Hospital scoring model predicts high-quality surgical outcomes in low-volume centers

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Hospital scoring model predicts high-quality surgical outcomes in low-volume centers

MONTREAL – A “hospital ecosystem score” derived from examining high-volume, high-quality hospitals has good specificity in predicting which hospitals will have high-quality outcomes, though these hospitals have low surgical volume for a given procedure.

“What we’re talking about is a care delivery macro-environment,” said Dr. Anai Kothari, presenting results of a retrospective study of surgical outcomes at the Central Surgical Association’s annual meeting.

©Daniel Mirer/thinkstockphotos.com

The study built on previous work that had identified “hospital system factors that actually equipped hospitals to provide high quality care,” said Dr. Kothari, a surgical research resident at Loyola University Medical Center in Maywood, Ill. “These high-volume ecosystems do exist at low-volume hospitals,” he said.

The study was designed as a retrospective review of 24,784 patient encounters over a 5-year period from 302 hospitals; data were taken from the Hospital Consumer Assessment of Healthcare Providers and Services (HCAHPS) databases in California and Florida, with hospital resources data taken from the American Hospital Association (AHA) Annual Survey Database.

Adult patients were included if they had a malignancy of the esophagus, pancreas, or rectum, and had a surgical resection of the malignancy.

Dr. Kothari and his coinvestigators used patient mortality as a marker of quality, and analyzed the relationship between quality and case volume for each of the three procedures. “We used very strict definitions for high and low-volume” of surgical procedures, based on criteria set by the “Take the Volume Pledge” campaign that discourages surgeons from performing certain complex procedures unless they do them frequently, he said.

When procedural volume was mapped against risk-adjusted patient mortality in the data, the results could be divided into quadrants: high-volume/high-quality, high-volume/low-quality, low-volume/high-quality, and low-volume/low-quality.

Dr. Kothari said that an interesting pattern emerged, where a significant number of hospitals had low case volume but high quality outcomes. “In some cases … there are actually more low-volume/high-quality centers than high-volume/high-quality centers,” he said.

The researchers then looked at centers that performed at least two of the three surgical procedures at a high volume, to tease out some of the hospital system factors at play. They settled on examining 13 hospitals of over 300 initially studied, looking at more than 30 hospital characteristics that fell into five broad categories. These included infrastructure, size, staffing, perioperative services, and support intensity.

Within these categories, infrastructure characteristics associated with better outcomes included the facility’s being a level 1 trauma center and having transplant services. Size characteristics associated with better outcomes included total number of hospital admissions and total inpatient surgical volume. In terms of staffing, higher resident-to-bed and nurse-to-bed ratio (but not a higher physician-to-bed ratio) were both linked to better outcomes.

The perioperative services that mattered for outcomes were patient rehabilitation, geriatric services, speech and language pathology, and inpatient palliative care. Patients in facilities with a high level of oncology support also fared better.

Using different analytic models, Dr. Kothari and his colleagues attempted to determine whether these factors were predictive of a high-volume ecosystem that would result in better outcomes, even if volume for a particular procedure was low.

They found that their model, which assigned one point for each hospital ecosystem characteristic present at a given hospital, was very specific for identifying low-volume, high-quality care centers. “So a score of 7 and above has a specificity for low volume/high quality of care of over 70%” in esophageal resection, said Dr. Kothari.

Dr. Kothari noted how few high-volume centers were identified for this study, a finding that points to the practical importance for hospital administrators of knowing what factors may contribute to better surgical outcomes in smaller facilities.

Dr. Luke Funk, director of minimally invasive surgery research at the University of Wisconsin-Madison and a sometime collaborator of Dr. Kothari’s, had some suggestions for next steps. “Perhaps you could drill down qualitatively, going into some of these centers and talking to folks. Then you could take aspects from these programs and apply them to lower volume centers.” Dr. Kothari agreed, saying this would be a “very natural next step.”

Dr. Kothari reported no relevant disclosures; he is supported by an NIH training grant.

[email protected]

On Twitter @karioakes

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MONTREAL – A “hospital ecosystem score” derived from examining high-volume, high-quality hospitals has good specificity in predicting which hospitals will have high-quality outcomes, though these hospitals have low surgical volume for a given procedure.

“What we’re talking about is a care delivery macro-environment,” said Dr. Anai Kothari, presenting results of a retrospective study of surgical outcomes at the Central Surgical Association’s annual meeting.

©Daniel Mirer/thinkstockphotos.com

The study built on previous work that had identified “hospital system factors that actually equipped hospitals to provide high quality care,” said Dr. Kothari, a surgical research resident at Loyola University Medical Center in Maywood, Ill. “These high-volume ecosystems do exist at low-volume hospitals,” he said.

The study was designed as a retrospective review of 24,784 patient encounters over a 5-year period from 302 hospitals; data were taken from the Hospital Consumer Assessment of Healthcare Providers and Services (HCAHPS) databases in California and Florida, with hospital resources data taken from the American Hospital Association (AHA) Annual Survey Database.

Adult patients were included if they had a malignancy of the esophagus, pancreas, or rectum, and had a surgical resection of the malignancy.

Dr. Kothari and his coinvestigators used patient mortality as a marker of quality, and analyzed the relationship between quality and case volume for each of the three procedures. “We used very strict definitions for high and low-volume” of surgical procedures, based on criteria set by the “Take the Volume Pledge” campaign that discourages surgeons from performing certain complex procedures unless they do them frequently, he said.

When procedural volume was mapped against risk-adjusted patient mortality in the data, the results could be divided into quadrants: high-volume/high-quality, high-volume/low-quality, low-volume/high-quality, and low-volume/low-quality.

Dr. Kothari said that an interesting pattern emerged, where a significant number of hospitals had low case volume but high quality outcomes. “In some cases … there are actually more low-volume/high-quality centers than high-volume/high-quality centers,” he said.

The researchers then looked at centers that performed at least two of the three surgical procedures at a high volume, to tease out some of the hospital system factors at play. They settled on examining 13 hospitals of over 300 initially studied, looking at more than 30 hospital characteristics that fell into five broad categories. These included infrastructure, size, staffing, perioperative services, and support intensity.

Within these categories, infrastructure characteristics associated with better outcomes included the facility’s being a level 1 trauma center and having transplant services. Size characteristics associated with better outcomes included total number of hospital admissions and total inpatient surgical volume. In terms of staffing, higher resident-to-bed and nurse-to-bed ratio (but not a higher physician-to-bed ratio) were both linked to better outcomes.

The perioperative services that mattered for outcomes were patient rehabilitation, geriatric services, speech and language pathology, and inpatient palliative care. Patients in facilities with a high level of oncology support also fared better.

Using different analytic models, Dr. Kothari and his colleagues attempted to determine whether these factors were predictive of a high-volume ecosystem that would result in better outcomes, even if volume for a particular procedure was low.

They found that their model, which assigned one point for each hospital ecosystem characteristic present at a given hospital, was very specific for identifying low-volume, high-quality care centers. “So a score of 7 and above has a specificity for low volume/high quality of care of over 70%” in esophageal resection, said Dr. Kothari.

Dr. Kothari noted how few high-volume centers were identified for this study, a finding that points to the practical importance for hospital administrators of knowing what factors may contribute to better surgical outcomes in smaller facilities.

Dr. Luke Funk, director of minimally invasive surgery research at the University of Wisconsin-Madison and a sometime collaborator of Dr. Kothari’s, had some suggestions for next steps. “Perhaps you could drill down qualitatively, going into some of these centers and talking to folks. Then you could take aspects from these programs and apply them to lower volume centers.” Dr. Kothari agreed, saying this would be a “very natural next step.”

Dr. Kothari reported no relevant disclosures; he is supported by an NIH training grant.

[email protected]

On Twitter @karioakes

MONTREAL – A “hospital ecosystem score” derived from examining high-volume, high-quality hospitals has good specificity in predicting which hospitals will have high-quality outcomes, though these hospitals have low surgical volume for a given procedure.

“What we’re talking about is a care delivery macro-environment,” said Dr. Anai Kothari, presenting results of a retrospective study of surgical outcomes at the Central Surgical Association’s annual meeting.

©Daniel Mirer/thinkstockphotos.com

The study built on previous work that had identified “hospital system factors that actually equipped hospitals to provide high quality care,” said Dr. Kothari, a surgical research resident at Loyola University Medical Center in Maywood, Ill. “These high-volume ecosystems do exist at low-volume hospitals,” he said.

The study was designed as a retrospective review of 24,784 patient encounters over a 5-year period from 302 hospitals; data were taken from the Hospital Consumer Assessment of Healthcare Providers and Services (HCAHPS) databases in California and Florida, with hospital resources data taken from the American Hospital Association (AHA) Annual Survey Database.

Adult patients were included if they had a malignancy of the esophagus, pancreas, or rectum, and had a surgical resection of the malignancy.

Dr. Kothari and his coinvestigators used patient mortality as a marker of quality, and analyzed the relationship between quality and case volume for each of the three procedures. “We used very strict definitions for high and low-volume” of surgical procedures, based on criteria set by the “Take the Volume Pledge” campaign that discourages surgeons from performing certain complex procedures unless they do them frequently, he said.

When procedural volume was mapped against risk-adjusted patient mortality in the data, the results could be divided into quadrants: high-volume/high-quality, high-volume/low-quality, low-volume/high-quality, and low-volume/low-quality.

Dr. Kothari said that an interesting pattern emerged, where a significant number of hospitals had low case volume but high quality outcomes. “In some cases … there are actually more low-volume/high-quality centers than high-volume/high-quality centers,” he said.

The researchers then looked at centers that performed at least two of the three surgical procedures at a high volume, to tease out some of the hospital system factors at play. They settled on examining 13 hospitals of over 300 initially studied, looking at more than 30 hospital characteristics that fell into five broad categories. These included infrastructure, size, staffing, perioperative services, and support intensity.

Within these categories, infrastructure characteristics associated with better outcomes included the facility’s being a level 1 trauma center and having transplant services. Size characteristics associated with better outcomes included total number of hospital admissions and total inpatient surgical volume. In terms of staffing, higher resident-to-bed and nurse-to-bed ratio (but not a higher physician-to-bed ratio) were both linked to better outcomes.

The perioperative services that mattered for outcomes were patient rehabilitation, geriatric services, speech and language pathology, and inpatient palliative care. Patients in facilities with a high level of oncology support also fared better.

Using different analytic models, Dr. Kothari and his colleagues attempted to determine whether these factors were predictive of a high-volume ecosystem that would result in better outcomes, even if volume for a particular procedure was low.

They found that their model, which assigned one point for each hospital ecosystem characteristic present at a given hospital, was very specific for identifying low-volume, high-quality care centers. “So a score of 7 and above has a specificity for low volume/high quality of care of over 70%” in esophageal resection, said Dr. Kothari.

Dr. Kothari noted how few high-volume centers were identified for this study, a finding that points to the practical importance for hospital administrators of knowing what factors may contribute to better surgical outcomes in smaller facilities.

Dr. Luke Funk, director of minimally invasive surgery research at the University of Wisconsin-Madison and a sometime collaborator of Dr. Kothari’s, had some suggestions for next steps. “Perhaps you could drill down qualitatively, going into some of these centers and talking to folks. Then you could take aspects from these programs and apply them to lower volume centers.” Dr. Kothari agreed, saying this would be a “very natural next step.”

Dr. Kothari reported no relevant disclosures; he is supported by an NIH training grant.

[email protected]

On Twitter @karioakes

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Hospital scoring model predicts high-quality surgical outcomes in low-volume centers
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AT THE ANNUAL MEETING OF THE CENTRAL SURGICAL ASSOCIATION

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Inside the Article

Vitals

Key clinical point: Hospital macro-environment factors can predict good outcomes even with low procedural volume.

Major finding: A “hospital ecosystem score” can predict which low-volume centers will have high-quality outcomes for some surgeries.

Data source: Retrospective review of 5 years of patient-level data, yielding 24,784 encounters from 302 hospitals from the Hospital Consumer Assessment of Healthcare Providers and Services (HCAHPS) database; hospital resource data taken from the American Hospital Association (AHA) Annual Survey Database.

Disclosures: The study authors reported no relevant disclosures.

Trauma checklist in ED can increase discharge rates

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Trauma checklist in ED can increase discharge rates

MONTREAL – A trauma checklist may help increase the proportion of trauma patients who are discharged home from an emergency department, according to a single-center study that tracked trauma admissions before and after institution of a trauma checklist.

Dr. Amani Jambhekar, a surgery resident at New York Methodist Hospital, Brooklyn, presented the study findings at the Central Surgical Association’s annual meeting. Discharges in July and August of 2015, after the checklist had been implemented, increased significantly, from a 6.5% rate in the first study month, before the checklist was implemented, to a 23.4% and 16.7% rate for the last two study months (P = .004).

Dr. Amani Jambhekar

However, the injury severity score decreased over the period of the study, from a mean of 7.27 in the first month of the study to 4.60 in the last month of the study (P = .019), and the injury severity level was generally low.

When a trauma patient is admitted who might fare well at home, not only does the admission represent a potentially avoidable cost, it also exposes patients, particularly elderly patients, to infection risk, increased immobility, and other negative effects of hospitalization.

“Why don’t we discharge patients from the emergency department more? Well, there’s a significant fear of ‘bounce-backs,’ ” Dr. Jambhekar said. The bounce-back phenomenon, where patients who are discharged and then present again and are admitted, had not been well studied among trauma patients discharged from the emergency department, he added.

Risk factors for readmission after a hospital discharge had been studied, and may include low socioeconomic status, no insurance or publicly provided insurance, long initial inpatient stay, and higher Injury Severity Score (ISS). “But none of this had been evaluated in patients who were initially discharged from the emergency department,” said Dr. Jambhekar.

New York Methodist, the study site, is a 651-bed urban community hospital. It sees approximately 100,000 emergency department (ED) visits per year, with 8,000 trauma patients coming through the door of the ED in the first 11 months of the hospital’s designation as a level II trauma center.

Dr. Jambhekar and her colleagues evaluated 376 trauma patients, divided into two groups. The first group of 198 patients was seen in the 3 months before the checklist was put in place. The second group of 178 patients was seen in the 60 days after the trauma checklist was mandated. Patients were included in the study if they had been evaluated by the trauma surgery service.

The trauma checklist contained basic demographic and history information, as well as information about the patients’ ED course – for example, what imaging studied were obtained, lab values, what consults they received. The ISS was calculated prior to patient disposition.

“We wanted to present a template to all of our providers to use, in order to correctly document patients’ injuries. If they knew the extent of every patient’s injuries, they could correctly identify patients who were safe to discharge from the emergency department.” One limitation of the study, said Dr. Jambhekar, is overtriage of patients to the trauma center. This is evidenced by the relatively low ISS scores. “As our trauma center became more popular in Brooklyn and in New York City, more patients were brought to our trauma center, even when they could have adequately been treated elsewhere.”

The study didn’t have long-term follow-up of patients to see if they were satisfied with their care, and if they had recovered from their injuries. The exact cost of outpatient follow-up is also uncertain, said Dr. Jambhekar.

Dr. Jambhekar and her colleagues plan to investigate safety and cost outcomes for discharge of trauma patients from the ED; they also will look at the bounce-back phenomenon, and long-term outcomes for outpatient care of trauma patients.

They reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

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MONTREAL – A trauma checklist may help increase the proportion of trauma patients who are discharged home from an emergency department, according to a single-center study that tracked trauma admissions before and after institution of a trauma checklist.

Dr. Amani Jambhekar, a surgery resident at New York Methodist Hospital, Brooklyn, presented the study findings at the Central Surgical Association’s annual meeting. Discharges in July and August of 2015, after the checklist had been implemented, increased significantly, from a 6.5% rate in the first study month, before the checklist was implemented, to a 23.4% and 16.7% rate for the last two study months (P = .004).

Dr. Amani Jambhekar

However, the injury severity score decreased over the period of the study, from a mean of 7.27 in the first month of the study to 4.60 in the last month of the study (P = .019), and the injury severity level was generally low.

When a trauma patient is admitted who might fare well at home, not only does the admission represent a potentially avoidable cost, it also exposes patients, particularly elderly patients, to infection risk, increased immobility, and other negative effects of hospitalization.

“Why don’t we discharge patients from the emergency department more? Well, there’s a significant fear of ‘bounce-backs,’ ” Dr. Jambhekar said. The bounce-back phenomenon, where patients who are discharged and then present again and are admitted, had not been well studied among trauma patients discharged from the emergency department, he added.

Risk factors for readmission after a hospital discharge had been studied, and may include low socioeconomic status, no insurance or publicly provided insurance, long initial inpatient stay, and higher Injury Severity Score (ISS). “But none of this had been evaluated in patients who were initially discharged from the emergency department,” said Dr. Jambhekar.

New York Methodist, the study site, is a 651-bed urban community hospital. It sees approximately 100,000 emergency department (ED) visits per year, with 8,000 trauma patients coming through the door of the ED in the first 11 months of the hospital’s designation as a level II trauma center.

Dr. Jambhekar and her colleagues evaluated 376 trauma patients, divided into two groups. The first group of 198 patients was seen in the 3 months before the checklist was put in place. The second group of 178 patients was seen in the 60 days after the trauma checklist was mandated. Patients were included in the study if they had been evaluated by the trauma surgery service.

The trauma checklist contained basic demographic and history information, as well as information about the patients’ ED course – for example, what imaging studied were obtained, lab values, what consults they received. The ISS was calculated prior to patient disposition.

“We wanted to present a template to all of our providers to use, in order to correctly document patients’ injuries. If they knew the extent of every patient’s injuries, they could correctly identify patients who were safe to discharge from the emergency department.” One limitation of the study, said Dr. Jambhekar, is overtriage of patients to the trauma center. This is evidenced by the relatively low ISS scores. “As our trauma center became more popular in Brooklyn and in New York City, more patients were brought to our trauma center, even when they could have adequately been treated elsewhere.”

The study didn’t have long-term follow-up of patients to see if they were satisfied with their care, and if they had recovered from their injuries. The exact cost of outpatient follow-up is also uncertain, said Dr. Jambhekar.

Dr. Jambhekar and her colleagues plan to investigate safety and cost outcomes for discharge of trauma patients from the ED; they also will look at the bounce-back phenomenon, and long-term outcomes for outpatient care of trauma patients.

They reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

MONTREAL – A trauma checklist may help increase the proportion of trauma patients who are discharged home from an emergency department, according to a single-center study that tracked trauma admissions before and after institution of a trauma checklist.

Dr. Amani Jambhekar, a surgery resident at New York Methodist Hospital, Brooklyn, presented the study findings at the Central Surgical Association’s annual meeting. Discharges in July and August of 2015, after the checklist had been implemented, increased significantly, from a 6.5% rate in the first study month, before the checklist was implemented, to a 23.4% and 16.7% rate for the last two study months (P = .004).

Dr. Amani Jambhekar

However, the injury severity score decreased over the period of the study, from a mean of 7.27 in the first month of the study to 4.60 in the last month of the study (P = .019), and the injury severity level was generally low.

When a trauma patient is admitted who might fare well at home, not only does the admission represent a potentially avoidable cost, it also exposes patients, particularly elderly patients, to infection risk, increased immobility, and other negative effects of hospitalization.

“Why don’t we discharge patients from the emergency department more? Well, there’s a significant fear of ‘bounce-backs,’ ” Dr. Jambhekar said. The bounce-back phenomenon, where patients who are discharged and then present again and are admitted, had not been well studied among trauma patients discharged from the emergency department, he added.

Risk factors for readmission after a hospital discharge had been studied, and may include low socioeconomic status, no insurance or publicly provided insurance, long initial inpatient stay, and higher Injury Severity Score (ISS). “But none of this had been evaluated in patients who were initially discharged from the emergency department,” said Dr. Jambhekar.

New York Methodist, the study site, is a 651-bed urban community hospital. It sees approximately 100,000 emergency department (ED) visits per year, with 8,000 trauma patients coming through the door of the ED in the first 11 months of the hospital’s designation as a level II trauma center.

Dr. Jambhekar and her colleagues evaluated 376 trauma patients, divided into two groups. The first group of 198 patients was seen in the 3 months before the checklist was put in place. The second group of 178 patients was seen in the 60 days after the trauma checklist was mandated. Patients were included in the study if they had been evaluated by the trauma surgery service.

The trauma checklist contained basic demographic and history information, as well as information about the patients’ ED course – for example, what imaging studied were obtained, lab values, what consults they received. The ISS was calculated prior to patient disposition.

“We wanted to present a template to all of our providers to use, in order to correctly document patients’ injuries. If they knew the extent of every patient’s injuries, they could correctly identify patients who were safe to discharge from the emergency department.” One limitation of the study, said Dr. Jambhekar, is overtriage of patients to the trauma center. This is evidenced by the relatively low ISS scores. “As our trauma center became more popular in Brooklyn and in New York City, more patients were brought to our trauma center, even when they could have adequately been treated elsewhere.”

The study didn’t have long-term follow-up of patients to see if they were satisfied with their care, and if they had recovered from their injuries. The exact cost of outpatient follow-up is also uncertain, said Dr. Jambhekar.

Dr. Jambhekar and her colleagues plan to investigate safety and cost outcomes for discharge of trauma patients from the ED; they also will look at the bounce-back phenomenon, and long-term outcomes for outpatient care of trauma patients.

They reported no relevant financial disclosures.

[email protected]

On Twitter @karioakes

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Trauma checklist in ED can increase discharge rates
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AT THE ANNUAL MEETING OF THE CENTRAL SURGICAL ASSOCIATION

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Inside the Article

Vitals

Key clinical point: Use of a standardized trauma checklist in the emergency department (ED) may increase discharge rates.

Major finding: Discharge rates increased significantly after implementation of a trauma checklist.

Data source: Single-center study comparing discharge rates before and after implementation of a trauma checklist.

Disclosures: Dr. Ambhekar and her colleagues reported no disclosures.

Pump-delivered anesthetic reduces pain post-hernia repair

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Pump-delivered anesthetic reduces pain post-hernia repair

MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.

The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.

“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.

Francis DeAsis

“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.

In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.

Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.

Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.

Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.

In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).

“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.

The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).

Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.

The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”

The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.

[email protected]

On Twitter @karioakes

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MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.

The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.

“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.

Francis DeAsis

“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.

In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.

Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.

Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.

Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.

In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).

“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.

The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).

Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.

The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”

The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.

[email protected]

On Twitter @karioakes

MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.

The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.

“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.

Francis DeAsis

“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.

In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.

Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.

Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.

Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.

In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).

“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.

The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).

Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.

The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”

The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.

[email protected]

On Twitter @karioakes

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AT THE ANNUAL MEETING OF THE CENTRAL SURGICAL ASSOCIATION

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Inside the Article

Vitals

Key clinical point: Pain scores were reduced when patients had pump-delivered local anesthetic after hernia repair.

Major finding: Pain level and frequency of pain were reduced, and satisfaction with pain control was increased, when patients received local anesthetic via pump after laparoscopic ventral hernia repair.

Data source: Single-center double-blind, placebo-controlled study of elastomeric pump-delivered bupivacaine vs. placebo in 29 patients undergoing laparoscopic ventral hernia repair.

Disclosures: The pump was supplied by the manufacturer (On-Q); the investigators reported no other relevant disclosures.

Pump-delivered anesthetic reduces pain post-hernia repair

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Pump-delivered anesthetic reduces pain post-hernia repair

MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.

The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.

“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.

Francis DeAsis

“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.

In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.

Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.

Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.

Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.

In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).

“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.

The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).

Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.

The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”

The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.

[email protected]

On Twitter @karioakes

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MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.

The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.

“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.

Francis DeAsis

“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.

In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.

Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.

Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.

Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.

In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).

“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.

The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).

Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.

The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”

The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.

[email protected]

On Twitter @karioakes

MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.

The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.

“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.

Francis DeAsis

“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.

In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.

Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.

Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.

Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.

In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).

“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.

The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).

Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.

The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”

The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.

[email protected]

On Twitter @karioakes

References

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Article Type
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Pump-delivered anesthetic reduces pain post-hernia repair
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Pump-delivered anesthetic reduces pain post-hernia repair
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AT THE ANNUAL MEETING OF THE CENTRAL SURGICAL ASSOCIATION

PURLs Copyright

Inside the Article

Vitals

Key clinical point: Pain scores were reduced when patients had pump-delivered local anesthetic after hernia repair.

Major finding: Pain level and frequency of pain were reduced, and satisfaction with pain control was increased, when patients received local anesthetic via pump after laparoscopic ventral hernia repair.

Data source: Single-center double-blind, placebo-controlled study of elastomeric pump-delivered bupivacaine vs. placebo in 29 patients undergoing laparoscopic ventral hernia repair.

Disclosures: The pump was supplied by the manufacturer (On-Q); the investigators reported no other relevant disclosures.

Experts offer insight into changing payment models for new technologies

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Experts offer insight into changing payment models for new technologies

BOSTON – Many developers of innovative medical technologies don’t realize that insurers are going to want to see evidence that a new technology improves health outcomes before they will consider paying for it, according to Dr. Louis Jacques, senior vice president and chief clinical officer for ADVI, a health care advisory services firm in Washington.

The Centers for Medicare & Medicaid Services generally seeks “adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population” when determining Medicare coverage, Dr. Jacques said in a presentation at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Dr. Louis Jacques

Medicare is less likely to pay if there is something controversial about the available evidence, he said in an interview. “The controversy is usually about inadequate evidence or lack of applicability to the affected Medicare beneficiary population,” Dr. Jacques said, noting that the typical Medicare patient, a 74-year-old woman with comorbid conditions taking multiple medications, often is not the type of person included in clinical trials that would generate such evidence.

Medicare is looking for “adequate evidence that a treatment strategy using the new therapeutic technology, compared to alternatives, leads to improved clinically meaningful health outcomes in Medicare beneficiaries,” he said.

Similarly, new diagnostic technologies should provide the physician with additional information that can alter treatment recommendations, resulting in therapeutic changes that improve outcomes.

Dr. Jacques noted that over the next several years, the health care system will move away from fee for service and begin more and more to pay for value, with physicians becoming more accountable for outcomes and cost.

He advised those developing a new device or treatment to think about how they would justify a particular treatment approach to their colleagues. They need to ask themselves: “What is the value proposition that supports what they are recommending? Are they choosing it because it has better outcomes, is less likely to have an adverse event, is more efficiently provided, or is it something that is less expensive?” he said.

Harry Glorikian

Two major health reform laws will change how insurers pay for new medical devices, though the impact of these changes remains to be seen. According to Harry Glorikian, a health care consultant based in Lexington, Mass., the Affordable Care Act and the Medicaid and CHIP Reauthorization Act (MACRA) put many items into play, most notably fundamental changes in Medicare/Medicaid and the shift from fee-for-service to value-based payment.

“It’s a crazy time because of the need for virtually all hospital-based organizations to operate under both fee-for-service and non–fee-for-service payment arrangements right now,” he said in an interview.

Along with those two reform laws, the Health & Human Services department has set a schedule for transitioning to paying for the value – rather than the volume – of care. The initial goal – 30% of Medicare payments based on value by the end of 2016 – was reached in early March.

“HHS also set a goal of tying 85% of all traditional Medicare payments to quality or value by 2016 and 90% by 2018 through programs such as the Hospital Value-Based Purchasing and the Hospital Readmissions Reduction programs. This will be huge, and its impact will be tremendous,” he added.

One tool physicians can leverage to show value in this new payment landscape is the AGA Digestive Health Recognition Program, a quality improvement program and clinical data registry that allows clinicians to demonstrate quality of care for several disease states (colorectal cancer, hepatitis C virus, and irritable bowel disease) (www.gastro.org/DHRP).

Over the next 5-10 years, watch for changes in value-based payment models and a long-term move to a single-payer system, said Mr. Glorikian. In addition, expect changes in the workforce in terms of who delivers care and how.

Finally, physicians will need to use big data to manage patients, prescribe therapy, and integrate all aspects of medical practice, he said.

Dr. Jacques disclosed that he has financial relationships with Exact Sciences and Medtronic.

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BOSTON – Many developers of innovative medical technologies don’t realize that insurers are going to want to see evidence that a new technology improves health outcomes before they will consider paying for it, according to Dr. Louis Jacques, senior vice president and chief clinical officer for ADVI, a health care advisory services firm in Washington.

The Centers for Medicare & Medicaid Services generally seeks “adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population” when determining Medicare coverage, Dr. Jacques said in a presentation at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Dr. Louis Jacques

Medicare is less likely to pay if there is something controversial about the available evidence, he said in an interview. “The controversy is usually about inadequate evidence or lack of applicability to the affected Medicare beneficiary population,” Dr. Jacques said, noting that the typical Medicare patient, a 74-year-old woman with comorbid conditions taking multiple medications, often is not the type of person included in clinical trials that would generate such evidence.

Medicare is looking for “adequate evidence that a treatment strategy using the new therapeutic technology, compared to alternatives, leads to improved clinically meaningful health outcomes in Medicare beneficiaries,” he said.

Similarly, new diagnostic technologies should provide the physician with additional information that can alter treatment recommendations, resulting in therapeutic changes that improve outcomes.

Dr. Jacques noted that over the next several years, the health care system will move away from fee for service and begin more and more to pay for value, with physicians becoming more accountable for outcomes and cost.

He advised those developing a new device or treatment to think about how they would justify a particular treatment approach to their colleagues. They need to ask themselves: “What is the value proposition that supports what they are recommending? Are they choosing it because it has better outcomes, is less likely to have an adverse event, is more efficiently provided, or is it something that is less expensive?” he said.

Harry Glorikian

Two major health reform laws will change how insurers pay for new medical devices, though the impact of these changes remains to be seen. According to Harry Glorikian, a health care consultant based in Lexington, Mass., the Affordable Care Act and the Medicaid and CHIP Reauthorization Act (MACRA) put many items into play, most notably fundamental changes in Medicare/Medicaid and the shift from fee-for-service to value-based payment.

“It’s a crazy time because of the need for virtually all hospital-based organizations to operate under both fee-for-service and non–fee-for-service payment arrangements right now,” he said in an interview.

Along with those two reform laws, the Health & Human Services department has set a schedule for transitioning to paying for the value – rather than the volume – of care. The initial goal – 30% of Medicare payments based on value by the end of 2016 – was reached in early March.

“HHS also set a goal of tying 85% of all traditional Medicare payments to quality or value by 2016 and 90% by 2018 through programs such as the Hospital Value-Based Purchasing and the Hospital Readmissions Reduction programs. This will be huge, and its impact will be tremendous,” he added.

One tool physicians can leverage to show value in this new payment landscape is the AGA Digestive Health Recognition Program, a quality improvement program and clinical data registry that allows clinicians to demonstrate quality of care for several disease states (colorectal cancer, hepatitis C virus, and irritable bowel disease) (www.gastro.org/DHRP).

Over the next 5-10 years, watch for changes in value-based payment models and a long-term move to a single-payer system, said Mr. Glorikian. In addition, expect changes in the workforce in terms of who delivers care and how.

Finally, physicians will need to use big data to manage patients, prescribe therapy, and integrate all aspects of medical practice, he said.

Dr. Jacques disclosed that he has financial relationships with Exact Sciences and Medtronic.

BOSTON – Many developers of innovative medical technologies don’t realize that insurers are going to want to see evidence that a new technology improves health outcomes before they will consider paying for it, according to Dr. Louis Jacques, senior vice president and chief clinical officer for ADVI, a health care advisory services firm in Washington.

The Centers for Medicare & Medicaid Services generally seeks “adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population” when determining Medicare coverage, Dr. Jacques said in a presentation at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Dr. Louis Jacques

Medicare is less likely to pay if there is something controversial about the available evidence, he said in an interview. “The controversy is usually about inadequate evidence or lack of applicability to the affected Medicare beneficiary population,” Dr. Jacques said, noting that the typical Medicare patient, a 74-year-old woman with comorbid conditions taking multiple medications, often is not the type of person included in clinical trials that would generate such evidence.

Medicare is looking for “adequate evidence that a treatment strategy using the new therapeutic technology, compared to alternatives, leads to improved clinically meaningful health outcomes in Medicare beneficiaries,” he said.

Similarly, new diagnostic technologies should provide the physician with additional information that can alter treatment recommendations, resulting in therapeutic changes that improve outcomes.

Dr. Jacques noted that over the next several years, the health care system will move away from fee for service and begin more and more to pay for value, with physicians becoming more accountable for outcomes and cost.

He advised those developing a new device or treatment to think about how they would justify a particular treatment approach to their colleagues. They need to ask themselves: “What is the value proposition that supports what they are recommending? Are they choosing it because it has better outcomes, is less likely to have an adverse event, is more efficiently provided, or is it something that is less expensive?” he said.

Harry Glorikian

Two major health reform laws will change how insurers pay for new medical devices, though the impact of these changes remains to be seen. According to Harry Glorikian, a health care consultant based in Lexington, Mass., the Affordable Care Act and the Medicaid and CHIP Reauthorization Act (MACRA) put many items into play, most notably fundamental changes in Medicare/Medicaid and the shift from fee-for-service to value-based payment.

“It’s a crazy time because of the need for virtually all hospital-based organizations to operate under both fee-for-service and non–fee-for-service payment arrangements right now,” he said in an interview.

Along with those two reform laws, the Health & Human Services department has set a schedule for transitioning to paying for the value – rather than the volume – of care. The initial goal – 30% of Medicare payments based on value by the end of 2016 – was reached in early March.

“HHS also set a goal of tying 85% of all traditional Medicare payments to quality or value by 2016 and 90% by 2018 through programs such as the Hospital Value-Based Purchasing and the Hospital Readmissions Reduction programs. This will be huge, and its impact will be tremendous,” he added.

One tool physicians can leverage to show value in this new payment landscape is the AGA Digestive Health Recognition Program, a quality improvement program and clinical data registry that allows clinicians to demonstrate quality of care for several disease states (colorectal cancer, hepatitis C virus, and irritable bowel disease) (www.gastro.org/DHRP).

Over the next 5-10 years, watch for changes in value-based payment models and a long-term move to a single-payer system, said Mr. Glorikian. In addition, expect changes in the workforce in terms of who delivers care and how.

Finally, physicians will need to use big data to manage patients, prescribe therapy, and integrate all aspects of medical practice, he said.

Dr. Jacques disclosed that he has financial relationships with Exact Sciences and Medtronic.

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EXPERT ANALYSIS FROM THE 2016 AGA TECH SUMMIT

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Gastroenterology is fertile ground for personalized medicine

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BOSTON – The time is ripe for gastroenterologists to embrace personalized medicine, a leader in the genomics industry said at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Personalized medicine has made the most inroads in oncology, but there are compelling reasons for GI experts to get involved as well, said Mara Aspinall, executive chair of the computational genomics company GenePeeks, and president and CEO of Health Catalysts, a firm dedicated to the growth of new healthcare companies.

Nick Piegari/Frontline Medical News
Mara Aspinall

Virtually all aspects of gastroenterology today are emerging as fertile ground for genomic stratification of patients, Ms. Aspinall said. Inflammatory bowel disease is the first area where there already has been much work done on genomic polymorphism and how differences between patients’ disease progression can be explained, she said, and drug dosing is the first “low hanging fruit” in the area.

In addition, new areas of research can be viewed as opportunities for GI, Ms. Aspinall said. One example is the microbiome: “That’s a cutting-edge area where GI specialists can look to understand the current learning and translate them into the unique impact on their patients.” Another area is the increasingly important role of nutrition in managing patients with everything from metabolic disease to cancer. Nutritional analysis and advice has traditionally been delegated to dietitians more than gastroenterologists, but Ms. Aspinall said she believes personalized medicine in its broadest form will take the shape of using food as drugs, which puts it in GI’s wheelhouse.

Furthermore, there is much more work to be done on the gastrointestinal causes and consequences of immunological diseases, which have been understudied and underdeveloped, she said, looking in particular at patient populations at risk: children, whose immune systems and GI tracts are closely related; and women, who account for the vast majority of immune disorders such as allergies, multiple sclerosis, or lupus. “What role can the GI doc play in better diagnosis and treatment?” Ms. Aspinall said.

Over the past 50 years, the history of medicine has really been a story of diagnostics emergence, Ms. Aspinall said, including the growth of imaging, MRI, PET scans, molecular technologies, and sequencing. “We look at diagnostics as the bridge between theory and therapy,” she said.

“The headlines have been all about the new drugs and new procedures,” she said. “While that’s important, I would argue that it’s not as important as the change in diagnostics. A patient has nothing without an accurate and timely diagnosis.”

Ms. Aspinall said she sees a wider role for the field: “We need to define gastroenterology in a broader context in order to capture personalized medicine.” GI experts should start collecting data on patients’ outcomes, family histories, and complication rates as a start, she said, to look for patterns that could inform improved treatment regimens – particularly in light of genomic differences in those patients. “The reality is you’re probably not helping today’s patients but you will help patients 5 years from now,” she said.

“Cancer treatment today is organ-based,” said Ms. Aspinall. She predicted that in the not-too-distant future, cancer treatment will move more toward pathway-based treatments, as treatment is guided more and more by genetic polymorphisms.

The plummeting cost of genome sequencing is a key development that holds great promise for gastrointestinal cancers, said Raju Kucherlapati, Ph.D., who also spoke about personalized medicine in gastrointestinal cancers. Dr. Kucherlapati, a professor of genetics at Harvard Medical School and the Brigham and Women’s Hospital, Boston, said that sequencing tumor DNA is leading to risk stratification and targeted therapy in ever-increasing numbers of cancer types.

It turns out that many gastrointestinal cancers have mutations that are shared by other cancers, meaning that already-approved therapies may work for some patients with GI cancers, said Dr. Kucherlapati. For example, about 4% of colorectal cancers have amplifications of the ERBB2 gene, meaning that these patients could benefit from trastuzumab (Herceptin). “One of the aspects that’s remarkable is that drugs are already available for many of these targets, reducing the costs and time tremendously,” said Dr. Kucherlapati.

Where will this lead? The nomenclature of cancer is changing to the point where patients and their physicians in the future won’t say they have colon cancer or lung cancer but instead talk of EGFR cancer or c-KIT mutation cancer, Ms. Aspinall said: “If that happens in cancer, I am confident that it will be relevant to other specialties as well.”

In the panel discussion following the morning’s presentations, Dr. Michael Camilleri, AGA president and professor of medicine at Mayo Medical School, Rochester, Minn., agreed that a focus on personalized medicine makes sense in the GI space. “I love the idea that we need to focus on one or two big ideas,” and linking genotype to patient phenotype to target therapy should be one of them.

 

 

Ms. Aspinall and Dr. Kucherlapati reported no relevant financial disclosures.

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BOSTON – The time is ripe for gastroenterologists to embrace personalized medicine, a leader in the genomics industry said at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Personalized medicine has made the most inroads in oncology, but there are compelling reasons for GI experts to get involved as well, said Mara Aspinall, executive chair of the computational genomics company GenePeeks, and president and CEO of Health Catalysts, a firm dedicated to the growth of new healthcare companies.

Nick Piegari/Frontline Medical News
Mara Aspinall

Virtually all aspects of gastroenterology today are emerging as fertile ground for genomic stratification of patients, Ms. Aspinall said. Inflammatory bowel disease is the first area where there already has been much work done on genomic polymorphism and how differences between patients’ disease progression can be explained, she said, and drug dosing is the first “low hanging fruit” in the area.

In addition, new areas of research can be viewed as opportunities for GI, Ms. Aspinall said. One example is the microbiome: “That’s a cutting-edge area where GI specialists can look to understand the current learning and translate them into the unique impact on their patients.” Another area is the increasingly important role of nutrition in managing patients with everything from metabolic disease to cancer. Nutritional analysis and advice has traditionally been delegated to dietitians more than gastroenterologists, but Ms. Aspinall said she believes personalized medicine in its broadest form will take the shape of using food as drugs, which puts it in GI’s wheelhouse.

Furthermore, there is much more work to be done on the gastrointestinal causes and consequences of immunological diseases, which have been understudied and underdeveloped, she said, looking in particular at patient populations at risk: children, whose immune systems and GI tracts are closely related; and women, who account for the vast majority of immune disorders such as allergies, multiple sclerosis, or lupus. “What role can the GI doc play in better diagnosis and treatment?” Ms. Aspinall said.

Over the past 50 years, the history of medicine has really been a story of diagnostics emergence, Ms. Aspinall said, including the growth of imaging, MRI, PET scans, molecular technologies, and sequencing. “We look at diagnostics as the bridge between theory and therapy,” she said.

“The headlines have been all about the new drugs and new procedures,” she said. “While that’s important, I would argue that it’s not as important as the change in diagnostics. A patient has nothing without an accurate and timely diagnosis.”

Ms. Aspinall said she sees a wider role for the field: “We need to define gastroenterology in a broader context in order to capture personalized medicine.” GI experts should start collecting data on patients’ outcomes, family histories, and complication rates as a start, she said, to look for patterns that could inform improved treatment regimens – particularly in light of genomic differences in those patients. “The reality is you’re probably not helping today’s patients but you will help patients 5 years from now,” she said.

“Cancer treatment today is organ-based,” said Ms. Aspinall. She predicted that in the not-too-distant future, cancer treatment will move more toward pathway-based treatments, as treatment is guided more and more by genetic polymorphisms.

The plummeting cost of genome sequencing is a key development that holds great promise for gastrointestinal cancers, said Raju Kucherlapati, Ph.D., who also spoke about personalized medicine in gastrointestinal cancers. Dr. Kucherlapati, a professor of genetics at Harvard Medical School and the Brigham and Women’s Hospital, Boston, said that sequencing tumor DNA is leading to risk stratification and targeted therapy in ever-increasing numbers of cancer types.

It turns out that many gastrointestinal cancers have mutations that are shared by other cancers, meaning that already-approved therapies may work for some patients with GI cancers, said Dr. Kucherlapati. For example, about 4% of colorectal cancers have amplifications of the ERBB2 gene, meaning that these patients could benefit from trastuzumab (Herceptin). “One of the aspects that’s remarkable is that drugs are already available for many of these targets, reducing the costs and time tremendously,” said Dr. Kucherlapati.

Where will this lead? The nomenclature of cancer is changing to the point where patients and their physicians in the future won’t say they have colon cancer or lung cancer but instead talk of EGFR cancer or c-KIT mutation cancer, Ms. Aspinall said: “If that happens in cancer, I am confident that it will be relevant to other specialties as well.”

In the panel discussion following the morning’s presentations, Dr. Michael Camilleri, AGA president and professor of medicine at Mayo Medical School, Rochester, Minn., agreed that a focus on personalized medicine makes sense in the GI space. “I love the idea that we need to focus on one or two big ideas,” and linking genotype to patient phenotype to target therapy should be one of them.

 

 

Ms. Aspinall and Dr. Kucherlapati reported no relevant financial disclosures.

BOSTON – The time is ripe for gastroenterologists to embrace personalized medicine, a leader in the genomics industry said at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Personalized medicine has made the most inroads in oncology, but there are compelling reasons for GI experts to get involved as well, said Mara Aspinall, executive chair of the computational genomics company GenePeeks, and president and CEO of Health Catalysts, a firm dedicated to the growth of new healthcare companies.

Nick Piegari/Frontline Medical News
Mara Aspinall

Virtually all aspects of gastroenterology today are emerging as fertile ground for genomic stratification of patients, Ms. Aspinall said. Inflammatory bowel disease is the first area where there already has been much work done on genomic polymorphism and how differences between patients’ disease progression can be explained, she said, and drug dosing is the first “low hanging fruit” in the area.

In addition, new areas of research can be viewed as opportunities for GI, Ms. Aspinall said. One example is the microbiome: “That’s a cutting-edge area where GI specialists can look to understand the current learning and translate them into the unique impact on their patients.” Another area is the increasingly important role of nutrition in managing patients with everything from metabolic disease to cancer. Nutritional analysis and advice has traditionally been delegated to dietitians more than gastroenterologists, but Ms. Aspinall said she believes personalized medicine in its broadest form will take the shape of using food as drugs, which puts it in GI’s wheelhouse.

Furthermore, there is much more work to be done on the gastrointestinal causes and consequences of immunological diseases, which have been understudied and underdeveloped, she said, looking in particular at patient populations at risk: children, whose immune systems and GI tracts are closely related; and women, who account for the vast majority of immune disorders such as allergies, multiple sclerosis, or lupus. “What role can the GI doc play in better diagnosis and treatment?” Ms. Aspinall said.

Over the past 50 years, the history of medicine has really been a story of diagnostics emergence, Ms. Aspinall said, including the growth of imaging, MRI, PET scans, molecular technologies, and sequencing. “We look at diagnostics as the bridge between theory and therapy,” she said.

“The headlines have been all about the new drugs and new procedures,” she said. “While that’s important, I would argue that it’s not as important as the change in diagnostics. A patient has nothing without an accurate and timely diagnosis.”

Ms. Aspinall said she sees a wider role for the field: “We need to define gastroenterology in a broader context in order to capture personalized medicine.” GI experts should start collecting data on patients’ outcomes, family histories, and complication rates as a start, she said, to look for patterns that could inform improved treatment regimens – particularly in light of genomic differences in those patients. “The reality is you’re probably not helping today’s patients but you will help patients 5 years from now,” she said.

“Cancer treatment today is organ-based,” said Ms. Aspinall. She predicted that in the not-too-distant future, cancer treatment will move more toward pathway-based treatments, as treatment is guided more and more by genetic polymorphisms.

The plummeting cost of genome sequencing is a key development that holds great promise for gastrointestinal cancers, said Raju Kucherlapati, Ph.D., who also spoke about personalized medicine in gastrointestinal cancers. Dr. Kucherlapati, a professor of genetics at Harvard Medical School and the Brigham and Women’s Hospital, Boston, said that sequencing tumor DNA is leading to risk stratification and targeted therapy in ever-increasing numbers of cancer types.

It turns out that many gastrointestinal cancers have mutations that are shared by other cancers, meaning that already-approved therapies may work for some patients with GI cancers, said Dr. Kucherlapati. For example, about 4% of colorectal cancers have amplifications of the ERBB2 gene, meaning that these patients could benefit from trastuzumab (Herceptin). “One of the aspects that’s remarkable is that drugs are already available for many of these targets, reducing the costs and time tremendously,” said Dr. Kucherlapati.

Where will this lead? The nomenclature of cancer is changing to the point where patients and their physicians in the future won’t say they have colon cancer or lung cancer but instead talk of EGFR cancer or c-KIT mutation cancer, Ms. Aspinall said: “If that happens in cancer, I am confident that it will be relevant to other specialties as well.”

In the panel discussion following the morning’s presentations, Dr. Michael Camilleri, AGA president and professor of medicine at Mayo Medical School, Rochester, Minn., agreed that a focus on personalized medicine makes sense in the GI space. “I love the idea that we need to focus on one or two big ideas,” and linking genotype to patient phenotype to target therapy should be one of them.

 

 

Ms. Aspinall and Dr. Kucherlapati reported no relevant financial disclosures.

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Cannabinoids for seizures: Frankness, comfort, and follow-up are key to gathering data

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Since Colorado is “ground zero” for medical marijuana use, the rest of the nation can learn from how pediatric neurologists there are taking care of children with seizures who use cannabinoids.

Dr. Amy Brooks-Kayal, chief of pediatric neurology at the University of Colorado at Denver, Aurora, shared her facility’s experiences at Marijuana and Cannabinoids: A Neuroscience Research Summit sponsored by the National Institutes of Health.

“Our odyssey in Colorado started before I arrived there,” she said, since the state has allowed medical use of marijuana since November 2000. Of the state’s 107,798 patients who hold the “red card” that permits medical marijuana use, 349, or about 0.3%, are minors.

Dr. Amy Brooks-Kayal

Seizures are a relatively rare reason for medical marijuana use, and Dr. Brooks-Kayal said that she is not aware of any neurologists or pediatricians who prescribe cannabinoids for pediatric seizures (“red cards” can be issued by any physician who has a relationship with the patient; two physicians are needed for minors).

To examine the use of medical marijuana in Colorado for children with seizure disorders, Dr. Craig Press, then a pediatric neurology resident at Children’s Hospital Colorado, and his coauthors studied 75 pediatric seizure patients who used medical marijuana (Epilepsy Behav. 2015 Apr;45:49-52). “This was completely an observational study. Obviously, we had no ability to determine what was in the substances given, other than parental report,” Dr. Brooks-Kayal said.

Overall, 33% of parents reported a greater than 50% reduction in seizures; this group was judged to be responders, with no significant difference in response rate by seizure type. A variety of cannabis products were used, including cannabidiol alone and cannabidiol with other oral cannabis extracts (OCEs). All produced similar response rates.

However, only 30 patients had pre- and post-cannabis EEGs. Of this group, none of the cannabis responders had an improvement in their EEGs after cannabis use, whereas three of the nonresponders showed EEG improvement. “The most interesting finding that we saw was that the response rate dramatically varied depending on whether the families had moved out of state,” Dr. Brooks-Kayal said. Families who had moved to Colorado from another state for treatment were three times more likely to report response to OCEs, compared with those families who were from Colorado (16/34, 47%, vs. 9/41, 22%; odds ratio, 3.16; P less than .025).

This result, she said, raised the possibility that “the degree of investment that the family had made in getting this therapy might be impacting the parents’ perception of response.”

Since state policies vary widely and “federal policies are fragmented,” it’s hard to know what to do when a family comes to you asking about cannabis for pediatric seizure control, Dr. Brooks-Kayal said.

Dr. Brooks-Kayal outlined the approach used at Children’s Hospital Colorado. There, “providers do not recommend use of cannabinoids for treatment of epilepsy outside of a clinical trial,” she said.

However, families are provided with the most current information about cannabinoids. This includes being frank about the current lack of evidence regarding efficacy and safety, as well as unknowns around dosing and drug interactions. She said providers also share concerns about what’s in artisanal marijuana products, since purity and consistency of content aren’t regulated.

It’s critical for families to feel comfortable disclosing whether they’re using cannabinoids for their children with seizures, so providers can help track safety and efficacy. Disclosure may be more likely if you reinforce that you won’t stop caring for these children if they are on cannabinoids, Dr. Brooks-Kayal said. “We strongly encourage disclosure,” and it’s a standard part of intake at every appointment to ask about cannabinoids, she said.

When cannabinoids are being used, Dr. Brooks-Kayal recommends obtaining the following labs at baseline and monthly thereafter: CBC, liver function tests, basic metabolic panel, and trough anti-seizure medication levels. Clobazam, N-desmethylclobazam, and valproic acid levels have all been seen to change with concomitant cannabinoid use, she said.

“We ask families not to change other medications,” Dr. Brooks-Kayal said. Her practice frequently sees unwanted status epilepticus when other medications are stopped and cannabinoids started, she said. “That is a huge risk.”

To help families and providers track efficacy when cannabinoids are being used, Dr. Brooks-Kayal asks families to keep a seizure diary. She obtains a baseline EEG and repeats it about 3 months after the baseline. Since the EEG should capture seizure frequency, the length of the EEG is tailored to the patient’s seizure frequency. For Dr. Brooks-Kayal’s patients, this means she often obtains 24-hour EEGs.

If it’s appropriate, families can enroll their children in an observational research study, and families can also consider participating in pharmaceutical double-blind, placebo-controlled trials. Other practical tips include standardizing the way you care for cannabinoid-using children in your practice, and working with hospital administrators and the inpatient pharmacy in advance about how use of these products will be addressed for inpatients.

 

 

A 2014 Cochrane review concluded that “no reliable conclusions can be drawn at present regarding the efficacy of cannabinoids as a treatment for epilepsy,” Dr. Brooks-Kayal said (Cochrane Database Syst Rev. 2012 Jun 13;6:CD009270). The American Academy of Neurology’s own systematic review reached the same conclusions (Neurology. 2014 Apr 29;82[17]:1556-63). The American Epilepsy Society, the American Academy of Pediatrics, and the American Medical Association do not recommend routine clinical use of cannabinoids for seizures, but do call for additional research. “We need better data!” Dr. Brooks-Kayal said.

Dr. Brooks-Kayal disclosed that as past president of the American Epilepsy Society (AES), she was a coauthor and promoter of the AES position statement on the use of medical marijuana for epilepsy.

[email protected]

On Twitter @karioakes

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Since Colorado is “ground zero” for medical marijuana use, the rest of the nation can learn from how pediatric neurologists there are taking care of children with seizures who use cannabinoids.

Dr. Amy Brooks-Kayal, chief of pediatric neurology at the University of Colorado at Denver, Aurora, shared her facility’s experiences at Marijuana and Cannabinoids: A Neuroscience Research Summit sponsored by the National Institutes of Health.

“Our odyssey in Colorado started before I arrived there,” she said, since the state has allowed medical use of marijuana since November 2000. Of the state’s 107,798 patients who hold the “red card” that permits medical marijuana use, 349, or about 0.3%, are minors.

Dr. Amy Brooks-Kayal

Seizures are a relatively rare reason for medical marijuana use, and Dr. Brooks-Kayal said that she is not aware of any neurologists or pediatricians who prescribe cannabinoids for pediatric seizures (“red cards” can be issued by any physician who has a relationship with the patient; two physicians are needed for minors).

To examine the use of medical marijuana in Colorado for children with seizure disorders, Dr. Craig Press, then a pediatric neurology resident at Children’s Hospital Colorado, and his coauthors studied 75 pediatric seizure patients who used medical marijuana (Epilepsy Behav. 2015 Apr;45:49-52). “This was completely an observational study. Obviously, we had no ability to determine what was in the substances given, other than parental report,” Dr. Brooks-Kayal said.

Overall, 33% of parents reported a greater than 50% reduction in seizures; this group was judged to be responders, with no significant difference in response rate by seizure type. A variety of cannabis products were used, including cannabidiol alone and cannabidiol with other oral cannabis extracts (OCEs). All produced similar response rates.

However, only 30 patients had pre- and post-cannabis EEGs. Of this group, none of the cannabis responders had an improvement in their EEGs after cannabis use, whereas three of the nonresponders showed EEG improvement. “The most interesting finding that we saw was that the response rate dramatically varied depending on whether the families had moved out of state,” Dr. Brooks-Kayal said. Families who had moved to Colorado from another state for treatment were three times more likely to report response to OCEs, compared with those families who were from Colorado (16/34, 47%, vs. 9/41, 22%; odds ratio, 3.16; P less than .025).

This result, she said, raised the possibility that “the degree of investment that the family had made in getting this therapy might be impacting the parents’ perception of response.”

Since state policies vary widely and “federal policies are fragmented,” it’s hard to know what to do when a family comes to you asking about cannabis for pediatric seizure control, Dr. Brooks-Kayal said.

Dr. Brooks-Kayal outlined the approach used at Children’s Hospital Colorado. There, “providers do not recommend use of cannabinoids for treatment of epilepsy outside of a clinical trial,” she said.

However, families are provided with the most current information about cannabinoids. This includes being frank about the current lack of evidence regarding efficacy and safety, as well as unknowns around dosing and drug interactions. She said providers also share concerns about what’s in artisanal marijuana products, since purity and consistency of content aren’t regulated.

It’s critical for families to feel comfortable disclosing whether they’re using cannabinoids for their children with seizures, so providers can help track safety and efficacy. Disclosure may be more likely if you reinforce that you won’t stop caring for these children if they are on cannabinoids, Dr. Brooks-Kayal said. “We strongly encourage disclosure,” and it’s a standard part of intake at every appointment to ask about cannabinoids, she said.

When cannabinoids are being used, Dr. Brooks-Kayal recommends obtaining the following labs at baseline and monthly thereafter: CBC, liver function tests, basic metabolic panel, and trough anti-seizure medication levels. Clobazam, N-desmethylclobazam, and valproic acid levels have all been seen to change with concomitant cannabinoid use, she said.

“We ask families not to change other medications,” Dr. Brooks-Kayal said. Her practice frequently sees unwanted status epilepticus when other medications are stopped and cannabinoids started, she said. “That is a huge risk.”

To help families and providers track efficacy when cannabinoids are being used, Dr. Brooks-Kayal asks families to keep a seizure diary. She obtains a baseline EEG and repeats it about 3 months after the baseline. Since the EEG should capture seizure frequency, the length of the EEG is tailored to the patient’s seizure frequency. For Dr. Brooks-Kayal’s patients, this means she often obtains 24-hour EEGs.

If it’s appropriate, families can enroll their children in an observational research study, and families can also consider participating in pharmaceutical double-blind, placebo-controlled trials. Other practical tips include standardizing the way you care for cannabinoid-using children in your practice, and working with hospital administrators and the inpatient pharmacy in advance about how use of these products will be addressed for inpatients.

 

 

A 2014 Cochrane review concluded that “no reliable conclusions can be drawn at present regarding the efficacy of cannabinoids as a treatment for epilepsy,” Dr. Brooks-Kayal said (Cochrane Database Syst Rev. 2012 Jun 13;6:CD009270). The American Academy of Neurology’s own systematic review reached the same conclusions (Neurology. 2014 Apr 29;82[17]:1556-63). The American Epilepsy Society, the American Academy of Pediatrics, and the American Medical Association do not recommend routine clinical use of cannabinoids for seizures, but do call for additional research. “We need better data!” Dr. Brooks-Kayal said.

Dr. Brooks-Kayal disclosed that as past president of the American Epilepsy Society (AES), she was a coauthor and promoter of the AES position statement on the use of medical marijuana for epilepsy.

[email protected]

On Twitter @karioakes

Since Colorado is “ground zero” for medical marijuana use, the rest of the nation can learn from how pediatric neurologists there are taking care of children with seizures who use cannabinoids.

Dr. Amy Brooks-Kayal, chief of pediatric neurology at the University of Colorado at Denver, Aurora, shared her facility’s experiences at Marijuana and Cannabinoids: A Neuroscience Research Summit sponsored by the National Institutes of Health.

“Our odyssey in Colorado started before I arrived there,” she said, since the state has allowed medical use of marijuana since November 2000. Of the state’s 107,798 patients who hold the “red card” that permits medical marijuana use, 349, or about 0.3%, are minors.

Dr. Amy Brooks-Kayal

Seizures are a relatively rare reason for medical marijuana use, and Dr. Brooks-Kayal said that she is not aware of any neurologists or pediatricians who prescribe cannabinoids for pediatric seizures (“red cards” can be issued by any physician who has a relationship with the patient; two physicians are needed for minors).

To examine the use of medical marijuana in Colorado for children with seizure disorders, Dr. Craig Press, then a pediatric neurology resident at Children’s Hospital Colorado, and his coauthors studied 75 pediatric seizure patients who used medical marijuana (Epilepsy Behav. 2015 Apr;45:49-52). “This was completely an observational study. Obviously, we had no ability to determine what was in the substances given, other than parental report,” Dr. Brooks-Kayal said.

Overall, 33% of parents reported a greater than 50% reduction in seizures; this group was judged to be responders, with no significant difference in response rate by seizure type. A variety of cannabis products were used, including cannabidiol alone and cannabidiol with other oral cannabis extracts (OCEs). All produced similar response rates.

However, only 30 patients had pre- and post-cannabis EEGs. Of this group, none of the cannabis responders had an improvement in their EEGs after cannabis use, whereas three of the nonresponders showed EEG improvement. “The most interesting finding that we saw was that the response rate dramatically varied depending on whether the families had moved out of state,” Dr. Brooks-Kayal said. Families who had moved to Colorado from another state for treatment were three times more likely to report response to OCEs, compared with those families who were from Colorado (16/34, 47%, vs. 9/41, 22%; odds ratio, 3.16; P less than .025).

This result, she said, raised the possibility that “the degree of investment that the family had made in getting this therapy might be impacting the parents’ perception of response.”

Since state policies vary widely and “federal policies are fragmented,” it’s hard to know what to do when a family comes to you asking about cannabis for pediatric seizure control, Dr. Brooks-Kayal said.

Dr. Brooks-Kayal outlined the approach used at Children’s Hospital Colorado. There, “providers do not recommend use of cannabinoids for treatment of epilepsy outside of a clinical trial,” she said.

However, families are provided with the most current information about cannabinoids. This includes being frank about the current lack of evidence regarding efficacy and safety, as well as unknowns around dosing and drug interactions. She said providers also share concerns about what’s in artisanal marijuana products, since purity and consistency of content aren’t regulated.

It’s critical for families to feel comfortable disclosing whether they’re using cannabinoids for their children with seizures, so providers can help track safety and efficacy. Disclosure may be more likely if you reinforce that you won’t stop caring for these children if they are on cannabinoids, Dr. Brooks-Kayal said. “We strongly encourage disclosure,” and it’s a standard part of intake at every appointment to ask about cannabinoids, she said.

When cannabinoids are being used, Dr. Brooks-Kayal recommends obtaining the following labs at baseline and monthly thereafter: CBC, liver function tests, basic metabolic panel, and trough anti-seizure medication levels. Clobazam, N-desmethylclobazam, and valproic acid levels have all been seen to change with concomitant cannabinoid use, she said.

“We ask families not to change other medications,” Dr. Brooks-Kayal said. Her practice frequently sees unwanted status epilepticus when other medications are stopped and cannabinoids started, she said. “That is a huge risk.”

To help families and providers track efficacy when cannabinoids are being used, Dr. Brooks-Kayal asks families to keep a seizure diary. She obtains a baseline EEG and repeats it about 3 months after the baseline. Since the EEG should capture seizure frequency, the length of the EEG is tailored to the patient’s seizure frequency. For Dr. Brooks-Kayal’s patients, this means she often obtains 24-hour EEGs.

If it’s appropriate, families can enroll their children in an observational research study, and families can also consider participating in pharmaceutical double-blind, placebo-controlled trials. Other practical tips include standardizing the way you care for cannabinoid-using children in your practice, and working with hospital administrators and the inpatient pharmacy in advance about how use of these products will be addressed for inpatients.

 

 

A 2014 Cochrane review concluded that “no reliable conclusions can be drawn at present regarding the efficacy of cannabinoids as a treatment for epilepsy,” Dr. Brooks-Kayal said (Cochrane Database Syst Rev. 2012 Jun 13;6:CD009270). The American Academy of Neurology’s own systematic review reached the same conclusions (Neurology. 2014 Apr 29;82[17]:1556-63). The American Epilepsy Society, the American Academy of Pediatrics, and the American Medical Association do not recommend routine clinical use of cannabinoids for seizures, but do call for additional research. “We need better data!” Dr. Brooks-Kayal said.

Dr. Brooks-Kayal disclosed that as past president of the American Epilepsy Society (AES), she was a coauthor and promoter of the AES position statement on the use of medical marijuana for epilepsy.

[email protected]

On Twitter @karioakes

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Malpractice claims for small bowel obstruction costly, frequent for general surgeons

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MONTREAL – When surgeons are sued and lose or settle in cases relating to management of small bowel obstruction, the payout is often costly, according a study involving a close examination of 158 such cases.

The odds of a positive outcome aren’t great. “When looking at award payouts, close to half of cases resulted in a verdict with monetary compensation for the patient,” said Dr. Asad Choudhry, a postdoctoral fellow in the department of trauma, critical care, and surgery at the Mayo Clinic, Rochester, Minn.

Courtesy Wikimedia Commons/James Heilman/Creative Commons License

Dr. Choudhry, presenting his findings at the annual meeting of the Central Surgical Association, said that general surgeons are the third most likely specialty to be sued, coming only after neurosurgeons and cardiothoracic surgeons. In a given year, about 15% of all general surgeons will be sued, with almost a third of those suits resulting in a payment to the plaintiff. By age 65 years, said Dr. Choudhry, 99% of physicians in higher-risk specialties will face a malpractice claim, compared with 75% of those in lower-risk specialties.

Overall, one-third of malpractice payments come from suits that allege diagnostic error; 24% of suits allege malpractice in surgery. “Small bowel obstruction accounts for 12% to 16% of surgical admissions, with 300,000 operations performed each year,” he said.

Dr. Choudhry and his colleagues searched the Westlaw database using key search terms to identify U.S. malpractice cases that involved small bowel obstruction (SBO), focusing only on cases in which management of SBO was the primary reason for the suit. Cases from 1982 to 2015 were included.

Looking more closely at the 158 cases that resulted from the search, Dr. Choudhry examined variables that included patient demographics, the alleged reason for the malpractice, the settlement or verdict, and the amount paid out, adjusted to 2015 dollars.

In this sample of SBO cases, 139 patients were adults and 19 were children. The median age was 45 years. Over half of the patients in the group died (94/158, 60%), although neither age nor patient death were factors significantly associated with verdict outcome or award amount, he said.

The decade-over-decade growth in the number of suits was striking, increasing 188% during the 1994-2004 period from the previous decade and another 87% from 2005 to 2015.

In a lawsuit involving a SBO, the defendant is more likely to be a general surgeon than to belong to any other specialty. General surgeons were the defendant in 37% of cases, followed by internists in 24% and emergency physicians in 11%.

Dr. Choudhry and his associates conceptually grouped the reasons for the suits into preoperative, intraoperative, and postoperative care. Among the reasons for litigation, by far the most common was untimely intervention in managing of the SBO, a preoperative care component. This was the primary allegation in over 100 of the 158 cases; the next most common reason for bringing suit was incomplete or incorrect surgical procedure, deemed an intraoperative problem and seen in fewer than 20 of the suits.

Almost half of the cases resulted either in a verdict in favor of the plaintiff (n = 37, 23%) or a settlement (n = 36, 23%). When verdicts were returned against the defendant physician, payout amounts varied widely. The smallest amount paid was $29,575 and the largest was over $12 million. Payment amounts were larger with a verdict in favor of the plaintiff, at a median $1,438,800, compared with the median of $1,043,100 received by the plaintiff in a settlement.

Dr. Choudhry noted that early intervention may improve mortality from SBO in some patient groups. “Small bowel obstruction protocols which identify patients at high risk for adverse outcomes and ensure timely management may lessen the chance of litigation,” he said.

Dr. Choudhry acknowledged that the Westlaw database included just a limited amount of medical information. Various tort reform initiatives may have had a confounding effect on award size. It’s possible that using malpractice insurance data could provide more detailed medical information, he said.

Dr. Choudhry reported no relevant disclosures.

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MONTREAL – When surgeons are sued and lose or settle in cases relating to management of small bowel obstruction, the payout is often costly, according a study involving a close examination of 158 such cases.

The odds of a positive outcome aren’t great. “When looking at award payouts, close to half of cases resulted in a verdict with monetary compensation for the patient,” said Dr. Asad Choudhry, a postdoctoral fellow in the department of trauma, critical care, and surgery at the Mayo Clinic, Rochester, Minn.

Courtesy Wikimedia Commons/James Heilman/Creative Commons License

Dr. Choudhry, presenting his findings at the annual meeting of the Central Surgical Association, said that general surgeons are the third most likely specialty to be sued, coming only after neurosurgeons and cardiothoracic surgeons. In a given year, about 15% of all general surgeons will be sued, with almost a third of those suits resulting in a payment to the plaintiff. By age 65 years, said Dr. Choudhry, 99% of physicians in higher-risk specialties will face a malpractice claim, compared with 75% of those in lower-risk specialties.

Overall, one-third of malpractice payments come from suits that allege diagnostic error; 24% of suits allege malpractice in surgery. “Small bowel obstruction accounts for 12% to 16% of surgical admissions, with 300,000 operations performed each year,” he said.

Dr. Choudhry and his colleagues searched the Westlaw database using key search terms to identify U.S. malpractice cases that involved small bowel obstruction (SBO), focusing only on cases in which management of SBO was the primary reason for the suit. Cases from 1982 to 2015 were included.

Looking more closely at the 158 cases that resulted from the search, Dr. Choudhry examined variables that included patient demographics, the alleged reason for the malpractice, the settlement or verdict, and the amount paid out, adjusted to 2015 dollars.

In this sample of SBO cases, 139 patients were adults and 19 were children. The median age was 45 years. Over half of the patients in the group died (94/158, 60%), although neither age nor patient death were factors significantly associated with verdict outcome or award amount, he said.

The decade-over-decade growth in the number of suits was striking, increasing 188% during the 1994-2004 period from the previous decade and another 87% from 2005 to 2015.

In a lawsuit involving a SBO, the defendant is more likely to be a general surgeon than to belong to any other specialty. General surgeons were the defendant in 37% of cases, followed by internists in 24% and emergency physicians in 11%.

Dr. Choudhry and his associates conceptually grouped the reasons for the suits into preoperative, intraoperative, and postoperative care. Among the reasons for litigation, by far the most common was untimely intervention in managing of the SBO, a preoperative care component. This was the primary allegation in over 100 of the 158 cases; the next most common reason for bringing suit was incomplete or incorrect surgical procedure, deemed an intraoperative problem and seen in fewer than 20 of the suits.

Almost half of the cases resulted either in a verdict in favor of the plaintiff (n = 37, 23%) or a settlement (n = 36, 23%). When verdicts were returned against the defendant physician, payout amounts varied widely. The smallest amount paid was $29,575 and the largest was over $12 million. Payment amounts were larger with a verdict in favor of the plaintiff, at a median $1,438,800, compared with the median of $1,043,100 received by the plaintiff in a settlement.

Dr. Choudhry noted that early intervention may improve mortality from SBO in some patient groups. “Small bowel obstruction protocols which identify patients at high risk for adverse outcomes and ensure timely management may lessen the chance of litigation,” he said.

Dr. Choudhry acknowledged that the Westlaw database included just a limited amount of medical information. Various tort reform initiatives may have had a confounding effect on award size. It’s possible that using malpractice insurance data could provide more detailed medical information, he said.

Dr. Choudhry reported no relevant disclosures.

[email protected]

On Twitter @karioakes

MONTREAL – When surgeons are sued and lose or settle in cases relating to management of small bowel obstruction, the payout is often costly, according a study involving a close examination of 158 such cases.

The odds of a positive outcome aren’t great. “When looking at award payouts, close to half of cases resulted in a verdict with monetary compensation for the patient,” said Dr. Asad Choudhry, a postdoctoral fellow in the department of trauma, critical care, and surgery at the Mayo Clinic, Rochester, Minn.

Courtesy Wikimedia Commons/James Heilman/Creative Commons License

Dr. Choudhry, presenting his findings at the annual meeting of the Central Surgical Association, said that general surgeons are the third most likely specialty to be sued, coming only after neurosurgeons and cardiothoracic surgeons. In a given year, about 15% of all general surgeons will be sued, with almost a third of those suits resulting in a payment to the plaintiff. By age 65 years, said Dr. Choudhry, 99% of physicians in higher-risk specialties will face a malpractice claim, compared with 75% of those in lower-risk specialties.

Overall, one-third of malpractice payments come from suits that allege diagnostic error; 24% of suits allege malpractice in surgery. “Small bowel obstruction accounts for 12% to 16% of surgical admissions, with 300,000 operations performed each year,” he said.

Dr. Choudhry and his colleagues searched the Westlaw database using key search terms to identify U.S. malpractice cases that involved small bowel obstruction (SBO), focusing only on cases in which management of SBO was the primary reason for the suit. Cases from 1982 to 2015 were included.

Looking more closely at the 158 cases that resulted from the search, Dr. Choudhry examined variables that included patient demographics, the alleged reason for the malpractice, the settlement or verdict, and the amount paid out, adjusted to 2015 dollars.

In this sample of SBO cases, 139 patients were adults and 19 were children. The median age was 45 years. Over half of the patients in the group died (94/158, 60%), although neither age nor patient death were factors significantly associated with verdict outcome or award amount, he said.

The decade-over-decade growth in the number of suits was striking, increasing 188% during the 1994-2004 period from the previous decade and another 87% from 2005 to 2015.

In a lawsuit involving a SBO, the defendant is more likely to be a general surgeon than to belong to any other specialty. General surgeons were the defendant in 37% of cases, followed by internists in 24% and emergency physicians in 11%.

Dr. Choudhry and his associates conceptually grouped the reasons for the suits into preoperative, intraoperative, and postoperative care. Among the reasons for litigation, by far the most common was untimely intervention in managing of the SBO, a preoperative care component. This was the primary allegation in over 100 of the 158 cases; the next most common reason for bringing suit was incomplete or incorrect surgical procedure, deemed an intraoperative problem and seen in fewer than 20 of the suits.

Almost half of the cases resulted either in a verdict in favor of the plaintiff (n = 37, 23%) or a settlement (n = 36, 23%). When verdicts were returned against the defendant physician, payout amounts varied widely. The smallest amount paid was $29,575 and the largest was over $12 million. Payment amounts were larger with a verdict in favor of the plaintiff, at a median $1,438,800, compared with the median of $1,043,100 received by the plaintiff in a settlement.

Dr. Choudhry noted that early intervention may improve mortality from SBO in some patient groups. “Small bowel obstruction protocols which identify patients at high risk for adverse outcomes and ensure timely management may lessen the chance of litigation,” he said.

Dr. Choudhry acknowledged that the Westlaw database included just a limited amount of medical information. Various tort reform initiatives may have had a confounding effect on award size. It’s possible that using malpractice insurance data could provide more detailed medical information, he said.

Dr. Choudhry reported no relevant disclosures.

[email protected]

On Twitter @karioakes

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AT THE ANNUAL MEETING OF THE CENTRAL SURGICAL ASSOCIATION

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Key clinical point: Almost half of surgical small bowel obstruction lawsuits involved a payout of a median $1.1 million.

Major finding: About 15% of general surgeons are sued annually, and SBO is a common diagnosis in these suits.

Data source: Review of the Westlaw database that identified 158 lawsuits involving general surgeons and small bowel obstruction from 1982 to 2015.

Disclosures: The study authors reported no relevant disclosures.

Strong showing for ob.gyn. on Match Day 2016

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MADISON, WIS.– One-hundred and seventy-six fourth-year medical students, 12 of them seeking residency matches in obstetrics and gynecology, gathered with family and friends at the University of Wisconsin-Madison for the School of Medicine and Public Health’s annual Match Day ceremony. In introductory remarks, Dr. Gwen McIntosh, assistant dean for students at the School of Medicine and Public Health, spoke of the whirlwind tour of residency interviews, ultimately leading to one highly significant line of text tucked inside an envelope. “This process is like speed dating, ending in an arranged marriage,” Dr. McIntosh said. The hall erupted in laughter, and the envelope opening began.

Ob.gyn. continues to fill nearly all available PGY-1 residency slots: just eight of the 1,265 positions were unfilled after Match Day, meaning that 99.4% of the specialty’s spots were filled. In 2015, ob.gyn. filled all its spots, but offered 10 fewer residency positions than in 2016.

Ob.gyn. residency programs filled 981 positions with senior medical students from the United States. This figure is less than 2015, when 1,002 U.S. seniors matched into ob.gyn, but more than the 950 U.S. seniors going into ob.gyn. in 2014.

UW-Madison’s ob.gyn. residency program director, Dr. Ellen Hartenbach, said in an interview that she was delighted with the new class of residents she’ll welcome this summer. The program offers six residency positions, and all openings were filled with strong students, she said. All 12 of UW-Madison’s senior medical students who sought an ob.gyn. residency also matched into that specialty.

“Obstetrics and gynecology as a field is fortunate to be having increasing numbers of applicants,” said Dr. Hartenbach. “We’re getting top medical students.” Dr. Hartenbach said she’s seeing increasing interest in the specialty, as well as a growing appetite for subspecialty training. Female pelvic medicine, minimally invasive gynecology, and reproductive endocrinology and fertility are all current areas of growth, she said.

Frontline Medical News/Kari OakesLiliana Palencia and her father Dr. Mauricio Palencia

Liliana Palencia, a fourth year medical student at UW-Madison, is headed to her first choice, Southern Illinois University in Springfield, for her ob.gyn. residency. Ms. Palencia said she liked everything she experienced when she visited Southern Illinois University for her interview. “I got the best feeling from them. The faculty and residents really seemed to care about each other and to work together. The facilities, the curriculum – they were all great.”

She didn’t know she wanted to be an ob.gyn. when she came to medical school, though she had known she wanted to be a physician for a long time. Her father, who brought her family to the United States from Honduras for his residency when Liliana was small, is a family practice physician.

Ms. Palencia’s third-year ob.gyn. rotation at an urban Milwaukee site really solidified her specialty choice, and a sub-internship in gynecologic oncology helped her realize the variety available to ob.gyns. “This specialty represents everything I want in a career – it’s varied, there’s a clinical portion, there’s labor and delivery, and there’s the opportunity to perform surgery,” she said.

Asked if she was nervous about her residency, Ms. Palencia said, “Transitions are hard, and I’m expecting a steep learning curve. But I know that in the program I’m going to, I’ll be able to lean on those around me.” She thinks the hard work will be worth it, saying, “It’s important for women to have a physician they can trust.”

[email protected]

On Twitter @karioakes

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MADISON, WIS.– One-hundred and seventy-six fourth-year medical students, 12 of them seeking residency matches in obstetrics and gynecology, gathered with family and friends at the University of Wisconsin-Madison for the School of Medicine and Public Health’s annual Match Day ceremony. In introductory remarks, Dr. Gwen McIntosh, assistant dean for students at the School of Medicine and Public Health, spoke of the whirlwind tour of residency interviews, ultimately leading to one highly significant line of text tucked inside an envelope. “This process is like speed dating, ending in an arranged marriage,” Dr. McIntosh said. The hall erupted in laughter, and the envelope opening began.

Ob.gyn. continues to fill nearly all available PGY-1 residency slots: just eight of the 1,265 positions were unfilled after Match Day, meaning that 99.4% of the specialty’s spots were filled. In 2015, ob.gyn. filled all its spots, but offered 10 fewer residency positions than in 2016.

Ob.gyn. residency programs filled 981 positions with senior medical students from the United States. This figure is less than 2015, when 1,002 U.S. seniors matched into ob.gyn, but more than the 950 U.S. seniors going into ob.gyn. in 2014.

UW-Madison’s ob.gyn. residency program director, Dr. Ellen Hartenbach, said in an interview that she was delighted with the new class of residents she’ll welcome this summer. The program offers six residency positions, and all openings were filled with strong students, she said. All 12 of UW-Madison’s senior medical students who sought an ob.gyn. residency also matched into that specialty.

“Obstetrics and gynecology as a field is fortunate to be having increasing numbers of applicants,” said Dr. Hartenbach. “We’re getting top medical students.” Dr. Hartenbach said she’s seeing increasing interest in the specialty, as well as a growing appetite for subspecialty training. Female pelvic medicine, minimally invasive gynecology, and reproductive endocrinology and fertility are all current areas of growth, she said.

Frontline Medical News/Kari OakesLiliana Palencia and her father Dr. Mauricio Palencia

Liliana Palencia, a fourth year medical student at UW-Madison, is headed to her first choice, Southern Illinois University in Springfield, for her ob.gyn. residency. Ms. Palencia said she liked everything she experienced when she visited Southern Illinois University for her interview. “I got the best feeling from them. The faculty and residents really seemed to care about each other and to work together. The facilities, the curriculum – they were all great.”

She didn’t know she wanted to be an ob.gyn. when she came to medical school, though she had known she wanted to be a physician for a long time. Her father, who brought her family to the United States from Honduras for his residency when Liliana was small, is a family practice physician.

Ms. Palencia’s third-year ob.gyn. rotation at an urban Milwaukee site really solidified her specialty choice, and a sub-internship in gynecologic oncology helped her realize the variety available to ob.gyns. “This specialty represents everything I want in a career – it’s varied, there’s a clinical portion, there’s labor and delivery, and there’s the opportunity to perform surgery,” she said.

Asked if she was nervous about her residency, Ms. Palencia said, “Transitions are hard, and I’m expecting a steep learning curve. But I know that in the program I’m going to, I’ll be able to lean on those around me.” She thinks the hard work will be worth it, saying, “It’s important for women to have a physician they can trust.”

[email protected]

On Twitter @karioakes

MADISON, WIS.– One-hundred and seventy-six fourth-year medical students, 12 of them seeking residency matches in obstetrics and gynecology, gathered with family and friends at the University of Wisconsin-Madison for the School of Medicine and Public Health’s annual Match Day ceremony. In introductory remarks, Dr. Gwen McIntosh, assistant dean for students at the School of Medicine and Public Health, spoke of the whirlwind tour of residency interviews, ultimately leading to one highly significant line of text tucked inside an envelope. “This process is like speed dating, ending in an arranged marriage,” Dr. McIntosh said. The hall erupted in laughter, and the envelope opening began.

Ob.gyn. continues to fill nearly all available PGY-1 residency slots: just eight of the 1,265 positions were unfilled after Match Day, meaning that 99.4% of the specialty’s spots were filled. In 2015, ob.gyn. filled all its spots, but offered 10 fewer residency positions than in 2016.

Ob.gyn. residency programs filled 981 positions with senior medical students from the United States. This figure is less than 2015, when 1,002 U.S. seniors matched into ob.gyn, but more than the 950 U.S. seniors going into ob.gyn. in 2014.

UW-Madison’s ob.gyn. residency program director, Dr. Ellen Hartenbach, said in an interview that she was delighted with the new class of residents she’ll welcome this summer. The program offers six residency positions, and all openings were filled with strong students, she said. All 12 of UW-Madison’s senior medical students who sought an ob.gyn. residency also matched into that specialty.

“Obstetrics and gynecology as a field is fortunate to be having increasing numbers of applicants,” said Dr. Hartenbach. “We’re getting top medical students.” Dr. Hartenbach said she’s seeing increasing interest in the specialty, as well as a growing appetite for subspecialty training. Female pelvic medicine, minimally invasive gynecology, and reproductive endocrinology and fertility are all current areas of growth, she said.

Frontline Medical News/Kari OakesLiliana Palencia and her father Dr. Mauricio Palencia

Liliana Palencia, a fourth year medical student at UW-Madison, is headed to her first choice, Southern Illinois University in Springfield, for her ob.gyn. residency. Ms. Palencia said she liked everything she experienced when she visited Southern Illinois University for her interview. “I got the best feeling from them. The faculty and residents really seemed to care about each other and to work together. The facilities, the curriculum – they were all great.”

She didn’t know she wanted to be an ob.gyn. when she came to medical school, though she had known she wanted to be a physician for a long time. Her father, who brought her family to the United States from Honduras for his residency when Liliana was small, is a family practice physician.

Ms. Palencia’s third-year ob.gyn. rotation at an urban Milwaukee site really solidified her specialty choice, and a sub-internship in gynecologic oncology helped her realize the variety available to ob.gyns. “This specialty represents everything I want in a career – it’s varied, there’s a clinical portion, there’s labor and delivery, and there’s the opportunity to perform surgery,” she said.

Asked if she was nervous about her residency, Ms. Palencia said, “Transitions are hard, and I’m expecting a steep learning curve. But I know that in the program I’m going to, I’ll be able to lean on those around me.” She thinks the hard work will be worth it, saying, “It’s important for women to have a physician they can trust.”

[email protected]

On Twitter @karioakes

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MATCH DAY 2016

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Outcomes in major surgery unchanged by continuing clopidogrel

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Outcomes in major surgery unchanged by continuing clopidogrel

MONTREAL – Patients who stayed on antiplatelet therapy close to – or even up until – major surgery fared just as well as those who stopped their medication earlier in a retrospective, single-center study.

The study found no difference in blood product administration, adverse perioperative events, or all-cause 30-day mortality regardless of whether patients stopped clopidogrel (Plavix) the recommended 5 days before surgery.

“We believe that continuing clopidogrel in elective and emergent surgical situations appears to be safe, and may challenge the current recommendations,” said presenter Dr. David Strosberg.

Kari Oakes/Frontline Medical News
Dr. David Strosberg

The study addressed a thorny question for surgeons, Dr. Strosberg said. “As surgeons, we face a dilemma: Do we take the risk of thrombotic complications in stopping the antiplatelet drugs, or do we take the risk of increased surgical bleeding with continuing therapy?”

The package insert for clopidogrel advises discontinuation 5 days prior to surgery. However, manufacturer labeling also states that discontinuation of clopidogrel can lead to adverse cardiac events, said Dr. Strosberg, a general surgery resident at Ohio State University in Columbus.

The aim of the study, presented at the annual meeting of the Central Surgical Association, was to ascertain whether continuing antiplatelet therapy increased the rate of adverse surgical outcomes in those undergoing major emergent or elective surgery.

Dr. Strosberg and his colleagues retrospectively reviewed the record of patients over a 4-year period at a single institution and included those undergoing major general, thoracic, or vascular surgery who were taking clopidogrel at the time of presentation.

Data collected included patient characteristics, including demographic data and comorbidities, as well as transfusion requirements and perioperative events.

A total of 200 patients who had 205 qualifying procedures and were taking clopidogrel were included in the study. Of these, 116 patients (Group A) had their clopidogrel held for at least 5 days preoperatively. The remaining 89 patients (Group B) had their clopidogrel held for less than 5 days, or not at all.

Patient demographics were similar between the two groups. Patients in Group A were more likely to have emergency surgery, to have peripheral stents placed, to have COPD or peripheral vascular disease, to have a malignancy, and to have received aspirin within five days of surgery (P less than .01 for all).

Blood product administration rates and volumes did not differ significantly between the two groups, and there was no difference between the groups in the incidence of myocardial infarctions, cerebrovascular events, or acute visceral or lower extremity ischemia.

Three patients in each group died within 30 days of the procedure, a nonsignificant difference. However, in the group that had clopidogrel held, three patients had perioperative myocardial infarctions, and two of these patients died. In discussing the study, Dr. Michael Dalsing said, “I think a lot of us would accept bleeding more over myocardial infarction.”

A subgroup analysis of the group who had clopidogrel held for fewer than 5 days compared outcomes for emergent vs. non-emergent surgery. The emergent surgery subgroup had a significantly higher rate of preoperative platelet transfusions, although numbers overall were small (2/17, 11.8%, vs. 0/72; P = .03).

Dr. Strosberg noted study limitations that included the retrospective, single-center nature of the study, and the fact that one variable, estimated blood loss, is notoriously subjective and inaccurate.

Dr. Dalsing, chief of vascular surgery at Indiana University, Indianapolis, said that he “was surprised that not even one patient went back for postoperative bleeding in this high-risk group of patients,” and raised the question of potential selection bias. Dr. Strosberg replied that comorbidities were ascertained by the physician at the time of surgery planning; since no differences were seen between study groups, investigators didn’t go back and parse out details about comorbid conditions.

In discussion following the presentation, surgeons spoke to the real-world challenges of performing surgery on a patient with antiplatelet therapy on board.

“Overall, I think your data support kind of a bias I have. Since I’m a vascular surgeon, we almost always operate on clopidogrel, and I don’t know if our bleeding risk is worse or better. But it’s something we almost have to do to keep our grafts going,” Dr. Dalsing said.

Dr. Peter Henke, professor of vascular surgery at the University of Michigan, Ann Arbor, said, “I’d be a little bit cautious with this. If you’ve ever done a big aortic procedure on someone on Plavix, I’ve seen them lose up to a couple of liters of blood just with oozing.”

“Those of us who do open aortic surgery know that very few things bleed like the back wall of an aortic anastomosis of a patient on Plavix,” echoed Dr. Peter Rossi, associate professor of vascular surgery at the Medical College of Wisconsin, Milwaukee.

 

 

The study authors reported no relevant disclosures.

[email protected]

On Twitter @karioakes

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MONTREAL – Patients who stayed on antiplatelet therapy close to – or even up until – major surgery fared just as well as those who stopped their medication earlier in a retrospective, single-center study.

The study found no difference in blood product administration, adverse perioperative events, or all-cause 30-day mortality regardless of whether patients stopped clopidogrel (Plavix) the recommended 5 days before surgery.

“We believe that continuing clopidogrel in elective and emergent surgical situations appears to be safe, and may challenge the current recommendations,” said presenter Dr. David Strosberg.

Kari Oakes/Frontline Medical News
Dr. David Strosberg

The study addressed a thorny question for surgeons, Dr. Strosberg said. “As surgeons, we face a dilemma: Do we take the risk of thrombotic complications in stopping the antiplatelet drugs, or do we take the risk of increased surgical bleeding with continuing therapy?”

The package insert for clopidogrel advises discontinuation 5 days prior to surgery. However, manufacturer labeling also states that discontinuation of clopidogrel can lead to adverse cardiac events, said Dr. Strosberg, a general surgery resident at Ohio State University in Columbus.

The aim of the study, presented at the annual meeting of the Central Surgical Association, was to ascertain whether continuing antiplatelet therapy increased the rate of adverse surgical outcomes in those undergoing major emergent or elective surgery.

Dr. Strosberg and his colleagues retrospectively reviewed the record of patients over a 4-year period at a single institution and included those undergoing major general, thoracic, or vascular surgery who were taking clopidogrel at the time of presentation.

Data collected included patient characteristics, including demographic data and comorbidities, as well as transfusion requirements and perioperative events.

A total of 200 patients who had 205 qualifying procedures and were taking clopidogrel were included in the study. Of these, 116 patients (Group A) had their clopidogrel held for at least 5 days preoperatively. The remaining 89 patients (Group B) had their clopidogrel held for less than 5 days, or not at all.

Patient demographics were similar between the two groups. Patients in Group A were more likely to have emergency surgery, to have peripheral stents placed, to have COPD or peripheral vascular disease, to have a malignancy, and to have received aspirin within five days of surgery (P less than .01 for all).

Blood product administration rates and volumes did not differ significantly between the two groups, and there was no difference between the groups in the incidence of myocardial infarctions, cerebrovascular events, or acute visceral or lower extremity ischemia.

Three patients in each group died within 30 days of the procedure, a nonsignificant difference. However, in the group that had clopidogrel held, three patients had perioperative myocardial infarctions, and two of these patients died. In discussing the study, Dr. Michael Dalsing said, “I think a lot of us would accept bleeding more over myocardial infarction.”

A subgroup analysis of the group who had clopidogrel held for fewer than 5 days compared outcomes for emergent vs. non-emergent surgery. The emergent surgery subgroup had a significantly higher rate of preoperative platelet transfusions, although numbers overall were small (2/17, 11.8%, vs. 0/72; P = .03).

Dr. Strosberg noted study limitations that included the retrospective, single-center nature of the study, and the fact that one variable, estimated blood loss, is notoriously subjective and inaccurate.

Dr. Dalsing, chief of vascular surgery at Indiana University, Indianapolis, said that he “was surprised that not even one patient went back for postoperative bleeding in this high-risk group of patients,” and raised the question of potential selection bias. Dr. Strosberg replied that comorbidities were ascertained by the physician at the time of surgery planning; since no differences were seen between study groups, investigators didn’t go back and parse out details about comorbid conditions.

In discussion following the presentation, surgeons spoke to the real-world challenges of performing surgery on a patient with antiplatelet therapy on board.

“Overall, I think your data support kind of a bias I have. Since I’m a vascular surgeon, we almost always operate on clopidogrel, and I don’t know if our bleeding risk is worse or better. But it’s something we almost have to do to keep our grafts going,” Dr. Dalsing said.

Dr. Peter Henke, professor of vascular surgery at the University of Michigan, Ann Arbor, said, “I’d be a little bit cautious with this. If you’ve ever done a big aortic procedure on someone on Plavix, I’ve seen them lose up to a couple of liters of blood just with oozing.”

“Those of us who do open aortic surgery know that very few things bleed like the back wall of an aortic anastomosis of a patient on Plavix,” echoed Dr. Peter Rossi, associate professor of vascular surgery at the Medical College of Wisconsin, Milwaukee.

 

 

The study authors reported no relevant disclosures.

[email protected]

On Twitter @karioakes

MONTREAL – Patients who stayed on antiplatelet therapy close to – or even up until – major surgery fared just as well as those who stopped their medication earlier in a retrospective, single-center study.

The study found no difference in blood product administration, adverse perioperative events, or all-cause 30-day mortality regardless of whether patients stopped clopidogrel (Plavix) the recommended 5 days before surgery.

“We believe that continuing clopidogrel in elective and emergent surgical situations appears to be safe, and may challenge the current recommendations,” said presenter Dr. David Strosberg.

Kari Oakes/Frontline Medical News
Dr. David Strosberg

The study addressed a thorny question for surgeons, Dr. Strosberg said. “As surgeons, we face a dilemma: Do we take the risk of thrombotic complications in stopping the antiplatelet drugs, or do we take the risk of increased surgical bleeding with continuing therapy?”

The package insert for clopidogrel advises discontinuation 5 days prior to surgery. However, manufacturer labeling also states that discontinuation of clopidogrel can lead to adverse cardiac events, said Dr. Strosberg, a general surgery resident at Ohio State University in Columbus.

The aim of the study, presented at the annual meeting of the Central Surgical Association, was to ascertain whether continuing antiplatelet therapy increased the rate of adverse surgical outcomes in those undergoing major emergent or elective surgery.

Dr. Strosberg and his colleagues retrospectively reviewed the record of patients over a 4-year period at a single institution and included those undergoing major general, thoracic, or vascular surgery who were taking clopidogrel at the time of presentation.

Data collected included patient characteristics, including demographic data and comorbidities, as well as transfusion requirements and perioperative events.

A total of 200 patients who had 205 qualifying procedures and were taking clopidogrel were included in the study. Of these, 116 patients (Group A) had their clopidogrel held for at least 5 days preoperatively. The remaining 89 patients (Group B) had their clopidogrel held for less than 5 days, or not at all.

Patient demographics were similar between the two groups. Patients in Group A were more likely to have emergency surgery, to have peripheral stents placed, to have COPD or peripheral vascular disease, to have a malignancy, and to have received aspirin within five days of surgery (P less than .01 for all).

Blood product administration rates and volumes did not differ significantly between the two groups, and there was no difference between the groups in the incidence of myocardial infarctions, cerebrovascular events, or acute visceral or lower extremity ischemia.

Three patients in each group died within 30 days of the procedure, a nonsignificant difference. However, in the group that had clopidogrel held, three patients had perioperative myocardial infarctions, and two of these patients died. In discussing the study, Dr. Michael Dalsing said, “I think a lot of us would accept bleeding more over myocardial infarction.”

A subgroup analysis of the group who had clopidogrel held for fewer than 5 days compared outcomes for emergent vs. non-emergent surgery. The emergent surgery subgroup had a significantly higher rate of preoperative platelet transfusions, although numbers overall were small (2/17, 11.8%, vs. 0/72; P = .03).

Dr. Strosberg noted study limitations that included the retrospective, single-center nature of the study, and the fact that one variable, estimated blood loss, is notoriously subjective and inaccurate.

Dr. Dalsing, chief of vascular surgery at Indiana University, Indianapolis, said that he “was surprised that not even one patient went back for postoperative bleeding in this high-risk group of patients,” and raised the question of potential selection bias. Dr. Strosberg replied that comorbidities were ascertained by the physician at the time of surgery planning; since no differences were seen between study groups, investigators didn’t go back and parse out details about comorbid conditions.

In discussion following the presentation, surgeons spoke to the real-world challenges of performing surgery on a patient with antiplatelet therapy on board.

“Overall, I think your data support kind of a bias I have. Since I’m a vascular surgeon, we almost always operate on clopidogrel, and I don’t know if our bleeding risk is worse or better. But it’s something we almost have to do to keep our grafts going,” Dr. Dalsing said.

Dr. Peter Henke, professor of vascular surgery at the University of Michigan, Ann Arbor, said, “I’d be a little bit cautious with this. If you’ve ever done a big aortic procedure on someone on Plavix, I’ve seen them lose up to a couple of liters of blood just with oozing.”

“Those of us who do open aortic surgery know that very few things bleed like the back wall of an aortic anastomosis of a patient on Plavix,” echoed Dr. Peter Rossi, associate professor of vascular surgery at the Medical College of Wisconsin, Milwaukee.

 

 

The study authors reported no relevant disclosures.

[email protected]

On Twitter @karioakes

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AT THE ANNUAL MEETING OF THE CENTRAL SURGICAL ASSOCIATION

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Inside the Article

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Key clinical point: Outcomes were similar whether patients did or didn’t stop clopidogrel before major surgery.

Major finding: No significant differences in blood product use, adverse events, or death were seen with continuing clopidogrel.

Data source: Retrospective, single-center review of 200 patients undergoing major elective or emergent surgery and taking clopidogrel.

Disclosures: The study authors reported no relevant disclosures.