Clinic, Rochester, MN, who moderated the session at the annual meeting of the American Society of Breast Surgeons where the research was presented.
“MRI is a valuable tool, and we’re still trying to figure out who it should be performed in,” said lead author Sarah McLaughlin, MD, of the Mayo Clinic, Jacksonville, FL, in an interview.
The researchers retrospectively analyzed data from 683 women at their institution who underwent preoperative MRI between 2007 and 2011. They grouped them by mammography results into LD (33%; Breast Imaging–Reporting and Data System density, 1 and 2) and HD (67%; BI-RADS density, 3 and 4).
Patients in the HD group more often had ipsilateral MRI findings (42% vs. 31%; P = .005), but ,of those with MRI findings, a similar number of patients in each group needed a second site biopsy (HD 65% vs. LD 67%; P = .78).
In all patients who had an additional MRI finding, the odds of detecting an additional ipsilateral cancer were not statistically significant between HD (32%) and LD (23%; P = .15) patients.
HD patients were also more likely to have abnormalities in the contralateral breast (25% vs. 14%; P = .009), but there were no statistically significant differences in rates of second-site biopsy recommendations or in the percentages of abnormalities that turned out to be cancerous (HD 6% vs. LD 3%; P = 1.0).
Following MRI, 70% of LD patients expressed a preference for breast-conserving surgery, compared with 53% of HD patients (P = .0001).
Over a median 7 years of follow-up, there was no difference in freedom from recurrence rates between the two groups (91% in LD vs. 90% in HD; P = .57).
“To me, it says that you don’t have to order an MRI just because they have cancer in a high density breast. You can feel reassured by your surgical plan and treatment recommendations based on conventional imaging,” said Dr. McLaughlin.
The researchers can’t determine if having an MRI done increased patient worry and potentially led to the higher rate of mastectomies chosen by women in the HD group. “Is that a result of the MRI? I don’t think we can say that, but there’s this whole other discussion piece that goes into it. You definitely see patients who say, ‘But it found these other things, and I’m going to have a mastectomy.’ So, there’s that patient preference and worry piece,” said Dr. McLaughlin.
The study results should offer some reassurance to patients. “There were no differences in local recurrence rates according to density. Maybe the next angle is allaying some of that fear, because the outcomes were the same. It’s really driven more by tumor biology and multimodality therapy,” said Dr. McLaughlin.
The study doesn’t provide the final word on breast density and MRI, according to Dr. Boughey. “I think this is an area that needs to be studied more with a clinical trial. There are several going on in different countries, and this is an area where we need level 1 data. This study does fit with what many other studies have shown, which is that MRI probably doesn’t have as much benefit as patients believe it does, so our role really is to try to help educate patients.”
LAS VEGAS – In women with higher density (HD) breasts, preoperative MRI revealed more abnormalities than were seen in women with lower density (LD) breasts, but there was no difference in the number of secondary cancers detected or long-term recurrence rates.
Breast density is often cited by radiologists as a reason to conduct a preoperative MRI, but the study suggests that it should not be a driving factor. “It’s a real challenge when our radiologists provide us reports that say, ‘Due to increased density, we recommend MRI,’ because it’s really hard to then disregard that. I think this is very important data,” said Judy Boughey, MD, professor of surgery at the Mayo Clinic, Rochester, MN, who moderated the session at the annual meeting of the American Society of Breast Surgeons where the research was presented.
“MRI is a valuable tool, and we’re still trying to figure out who it should be performed in,” said lead author Sarah McLaughlin, MD, of the Mayo Clinic, Jacksonville, FL, in an interview.
The researchers retrospectively analyzed data from 683 women at their institution who underwent preoperative MRI between 2007 and 2011. They grouped them by mammography results into LD (33%; Breast Imaging–Reporting and Data System density, 1 and 2) and HD (67%; BI-RADS density, 3 and 4).
Patients in the HD group more often had ipsilateral MRI findings (42% vs. 31%; P = .005), but ,of those with MRI findings, a similar number of patients in each group needed a second site biopsy (HD 65% vs. LD 67%; P = .78).
In all patients who had an additional MRI finding, the odds of detecting an additional ipsilateral cancer were not statistically significant between HD (32%) and LD (23%; P = .15) patients.
HD patients were also more likely to have abnormalities in the contralateral breast (25% vs. 14%; P = .009), but there were no statistically significant differences in rates of second-site biopsy recommendations or in the percentages of abnormalities that turned out to be cancerous (HD 6% vs. LD 3%; P = 1.0).
Following MRI, 70% of LD patients expressed a preference for breast-conserving surgery, compared with 53% of HD patients (P = .0001).
Over a median 7 years of follow-up, there was no difference in freedom from recurrence rates between the two groups (91% in LD vs. 90% in HD; P = .57).
“To me, it says that you don’t have to order an MRI just because they have cancer in a high density breast. You can feel reassured by your surgical plan and treatment recommendations based on conventional imaging,” said Dr. McLaughlin.
The researchers can’t determine if having an MRI done increased patient worry and potentially led to the higher rate of mastectomies chosen by women in the HD group. “Is that a result of the MRI? I don’t think we can say that, but there’s this whole other discussion piece that goes into it. You definitely see patients who say, ‘But it found these other things, and I’m going to have a mastectomy.’ So, there’s that patient preference and worry piece,” said Dr. McLaughlin.
The study results should offer some reassurance to patients. “There were no differences in local recurrence rates according to density. Maybe the next angle is allaying some of that fear, because the outcomes were the same. It’s really driven more by tumor biology and multimodality therapy,” said Dr. McLaughlin.
The study doesn’t provide the final word on breast density and MRI, according to Dr. Boughey. “I think this is an area that needs to be studied more with a clinical trial. There are several going on in different countries, and this is an area where we need level 1 data. This study does fit with what many other studies have shown, which is that MRI probably doesn’t have as much benefit as patients believe it does, so our role really is to try to help educate patients.”
AT ASBS 2017
Key clinical point: High breast density is probably not cause enough to order preoperative MRI.
Major finding: Freedom from recurrence rates were 90% in high density and 91% in low.
Data source: Retrospective analysis of 683 women at a single institution.
Disclosures: The study was funded internally. Dr. McLaughlin and Dr. Boughey reported having no relevant financial relationships.
Radiation bests mastectomy for occult breast cancer
LAS VEGAS – Overall survival was better when women with occult breast cancer had axillary lymph node dissection and radiation, instead of mastectomy, in a database review of 934 cases by the University of Maryland Medical Center, Baltimore, the largest review to date of how best to handle the problem.
Five- and 10-year overall survival was 90.8% and 84.8%, respectively, among the 342 women treated with axillary lymph node dissection (ALND) plus adjuvant radiation, versus 80.0% and 69.8% among the 592 who had ALND and mastectomies, plus or minus radiation, according to an analysis of the National Cancer Database from 2004-2013. The results were presented at the annual meeting of the American Society of Breast Surgeons.
ALND plus radiation was independently associated with overall survival on multivariate analysis (HR 0.51, 95% CI 0.32-0.81, P = .004), and was associated with fewer comorbidities, use of chemotherapy, number of positive nodes, and number of nodes examined, compared with mastectomy.
Women treated with ALND plus radiation “had significantly better overall survival than those treated with mastectomy, even after adjusting for other covariates. We believe the study supports overall use of this treatment approach in patients with occult breast cancer,” said lead investigator, Lindsay Hessler, MD, of University of Maryland, Baltimore.
Occult breast cancer – axillary lymph node metastases without clinical or radiologic evidence of a primary breast tumor – is rare and accounted for less than 0.1% of the 2.03 million breast cancer cases in the database. It’s been unclear how best to treat it; most of the previous investigations were small single-center series and case reports.
The only other significant review was smaller, with 750 women in the Surveillance, Epidemiology, and End Results database treated from 1983 to 2006, the “vast majority” before routine use of breast MRI. It showed that “definitive locoregional treatment with either mastectomy or [radiation therapy] improves [overall survival] in patients with occult breast cancer and axillary metastasis who undergo ALND,” but it didn’t suggest which option is best. The National Comprehensive Cancer Network recommends either approach (Cancer. 2010 Sep 1;116[17]:4000-6).
The new University of Maryland findings “confirm that women do not need to have a mastectomy if you can’t find the cancer in their breast. Women do better if you radiate the breast instead of removing it. A lot of academic centers are doing this now, but some people don’t know about it. This needs to be implemented in a more widespread fashion,” said Shelley Hwang, MD, a surgical oncologist at Duke University, Durham, N.C., who moderated Dr. Hessler’s presentation.
Indeed, patients were most likely to be treated with radiation and ALND at an academic center (OR 2.03, 95% CI 1.5-2.74, P less than .001), the only factor on multivariate analysis related to treatment choice.
The review excluded women with only internal mammary lymph node involvement, those with lumpectomies, and women who had less than four nodes recovered on ALND. Mastectomy and radiation patients were similar in nodal stage, race, income, insurance, estrogen receptor status, comorbidities, and year of diagnosis. On pathology, a tumor was found in about a third of the patients who had mastectomies. MRI use and recurrence rates were unavailable in the National Cancer Database.
The findings are subject to all the limits of database reviews, including the possible confounder that women treated at university hospitals might also have had more optimal systemic therapy, as an audience member noted.
The investigators said they had no financial disclosures.
LAS VEGAS – Overall survival was better when women with occult breast cancer had axillary lymph node dissection and radiation, instead of mastectomy, in a database review of 934 cases by the University of Maryland Medical Center, Baltimore, the largest review to date of how best to handle the problem.
Five- and 10-year overall survival was 90.8% and 84.8%, respectively, among the 342 women treated with axillary lymph node dissection (ALND) plus adjuvant radiation, versus 80.0% and 69.8% among the 592 who had ALND and mastectomies, plus or minus radiation, according to an analysis of the National Cancer Database from 2004-2013. The results were presented at the annual meeting of the American Society of Breast Surgeons.
ALND plus radiation was independently associated with overall survival on multivariate analysis (HR 0.51, 95% CI 0.32-0.81, P = .004), and was associated with fewer comorbidities, use of chemotherapy, number of positive nodes, and number of nodes examined, compared with mastectomy.
Women treated with ALND plus radiation “had significantly better overall survival than those treated with mastectomy, even after adjusting for other covariates. We believe the study supports overall use of this treatment approach in patients with occult breast cancer,” said lead investigator, Lindsay Hessler, MD, of University of Maryland, Baltimore.
Occult breast cancer – axillary lymph node metastases without clinical or radiologic evidence of a primary breast tumor – is rare and accounted for less than 0.1% of the 2.03 million breast cancer cases in the database. It’s been unclear how best to treat it; most of the previous investigations were small single-center series and case reports.
The only other significant review was smaller, with 750 women in the Surveillance, Epidemiology, and End Results database treated from 1983 to 2006, the “vast majority” before routine use of breast MRI. It showed that “definitive locoregional treatment with either mastectomy or [radiation therapy] improves [overall survival] in patients with occult breast cancer and axillary metastasis who undergo ALND,” but it didn’t suggest which option is best. The National Comprehensive Cancer Network recommends either approach (Cancer. 2010 Sep 1;116[17]:4000-6).
The new University of Maryland findings “confirm that women do not need to have a mastectomy if you can’t find the cancer in their breast. Women do better if you radiate the breast instead of removing it. A lot of academic centers are doing this now, but some people don’t know about it. This needs to be implemented in a more widespread fashion,” said Shelley Hwang, MD, a surgical oncologist at Duke University, Durham, N.C., who moderated Dr. Hessler’s presentation.
Indeed, patients were most likely to be treated with radiation and ALND at an academic center (OR 2.03, 95% CI 1.5-2.74, P less than .001), the only factor on multivariate analysis related to treatment choice.
The review excluded women with only internal mammary lymph node involvement, those with lumpectomies, and women who had less than four nodes recovered on ALND. Mastectomy and radiation patients were similar in nodal stage, race, income, insurance, estrogen receptor status, comorbidities, and year of diagnosis. On pathology, a tumor was found in about a third of the patients who had mastectomies. MRI use and recurrence rates were unavailable in the National Cancer Database.
The findings are subject to all the limits of database reviews, including the possible confounder that women treated at university hospitals might also have had more optimal systemic therapy, as an audience member noted.
The investigators said they had no financial disclosures.
LAS VEGAS – Overall survival was better when women with occult breast cancer had axillary lymph node dissection and radiation, instead of mastectomy, in a database review of 934 cases by the University of Maryland Medical Center, Baltimore, the largest review to date of how best to handle the problem.
Five- and 10-year overall survival was 90.8% and 84.8%, respectively, among the 342 women treated with axillary lymph node dissection (ALND) plus adjuvant radiation, versus 80.0% and 69.8% among the 592 who had ALND and mastectomies, plus or minus radiation, according to an analysis of the National Cancer Database from 2004-2013. The results were presented at the annual meeting of the American Society of Breast Surgeons.
ALND plus radiation was independently associated with overall survival on multivariate analysis (HR 0.51, 95% CI 0.32-0.81, P = .004), and was associated with fewer comorbidities, use of chemotherapy, number of positive nodes, and number of nodes examined, compared with mastectomy.
Women treated with ALND plus radiation “had significantly better overall survival than those treated with mastectomy, even after adjusting for other covariates. We believe the study supports overall use of this treatment approach in patients with occult breast cancer,” said lead investigator, Lindsay Hessler, MD, of University of Maryland, Baltimore.
Occult breast cancer – axillary lymph node metastases without clinical or radiologic evidence of a primary breast tumor – is rare and accounted for less than 0.1% of the 2.03 million breast cancer cases in the database. It’s been unclear how best to treat it; most of the previous investigations were small single-center series and case reports.
The only other significant review was smaller, with 750 women in the Surveillance, Epidemiology, and End Results database treated from 1983 to 2006, the “vast majority” before routine use of breast MRI. It showed that “definitive locoregional treatment with either mastectomy or [radiation therapy] improves [overall survival] in patients with occult breast cancer and axillary metastasis who undergo ALND,” but it didn’t suggest which option is best. The National Comprehensive Cancer Network recommends either approach (Cancer. 2010 Sep 1;116[17]:4000-6).
The new University of Maryland findings “confirm that women do not need to have a mastectomy if you can’t find the cancer in their breast. Women do better if you radiate the breast instead of removing it. A lot of academic centers are doing this now, but some people don’t know about it. This needs to be implemented in a more widespread fashion,” said Shelley Hwang, MD, a surgical oncologist at Duke University, Durham, N.C., who moderated Dr. Hessler’s presentation.
Indeed, patients were most likely to be treated with radiation and ALND at an academic center (OR 2.03, 95% CI 1.5-2.74, P less than .001), the only factor on multivariate analysis related to treatment choice.
The review excluded women with only internal mammary lymph node involvement, those with lumpectomies, and women who had less than four nodes recovered on ALND. Mastectomy and radiation patients were similar in nodal stage, race, income, insurance, estrogen receptor status, comorbidities, and year of diagnosis. On pathology, a tumor was found in about a third of the patients who had mastectomies. MRI use and recurrence rates were unavailable in the National Cancer Database.
The findings are subject to all the limits of database reviews, including the possible confounder that women treated at university hospitals might also have had more optimal systemic therapy, as an audience member noted.
The investigators said they had no financial disclosures.
AT ASBS 2017
Key clinical point:
Major finding: Five- and 10-year overall survival was 90.8% and 84.8%, respectively, among the 342 women treated with axillary lymph node dissection (ALND) plus adjuvant radiation, versus 80.0% and 69.8% among the 592 who had ALND and mastectomies, plus or minus radiation.
Data source: Review of 934 cases in the National Cancer Database.
Disclosures: The investigators said they had no financial disclosures.