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Official Newspaper of the American College of Surgeons
Patient instructions in surgery exceed recommended reading grade level
JACKSONVILLE, FLA. – The American Medical Association and National Institutes of Health recommend that patient instructions should be written at a sixth-grade level, and the Centers for Disease Control and Prevention recommend an eighth-grade level so patients and caregivers can easily understand them, but a study of education materials that patients get for surgery finds that they typically overshoot that mark – in some cases considerably.
A study of patient education materials distributed at the University of Alabama at Birmingham has revealed that the , second-year medical student Callie Perkins reported at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
“Only 16% of our collected material actually met the standards for readability,” Ms. Perkins said. “As far as surgical subspecialties go, neurosurgery had the highest grade level and plastic surgery had the lowest.”
Nine of the 12 surgical disciplines had no materials at the sixth-grade level or below. Plastic surgery had the highest percentage of materials that met the recommended standard: 47%. Overall, plastic surgery education materials had the lowest FKGL score, at the equivalent of grade 6.34. Neurosurgery had the highest, at 9.83. Other disciplines with an FKGL of 9 or greater are thoracic surgery (9.61) and pancreatic surgery (9.18), while vascular surgery had a level of 8.95.
The study also looked at specific words commonly used in patient literature with FKGL scores that far exceed the recommended level, Ms. Perkins said. They include strenuous (21 FKGL), anesthesia (26.2 FKGL), narcotic (21.5 FKGL) and incision (16.8 FKGL).
The findings, Ms. Perkins said, “provide a clear opportunity for improvement of our patient materials at UAB.” She noted that Microsoft Word has a tool for evaluating the FKGL of text, although the software does not account for potentially more challenging anatomical terms.
Ms. Perkins suggested a way forward may be to hold focus groups with surgeons and nursing clinical care coordinators to educate them about more patient-friendly terminology. In the meantime, Ms. Perkins said, using the FKGL tool in Microsoft Word is the most accessible solution to gauge education materials that talk over the patient’s head.
Ms. Perkins reported having no financial relationships to disclose.
SOURCE: Perkins, C et al. Abstract 67.08
JACKSONVILLE, FLA. – The American Medical Association and National Institutes of Health recommend that patient instructions should be written at a sixth-grade level, and the Centers for Disease Control and Prevention recommend an eighth-grade level so patients and caregivers can easily understand them, but a study of education materials that patients get for surgery finds that they typically overshoot that mark – in some cases considerably.
A study of patient education materials distributed at the University of Alabama at Birmingham has revealed that the , second-year medical student Callie Perkins reported at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
“Only 16% of our collected material actually met the standards for readability,” Ms. Perkins said. “As far as surgical subspecialties go, neurosurgery had the highest grade level and plastic surgery had the lowest.”
Nine of the 12 surgical disciplines had no materials at the sixth-grade level or below. Plastic surgery had the highest percentage of materials that met the recommended standard: 47%. Overall, plastic surgery education materials had the lowest FKGL score, at the equivalent of grade 6.34. Neurosurgery had the highest, at 9.83. Other disciplines with an FKGL of 9 or greater are thoracic surgery (9.61) and pancreatic surgery (9.18), while vascular surgery had a level of 8.95.
The study also looked at specific words commonly used in patient literature with FKGL scores that far exceed the recommended level, Ms. Perkins said. They include strenuous (21 FKGL), anesthesia (26.2 FKGL), narcotic (21.5 FKGL) and incision (16.8 FKGL).
The findings, Ms. Perkins said, “provide a clear opportunity for improvement of our patient materials at UAB.” She noted that Microsoft Word has a tool for evaluating the FKGL of text, although the software does not account for potentially more challenging anatomical terms.
Ms. Perkins suggested a way forward may be to hold focus groups with surgeons and nursing clinical care coordinators to educate them about more patient-friendly terminology. In the meantime, Ms. Perkins said, using the FKGL tool in Microsoft Word is the most accessible solution to gauge education materials that talk over the patient’s head.
Ms. Perkins reported having no financial relationships to disclose.
SOURCE: Perkins, C et al. Abstract 67.08
JACKSONVILLE, FLA. – The American Medical Association and National Institutes of Health recommend that patient instructions should be written at a sixth-grade level, and the Centers for Disease Control and Prevention recommend an eighth-grade level so patients and caregivers can easily understand them, but a study of education materials that patients get for surgery finds that they typically overshoot that mark – in some cases considerably.
A study of patient education materials distributed at the University of Alabama at Birmingham has revealed that the , second-year medical student Callie Perkins reported at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
“Only 16% of our collected material actually met the standards for readability,” Ms. Perkins said. “As far as surgical subspecialties go, neurosurgery had the highest grade level and plastic surgery had the lowest.”
Nine of the 12 surgical disciplines had no materials at the sixth-grade level or below. Plastic surgery had the highest percentage of materials that met the recommended standard: 47%. Overall, plastic surgery education materials had the lowest FKGL score, at the equivalent of grade 6.34. Neurosurgery had the highest, at 9.83. Other disciplines with an FKGL of 9 or greater are thoracic surgery (9.61) and pancreatic surgery (9.18), while vascular surgery had a level of 8.95.
The study also looked at specific words commonly used in patient literature with FKGL scores that far exceed the recommended level, Ms. Perkins said. They include strenuous (21 FKGL), anesthesia (26.2 FKGL), narcotic (21.5 FKGL) and incision (16.8 FKGL).
The findings, Ms. Perkins said, “provide a clear opportunity for improvement of our patient materials at UAB.” She noted that Microsoft Word has a tool for evaluating the FKGL of text, although the software does not account for potentially more challenging anatomical terms.
Ms. Perkins suggested a way forward may be to hold focus groups with surgeons and nursing clinical care coordinators to educate them about more patient-friendly terminology. In the meantime, Ms. Perkins said, using the FKGL tool in Microsoft Word is the most accessible solution to gauge education materials that talk over the patient’s head.
Ms. Perkins reported having no financial relationships to disclose.
SOURCE: Perkins, C et al. Abstract 67.08
AT THE ACADEMIC SURGICAL CONGRESS
Key clinical point: Patient education materials in surgery typically exceed the recommended guidelines of being at a sixth-grade reading level.
Major finding: Only 16% of patient education materials from surgical specialties met the recommended guideline.
Data source: Flesch-Kincaid Grade Level analysis of 112 education materials collected from 12 different surgical specialties at the University of Alabama at Birmingham.
Disclosure: Ms. Perkins reported having no financial relationships to disclose.
Source: Perkins, C et al. Abstract 67.08.
Spray-dried plasma inches toward clinical trials
SAN DIEGO – Spray-dried plasma compared well with fresh frozen plasma in two in vitro studies, but clinical studies are needed to confirm the findings, researchers reported at the annual meeting of the American Association of Blood Banks.
The product’s logistical benefits include ease of transport, stability at room temperature, and the ability to be rapidly reconstituted – attributes that make it particularly useful in combat situations and prehospital settings where it is impractical to administer fresh frozen plasma (FFP).
The advantages of reconstituted blood products in combat settings have prompted recent efforts to speed their availability. The Food and Drug Administration and the Department of Defense recently announced a joint program to expedite the FDA’s review of products that could diagnose, treat, or prevent life-threatening conditions facing U.S. military personnel. It would be a fast-track process similar to how the FDA handles the breakthrough designation program.
In the first study, the investigators compared spray-dried plasma (SpDP) and FFP in reconstituted whole blood to test their hypothesis that SpDP is not inferior to FFP in facilitating platelet adhesion and thrombus formation, as evaluated by using a microfusion assay.
“Trauma is frequently associated with the use of plasma,” said Rachel S. Bercovitz, MD, MS, of the BloodCenter of Wisconsin and associate professor of pediatrics (hematology, oncology, and stem cell transplantation) at Northwestern University, Chicago.
Compared with FFP, SpDP can be reconstituted in 5 minutes and has more than 80% of the procoagulation and anticoagulation proteins, she explained. “Factor 8 levels were lower in the spray-dried plasma and were about at the 70% level of FFP. The other factor that was reduced, as compared to the FFP, was the von Willebrand factor (vWF), which was about 60% in SpDP compared to FFP.”
Whole blood was obtained from healthy volunteers and red blood cells (RBCs) were separated from platelet-rich plasma, and following standard procedures, resuspended in either SpDP or FFP and recombined with the packed red blood cells to create reconstituted whole blood with hematocrit of 34%-40% and 150,000-250,000 platelets per mcL.
After fluorescent labeling, the samples were flowed through a type I collagen-coated microchannel and still images of adherent platelets and thrombi were captured in order to calculate surface area coverage along the length of the channel. Next, the investigators used a ratio paired t-test to compare surface area coverage in SpDP versus FFP. The margin of noninferiority was 20% (SpDP/FFP greater than 0.8).
A total of six batches of SpDP and FFP were evaluated with 17 donors, and there was no statistical difference between the SpDP versus FFP pairs (P = .7558).
The mean ratio of SpDP versus FFP was 1.21 with a 95% confidence interval of 0.84-1.57. The surface area coverage in samples that were reconstituted with SpDP were, on average, 20% greater than in samples reconstituted with FFP. The lower limit of the 95% confidence interval was a difference of 16%, and therefore lower than the a priori determined margin of noninferiority of 20%.
“We found that SpDP is not inferior to FFP in supporting platelet adhesion and thrombus formation in our in vitro model,” Dr. Bercovitz said. “We feel that these in vitro assays support further in vivo studies of safety and efficacy of spray dried plasma.”
In a second study, Michael A. Meledeo, PhD, of the U.S. Army Institute of Surgical Research (coagulation and blood research), and his colleagues examined methods of reconstituting SpDP. They noted that a single unit process has been developed that produces a long-lived and readily stored SpDP product, which decreased high-molecular-weight multimers of vWF but increased low-molecular-weight multimers. vWF is critical in the process of platelet adhesion and thrombus formation, Dr. Meledeo said.
The researchers examined different reconstitution solutions: FFP, FFP with glycine, regular SpDP without pretreatment and rehydrated with glycine-hydrochloride:glycine, SpDP pretreated with glycine-HCl, or glycine-HCl:glycine and rehydrated with water.
Several in vitro analyses were performed, including measurement of vWF activity, fibrin polymerization kinetics, thrombin generation, coagulation properties and platelet adhesion to collagen.
Pretreated SpDP had better vWF activity, compared with regular SpDP (P less than .05). As compared with FFP, fibrin polymerization density was slightly lower in regular SpDP (0.879 vs. 0.742 optical density; P less than .01), although generation of thrombin was similar.
The researchers also found that the bicarbonate/base excess were lower in SpDP samples versus FFP (P less than .001). Thromboelastography results (used to measure coagulation properties) remained unchanged in plasma-only samples, but clot strength in reconstructed whole blood was reduced in all SpDP samples, compared with FFP (63.82 vs. 55-59.38; P less than .01).
Finally, platelet adhesion was equivalent in pretreated SpDP samples and FFP, while with regular SpDP, it was improved as compared with all other samples (71.53% surface coverage vs. 30.26%-43.87%; P less than .05).
“Based on these results, spray dried plasma was equivalent or superior to FFP in most of the in vitro hemostasis assays,” Dr. Meledeo said. “Reconstitution with glycine-HCl or glycine-HCl:glycine induced a superior von Willebrand function, but it was inferior in terms of supporting a flowing platelet adhesion to collagen.”
Dr. Bercovitz and Dr. Meledeo reported having no financial disclosures.
SOURCES: Bercovitz R et al. AABB 17 Abstract C20-A02B; Meledeo M et al. AABB 17 Abstract C21-A02B.
SAN DIEGO – Spray-dried plasma compared well with fresh frozen plasma in two in vitro studies, but clinical studies are needed to confirm the findings, researchers reported at the annual meeting of the American Association of Blood Banks.
The product’s logistical benefits include ease of transport, stability at room temperature, and the ability to be rapidly reconstituted – attributes that make it particularly useful in combat situations and prehospital settings where it is impractical to administer fresh frozen plasma (FFP).
The advantages of reconstituted blood products in combat settings have prompted recent efforts to speed their availability. The Food and Drug Administration and the Department of Defense recently announced a joint program to expedite the FDA’s review of products that could diagnose, treat, or prevent life-threatening conditions facing U.S. military personnel. It would be a fast-track process similar to how the FDA handles the breakthrough designation program.
In the first study, the investigators compared spray-dried plasma (SpDP) and FFP in reconstituted whole blood to test their hypothesis that SpDP is not inferior to FFP in facilitating platelet adhesion and thrombus formation, as evaluated by using a microfusion assay.
“Trauma is frequently associated with the use of plasma,” said Rachel S. Bercovitz, MD, MS, of the BloodCenter of Wisconsin and associate professor of pediatrics (hematology, oncology, and stem cell transplantation) at Northwestern University, Chicago.
Compared with FFP, SpDP can be reconstituted in 5 minutes and has more than 80% of the procoagulation and anticoagulation proteins, she explained. “Factor 8 levels were lower in the spray-dried plasma and were about at the 70% level of FFP. The other factor that was reduced, as compared to the FFP, was the von Willebrand factor (vWF), which was about 60% in SpDP compared to FFP.”
Whole blood was obtained from healthy volunteers and red blood cells (RBCs) were separated from platelet-rich plasma, and following standard procedures, resuspended in either SpDP or FFP and recombined with the packed red blood cells to create reconstituted whole blood with hematocrit of 34%-40% and 150,000-250,000 platelets per mcL.
After fluorescent labeling, the samples were flowed through a type I collagen-coated microchannel and still images of adherent platelets and thrombi were captured in order to calculate surface area coverage along the length of the channel. Next, the investigators used a ratio paired t-test to compare surface area coverage in SpDP versus FFP. The margin of noninferiority was 20% (SpDP/FFP greater than 0.8).
A total of six batches of SpDP and FFP were evaluated with 17 donors, and there was no statistical difference between the SpDP versus FFP pairs (P = .7558).
The mean ratio of SpDP versus FFP was 1.21 with a 95% confidence interval of 0.84-1.57. The surface area coverage in samples that were reconstituted with SpDP were, on average, 20% greater than in samples reconstituted with FFP. The lower limit of the 95% confidence interval was a difference of 16%, and therefore lower than the a priori determined margin of noninferiority of 20%.
“We found that SpDP is not inferior to FFP in supporting platelet adhesion and thrombus formation in our in vitro model,” Dr. Bercovitz said. “We feel that these in vitro assays support further in vivo studies of safety and efficacy of spray dried plasma.”
In a second study, Michael A. Meledeo, PhD, of the U.S. Army Institute of Surgical Research (coagulation and blood research), and his colleagues examined methods of reconstituting SpDP. They noted that a single unit process has been developed that produces a long-lived and readily stored SpDP product, which decreased high-molecular-weight multimers of vWF but increased low-molecular-weight multimers. vWF is critical in the process of platelet adhesion and thrombus formation, Dr. Meledeo said.
The researchers examined different reconstitution solutions: FFP, FFP with glycine, regular SpDP without pretreatment and rehydrated with glycine-hydrochloride:glycine, SpDP pretreated with glycine-HCl, or glycine-HCl:glycine and rehydrated with water.
Several in vitro analyses were performed, including measurement of vWF activity, fibrin polymerization kinetics, thrombin generation, coagulation properties and platelet adhesion to collagen.
Pretreated SpDP had better vWF activity, compared with regular SpDP (P less than .05). As compared with FFP, fibrin polymerization density was slightly lower in regular SpDP (0.879 vs. 0.742 optical density; P less than .01), although generation of thrombin was similar.
The researchers also found that the bicarbonate/base excess were lower in SpDP samples versus FFP (P less than .001). Thromboelastography results (used to measure coagulation properties) remained unchanged in plasma-only samples, but clot strength in reconstructed whole blood was reduced in all SpDP samples, compared with FFP (63.82 vs. 55-59.38; P less than .01).
Finally, platelet adhesion was equivalent in pretreated SpDP samples and FFP, while with regular SpDP, it was improved as compared with all other samples (71.53% surface coverage vs. 30.26%-43.87%; P less than .05).
“Based on these results, spray dried plasma was equivalent or superior to FFP in most of the in vitro hemostasis assays,” Dr. Meledeo said. “Reconstitution with glycine-HCl or glycine-HCl:glycine induced a superior von Willebrand function, but it was inferior in terms of supporting a flowing platelet adhesion to collagen.”
Dr. Bercovitz and Dr. Meledeo reported having no financial disclosures.
SOURCES: Bercovitz R et al. AABB 17 Abstract C20-A02B; Meledeo M et al. AABB 17 Abstract C21-A02B.
SAN DIEGO – Spray-dried plasma compared well with fresh frozen plasma in two in vitro studies, but clinical studies are needed to confirm the findings, researchers reported at the annual meeting of the American Association of Blood Banks.
The product’s logistical benefits include ease of transport, stability at room temperature, and the ability to be rapidly reconstituted – attributes that make it particularly useful in combat situations and prehospital settings where it is impractical to administer fresh frozen plasma (FFP).
The advantages of reconstituted blood products in combat settings have prompted recent efforts to speed their availability. The Food and Drug Administration and the Department of Defense recently announced a joint program to expedite the FDA’s review of products that could diagnose, treat, or prevent life-threatening conditions facing U.S. military personnel. It would be a fast-track process similar to how the FDA handles the breakthrough designation program.
In the first study, the investigators compared spray-dried plasma (SpDP) and FFP in reconstituted whole blood to test their hypothesis that SpDP is not inferior to FFP in facilitating platelet adhesion and thrombus formation, as evaluated by using a microfusion assay.
“Trauma is frequently associated with the use of plasma,” said Rachel S. Bercovitz, MD, MS, of the BloodCenter of Wisconsin and associate professor of pediatrics (hematology, oncology, and stem cell transplantation) at Northwestern University, Chicago.
Compared with FFP, SpDP can be reconstituted in 5 minutes and has more than 80% of the procoagulation and anticoagulation proteins, she explained. “Factor 8 levels were lower in the spray-dried plasma and were about at the 70% level of FFP. The other factor that was reduced, as compared to the FFP, was the von Willebrand factor (vWF), which was about 60% in SpDP compared to FFP.”
Whole blood was obtained from healthy volunteers and red blood cells (RBCs) were separated from platelet-rich plasma, and following standard procedures, resuspended in either SpDP or FFP and recombined with the packed red blood cells to create reconstituted whole blood with hematocrit of 34%-40% and 150,000-250,000 platelets per mcL.
After fluorescent labeling, the samples were flowed through a type I collagen-coated microchannel and still images of adherent platelets and thrombi were captured in order to calculate surface area coverage along the length of the channel. Next, the investigators used a ratio paired t-test to compare surface area coverage in SpDP versus FFP. The margin of noninferiority was 20% (SpDP/FFP greater than 0.8).
A total of six batches of SpDP and FFP were evaluated with 17 donors, and there was no statistical difference between the SpDP versus FFP pairs (P = .7558).
The mean ratio of SpDP versus FFP was 1.21 with a 95% confidence interval of 0.84-1.57. The surface area coverage in samples that were reconstituted with SpDP were, on average, 20% greater than in samples reconstituted with FFP. The lower limit of the 95% confidence interval was a difference of 16%, and therefore lower than the a priori determined margin of noninferiority of 20%.
“We found that SpDP is not inferior to FFP in supporting platelet adhesion and thrombus formation in our in vitro model,” Dr. Bercovitz said. “We feel that these in vitro assays support further in vivo studies of safety and efficacy of spray dried plasma.”
In a second study, Michael A. Meledeo, PhD, of the U.S. Army Institute of Surgical Research (coagulation and blood research), and his colleagues examined methods of reconstituting SpDP. They noted that a single unit process has been developed that produces a long-lived and readily stored SpDP product, which decreased high-molecular-weight multimers of vWF but increased low-molecular-weight multimers. vWF is critical in the process of platelet adhesion and thrombus formation, Dr. Meledeo said.
The researchers examined different reconstitution solutions: FFP, FFP with glycine, regular SpDP without pretreatment and rehydrated with glycine-hydrochloride:glycine, SpDP pretreated with glycine-HCl, or glycine-HCl:glycine and rehydrated with water.
Several in vitro analyses were performed, including measurement of vWF activity, fibrin polymerization kinetics, thrombin generation, coagulation properties and platelet adhesion to collagen.
Pretreated SpDP had better vWF activity, compared with regular SpDP (P less than .05). As compared with FFP, fibrin polymerization density was slightly lower in regular SpDP (0.879 vs. 0.742 optical density; P less than .01), although generation of thrombin was similar.
The researchers also found that the bicarbonate/base excess were lower in SpDP samples versus FFP (P less than .001). Thromboelastography results (used to measure coagulation properties) remained unchanged in plasma-only samples, but clot strength in reconstructed whole blood was reduced in all SpDP samples, compared with FFP (63.82 vs. 55-59.38; P less than .01).
Finally, platelet adhesion was equivalent in pretreated SpDP samples and FFP, while with regular SpDP, it was improved as compared with all other samples (71.53% surface coverage vs. 30.26%-43.87%; P less than .05).
“Based on these results, spray dried plasma was equivalent or superior to FFP in most of the in vitro hemostasis assays,” Dr. Meledeo said. “Reconstitution with glycine-HCl or glycine-HCl:glycine induced a superior von Willebrand function, but it was inferior in terms of supporting a flowing platelet adhesion to collagen.”
Dr. Bercovitz and Dr. Meledeo reported having no financial disclosures.
SOURCES: Bercovitz R et al. AABB 17 Abstract C20-A02B; Meledeo M et al. AABB 17 Abstract C21-A02B.
REPORTING FROM AABB 17
Key clinical point:
Major finding: Spray-dried plasma was equal to, or superior to, fresh frozen plasma in many of the in vitro assays utilized, especially when pretreated in glycine solutions.
Study details: Two in vitro assays that compared spray-dried plasma with fresh frozen plasma.
Disclosures: Dr. Bercovitz and Dr. Meledeo reported having no financial disclosures.
Sources: Bercovitz R et al. AABB 17 Abstract C20-A02B; Meledeo M et al. AABB 17 Abstract C21-A02B.
Know risk factors for ischemic colitis after AAA repair
EXPERT ANALYSIS FROM THE NORTHWESTERN VASCULAR SYMPOSIUM
CHICAGO – Postoperative ischemic colitis after abdominal aortic aneurysm (AAA) repair is a feared, potentially devastating complication with a mortality approaching 50%, but early diagnosis can mitigate that risk, Roy M. Fujitani, MD, said at a symposium on vascular surgery sponsored by Northwestern University in Chicago.
The most common etiology of ischemic colitis following AAA repair is hypoperfusion of the mesenteric vasculature leading to nonocclusive ischemia. Caught early – in the initial hyperactive phase of colonic ischemia – the complication is typically transient and can be managed medically without further sequelae. Improvement is generally noted within a day or 2, with complete resolution within 1-2 weeks.
The earliest indicator that a patient is in the hyperactive phase of ischemic colitis following completion of an AAA repair can be defecation while still on the operating table.
“When you’ve just completed an operation and the patient has a bowel movement right on the operating table, that always makes me very, very concerned because of the likelihood of an associated ischemic colitis,” the surgeon noted.
A conscious patient in the first phase of ischemic colitis will describe an urgent desire to defecate, along with crampy pain and loose bowel movements with or without blood in the stool.
In the second, paralytic phase of ischemic colitis, the pain diminishes in intensity but becomes more continuous and diffuse, usually in the lateral borders of the abdomen. The abdomen becomes distended and much more tender, and there are no bowel sounds.
In patients whose ischemic colitis has been misdiagnosed or undiagnosed, the shock phase comes next. This is marked by massive fluid, protein, and electrolyte loss through the gangrenous mucosa. The result is severe dehydration, metabolic acidosis, and hypovolemic shock.
Nonocclusive colonic ischemia most often affects the watershed areas of the colon, such as the Sudeck point at the rectosigmoid junction.
The two other etiologies of ischemic colitis occurring as a complication of AAA repair are acute arterial occlusion, typically caused by iatrogenic embolization from a proximal source, often during endovascular aneurysm repair (EVAR), or rarely, venous thrombosis.
Making the diagnosis
When a patient is suspected of having ischemic colitis, one of the easiest ways of advancing toward a diagnosis is to obtain an abdominal plain x-ray, which classically shows thumb printing indicative of submucosal edema. CT with IV contrast typically shows bowel wall thickening, pericolonic fat stranding, and – most significantly – there may be free air within the colonic wall, an indicator of more advanced ischemia that occurs shortly before transmural gangrenous changes.
Colonoscopy is, however, the mainstay of diagnosis. It should be performed in any patient where postoperative ischemic colitis is suspected.
Ischemic colitis risk factors and outcomes
Dr. Fujitani was senior author of the largest ever study of risk factors for and outcomes of postoperative ischemic colitis in patients undergoing contemporary methods of open and endovascular AAA repair. This retrospective analysis of the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database included 3,486 patients who underwent AAA repair in U.S. hospitals during 2011-2012. Twelve percent had an open repair, while the other 88% underwent EVAR.
The incidence of postoperative ischemic colitis was 2.2%. The median time of diagnosis was on postoperative day 2. The rate was nearly threefold higher in the open repair group: 5.2% versus 1.8%. However, the open-repair group had a higher rate of emergency admission, ruptured aneurysm before surgery, and other high-risk features. Upon multivariate analysis, the adjusted risk of postoperative ischemic colitis was no longer significantly different in the open-repair and EVAR groups.
The mean hospital length of stay in patients with postoperative ischemic colitis was 20 days, compared with 5 days in those without the complication. The unadjusted in-hospital mortality rate in patients with ischemic colitis was 39% versus 4% in those without ischemic colitis.
Of the 75 patients who developed postoperative ischemic colitis, 37 were managed medically, 38 surgically.
“What was quite surprising was that there was a 56.8% in-hospital mortality in the surgically treated patients. The point being that if you end up having ischemic colitis, there’s a 50% chance you’ll end up requiring an operation, and if you do undergo an operation you have more than a 50% chance of succumbing from the process,” Dr. Fujitani observed.
Dr. Fujitani and his coinvestigators scrutinized a plethora of potential risk factors for postoperative ischemic colitis. Six emerged as significant upon multivariate analysis: ruptured aneurysm before surgery, with an associated adjusted 4.1-fold increased risk; need for intra- or postoperative transfusion, with a 6-fold increased risk; renal failure requiring dialysis, with a 3.9-fold risk; proximal extension of the aneurysm, with a 2.2-fold elevation in risk; diabetes, with a 1.9-fold risk; and female sex, with an adjusted 1.75-fold increased risk (J Vasc Surg. 2016 Apr;63[4]:866-72).
Of note, these risk factors are largely unmodifiable, which underscores the importance of vigorous surveillance for possible signs of ischemic colitis during the first 4 days after AAA repair, especially in patients with multiple risk factors, Dr. Fujitani said.
Also, careful intraoperative assessment of the collateral mesenteric vascular anatomy is important in assessing a patient’s risk for postoperative ischemic colitis. This assessment should include the superior and inferior mesenteric arteries, as well as the celiac and internal iliac arteries. It’s worth bearing in mind that, even though collateral flow may appear adequate, it can be affected by hypovolemia, hypotension, or low cardiac output, the surgeon continued.
In the NSQIP data analysis, no patients who underwent reimplantation of the inferior mesenteric artery during open repair developed postoperative ischemic colitis. While this is an encouraging finding, the numbers were too small to draw definitive conclusions as to whether reimplantation of the artery is protective. It’s an important issue for further study, though, since so few of the recognized risk factors for the complication are modifiable, Dr. Fujitani noted.
He reported having no financial conflicts regarding his presentation.
EXPERT ANALYSIS FROM THE NORTHWESTERN VASCULAR SYMPOSIUM
CHICAGO – Postoperative ischemic colitis after abdominal aortic aneurysm (AAA) repair is a feared, potentially devastating complication with a mortality approaching 50%, but early diagnosis can mitigate that risk, Roy M. Fujitani, MD, said at a symposium on vascular surgery sponsored by Northwestern University in Chicago.
The most common etiology of ischemic colitis following AAA repair is hypoperfusion of the mesenteric vasculature leading to nonocclusive ischemia. Caught early – in the initial hyperactive phase of colonic ischemia – the complication is typically transient and can be managed medically without further sequelae. Improvement is generally noted within a day or 2, with complete resolution within 1-2 weeks.
The earliest indicator that a patient is in the hyperactive phase of ischemic colitis following completion of an AAA repair can be defecation while still on the operating table.
“When you’ve just completed an operation and the patient has a bowel movement right on the operating table, that always makes me very, very concerned because of the likelihood of an associated ischemic colitis,” the surgeon noted.
A conscious patient in the first phase of ischemic colitis will describe an urgent desire to defecate, along with crampy pain and loose bowel movements with or without blood in the stool.
In the second, paralytic phase of ischemic colitis, the pain diminishes in intensity but becomes more continuous and diffuse, usually in the lateral borders of the abdomen. The abdomen becomes distended and much more tender, and there are no bowel sounds.
In patients whose ischemic colitis has been misdiagnosed or undiagnosed, the shock phase comes next. This is marked by massive fluid, protein, and electrolyte loss through the gangrenous mucosa. The result is severe dehydration, metabolic acidosis, and hypovolemic shock.
Nonocclusive colonic ischemia most often affects the watershed areas of the colon, such as the Sudeck point at the rectosigmoid junction.
The two other etiologies of ischemic colitis occurring as a complication of AAA repair are acute arterial occlusion, typically caused by iatrogenic embolization from a proximal source, often during endovascular aneurysm repair (EVAR), or rarely, venous thrombosis.
Making the diagnosis
When a patient is suspected of having ischemic colitis, one of the easiest ways of advancing toward a diagnosis is to obtain an abdominal plain x-ray, which classically shows thumb printing indicative of submucosal edema. CT with IV contrast typically shows bowel wall thickening, pericolonic fat stranding, and – most significantly – there may be free air within the colonic wall, an indicator of more advanced ischemia that occurs shortly before transmural gangrenous changes.
Colonoscopy is, however, the mainstay of diagnosis. It should be performed in any patient where postoperative ischemic colitis is suspected.
Ischemic colitis risk factors and outcomes
Dr. Fujitani was senior author of the largest ever study of risk factors for and outcomes of postoperative ischemic colitis in patients undergoing contemporary methods of open and endovascular AAA repair. This retrospective analysis of the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database included 3,486 patients who underwent AAA repair in U.S. hospitals during 2011-2012. Twelve percent had an open repair, while the other 88% underwent EVAR.
The incidence of postoperative ischemic colitis was 2.2%. The median time of diagnosis was on postoperative day 2. The rate was nearly threefold higher in the open repair group: 5.2% versus 1.8%. However, the open-repair group had a higher rate of emergency admission, ruptured aneurysm before surgery, and other high-risk features. Upon multivariate analysis, the adjusted risk of postoperative ischemic colitis was no longer significantly different in the open-repair and EVAR groups.
The mean hospital length of stay in patients with postoperative ischemic colitis was 20 days, compared with 5 days in those without the complication. The unadjusted in-hospital mortality rate in patients with ischemic colitis was 39% versus 4% in those without ischemic colitis.
Of the 75 patients who developed postoperative ischemic colitis, 37 were managed medically, 38 surgically.
“What was quite surprising was that there was a 56.8% in-hospital mortality in the surgically treated patients. The point being that if you end up having ischemic colitis, there’s a 50% chance you’ll end up requiring an operation, and if you do undergo an operation you have more than a 50% chance of succumbing from the process,” Dr. Fujitani observed.
Dr. Fujitani and his coinvestigators scrutinized a plethora of potential risk factors for postoperative ischemic colitis. Six emerged as significant upon multivariate analysis: ruptured aneurysm before surgery, with an associated adjusted 4.1-fold increased risk; need for intra- or postoperative transfusion, with a 6-fold increased risk; renal failure requiring dialysis, with a 3.9-fold risk; proximal extension of the aneurysm, with a 2.2-fold elevation in risk; diabetes, with a 1.9-fold risk; and female sex, with an adjusted 1.75-fold increased risk (J Vasc Surg. 2016 Apr;63[4]:866-72).
Of note, these risk factors are largely unmodifiable, which underscores the importance of vigorous surveillance for possible signs of ischemic colitis during the first 4 days after AAA repair, especially in patients with multiple risk factors, Dr. Fujitani said.
Also, careful intraoperative assessment of the collateral mesenteric vascular anatomy is important in assessing a patient’s risk for postoperative ischemic colitis. This assessment should include the superior and inferior mesenteric arteries, as well as the celiac and internal iliac arteries. It’s worth bearing in mind that, even though collateral flow may appear adequate, it can be affected by hypovolemia, hypotension, or low cardiac output, the surgeon continued.
In the NSQIP data analysis, no patients who underwent reimplantation of the inferior mesenteric artery during open repair developed postoperative ischemic colitis. While this is an encouraging finding, the numbers were too small to draw definitive conclusions as to whether reimplantation of the artery is protective. It’s an important issue for further study, though, since so few of the recognized risk factors for the complication are modifiable, Dr. Fujitani noted.
He reported having no financial conflicts regarding his presentation.
EXPERT ANALYSIS FROM THE NORTHWESTERN VASCULAR SYMPOSIUM
CHICAGO – Postoperative ischemic colitis after abdominal aortic aneurysm (AAA) repair is a feared, potentially devastating complication with a mortality approaching 50%, but early diagnosis can mitigate that risk, Roy M. Fujitani, MD, said at a symposium on vascular surgery sponsored by Northwestern University in Chicago.
The most common etiology of ischemic colitis following AAA repair is hypoperfusion of the mesenteric vasculature leading to nonocclusive ischemia. Caught early – in the initial hyperactive phase of colonic ischemia – the complication is typically transient and can be managed medically without further sequelae. Improvement is generally noted within a day or 2, with complete resolution within 1-2 weeks.
The earliest indicator that a patient is in the hyperactive phase of ischemic colitis following completion of an AAA repair can be defecation while still on the operating table.
“When you’ve just completed an operation and the patient has a bowel movement right on the operating table, that always makes me very, very concerned because of the likelihood of an associated ischemic colitis,” the surgeon noted.
A conscious patient in the first phase of ischemic colitis will describe an urgent desire to defecate, along with crampy pain and loose bowel movements with or without blood in the stool.
In the second, paralytic phase of ischemic colitis, the pain diminishes in intensity but becomes more continuous and diffuse, usually in the lateral borders of the abdomen. The abdomen becomes distended and much more tender, and there are no bowel sounds.
In patients whose ischemic colitis has been misdiagnosed or undiagnosed, the shock phase comes next. This is marked by massive fluid, protein, and electrolyte loss through the gangrenous mucosa. The result is severe dehydration, metabolic acidosis, and hypovolemic shock.
Nonocclusive colonic ischemia most often affects the watershed areas of the colon, such as the Sudeck point at the rectosigmoid junction.
The two other etiologies of ischemic colitis occurring as a complication of AAA repair are acute arterial occlusion, typically caused by iatrogenic embolization from a proximal source, often during endovascular aneurysm repair (EVAR), or rarely, venous thrombosis.
Making the diagnosis
When a patient is suspected of having ischemic colitis, one of the easiest ways of advancing toward a diagnosis is to obtain an abdominal plain x-ray, which classically shows thumb printing indicative of submucosal edema. CT with IV contrast typically shows bowel wall thickening, pericolonic fat stranding, and – most significantly – there may be free air within the colonic wall, an indicator of more advanced ischemia that occurs shortly before transmural gangrenous changes.
Colonoscopy is, however, the mainstay of diagnosis. It should be performed in any patient where postoperative ischemic colitis is suspected.
Ischemic colitis risk factors and outcomes
Dr. Fujitani was senior author of the largest ever study of risk factors for and outcomes of postoperative ischemic colitis in patients undergoing contemporary methods of open and endovascular AAA repair. This retrospective analysis of the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database included 3,486 patients who underwent AAA repair in U.S. hospitals during 2011-2012. Twelve percent had an open repair, while the other 88% underwent EVAR.
The incidence of postoperative ischemic colitis was 2.2%. The median time of diagnosis was on postoperative day 2. The rate was nearly threefold higher in the open repair group: 5.2% versus 1.8%. However, the open-repair group had a higher rate of emergency admission, ruptured aneurysm before surgery, and other high-risk features. Upon multivariate analysis, the adjusted risk of postoperative ischemic colitis was no longer significantly different in the open-repair and EVAR groups.
The mean hospital length of stay in patients with postoperative ischemic colitis was 20 days, compared with 5 days in those without the complication. The unadjusted in-hospital mortality rate in patients with ischemic colitis was 39% versus 4% in those without ischemic colitis.
Of the 75 patients who developed postoperative ischemic colitis, 37 were managed medically, 38 surgically.
“What was quite surprising was that there was a 56.8% in-hospital mortality in the surgically treated patients. The point being that if you end up having ischemic colitis, there’s a 50% chance you’ll end up requiring an operation, and if you do undergo an operation you have more than a 50% chance of succumbing from the process,” Dr. Fujitani observed.
Dr. Fujitani and his coinvestigators scrutinized a plethora of potential risk factors for postoperative ischemic colitis. Six emerged as significant upon multivariate analysis: ruptured aneurysm before surgery, with an associated adjusted 4.1-fold increased risk; need for intra- or postoperative transfusion, with a 6-fold increased risk; renal failure requiring dialysis, with a 3.9-fold risk; proximal extension of the aneurysm, with a 2.2-fold elevation in risk; diabetes, with a 1.9-fold risk; and female sex, with an adjusted 1.75-fold increased risk (J Vasc Surg. 2016 Apr;63[4]:866-72).
Of note, these risk factors are largely unmodifiable, which underscores the importance of vigorous surveillance for possible signs of ischemic colitis during the first 4 days after AAA repair, especially in patients with multiple risk factors, Dr. Fujitani said.
Also, careful intraoperative assessment of the collateral mesenteric vascular anatomy is important in assessing a patient’s risk for postoperative ischemic colitis. This assessment should include the superior and inferior mesenteric arteries, as well as the celiac and internal iliac arteries. It’s worth bearing in mind that, even though collateral flow may appear adequate, it can be affected by hypovolemia, hypotension, or low cardiac output, the surgeon continued.
In the NSQIP data analysis, no patients who underwent reimplantation of the inferior mesenteric artery during open repair developed postoperative ischemic colitis. While this is an encouraging finding, the numbers were too small to draw definitive conclusions as to whether reimplantation of the artery is protective. It’s an important issue for further study, though, since so few of the recognized risk factors for the complication are modifiable, Dr. Fujitani noted.
He reported having no financial conflicts regarding his presentation.
Preop physiotherapy training reduces risk of postop pulmonary complications
A single 30-minute coaching session with a physiotherapist within 6 weeks of major upper abdominal surgery significantly reduced postoperative pulmonary complications (PPC), according to the results of a prospective trial.
Ianthe Boden and her colleagues recruited 441 eligible adults scheduled for elective major upper abdominal surgery to participate in the prospective, multicenter, double-blinded, controlled superiority study to assess whether PPC outcomes were affected by preoperative physiotherapy. Consecutive participants were obtained from outpatient preadmission assessment clinics during June 2013 to August 2015; they were assigned randomly in a 1:1 ratio to the control (219) or intervention (222) groups. The median patient age was 68 years for the control and 63 for the intervention group, and each group was composed of 31% women.
Immediately after receiving the booklets, however, participants in the intervention group were also given an added 30-minute education and training session by preoperative physiotherapists. This instruction covered factors contributing to PPC occurrence, strategies to help prevention it, and three coached repetitions of breathing exercises. Emphasis was placed on initiating prescribed breathing exercises upon regaining postoperative consciousness and continuing them every hour until the patients were fully ambulatory.
The primary outcome was evaluated by masked assessors using the Melbourne group score criteria to determine PPC incidence within 14 postoperative days or by the time of hospital discharge, whichever was sooner. Nine participants, 4 from the intervention and 5 from the control group, withdrew from the study. Of the total remaining 432 participants, 85 (20%) had a documented PPC incident, including hospital acquired pneumonia, within the specified postoperative time frame, as reported in the BMJ.
Results showed that the physiotherapy group had significantly fewer PPC occurrences (27/218, 12%) than did the control group (58/214, 27%). The calculated absolute risk reduction was 15% (P less than .001). Adjustment for three of the prespecified covariates (age, respiratory comorbidity, and surgical procedure) showed PPC incidence remained halved (hazard ratio, 0.48; P = .001) for the intervention group with a number needed to treat of 7 (95% confidence interval, 5-14).
Secondary outcomes included incidence of hospital acquired pneumonia, hospital utilization, mobility, patient reported complications at 6 weeks, and mortality rates in hospital, at 6 weeks, and at 12 months. For secondary outcomes in the adjusted analysis, incidences of pneumonia were halved in the physiotherapy intervention group with a number needed to treat of 9 (95% CI, 6-21). No significant differences in secondary outcomes were detected between the control and treatment groups.
Sensitivity analysis that removed participants who had lower abdominal and laparoscopic surgery strengthened both primary and secondary outcome results to favor the preoperative physiotherapy intervention for reducing PPC. The researchers found that, in an adjusted analysis of subgroup effects, there was a gradient in reduction of PPCs according to surgical category.
Shorter lengths hospital stay and lower all-cause 12-month mortality were also associated with more experienced physiotherapists providing the preoperative education and training.
Ms. Boden and her colleagues proposed that the timing for patients to begin breathing exercises after major open upper abdominal surgery could be critical in reducing PPC incidence. Initiating breathing exercises within the first 24 hours after surgery – in contrast to the common practice of waiting 1-2 days to begin postoperative physiotherapy – could prevent general anesthesia-associated mild atelectasis from developing into severe atelectasis and PPCs.
The researchers concluded that “in a general population of patients listed for elective upper abdominal surgery, a 30-minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay.”
The authors reported that they received grants from the Clifford Craig Foundation; the University of Tasmania (Hobart), Australia; and the Waitemata District Health Board in Auckland, New Zealand.
SOURCE: Boden I et al. BMJ. 2018. doi: 10.1136/bmj.j5916.
A single 30-minute coaching session with a physiotherapist within 6 weeks of major upper abdominal surgery significantly reduced postoperative pulmonary complications (PPC), according to the results of a prospective trial.
Ianthe Boden and her colleagues recruited 441 eligible adults scheduled for elective major upper abdominal surgery to participate in the prospective, multicenter, double-blinded, controlled superiority study to assess whether PPC outcomes were affected by preoperative physiotherapy. Consecutive participants were obtained from outpatient preadmission assessment clinics during June 2013 to August 2015; they were assigned randomly in a 1:1 ratio to the control (219) or intervention (222) groups. The median patient age was 68 years for the control and 63 for the intervention group, and each group was composed of 31% women.
Immediately after receiving the booklets, however, participants in the intervention group were also given an added 30-minute education and training session by preoperative physiotherapists. This instruction covered factors contributing to PPC occurrence, strategies to help prevention it, and three coached repetitions of breathing exercises. Emphasis was placed on initiating prescribed breathing exercises upon regaining postoperative consciousness and continuing them every hour until the patients were fully ambulatory.
The primary outcome was evaluated by masked assessors using the Melbourne group score criteria to determine PPC incidence within 14 postoperative days or by the time of hospital discharge, whichever was sooner. Nine participants, 4 from the intervention and 5 from the control group, withdrew from the study. Of the total remaining 432 participants, 85 (20%) had a documented PPC incident, including hospital acquired pneumonia, within the specified postoperative time frame, as reported in the BMJ.
Results showed that the physiotherapy group had significantly fewer PPC occurrences (27/218, 12%) than did the control group (58/214, 27%). The calculated absolute risk reduction was 15% (P less than .001). Adjustment for three of the prespecified covariates (age, respiratory comorbidity, and surgical procedure) showed PPC incidence remained halved (hazard ratio, 0.48; P = .001) for the intervention group with a number needed to treat of 7 (95% confidence interval, 5-14).
Secondary outcomes included incidence of hospital acquired pneumonia, hospital utilization, mobility, patient reported complications at 6 weeks, and mortality rates in hospital, at 6 weeks, and at 12 months. For secondary outcomes in the adjusted analysis, incidences of pneumonia were halved in the physiotherapy intervention group with a number needed to treat of 9 (95% CI, 6-21). No significant differences in secondary outcomes were detected between the control and treatment groups.
Sensitivity analysis that removed participants who had lower abdominal and laparoscopic surgery strengthened both primary and secondary outcome results to favor the preoperative physiotherapy intervention for reducing PPC. The researchers found that, in an adjusted analysis of subgroup effects, there was a gradient in reduction of PPCs according to surgical category.
Shorter lengths hospital stay and lower all-cause 12-month mortality were also associated with more experienced physiotherapists providing the preoperative education and training.
Ms. Boden and her colleagues proposed that the timing for patients to begin breathing exercises after major open upper abdominal surgery could be critical in reducing PPC incidence. Initiating breathing exercises within the first 24 hours after surgery – in contrast to the common practice of waiting 1-2 days to begin postoperative physiotherapy – could prevent general anesthesia-associated mild atelectasis from developing into severe atelectasis and PPCs.
The researchers concluded that “in a general population of patients listed for elective upper abdominal surgery, a 30-minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay.”
The authors reported that they received grants from the Clifford Craig Foundation; the University of Tasmania (Hobart), Australia; and the Waitemata District Health Board in Auckland, New Zealand.
SOURCE: Boden I et al. BMJ. 2018. doi: 10.1136/bmj.j5916.
A single 30-minute coaching session with a physiotherapist within 6 weeks of major upper abdominal surgery significantly reduced postoperative pulmonary complications (PPC), according to the results of a prospective trial.
Ianthe Boden and her colleagues recruited 441 eligible adults scheduled for elective major upper abdominal surgery to participate in the prospective, multicenter, double-blinded, controlled superiority study to assess whether PPC outcomes were affected by preoperative physiotherapy. Consecutive participants were obtained from outpatient preadmission assessment clinics during June 2013 to August 2015; they were assigned randomly in a 1:1 ratio to the control (219) or intervention (222) groups. The median patient age was 68 years for the control and 63 for the intervention group, and each group was composed of 31% women.
Immediately after receiving the booklets, however, participants in the intervention group were also given an added 30-minute education and training session by preoperative physiotherapists. This instruction covered factors contributing to PPC occurrence, strategies to help prevention it, and three coached repetitions of breathing exercises. Emphasis was placed on initiating prescribed breathing exercises upon regaining postoperative consciousness and continuing them every hour until the patients were fully ambulatory.
The primary outcome was evaluated by masked assessors using the Melbourne group score criteria to determine PPC incidence within 14 postoperative days or by the time of hospital discharge, whichever was sooner. Nine participants, 4 from the intervention and 5 from the control group, withdrew from the study. Of the total remaining 432 participants, 85 (20%) had a documented PPC incident, including hospital acquired pneumonia, within the specified postoperative time frame, as reported in the BMJ.
Results showed that the physiotherapy group had significantly fewer PPC occurrences (27/218, 12%) than did the control group (58/214, 27%). The calculated absolute risk reduction was 15% (P less than .001). Adjustment for three of the prespecified covariates (age, respiratory comorbidity, and surgical procedure) showed PPC incidence remained halved (hazard ratio, 0.48; P = .001) for the intervention group with a number needed to treat of 7 (95% confidence interval, 5-14).
Secondary outcomes included incidence of hospital acquired pneumonia, hospital utilization, mobility, patient reported complications at 6 weeks, and mortality rates in hospital, at 6 weeks, and at 12 months. For secondary outcomes in the adjusted analysis, incidences of pneumonia were halved in the physiotherapy intervention group with a number needed to treat of 9 (95% CI, 6-21). No significant differences in secondary outcomes were detected between the control and treatment groups.
Sensitivity analysis that removed participants who had lower abdominal and laparoscopic surgery strengthened both primary and secondary outcome results to favor the preoperative physiotherapy intervention for reducing PPC. The researchers found that, in an adjusted analysis of subgroup effects, there was a gradient in reduction of PPCs according to surgical category.
Shorter lengths hospital stay and lower all-cause 12-month mortality were also associated with more experienced physiotherapists providing the preoperative education and training.
Ms. Boden and her colleagues proposed that the timing for patients to begin breathing exercises after major open upper abdominal surgery could be critical in reducing PPC incidence. Initiating breathing exercises within the first 24 hours after surgery – in contrast to the common practice of waiting 1-2 days to begin postoperative physiotherapy – could prevent general anesthesia-associated mild atelectasis from developing into severe atelectasis and PPCs.
The researchers concluded that “in a general population of patients listed for elective upper abdominal surgery, a 30-minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay.”
The authors reported that they received grants from the Clifford Craig Foundation; the University of Tasmania (Hobart), Australia; and the Waitemata District Health Board in Auckland, New Zealand.
SOURCE: Boden I et al. BMJ. 2018. doi: 10.1136/bmj.j5916.
FROM THE BMJ
Key clinical point: Reduction in PPC incidences corresponded to physiotherapists providing preoperative education and coaching intervention.
Major finding: Compared with the control group, Absolute risk was reduced by 15%, and seven was determined as number needed to treat.
Study details: Prospective, blinded study of 441 adult participants randomly assigned in a 1:1 ratio, comparing PPC outcomes associated with preop practices for upper abdominal surgeries.
Disclosures: The authors reported that they received grants from the Clifford Craig Foundation; the University of Tasmania (Hobart), Australia; and the Waitemata District Health Board in Auckland, New Zealand.
Source: Boden I. et al. BMJ. 2018. doi: 10.1136/bmj.j5916.
Surgery team scorecard improved patient satisfaction
JACKSONVILLE, FLA. – A scorecard enables spectators at a baseball game to keep track of who the players are, and a scorecard of the surgery team can do the same for inpatients, researchers at Johns Hopkins University in Baltimore found.
They gave patients a “facesheet” that included photographs and biographies of all members of their surgery team, which helped patients to better understand the team members’ roles in their care and led to improvements in overall satisfaction scores, according to a study reported at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
The study involved two intervals: a prefacesheet phase of 153 patients and a postfacesheet phase of 100 patients. The two groups, all gastrointestinal surgery inpatients, were administered preintervention discharge surveys to evaluate their level of patient satisfaction according to a 5-point Likert scale (1 = strongly disagree and 5 = strongly agree).
“We found that using these facesheets helped patients know the roles of their team members, and the patients felt that it was important to [have this information],” Dr. DiBrito said.
The share of patients answering 4 (agreed) or 5 (strongly agreed) for overall satisfaction rose from 83% before the facesheet intervention to 88% afterward (P = .5). The number of patients agreeing that they understood their providers’ roles increased from 72% to 83% (P = .05), and the number who agreed that it was important to know who their surgical team members were increased from 85% to 94% (P = .04). The latter finding somewhat surprised the researchers. Dr. DiBrito said, “That’s not exactly what we were anticipating.”
The study also revealed a trend in patients’ feeling more confident in their team overall after the facesheet intervention, rising from 89% to 95%, Dr. DiBrito said.
She said the Johns Hopkins team is not continuing the initiative currently but would like to roll it out more broadly to other hospital services. Other groups within the hospital, including nursing and clinical customer services, must get on board, she said. “We really need buy-in from higher levels in the hospital, and this was part of the proof that we needed,” Dr. DiBrito said.
The premise of the study was that patients need to identify a member of their care team as a point person, she added. “We’re trying to give the patients, and their family members as well, some people to look out for,” Dr. DiBrito said.
Dr. DiBrito and her coauthors had no financial relationships to disclose.
SOURCE: Dibrito SR et al. Academic Surgical Congress 2018, Abstract 09.04.
JACKSONVILLE, FLA. – A scorecard enables spectators at a baseball game to keep track of who the players are, and a scorecard of the surgery team can do the same for inpatients, researchers at Johns Hopkins University in Baltimore found.
They gave patients a “facesheet” that included photographs and biographies of all members of their surgery team, which helped patients to better understand the team members’ roles in their care and led to improvements in overall satisfaction scores, according to a study reported at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
The study involved two intervals: a prefacesheet phase of 153 patients and a postfacesheet phase of 100 patients. The two groups, all gastrointestinal surgery inpatients, were administered preintervention discharge surveys to evaluate their level of patient satisfaction according to a 5-point Likert scale (1 = strongly disagree and 5 = strongly agree).
“We found that using these facesheets helped patients know the roles of their team members, and the patients felt that it was important to [have this information],” Dr. DiBrito said.
The share of patients answering 4 (agreed) or 5 (strongly agreed) for overall satisfaction rose from 83% before the facesheet intervention to 88% afterward (P = .5). The number of patients agreeing that they understood their providers’ roles increased from 72% to 83% (P = .05), and the number who agreed that it was important to know who their surgical team members were increased from 85% to 94% (P = .04). The latter finding somewhat surprised the researchers. Dr. DiBrito said, “That’s not exactly what we were anticipating.”
The study also revealed a trend in patients’ feeling more confident in their team overall after the facesheet intervention, rising from 89% to 95%, Dr. DiBrito said.
She said the Johns Hopkins team is not continuing the initiative currently but would like to roll it out more broadly to other hospital services. Other groups within the hospital, including nursing and clinical customer services, must get on board, she said. “We really need buy-in from higher levels in the hospital, and this was part of the proof that we needed,” Dr. DiBrito said.
The premise of the study was that patients need to identify a member of their care team as a point person, she added. “We’re trying to give the patients, and their family members as well, some people to look out for,” Dr. DiBrito said.
Dr. DiBrito and her coauthors had no financial relationships to disclose.
SOURCE: Dibrito SR et al. Academic Surgical Congress 2018, Abstract 09.04.
JACKSONVILLE, FLA. – A scorecard enables spectators at a baseball game to keep track of who the players are, and a scorecard of the surgery team can do the same for inpatients, researchers at Johns Hopkins University in Baltimore found.
They gave patients a “facesheet” that included photographs and biographies of all members of their surgery team, which helped patients to better understand the team members’ roles in their care and led to improvements in overall satisfaction scores, according to a study reported at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
The study involved two intervals: a prefacesheet phase of 153 patients and a postfacesheet phase of 100 patients. The two groups, all gastrointestinal surgery inpatients, were administered preintervention discharge surveys to evaluate their level of patient satisfaction according to a 5-point Likert scale (1 = strongly disagree and 5 = strongly agree).
“We found that using these facesheets helped patients know the roles of their team members, and the patients felt that it was important to [have this information],” Dr. DiBrito said.
The share of patients answering 4 (agreed) or 5 (strongly agreed) for overall satisfaction rose from 83% before the facesheet intervention to 88% afterward (P = .5). The number of patients agreeing that they understood their providers’ roles increased from 72% to 83% (P = .05), and the number who agreed that it was important to know who their surgical team members were increased from 85% to 94% (P = .04). The latter finding somewhat surprised the researchers. Dr. DiBrito said, “That’s not exactly what we were anticipating.”
The study also revealed a trend in patients’ feeling more confident in their team overall after the facesheet intervention, rising from 89% to 95%, Dr. DiBrito said.
She said the Johns Hopkins team is not continuing the initiative currently but would like to roll it out more broadly to other hospital services. Other groups within the hospital, including nursing and clinical customer services, must get on board, she said. “We really need buy-in from higher levels in the hospital, and this was part of the proof that we needed,” Dr. DiBrito said.
The premise of the study was that patients need to identify a member of their care team as a point person, she added. “We’re trying to give the patients, and their family members as well, some people to look out for,” Dr. DiBrito said.
Dr. DiBrito and her coauthors had no financial relationships to disclose.
SOURCE: Dibrito SR et al. Academic Surgical Congress 2018, Abstract 09.04.
REPORTING FROM THE ACADEMIC SURGICAL CONGRESS
Key clinical point: A “facesheet” that includes photographs and biographies of the surgical care team improves patient satisfaction.
Major finding: Overall satisfaction scores increased from 83% preintervention to 88% postintervention.
Data source: Analysis of the survey responses from 253 gastrointestinal surgery patients pre- and postintervention from February 2017 to May 2017.
Disclosures: Dr. DiBrito and her coauthors had no financial relationships to disclose.
Source: Dibrito SR et al. Academic Surgical Congress 2018, Abstract 09.04.
Expert advice for the corporate titans taking on health care
An announcement Jan. 30 by three of the nation’s corporate titans – Amazon, Berkshire Hathaway, and JPMorgan Chase & Co. – that they are joining forces to address the high costs of employee health care has stirred the health policy pot. It immediately sent shock waves through the health sector of the stock market and reinvigorated talk about health care technology, value, and quality.
Though details regarding the undertaking are thin, the companies said in a statement that their partnership’s intent is to improve employee satisfaction and hold down costs by bringing “their scale and complementary expertise to this long-term effort.”
They plan to create an independent company, “free from profit-making incentives and constraints,” to focus on “technology solutions.”
Berkshire Hathaway CEO Warren Buffett described health care costs as “a hungry tapeworm on the American economy,” and Amazon founder and CEO Jeff Bezos said the partnership was “open-eyed about the degree of difficulty” ahead. Jamie Dimon, chairman and CEO of JPMorgan, said the results could benefit the employees of these companies and possibly all Americans.
But what does all of this mean and how can it be successful when so many other initiatives have fallen short? Kaiser Health News asked a variety of health policy experts for their thoughts on this venture, and what advice they would offer these CEOs as they go forward. Some of the advice has been edited for clarity and length.
Tom Miller, resident fellow, American Enterprise Institute:
“It’s great that someone theoretically with resources would try to build a better mousetrap. But it’s been difficult to do, and part of it is regulatory and competitive barriers are well-constructed in the health care sphere, which tend to make it less receptive or subject to competitive pressures.
“I welcome any new capital trying to disrupt health care. … The incumbents are comfortable and could use disruption. If Amazon has an idea, and is willing to put some money behind it, that’s wonderful. What they are willing to do other than fly low-cost providers for home visits in drones – I don’t know. They’d probably have to miniaturize them, wouldn’t they?”
Stan Dorn, senior fellow, Families USA:
“Number one, look at prices. America doesn’t use more health care than European countries, but we pay a lot more and that’s because of prices more than anything else. Look at hospital prices and prescription drug prices. I would also say, look to eliminate middlemen operating in darkness. I’m thinking in particular of pharmacy benefit managers. Often, the supply chain is hidden and complex, and every step along the way the middlemen are taking their share, and it winds up costing a huge amount of money.”
Bob Kocher, MD, partner, Venrock:
“It has been said that health care is complicated. One thing that is not complicated is that the way to save money is to focus on the sickest patients. And that’s the only thing that has proven to work in great primary care. I hope Amazon realizes this early and does not think that [its smart digital assistant] Alexa and apps are going to make us healthier and save any money.
“It would sure be nice if they invest in a ‘post-CPT-ICD-10-and-many-bills-per-visit’ world where we know prices, can easily know what is known about quality and experience, and have same-day service.”
Tracy Watts, senior partner, Mercer:
“Everyone thinks millennials want to do everything on their phones. But that’s not necessarily the case.
“[There was a recent] survey about this – specifically, millennials are the most interested in new health care offerings, but it wasn’t as much high-tech as it is convenience they are interested in – same-day appointments with a family doctor, guaranteed appointments with specialists, home visits, a wider array of services available at retail clinics. That was kind of an ‘aha’ – this kind of convenience and high-touch experience is what they’re looking for. And when you think of ‘health care of the future,’ that’s not what comes to mind.”
John Rother, president and CEO, National Coalition on Health Care:
“Health care is complex and expensive, so the aim should always be simplicity and affordability. Three keys to success: Manage chronic conditions recognizing the life context of the patient, emphasize primary care-based medical homes, and aggressively negotiate prescription drug costs.”
Suzanne Delbanco, executive director, Catalyst for Payment Reform:
“The biggest driver of health care costs is prices. Those are being driven up by health care providers who have consolidated and will continue to consolidate and amass more market power.
“It sounds like they [the companies] are limiting the use of health plans, but if they’re going to get into that business, they’re going to come up with the same challenges health plans face. What would be really innovative would be to build some provider systems from the ground up where they can truly get a handle on the actual costs and eliminate the market power that drives the prices up, and they can have control over their prices.”
Brian Marcotte, president and CEO, National Business Group on Health:
“They recognize this is [a] long-term play to get involved in this. I’d have to say, this industry is ripe for disruption.
“I think we know technology will continue to play an increasing role in how consumers access and receive health care. We’ve also learned most consumers do not touch the health care delivery system with enough frequency to ever be a sophisticated consumer. What’s intriguing about this partnership is Amazon for many consumers has become part of their day-to-day world, part of their routine. It’s intriguing to consider the possibilities of integrating health care into consumer routine.
“And I think that therein lies the opportunity. Employers offer a lot of resources to their employees to help them maximize their experience, and their No. 1 challenge is engagement.”
Joseph Antos, health economist, American Enterprise Institute:
“My first suggestion is to look at what other employers have done (some unsuccessfully) and consider how to adapt those ideas for the three companies and more broadly. Change incentives for providers. Change incentives for consumers. Work on ways to reduce the effects of market consolidation. The bottom line: Don’t keep doing what we are doing now. I don’t see that these three companies have enough presence in health markets to pull this off anytime soon, but perhaps this should be viewed as the private-sector version of the Affordable Care Act’s Innovation Center – except, this time, there may be some new ideas to test.”
Ceci Connolly, president and CEO, Alliance of Community Health Plans:
“We know that 5% of any population consumes 50% of the health care dollar. I would encourage this group to focus on how to better serve those individuals who need help managing multiple chronic conditions.”
David Lansky, CEO, Pacific Business Group on Health:
“The incumbent providers of services to our members are not doing as much as we need done for affordability and quality. So, we are pleased to see them go down this path. We don’t know what piece of the puzzle they will tackle.
“We know well-intended efforts over the years haven’t added up to material impact on cost and quality. I would suspect they are looking at doing something broader, more disruptive than initiatives we have tried before.
“I think across the board they have the opportunity to set high standards for the health system in whatever platform they use. These companies have a history of raising the bar. Potentially, it could be a help to all of us.”
Staff writers Julie Appleby, Rachel Bluth, Jenny Gold, Jay Hancock, Shefali Luthra, Jordan Rau, Julie Rovner and Chad Terhune contributed to this report. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
An announcement Jan. 30 by three of the nation’s corporate titans – Amazon, Berkshire Hathaway, and JPMorgan Chase & Co. – that they are joining forces to address the high costs of employee health care has stirred the health policy pot. It immediately sent shock waves through the health sector of the stock market and reinvigorated talk about health care technology, value, and quality.
Though details regarding the undertaking are thin, the companies said in a statement that their partnership’s intent is to improve employee satisfaction and hold down costs by bringing “their scale and complementary expertise to this long-term effort.”
They plan to create an independent company, “free from profit-making incentives and constraints,” to focus on “technology solutions.”
Berkshire Hathaway CEO Warren Buffett described health care costs as “a hungry tapeworm on the American economy,” and Amazon founder and CEO Jeff Bezos said the partnership was “open-eyed about the degree of difficulty” ahead. Jamie Dimon, chairman and CEO of JPMorgan, said the results could benefit the employees of these companies and possibly all Americans.
But what does all of this mean and how can it be successful when so many other initiatives have fallen short? Kaiser Health News asked a variety of health policy experts for their thoughts on this venture, and what advice they would offer these CEOs as they go forward. Some of the advice has been edited for clarity and length.
Tom Miller, resident fellow, American Enterprise Institute:
“It’s great that someone theoretically with resources would try to build a better mousetrap. But it’s been difficult to do, and part of it is regulatory and competitive barriers are well-constructed in the health care sphere, which tend to make it less receptive or subject to competitive pressures.
“I welcome any new capital trying to disrupt health care. … The incumbents are comfortable and could use disruption. If Amazon has an idea, and is willing to put some money behind it, that’s wonderful. What they are willing to do other than fly low-cost providers for home visits in drones – I don’t know. They’d probably have to miniaturize them, wouldn’t they?”
Stan Dorn, senior fellow, Families USA:
“Number one, look at prices. America doesn’t use more health care than European countries, but we pay a lot more and that’s because of prices more than anything else. Look at hospital prices and prescription drug prices. I would also say, look to eliminate middlemen operating in darkness. I’m thinking in particular of pharmacy benefit managers. Often, the supply chain is hidden and complex, and every step along the way the middlemen are taking their share, and it winds up costing a huge amount of money.”
Bob Kocher, MD, partner, Venrock:
“It has been said that health care is complicated. One thing that is not complicated is that the way to save money is to focus on the sickest patients. And that’s the only thing that has proven to work in great primary care. I hope Amazon realizes this early and does not think that [its smart digital assistant] Alexa and apps are going to make us healthier and save any money.
“It would sure be nice if they invest in a ‘post-CPT-ICD-10-and-many-bills-per-visit’ world where we know prices, can easily know what is known about quality and experience, and have same-day service.”
Tracy Watts, senior partner, Mercer:
“Everyone thinks millennials want to do everything on their phones. But that’s not necessarily the case.
“[There was a recent] survey about this – specifically, millennials are the most interested in new health care offerings, but it wasn’t as much high-tech as it is convenience they are interested in – same-day appointments with a family doctor, guaranteed appointments with specialists, home visits, a wider array of services available at retail clinics. That was kind of an ‘aha’ – this kind of convenience and high-touch experience is what they’re looking for. And when you think of ‘health care of the future,’ that’s not what comes to mind.”
John Rother, president and CEO, National Coalition on Health Care:
“Health care is complex and expensive, so the aim should always be simplicity and affordability. Three keys to success: Manage chronic conditions recognizing the life context of the patient, emphasize primary care-based medical homes, and aggressively negotiate prescription drug costs.”
Suzanne Delbanco, executive director, Catalyst for Payment Reform:
“The biggest driver of health care costs is prices. Those are being driven up by health care providers who have consolidated and will continue to consolidate and amass more market power.
“It sounds like they [the companies] are limiting the use of health plans, but if they’re going to get into that business, they’re going to come up with the same challenges health plans face. What would be really innovative would be to build some provider systems from the ground up where they can truly get a handle on the actual costs and eliminate the market power that drives the prices up, and they can have control over their prices.”
Brian Marcotte, president and CEO, National Business Group on Health:
“They recognize this is [a] long-term play to get involved in this. I’d have to say, this industry is ripe for disruption.
“I think we know technology will continue to play an increasing role in how consumers access and receive health care. We’ve also learned most consumers do not touch the health care delivery system with enough frequency to ever be a sophisticated consumer. What’s intriguing about this partnership is Amazon for many consumers has become part of their day-to-day world, part of their routine. It’s intriguing to consider the possibilities of integrating health care into consumer routine.
“And I think that therein lies the opportunity. Employers offer a lot of resources to their employees to help them maximize their experience, and their No. 1 challenge is engagement.”
Joseph Antos, health economist, American Enterprise Institute:
“My first suggestion is to look at what other employers have done (some unsuccessfully) and consider how to adapt those ideas for the three companies and more broadly. Change incentives for providers. Change incentives for consumers. Work on ways to reduce the effects of market consolidation. The bottom line: Don’t keep doing what we are doing now. I don’t see that these three companies have enough presence in health markets to pull this off anytime soon, but perhaps this should be viewed as the private-sector version of the Affordable Care Act’s Innovation Center – except, this time, there may be some new ideas to test.”
Ceci Connolly, president and CEO, Alliance of Community Health Plans:
“We know that 5% of any population consumes 50% of the health care dollar. I would encourage this group to focus on how to better serve those individuals who need help managing multiple chronic conditions.”
David Lansky, CEO, Pacific Business Group on Health:
“The incumbent providers of services to our members are not doing as much as we need done for affordability and quality. So, we are pleased to see them go down this path. We don’t know what piece of the puzzle they will tackle.
“We know well-intended efforts over the years haven’t added up to material impact on cost and quality. I would suspect they are looking at doing something broader, more disruptive than initiatives we have tried before.
“I think across the board they have the opportunity to set high standards for the health system in whatever platform they use. These companies have a history of raising the bar. Potentially, it could be a help to all of us.”
Staff writers Julie Appleby, Rachel Bluth, Jenny Gold, Jay Hancock, Shefali Luthra, Jordan Rau, Julie Rovner and Chad Terhune contributed to this report. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
An announcement Jan. 30 by three of the nation’s corporate titans – Amazon, Berkshire Hathaway, and JPMorgan Chase & Co. – that they are joining forces to address the high costs of employee health care has stirred the health policy pot. It immediately sent shock waves through the health sector of the stock market and reinvigorated talk about health care technology, value, and quality.
Though details regarding the undertaking are thin, the companies said in a statement that their partnership’s intent is to improve employee satisfaction and hold down costs by bringing “their scale and complementary expertise to this long-term effort.”
They plan to create an independent company, “free from profit-making incentives and constraints,” to focus on “technology solutions.”
Berkshire Hathaway CEO Warren Buffett described health care costs as “a hungry tapeworm on the American economy,” and Amazon founder and CEO Jeff Bezos said the partnership was “open-eyed about the degree of difficulty” ahead. Jamie Dimon, chairman and CEO of JPMorgan, said the results could benefit the employees of these companies and possibly all Americans.
But what does all of this mean and how can it be successful when so many other initiatives have fallen short? Kaiser Health News asked a variety of health policy experts for their thoughts on this venture, and what advice they would offer these CEOs as they go forward. Some of the advice has been edited for clarity and length.
Tom Miller, resident fellow, American Enterprise Institute:
“It’s great that someone theoretically with resources would try to build a better mousetrap. But it’s been difficult to do, and part of it is regulatory and competitive barriers are well-constructed in the health care sphere, which tend to make it less receptive or subject to competitive pressures.
“I welcome any new capital trying to disrupt health care. … The incumbents are comfortable and could use disruption. If Amazon has an idea, and is willing to put some money behind it, that’s wonderful. What they are willing to do other than fly low-cost providers for home visits in drones – I don’t know. They’d probably have to miniaturize them, wouldn’t they?”
Stan Dorn, senior fellow, Families USA:
“Number one, look at prices. America doesn’t use more health care than European countries, but we pay a lot more and that’s because of prices more than anything else. Look at hospital prices and prescription drug prices. I would also say, look to eliminate middlemen operating in darkness. I’m thinking in particular of pharmacy benefit managers. Often, the supply chain is hidden and complex, and every step along the way the middlemen are taking their share, and it winds up costing a huge amount of money.”
Bob Kocher, MD, partner, Venrock:
“It has been said that health care is complicated. One thing that is not complicated is that the way to save money is to focus on the sickest patients. And that’s the only thing that has proven to work in great primary care. I hope Amazon realizes this early and does not think that [its smart digital assistant] Alexa and apps are going to make us healthier and save any money.
“It would sure be nice if they invest in a ‘post-CPT-ICD-10-and-many-bills-per-visit’ world where we know prices, can easily know what is known about quality and experience, and have same-day service.”
Tracy Watts, senior partner, Mercer:
“Everyone thinks millennials want to do everything on their phones. But that’s not necessarily the case.
“[There was a recent] survey about this – specifically, millennials are the most interested in new health care offerings, but it wasn’t as much high-tech as it is convenience they are interested in – same-day appointments with a family doctor, guaranteed appointments with specialists, home visits, a wider array of services available at retail clinics. That was kind of an ‘aha’ – this kind of convenience and high-touch experience is what they’re looking for. And when you think of ‘health care of the future,’ that’s not what comes to mind.”
John Rother, president and CEO, National Coalition on Health Care:
“Health care is complex and expensive, so the aim should always be simplicity and affordability. Three keys to success: Manage chronic conditions recognizing the life context of the patient, emphasize primary care-based medical homes, and aggressively negotiate prescription drug costs.”
Suzanne Delbanco, executive director, Catalyst for Payment Reform:
“The biggest driver of health care costs is prices. Those are being driven up by health care providers who have consolidated and will continue to consolidate and amass more market power.
“It sounds like they [the companies] are limiting the use of health plans, but if they’re going to get into that business, they’re going to come up with the same challenges health plans face. What would be really innovative would be to build some provider systems from the ground up where they can truly get a handle on the actual costs and eliminate the market power that drives the prices up, and they can have control over their prices.”
Brian Marcotte, president and CEO, National Business Group on Health:
“They recognize this is [a] long-term play to get involved in this. I’d have to say, this industry is ripe for disruption.
“I think we know technology will continue to play an increasing role in how consumers access and receive health care. We’ve also learned most consumers do not touch the health care delivery system with enough frequency to ever be a sophisticated consumer. What’s intriguing about this partnership is Amazon for many consumers has become part of their day-to-day world, part of their routine. It’s intriguing to consider the possibilities of integrating health care into consumer routine.
“And I think that therein lies the opportunity. Employers offer a lot of resources to their employees to help them maximize their experience, and their No. 1 challenge is engagement.”
Joseph Antos, health economist, American Enterprise Institute:
“My first suggestion is to look at what other employers have done (some unsuccessfully) and consider how to adapt those ideas for the three companies and more broadly. Change incentives for providers. Change incentives for consumers. Work on ways to reduce the effects of market consolidation. The bottom line: Don’t keep doing what we are doing now. I don’t see that these three companies have enough presence in health markets to pull this off anytime soon, but perhaps this should be viewed as the private-sector version of the Affordable Care Act’s Innovation Center – except, this time, there may be some new ideas to test.”
Ceci Connolly, president and CEO, Alliance of Community Health Plans:
“We know that 5% of any population consumes 50% of the health care dollar. I would encourage this group to focus on how to better serve those individuals who need help managing multiple chronic conditions.”
David Lansky, CEO, Pacific Business Group on Health:
“The incumbent providers of services to our members are not doing as much as we need done for affordability and quality. So, we are pleased to see them go down this path. We don’t know what piece of the puzzle they will tackle.
“We know well-intended efforts over the years haven’t added up to material impact on cost and quality. I would suspect they are looking at doing something broader, more disruptive than initiatives we have tried before.
“I think across the board they have the opportunity to set high standards for the health system in whatever platform they use. These companies have a history of raising the bar. Potentially, it could be a help to all of us.”
Staff writers Julie Appleby, Rachel Bluth, Jenny Gold, Jay Hancock, Shefali Luthra, Jordan Rau, Julie Rovner and Chad Terhune contributed to this report. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Health care gets little attention in State of the Union address
President Trump reaffirmed his campaign promise to lower prescription drug prices during his first State of the Union address – but gave no details on how he plans to do so.
“One of my greatest priorities is to reduce the price of prescription drugs,” President Trump said in his Jan. 30 address to a joint session of Congress. “In many other countries, these drugs cost far less than what we pay in the United States, and it is very, very unfair. That is why I have directed my administration to make fixing the injustice of high drug prices one of my top priorities for the year.”
His words followed the confirmation of Alex Azar as Health & Human Services secretary. Mr. Azar’s nomination was criticized by some who questioned whether the former president of Eli Lilly’s U.S. operations could be effective at tackling the surging prices of pharmaceuticals.
President Trump also expressed his support for allowing terminally ill patients to access experimental drugs prior to Food and Drug Administration approval, the so-called right to try.
“We also believe that patients with terminal conditions, terminal illness, should have access to experimental treatment immediately that could potentially save their lives,” he said. “People who are terminally ill should not have to go from country to country to seek a cure. I want to give them a chance right here at home. It’s time for the Congress to give these wonderful incredible Americans the right to try.”
The Senate passed a right to try bill (S. 204) in 2017 by unanimous consent, but the House has yet to act upon it.
President Trump reaffirmed his commitment to fighting the opioid epidemic and made a loose connection between it and his overall platform for immigration reform, saying that “these reforms will also support our response to the terrible crisis of opioid and drug addiction.”
As far as addressing the epidemic itself, Mr. Trump said that his administration “is committed to fighting the drug epidemic and helping get treatment for those in need, for those who have been so terribly hurt. The struggle will be long and it will be difficult, but, as Americans always do, in the end we will succeed. We will prevail.”
The president also commended Congress for effectively eliminating the Affordable Care Act’s individual mandate that required people to have health insurance or suffer a financial penalty.
President Trump reaffirmed his campaign promise to lower prescription drug prices during his first State of the Union address – but gave no details on how he plans to do so.
“One of my greatest priorities is to reduce the price of prescription drugs,” President Trump said in his Jan. 30 address to a joint session of Congress. “In many other countries, these drugs cost far less than what we pay in the United States, and it is very, very unfair. That is why I have directed my administration to make fixing the injustice of high drug prices one of my top priorities for the year.”
His words followed the confirmation of Alex Azar as Health & Human Services secretary. Mr. Azar’s nomination was criticized by some who questioned whether the former president of Eli Lilly’s U.S. operations could be effective at tackling the surging prices of pharmaceuticals.
President Trump also expressed his support for allowing terminally ill patients to access experimental drugs prior to Food and Drug Administration approval, the so-called right to try.
“We also believe that patients with terminal conditions, terminal illness, should have access to experimental treatment immediately that could potentially save their lives,” he said. “People who are terminally ill should not have to go from country to country to seek a cure. I want to give them a chance right here at home. It’s time for the Congress to give these wonderful incredible Americans the right to try.”
The Senate passed a right to try bill (S. 204) in 2017 by unanimous consent, but the House has yet to act upon it.
President Trump reaffirmed his commitment to fighting the opioid epidemic and made a loose connection between it and his overall platform for immigration reform, saying that “these reforms will also support our response to the terrible crisis of opioid and drug addiction.”
As far as addressing the epidemic itself, Mr. Trump said that his administration “is committed to fighting the drug epidemic and helping get treatment for those in need, for those who have been so terribly hurt. The struggle will be long and it will be difficult, but, as Americans always do, in the end we will succeed. We will prevail.”
The president also commended Congress for effectively eliminating the Affordable Care Act’s individual mandate that required people to have health insurance or suffer a financial penalty.
President Trump reaffirmed his campaign promise to lower prescription drug prices during his first State of the Union address – but gave no details on how he plans to do so.
“One of my greatest priorities is to reduce the price of prescription drugs,” President Trump said in his Jan. 30 address to a joint session of Congress. “In many other countries, these drugs cost far less than what we pay in the United States, and it is very, very unfair. That is why I have directed my administration to make fixing the injustice of high drug prices one of my top priorities for the year.”
His words followed the confirmation of Alex Azar as Health & Human Services secretary. Mr. Azar’s nomination was criticized by some who questioned whether the former president of Eli Lilly’s U.S. operations could be effective at tackling the surging prices of pharmaceuticals.
President Trump also expressed his support for allowing terminally ill patients to access experimental drugs prior to Food and Drug Administration approval, the so-called right to try.
“We also believe that patients with terminal conditions, terminal illness, should have access to experimental treatment immediately that could potentially save their lives,” he said. “People who are terminally ill should not have to go from country to country to seek a cure. I want to give them a chance right here at home. It’s time for the Congress to give these wonderful incredible Americans the right to try.”
The Senate passed a right to try bill (S. 204) in 2017 by unanimous consent, but the House has yet to act upon it.
President Trump reaffirmed his commitment to fighting the opioid epidemic and made a loose connection between it and his overall platform for immigration reform, saying that “these reforms will also support our response to the terrible crisis of opioid and drug addiction.”
As far as addressing the epidemic itself, Mr. Trump said that his administration “is committed to fighting the drug epidemic and helping get treatment for those in need, for those who have been so terribly hurt. The struggle will be long and it will be difficult, but, as Americans always do, in the end we will succeed. We will prevail.”
The president also commended Congress for effectively eliminating the Affordable Care Act’s individual mandate that required people to have health insurance or suffer a financial penalty.
Notable acute care surgery papers from 2017
LAKE BUENA VISTA, FLA. – Every year brings new studies, updates, and trials, and it can be a challenge to keep up.
Christian Jones, MD, FACS, a general surgeon in the division of acute care surgery at Johns Hopkins University, Baltimore, ranked some of the more notable trauma studies published in the past year and presented his perspective on them at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
Day 2 is the “sweet spot” for cholecystectomy
When it comes to cholecystectomy, acute cholecystitis (AC) patients appear to fare the best when operations are conducted on day 2 after admission, according to a study of patients registered in the Swedish Registry of Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography (GallRiks).
The retrospective study of 15,760 AC patients found that the rate of 30-day mortality of AC patients was significantly higher for patients who underwent a cholecystectomy on day of (odds ratio = .42) 3 days after (OR = .34), and 4 days after admission (OR = 1.0), compared with those who were operated on between 1 day after (OR = .23), and 2 days after (OR = .29) admission.
Lead author My Blohm, MD, of the department of clinical sciences, intervention, and technology at the Karolinska Institutet, Stockholm, and fellow investigators hypothesized that waiting allows patients to be medically optimized for surgery (J Gastrointest Surg. 2017;21[1]: 33-40).
With 90-day mortality rates showing nearly identical results for day 1 and day 2, holding off on surgery may be the best move for the patient, even if it is not the ideal situation for a provider.
“Sure, as we all know by now, delayed cholecystectomy is seldom necessary, later surgery is more difficult, and more likely to be associated with complications at least with an equal conversion to an open procedure, but even more surprising is the higher mortality on the admissions day,” said Dr. Jones.
Antibiotics for abscess drainage patients
For patients requiring abscess drainage, antibiotics may be the best bet to keep infection at bay, according to a study published in the New England Journal of Medicine in June 2017.
The prospective, randomized, placebo-controlled, double-blind, study of 786 simple skin abscess drainage patients found clindamycin and Bactrim (sulfamethoxazole and trimethoprim) outperformed a placebo in an evaluation of symptoms of true ongoing infection in patients even 30 days after the procedure (N Engl J Med. 2017 Jun 29;376[26]:2545-55).
Patients studied had Staphylococcus aureus (527) or methicillin-resistant S. aureus (388).
After 10 days of therapy, cure rate of infection for the clindamycin and Bactrim groups were 83% and 82% respectively, compared with 70% in the placebo group, according to Robert S. Daum, MD, principal investigator at the MRSA Research Center, University of Chicago. After 30 days, cure rate for both antibiotic groups remained superior to that of the placebo group.
While these treatments were successful, concern of drug resistance is notable and should be taken into consideration when deciding on treatment options.
“This does get to our typical concern with increased antibiotic usage, and that’s the concern of the health of the community versus the health of the individual patient,” said Dr. Jones. “Is the increased rate of [antibiotic] resistance important enough to have a lower cure rate of simple abscess drainage? We don’t know the answer to that.”
Loop ileostomies look good for C. diff patients
This minimally invasive procedure has been the subject of some well-received studies with findings that indicate it is a promising choice for patients with a Clostridium difficile–associated disease (CDAD) over total colectomy, Dr. Jones said.
In a study published in the Journal of Trauma and Acute Care Surgery, a study group of patients with CDAD who had loop ileostomy had no statistical difference in almost any recorded characteristic compared with those who underwent a total colectomy, except mortality rate. The retrospective, multicenter study of 98 CDAD patients found the mortality rate of the loop ileostomy group to be 17.2%, compared with 39.7% in the total colectomy group (J Trauma Acute Care Surg. 2017 Jul;83[1]:36-40).
“The outcomes all favored loop ileostomy in a statistically significant fashion,” said Dr. Jones. “Unsurprisingly, estimated blood loss and need for transfusions were all significantly less in the loop ileostomy patients, and the adjusted overall mortality, even if requiring a reoperation, still favored doing the loop ileostomy first.”
The one difference between LI and colectomy patients was a longer time from initial diagnosis to operation among LI patients, with about 12 hours from diagnosis for the colectomy versus 24 hours for LI patients, according to lead author Paula Ferrada, MD, FACS, director of the surgical and trauma intensive care unit at Virginia Commonwealth University, Richmond, and her fellow investigators,
Contrary to previous findings, the study found that LI can be performed on sick patients as well, according to the researchers, and failure of the procedure is not associated with increased mortality.
While these findings are encouraging, “there are things that the individual patient may reveal to you on your examination that tell you they are not a candidate and that you should go to total colectomy,” said Dr. Jones. “Keep in mind that perhaps we can be a bit more aggressive in this less invasive procedure.”
The skin vac actually works
A study published in Annals of Surgery found prophylactic negative-pressure dressings are associated with a decreased rate of surgical site infections in laparotomy wounds.
“The biggest surprise to me out of all of these studies is that a new piece of technology actually seems to work,” said Dr. Jones.
The randomized study included 50 laparotomy patients with a stapled wound, half of whom received a skin vac over their incision while the other half had a standard OpSite occlusive dressing (Ann Surg. 2017 Jun;265[6]:1082-6).
Patients in both arms had the same type of wound and had their dressings on for 4 days before being switched.
Rate of surgical site infections for the skin vac group was 8.3% over 30 days from operation, compared with 32% in the OpSite group. Average length of stay for patients with the pressure dressing was 6.1 days, while patients with an OpSite dressing had a length of 14.7 days, more than double, according to lead author Donal Peter O’Leary, MD, surgeon at Cork University Hospital, Ireland.
The difference in length of stay does become insignificant if six OpSite patients who stayed longer than 20 days are discounted, only two of whom were delayed because of wound complications as opposed to placement issues or unassociated infections.
“But a surgical site infection difference of 50% or more using a skin vac instead of a standard dressing, whether you’re talking about clean, clean-contaminated, or contaminated cases with a skin closure, seems to be worthy of notice,” explained Dr. Jones.
LAKE BUENA VISTA, FLA. – Every year brings new studies, updates, and trials, and it can be a challenge to keep up.
Christian Jones, MD, FACS, a general surgeon in the division of acute care surgery at Johns Hopkins University, Baltimore, ranked some of the more notable trauma studies published in the past year and presented his perspective on them at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
Day 2 is the “sweet spot” for cholecystectomy
When it comes to cholecystectomy, acute cholecystitis (AC) patients appear to fare the best when operations are conducted on day 2 after admission, according to a study of patients registered in the Swedish Registry of Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography (GallRiks).
The retrospective study of 15,760 AC patients found that the rate of 30-day mortality of AC patients was significantly higher for patients who underwent a cholecystectomy on day of (odds ratio = .42) 3 days after (OR = .34), and 4 days after admission (OR = 1.0), compared with those who were operated on between 1 day after (OR = .23), and 2 days after (OR = .29) admission.
Lead author My Blohm, MD, of the department of clinical sciences, intervention, and technology at the Karolinska Institutet, Stockholm, and fellow investigators hypothesized that waiting allows patients to be medically optimized for surgery (J Gastrointest Surg. 2017;21[1]: 33-40).
With 90-day mortality rates showing nearly identical results for day 1 and day 2, holding off on surgery may be the best move for the patient, even if it is not the ideal situation for a provider.
“Sure, as we all know by now, delayed cholecystectomy is seldom necessary, later surgery is more difficult, and more likely to be associated with complications at least with an equal conversion to an open procedure, but even more surprising is the higher mortality on the admissions day,” said Dr. Jones.
Antibiotics for abscess drainage patients
For patients requiring abscess drainage, antibiotics may be the best bet to keep infection at bay, according to a study published in the New England Journal of Medicine in June 2017.
The prospective, randomized, placebo-controlled, double-blind, study of 786 simple skin abscess drainage patients found clindamycin and Bactrim (sulfamethoxazole and trimethoprim) outperformed a placebo in an evaluation of symptoms of true ongoing infection in patients even 30 days after the procedure (N Engl J Med. 2017 Jun 29;376[26]:2545-55).
Patients studied had Staphylococcus aureus (527) or methicillin-resistant S. aureus (388).
After 10 days of therapy, cure rate of infection for the clindamycin and Bactrim groups were 83% and 82% respectively, compared with 70% in the placebo group, according to Robert S. Daum, MD, principal investigator at the MRSA Research Center, University of Chicago. After 30 days, cure rate for both antibiotic groups remained superior to that of the placebo group.
While these treatments were successful, concern of drug resistance is notable and should be taken into consideration when deciding on treatment options.
“This does get to our typical concern with increased antibiotic usage, and that’s the concern of the health of the community versus the health of the individual patient,” said Dr. Jones. “Is the increased rate of [antibiotic] resistance important enough to have a lower cure rate of simple abscess drainage? We don’t know the answer to that.”
Loop ileostomies look good for C. diff patients
This minimally invasive procedure has been the subject of some well-received studies with findings that indicate it is a promising choice for patients with a Clostridium difficile–associated disease (CDAD) over total colectomy, Dr. Jones said.
In a study published in the Journal of Trauma and Acute Care Surgery, a study group of patients with CDAD who had loop ileostomy had no statistical difference in almost any recorded characteristic compared with those who underwent a total colectomy, except mortality rate. The retrospective, multicenter study of 98 CDAD patients found the mortality rate of the loop ileostomy group to be 17.2%, compared with 39.7% in the total colectomy group (J Trauma Acute Care Surg. 2017 Jul;83[1]:36-40).
“The outcomes all favored loop ileostomy in a statistically significant fashion,” said Dr. Jones. “Unsurprisingly, estimated blood loss and need for transfusions were all significantly less in the loop ileostomy patients, and the adjusted overall mortality, even if requiring a reoperation, still favored doing the loop ileostomy first.”
The one difference between LI and colectomy patients was a longer time from initial diagnosis to operation among LI patients, with about 12 hours from diagnosis for the colectomy versus 24 hours for LI patients, according to lead author Paula Ferrada, MD, FACS, director of the surgical and trauma intensive care unit at Virginia Commonwealth University, Richmond, and her fellow investigators,
Contrary to previous findings, the study found that LI can be performed on sick patients as well, according to the researchers, and failure of the procedure is not associated with increased mortality.
While these findings are encouraging, “there are things that the individual patient may reveal to you on your examination that tell you they are not a candidate and that you should go to total colectomy,” said Dr. Jones. “Keep in mind that perhaps we can be a bit more aggressive in this less invasive procedure.”
The skin vac actually works
A study published in Annals of Surgery found prophylactic negative-pressure dressings are associated with a decreased rate of surgical site infections in laparotomy wounds.
“The biggest surprise to me out of all of these studies is that a new piece of technology actually seems to work,” said Dr. Jones.
The randomized study included 50 laparotomy patients with a stapled wound, half of whom received a skin vac over their incision while the other half had a standard OpSite occlusive dressing (Ann Surg. 2017 Jun;265[6]:1082-6).
Patients in both arms had the same type of wound and had their dressings on for 4 days before being switched.
Rate of surgical site infections for the skin vac group was 8.3% over 30 days from operation, compared with 32% in the OpSite group. Average length of stay for patients with the pressure dressing was 6.1 days, while patients with an OpSite dressing had a length of 14.7 days, more than double, according to lead author Donal Peter O’Leary, MD, surgeon at Cork University Hospital, Ireland.
The difference in length of stay does become insignificant if six OpSite patients who stayed longer than 20 days are discounted, only two of whom were delayed because of wound complications as opposed to placement issues or unassociated infections.
“But a surgical site infection difference of 50% or more using a skin vac instead of a standard dressing, whether you’re talking about clean, clean-contaminated, or contaminated cases with a skin closure, seems to be worthy of notice,” explained Dr. Jones.
LAKE BUENA VISTA, FLA. – Every year brings new studies, updates, and trials, and it can be a challenge to keep up.
Christian Jones, MD, FACS, a general surgeon in the division of acute care surgery at Johns Hopkins University, Baltimore, ranked some of the more notable trauma studies published in the past year and presented his perspective on them at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
Day 2 is the “sweet spot” for cholecystectomy
When it comes to cholecystectomy, acute cholecystitis (AC) patients appear to fare the best when operations are conducted on day 2 after admission, according to a study of patients registered in the Swedish Registry of Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography (GallRiks).
The retrospective study of 15,760 AC patients found that the rate of 30-day mortality of AC patients was significantly higher for patients who underwent a cholecystectomy on day of (odds ratio = .42) 3 days after (OR = .34), and 4 days after admission (OR = 1.0), compared with those who were operated on between 1 day after (OR = .23), and 2 days after (OR = .29) admission.
Lead author My Blohm, MD, of the department of clinical sciences, intervention, and technology at the Karolinska Institutet, Stockholm, and fellow investigators hypothesized that waiting allows patients to be medically optimized for surgery (J Gastrointest Surg. 2017;21[1]: 33-40).
With 90-day mortality rates showing nearly identical results for day 1 and day 2, holding off on surgery may be the best move for the patient, even if it is not the ideal situation for a provider.
“Sure, as we all know by now, delayed cholecystectomy is seldom necessary, later surgery is more difficult, and more likely to be associated with complications at least with an equal conversion to an open procedure, but even more surprising is the higher mortality on the admissions day,” said Dr. Jones.
Antibiotics for abscess drainage patients
For patients requiring abscess drainage, antibiotics may be the best bet to keep infection at bay, according to a study published in the New England Journal of Medicine in June 2017.
The prospective, randomized, placebo-controlled, double-blind, study of 786 simple skin abscess drainage patients found clindamycin and Bactrim (sulfamethoxazole and trimethoprim) outperformed a placebo in an evaluation of symptoms of true ongoing infection in patients even 30 days after the procedure (N Engl J Med. 2017 Jun 29;376[26]:2545-55).
Patients studied had Staphylococcus aureus (527) or methicillin-resistant S. aureus (388).
After 10 days of therapy, cure rate of infection for the clindamycin and Bactrim groups were 83% and 82% respectively, compared with 70% in the placebo group, according to Robert S. Daum, MD, principal investigator at the MRSA Research Center, University of Chicago. After 30 days, cure rate for both antibiotic groups remained superior to that of the placebo group.
While these treatments were successful, concern of drug resistance is notable and should be taken into consideration when deciding on treatment options.
“This does get to our typical concern with increased antibiotic usage, and that’s the concern of the health of the community versus the health of the individual patient,” said Dr. Jones. “Is the increased rate of [antibiotic] resistance important enough to have a lower cure rate of simple abscess drainage? We don’t know the answer to that.”
Loop ileostomies look good for C. diff patients
This minimally invasive procedure has been the subject of some well-received studies with findings that indicate it is a promising choice for patients with a Clostridium difficile–associated disease (CDAD) over total colectomy, Dr. Jones said.
In a study published in the Journal of Trauma and Acute Care Surgery, a study group of patients with CDAD who had loop ileostomy had no statistical difference in almost any recorded characteristic compared with those who underwent a total colectomy, except mortality rate. The retrospective, multicenter study of 98 CDAD patients found the mortality rate of the loop ileostomy group to be 17.2%, compared with 39.7% in the total colectomy group (J Trauma Acute Care Surg. 2017 Jul;83[1]:36-40).
“The outcomes all favored loop ileostomy in a statistically significant fashion,” said Dr. Jones. “Unsurprisingly, estimated blood loss and need for transfusions were all significantly less in the loop ileostomy patients, and the adjusted overall mortality, even if requiring a reoperation, still favored doing the loop ileostomy first.”
The one difference between LI and colectomy patients was a longer time from initial diagnosis to operation among LI patients, with about 12 hours from diagnosis for the colectomy versus 24 hours for LI patients, according to lead author Paula Ferrada, MD, FACS, director of the surgical and trauma intensive care unit at Virginia Commonwealth University, Richmond, and her fellow investigators,
Contrary to previous findings, the study found that LI can be performed on sick patients as well, according to the researchers, and failure of the procedure is not associated with increased mortality.
While these findings are encouraging, “there are things that the individual patient may reveal to you on your examination that tell you they are not a candidate and that you should go to total colectomy,” said Dr. Jones. “Keep in mind that perhaps we can be a bit more aggressive in this less invasive procedure.”
The skin vac actually works
A study published in Annals of Surgery found prophylactic negative-pressure dressings are associated with a decreased rate of surgical site infections in laparotomy wounds.
“The biggest surprise to me out of all of these studies is that a new piece of technology actually seems to work,” said Dr. Jones.
The randomized study included 50 laparotomy patients with a stapled wound, half of whom received a skin vac over their incision while the other half had a standard OpSite occlusive dressing (Ann Surg. 2017 Jun;265[6]:1082-6).
Patients in both arms had the same type of wound and had their dressings on for 4 days before being switched.
Rate of surgical site infections for the skin vac group was 8.3% over 30 days from operation, compared with 32% in the OpSite group. Average length of stay for patients with the pressure dressing was 6.1 days, while patients with an OpSite dressing had a length of 14.7 days, more than double, according to lead author Donal Peter O’Leary, MD, surgeon at Cork University Hospital, Ireland.
The difference in length of stay does become insignificant if six OpSite patients who stayed longer than 20 days are discounted, only two of whom were delayed because of wound complications as opposed to placement issues or unassociated infections.
“But a surgical site infection difference of 50% or more using a skin vac instead of a standard dressing, whether you’re talking about clean, clean-contaminated, or contaminated cases with a skin closure, seems to be worthy of notice,” explained Dr. Jones.
REPORTING FROM EAST 2018
Late thrombectomy for stroke has low number needed to treat for benefit
LOS ANGELES – The number of ischemic stroke patients with a clinical core mismatch showing salvageable tissue who need to be treated with thrombectomy to obtain a significant benefit on functional outcomes is just 2 when the time frame from last known well extends out to 24 hours, according a subanalysis of results from the DAWN trial.
The Jan. 4, 2018, publication of the DAWN trial revealed that patients with ischemic strokes can benefit from thrombectomy long after the time window generally thought to afford benefits had closed (N Engl J Med. 2018;378:11-21). The procedure yielded significant benefits in functional outcomes at 90 days in patients with a clinical core mismatch showing salvageable tissue.
The results are important because health care systems must now make decisions about allocating resources for the treatment of these patients, which will include installing imaging techniques and expertise at various centers. “It will be practical in some primary stroke centers and not in others. We’re going to see a lot of interesting research about what frontline hospitals should do. There are lots of options at that screening step, and we’re going to need experience to see what’s best. It won’t be the same answer for everyone,” Jeffrey Saver, MD, said during a press conference announcing the results at the meeting, which was sponsored by the American Heart Association. Dr. Saver is director of the stroke unit at the University of California, Los Angeles, and professor of clinical neurology at the university.
The DAWN trial randomized 206 patients to thrombectomy plus standard care or standard care alone. The study was halted at an enrollment of 206 patients because of overwhelming efficacy. To be eligible, the patients had to have a mismatch between the severity of clinical deficit and the infarct volume as measured via automated analysis (RAPID software, SchemaView) of diffusion-weighted MRI or perfusion CT. They had to have substantial clinical deficits, but limited infarct size, with specific criteria varying with age, National Institutes of Health Stroke Scale score, and infarct size.
The NNT for an mRS score of 0 (asymptomatic) was 19. For freedom from disability (mRS, 0-1), the NNT was 4. For functional independence (mRS, 0-2), it was 3. To achieve ambulatory status (mRS, 0-3), it was 3. To avoid a requirement for constant care (mRS, 0-4), the NNT was 9.
To achieve any reduction in disability at all, the NNT was 2. This value was identical when looking at patients in the 6- to 12-hour window and those in the 12- to 24-hour window. However, the nature of the benefit was different. “In the late window (12-24 hours), outcomes went from really bad to pretty good. In the early window, it was somewhat bad to very good. So it’s still better to be treated early,” Dr. Saver said.
In short, for every 100 patients treated, 50 would gain an improvement in disability-related quality of life, and 36 would gain functional independence. In the 6- to 12-hour group, 45 of every 100 patients would experience lower disability as a result of treatment, as would 56 of every 100 treated patients in the 12- to 24-hour group.
Stryker Neurovascular funded the study. Dr. Saver has consulted for Stryker and received travel reimbursement.
LOS ANGELES – The number of ischemic stroke patients with a clinical core mismatch showing salvageable tissue who need to be treated with thrombectomy to obtain a significant benefit on functional outcomes is just 2 when the time frame from last known well extends out to 24 hours, according a subanalysis of results from the DAWN trial.
The Jan. 4, 2018, publication of the DAWN trial revealed that patients with ischemic strokes can benefit from thrombectomy long after the time window generally thought to afford benefits had closed (N Engl J Med. 2018;378:11-21). The procedure yielded significant benefits in functional outcomes at 90 days in patients with a clinical core mismatch showing salvageable tissue.
The results are important because health care systems must now make decisions about allocating resources for the treatment of these patients, which will include installing imaging techniques and expertise at various centers. “It will be practical in some primary stroke centers and not in others. We’re going to see a lot of interesting research about what frontline hospitals should do. There are lots of options at that screening step, and we’re going to need experience to see what’s best. It won’t be the same answer for everyone,” Jeffrey Saver, MD, said during a press conference announcing the results at the meeting, which was sponsored by the American Heart Association. Dr. Saver is director of the stroke unit at the University of California, Los Angeles, and professor of clinical neurology at the university.
The DAWN trial randomized 206 patients to thrombectomy plus standard care or standard care alone. The study was halted at an enrollment of 206 patients because of overwhelming efficacy. To be eligible, the patients had to have a mismatch between the severity of clinical deficit and the infarct volume as measured via automated analysis (RAPID software, SchemaView) of diffusion-weighted MRI or perfusion CT. They had to have substantial clinical deficits, but limited infarct size, with specific criteria varying with age, National Institutes of Health Stroke Scale score, and infarct size.
The NNT for an mRS score of 0 (asymptomatic) was 19. For freedom from disability (mRS, 0-1), the NNT was 4. For functional independence (mRS, 0-2), it was 3. To achieve ambulatory status (mRS, 0-3), it was 3. To avoid a requirement for constant care (mRS, 0-4), the NNT was 9.
To achieve any reduction in disability at all, the NNT was 2. This value was identical when looking at patients in the 6- to 12-hour window and those in the 12- to 24-hour window. However, the nature of the benefit was different. “In the late window (12-24 hours), outcomes went from really bad to pretty good. In the early window, it was somewhat bad to very good. So it’s still better to be treated early,” Dr. Saver said.
In short, for every 100 patients treated, 50 would gain an improvement in disability-related quality of life, and 36 would gain functional independence. In the 6- to 12-hour group, 45 of every 100 patients would experience lower disability as a result of treatment, as would 56 of every 100 treated patients in the 12- to 24-hour group.
Stryker Neurovascular funded the study. Dr. Saver has consulted for Stryker and received travel reimbursement.
LOS ANGELES – The number of ischemic stroke patients with a clinical core mismatch showing salvageable tissue who need to be treated with thrombectomy to obtain a significant benefit on functional outcomes is just 2 when the time frame from last known well extends out to 24 hours, according a subanalysis of results from the DAWN trial.
The Jan. 4, 2018, publication of the DAWN trial revealed that patients with ischemic strokes can benefit from thrombectomy long after the time window generally thought to afford benefits had closed (N Engl J Med. 2018;378:11-21). The procedure yielded significant benefits in functional outcomes at 90 days in patients with a clinical core mismatch showing salvageable tissue.
The results are important because health care systems must now make decisions about allocating resources for the treatment of these patients, which will include installing imaging techniques and expertise at various centers. “It will be practical in some primary stroke centers and not in others. We’re going to see a lot of interesting research about what frontline hospitals should do. There are lots of options at that screening step, and we’re going to need experience to see what’s best. It won’t be the same answer for everyone,” Jeffrey Saver, MD, said during a press conference announcing the results at the meeting, which was sponsored by the American Heart Association. Dr. Saver is director of the stroke unit at the University of California, Los Angeles, and professor of clinical neurology at the university.
The DAWN trial randomized 206 patients to thrombectomy plus standard care or standard care alone. The study was halted at an enrollment of 206 patients because of overwhelming efficacy. To be eligible, the patients had to have a mismatch between the severity of clinical deficit and the infarct volume as measured via automated analysis (RAPID software, SchemaView) of diffusion-weighted MRI or perfusion CT. They had to have substantial clinical deficits, but limited infarct size, with specific criteria varying with age, National Institutes of Health Stroke Scale score, and infarct size.
The NNT for an mRS score of 0 (asymptomatic) was 19. For freedom from disability (mRS, 0-1), the NNT was 4. For functional independence (mRS, 0-2), it was 3. To achieve ambulatory status (mRS, 0-3), it was 3. To avoid a requirement for constant care (mRS, 0-4), the NNT was 9.
To achieve any reduction in disability at all, the NNT was 2. This value was identical when looking at patients in the 6- to 12-hour window and those in the 12- to 24-hour window. However, the nature of the benefit was different. “In the late window (12-24 hours), outcomes went from really bad to pretty good. In the early window, it was somewhat bad to very good. So it’s still better to be treated early,” Dr. Saver said.
In short, for every 100 patients treated, 50 would gain an improvement in disability-related quality of life, and 36 would gain functional independence. In the 6- to 12-hour group, 45 of every 100 patients would experience lower disability as a result of treatment, as would 56 of every 100 treated patients in the 12- to 24-hour group.
Stryker Neurovascular funded the study. Dr. Saver has consulted for Stryker and received travel reimbursement.
REPORTING FROM ISC 2018
Key clinical point:
Major finding: To achieve a functional improvement at 90 days, the number needed to treat was 2.
Data source: Subanalysis of the randomized, controlled DAWN trial (n = 206).
Disclosures: Stryker Neurovascular funded the study. Dr. Saver has consulted for Stryker and received travel reimbursement.
Source: Saver J et al. ISC 2018 abstract LB3
Retroperitoneal lymphadenectomy did not impact OS and DFS for high risk, nonmetastatic renal cell carcinoma
according to a secondary analysis of the ASSURE adjuvant trial.
Patients were randomized to adjuvant sorafenib, sunitinib, or placebo in the ASSURE (Adjuvant Sorafenib and Sunitinib for Unfavorable Renal Carcinoma) trial, and those at high risk – which was defined by cN+ disease or determined at their surgeon’s discretion – underwent LND. The primary objective was to assess the effect of LND on overall survival; secondary objectives included the effect of LND on disease-free survival and the benefit of adjuvant therapy vs. placebo in patients who underwent LND.
Overall, 1,943 patients were enrolled in the ASSURE trial, of which 36.1% (701 patients) underwent LND. A median of three lymph nodes (interquartile range, one to eight) was examined, and disease was pN+ in 23.4% patients. A majority of the patients were male (67.4%), with a median age of 56 years. Most (94.5%) patients underwent radical nephrectomy, and 57.2% patients had open surgery rather than laparoscopic. Tumors were clear cell in 81.7% of cases and Fuhrman grade 3-4 in 66.1%, investigators reported in the Journal Of Urology.
“There was no improvement in overall survival for lymphadenectomy relative to no lymphadenectomy (HR, 1.14; 95% CI, 0.93-1.39; P = .20). For patients who underwent lymphadenectomy with pN+ disease, no improvement in overall or disease-free survival was observed for adjuvant therapy relative to placebo. Lymphadenectomy was overall safe, and did not increase the risk of surgical complications (14.2% vs. 13.4%; P = .63),” wrote Benjamin Ristau, MD, of Fox Chase Cancer Center in Philadelphia and his colleagues. LND was independently associated with other markers of aggressive surgical resection, such as open surgery, radical nephrectomy, and adrenalectomy.
The role of lymphadenectomy in patients undergoing surgery for high-risk renal cell carcinoma remains elusive, the authors wrote. Future strategies include a prospective trial in which patients with high-risk renal cell carcinoma are randomized to specific lymphadenectomy templates.
This study was supported by the National Cancer Institute of National Institutes of Health and the Canadian Cancer Research Institute. Christopher G. Wood reported conflicts of interest with Pfizer, Novartis and Argos. Other authors reported no conflicts of interest.
SOURCE: Ristau BT et al. J Urol. 2018 Jan. doi: 10.1016/j.juro.2017.07.042.
according to a secondary analysis of the ASSURE adjuvant trial.
Patients were randomized to adjuvant sorafenib, sunitinib, or placebo in the ASSURE (Adjuvant Sorafenib and Sunitinib for Unfavorable Renal Carcinoma) trial, and those at high risk – which was defined by cN+ disease or determined at their surgeon’s discretion – underwent LND. The primary objective was to assess the effect of LND on overall survival; secondary objectives included the effect of LND on disease-free survival and the benefit of adjuvant therapy vs. placebo in patients who underwent LND.
Overall, 1,943 patients were enrolled in the ASSURE trial, of which 36.1% (701 patients) underwent LND. A median of three lymph nodes (interquartile range, one to eight) was examined, and disease was pN+ in 23.4% patients. A majority of the patients were male (67.4%), with a median age of 56 years. Most (94.5%) patients underwent radical nephrectomy, and 57.2% patients had open surgery rather than laparoscopic. Tumors were clear cell in 81.7% of cases and Fuhrman grade 3-4 in 66.1%, investigators reported in the Journal Of Urology.
“There was no improvement in overall survival for lymphadenectomy relative to no lymphadenectomy (HR, 1.14; 95% CI, 0.93-1.39; P = .20). For patients who underwent lymphadenectomy with pN+ disease, no improvement in overall or disease-free survival was observed for adjuvant therapy relative to placebo. Lymphadenectomy was overall safe, and did not increase the risk of surgical complications (14.2% vs. 13.4%; P = .63),” wrote Benjamin Ristau, MD, of Fox Chase Cancer Center in Philadelphia and his colleagues. LND was independently associated with other markers of aggressive surgical resection, such as open surgery, radical nephrectomy, and adrenalectomy.
The role of lymphadenectomy in patients undergoing surgery for high-risk renal cell carcinoma remains elusive, the authors wrote. Future strategies include a prospective trial in which patients with high-risk renal cell carcinoma are randomized to specific lymphadenectomy templates.
This study was supported by the National Cancer Institute of National Institutes of Health and the Canadian Cancer Research Institute. Christopher G. Wood reported conflicts of interest with Pfizer, Novartis and Argos. Other authors reported no conflicts of interest.
SOURCE: Ristau BT et al. J Urol. 2018 Jan. doi: 10.1016/j.juro.2017.07.042.
according to a secondary analysis of the ASSURE adjuvant trial.
Patients were randomized to adjuvant sorafenib, sunitinib, or placebo in the ASSURE (Adjuvant Sorafenib and Sunitinib for Unfavorable Renal Carcinoma) trial, and those at high risk – which was defined by cN+ disease or determined at their surgeon’s discretion – underwent LND. The primary objective was to assess the effect of LND on overall survival; secondary objectives included the effect of LND on disease-free survival and the benefit of adjuvant therapy vs. placebo in patients who underwent LND.
Overall, 1,943 patients were enrolled in the ASSURE trial, of which 36.1% (701 patients) underwent LND. A median of three lymph nodes (interquartile range, one to eight) was examined, and disease was pN+ in 23.4% patients. A majority of the patients were male (67.4%), with a median age of 56 years. Most (94.5%) patients underwent radical nephrectomy, and 57.2% patients had open surgery rather than laparoscopic. Tumors were clear cell in 81.7% of cases and Fuhrman grade 3-4 in 66.1%, investigators reported in the Journal Of Urology.
“There was no improvement in overall survival for lymphadenectomy relative to no lymphadenectomy (HR, 1.14; 95% CI, 0.93-1.39; P = .20). For patients who underwent lymphadenectomy with pN+ disease, no improvement in overall or disease-free survival was observed for adjuvant therapy relative to placebo. Lymphadenectomy was overall safe, and did not increase the risk of surgical complications (14.2% vs. 13.4%; P = .63),” wrote Benjamin Ristau, MD, of Fox Chase Cancer Center in Philadelphia and his colleagues. LND was independently associated with other markers of aggressive surgical resection, such as open surgery, radical nephrectomy, and adrenalectomy.
The role of lymphadenectomy in patients undergoing surgery for high-risk renal cell carcinoma remains elusive, the authors wrote. Future strategies include a prospective trial in which patients with high-risk renal cell carcinoma are randomized to specific lymphadenectomy templates.
This study was supported by the National Cancer Institute of National Institutes of Health and the Canadian Cancer Research Institute. Christopher G. Wood reported conflicts of interest with Pfizer, Novartis and Argos. Other authors reported no conflicts of interest.
SOURCE: Ristau BT et al. J Urol. 2018 Jan. doi: 10.1016/j.juro.2017.07.042.
FROM THE JOURNAL OF UROLOGY
Key clinical point: Lymphadenectomy did not improve overall survival or disease-free survival in patients with high-risk, nonmetastatic renal cell carcinoma who received either adjuvant therapy or placebo.
Major finding: There was no overall survival benefit for lymphadenectomy relative to no lymphadenectomy (HR, 1.14; 95% CI, 0.93-1.39; P = .20).
Study details: Patients enrolled prospectively in the ASSURE trial.
Disclosures: The study was funded by the National Cancer Institute of National Institutes of Health and the Canadian Cancer Research Institute. Although one author did report conflicts of interest with Pfizer, Novartis, and Argos, the rest reported no conflicts of interest.
Source: Ristau BT et al. J Urol. Jan 2018. doi: 10.1016/j.juro.2017.07.042.