User login
Vascular surgeons have better outcomes for aneurysm repair, endarterectomy
SAN FRANCISCO – Patients undergoing carotid endarterectomy and open abdominal aortic aneurysm repair are less likely to have complications and die if their surgeon is a vascular specialist, according to a study reported at the annual clinical congress of the American College of Surgeons.
“We feel that carotid endarterectomy and open triple-A repair performed by a vascular surgeon is an independent predictor of improved morbidity and mortality. Hospitals should consider utilizing this specialty-specific information to identify potential quality improvement initiatives,” recommended lead investigator Dr. Carla C. Moreira, a surgeon in the division of vascular and endovascular surgery, Boston Medical Center.
She and her colleagues analyzed data from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP), assessing outcomes for 94,029 patients who underwent open vascular procedures between 2006 and 2012. Some 8% had abdominal aneurysm repairs, 57% had carotid endarterectomies, and 35% had lower-extremity bypasses.
Overall, 94% of the procedures were performed by vascular surgeons, while the rest were performed by other types of surgeons (including cardiac surgeons because their numbers were too small to tease out, according to Dr. Moreira).
Results showed that for patients undergoing abdominal aneurysm repair, the unadjusted rate of 30-day mortality did not differ significantly by surgeon specialty. However, in multivariate, propensity-matched analysis, the odds of complications were reduced by half when the repair was done by a vascular surgeon as compared with some other type of surgeon (odds ratio, 0.50).
Patients undergoing carotid endarterectomy had a lower unadjusted mortality if the operation was performed by a vascular surgeon (0.7% vs. 1.0%), although the difference was no longer significant after multivariate adjustment. However, they had significantly lower adjusted odds of complications (odds ratio, 0.62).
For patients undergoing lower-extremity bypass, neither the rate of mortality nor the odds of complications differed significantly by surgeon specialty.
An analysis of temporal trends showed that the proportions of all eligible patients undergoing open abdominal aneurysm repair and lower-extremity bypass during the study period fell, regardless of surgeon type, whereas the proportion of eligible patients undergoing carotid endarterectomies remained stable. “I think this is reflective likely of the penetration of endovascular procedures when it comes to the treatment of abdominal aneurysm and lower-extremity peripheral arterial disease, as compared to carotid disease,” speculated Dr. Moreira, who disclosed that she had no relevant conflicts of interest.
Session moderator Dr. Peter K. Henke, associate chair of research, department of surgery, and Leland Ira Doan Professor of Vascular Surgery at the University of Michigan in Ann Arbor, asked whether the findings have implications for surgeon training.
“Our results were different from what has been previously published for open aneurysm repair. I think that open aneurysm repair is probably becoming more and more specialized in terms that more and more, you are going to see just vascular surgeons performing it as compared to other specialties, especially as I have shown that there is a decreasing number of general surgeons being exposed to open vascular procedures,” Dr. Moreira replied. “So I think this [speaks] to individual surgeons and their individual experience with triple-A repair. Our data does show that general surgeons who are performing these procedures are doing a good job because there is not a difference in outcome at least in terms of mortality. But as the easy triple-A repairs go away, I think it’s going to push the procedure to be done more by specialized surgeons.”
In an interview, Dr. Henke commented, “I think it has been alluded to in other studies and other reports in the literature, but this study brings to the forefront the fact that overall numbers of open vascular procedures are less and less, so the surgeons performing those procedures need to be specialists. And I’d say within the U.S. anyway, most practitioners who do vascular procedures are vascular surgeons or cardiovascularly trained, as compared with general surgeons. I suspect that some of the general surgeons who are still doing these procedures may be at a place where they are the only ones who can do it or there are no vascular specialists there.
“The other issue that this study may impact, as more of these reports come out, is hospital credentialing, because hospital credentialing of surgeons really determines what they can and cannot do at that hospital,” he added. “So as more hospital credentialing boards see this type of data, I think they will limit open vascular procedures to vascular specialists who have had training in vascular disease.”
SAN FRANCISCO – Patients undergoing carotid endarterectomy and open abdominal aortic aneurysm repair are less likely to have complications and die if their surgeon is a vascular specialist, according to a study reported at the annual clinical congress of the American College of Surgeons.
“We feel that carotid endarterectomy and open triple-A repair performed by a vascular surgeon is an independent predictor of improved morbidity and mortality. Hospitals should consider utilizing this specialty-specific information to identify potential quality improvement initiatives,” recommended lead investigator Dr. Carla C. Moreira, a surgeon in the division of vascular and endovascular surgery, Boston Medical Center.
She and her colleagues analyzed data from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP), assessing outcomes for 94,029 patients who underwent open vascular procedures between 2006 and 2012. Some 8% had abdominal aneurysm repairs, 57% had carotid endarterectomies, and 35% had lower-extremity bypasses.
Overall, 94% of the procedures were performed by vascular surgeons, while the rest were performed by other types of surgeons (including cardiac surgeons because their numbers were too small to tease out, according to Dr. Moreira).
Results showed that for patients undergoing abdominal aneurysm repair, the unadjusted rate of 30-day mortality did not differ significantly by surgeon specialty. However, in multivariate, propensity-matched analysis, the odds of complications were reduced by half when the repair was done by a vascular surgeon as compared with some other type of surgeon (odds ratio, 0.50).
Patients undergoing carotid endarterectomy had a lower unadjusted mortality if the operation was performed by a vascular surgeon (0.7% vs. 1.0%), although the difference was no longer significant after multivariate adjustment. However, they had significantly lower adjusted odds of complications (odds ratio, 0.62).
For patients undergoing lower-extremity bypass, neither the rate of mortality nor the odds of complications differed significantly by surgeon specialty.
An analysis of temporal trends showed that the proportions of all eligible patients undergoing open abdominal aneurysm repair and lower-extremity bypass during the study period fell, regardless of surgeon type, whereas the proportion of eligible patients undergoing carotid endarterectomies remained stable. “I think this is reflective likely of the penetration of endovascular procedures when it comes to the treatment of abdominal aneurysm and lower-extremity peripheral arterial disease, as compared to carotid disease,” speculated Dr. Moreira, who disclosed that she had no relevant conflicts of interest.
Session moderator Dr. Peter K. Henke, associate chair of research, department of surgery, and Leland Ira Doan Professor of Vascular Surgery at the University of Michigan in Ann Arbor, asked whether the findings have implications for surgeon training.
“Our results were different from what has been previously published for open aneurysm repair. I think that open aneurysm repair is probably becoming more and more specialized in terms that more and more, you are going to see just vascular surgeons performing it as compared to other specialties, especially as I have shown that there is a decreasing number of general surgeons being exposed to open vascular procedures,” Dr. Moreira replied. “So I think this [speaks] to individual surgeons and their individual experience with triple-A repair. Our data does show that general surgeons who are performing these procedures are doing a good job because there is not a difference in outcome at least in terms of mortality. But as the easy triple-A repairs go away, I think it’s going to push the procedure to be done more by specialized surgeons.”
In an interview, Dr. Henke commented, “I think it has been alluded to in other studies and other reports in the literature, but this study brings to the forefront the fact that overall numbers of open vascular procedures are less and less, so the surgeons performing those procedures need to be specialists. And I’d say within the U.S. anyway, most practitioners who do vascular procedures are vascular surgeons or cardiovascularly trained, as compared with general surgeons. I suspect that some of the general surgeons who are still doing these procedures may be at a place where they are the only ones who can do it or there are no vascular specialists there.
“The other issue that this study may impact, as more of these reports come out, is hospital credentialing, because hospital credentialing of surgeons really determines what they can and cannot do at that hospital,” he added. “So as more hospital credentialing boards see this type of data, I think they will limit open vascular procedures to vascular specialists who have had training in vascular disease.”
SAN FRANCISCO – Patients undergoing carotid endarterectomy and open abdominal aortic aneurysm repair are less likely to have complications and die if their surgeon is a vascular specialist, according to a study reported at the annual clinical congress of the American College of Surgeons.
“We feel that carotid endarterectomy and open triple-A repair performed by a vascular surgeon is an independent predictor of improved morbidity and mortality. Hospitals should consider utilizing this specialty-specific information to identify potential quality improvement initiatives,” recommended lead investigator Dr. Carla C. Moreira, a surgeon in the division of vascular and endovascular surgery, Boston Medical Center.
She and her colleagues analyzed data from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP), assessing outcomes for 94,029 patients who underwent open vascular procedures between 2006 and 2012. Some 8% had abdominal aneurysm repairs, 57% had carotid endarterectomies, and 35% had lower-extremity bypasses.
Overall, 94% of the procedures were performed by vascular surgeons, while the rest were performed by other types of surgeons (including cardiac surgeons because their numbers were too small to tease out, according to Dr. Moreira).
Results showed that for patients undergoing abdominal aneurysm repair, the unadjusted rate of 30-day mortality did not differ significantly by surgeon specialty. However, in multivariate, propensity-matched analysis, the odds of complications were reduced by half when the repair was done by a vascular surgeon as compared with some other type of surgeon (odds ratio, 0.50).
Patients undergoing carotid endarterectomy had a lower unadjusted mortality if the operation was performed by a vascular surgeon (0.7% vs. 1.0%), although the difference was no longer significant after multivariate adjustment. However, they had significantly lower adjusted odds of complications (odds ratio, 0.62).
For patients undergoing lower-extremity bypass, neither the rate of mortality nor the odds of complications differed significantly by surgeon specialty.
An analysis of temporal trends showed that the proportions of all eligible patients undergoing open abdominal aneurysm repair and lower-extremity bypass during the study period fell, regardless of surgeon type, whereas the proportion of eligible patients undergoing carotid endarterectomies remained stable. “I think this is reflective likely of the penetration of endovascular procedures when it comes to the treatment of abdominal aneurysm and lower-extremity peripheral arterial disease, as compared to carotid disease,” speculated Dr. Moreira, who disclosed that she had no relevant conflicts of interest.
Session moderator Dr. Peter K. Henke, associate chair of research, department of surgery, and Leland Ira Doan Professor of Vascular Surgery at the University of Michigan in Ann Arbor, asked whether the findings have implications for surgeon training.
“Our results were different from what has been previously published for open aneurysm repair. I think that open aneurysm repair is probably becoming more and more specialized in terms that more and more, you are going to see just vascular surgeons performing it as compared to other specialties, especially as I have shown that there is a decreasing number of general surgeons being exposed to open vascular procedures,” Dr. Moreira replied. “So I think this [speaks] to individual surgeons and their individual experience with triple-A repair. Our data does show that general surgeons who are performing these procedures are doing a good job because there is not a difference in outcome at least in terms of mortality. But as the easy triple-A repairs go away, I think it’s going to push the procedure to be done more by specialized surgeons.”
In an interview, Dr. Henke commented, “I think it has been alluded to in other studies and other reports in the literature, but this study brings to the forefront the fact that overall numbers of open vascular procedures are less and less, so the surgeons performing those procedures need to be specialists. And I’d say within the U.S. anyway, most practitioners who do vascular procedures are vascular surgeons or cardiovascularly trained, as compared with general surgeons. I suspect that some of the general surgeons who are still doing these procedures may be at a place where they are the only ones who can do it or there are no vascular specialists there.
“The other issue that this study may impact, as more of these reports come out, is hospital credentialing, because hospital credentialing of surgeons really determines what they can and cannot do at that hospital,” he added. “So as more hospital credentialing boards see this type of data, I think they will limit open vascular procedures to vascular specialists who have had training in vascular disease.”
AT THE ACS CLINICAL CONGRESS
Key clinical point: Patients undergoing certain open vascular procedures have better outcomes when operated on by vascular surgeons.
Major finding: Vascular surgeons achieved lower rates of morbidity and mortality in cases of open abdominal aneurysm repair and carotid endarterectomy.
Data source: An analysis of NSQIP data for 94,029 patients undergoing open vascular procedures.
Disclosures: Dr. Moreira disclosed that she had no relevant conflicts of interest.
FDA investigating risk of death with DAPT
Credit: CDC
The US Food and Drug Administration (FDA) is evaluating trial data suggesting that 30 months of dual antiplatelet therapy (DAPT), compared to 12 months of the therapy, can increase the overall risk of death among patients who have a drug-eluting coronary stent.
The trial, which was published in NEJM, also indicates that longer-term DAPT can decrease the risk of stent thrombosis and major cardiovascular and cerebrovascular events.
For this trial, researchers compared 12 months and 30 months of DAPT—aspirin plus either clopidogrel or prasugrel—in 9961 patients who had a drug-eluting stent. The team also enrolled patients with bare-metal stents, but those patients were not included in this publication.
All 9961 patients received aspirin and clopidogrel/prasugrel for 12 months. Then, they were randomized to continue DAPT for another 18 months or to receive aspirin and placebo during that period.
In the 30-month group, 65.2% of patients received clopidogrel, and 34.8% received prasugrel. In the 12-month group, 65.4% of patients received clopidogrel, and 34.6% received prasugrel.
The investigators followed all patients for 33 months. At that point, 4732 patients in the 30-month group and 4658 patients in the 12-month group were evaluable.
The researchers observed a significant reduction in stent thrombosis for patients who received DAPT for 30 months compared to 12 months—0.4% vs 1.4% (hazard ratio [HR]=0.29, P<0.001).
Patients who received DAPT for 30 months also saw a reduction in major cardiovascular and cerebrovascular events, a combined endpoint of all-cause death, myocardial infarction, and stroke. The rate was 4.3% for the 30-month group and 5.9% for the 12-month group (HR 0.71, P<0.001).
The reduction in the risk of major cardiovascular and cerebrovascular events was driven by a decrease in the rate of non-fatal myocardial infarction. There were no differences in the rates of cardiovascular death or stroke.
The investigators also found that the overall death rate was higher among patients receiving DAPT for a longer period. The rate was 2.0% in the 30-month group and 1.5% in the 12-month group (HR=1.36, P=0.05).
The researchers said this can be explained by an increase in non-cardiovascular deaths (1% vs 0.5%, HR 2.2, P=0.002). The most frequent causes of non-cardiovascular death were cancer (34 deaths vs 17 deaths) and trauma (8 deaths vs 2 deaths) for 30 months and 12 months of DAPT, respectively.
The increase in overall mortality was present in clopidogrel-treated patients (2.2% vs 1.5%, respectively) but not prasugrel-treated patients (1.6% vs 1.6%). The FDA noted that other large clopidogrel trials have not shown an increase in the risk of non-cardiovascular death.
The FDA said it plans to evaluate the results from this trial and other relevant data, then announce its conclusions and recommendations.
For now, the agency said healthcare professionals should not change the way they administer DAPT. And patients should not stop taking these drugs, as this may result in an increased risk of heart attacks, thrombosis, strokes, and other major cardiovascular problems.
Healthcare professionals and patients can report adverse events or side effects related to the aforementioned drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. 
Credit: CDC
The US Food and Drug Administration (FDA) is evaluating trial data suggesting that 30 months of dual antiplatelet therapy (DAPT), compared to 12 months of the therapy, can increase the overall risk of death among patients who have a drug-eluting coronary stent.
The trial, which was published in NEJM, also indicates that longer-term DAPT can decrease the risk of stent thrombosis and major cardiovascular and cerebrovascular events.
For this trial, researchers compared 12 months and 30 months of DAPT—aspirin plus either clopidogrel or prasugrel—in 9961 patients who had a drug-eluting stent. The team also enrolled patients with bare-metal stents, but those patients were not included in this publication.
All 9961 patients received aspirin and clopidogrel/prasugrel for 12 months. Then, they were randomized to continue DAPT for another 18 months or to receive aspirin and placebo during that period.
In the 30-month group, 65.2% of patients received clopidogrel, and 34.8% received prasugrel. In the 12-month group, 65.4% of patients received clopidogrel, and 34.6% received prasugrel.
The investigators followed all patients for 33 months. At that point, 4732 patients in the 30-month group and 4658 patients in the 12-month group were evaluable.
The researchers observed a significant reduction in stent thrombosis for patients who received DAPT for 30 months compared to 12 months—0.4% vs 1.4% (hazard ratio [HR]=0.29, P<0.001).
Patients who received DAPT for 30 months also saw a reduction in major cardiovascular and cerebrovascular events, a combined endpoint of all-cause death, myocardial infarction, and stroke. The rate was 4.3% for the 30-month group and 5.9% for the 12-month group (HR 0.71, P<0.001).
The reduction in the risk of major cardiovascular and cerebrovascular events was driven by a decrease in the rate of non-fatal myocardial infarction. There were no differences in the rates of cardiovascular death or stroke.
The investigators also found that the overall death rate was higher among patients receiving DAPT for a longer period. The rate was 2.0% in the 30-month group and 1.5% in the 12-month group (HR=1.36, P=0.05).
The researchers said this can be explained by an increase in non-cardiovascular deaths (1% vs 0.5%, HR 2.2, P=0.002). The most frequent causes of non-cardiovascular death were cancer (34 deaths vs 17 deaths) and trauma (8 deaths vs 2 deaths) for 30 months and 12 months of DAPT, respectively.
The increase in overall mortality was present in clopidogrel-treated patients (2.2% vs 1.5%, respectively) but not prasugrel-treated patients (1.6% vs 1.6%). The FDA noted that other large clopidogrel trials have not shown an increase in the risk of non-cardiovascular death.
The FDA said it plans to evaluate the results from this trial and other relevant data, then announce its conclusions and recommendations.
For now, the agency said healthcare professionals should not change the way they administer DAPT. And patients should not stop taking these drugs, as this may result in an increased risk of heart attacks, thrombosis, strokes, and other major cardiovascular problems.
Healthcare professionals and patients can report adverse events or side effects related to the aforementioned drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Credit: CDC
The US Food and Drug Administration (FDA) is evaluating trial data suggesting that 30 months of dual antiplatelet therapy (DAPT), compared to 12 months of the therapy, can increase the overall risk of death among patients who have a drug-eluting coronary stent.
The trial, which was published in NEJM, also indicates that longer-term DAPT can decrease the risk of stent thrombosis and major cardiovascular and cerebrovascular events.
For this trial, researchers compared 12 months and 30 months of DAPT—aspirin plus either clopidogrel or prasugrel—in 9961 patients who had a drug-eluting stent. The team also enrolled patients with bare-metal stents, but those patients were not included in this publication.
All 9961 patients received aspirin and clopidogrel/prasugrel for 12 months. Then, they were randomized to continue DAPT for another 18 months or to receive aspirin and placebo during that period.
In the 30-month group, 65.2% of patients received clopidogrel, and 34.8% received prasugrel. In the 12-month group, 65.4% of patients received clopidogrel, and 34.6% received prasugrel.
The investigators followed all patients for 33 months. At that point, 4732 patients in the 30-month group and 4658 patients in the 12-month group were evaluable.
The researchers observed a significant reduction in stent thrombosis for patients who received DAPT for 30 months compared to 12 months—0.4% vs 1.4% (hazard ratio [HR]=0.29, P<0.001).
Patients who received DAPT for 30 months also saw a reduction in major cardiovascular and cerebrovascular events, a combined endpoint of all-cause death, myocardial infarction, and stroke. The rate was 4.3% for the 30-month group and 5.9% for the 12-month group (HR 0.71, P<0.001).
The reduction in the risk of major cardiovascular and cerebrovascular events was driven by a decrease in the rate of non-fatal myocardial infarction. There were no differences in the rates of cardiovascular death or stroke.
The investigators also found that the overall death rate was higher among patients receiving DAPT for a longer period. The rate was 2.0% in the 30-month group and 1.5% in the 12-month group (HR=1.36, P=0.05).
The researchers said this can be explained by an increase in non-cardiovascular deaths (1% vs 0.5%, HR 2.2, P=0.002). The most frequent causes of non-cardiovascular death were cancer (34 deaths vs 17 deaths) and trauma (8 deaths vs 2 deaths) for 30 months and 12 months of DAPT, respectively.
The increase in overall mortality was present in clopidogrel-treated patients (2.2% vs 1.5%, respectively) but not prasugrel-treated patients (1.6% vs 1.6%). The FDA noted that other large clopidogrel trials have not shown an increase in the risk of non-cardiovascular death.
The FDA said it plans to evaluate the results from this trial and other relevant data, then announce its conclusions and recommendations.
For now, the agency said healthcare professionals should not change the way they administer DAPT. And patients should not stop taking these drugs, as this may result in an increased risk of heart attacks, thrombosis, strokes, and other major cardiovascular problems.
Healthcare professionals and patients can report adverse events or side effects related to the aforementioned drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Acting Surgeon General Confident in the Battle Against Tobacco, Ebola, and Preventable Diseases
Not many health care leaders can transition smoothly from discussing the importance of walking 30 minutes per day to the need to send PHS officers to help control the Ebola epidemic in West Africa. The Surgeon General has to. As the most prominent public health official, the Surgeon General must offer a reassuring voice on health care issues big and small. With over 26 years at the PHS, Rear Admiral (RADM) Boris D. Lushniak, MD, MPH, is well equipped to handle the challenging role.
A year after assuming the role and just before delivering a plenary address at the 2014 AMSUS meeting, RADM Lushniak agreed to a wide-ranging conversation with Federal Practitioner. The following is condensed and edited, but the complete interview can be found at http://www.fedprac.com.
The 50th anniversary of the Surgeon General’s report on smoking
RADM Boris D. Lushniak, Acting Surgeon General. Go back to January 1964 and realize what a different world we lived in back then. In fact, that report, which came out after a year and a half of scientific deliberations, of looking at facts, of searching through the literature, came up with a very important conclusion. That conclusion, simply put was: Smoking is bad for you.
Now it really was a landmark report from that perspective, but when we look back 50 years, what did it prove? It proved that cigarette smoking was directly associated with only 1 cancer at that point, specifically lung cancer in men. The report had a very simple but beautiful conclusion. It said that cigarette smoking is a health hazard of significant importance in the U.S. to warrant appropriate remedial action....
A half-century later, the social norms of our society have changed. We don’t have ashtrays all around. We don’t smoke on airplanes anymore. We oftentimes can’t smoke in bars and restaurants and establishments like that. We’ve moved from 43% of our population that smoked in 1964 to 18% currently.
We’ve had 32 Surgeons’ General reports since that first one....We brought up the issue of secondhand smoke 25 years ago. We talked about the successes and failures over these years, but 50 years later smoking remains a major public health problem in this country....
When we look to the future, what’s the goal? Well we really want to get to a zero point. We reannounced with the 50th anniversary report, which was released in January 2014, that this is an endgame strategy. At some point we have to realize that it’s not good enough to get down to 18% because of the health impact. Cigarettes and tobacco use in this country bring no good; no good to the individual, no good to the individual who has to deal with secondhand smoke, and no good for the future of our nation. So we’re really talking about an endgame strategy....
Our 50th anniversary report wasn’t just looking backward....It contains current data that now show us that we’re up to 13 different cancers caused by tobacco use. We know the impact on the whole human body. In essence, it affects almost every single system of the human body now. Brand-new diseases, formerly not associated with smoking, are still being discovered.
Most recently, we’ve seen diabetes and colon and rectal cancers as some of those diseases. We’re talking about blindness associated with smoking. We’re talking about diseases such as erectile dysfunction, which are associated with smoking. This product has brought nothing but grief and sorrow into our society and continues to do so.
Now it’s not only an impact on the United States for the Office of the Surgeon General’s to speak, but also in essence we know that internationally people look at the Surgeon General reports that come out of this office as that stellar scientific information that then can be translated worldwide.
Not only do we see leadership of public health here within the United States, but we also see leadership on an international level by profiling some of the major public health issues.
The PHS response to Ebola in the U.S. and Africa
RADM Lushniak. As many of the readers may know, the Surgeon General is the commander of the U.S. Public Health Service Commissioned Corps. We have 6,800 public health professionals. These are officers working in 11 different categories working across the government, to protect, promote, and advance the health and safety of the nation.
[In October] I was in Anniston, Alabama, seeing about 70 of my officers being trained for deployment to Liberia. And in fact, in the next weeks, we will have a full team in Liberia who will be serving in the Monrovia Medical Unit and providing health care to both Liberian as well as foreign health care workers. I want to get that message out, because this battle against Ebola is occurring here in the U.S. and being done very well by the CDC and the NIH and elements of the Commissioned Corps who are working with the CDC.
At the same time, we know that the real success of eliminating Ebola and stopping the epidemic lies in Western Africa. Dr. Frieden has said that. We’re confident that there will not be an Ebola outbreak on U.S. soil; however, we need to be able to stop this outbreak. Therefore, I’m very proud of my officers who are heading off to Western Africa.
The role of the PHS Commissioned Corps
RADM Lushniak. Most of my officers are dedicated to who? To serving the underserved and vulnerable populations. Many of my clinical officers are assigned, for example, to the Indian Health Service and are providing care to that important population of our nation. They’re assigned to the Federal Bureau of Prisons and, therefore, working with the Department of Justice in getting health care to, again, a vulnerable and underserved population. They’re working at the NIH in a clinical perspective. They’re treating the Coast Guard as the main medical and dental and environment health officers. So I have officers scattered all around, and in essence, they see everything that any other practitioner sees in this country.
The emphasis certainly from the Office of the Surgeon General has been on prevention. It’s prevention of preventable diseases; many of them are chronic diseases. And certainly, my officers not only are out there treating those individual patients, but at the same time are implementing and taking to task on the importance of prevention as a general theme. We make sure that the word of the Surgeon General’s office gets spread to local communities through our practitioners.
Raising the Commissioned Corps profile
RADM Lushniak. We need to get the word out. Part of our issue, I’ll be honest with you, is that oftentimes people don’t even know the U.S. Public Health Service Commissioned Corps exists. Therefore, even when my officers are part of a Centers for Disease Control and Prevention response, they’re embedded with other facets of CDC.
What I want to proudly say is that right now this Monrovia Medical Unit will be run by U.S. Public Health Service Commissioned Corps. This is the only entity of the U.S. government that will actually have direct patient care responsibilities in Western Africa. That being said, we’re also proud that this year is the 125th anniversary of the Commissioned Corps as a uniformed service in this country. So 125 years ago an act was passed by Congress to be able to establish this uniformed service.
Finally, I’d like to say that no other nation has a uniformed service like this. I keep saying that I love my sister services. I love the Army, the Navy, the Air Force, the Marines, the Coast Guard; but many other nations have similar type entities.
The reality of the situation is that no other nation on this planet has a uniformed service purely dedicated to public health. We are an unarmed service, and we are part of the Department of Health and Human Services, but we are just as proud to be officers. We are just as proud to be serving our nation in uniform on a slightly different mission but one that has, again, a noble cause associated with it.
Reaching the top of the PHS
RADM Lushniak. I’m honored and humbled to be in this position at this stage of my career. I came in 26, almost 27 years ago into the United States Public Health Service as a young lieutenant. My goal at that time was to be an Epidemic Intelligence Service Officer at the Centers for Disease Control and Prevention. That’s how I started my career, doing what’s deemed to be shoe leather epidemiology, going out there and getting my hands dirty and being able to try to make this nation a better place and to protect the public’s health.
It’s been a great ride from the CDC to the FDA, and then ultimately, to the Office of the Secretary here within the Office of the Surgeon General as the Deputy and now as the Acting Surgeon General. The message is everyone should, first of all, acknowledge the fact that we have an incredible mission to undertake. The mission of the Commissioned Corps of the PHS is to protect, promote, and advance the health and safety of our nation. And I dare say although we captured that as our mission, that mission is translatable to almost every federal practitioner that is out there.
The burden of that is apparent—to protect, promote, and advance the health and safety of our nation. And yet it’s a bold and noble mission, one that is achievable. We’ve had incredible successes. We still have a lot of work ahead of us.
So first and foremost, I tell my young officers and I tell everyone who may be exposed to this conversation is the sense that do your job and do it well. That’s really the prime thing I’m asking my officers to do: Be dedicated to the mission and realize that incredible things are still achievable.
The National Prevention Strategy
The goal is for us to have a healthy population at every stage of life. And so 20 federal partners...came up with a National Prevention Strategy, which is a focus of priming our nation towards prevention and wellness. It’s based on 4 strategic aims, which includes the importance of healthy and safe communities. It also entails the idea of clinical community preventive services. It talks about the empowerment of people, which is a key component of change in this nation, and the elimination of health disparities throughout the nation. It focuses on the really important preventable diseases. And among them, include the elimination of tobacco use, the importance of our really looking at alcohol and substance use in general. It’s looking at the concept of active living, the importance that we move our bodies, and the importance of healthy eating.
Office of the Surgeon General initiatives
RADM Lushniak. First and foremost, the smoking issue still continues, and there will be more on tobacco use and smoking from us. We won’t give up that fight until we’re zeroed out.
In addition, recently we released a call to action on skin cancer prevention. That’s, I think, an important issue as well because we have over 5 million people in the United States each and every year who are treated for skin cancers. We have over 60,000 people who are diagnosed with the most deadly form of skin cancer, melanoma, and 9,000 people, that’s 1 person every hour, dying of melanoma. It has an incredible impact on our country, and it is, again, one of those preventable diseases. So we look at the idea of getting the message out that we, in the Office of Surgeon General, want people to live an active lifestyle. That’s an important part of the National Prevention Strategy.
I want people to be outdoors, I want them to be runners and walkers and enjoying nature; but at the same time, I need to get the message out that we need to be wary of ultraviolet radiation from sunlight, that we can protect ourselves, seek shade when possible, put on a big hat that produces shade on your face and neck and ears. Wear glasses, put on protective clothing, and then use sunscreens, broad-spectrum sunscreens of a UV protective factor of at least 15. That’s one of the initiatives that we recently released.
In the future, where we’re priming, we’re really getting back into the fitness mode. One of the things that we’re working on, and it really simplifies, I think, what has become too complex a message—the idea of how do we have a healthy and fit nation?...
I want people to start walking 30 minutes a day, 5 days a week. Do you realize just by that simple act of walking how good our nation could do in the future? How healthy we can be as a people. So we’re really looking at an emphasis on walking and walkable communities, because not every community is walkable at this stage.
Speaking at the AMSUS Continuing Education Meeting in Washington, D.C.
RADM Lushniak. AMSUS has always provided an excellent forum for the United States Public Health Service Commissioned Corps, of which I am the commander, to be able to share our information with other federal practitioners, with other parties within the federal family that are interested in health care, in public health, in contact with patients on the clinical side and the scientific side....
I’ve been a member over many years, and I’ve been a regular attendee at the meetings. It allows us to cross-fertilize, to have that ability to sit down with our sister services, to be able to sit down with nonuniformed professionals who serve in the federal system under the flag of health care or under the flag of medical care or under the big flag of science, medical science.
Not many health care leaders can transition smoothly from discussing the importance of walking 30 minutes per day to the need to send PHS officers to help control the Ebola epidemic in West Africa. The Surgeon General has to. As the most prominent public health official, the Surgeon General must offer a reassuring voice on health care issues big and small. With over 26 years at the PHS, Rear Admiral (RADM) Boris D. Lushniak, MD, MPH, is well equipped to handle the challenging role.
A year after assuming the role and just before delivering a plenary address at the 2014 AMSUS meeting, RADM Lushniak agreed to a wide-ranging conversation with Federal Practitioner. The following is condensed and edited, but the complete interview can be found at http://www.fedprac.com.
The 50th anniversary of the Surgeon General’s report on smoking
RADM Boris D. Lushniak, Acting Surgeon General. Go back to January 1964 and realize what a different world we lived in back then. In fact, that report, which came out after a year and a half of scientific deliberations, of looking at facts, of searching through the literature, came up with a very important conclusion. That conclusion, simply put was: Smoking is bad for you.
Now it really was a landmark report from that perspective, but when we look back 50 years, what did it prove? It proved that cigarette smoking was directly associated with only 1 cancer at that point, specifically lung cancer in men. The report had a very simple but beautiful conclusion. It said that cigarette smoking is a health hazard of significant importance in the U.S. to warrant appropriate remedial action....
A half-century later, the social norms of our society have changed. We don’t have ashtrays all around. We don’t smoke on airplanes anymore. We oftentimes can’t smoke in bars and restaurants and establishments like that. We’ve moved from 43% of our population that smoked in 1964 to 18% currently.
We’ve had 32 Surgeons’ General reports since that first one....We brought up the issue of secondhand smoke 25 years ago. We talked about the successes and failures over these years, but 50 years later smoking remains a major public health problem in this country....
When we look to the future, what’s the goal? Well we really want to get to a zero point. We reannounced with the 50th anniversary report, which was released in January 2014, that this is an endgame strategy. At some point we have to realize that it’s not good enough to get down to 18% because of the health impact. Cigarettes and tobacco use in this country bring no good; no good to the individual, no good to the individual who has to deal with secondhand smoke, and no good for the future of our nation. So we’re really talking about an endgame strategy....
Our 50th anniversary report wasn’t just looking backward....It contains current data that now show us that we’re up to 13 different cancers caused by tobacco use. We know the impact on the whole human body. In essence, it affects almost every single system of the human body now. Brand-new diseases, formerly not associated with smoking, are still being discovered.
Most recently, we’ve seen diabetes and colon and rectal cancers as some of those diseases. We’re talking about blindness associated with smoking. We’re talking about diseases such as erectile dysfunction, which are associated with smoking. This product has brought nothing but grief and sorrow into our society and continues to do so.
Now it’s not only an impact on the United States for the Office of the Surgeon General’s to speak, but also in essence we know that internationally people look at the Surgeon General reports that come out of this office as that stellar scientific information that then can be translated worldwide.
Not only do we see leadership of public health here within the United States, but we also see leadership on an international level by profiling some of the major public health issues.
The PHS response to Ebola in the U.S. and Africa
RADM Lushniak. As many of the readers may know, the Surgeon General is the commander of the U.S. Public Health Service Commissioned Corps. We have 6,800 public health professionals. These are officers working in 11 different categories working across the government, to protect, promote, and advance the health and safety of the nation.
[In October] I was in Anniston, Alabama, seeing about 70 of my officers being trained for deployment to Liberia. And in fact, in the next weeks, we will have a full team in Liberia who will be serving in the Monrovia Medical Unit and providing health care to both Liberian as well as foreign health care workers. I want to get that message out, because this battle against Ebola is occurring here in the U.S. and being done very well by the CDC and the NIH and elements of the Commissioned Corps who are working with the CDC.
At the same time, we know that the real success of eliminating Ebola and stopping the epidemic lies in Western Africa. Dr. Frieden has said that. We’re confident that there will not be an Ebola outbreak on U.S. soil; however, we need to be able to stop this outbreak. Therefore, I’m very proud of my officers who are heading off to Western Africa.
The role of the PHS Commissioned Corps
RADM Lushniak. Most of my officers are dedicated to who? To serving the underserved and vulnerable populations. Many of my clinical officers are assigned, for example, to the Indian Health Service and are providing care to that important population of our nation. They’re assigned to the Federal Bureau of Prisons and, therefore, working with the Department of Justice in getting health care to, again, a vulnerable and underserved population. They’re working at the NIH in a clinical perspective. They’re treating the Coast Guard as the main medical and dental and environment health officers. So I have officers scattered all around, and in essence, they see everything that any other practitioner sees in this country.
The emphasis certainly from the Office of the Surgeon General has been on prevention. It’s prevention of preventable diseases; many of them are chronic diseases. And certainly, my officers not only are out there treating those individual patients, but at the same time are implementing and taking to task on the importance of prevention as a general theme. We make sure that the word of the Surgeon General’s office gets spread to local communities through our practitioners.
Raising the Commissioned Corps profile
RADM Lushniak. We need to get the word out. Part of our issue, I’ll be honest with you, is that oftentimes people don’t even know the U.S. Public Health Service Commissioned Corps exists. Therefore, even when my officers are part of a Centers for Disease Control and Prevention response, they’re embedded with other facets of CDC.
What I want to proudly say is that right now this Monrovia Medical Unit will be run by U.S. Public Health Service Commissioned Corps. This is the only entity of the U.S. government that will actually have direct patient care responsibilities in Western Africa. That being said, we’re also proud that this year is the 125th anniversary of the Commissioned Corps as a uniformed service in this country. So 125 years ago an act was passed by Congress to be able to establish this uniformed service.
Finally, I’d like to say that no other nation has a uniformed service like this. I keep saying that I love my sister services. I love the Army, the Navy, the Air Force, the Marines, the Coast Guard; but many other nations have similar type entities.
The reality of the situation is that no other nation on this planet has a uniformed service purely dedicated to public health. We are an unarmed service, and we are part of the Department of Health and Human Services, but we are just as proud to be officers. We are just as proud to be serving our nation in uniform on a slightly different mission but one that has, again, a noble cause associated with it.
Reaching the top of the PHS
RADM Lushniak. I’m honored and humbled to be in this position at this stage of my career. I came in 26, almost 27 years ago into the United States Public Health Service as a young lieutenant. My goal at that time was to be an Epidemic Intelligence Service Officer at the Centers for Disease Control and Prevention. That’s how I started my career, doing what’s deemed to be shoe leather epidemiology, going out there and getting my hands dirty and being able to try to make this nation a better place and to protect the public’s health.
It’s been a great ride from the CDC to the FDA, and then ultimately, to the Office of the Secretary here within the Office of the Surgeon General as the Deputy and now as the Acting Surgeon General. The message is everyone should, first of all, acknowledge the fact that we have an incredible mission to undertake. The mission of the Commissioned Corps of the PHS is to protect, promote, and advance the health and safety of our nation. And I dare say although we captured that as our mission, that mission is translatable to almost every federal practitioner that is out there.
The burden of that is apparent—to protect, promote, and advance the health and safety of our nation. And yet it’s a bold and noble mission, one that is achievable. We’ve had incredible successes. We still have a lot of work ahead of us.
So first and foremost, I tell my young officers and I tell everyone who may be exposed to this conversation is the sense that do your job and do it well. That’s really the prime thing I’m asking my officers to do: Be dedicated to the mission and realize that incredible things are still achievable.
The National Prevention Strategy
The goal is for us to have a healthy population at every stage of life. And so 20 federal partners...came up with a National Prevention Strategy, which is a focus of priming our nation towards prevention and wellness. It’s based on 4 strategic aims, which includes the importance of healthy and safe communities. It also entails the idea of clinical community preventive services. It talks about the empowerment of people, which is a key component of change in this nation, and the elimination of health disparities throughout the nation. It focuses on the really important preventable diseases. And among them, include the elimination of tobacco use, the importance of our really looking at alcohol and substance use in general. It’s looking at the concept of active living, the importance that we move our bodies, and the importance of healthy eating.
Office of the Surgeon General initiatives
RADM Lushniak. First and foremost, the smoking issue still continues, and there will be more on tobacco use and smoking from us. We won’t give up that fight until we’re zeroed out.
In addition, recently we released a call to action on skin cancer prevention. That’s, I think, an important issue as well because we have over 5 million people in the United States each and every year who are treated for skin cancers. We have over 60,000 people who are diagnosed with the most deadly form of skin cancer, melanoma, and 9,000 people, that’s 1 person every hour, dying of melanoma. It has an incredible impact on our country, and it is, again, one of those preventable diseases. So we look at the idea of getting the message out that we, in the Office of Surgeon General, want people to live an active lifestyle. That’s an important part of the National Prevention Strategy.
I want people to be outdoors, I want them to be runners and walkers and enjoying nature; but at the same time, I need to get the message out that we need to be wary of ultraviolet radiation from sunlight, that we can protect ourselves, seek shade when possible, put on a big hat that produces shade on your face and neck and ears. Wear glasses, put on protective clothing, and then use sunscreens, broad-spectrum sunscreens of a UV protective factor of at least 15. That’s one of the initiatives that we recently released.
In the future, where we’re priming, we’re really getting back into the fitness mode. One of the things that we’re working on, and it really simplifies, I think, what has become too complex a message—the idea of how do we have a healthy and fit nation?...
I want people to start walking 30 minutes a day, 5 days a week. Do you realize just by that simple act of walking how good our nation could do in the future? How healthy we can be as a people. So we’re really looking at an emphasis on walking and walkable communities, because not every community is walkable at this stage.
Speaking at the AMSUS Continuing Education Meeting in Washington, D.C.
RADM Lushniak. AMSUS has always provided an excellent forum for the United States Public Health Service Commissioned Corps, of which I am the commander, to be able to share our information with other federal practitioners, with other parties within the federal family that are interested in health care, in public health, in contact with patients on the clinical side and the scientific side....
I’ve been a member over many years, and I’ve been a regular attendee at the meetings. It allows us to cross-fertilize, to have that ability to sit down with our sister services, to be able to sit down with nonuniformed professionals who serve in the federal system under the flag of health care or under the flag of medical care or under the big flag of science, medical science.
Not many health care leaders can transition smoothly from discussing the importance of walking 30 minutes per day to the need to send PHS officers to help control the Ebola epidemic in West Africa. The Surgeon General has to. As the most prominent public health official, the Surgeon General must offer a reassuring voice on health care issues big and small. With over 26 years at the PHS, Rear Admiral (RADM) Boris D. Lushniak, MD, MPH, is well equipped to handle the challenging role.
A year after assuming the role and just before delivering a plenary address at the 2014 AMSUS meeting, RADM Lushniak agreed to a wide-ranging conversation with Federal Practitioner. The following is condensed and edited, but the complete interview can be found at http://www.fedprac.com.
The 50th anniversary of the Surgeon General’s report on smoking
RADM Boris D. Lushniak, Acting Surgeon General. Go back to January 1964 and realize what a different world we lived in back then. In fact, that report, which came out after a year and a half of scientific deliberations, of looking at facts, of searching through the literature, came up with a very important conclusion. That conclusion, simply put was: Smoking is bad for you.
Now it really was a landmark report from that perspective, but when we look back 50 years, what did it prove? It proved that cigarette smoking was directly associated with only 1 cancer at that point, specifically lung cancer in men. The report had a very simple but beautiful conclusion. It said that cigarette smoking is a health hazard of significant importance in the U.S. to warrant appropriate remedial action....
A half-century later, the social norms of our society have changed. We don’t have ashtrays all around. We don’t smoke on airplanes anymore. We oftentimes can’t smoke in bars and restaurants and establishments like that. We’ve moved from 43% of our population that smoked in 1964 to 18% currently.
We’ve had 32 Surgeons’ General reports since that first one....We brought up the issue of secondhand smoke 25 years ago. We talked about the successes and failures over these years, but 50 years later smoking remains a major public health problem in this country....
When we look to the future, what’s the goal? Well we really want to get to a zero point. We reannounced with the 50th anniversary report, which was released in January 2014, that this is an endgame strategy. At some point we have to realize that it’s not good enough to get down to 18% because of the health impact. Cigarettes and tobacco use in this country bring no good; no good to the individual, no good to the individual who has to deal with secondhand smoke, and no good for the future of our nation. So we’re really talking about an endgame strategy....
Our 50th anniversary report wasn’t just looking backward....It contains current data that now show us that we’re up to 13 different cancers caused by tobacco use. We know the impact on the whole human body. In essence, it affects almost every single system of the human body now. Brand-new diseases, formerly not associated with smoking, are still being discovered.
Most recently, we’ve seen diabetes and colon and rectal cancers as some of those diseases. We’re talking about blindness associated with smoking. We’re talking about diseases such as erectile dysfunction, which are associated with smoking. This product has brought nothing but grief and sorrow into our society and continues to do so.
Now it’s not only an impact on the United States for the Office of the Surgeon General’s to speak, but also in essence we know that internationally people look at the Surgeon General reports that come out of this office as that stellar scientific information that then can be translated worldwide.
Not only do we see leadership of public health here within the United States, but we also see leadership on an international level by profiling some of the major public health issues.
The PHS response to Ebola in the U.S. and Africa
RADM Lushniak. As many of the readers may know, the Surgeon General is the commander of the U.S. Public Health Service Commissioned Corps. We have 6,800 public health professionals. These are officers working in 11 different categories working across the government, to protect, promote, and advance the health and safety of the nation.
[In October] I was in Anniston, Alabama, seeing about 70 of my officers being trained for deployment to Liberia. And in fact, in the next weeks, we will have a full team in Liberia who will be serving in the Monrovia Medical Unit and providing health care to both Liberian as well as foreign health care workers. I want to get that message out, because this battle against Ebola is occurring here in the U.S. and being done very well by the CDC and the NIH and elements of the Commissioned Corps who are working with the CDC.
At the same time, we know that the real success of eliminating Ebola and stopping the epidemic lies in Western Africa. Dr. Frieden has said that. We’re confident that there will not be an Ebola outbreak on U.S. soil; however, we need to be able to stop this outbreak. Therefore, I’m very proud of my officers who are heading off to Western Africa.
The role of the PHS Commissioned Corps
RADM Lushniak. Most of my officers are dedicated to who? To serving the underserved and vulnerable populations. Many of my clinical officers are assigned, for example, to the Indian Health Service and are providing care to that important population of our nation. They’re assigned to the Federal Bureau of Prisons and, therefore, working with the Department of Justice in getting health care to, again, a vulnerable and underserved population. They’re working at the NIH in a clinical perspective. They’re treating the Coast Guard as the main medical and dental and environment health officers. So I have officers scattered all around, and in essence, they see everything that any other practitioner sees in this country.
The emphasis certainly from the Office of the Surgeon General has been on prevention. It’s prevention of preventable diseases; many of them are chronic diseases. And certainly, my officers not only are out there treating those individual patients, but at the same time are implementing and taking to task on the importance of prevention as a general theme. We make sure that the word of the Surgeon General’s office gets spread to local communities through our practitioners.
Raising the Commissioned Corps profile
RADM Lushniak. We need to get the word out. Part of our issue, I’ll be honest with you, is that oftentimes people don’t even know the U.S. Public Health Service Commissioned Corps exists. Therefore, even when my officers are part of a Centers for Disease Control and Prevention response, they’re embedded with other facets of CDC.
What I want to proudly say is that right now this Monrovia Medical Unit will be run by U.S. Public Health Service Commissioned Corps. This is the only entity of the U.S. government that will actually have direct patient care responsibilities in Western Africa. That being said, we’re also proud that this year is the 125th anniversary of the Commissioned Corps as a uniformed service in this country. So 125 years ago an act was passed by Congress to be able to establish this uniformed service.
Finally, I’d like to say that no other nation has a uniformed service like this. I keep saying that I love my sister services. I love the Army, the Navy, the Air Force, the Marines, the Coast Guard; but many other nations have similar type entities.
The reality of the situation is that no other nation on this planet has a uniformed service purely dedicated to public health. We are an unarmed service, and we are part of the Department of Health and Human Services, but we are just as proud to be officers. We are just as proud to be serving our nation in uniform on a slightly different mission but one that has, again, a noble cause associated with it.
Reaching the top of the PHS
RADM Lushniak. I’m honored and humbled to be in this position at this stage of my career. I came in 26, almost 27 years ago into the United States Public Health Service as a young lieutenant. My goal at that time was to be an Epidemic Intelligence Service Officer at the Centers for Disease Control and Prevention. That’s how I started my career, doing what’s deemed to be shoe leather epidemiology, going out there and getting my hands dirty and being able to try to make this nation a better place and to protect the public’s health.
It’s been a great ride from the CDC to the FDA, and then ultimately, to the Office of the Secretary here within the Office of the Surgeon General as the Deputy and now as the Acting Surgeon General. The message is everyone should, first of all, acknowledge the fact that we have an incredible mission to undertake. The mission of the Commissioned Corps of the PHS is to protect, promote, and advance the health and safety of our nation. And I dare say although we captured that as our mission, that mission is translatable to almost every federal practitioner that is out there.
The burden of that is apparent—to protect, promote, and advance the health and safety of our nation. And yet it’s a bold and noble mission, one that is achievable. We’ve had incredible successes. We still have a lot of work ahead of us.
So first and foremost, I tell my young officers and I tell everyone who may be exposed to this conversation is the sense that do your job and do it well. That’s really the prime thing I’m asking my officers to do: Be dedicated to the mission and realize that incredible things are still achievable.
The National Prevention Strategy
The goal is for us to have a healthy population at every stage of life. And so 20 federal partners...came up with a National Prevention Strategy, which is a focus of priming our nation towards prevention and wellness. It’s based on 4 strategic aims, which includes the importance of healthy and safe communities. It also entails the idea of clinical community preventive services. It talks about the empowerment of people, which is a key component of change in this nation, and the elimination of health disparities throughout the nation. It focuses on the really important preventable diseases. And among them, include the elimination of tobacco use, the importance of our really looking at alcohol and substance use in general. It’s looking at the concept of active living, the importance that we move our bodies, and the importance of healthy eating.
Office of the Surgeon General initiatives
RADM Lushniak. First and foremost, the smoking issue still continues, and there will be more on tobacco use and smoking from us. We won’t give up that fight until we’re zeroed out.
In addition, recently we released a call to action on skin cancer prevention. That’s, I think, an important issue as well because we have over 5 million people in the United States each and every year who are treated for skin cancers. We have over 60,000 people who are diagnosed with the most deadly form of skin cancer, melanoma, and 9,000 people, that’s 1 person every hour, dying of melanoma. It has an incredible impact on our country, and it is, again, one of those preventable diseases. So we look at the idea of getting the message out that we, in the Office of Surgeon General, want people to live an active lifestyle. That’s an important part of the National Prevention Strategy.
I want people to be outdoors, I want them to be runners and walkers and enjoying nature; but at the same time, I need to get the message out that we need to be wary of ultraviolet radiation from sunlight, that we can protect ourselves, seek shade when possible, put on a big hat that produces shade on your face and neck and ears. Wear glasses, put on protective clothing, and then use sunscreens, broad-spectrum sunscreens of a UV protective factor of at least 15. That’s one of the initiatives that we recently released.
In the future, where we’re priming, we’re really getting back into the fitness mode. One of the things that we’re working on, and it really simplifies, I think, what has become too complex a message—the idea of how do we have a healthy and fit nation?...
I want people to start walking 30 minutes a day, 5 days a week. Do you realize just by that simple act of walking how good our nation could do in the future? How healthy we can be as a people. So we’re really looking at an emphasis on walking and walkable communities, because not every community is walkable at this stage.
Speaking at the AMSUS Continuing Education Meeting in Washington, D.C.
RADM Lushniak. AMSUS has always provided an excellent forum for the United States Public Health Service Commissioned Corps, of which I am the commander, to be able to share our information with other federal practitioners, with other parties within the federal family that are interested in health care, in public health, in contact with patients on the clinical side and the scientific side....
I’ve been a member over many years, and I’ve been a regular attendee at the meetings. It allows us to cross-fertilize, to have that ability to sit down with our sister services, to be able to sit down with nonuniformed professionals who serve in the federal system under the flag of health care or under the flag of medical care or under the big flag of science, medical science.
Failure to control INR may increase risk of dementia
CHICAGO—Long-term overtreatment with warfarin given in combination with antiplatelet therapy may increase the risk of dementia in patients with atrial fibrillation, a new study suggests.
Researchers retrospectively analyzed patients who received warfarin plus aspirin or clopidogrel for up to 10 years.
And patients who had an international normalized ratio (INR) above the acceptable range more than 25% of the time had an increased risk of dementia.
T. Jared Bunch, MD, of the Intermountain Medical Center Heart Institute in Murray, Utah, presented these findings at the American Heart Association’s Scientific Sessions 2014 (abstract 13426).
“[W]e have to consider that long-term exposure to anticlotting drugs such as warfarin, if not well controlled, can significantly increase bleeding risk,” Dr Bunch said. “This may result in micro bleeds in the brain that don’t cause symptoms right away but accumulate over time, raising the risk of dementia.”
Dr Bunch and his colleagues studied 1031 patients with no previous history of stroke or dementia for up to 10 years while they received warfarin plus aspirin or clopidogrel.
Among patients who had an INR higher than 3 more than 25% of the time, 2.7% developed dementia.
The researchers adjusted their analysis for traditional stroke and bleeding risk factors and found that patients with supratherapeutic INR levels more than 25% of the time had more than double the risk of dementia compared to patients with supratherapeutic INR levels less than 10% of the time. The hazard ratio was 2.40 (P=0.04).
This increase is higher than what researchers found in a previous study of warfarin alone.
Previous research also suggested that patients with atrial fibrillation taking warfarin were more likely to develop dementia if their INRs were too high or too low.
From those results, the researchers concluded that brain injury from both small bleeds and blood clots is likely important in the development of dementia in patients with atrial fibrillation.
“Even at skilled centers, it’s very common to have INR outside the ideal range up to 40% of the time,” Dr Bunch noted. “And, over the years, there may be an accumulative negative impact on cognitive ability.”
CHICAGO—Long-term overtreatment with warfarin given in combination with antiplatelet therapy may increase the risk of dementia in patients with atrial fibrillation, a new study suggests.
Researchers retrospectively analyzed patients who received warfarin plus aspirin or clopidogrel for up to 10 years.
And patients who had an international normalized ratio (INR) above the acceptable range more than 25% of the time had an increased risk of dementia.
T. Jared Bunch, MD, of the Intermountain Medical Center Heart Institute in Murray, Utah, presented these findings at the American Heart Association’s Scientific Sessions 2014 (abstract 13426).
“[W]e have to consider that long-term exposure to anticlotting drugs such as warfarin, if not well controlled, can significantly increase bleeding risk,” Dr Bunch said. “This may result in micro bleeds in the brain that don’t cause symptoms right away but accumulate over time, raising the risk of dementia.”
Dr Bunch and his colleagues studied 1031 patients with no previous history of stroke or dementia for up to 10 years while they received warfarin plus aspirin or clopidogrel.
Among patients who had an INR higher than 3 more than 25% of the time, 2.7% developed dementia.
The researchers adjusted their analysis for traditional stroke and bleeding risk factors and found that patients with supratherapeutic INR levels more than 25% of the time had more than double the risk of dementia compared to patients with supratherapeutic INR levels less than 10% of the time. The hazard ratio was 2.40 (P=0.04).
This increase is higher than what researchers found in a previous study of warfarin alone.
Previous research also suggested that patients with atrial fibrillation taking warfarin were more likely to develop dementia if their INRs were too high or too low.
From those results, the researchers concluded that brain injury from both small bleeds and blood clots is likely important in the development of dementia in patients with atrial fibrillation.
“Even at skilled centers, it’s very common to have INR outside the ideal range up to 40% of the time,” Dr Bunch noted. “And, over the years, there may be an accumulative negative impact on cognitive ability.”
CHICAGO—Long-term overtreatment with warfarin given in combination with antiplatelet therapy may increase the risk of dementia in patients with atrial fibrillation, a new study suggests.
Researchers retrospectively analyzed patients who received warfarin plus aspirin or clopidogrel for up to 10 years.
And patients who had an international normalized ratio (INR) above the acceptable range more than 25% of the time had an increased risk of dementia.
T. Jared Bunch, MD, of the Intermountain Medical Center Heart Institute in Murray, Utah, presented these findings at the American Heart Association’s Scientific Sessions 2014 (abstract 13426).
“[W]e have to consider that long-term exposure to anticlotting drugs such as warfarin, if not well controlled, can significantly increase bleeding risk,” Dr Bunch said. “This may result in micro bleeds in the brain that don’t cause symptoms right away but accumulate over time, raising the risk of dementia.”
Dr Bunch and his colleagues studied 1031 patients with no previous history of stroke or dementia for up to 10 years while they received warfarin plus aspirin or clopidogrel.
Among patients who had an INR higher than 3 more than 25% of the time, 2.7% developed dementia.
The researchers adjusted their analysis for traditional stroke and bleeding risk factors and found that patients with supratherapeutic INR levels more than 25% of the time had more than double the risk of dementia compared to patients with supratherapeutic INR levels less than 10% of the time. The hazard ratio was 2.40 (P=0.04).
This increase is higher than what researchers found in a previous study of warfarin alone.
Previous research also suggested that patients with atrial fibrillation taking warfarin were more likely to develop dementia if their INRs were too high or too low.
From those results, the researchers concluded that brain injury from both small bleeds and blood clots is likely important in the development of dementia in patients with atrial fibrillation.
“Even at skilled centers, it’s very common to have INR outside the ideal range up to 40% of the time,” Dr Bunch noted. “And, over the years, there may be an accumulative negative impact on cognitive ability.”
Radioactive Iodine Scintiphotos of a Man With Thyroid Cancer
The contemporary management of differentiated thyroid cancer includes posttreatment monitoring for recurrence or metastasis.1 This monitoring includes clinical, biochemical, and imaging evaluation. Follow-up treatment can then be tailored based on the results of this monitoring.
Our patient was a 61-year-old man with a history of papillary thyroid carcinoma, including lymph node involvement and an extension of the primary focus into skeletal muscle (pT3N1bMX, stage IVa). The patient’s status was posttotal thyroidectomy and radioiodine ablation therapy (196.2 mCi iodine-131) in April 2009. The patient underwent follow-up thyrotropin alpha stimulated whole-body radioiodine surveillance scanning in May 2010.
Images demonstrated residual thyroid tissue/carcinoma regional to the thyroid bed, corresponding to prior posttherapy images. Whole body scintiphotos also demonstrated abnormal iodine localization that raised the possibility of distant bony metastasis in the region of the right hip (see Figures 1A and 1B). Current treatment standards for isolated bony metastases recommend repeated radioactive iodine therapy and potential external beam radiation. Imaging is required for accurate verification.1 This abnormal osseous finding was questionable on initial review, as it was present on the posterior, not anterior, view. The patient was instructed to continue hydration and return for additional delayed scintiphotos for further evaluation.
The patient returned 4 days later for delayed scintiphotos, which again demonstrated abnormal iodine localization near the right hip. However, iodine distribution was different, including now being visible on both the anterior and posterior views (see Figures 2A and 2B on the next page).
- What is your diagnosis?
- How would you treat this patient?
[Click through to the next page to see the answer.]
Our Treatment
The patient had no pain in the area and, upon further questioning, reported that he returned wearing the same athletic shorts. Given that radioiodine is excreted in the urine, this atypical distribution was thought to reflect urinary contamination. When images were taken again with the shorts removed, no abnormal radioiodine activity was present (see Figures 2C and 2D). Additional findings with thyrotropin alfa stimulation included increased quantitative thyroglobulin values of 20.2 ng/mL with antithyroglobulin antibody < 20.0 U/mL. Radioiodine ablation therapy using thyrotropin alfa was repeated. Iodine localization also was not present in the hip on posttherapy imaging (not shown).
Despite advances in imaging techniques, radioiodine scanning remains an imperfect science. Artifacts and pitfalls have been identified; in part, these are related to the accumulation of iodide in organs other than the thyroid, such as the nasopharynx and stomach, as well as the apparent accumulation due to excretion in the gut and bladder.2-4 These variations can be divided into ectopic normal thyroid tissue, physiologic accumulation in nonthyroidal tissue, and contamination by physiologic secretions. Recent case reports have confirmed this classification. Abnormal radioiodine uptake has been described in vertebral hemangioma,5 liver abscess6 and hydatid cyst,7 bronchiectasis,8 bronchogenic cyst and mucinous cystadenoma (2 fluid-filled cavities),9 chronic submandibular sialadenitis,10 esophageal diverticulum,11 hiatal hernia,12 appendix,13 indwelling Hickman catheter,14 renal cyst,15 and, similar to this case, contamination of the hair.16
Contaminated clothing is not uncommon; however, a persistent abnormality from contaminated clothing on repeat follow-up is unusual and could easily be misinterpreted.2 It would be valuable for all providers to be aware of the pitfalls of imaging before embarking on an unnecessary and potentially hazardous—not to mention costly—treatment course.
Acknowledgments
The authors acknowledge the assistance of Richard Cacciato, MLIS, Medical Librarian, who assisted in the literature review.
Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.
Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.
1. Cooper, DS, Doherty GM, Haugen BR, et al; American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid. 2009;19(11):1167-1214.
2. Carlisle MR, Lu C, McDougall IR. The interpretation of 131I scans in the evaluation of thyroid cancer, with an emphasis on false positive findings. Nucl Med Commun. 2003;24(6):715-735.
3. Shapiro B, Rufini V, Jarwan A, et al. Artifacts, anatomical and physiological variants, and unrelated diseases that might cause false-positive whole-body 131-I scans in patients with thyroid cancer. Semin Nucl Med. 2000;30(2):115-132.
4. Mitchell G, Pratt BE, Vini L, McCready VR, Harmer CL. False positive 131I whole body scans in thyroid cancer. Br J Radiol. 2000;73(870):627-635.
5. Khan S, Dunn J, Strickland N, Al-Nahhas A. Iodine-123 uptake in vertebral haemangiomas in a patient with papillary thyroid carcinoma. Nucl Med Rev Cent East Eur. 2008;11(1):30-33.
6. Pena Pardo FJ, Crespo de la Jara A, Fernández Morejón FJ, Sureda González M, Forteza Vila J, Brugarolas Masllorens A. Solitary focus in the liver in a thyroid cancer patient after a whole body scan with 131 iodine. Rev Esp Med Nucl. 2007;26(5):294-296.
7. Omür O, Ozbek SS, Akgün A, Yazici B, Mutlukoca N, Ozcan Z. False-positive I-131 accumulation in a hepatic hydatid cyst. Clin Nucl Med. 2007;32(12):930-932.
8. Jong I, Taubman K, Schlicht S. Bronchiectasis simulating pulmonary metastases on iodine-131 scintigraphy in well-differentiated thyroid carcinoma. Clin Nucl Med. 2005;30(10):688-689.
9. Agriantonis DJ, Hall L, Wilson MA. Pitfalls of I-131 whole body scan interpretation: Bronchogenic cyst and mucinous cystadenoma. Clin Nucl Med. 2008;33(5):325-327.
10. Ozguven M, Ilgan S, Karacalioglu AO, Arslan N, Ozturk E. Unusual patterns of I-131 accumulation. Clin Nucl Med. 2004;29(11):738-740.
11. Rashid K, Johns W, Chasse K, Walker M, Gupta SM. Esophageal diverticulum presenting as metastatic thyroid mass on iodine-131 scintigraphy. Clin Nucl Med. 2006;31(7):405-408.
12. Ceylan Gunay E, Erdogan A. Mediastinal radioiodine uptake due to hiatal hernia: A false-positive reaction in 131I scan. Rev Esp Med Nucl. 2010;29(2):95.
13. Borkar S, Grewal R, Schoder H. I-131 uptake demonstrated in the appendix on a posttreatment scan in a patient with thyroid cancer. Clin Nucl Med. 2008;33(8):551-552.
14. Groskin SA, McCrohan G. Pseudometastasis of the chest wall resulting from a Hickman catheter. J Thorac Imaging. 1994;9(3):169-171.
15. Thust S, Fernando R, Barwick T, Mohan H, Clarke SE. SPECT/CT identification of post-radioactive iodine treatment false-positive uptake in a simple renal cyst. Thyroid. 2009;19(1):75-76.
16. Sinha A, Bradley KM, Steatham J, Weaver A. Asymmetric breast uptake of radioiodine in a patient with thyroid malignancy: Metastases or not? J R Soc Med. 2008;101(6):319-320.
The contemporary management of differentiated thyroid cancer includes posttreatment monitoring for recurrence or metastasis.1 This monitoring includes clinical, biochemical, and imaging evaluation. Follow-up treatment can then be tailored based on the results of this monitoring.
Our patient was a 61-year-old man with a history of papillary thyroid carcinoma, including lymph node involvement and an extension of the primary focus into skeletal muscle (pT3N1bMX, stage IVa). The patient’s status was posttotal thyroidectomy and radioiodine ablation therapy (196.2 mCi iodine-131) in April 2009. The patient underwent follow-up thyrotropin alpha stimulated whole-body radioiodine surveillance scanning in May 2010.
Images demonstrated residual thyroid tissue/carcinoma regional to the thyroid bed, corresponding to prior posttherapy images. Whole body scintiphotos also demonstrated abnormal iodine localization that raised the possibility of distant bony metastasis in the region of the right hip (see Figures 1A and 1B). Current treatment standards for isolated bony metastases recommend repeated radioactive iodine therapy and potential external beam radiation. Imaging is required for accurate verification.1 This abnormal osseous finding was questionable on initial review, as it was present on the posterior, not anterior, view. The patient was instructed to continue hydration and return for additional delayed scintiphotos for further evaluation.
The patient returned 4 days later for delayed scintiphotos, which again demonstrated abnormal iodine localization near the right hip. However, iodine distribution was different, including now being visible on both the anterior and posterior views (see Figures 2A and 2B on the next page).
- What is your diagnosis?
- How would you treat this patient?
[Click through to the next page to see the answer.]
Our Treatment
The patient had no pain in the area and, upon further questioning, reported that he returned wearing the same athletic shorts. Given that radioiodine is excreted in the urine, this atypical distribution was thought to reflect urinary contamination. When images were taken again with the shorts removed, no abnormal radioiodine activity was present (see Figures 2C and 2D). Additional findings with thyrotropin alfa stimulation included increased quantitative thyroglobulin values of 20.2 ng/mL with antithyroglobulin antibody < 20.0 U/mL. Radioiodine ablation therapy using thyrotropin alfa was repeated. Iodine localization also was not present in the hip on posttherapy imaging (not shown).
Despite advances in imaging techniques, radioiodine scanning remains an imperfect science. Artifacts and pitfalls have been identified; in part, these are related to the accumulation of iodide in organs other than the thyroid, such as the nasopharynx and stomach, as well as the apparent accumulation due to excretion in the gut and bladder.2-4 These variations can be divided into ectopic normal thyroid tissue, physiologic accumulation in nonthyroidal tissue, and contamination by physiologic secretions. Recent case reports have confirmed this classification. Abnormal radioiodine uptake has been described in vertebral hemangioma,5 liver abscess6 and hydatid cyst,7 bronchiectasis,8 bronchogenic cyst and mucinous cystadenoma (2 fluid-filled cavities),9 chronic submandibular sialadenitis,10 esophageal diverticulum,11 hiatal hernia,12 appendix,13 indwelling Hickman catheter,14 renal cyst,15 and, similar to this case, contamination of the hair.16
Contaminated clothing is not uncommon; however, a persistent abnormality from contaminated clothing on repeat follow-up is unusual and could easily be misinterpreted.2 It would be valuable for all providers to be aware of the pitfalls of imaging before embarking on an unnecessary and potentially hazardous—not to mention costly—treatment course.
Acknowledgments
The authors acknowledge the assistance of Richard Cacciato, MLIS, Medical Librarian, who assisted in the literature review.
Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.
Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.
The contemporary management of differentiated thyroid cancer includes posttreatment monitoring for recurrence or metastasis.1 This monitoring includes clinical, biochemical, and imaging evaluation. Follow-up treatment can then be tailored based on the results of this monitoring.
Our patient was a 61-year-old man with a history of papillary thyroid carcinoma, including lymph node involvement and an extension of the primary focus into skeletal muscle (pT3N1bMX, stage IVa). The patient’s status was posttotal thyroidectomy and radioiodine ablation therapy (196.2 mCi iodine-131) in April 2009. The patient underwent follow-up thyrotropin alpha stimulated whole-body radioiodine surveillance scanning in May 2010.
Images demonstrated residual thyroid tissue/carcinoma regional to the thyroid bed, corresponding to prior posttherapy images. Whole body scintiphotos also demonstrated abnormal iodine localization that raised the possibility of distant bony metastasis in the region of the right hip (see Figures 1A and 1B). Current treatment standards for isolated bony metastases recommend repeated radioactive iodine therapy and potential external beam radiation. Imaging is required for accurate verification.1 This abnormal osseous finding was questionable on initial review, as it was present on the posterior, not anterior, view. The patient was instructed to continue hydration and return for additional delayed scintiphotos for further evaluation.
The patient returned 4 days later for delayed scintiphotos, which again demonstrated abnormal iodine localization near the right hip. However, iodine distribution was different, including now being visible on both the anterior and posterior views (see Figures 2A and 2B on the next page).
- What is your diagnosis?
- How would you treat this patient?
[Click through to the next page to see the answer.]
Our Treatment
The patient had no pain in the area and, upon further questioning, reported that he returned wearing the same athletic shorts. Given that radioiodine is excreted in the urine, this atypical distribution was thought to reflect urinary contamination. When images were taken again with the shorts removed, no abnormal radioiodine activity was present (see Figures 2C and 2D). Additional findings with thyrotropin alfa stimulation included increased quantitative thyroglobulin values of 20.2 ng/mL with antithyroglobulin antibody < 20.0 U/mL. Radioiodine ablation therapy using thyrotropin alfa was repeated. Iodine localization also was not present in the hip on posttherapy imaging (not shown).
Despite advances in imaging techniques, radioiodine scanning remains an imperfect science. Artifacts and pitfalls have been identified; in part, these are related to the accumulation of iodide in organs other than the thyroid, such as the nasopharynx and stomach, as well as the apparent accumulation due to excretion in the gut and bladder.2-4 These variations can be divided into ectopic normal thyroid tissue, physiologic accumulation in nonthyroidal tissue, and contamination by physiologic secretions. Recent case reports have confirmed this classification. Abnormal radioiodine uptake has been described in vertebral hemangioma,5 liver abscess6 and hydatid cyst,7 bronchiectasis,8 bronchogenic cyst and mucinous cystadenoma (2 fluid-filled cavities),9 chronic submandibular sialadenitis,10 esophageal diverticulum,11 hiatal hernia,12 appendix,13 indwelling Hickman catheter,14 renal cyst,15 and, similar to this case, contamination of the hair.16
Contaminated clothing is not uncommon; however, a persistent abnormality from contaminated clothing on repeat follow-up is unusual and could easily be misinterpreted.2 It would be valuable for all providers to be aware of the pitfalls of imaging before embarking on an unnecessary and potentially hazardous—not to mention costly—treatment course.
Acknowledgments
The authors acknowledge the assistance of Richard Cacciato, MLIS, Medical Librarian, who assisted in the literature review.
Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.
Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.
1. Cooper, DS, Doherty GM, Haugen BR, et al; American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid. 2009;19(11):1167-1214.
2. Carlisle MR, Lu C, McDougall IR. The interpretation of 131I scans in the evaluation of thyroid cancer, with an emphasis on false positive findings. Nucl Med Commun. 2003;24(6):715-735.
3. Shapiro B, Rufini V, Jarwan A, et al. Artifacts, anatomical and physiological variants, and unrelated diseases that might cause false-positive whole-body 131-I scans in patients with thyroid cancer. Semin Nucl Med. 2000;30(2):115-132.
4. Mitchell G, Pratt BE, Vini L, McCready VR, Harmer CL. False positive 131I whole body scans in thyroid cancer. Br J Radiol. 2000;73(870):627-635.
5. Khan S, Dunn J, Strickland N, Al-Nahhas A. Iodine-123 uptake in vertebral haemangiomas in a patient with papillary thyroid carcinoma. Nucl Med Rev Cent East Eur. 2008;11(1):30-33.
6. Pena Pardo FJ, Crespo de la Jara A, Fernández Morejón FJ, Sureda González M, Forteza Vila J, Brugarolas Masllorens A. Solitary focus in the liver in a thyroid cancer patient after a whole body scan with 131 iodine. Rev Esp Med Nucl. 2007;26(5):294-296.
7. Omür O, Ozbek SS, Akgün A, Yazici B, Mutlukoca N, Ozcan Z. False-positive I-131 accumulation in a hepatic hydatid cyst. Clin Nucl Med. 2007;32(12):930-932.
8. Jong I, Taubman K, Schlicht S. Bronchiectasis simulating pulmonary metastases on iodine-131 scintigraphy in well-differentiated thyroid carcinoma. Clin Nucl Med. 2005;30(10):688-689.
9. Agriantonis DJ, Hall L, Wilson MA. Pitfalls of I-131 whole body scan interpretation: Bronchogenic cyst and mucinous cystadenoma. Clin Nucl Med. 2008;33(5):325-327.
10. Ozguven M, Ilgan S, Karacalioglu AO, Arslan N, Ozturk E. Unusual patterns of I-131 accumulation. Clin Nucl Med. 2004;29(11):738-740.
11. Rashid K, Johns W, Chasse K, Walker M, Gupta SM. Esophageal diverticulum presenting as metastatic thyroid mass on iodine-131 scintigraphy. Clin Nucl Med. 2006;31(7):405-408.
12. Ceylan Gunay E, Erdogan A. Mediastinal radioiodine uptake due to hiatal hernia: A false-positive reaction in 131I scan. Rev Esp Med Nucl. 2010;29(2):95.
13. Borkar S, Grewal R, Schoder H. I-131 uptake demonstrated in the appendix on a posttreatment scan in a patient with thyroid cancer. Clin Nucl Med. 2008;33(8):551-552.
14. Groskin SA, McCrohan G. Pseudometastasis of the chest wall resulting from a Hickman catheter. J Thorac Imaging. 1994;9(3):169-171.
15. Thust S, Fernando R, Barwick T, Mohan H, Clarke SE. SPECT/CT identification of post-radioactive iodine treatment false-positive uptake in a simple renal cyst. Thyroid. 2009;19(1):75-76.
16. Sinha A, Bradley KM, Steatham J, Weaver A. Asymmetric breast uptake of radioiodine in a patient with thyroid malignancy: Metastases or not? J R Soc Med. 2008;101(6):319-320.
1. Cooper, DS, Doherty GM, Haugen BR, et al; American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid. 2009;19(11):1167-1214.
2. Carlisle MR, Lu C, McDougall IR. The interpretation of 131I scans in the evaluation of thyroid cancer, with an emphasis on false positive findings. Nucl Med Commun. 2003;24(6):715-735.
3. Shapiro B, Rufini V, Jarwan A, et al. Artifacts, anatomical and physiological variants, and unrelated diseases that might cause false-positive whole-body 131-I scans in patients with thyroid cancer. Semin Nucl Med. 2000;30(2):115-132.
4. Mitchell G, Pratt BE, Vini L, McCready VR, Harmer CL. False positive 131I whole body scans in thyroid cancer. Br J Radiol. 2000;73(870):627-635.
5. Khan S, Dunn J, Strickland N, Al-Nahhas A. Iodine-123 uptake in vertebral haemangiomas in a patient with papillary thyroid carcinoma. Nucl Med Rev Cent East Eur. 2008;11(1):30-33.
6. Pena Pardo FJ, Crespo de la Jara A, Fernández Morejón FJ, Sureda González M, Forteza Vila J, Brugarolas Masllorens A. Solitary focus in the liver in a thyroid cancer patient after a whole body scan with 131 iodine. Rev Esp Med Nucl. 2007;26(5):294-296.
7. Omür O, Ozbek SS, Akgün A, Yazici B, Mutlukoca N, Ozcan Z. False-positive I-131 accumulation in a hepatic hydatid cyst. Clin Nucl Med. 2007;32(12):930-932.
8. Jong I, Taubman K, Schlicht S. Bronchiectasis simulating pulmonary metastases on iodine-131 scintigraphy in well-differentiated thyroid carcinoma. Clin Nucl Med. 2005;30(10):688-689.
9. Agriantonis DJ, Hall L, Wilson MA. Pitfalls of I-131 whole body scan interpretation: Bronchogenic cyst and mucinous cystadenoma. Clin Nucl Med. 2008;33(5):325-327.
10. Ozguven M, Ilgan S, Karacalioglu AO, Arslan N, Ozturk E. Unusual patterns of I-131 accumulation. Clin Nucl Med. 2004;29(11):738-740.
11. Rashid K, Johns W, Chasse K, Walker M, Gupta SM. Esophageal diverticulum presenting as metastatic thyroid mass on iodine-131 scintigraphy. Clin Nucl Med. 2006;31(7):405-408.
12. Ceylan Gunay E, Erdogan A. Mediastinal radioiodine uptake due to hiatal hernia: A false-positive reaction in 131I scan. Rev Esp Med Nucl. 2010;29(2):95.
13. Borkar S, Grewal R, Schoder H. I-131 uptake demonstrated in the appendix on a posttreatment scan in a patient with thyroid cancer. Clin Nucl Med. 2008;33(8):551-552.
14. Groskin SA, McCrohan G. Pseudometastasis of the chest wall resulting from a Hickman catheter. J Thorac Imaging. 1994;9(3):169-171.
15. Thust S, Fernando R, Barwick T, Mohan H, Clarke SE. SPECT/CT identification of post-radioactive iodine treatment false-positive uptake in a simple renal cyst. Thyroid. 2009;19(1):75-76.
16. Sinha A, Bradley KM, Steatham J, Weaver A. Asymmetric breast uptake of radioiodine in a patient with thyroid malignancy: Metastases or not? J R Soc Med. 2008;101(6):319-320.
Reorganizing a Hospital Ward
In 2001, the Institute of Medicine called for a major redesign of the US healthcare system, describing the chasm between the quality of care Americans receive and the quality of healthcare they deserve.[1] The healthcare community recognizes its ongoing quality and value gaps, but progress has been limited by outdated care models, fragmented organizational structures, and insufficient advances in system design.[2] Many healthcare organizations are searching for new care delivery models capable of producing greater value.
A major constraint in hospitals is the persistence of underperforming frontline clinical care teams.[3] Physicians typically travel from 1 unit or patient to the next in unpredictable patterns, resulting in missed opportunities to share perspectives and coordinate care with nurses, discharge planning personnel, pharmacists, therapists, and patients. This geographic fragmentation almost certainly contributes to interprofessional silos and hierarchies, nonspecific care plans, and failure to initiate or intensify therapy when indicated.[4] Modern hospital units could benefit from having a standard care model that synchronizes frontline professionals into teams routinely coordinating and progressing a shared plan of care.
EFFECTIVE CLINICAL MICROSYSTEMS REFLECTED IN THE DESIGN OF THE ACCOUNTABLE CARE UNIT
High‐value healthcare organizations deliberately design clinical microsystems.[5] An effective clinical microsystem combines several traits: (1) a small group of people who work together in a defined setting on a regular basis to provide care, (2) linked care processes and a shared information environment that includes individuals who receive that care, (3) performance outcomes, and (4) set service and care aims.[6] For the accountable care unit (ACU) to reflect the traits of an effective clinical microsystem, we designed it with analogous features: (1) unit‐based teams, (2) structured interdisciplinary bedside rounds (SIBR), (3) unit‐level performance reporting, and (4) unit‐level nurse and physician coleadership. We launched the ACU on September 1, 2010 in a high‐acuity 24‐bed medical unit at Emory University Hospital, a 579‐bed tertiary academic medical center. Herein we provide a brief report of our experience implementing and refining the ACU over a 4‐year period to help others gauge feasibility and sustainability.
FEATURES OF AN ACU
Unit‐Based Teams
Design
Geographic alignment fosters mutual respect, cohesiveness, communication, timeliness, and face‐to‐face problem solving,[7, 8] and has been linked to improved patient satisfaction, decreased length of stay, and reductions in morbidity and mortality.[9, 10, 11] At our hospital, though, patients newly admitted or transferred to the hospital medicine service traditionally had been distributed to physician teams without regard to geography, typically based on physician call schedules or traditions of balancing patient volumes across colleagues. These traditional practices geographically dispersed our teams. Physicians would be forced regularly to travel to 5 to 8 different units each day to see 10 to 18 patients. Nurses might perceive this as a parade of different physician teams coming and going off the unit at unpredictable times. To temporally and spatially align physicians with unit‐based staff, specific physician teams were assigned to the ACU.
Implementation
The first step in implementing unit‐based teams was to identify the smallest number of physician teams that could be assigned to the ACU. Two internal medicine resident teams are assigned to care for all medical patients in the unit. Each resident team consists of 1 hospital medicine attending physician, 1 internal medicine resident, 3 interns (2 covering the day shift and 1 overnight every other night), and up to 2 medical students. The 2 teams alternate a 24‐hour call cycle where the on‐call team admits every patient arriving to the unit. For patients arriving to the unit from 6 pm to 7 am, the on‐call overnight intern admits the patients and hands over care to the team in the morning. The on‐call team becomes aware of an incoming patient once the patient has been assigned a bed in the home unit. Several patients per day may arrive on the unit as transfers from a medical or surgical intensive care unit, but most patients arrive as emergency room or direct admissions. On any given day it is acceptable and typical for a team to have several patients off the ACU. No specific changes were made to nurse staffing, with the unit continuing to have 1 nurse unit manager, 1 charge nurse per shift, and a nurse‐to‐patient ratio of 1 to 4.
Results
Geographic patient assignment has been successful (Figure 1). Prior to implementing the ACU, more than 5 different hospital medicine physician teams cared for patients on the unit, with no single team caring for more than 25% of them. In the ACU, all medical patients are assigned to 1 of the 2 unit‐based physician teams (physician teams 1 and 2), which regularly represents more than 95% of all patients on the unit. Over the 4 years, these 2 ACU teams have had an average of 12.9 total patient encounters per day (compared to 11.8 in the year before the ACU when these teams were not unit based). The 2 unit‐based teams have over 90% of their patients on the ACU daily. In contrast, 3 attending‐only hospital medicine teams (physician teams 3, 4, and 5) are still dispersed over 6 to 8 units every day (Figure 2), primarily due to high hospital occupancy and a relative scarcity of units eligible to become dedicated hospital medicine units.
Effects of the Change
Through unit‐based teams, the ACU achieves the first trait of an effective clinical microsystem. Although an evaluation of the cultural gains are beyond the scope of this article, the logistical advantages are self‐evident; having the fewest necessary physician teams overseeing care for nearly all patients in 1 unit and where those physician teams simultaneously have nearly all of their patients on that 1 unit, makes it possible to schedule interdisciplinary teamwork activities, such as SIBR, not otherwise feasible.
Structured Interdisciplinary Bedside Rounds
Design
To reflect the second trait of an effective clinical microsystem, a hospital unit should routinely combine best practices for communication, including daily goals sheets,[12] safety checklists,[13] and multidisciplinary rounds.[14, 15] ACU design achieves this through SIBR, a patient‐ and family‐centered, team‐based approach to rounds that brings the nurse, physician, and available allied health professionals to the patient's bedside every day to exchange perspectives using a standard format to cross‐check information with the patient, family, and one another, and articulate a clear plan for the day. Before the SIBR hour starts, physicians and nurses have already performed independent patient assessments through usual activities such as handover, chart review, patient interviews, and physical examinations. Participants in SIBR are expected to give or receive inputs according to the standard SIBR communication protocol (Figure 3), review a quality‐safety checklist together, and ensure the plan of care is verbalized. Including the patient and family allows all parties to hear and be heard, cross‐check information for accuracy, and hold each person accountable for contributions.[16, 17]
Implementation
Each ACU staff member receives orientation to the SIBR communication protocol and is expected to be prepared and punctual for the midmorning start times. The charge nurse serves as the SIBR rounds manager, ensuring physicians waste no time searching for the next nurse and each team's eligible patients are seen in the SIBR hour. For each patient, SIBR begins when the nurse and physician are both present at the bedside. The intern begins SIBR by introducing team members before reviewing the patient's active problem list, response to treatment, and interval test results or consultant inputs. The nurse then relays the patient's goal for the day, overnight events, nursing concerns, and reviews the quality‐safety checklist. The intern then invites allied health professionals to share inputs that might impact medical decision making or discharge planning, before synthesizing all inputs into a shared plan for the day.
Throughout SIBR, the patient and family are encouraged to ask questions or correct misinformation. Although newcomers to SIBR often imagine that inviting patient inputs will disrupt efficiency, we have found teams readily learn to manage this risk, for instance discerning the core question among multiple seemingly disparate ones, or volunteering to return after the SIBR hour to explore a complex issue.
Results
Since the launch of the ACU on September 1, 2010, SIBR has been embedded as a routine on the unit with both physician teams and the nursing staff conducting it every day. Patients not considered eligible for SIBR are those whom the entire physician team has not yet evaluated, typically patients who arrived to the unit overnight. For patients who opt out due to personal preference, or for patients away from the unit for a procedure or a test, SIBR occurs without the patient so the rest of the team can still exchange inputs and formulate a plan of care. A visitor to the unit sees SIBR start punctually at 9 am and 10 am for successive teams, with each completing SIBR on eligible patients in under 60 minutes.
Effects of the Change
The second trait of an effective clinical microsystem is achieved through SIBR's routine forum for staff to share information with each other and the patient. By practicing SIBR every workday, staff are presented with multiple routine opportunities to experience an environment reflective of high‐performing frontline units.[18] We found that SIBR resembled other competencies, with a bell curve of performance. For this reason, by the start of the third year we added a SIBR certification program, a SIBR skills training program where permanent and rotating staff are evaluated through an in vivo observed structured clinical exam, typically with a charge nurse or physician as preceptor. When a nurse, medical student, intern, or resident demonstrates an ability to perform a series of specific high performance SIBR behaviors in 5 of 6 consecutive patients, they can achieve SIBR certification. In the first 2 years of this voluntary certification program, all daytime nursing staff and rotating interns have achieved this demonstration of interdisciplinary teamwork competence.
Unit‐Level Performance Reporting
Design
Hospital outcomes are determined on the clinical frontline. To be effective at managing unit outcomes, performance reports must be made available to unit leadership and staff.[5, 16] However, many hospitals still report performance at the level of the facility or service line. This limits the relevance of reports for the people who directly determine outcomes.
Implementation
For the first year, a data analyst was available to prepare and distribute unit‐level performance reports to unit leaders quarterly, including rates of in‐hospital mortality, blood stream infections, patient satisfaction, length of stay, and 30‐day readmissions. Preparation of these reports was labor intensive, requiring the analyst to acquire raw data from multiple data sources and to build the reports manually.
Results
In an analysis comparing outcomes for every patient spending at least 1 night on the unit in the year before and year after implementation, we observed reductions in in‐hospital mortality and length of stay. Unadjusted in‐hospital mortality decreased from 2.3% to 1.1% (P=0.004), with no change in referrals to hospice (5.4% to 4.5%) (P=0.176), and length‐of‐stay decreased from 5.0 to 4.5 days (P=0.001).[19] A complete report of these findings, including an analysis of concurrent control groups is beyond the scope of this article, but here we highlight an effect we observed on ACU leadership and staff from the reduction in in‐hospital mortality.
Effects of the Change
Noting the apparent mortality reduction, ACU leadership encouraged permanent staff and rotating trainees to consider an unexpected death as a never event. Although perhaps self‐evident, before the ACU we had never been organized to reflect on that concept or to use routines to do something about it. The unit considered an unexpected death one where the patient was not actively receiving comfort measures. At the monthly meet and greet, where ACU leadership bring the permanent staff and new rotating trainees together to introduce themselves by first name, the coleaders proposed that unexpected deaths in the month ahead could represent failures to recognize or respond to deterioration, to consider an alternative or under‐treated process, to transfer the patient to a higher level of care, or to deliver more timely and appropriate end‐of‐life care. It is our impression that this introspection was extraordinarily meaningful and would not have occurred without unit‐based teams, unit‐level performance data, and ACU leadership learning to utilize this rhetoric.
Unit‐Level Nurse and Physician Coleadership
Design
Effective leadership is a major driver of successful clinical microsystems.[20] The ACU is designed to be co‐led by a nurse unit manager and physician medical director. The leadership pair was charged simply with developing patient‐centered teams and ensuring the staff felt connected to the values of the organization and accountable to each other and the outcomes of the unit.
Implementation
Nursing leadership and hospital executives influenced the selection of the physician medical director, which was a way for them to demonstrate support for the care model. Over the first 4 years, the physician medical director position has been afforded a 10% to 20% reduction in clinical duties to fulfill the charge. The leadership pair sets expectations for the ACU's code of conduct, standard operating procedures (eg, SIBR), and best‐practice protocols.
Results
The leadership pair tries explicitly to role model the behaviors enumerated in the ACU's relational covenant, itself the product of a facilitated exercise they commissioned in the first year in which the entire staff drafted and signed a document listing behaviors they wished to see from each other (see Supporting Information, Appendix 1, in the online version of this article). The physician medical director, along with charge nurses, coach staff and trainees wishing to achieve SIBR certification. Over the 4 years, the pair has introduced best‐practice protocols for glycemic control, venous thromboembolism prophylaxis, removal of idle venous and bladder catheters, and bedside goals‐of‐care conversations.
Effects of the Change
Where there had previously been no explicit code of conduct, standard operating procedures such as SIBR, or focused efforts to optimize unit outcomes, the coleadership pair fills a management gap. These coleaders play an essential role in building momentum for the structure and processes of the ACU. The leadership pair has also become a primary resource for intraorganizational spread of the ACU model to medical and surgical wards, as well as geriatric, long‐term acute, and intensive care units.
CHALLENGES
Challenges with implementing the ACU fell into 3 primary categories: (1) performing change management required for a successful launch, (2) solving logistics of maintaining unit‐based physician teams, and (3) training physicians and nurses to perform SIBR at a high level.
For change management, the leadership pair was able to explain the rationale of the model to all staff in sufficient detail to launch the ACU. To build momentum for ACU routines and relationships, the physician leader and the nurse unit manager were both present on the unit daily for the first 100 days. As ACU operations became routine and competencies formed among clinicians, the amount of time spent by these leaders was de‐escalated.
Creating and maintaining unit‐based physician teams required shared understanding and coordination between on‐call hospital medicine physicians and the bed control office so that new admissions or transfers could be consistently assigned to unit‐based teams without adversely affecting patient flow. We found this challenge to be manageable once stakeholders accepted the rationale for the care mode and figured out how to support it.
The challenge of building high‐performance SIBR across the unit, including competence of rotating trainees new to the model, requires individualized assessment and feedback necessary for SIBR certification. We addressed this challenge by creating a SIBR train‐the‐trainer programa list of observable high‐performance SIBR behaviors coupled with a short course about giving effective feedback to learnersand found that once the ACU had several nurse and physician SIBR trainers in the staffing mix every day, the required amount of SIBR coaching expertise was available when needed.
CONCLUSION
Improving value and reliability in hospital care may require new models of care. The ACU is a hospital care model specifically designed to organize physicians, nurses, and allied health professionals into high‐functioning, unit‐based teams. It converges standard workflow, patient‐centered communication, quality‐safety checklists, best‐practice protocols, performance measurement, and progressive leadership. Our experience with the ACU suggests that hospital units can be reorganized as effective clinical microsystems where consistent unit professionals can share time and space, a sense of purpose, code of conduct, shared mental model for teamwork, an interprofessional management structure, and an important level of accountability to each other and their patients.
Disclosures: Jason Stein, MD: grant support from the US Health & Resources Services Administration to support organizational implementation of the care model described; recipient of consulting fees and royalties for licensed intellectual property to support implementation of the care model described; founder and president of nonprofit Centripital, provider of consulting services to hospital systems implementing the care model described. The terms of this arrangement have been reviewed and approved by Emory University in accordance with its conflict of interest policies. Liam Chadwick, PhD, and Diaz Clark, MS, RN: recipients of consulting fees through Centripital to support implementation of the care model described. Bryan W. Castle, MBA, RN: grant support from the US Health & Resources Services Administration to support organizational implementation of the care model described; recipient of consulting fees through Centripital to support implementation of the care model described. The authors report no other conflicts of interest.
- Institute of Medicine. Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press; 2001.
- , , . The triple aim: care, health, and cost. Health Aff (Millwood). 2008;27(3):759–769.
- . The end of the beginning: patient safety five years after “to err is human”. Health Aff (Millwood). 2004;Suppl Web Exclusives:W4‐534–545.
- , , , et al. Clinical inertia. Ann Intern Med. 2001;135(9):825–834.
- . The four habits of high‐value health care organizations. N Engl J Med. 2011;365(22):2045–2047.
- , , , . Using a Malcolm Baldrige framework to understand high‐performing clinical microsystems. Qual Saf Health Care. 2007;16(5):334–341.
- , , , . Relational coordination among nurses and other providers: impact on the quality of patient care. J Nurs Manag. 2010;18(8):926–937.
- , , , et al. Unit‐based care teams and the frequency and quality of physician‐nurse communications. Arch Pediatr Adolesc Med. 2011;165(5):424–428.
- , , , et al. Reducing cardiac arrests in the acute admissions unit: a quality improvement journey. BMJ Qual Saf. 2013;22(12):1025–1031.
- , , , et al. Evolving practice of hospital medicine and its impact on hospital throughput and efficiencies. J Hosp Med. 2012;7(8):649–654.
- , . Improvement projects led by unit‐based teams of nurse, physician, and quality leaders reduce infections, lower costs, improve patient satisfaction, and nurse‐physician communication. AHRQ Health Care Innovations Exchange. Available at: https://innovations.ahrq.gov/profiles/improvement‐projects‐led‐unit‐based‐teams‐nurse‐physician‐and‐quality‐leaders‐reduce. Accessed May 4, 2014.
- , , , , . The daily goals communication sheet: a simple and novel tool for improved communication and care. Jt Comm J Qual Patient Saf. 2008;34(10):608–613, 561.
- , , , et al. Implementation of a mandatory checklist of protocols and objectives improves compliance with a wide range of evidence‐based intensive care unit practices. Crit Care Med. 2009;37(10):2775–2781.
- , , , et al. Structured interdisciplinary rounds in a medical teaching unit: improving patient safety. Arch Intern Med. 2011;171(7):678–684.
- , , , , , . Improving teamwork: impact of structured interdisciplinary rounds on a hospitalist unit. J Hosp Med. 2011;6(2):88–93.
- , , . Integrating patient safety into the clinical microsystem. Qual Saf Health Care. 2004;13(suppl 2):ii34–ii38.
- , , , . Collaborative‐cross checking to enhance resilience. Cogn Tech Work. 2007;9:155–162.
- , , , et al. Microsystems in health care: Part 1. Learning from high‐performing front‐line clinical units. Jt Comm J Qual Improv. 2002;28(9):472–493.
- , , . Mortality reduction associated with structure process, and management redesign of a hospital medicine unit. J Hosp Med. 2012;7(suppl 2):115.
- , , , et al. Microsystems in health care: part 5. How leaders are leading. Jt Comm J Qual Saf. 2003;29(6):297–308.
In 2001, the Institute of Medicine called for a major redesign of the US healthcare system, describing the chasm between the quality of care Americans receive and the quality of healthcare they deserve.[1] The healthcare community recognizes its ongoing quality and value gaps, but progress has been limited by outdated care models, fragmented organizational structures, and insufficient advances in system design.[2] Many healthcare organizations are searching for new care delivery models capable of producing greater value.
A major constraint in hospitals is the persistence of underperforming frontline clinical care teams.[3] Physicians typically travel from 1 unit or patient to the next in unpredictable patterns, resulting in missed opportunities to share perspectives and coordinate care with nurses, discharge planning personnel, pharmacists, therapists, and patients. This geographic fragmentation almost certainly contributes to interprofessional silos and hierarchies, nonspecific care plans, and failure to initiate or intensify therapy when indicated.[4] Modern hospital units could benefit from having a standard care model that synchronizes frontline professionals into teams routinely coordinating and progressing a shared plan of care.
EFFECTIVE CLINICAL MICROSYSTEMS REFLECTED IN THE DESIGN OF THE ACCOUNTABLE CARE UNIT
High‐value healthcare organizations deliberately design clinical microsystems.[5] An effective clinical microsystem combines several traits: (1) a small group of people who work together in a defined setting on a regular basis to provide care, (2) linked care processes and a shared information environment that includes individuals who receive that care, (3) performance outcomes, and (4) set service and care aims.[6] For the accountable care unit (ACU) to reflect the traits of an effective clinical microsystem, we designed it with analogous features: (1) unit‐based teams, (2) structured interdisciplinary bedside rounds (SIBR), (3) unit‐level performance reporting, and (4) unit‐level nurse and physician coleadership. We launched the ACU on September 1, 2010 in a high‐acuity 24‐bed medical unit at Emory University Hospital, a 579‐bed tertiary academic medical center. Herein we provide a brief report of our experience implementing and refining the ACU over a 4‐year period to help others gauge feasibility and sustainability.
FEATURES OF AN ACU
Unit‐Based Teams
Design
Geographic alignment fosters mutual respect, cohesiveness, communication, timeliness, and face‐to‐face problem solving,[7, 8] and has been linked to improved patient satisfaction, decreased length of stay, and reductions in morbidity and mortality.[9, 10, 11] At our hospital, though, patients newly admitted or transferred to the hospital medicine service traditionally had been distributed to physician teams without regard to geography, typically based on physician call schedules or traditions of balancing patient volumes across colleagues. These traditional practices geographically dispersed our teams. Physicians would be forced regularly to travel to 5 to 8 different units each day to see 10 to 18 patients. Nurses might perceive this as a parade of different physician teams coming and going off the unit at unpredictable times. To temporally and spatially align physicians with unit‐based staff, specific physician teams were assigned to the ACU.
Implementation
The first step in implementing unit‐based teams was to identify the smallest number of physician teams that could be assigned to the ACU. Two internal medicine resident teams are assigned to care for all medical patients in the unit. Each resident team consists of 1 hospital medicine attending physician, 1 internal medicine resident, 3 interns (2 covering the day shift and 1 overnight every other night), and up to 2 medical students. The 2 teams alternate a 24‐hour call cycle where the on‐call team admits every patient arriving to the unit. For patients arriving to the unit from 6 pm to 7 am, the on‐call overnight intern admits the patients and hands over care to the team in the morning. The on‐call team becomes aware of an incoming patient once the patient has been assigned a bed in the home unit. Several patients per day may arrive on the unit as transfers from a medical or surgical intensive care unit, but most patients arrive as emergency room or direct admissions. On any given day it is acceptable and typical for a team to have several patients off the ACU. No specific changes were made to nurse staffing, with the unit continuing to have 1 nurse unit manager, 1 charge nurse per shift, and a nurse‐to‐patient ratio of 1 to 4.
Results
Geographic patient assignment has been successful (Figure 1). Prior to implementing the ACU, more than 5 different hospital medicine physician teams cared for patients on the unit, with no single team caring for more than 25% of them. In the ACU, all medical patients are assigned to 1 of the 2 unit‐based physician teams (physician teams 1 and 2), which regularly represents more than 95% of all patients on the unit. Over the 4 years, these 2 ACU teams have had an average of 12.9 total patient encounters per day (compared to 11.8 in the year before the ACU when these teams were not unit based). The 2 unit‐based teams have over 90% of their patients on the ACU daily. In contrast, 3 attending‐only hospital medicine teams (physician teams 3, 4, and 5) are still dispersed over 6 to 8 units every day (Figure 2), primarily due to high hospital occupancy and a relative scarcity of units eligible to become dedicated hospital medicine units.
Effects of the Change
Through unit‐based teams, the ACU achieves the first trait of an effective clinical microsystem. Although an evaluation of the cultural gains are beyond the scope of this article, the logistical advantages are self‐evident; having the fewest necessary physician teams overseeing care for nearly all patients in 1 unit and where those physician teams simultaneously have nearly all of their patients on that 1 unit, makes it possible to schedule interdisciplinary teamwork activities, such as SIBR, not otherwise feasible.
Structured Interdisciplinary Bedside Rounds
Design
To reflect the second trait of an effective clinical microsystem, a hospital unit should routinely combine best practices for communication, including daily goals sheets,[12] safety checklists,[13] and multidisciplinary rounds.[14, 15] ACU design achieves this through SIBR, a patient‐ and family‐centered, team‐based approach to rounds that brings the nurse, physician, and available allied health professionals to the patient's bedside every day to exchange perspectives using a standard format to cross‐check information with the patient, family, and one another, and articulate a clear plan for the day. Before the SIBR hour starts, physicians and nurses have already performed independent patient assessments through usual activities such as handover, chart review, patient interviews, and physical examinations. Participants in SIBR are expected to give or receive inputs according to the standard SIBR communication protocol (Figure 3), review a quality‐safety checklist together, and ensure the plan of care is verbalized. Including the patient and family allows all parties to hear and be heard, cross‐check information for accuracy, and hold each person accountable for contributions.[16, 17]
Implementation
Each ACU staff member receives orientation to the SIBR communication protocol and is expected to be prepared and punctual for the midmorning start times. The charge nurse serves as the SIBR rounds manager, ensuring physicians waste no time searching for the next nurse and each team's eligible patients are seen in the SIBR hour. For each patient, SIBR begins when the nurse and physician are both present at the bedside. The intern begins SIBR by introducing team members before reviewing the patient's active problem list, response to treatment, and interval test results or consultant inputs. The nurse then relays the patient's goal for the day, overnight events, nursing concerns, and reviews the quality‐safety checklist. The intern then invites allied health professionals to share inputs that might impact medical decision making or discharge planning, before synthesizing all inputs into a shared plan for the day.
Throughout SIBR, the patient and family are encouraged to ask questions or correct misinformation. Although newcomers to SIBR often imagine that inviting patient inputs will disrupt efficiency, we have found teams readily learn to manage this risk, for instance discerning the core question among multiple seemingly disparate ones, or volunteering to return after the SIBR hour to explore a complex issue.
Results
Since the launch of the ACU on September 1, 2010, SIBR has been embedded as a routine on the unit with both physician teams and the nursing staff conducting it every day. Patients not considered eligible for SIBR are those whom the entire physician team has not yet evaluated, typically patients who arrived to the unit overnight. For patients who opt out due to personal preference, or for patients away from the unit for a procedure or a test, SIBR occurs without the patient so the rest of the team can still exchange inputs and formulate a plan of care. A visitor to the unit sees SIBR start punctually at 9 am and 10 am for successive teams, with each completing SIBR on eligible patients in under 60 minutes.
Effects of the Change
The second trait of an effective clinical microsystem is achieved through SIBR's routine forum for staff to share information with each other and the patient. By practicing SIBR every workday, staff are presented with multiple routine opportunities to experience an environment reflective of high‐performing frontline units.[18] We found that SIBR resembled other competencies, with a bell curve of performance. For this reason, by the start of the third year we added a SIBR certification program, a SIBR skills training program where permanent and rotating staff are evaluated through an in vivo observed structured clinical exam, typically with a charge nurse or physician as preceptor. When a nurse, medical student, intern, or resident demonstrates an ability to perform a series of specific high performance SIBR behaviors in 5 of 6 consecutive patients, they can achieve SIBR certification. In the first 2 years of this voluntary certification program, all daytime nursing staff and rotating interns have achieved this demonstration of interdisciplinary teamwork competence.
Unit‐Level Performance Reporting
Design
Hospital outcomes are determined on the clinical frontline. To be effective at managing unit outcomes, performance reports must be made available to unit leadership and staff.[5, 16] However, many hospitals still report performance at the level of the facility or service line. This limits the relevance of reports for the people who directly determine outcomes.
Implementation
For the first year, a data analyst was available to prepare and distribute unit‐level performance reports to unit leaders quarterly, including rates of in‐hospital mortality, blood stream infections, patient satisfaction, length of stay, and 30‐day readmissions. Preparation of these reports was labor intensive, requiring the analyst to acquire raw data from multiple data sources and to build the reports manually.
Results
In an analysis comparing outcomes for every patient spending at least 1 night on the unit in the year before and year after implementation, we observed reductions in in‐hospital mortality and length of stay. Unadjusted in‐hospital mortality decreased from 2.3% to 1.1% (P=0.004), with no change in referrals to hospice (5.4% to 4.5%) (P=0.176), and length‐of‐stay decreased from 5.0 to 4.5 days (P=0.001).[19] A complete report of these findings, including an analysis of concurrent control groups is beyond the scope of this article, but here we highlight an effect we observed on ACU leadership and staff from the reduction in in‐hospital mortality.
Effects of the Change
Noting the apparent mortality reduction, ACU leadership encouraged permanent staff and rotating trainees to consider an unexpected death as a never event. Although perhaps self‐evident, before the ACU we had never been organized to reflect on that concept or to use routines to do something about it. The unit considered an unexpected death one where the patient was not actively receiving comfort measures. At the monthly meet and greet, where ACU leadership bring the permanent staff and new rotating trainees together to introduce themselves by first name, the coleaders proposed that unexpected deaths in the month ahead could represent failures to recognize or respond to deterioration, to consider an alternative or under‐treated process, to transfer the patient to a higher level of care, or to deliver more timely and appropriate end‐of‐life care. It is our impression that this introspection was extraordinarily meaningful and would not have occurred without unit‐based teams, unit‐level performance data, and ACU leadership learning to utilize this rhetoric.
Unit‐Level Nurse and Physician Coleadership
Design
Effective leadership is a major driver of successful clinical microsystems.[20] The ACU is designed to be co‐led by a nurse unit manager and physician medical director. The leadership pair was charged simply with developing patient‐centered teams and ensuring the staff felt connected to the values of the organization and accountable to each other and the outcomes of the unit.
Implementation
Nursing leadership and hospital executives influenced the selection of the physician medical director, which was a way for them to demonstrate support for the care model. Over the first 4 years, the physician medical director position has been afforded a 10% to 20% reduction in clinical duties to fulfill the charge. The leadership pair sets expectations for the ACU's code of conduct, standard operating procedures (eg, SIBR), and best‐practice protocols.
Results
The leadership pair tries explicitly to role model the behaviors enumerated in the ACU's relational covenant, itself the product of a facilitated exercise they commissioned in the first year in which the entire staff drafted and signed a document listing behaviors they wished to see from each other (see Supporting Information, Appendix 1, in the online version of this article). The physician medical director, along with charge nurses, coach staff and trainees wishing to achieve SIBR certification. Over the 4 years, the pair has introduced best‐practice protocols for glycemic control, venous thromboembolism prophylaxis, removal of idle venous and bladder catheters, and bedside goals‐of‐care conversations.
Effects of the Change
Where there had previously been no explicit code of conduct, standard operating procedures such as SIBR, or focused efforts to optimize unit outcomes, the coleadership pair fills a management gap. These coleaders play an essential role in building momentum for the structure and processes of the ACU. The leadership pair has also become a primary resource for intraorganizational spread of the ACU model to medical and surgical wards, as well as geriatric, long‐term acute, and intensive care units.
CHALLENGES
Challenges with implementing the ACU fell into 3 primary categories: (1) performing change management required for a successful launch, (2) solving logistics of maintaining unit‐based physician teams, and (3) training physicians and nurses to perform SIBR at a high level.
For change management, the leadership pair was able to explain the rationale of the model to all staff in sufficient detail to launch the ACU. To build momentum for ACU routines and relationships, the physician leader and the nurse unit manager were both present on the unit daily for the first 100 days. As ACU operations became routine and competencies formed among clinicians, the amount of time spent by these leaders was de‐escalated.
Creating and maintaining unit‐based physician teams required shared understanding and coordination between on‐call hospital medicine physicians and the bed control office so that new admissions or transfers could be consistently assigned to unit‐based teams without adversely affecting patient flow. We found this challenge to be manageable once stakeholders accepted the rationale for the care mode and figured out how to support it.
The challenge of building high‐performance SIBR across the unit, including competence of rotating trainees new to the model, requires individualized assessment and feedback necessary for SIBR certification. We addressed this challenge by creating a SIBR train‐the‐trainer programa list of observable high‐performance SIBR behaviors coupled with a short course about giving effective feedback to learnersand found that once the ACU had several nurse and physician SIBR trainers in the staffing mix every day, the required amount of SIBR coaching expertise was available when needed.
CONCLUSION
Improving value and reliability in hospital care may require new models of care. The ACU is a hospital care model specifically designed to organize physicians, nurses, and allied health professionals into high‐functioning, unit‐based teams. It converges standard workflow, patient‐centered communication, quality‐safety checklists, best‐practice protocols, performance measurement, and progressive leadership. Our experience with the ACU suggests that hospital units can be reorganized as effective clinical microsystems where consistent unit professionals can share time and space, a sense of purpose, code of conduct, shared mental model for teamwork, an interprofessional management structure, and an important level of accountability to each other and their patients.
Disclosures: Jason Stein, MD: grant support from the US Health & Resources Services Administration to support organizational implementation of the care model described; recipient of consulting fees and royalties for licensed intellectual property to support implementation of the care model described; founder and president of nonprofit Centripital, provider of consulting services to hospital systems implementing the care model described. The terms of this arrangement have been reviewed and approved by Emory University in accordance with its conflict of interest policies. Liam Chadwick, PhD, and Diaz Clark, MS, RN: recipients of consulting fees through Centripital to support implementation of the care model described. Bryan W. Castle, MBA, RN: grant support from the US Health & Resources Services Administration to support organizational implementation of the care model described; recipient of consulting fees through Centripital to support implementation of the care model described. The authors report no other conflicts of interest.
In 2001, the Institute of Medicine called for a major redesign of the US healthcare system, describing the chasm between the quality of care Americans receive and the quality of healthcare they deserve.[1] The healthcare community recognizes its ongoing quality and value gaps, but progress has been limited by outdated care models, fragmented organizational structures, and insufficient advances in system design.[2] Many healthcare organizations are searching for new care delivery models capable of producing greater value.
A major constraint in hospitals is the persistence of underperforming frontline clinical care teams.[3] Physicians typically travel from 1 unit or patient to the next in unpredictable patterns, resulting in missed opportunities to share perspectives and coordinate care with nurses, discharge planning personnel, pharmacists, therapists, and patients. This geographic fragmentation almost certainly contributes to interprofessional silos and hierarchies, nonspecific care plans, and failure to initiate or intensify therapy when indicated.[4] Modern hospital units could benefit from having a standard care model that synchronizes frontline professionals into teams routinely coordinating and progressing a shared plan of care.
EFFECTIVE CLINICAL MICROSYSTEMS REFLECTED IN THE DESIGN OF THE ACCOUNTABLE CARE UNIT
High‐value healthcare organizations deliberately design clinical microsystems.[5] An effective clinical microsystem combines several traits: (1) a small group of people who work together in a defined setting on a regular basis to provide care, (2) linked care processes and a shared information environment that includes individuals who receive that care, (3) performance outcomes, and (4) set service and care aims.[6] For the accountable care unit (ACU) to reflect the traits of an effective clinical microsystem, we designed it with analogous features: (1) unit‐based teams, (2) structured interdisciplinary bedside rounds (SIBR), (3) unit‐level performance reporting, and (4) unit‐level nurse and physician coleadership. We launched the ACU on September 1, 2010 in a high‐acuity 24‐bed medical unit at Emory University Hospital, a 579‐bed tertiary academic medical center. Herein we provide a brief report of our experience implementing and refining the ACU over a 4‐year period to help others gauge feasibility and sustainability.
FEATURES OF AN ACU
Unit‐Based Teams
Design
Geographic alignment fosters mutual respect, cohesiveness, communication, timeliness, and face‐to‐face problem solving,[7, 8] and has been linked to improved patient satisfaction, decreased length of stay, and reductions in morbidity and mortality.[9, 10, 11] At our hospital, though, patients newly admitted or transferred to the hospital medicine service traditionally had been distributed to physician teams without regard to geography, typically based on physician call schedules or traditions of balancing patient volumes across colleagues. These traditional practices geographically dispersed our teams. Physicians would be forced regularly to travel to 5 to 8 different units each day to see 10 to 18 patients. Nurses might perceive this as a parade of different physician teams coming and going off the unit at unpredictable times. To temporally and spatially align physicians with unit‐based staff, specific physician teams were assigned to the ACU.
Implementation
The first step in implementing unit‐based teams was to identify the smallest number of physician teams that could be assigned to the ACU. Two internal medicine resident teams are assigned to care for all medical patients in the unit. Each resident team consists of 1 hospital medicine attending physician, 1 internal medicine resident, 3 interns (2 covering the day shift and 1 overnight every other night), and up to 2 medical students. The 2 teams alternate a 24‐hour call cycle where the on‐call team admits every patient arriving to the unit. For patients arriving to the unit from 6 pm to 7 am, the on‐call overnight intern admits the patients and hands over care to the team in the morning. The on‐call team becomes aware of an incoming patient once the patient has been assigned a bed in the home unit. Several patients per day may arrive on the unit as transfers from a medical or surgical intensive care unit, but most patients arrive as emergency room or direct admissions. On any given day it is acceptable and typical for a team to have several patients off the ACU. No specific changes were made to nurse staffing, with the unit continuing to have 1 nurse unit manager, 1 charge nurse per shift, and a nurse‐to‐patient ratio of 1 to 4.
Results
Geographic patient assignment has been successful (Figure 1). Prior to implementing the ACU, more than 5 different hospital medicine physician teams cared for patients on the unit, with no single team caring for more than 25% of them. In the ACU, all medical patients are assigned to 1 of the 2 unit‐based physician teams (physician teams 1 and 2), which regularly represents more than 95% of all patients on the unit. Over the 4 years, these 2 ACU teams have had an average of 12.9 total patient encounters per day (compared to 11.8 in the year before the ACU when these teams were not unit based). The 2 unit‐based teams have over 90% of their patients on the ACU daily. In contrast, 3 attending‐only hospital medicine teams (physician teams 3, 4, and 5) are still dispersed over 6 to 8 units every day (Figure 2), primarily due to high hospital occupancy and a relative scarcity of units eligible to become dedicated hospital medicine units.
Effects of the Change
Through unit‐based teams, the ACU achieves the first trait of an effective clinical microsystem. Although an evaluation of the cultural gains are beyond the scope of this article, the logistical advantages are self‐evident; having the fewest necessary physician teams overseeing care for nearly all patients in 1 unit and where those physician teams simultaneously have nearly all of their patients on that 1 unit, makes it possible to schedule interdisciplinary teamwork activities, such as SIBR, not otherwise feasible.
Structured Interdisciplinary Bedside Rounds
Design
To reflect the second trait of an effective clinical microsystem, a hospital unit should routinely combine best practices for communication, including daily goals sheets,[12] safety checklists,[13] and multidisciplinary rounds.[14, 15] ACU design achieves this through SIBR, a patient‐ and family‐centered, team‐based approach to rounds that brings the nurse, physician, and available allied health professionals to the patient's bedside every day to exchange perspectives using a standard format to cross‐check information with the patient, family, and one another, and articulate a clear plan for the day. Before the SIBR hour starts, physicians and nurses have already performed independent patient assessments through usual activities such as handover, chart review, patient interviews, and physical examinations. Participants in SIBR are expected to give or receive inputs according to the standard SIBR communication protocol (Figure 3), review a quality‐safety checklist together, and ensure the plan of care is verbalized. Including the patient and family allows all parties to hear and be heard, cross‐check information for accuracy, and hold each person accountable for contributions.[16, 17]
Implementation
Each ACU staff member receives orientation to the SIBR communication protocol and is expected to be prepared and punctual for the midmorning start times. The charge nurse serves as the SIBR rounds manager, ensuring physicians waste no time searching for the next nurse and each team's eligible patients are seen in the SIBR hour. For each patient, SIBR begins when the nurse and physician are both present at the bedside. The intern begins SIBR by introducing team members before reviewing the patient's active problem list, response to treatment, and interval test results or consultant inputs. The nurse then relays the patient's goal for the day, overnight events, nursing concerns, and reviews the quality‐safety checklist. The intern then invites allied health professionals to share inputs that might impact medical decision making or discharge planning, before synthesizing all inputs into a shared plan for the day.
Throughout SIBR, the patient and family are encouraged to ask questions or correct misinformation. Although newcomers to SIBR often imagine that inviting patient inputs will disrupt efficiency, we have found teams readily learn to manage this risk, for instance discerning the core question among multiple seemingly disparate ones, or volunteering to return after the SIBR hour to explore a complex issue.
Results
Since the launch of the ACU on September 1, 2010, SIBR has been embedded as a routine on the unit with both physician teams and the nursing staff conducting it every day. Patients not considered eligible for SIBR are those whom the entire physician team has not yet evaluated, typically patients who arrived to the unit overnight. For patients who opt out due to personal preference, or for patients away from the unit for a procedure or a test, SIBR occurs without the patient so the rest of the team can still exchange inputs and formulate a plan of care. A visitor to the unit sees SIBR start punctually at 9 am and 10 am for successive teams, with each completing SIBR on eligible patients in under 60 minutes.
Effects of the Change
The second trait of an effective clinical microsystem is achieved through SIBR's routine forum for staff to share information with each other and the patient. By practicing SIBR every workday, staff are presented with multiple routine opportunities to experience an environment reflective of high‐performing frontline units.[18] We found that SIBR resembled other competencies, with a bell curve of performance. For this reason, by the start of the third year we added a SIBR certification program, a SIBR skills training program where permanent and rotating staff are evaluated through an in vivo observed structured clinical exam, typically with a charge nurse or physician as preceptor. When a nurse, medical student, intern, or resident demonstrates an ability to perform a series of specific high performance SIBR behaviors in 5 of 6 consecutive patients, they can achieve SIBR certification. In the first 2 years of this voluntary certification program, all daytime nursing staff and rotating interns have achieved this demonstration of interdisciplinary teamwork competence.
Unit‐Level Performance Reporting
Design
Hospital outcomes are determined on the clinical frontline. To be effective at managing unit outcomes, performance reports must be made available to unit leadership and staff.[5, 16] However, many hospitals still report performance at the level of the facility or service line. This limits the relevance of reports for the people who directly determine outcomes.
Implementation
For the first year, a data analyst was available to prepare and distribute unit‐level performance reports to unit leaders quarterly, including rates of in‐hospital mortality, blood stream infections, patient satisfaction, length of stay, and 30‐day readmissions. Preparation of these reports was labor intensive, requiring the analyst to acquire raw data from multiple data sources and to build the reports manually.
Results
In an analysis comparing outcomes for every patient spending at least 1 night on the unit in the year before and year after implementation, we observed reductions in in‐hospital mortality and length of stay. Unadjusted in‐hospital mortality decreased from 2.3% to 1.1% (P=0.004), with no change in referrals to hospice (5.4% to 4.5%) (P=0.176), and length‐of‐stay decreased from 5.0 to 4.5 days (P=0.001).[19] A complete report of these findings, including an analysis of concurrent control groups is beyond the scope of this article, but here we highlight an effect we observed on ACU leadership and staff from the reduction in in‐hospital mortality.
Effects of the Change
Noting the apparent mortality reduction, ACU leadership encouraged permanent staff and rotating trainees to consider an unexpected death as a never event. Although perhaps self‐evident, before the ACU we had never been organized to reflect on that concept or to use routines to do something about it. The unit considered an unexpected death one where the patient was not actively receiving comfort measures. At the monthly meet and greet, where ACU leadership bring the permanent staff and new rotating trainees together to introduce themselves by first name, the coleaders proposed that unexpected deaths in the month ahead could represent failures to recognize or respond to deterioration, to consider an alternative or under‐treated process, to transfer the patient to a higher level of care, or to deliver more timely and appropriate end‐of‐life care. It is our impression that this introspection was extraordinarily meaningful and would not have occurred without unit‐based teams, unit‐level performance data, and ACU leadership learning to utilize this rhetoric.
Unit‐Level Nurse and Physician Coleadership
Design
Effective leadership is a major driver of successful clinical microsystems.[20] The ACU is designed to be co‐led by a nurse unit manager and physician medical director. The leadership pair was charged simply with developing patient‐centered teams and ensuring the staff felt connected to the values of the organization and accountable to each other and the outcomes of the unit.
Implementation
Nursing leadership and hospital executives influenced the selection of the physician medical director, which was a way for them to demonstrate support for the care model. Over the first 4 years, the physician medical director position has been afforded a 10% to 20% reduction in clinical duties to fulfill the charge. The leadership pair sets expectations for the ACU's code of conduct, standard operating procedures (eg, SIBR), and best‐practice protocols.
Results
The leadership pair tries explicitly to role model the behaviors enumerated in the ACU's relational covenant, itself the product of a facilitated exercise they commissioned in the first year in which the entire staff drafted and signed a document listing behaviors they wished to see from each other (see Supporting Information, Appendix 1, in the online version of this article). The physician medical director, along with charge nurses, coach staff and trainees wishing to achieve SIBR certification. Over the 4 years, the pair has introduced best‐practice protocols for glycemic control, venous thromboembolism prophylaxis, removal of idle venous and bladder catheters, and bedside goals‐of‐care conversations.
Effects of the Change
Where there had previously been no explicit code of conduct, standard operating procedures such as SIBR, or focused efforts to optimize unit outcomes, the coleadership pair fills a management gap. These coleaders play an essential role in building momentum for the structure and processes of the ACU. The leadership pair has also become a primary resource for intraorganizational spread of the ACU model to medical and surgical wards, as well as geriatric, long‐term acute, and intensive care units.
CHALLENGES
Challenges with implementing the ACU fell into 3 primary categories: (1) performing change management required for a successful launch, (2) solving logistics of maintaining unit‐based physician teams, and (3) training physicians and nurses to perform SIBR at a high level.
For change management, the leadership pair was able to explain the rationale of the model to all staff in sufficient detail to launch the ACU. To build momentum for ACU routines and relationships, the physician leader and the nurse unit manager were both present on the unit daily for the first 100 days. As ACU operations became routine and competencies formed among clinicians, the amount of time spent by these leaders was de‐escalated.
Creating and maintaining unit‐based physician teams required shared understanding and coordination between on‐call hospital medicine physicians and the bed control office so that new admissions or transfers could be consistently assigned to unit‐based teams without adversely affecting patient flow. We found this challenge to be manageable once stakeholders accepted the rationale for the care mode and figured out how to support it.
The challenge of building high‐performance SIBR across the unit, including competence of rotating trainees new to the model, requires individualized assessment and feedback necessary for SIBR certification. We addressed this challenge by creating a SIBR train‐the‐trainer programa list of observable high‐performance SIBR behaviors coupled with a short course about giving effective feedback to learnersand found that once the ACU had several nurse and physician SIBR trainers in the staffing mix every day, the required amount of SIBR coaching expertise was available when needed.
CONCLUSION
Improving value and reliability in hospital care may require new models of care. The ACU is a hospital care model specifically designed to organize physicians, nurses, and allied health professionals into high‐functioning, unit‐based teams. It converges standard workflow, patient‐centered communication, quality‐safety checklists, best‐practice protocols, performance measurement, and progressive leadership. Our experience with the ACU suggests that hospital units can be reorganized as effective clinical microsystems where consistent unit professionals can share time and space, a sense of purpose, code of conduct, shared mental model for teamwork, an interprofessional management structure, and an important level of accountability to each other and their patients.
Disclosures: Jason Stein, MD: grant support from the US Health & Resources Services Administration to support organizational implementation of the care model described; recipient of consulting fees and royalties for licensed intellectual property to support implementation of the care model described; founder and president of nonprofit Centripital, provider of consulting services to hospital systems implementing the care model described. The terms of this arrangement have been reviewed and approved by Emory University in accordance with its conflict of interest policies. Liam Chadwick, PhD, and Diaz Clark, MS, RN: recipients of consulting fees through Centripital to support implementation of the care model described. Bryan W. Castle, MBA, RN: grant support from the US Health & Resources Services Administration to support organizational implementation of the care model described; recipient of consulting fees through Centripital to support implementation of the care model described. The authors report no other conflicts of interest.
- Institute of Medicine. Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press; 2001.
- , , . The triple aim: care, health, and cost. Health Aff (Millwood). 2008;27(3):759–769.
- . The end of the beginning: patient safety five years after “to err is human”. Health Aff (Millwood). 2004;Suppl Web Exclusives:W4‐534–545.
- , , , et al. Clinical inertia. Ann Intern Med. 2001;135(9):825–834.
- . The four habits of high‐value health care organizations. N Engl J Med. 2011;365(22):2045–2047.
- , , , . Using a Malcolm Baldrige framework to understand high‐performing clinical microsystems. Qual Saf Health Care. 2007;16(5):334–341.
- , , , . Relational coordination among nurses and other providers: impact on the quality of patient care. J Nurs Manag. 2010;18(8):926–937.
- , , , et al. Unit‐based care teams and the frequency and quality of physician‐nurse communications. Arch Pediatr Adolesc Med. 2011;165(5):424–428.
- , , , et al. Reducing cardiac arrests in the acute admissions unit: a quality improvement journey. BMJ Qual Saf. 2013;22(12):1025–1031.
- , , , et al. Evolving practice of hospital medicine and its impact on hospital throughput and efficiencies. J Hosp Med. 2012;7(8):649–654.
- , . Improvement projects led by unit‐based teams of nurse, physician, and quality leaders reduce infections, lower costs, improve patient satisfaction, and nurse‐physician communication. AHRQ Health Care Innovations Exchange. Available at: https://innovations.ahrq.gov/profiles/improvement‐projects‐led‐unit‐based‐teams‐nurse‐physician‐and‐quality‐leaders‐reduce. Accessed May 4, 2014.
- , , , , . The daily goals communication sheet: a simple and novel tool for improved communication and care. Jt Comm J Qual Patient Saf. 2008;34(10):608–613, 561.
- , , , et al. Implementation of a mandatory checklist of protocols and objectives improves compliance with a wide range of evidence‐based intensive care unit practices. Crit Care Med. 2009;37(10):2775–2781.
- , , , et al. Structured interdisciplinary rounds in a medical teaching unit: improving patient safety. Arch Intern Med. 2011;171(7):678–684.
- , , , , , . Improving teamwork: impact of structured interdisciplinary rounds on a hospitalist unit. J Hosp Med. 2011;6(2):88–93.
- , , . Integrating patient safety into the clinical microsystem. Qual Saf Health Care. 2004;13(suppl 2):ii34–ii38.
- , , , . Collaborative‐cross checking to enhance resilience. Cogn Tech Work. 2007;9:155–162.
- , , , et al. Microsystems in health care: Part 1. Learning from high‐performing front‐line clinical units. Jt Comm J Qual Improv. 2002;28(9):472–493.
- , , . Mortality reduction associated with structure process, and management redesign of a hospital medicine unit. J Hosp Med. 2012;7(suppl 2):115.
- , , , et al. Microsystems in health care: part 5. How leaders are leading. Jt Comm J Qual Saf. 2003;29(6):297–308.
- Institute of Medicine. Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press; 2001.
- , , . The triple aim: care, health, and cost. Health Aff (Millwood). 2008;27(3):759–769.
- . The end of the beginning: patient safety five years after “to err is human”. Health Aff (Millwood). 2004;Suppl Web Exclusives:W4‐534–545.
- , , , et al. Clinical inertia. Ann Intern Med. 2001;135(9):825–834.
- . The four habits of high‐value health care organizations. N Engl J Med. 2011;365(22):2045–2047.
- , , , . Using a Malcolm Baldrige framework to understand high‐performing clinical microsystems. Qual Saf Health Care. 2007;16(5):334–341.
- , , , . Relational coordination among nurses and other providers: impact on the quality of patient care. J Nurs Manag. 2010;18(8):926–937.
- , , , et al. Unit‐based care teams and the frequency and quality of physician‐nurse communications. Arch Pediatr Adolesc Med. 2011;165(5):424–428.
- , , , et al. Reducing cardiac arrests in the acute admissions unit: a quality improvement journey. BMJ Qual Saf. 2013;22(12):1025–1031.
- , , , et al. Evolving practice of hospital medicine and its impact on hospital throughput and efficiencies. J Hosp Med. 2012;7(8):649–654.
- , . Improvement projects led by unit‐based teams of nurse, physician, and quality leaders reduce infections, lower costs, improve patient satisfaction, and nurse‐physician communication. AHRQ Health Care Innovations Exchange. Available at: https://innovations.ahrq.gov/profiles/improvement‐projects‐led‐unit‐based‐teams‐nurse‐physician‐and‐quality‐leaders‐reduce. Accessed May 4, 2014.
- , , , , . The daily goals communication sheet: a simple and novel tool for improved communication and care. Jt Comm J Qual Patient Saf. 2008;34(10):608–613, 561.
- , , , et al. Implementation of a mandatory checklist of protocols and objectives improves compliance with a wide range of evidence‐based intensive care unit practices. Crit Care Med. 2009;37(10):2775–2781.
- , , , et al. Structured interdisciplinary rounds in a medical teaching unit: improving patient safety. Arch Intern Med. 2011;171(7):678–684.
- , , , , , . Improving teamwork: impact of structured interdisciplinary rounds on a hospitalist unit. J Hosp Med. 2011;6(2):88–93.
- , , . Integrating patient safety into the clinical microsystem. Qual Saf Health Care. 2004;13(suppl 2):ii34–ii38.
- , , , . Collaborative‐cross checking to enhance resilience. Cogn Tech Work. 2007;9:155–162.
- , , , et al. Microsystems in health care: Part 1. Learning from high‐performing front‐line clinical units. Jt Comm J Qual Improv. 2002;28(9):472–493.
- , , . Mortality reduction associated with structure process, and management redesign of a hospital medicine unit. J Hosp Med. 2012;7(suppl 2):115.
- , , , et al. Microsystems in health care: part 5. How leaders are leading. Jt Comm J Qual Saf. 2003;29(6):297–308.
Telephone CPR training boosts cardiac arrest survival
CHICAGO – Systematic implementation of a comprehensive telephone CPR bundle of care targeting EMS dispatch services resulted in substantial improvements in rates of survival to hospital discharge with good neurologic outcomes in patients with out-of-hospital cardiac arrest in a major Arizona statewide public health initiative.
How big was the intervention’s impact? The rate of survival to hospital discharge showed a 33% relative increase compared to preintervention, and survival with a favorable Cerebral Performance Category score of 0 or 1 increased by 42%, Dr. Bentley J. Bobrow reported at the American Heart Association Scientific Sessions.
“These results suggest that when deliberately implemented and measured, telephone CPR is a targeted, effective method to increase bystander CPR and survival on a vast scale with minimal capital expense. This is why we believe telephone CPR along with public training may be the most efficient way to move the needle on cardiac arrest survival,” declared Dr. Bobrow, professor of emergency medicine at the University of Arizona College of Medicine-Phoenix Campus and chair of the AHA Basic Life Support Subcommittee.
Telephone CPR (T-CPR) entails the provision of CPR instruction to bystanders who have called 911 regarding an out of hospital cardiac arrest (OHCA). It’s well established that bystander CPR commenced before EMS personnel arrive on the scene doubles or even triples OHCA survival, but it is provided in only about one-third of OHCA events. And while T-CPR is independently associated with increased rates of bystander CPR as well as patient survival, its utilization varies widely throughout the country and few EMS services measure performance.
Dr. Bobrow reported on an ambitious undertaking that involved systematic training in T-CPR for dispatchers, 911 managers, and medical directors at all nine of the regional emergency dispatch centers in Arizona, which together with 190 EMS agencies and 40 cardiac care hospitals participate in a statewide resuscitation program.
The training was designed to implement the latest AHA guidelines on T-CPR (Circulation 2012;125:648-55). The program entailed a half-day in-person training session plus completion of a 1-hour web-based interactive video. The protocol emphasizes asking two key questions of the 911 caller: “Is the patient conscious?” and “Is the patient breathing normally?” If the response is no to both, the dispatcher is to start issuing bystander CPR instructions without delay – no further questions – and continue the coaching until EMS personnel arrive on the scene to take over.
A core aspect of the T-CPR bundle is performance measurement for quality improvement, with auditing of 911 calls to learn the time from the start of the call to the bystander’s first chest compression and five other key performance metrics. Feedback is provided to the 911 call center regarding system- and case-level performance reports in a continuing education, quality improvement process. Individual dispatchers are singled out for exemplary performance, Dr. Bobrow explained.
He presented a prospective before-and-after study conducted at the three EMS dispatch centers serving Arizona’s Maricopa County, home to two-thirds of the state’s population. The study entailed auditing nearly 6,000 911 calls, each averaging 6.5 minutes in length. After excluding calls where CPR wasn’t indicated or the OHCA involved a patient less than 8 years old, investigators were left with two groups for comparison comprised of 1,289 pre- and 2,330 post-intervention events.
The improvements in process and clinical outcomes were dramatic. In 2012, after introduction of the T-CPR training program, the bystander CPR rate crossed the 50% threshold for the first time ever in Maricopa County. The rate of survival of OHCA to hospital discharge improved from 8.3% to 11%, a highly statistically significant 33% relative increase. Survival with a Cerebral Performance Category score of 0 or 1 climbed from 5.5% to 7.8%, a 42% relative increase. In a multivariate analysis adjusted for potential confounders, the adjusted odds ratio for survival of OHCA was 2.25-fold greater for all cases after implementation of the T-CPR program and similarly increased for arrests of cardiac origin.
Dr. Bobrow observed that this was not a randomized trial, which he considered would be both unethical and impractical.
“We controlled for known risk factors and confounders, and while we cannot prove that better outcomes resulted directly from the process improvements, the two are independently associated in this controlled study,” said the emergency physician, who is medical director of the Bureau of Emergency Medical Services and Trauma Systems at the Arizona Dept. of Health Services.
Audience members rose to praise the “fantastic” achievements in Arizona and ask why they’re not having similar success rates in their own districts, given that the AHA guidelines are readily available.
“A lot of places say they’re doing this,” Dr. Bobrow replied, “but when they realize what ‘this’ is, they understand that they really weren’t doing it in this type of depth. When we showed them the data on how marginal their performance was, I think that really made the difference.”
“I think that once most dispatch centers really understand the issues and their importance and the power that they have, and you can engage them, I’m confident that people would see the same changes,” he added.
His study was honored as the best oral abstract presentation at the AHA resuscitation science symposium.
Dr. Bobrow reported serving as co-principal investigator of the HeartRescue Project, funded by Medtronic Philanthropy.
CHICAGO – Systematic implementation of a comprehensive telephone CPR bundle of care targeting EMS dispatch services resulted in substantial improvements in rates of survival to hospital discharge with good neurologic outcomes in patients with out-of-hospital cardiac arrest in a major Arizona statewide public health initiative.
How big was the intervention’s impact? The rate of survival to hospital discharge showed a 33% relative increase compared to preintervention, and survival with a favorable Cerebral Performance Category score of 0 or 1 increased by 42%, Dr. Bentley J. Bobrow reported at the American Heart Association Scientific Sessions.
“These results suggest that when deliberately implemented and measured, telephone CPR is a targeted, effective method to increase bystander CPR and survival on a vast scale with minimal capital expense. This is why we believe telephone CPR along with public training may be the most efficient way to move the needle on cardiac arrest survival,” declared Dr. Bobrow, professor of emergency medicine at the University of Arizona College of Medicine-Phoenix Campus and chair of the AHA Basic Life Support Subcommittee.
Telephone CPR (T-CPR) entails the provision of CPR instruction to bystanders who have called 911 regarding an out of hospital cardiac arrest (OHCA). It’s well established that bystander CPR commenced before EMS personnel arrive on the scene doubles or even triples OHCA survival, but it is provided in only about one-third of OHCA events. And while T-CPR is independently associated with increased rates of bystander CPR as well as patient survival, its utilization varies widely throughout the country and few EMS services measure performance.
Dr. Bobrow reported on an ambitious undertaking that involved systematic training in T-CPR for dispatchers, 911 managers, and medical directors at all nine of the regional emergency dispatch centers in Arizona, which together with 190 EMS agencies and 40 cardiac care hospitals participate in a statewide resuscitation program.
The training was designed to implement the latest AHA guidelines on T-CPR (Circulation 2012;125:648-55). The program entailed a half-day in-person training session plus completion of a 1-hour web-based interactive video. The protocol emphasizes asking two key questions of the 911 caller: “Is the patient conscious?” and “Is the patient breathing normally?” If the response is no to both, the dispatcher is to start issuing bystander CPR instructions without delay – no further questions – and continue the coaching until EMS personnel arrive on the scene to take over.
A core aspect of the T-CPR bundle is performance measurement for quality improvement, with auditing of 911 calls to learn the time from the start of the call to the bystander’s first chest compression and five other key performance metrics. Feedback is provided to the 911 call center regarding system- and case-level performance reports in a continuing education, quality improvement process. Individual dispatchers are singled out for exemplary performance, Dr. Bobrow explained.
He presented a prospective before-and-after study conducted at the three EMS dispatch centers serving Arizona’s Maricopa County, home to two-thirds of the state’s population. The study entailed auditing nearly 6,000 911 calls, each averaging 6.5 minutes in length. After excluding calls where CPR wasn’t indicated or the OHCA involved a patient less than 8 years old, investigators were left with two groups for comparison comprised of 1,289 pre- and 2,330 post-intervention events.
The improvements in process and clinical outcomes were dramatic. In 2012, after introduction of the T-CPR training program, the bystander CPR rate crossed the 50% threshold for the first time ever in Maricopa County. The rate of survival of OHCA to hospital discharge improved from 8.3% to 11%, a highly statistically significant 33% relative increase. Survival with a Cerebral Performance Category score of 0 or 1 climbed from 5.5% to 7.8%, a 42% relative increase. In a multivariate analysis adjusted for potential confounders, the adjusted odds ratio for survival of OHCA was 2.25-fold greater for all cases after implementation of the T-CPR program and similarly increased for arrests of cardiac origin.
Dr. Bobrow observed that this was not a randomized trial, which he considered would be both unethical and impractical.
“We controlled for known risk factors and confounders, and while we cannot prove that better outcomes resulted directly from the process improvements, the two are independently associated in this controlled study,” said the emergency physician, who is medical director of the Bureau of Emergency Medical Services and Trauma Systems at the Arizona Dept. of Health Services.
Audience members rose to praise the “fantastic” achievements in Arizona and ask why they’re not having similar success rates in their own districts, given that the AHA guidelines are readily available.
“A lot of places say they’re doing this,” Dr. Bobrow replied, “but when they realize what ‘this’ is, they understand that they really weren’t doing it in this type of depth. When we showed them the data on how marginal their performance was, I think that really made the difference.”
“I think that once most dispatch centers really understand the issues and their importance and the power that they have, and you can engage them, I’m confident that people would see the same changes,” he added.
His study was honored as the best oral abstract presentation at the AHA resuscitation science symposium.
Dr. Bobrow reported serving as co-principal investigator of the HeartRescue Project, funded by Medtronic Philanthropy.
CHICAGO – Systematic implementation of a comprehensive telephone CPR bundle of care targeting EMS dispatch services resulted in substantial improvements in rates of survival to hospital discharge with good neurologic outcomes in patients with out-of-hospital cardiac arrest in a major Arizona statewide public health initiative.
How big was the intervention’s impact? The rate of survival to hospital discharge showed a 33% relative increase compared to preintervention, and survival with a favorable Cerebral Performance Category score of 0 or 1 increased by 42%, Dr. Bentley J. Bobrow reported at the American Heart Association Scientific Sessions.
“These results suggest that when deliberately implemented and measured, telephone CPR is a targeted, effective method to increase bystander CPR and survival on a vast scale with minimal capital expense. This is why we believe telephone CPR along with public training may be the most efficient way to move the needle on cardiac arrest survival,” declared Dr. Bobrow, professor of emergency medicine at the University of Arizona College of Medicine-Phoenix Campus and chair of the AHA Basic Life Support Subcommittee.
Telephone CPR (T-CPR) entails the provision of CPR instruction to bystanders who have called 911 regarding an out of hospital cardiac arrest (OHCA). It’s well established that bystander CPR commenced before EMS personnel arrive on the scene doubles or even triples OHCA survival, but it is provided in only about one-third of OHCA events. And while T-CPR is independently associated with increased rates of bystander CPR as well as patient survival, its utilization varies widely throughout the country and few EMS services measure performance.
Dr. Bobrow reported on an ambitious undertaking that involved systematic training in T-CPR for dispatchers, 911 managers, and medical directors at all nine of the regional emergency dispatch centers in Arizona, which together with 190 EMS agencies and 40 cardiac care hospitals participate in a statewide resuscitation program.
The training was designed to implement the latest AHA guidelines on T-CPR (Circulation 2012;125:648-55). The program entailed a half-day in-person training session plus completion of a 1-hour web-based interactive video. The protocol emphasizes asking two key questions of the 911 caller: “Is the patient conscious?” and “Is the patient breathing normally?” If the response is no to both, the dispatcher is to start issuing bystander CPR instructions without delay – no further questions – and continue the coaching until EMS personnel arrive on the scene to take over.
A core aspect of the T-CPR bundle is performance measurement for quality improvement, with auditing of 911 calls to learn the time from the start of the call to the bystander’s first chest compression and five other key performance metrics. Feedback is provided to the 911 call center regarding system- and case-level performance reports in a continuing education, quality improvement process. Individual dispatchers are singled out for exemplary performance, Dr. Bobrow explained.
He presented a prospective before-and-after study conducted at the three EMS dispatch centers serving Arizona’s Maricopa County, home to two-thirds of the state’s population. The study entailed auditing nearly 6,000 911 calls, each averaging 6.5 minutes in length. After excluding calls where CPR wasn’t indicated or the OHCA involved a patient less than 8 years old, investigators were left with two groups for comparison comprised of 1,289 pre- and 2,330 post-intervention events.
The improvements in process and clinical outcomes were dramatic. In 2012, after introduction of the T-CPR training program, the bystander CPR rate crossed the 50% threshold for the first time ever in Maricopa County. The rate of survival of OHCA to hospital discharge improved from 8.3% to 11%, a highly statistically significant 33% relative increase. Survival with a Cerebral Performance Category score of 0 or 1 climbed from 5.5% to 7.8%, a 42% relative increase. In a multivariate analysis adjusted for potential confounders, the adjusted odds ratio for survival of OHCA was 2.25-fold greater for all cases after implementation of the T-CPR program and similarly increased for arrests of cardiac origin.
Dr. Bobrow observed that this was not a randomized trial, which he considered would be both unethical and impractical.
“We controlled for known risk factors and confounders, and while we cannot prove that better outcomes resulted directly from the process improvements, the two are independently associated in this controlled study,” said the emergency physician, who is medical director of the Bureau of Emergency Medical Services and Trauma Systems at the Arizona Dept. of Health Services.
Audience members rose to praise the “fantastic” achievements in Arizona and ask why they’re not having similar success rates in their own districts, given that the AHA guidelines are readily available.
“A lot of places say they’re doing this,” Dr. Bobrow replied, “but when they realize what ‘this’ is, they understand that they really weren’t doing it in this type of depth. When we showed them the data on how marginal their performance was, I think that really made the difference.”
“I think that once most dispatch centers really understand the issues and their importance and the power that they have, and you can engage them, I’m confident that people would see the same changes,” he added.
His study was honored as the best oral abstract presentation at the AHA resuscitation science symposium.
Dr. Bobrow reported serving as co-principal investigator of the HeartRescue Project, funded by Medtronic Philanthropy.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point: Adoption of the most recent AHA guidelines on telephone CPR by EMS dispatchers will lead to vast improvement in survival for patients with out-of-hospital cardiac arrest.
Major finding: Following implementation of an Arizona statewide program to improve telephone CPR by 911 dispatchers to bystanders at the scene of out-of-hospital cardiac arrest, survival to hospital discharge climbed from 8.3% to 11.0%.
Data source: This was a prospective study comparing the outcomes of 1,289 calls to Arizona 911 centers regarding out-of-hospital cardiac arrests before introduction of a comprehensive statewide telephone CPR program to 2,330 calls received post-intervention.
Disclosures: The study was financially supported by Medtronic Philanthropy as part of the HeartRescue Project. The presenter is co-principal investigator of the project.
IL-6 inhibitor helps prevent GVHD
Credit: Chad McNeeley
Adding the interleukin 6 (IL-6) inhibitor tocilizumab can improve standard prophylaxis for graft-vs-host disease (GVHD), researchers have reported in The Lancet Oncology.
IL-6 is the main detectable and dysregulated cytokine secreted after allogeneic stem cell transplant (allo-SCT).
So the researchers theorized that inhibiting IL-6 with tocilizumab might protect patients from acute GVHD despite robust immune reconstitution.
In their phase 1/2 study, the team saw acute GVHD drop from the usual 50% observed in patients receiving standard GVHD prophylaxis to 12% in patients receiving tocilizumab.
“Severe cases—which often result in death—were reduced from 21% to 4%,” said Geoff Hill, MD, of QIMR Berghofer Medical Research Institute in Brisbane, Queensland, Australia.
He and his colleagues enrolled 48 patients in this study. They ranged in age from 18 to 65 and underwent T-replete, HLA-matched, allo-SCT from unrelated or sibling donors. Patients received either total-body-irradiation-based myeloablative conditioning or reduced-intensity conditioning.
As GVHD prophylaxis, patients received a single intravenous dose of tocilizumab (8 mg/kg, capped at 800 mg, over a 60-minute infusion) the day before transplant.
They also received standard GVHD prophylaxis—cyclosporin (5 mg/kg per day on days −1 to +1, then 3 mg/kg per day to maintain therapeutic levels [trough levels of 140-300 ng/mL] for 100 days) and methotrexate (15 mg/m2 on day 1, then 10 mg/m2 on days 3, 6, and 11).
The primary endpoint was the incidence of grade 2-4 acute GVHD at day 100, which was 12%. The incidence of grade 3-4 acute GVHD was 4%.
Five patients (10%) had grade 2-4 acute GVHD involving the skin, and 4 (8%) had grade 2-4 acute GVHD involving the gastrointestinal tract. None of the patients had GVHD involving the liver.
The researchers noted that the rate of grade 2-4 acute GVHD was low regardless of the conditioning regimen a patient received. The rate was 12% for both myeloablative and reduced-intensity conditioning.
In addition, patients’ immune reconstitution was preserved after receiving tocilizumab, but the researchers did observe suppression of known pathogenic STAT3-dependent pathways.
These results represent a significant advance in allo-SCT, according to study author Glen Kennedy, MBBS, also of QIMR Berghofer Medical Research Institute.
“The new therapy has the potential to make transplant safer,” he said, “and applicable to a larger group of patients.”
A phase 3 study of tocilizumab as GVHD prophylaxis is now underway. The drug is currently approved to treat rheumatoid arthritis.
Credit: Chad McNeeley
Adding the interleukin 6 (IL-6) inhibitor tocilizumab can improve standard prophylaxis for graft-vs-host disease (GVHD), researchers have reported in The Lancet Oncology.
IL-6 is the main detectable and dysregulated cytokine secreted after allogeneic stem cell transplant (allo-SCT).
So the researchers theorized that inhibiting IL-6 with tocilizumab might protect patients from acute GVHD despite robust immune reconstitution.
In their phase 1/2 study, the team saw acute GVHD drop from the usual 50% observed in patients receiving standard GVHD prophylaxis to 12% in patients receiving tocilizumab.
“Severe cases—which often result in death—were reduced from 21% to 4%,” said Geoff Hill, MD, of QIMR Berghofer Medical Research Institute in Brisbane, Queensland, Australia.
He and his colleagues enrolled 48 patients in this study. They ranged in age from 18 to 65 and underwent T-replete, HLA-matched, allo-SCT from unrelated or sibling donors. Patients received either total-body-irradiation-based myeloablative conditioning or reduced-intensity conditioning.
As GVHD prophylaxis, patients received a single intravenous dose of tocilizumab (8 mg/kg, capped at 800 mg, over a 60-minute infusion) the day before transplant.
They also received standard GVHD prophylaxis—cyclosporin (5 mg/kg per day on days −1 to +1, then 3 mg/kg per day to maintain therapeutic levels [trough levels of 140-300 ng/mL] for 100 days) and methotrexate (15 mg/m2 on day 1, then 10 mg/m2 on days 3, 6, and 11).
The primary endpoint was the incidence of grade 2-4 acute GVHD at day 100, which was 12%. The incidence of grade 3-4 acute GVHD was 4%.
Five patients (10%) had grade 2-4 acute GVHD involving the skin, and 4 (8%) had grade 2-4 acute GVHD involving the gastrointestinal tract. None of the patients had GVHD involving the liver.
The researchers noted that the rate of grade 2-4 acute GVHD was low regardless of the conditioning regimen a patient received. The rate was 12% for both myeloablative and reduced-intensity conditioning.
In addition, patients’ immune reconstitution was preserved after receiving tocilizumab, but the researchers did observe suppression of known pathogenic STAT3-dependent pathways.
These results represent a significant advance in allo-SCT, according to study author Glen Kennedy, MBBS, also of QIMR Berghofer Medical Research Institute.
“The new therapy has the potential to make transplant safer,” he said, “and applicable to a larger group of patients.”
A phase 3 study of tocilizumab as GVHD prophylaxis is now underway. The drug is currently approved to treat rheumatoid arthritis.
Credit: Chad McNeeley
Adding the interleukin 6 (IL-6) inhibitor tocilizumab can improve standard prophylaxis for graft-vs-host disease (GVHD), researchers have reported in The Lancet Oncology.
IL-6 is the main detectable and dysregulated cytokine secreted after allogeneic stem cell transplant (allo-SCT).
So the researchers theorized that inhibiting IL-6 with tocilizumab might protect patients from acute GVHD despite robust immune reconstitution.
In their phase 1/2 study, the team saw acute GVHD drop from the usual 50% observed in patients receiving standard GVHD prophylaxis to 12% in patients receiving tocilizumab.
“Severe cases—which often result in death—were reduced from 21% to 4%,” said Geoff Hill, MD, of QIMR Berghofer Medical Research Institute in Brisbane, Queensland, Australia.
He and his colleagues enrolled 48 patients in this study. They ranged in age from 18 to 65 and underwent T-replete, HLA-matched, allo-SCT from unrelated or sibling donors. Patients received either total-body-irradiation-based myeloablative conditioning or reduced-intensity conditioning.
As GVHD prophylaxis, patients received a single intravenous dose of tocilizumab (8 mg/kg, capped at 800 mg, over a 60-minute infusion) the day before transplant.
They also received standard GVHD prophylaxis—cyclosporin (5 mg/kg per day on days −1 to +1, then 3 mg/kg per day to maintain therapeutic levels [trough levels of 140-300 ng/mL] for 100 days) and methotrexate (15 mg/m2 on day 1, then 10 mg/m2 on days 3, 6, and 11).
The primary endpoint was the incidence of grade 2-4 acute GVHD at day 100, which was 12%. The incidence of grade 3-4 acute GVHD was 4%.
Five patients (10%) had grade 2-4 acute GVHD involving the skin, and 4 (8%) had grade 2-4 acute GVHD involving the gastrointestinal tract. None of the patients had GVHD involving the liver.
The researchers noted that the rate of grade 2-4 acute GVHD was low regardless of the conditioning regimen a patient received. The rate was 12% for both myeloablative and reduced-intensity conditioning.
In addition, patients’ immune reconstitution was preserved after receiving tocilizumab, but the researchers did observe suppression of known pathogenic STAT3-dependent pathways.
These results represent a significant advance in allo-SCT, according to study author Glen Kennedy, MBBS, also of QIMR Berghofer Medical Research Institute.
“The new therapy has the potential to make transplant safer,” he said, “and applicable to a larger group of patients.”
A phase 3 study of tocilizumab as GVHD prophylaxis is now underway. The drug is currently approved to treat rheumatoid arthritis.
Will US lift ban on MSM blood donation?
Credit: Daniel Gay
A committee that advises the US Department of Health and Human Services (HHS) has recommended changing the policy that prevents men who have sex with men (MSM) from donating blood.
The Advisory Committee on Blood and Tissue Safety and Availability decided MSM should be allowed to donate blood if they have abstained from sex for a year.
A group of advisers to the US Food and Drug Administration (FDA) will consider this recommendation in a meeting on December 2.
The HHS advisory committee plans to meet on December 5 to discuss establishing a donor transfusion-transmissible infection-monitoring system. The HHS has said such a system should be put in place before lifting the lifetime ban on MSM blood donation.
Should the FDA decide to change its policy, the US would follow other countries that have lifted the lifetime ban in recent years.
For instance, MSM in the UK and Australia are now allowed to donate blood if they have been celibate for a year, MSM in Canada must be celibate for 5 years, and MSM in South Africa can donate if they have been celibate or in a monogamous relationship for 6 months.
The safety of the blood supply
Lifting the lifetime ban on MSM blood donors may raise concerns about the safety of the blood supply, with transfusion recipients worrying they will have a greater risk of contracting HIV.
Although donated blood is tested for HIV, there is an 11-day window in which current tests cannot detect the virus in people who just contracted it. And MSM are more severely affected by HIV than any other group in the US, according to the Centers for Disease Control and Prevention.
Of course, deferring MSM donation for a year would allow enough time for HIV to be strong enough for tests to detect the virus. However, that assumes that donors are telling the truth about their sexual practices.
A study of more than 1000 MSM in Britain showed that 11% had donated blood after having penetrative sex with a man, and 3% had done so in the past 12 months, despite the lifetime ban on MSM blood donation. The study was conducted before the UK lifted the ban.
Still, study investigators said the results supported lifting the lifetime ban on MSM because men who did not comply with the ban generally said they would comply with a 1-year deferral period.
The AABB, America’s Blood Centers, and the American Red Cross have said they support a 1-year deferral period for MSM who want to donate blood in the US.
“This change in policy would align the donor deferral period for MSM with criteria for other activities that may pose a similar risk of transfusion-transmissible infections,” the groups said.
“We believe the current FDA indefinite blood donation deferral for a man who has sex with another man since 1977 is medically and scientifically unwarranted. The blood banking community strongly supports the use of rational, scientifically based deferral periods that are applied fairly and consistently among blood donors who engage in similar-risk activities.”
A report by the Williams Institute suggested that, if the FDA were to lift the ban on MSM completely, an additional 360,600 men could donate 615,300 additional pints of blood each year.
On the other hand, an HHS report suggested that the US supply of blood units is already surpassing demand. The report showed that 15.7 million units of whole blood and red blood cells were collected in 2011, and the total number of units transfused was 13.8 million.
Credit: Daniel Gay
A committee that advises the US Department of Health and Human Services (HHS) has recommended changing the policy that prevents men who have sex with men (MSM) from donating blood.
The Advisory Committee on Blood and Tissue Safety and Availability decided MSM should be allowed to donate blood if they have abstained from sex for a year.
A group of advisers to the US Food and Drug Administration (FDA) will consider this recommendation in a meeting on December 2.
The HHS advisory committee plans to meet on December 5 to discuss establishing a donor transfusion-transmissible infection-monitoring system. The HHS has said such a system should be put in place before lifting the lifetime ban on MSM blood donation.
Should the FDA decide to change its policy, the US would follow other countries that have lifted the lifetime ban in recent years.
For instance, MSM in the UK and Australia are now allowed to donate blood if they have been celibate for a year, MSM in Canada must be celibate for 5 years, and MSM in South Africa can donate if they have been celibate or in a monogamous relationship for 6 months.
The safety of the blood supply
Lifting the lifetime ban on MSM blood donors may raise concerns about the safety of the blood supply, with transfusion recipients worrying they will have a greater risk of contracting HIV.
Although donated blood is tested for HIV, there is an 11-day window in which current tests cannot detect the virus in people who just contracted it. And MSM are more severely affected by HIV than any other group in the US, according to the Centers for Disease Control and Prevention.
Of course, deferring MSM donation for a year would allow enough time for HIV to be strong enough for tests to detect the virus. However, that assumes that donors are telling the truth about their sexual practices.
A study of more than 1000 MSM in Britain showed that 11% had donated blood after having penetrative sex with a man, and 3% had done so in the past 12 months, despite the lifetime ban on MSM blood donation. The study was conducted before the UK lifted the ban.
Still, study investigators said the results supported lifting the lifetime ban on MSM because men who did not comply with the ban generally said they would comply with a 1-year deferral period.
The AABB, America’s Blood Centers, and the American Red Cross have said they support a 1-year deferral period for MSM who want to donate blood in the US.
“This change in policy would align the donor deferral period for MSM with criteria for other activities that may pose a similar risk of transfusion-transmissible infections,” the groups said.
“We believe the current FDA indefinite blood donation deferral for a man who has sex with another man since 1977 is medically and scientifically unwarranted. The blood banking community strongly supports the use of rational, scientifically based deferral periods that are applied fairly and consistently among blood donors who engage in similar-risk activities.”
A report by the Williams Institute suggested that, if the FDA were to lift the ban on MSM completely, an additional 360,600 men could donate 615,300 additional pints of blood each year.
On the other hand, an HHS report suggested that the US supply of blood units is already surpassing demand. The report showed that 15.7 million units of whole blood and red blood cells were collected in 2011, and the total number of units transfused was 13.8 million.
Credit: Daniel Gay
A committee that advises the US Department of Health and Human Services (HHS) has recommended changing the policy that prevents men who have sex with men (MSM) from donating blood.
The Advisory Committee on Blood and Tissue Safety and Availability decided MSM should be allowed to donate blood if they have abstained from sex for a year.
A group of advisers to the US Food and Drug Administration (FDA) will consider this recommendation in a meeting on December 2.
The HHS advisory committee plans to meet on December 5 to discuss establishing a donor transfusion-transmissible infection-monitoring system. The HHS has said such a system should be put in place before lifting the lifetime ban on MSM blood donation.
Should the FDA decide to change its policy, the US would follow other countries that have lifted the lifetime ban in recent years.
For instance, MSM in the UK and Australia are now allowed to donate blood if they have been celibate for a year, MSM in Canada must be celibate for 5 years, and MSM in South Africa can donate if they have been celibate or in a monogamous relationship for 6 months.
The safety of the blood supply
Lifting the lifetime ban on MSM blood donors may raise concerns about the safety of the blood supply, with transfusion recipients worrying they will have a greater risk of contracting HIV.
Although donated blood is tested for HIV, there is an 11-day window in which current tests cannot detect the virus in people who just contracted it. And MSM are more severely affected by HIV than any other group in the US, according to the Centers for Disease Control and Prevention.
Of course, deferring MSM donation for a year would allow enough time for HIV to be strong enough for tests to detect the virus. However, that assumes that donors are telling the truth about their sexual practices.
A study of more than 1000 MSM in Britain showed that 11% had donated blood after having penetrative sex with a man, and 3% had done so in the past 12 months, despite the lifetime ban on MSM blood donation. The study was conducted before the UK lifted the ban.
Still, study investigators said the results supported lifting the lifetime ban on MSM because men who did not comply with the ban generally said they would comply with a 1-year deferral period.
The AABB, America’s Blood Centers, and the American Red Cross have said they support a 1-year deferral period for MSM who want to donate blood in the US.
“This change in policy would align the donor deferral period for MSM with criteria for other activities that may pose a similar risk of transfusion-transmissible infections,” the groups said.
“We believe the current FDA indefinite blood donation deferral for a man who has sex with another man since 1977 is medically and scientifically unwarranted. The blood banking community strongly supports the use of rational, scientifically based deferral periods that are applied fairly and consistently among blood donors who engage in similar-risk activities.”
A report by the Williams Institute suggested that, if the FDA were to lift the ban on MSM completely, an additional 360,600 men could donate 615,300 additional pints of blood each year.
On the other hand, an HHS report suggested that the US supply of blood units is already surpassing demand. The report showed that 15.7 million units of whole blood and red blood cells were collected in 2011, and the total number of units transfused was 13.8 million.
Kidney donors at greater risk of preeclampsia, gestational hypertension
Women who donate a kidney are almost two and a half times more likely than are nondonors to have preeclampsia or gestational hypertension in pregnancy, according to a study presented at Kidney Week 2014 and published online simultaneously in the New England Journal of Medicine.
“Information on this potential risk should be included in clinical practice guidelines, shared in the informed-consent processes for potential donors and their recipients when a woman has reproductive potential, and used to guide the care of pregnant donors,” wrote the study authors, led by Dr. Amit X. Garg at the London Kidney Research Unit in London, Ont. (N. Engl. J. Med. 2014 Nov. 14 [doi:10.1056/NEJMoa1408932]).
The Canadian retrospective study matched 85 living kidney donors in a 1:6 ratio with 510 healthy nondonors and followed them for almost 11 years. During this time, 131 pregnancies occurred in the donor group and 788 in the nondonor group.
Gestational hypertension or preeclampsia was diagnosed in 15 donors and 38 nondonors (11% vs. 5%, odds ratio for donors, 2.4; 95% confidence interval, 1.2 to 5.0; P = .01), the investigators reported.
No significant differences were observed between groups for other maternal or fetal outcomes, and there were no maternal or perinatal deaths in the study that was part of the Donor Nephrectomy Outcomes Research Network (DONOR).
However, they noted that the study included limitations, such as not recording body mass index, medication use, or the race of study participants.
Confidence intervals for risk estimates also were wide, and physicians used clinical judgment when applying accepted diagnostic criteria for gestational hypertension and preeclampsia.
“It remains possible that gestational hypertension and preeclampsia were more likely to be diagnosed and recorded among donors than nondonors despite similar clinical presentations in two groups,” the investigators wrote.
“There may be a role for government programs to cover the costs of recommended pregnancy care for donors who lack health insurance, including any costs related to the treatment of hypertension,” they added.
The meeting was sponsored by the American Society of Nephrology. The study was supported by a grant from the Canadian Institute of Health Research as well as several other research institutions. Dr. Garg received grants from Astellas and Roche outside this study. Several other authors received grants from a number companies outside this study, while the remainder of the authors had no relevant disclosures.
Women who donate a kidney are almost two and a half times more likely than are nondonors to have preeclampsia or gestational hypertension in pregnancy, according to a study presented at Kidney Week 2014 and published online simultaneously in the New England Journal of Medicine.
“Information on this potential risk should be included in clinical practice guidelines, shared in the informed-consent processes for potential donors and their recipients when a woman has reproductive potential, and used to guide the care of pregnant donors,” wrote the study authors, led by Dr. Amit X. Garg at the London Kidney Research Unit in London, Ont. (N. Engl. J. Med. 2014 Nov. 14 [doi:10.1056/NEJMoa1408932]).
The Canadian retrospective study matched 85 living kidney donors in a 1:6 ratio with 510 healthy nondonors and followed them for almost 11 years. During this time, 131 pregnancies occurred in the donor group and 788 in the nondonor group.
Gestational hypertension or preeclampsia was diagnosed in 15 donors and 38 nondonors (11% vs. 5%, odds ratio for donors, 2.4; 95% confidence interval, 1.2 to 5.0; P = .01), the investigators reported.
No significant differences were observed between groups for other maternal or fetal outcomes, and there were no maternal or perinatal deaths in the study that was part of the Donor Nephrectomy Outcomes Research Network (DONOR).
However, they noted that the study included limitations, such as not recording body mass index, medication use, or the race of study participants.
Confidence intervals for risk estimates also were wide, and physicians used clinical judgment when applying accepted diagnostic criteria for gestational hypertension and preeclampsia.
“It remains possible that gestational hypertension and preeclampsia were more likely to be diagnosed and recorded among donors than nondonors despite similar clinical presentations in two groups,” the investigators wrote.
“There may be a role for government programs to cover the costs of recommended pregnancy care for donors who lack health insurance, including any costs related to the treatment of hypertension,” they added.
The meeting was sponsored by the American Society of Nephrology. The study was supported by a grant from the Canadian Institute of Health Research as well as several other research institutions. Dr. Garg received grants from Astellas and Roche outside this study. Several other authors received grants from a number companies outside this study, while the remainder of the authors had no relevant disclosures.
Women who donate a kidney are almost two and a half times more likely than are nondonors to have preeclampsia or gestational hypertension in pregnancy, according to a study presented at Kidney Week 2014 and published online simultaneously in the New England Journal of Medicine.
“Information on this potential risk should be included in clinical practice guidelines, shared in the informed-consent processes for potential donors and their recipients when a woman has reproductive potential, and used to guide the care of pregnant donors,” wrote the study authors, led by Dr. Amit X. Garg at the London Kidney Research Unit in London, Ont. (N. Engl. J. Med. 2014 Nov. 14 [doi:10.1056/NEJMoa1408932]).
The Canadian retrospective study matched 85 living kidney donors in a 1:6 ratio with 510 healthy nondonors and followed them for almost 11 years. During this time, 131 pregnancies occurred in the donor group and 788 in the nondonor group.
Gestational hypertension or preeclampsia was diagnosed in 15 donors and 38 nondonors (11% vs. 5%, odds ratio for donors, 2.4; 95% confidence interval, 1.2 to 5.0; P = .01), the investigators reported.
No significant differences were observed between groups for other maternal or fetal outcomes, and there were no maternal or perinatal deaths in the study that was part of the Donor Nephrectomy Outcomes Research Network (DONOR).
However, they noted that the study included limitations, such as not recording body mass index, medication use, or the race of study participants.
Confidence intervals for risk estimates also were wide, and physicians used clinical judgment when applying accepted diagnostic criteria for gestational hypertension and preeclampsia.
“It remains possible that gestational hypertension and preeclampsia were more likely to be diagnosed and recorded among donors than nondonors despite similar clinical presentations in two groups,” the investigators wrote.
“There may be a role for government programs to cover the costs of recommended pregnancy care for donors who lack health insurance, including any costs related to the treatment of hypertension,” they added.
The meeting was sponsored by the American Society of Nephrology. The study was supported by a grant from the Canadian Institute of Health Research as well as several other research institutions. Dr. Garg received grants from Astellas and Roche outside this study. Several other authors received grants from a number companies outside this study, while the remainder of the authors had no relevant disclosures.
FROM KIDNEY WEEK 2014
Key clinical point: Information on an increased risk for preeclampsia and gestational hypertension should be included in clinical practice guidelines and in informed-consent processes for potential kidney donors and their recipients.
Major finding: Women who donate a kidney are almost two and a half times more likely than are nondonors to have preeclampsia or gestational hypertension in pregnancy.
Data source: Retrospective cohort study of 85 kidney donors who were matched on a 1:6 ratio with 510 healthy nondonors and followed for a median of 10.9 years.
Disclosures:Dr. Garg received grants from Astellas and Roche outside this study. Several other authors received grants from a number companies outside this study, while the remainder of the authors had no relevant disclosures. The study was supported by a grant from the Canadian Institute of Health Research as well as several other research institutions. The meeting was sponsored by the American Society of Nephrology.
