General Surgery

Tedizolid, an oxazolidinone antibacterial drug, has been approved as an intravenous and oral treatment for acute bacterial skin and skin structure infections caused by gram positive bacteria, the Food and Drug Administration announced on June 20.

Tedizolid (Sivextro) is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by methicillin-resistant and methicillin-susceptible strains of Staphylococcus aureus, various streptococcus species, and Enterococcus faecalis.

At a meeting in March, the FDA’s Anti-infective Drugs Advisory Committee unanimously recommended that tedizolid be approved. The drug is the second new antibacterial drug to be approved by the FDA in the past month to treat ABSSSI. On May 23, the agency approved dalbavancin (Dalvance) to treat patients with ABSSSI caused by Staphylococcus aureus and various streptococcus species. Both drugs were designated as qualified infectious disease products, allowing them an additional 5 years of marketing exclusivity.

Tedizolid’s safety and efficacy were evaluated and shown to be as effective as linezolid in two clinical trials with 1,315 adults randomly assigned to receive tedizolid or linezolid.

One of the phase III studies, the ESTABLISH-2 study, an international, randomized study, compared 6 days of treatment with intravenous tedizolid to 10 days of treatment with IV linezolid in 666 patients with acute bacterial skin and skin structure infections, with the option of switching to oral treatment. The lesions were at least 75 cm² in size, and were known to be or were suspected to be associated with gram-positive bacteria. Half the patients had cellulitis, 20% had a major cutaneous abscess, and about 30% had an infected wound; about 27% had MRSA.

The primary endpoint, an early clinical response (at least a 20% reduction in the lesion area 48-72 hours after starting treatment), was achieved by 85% of those treated with tedizolid and by 83% of those treated with linezolid, a difference that met the non-inferiority margin. Clinical responses were also similar at 7-14 days. At late follow-up, 18-25 days after the end of treatment, outcomes of MRSA infections "matched the overall results," according to the study, which was published online in the Lancet Infectious Diseases.

Fewer patients on tedizolid (16%) developed gastrointestinal-related adverse events than those on linezolid (20%); otherwise, treatment- associated adverse events were similar in the two groups.

Tedizolid has not been evaluated in neutropenic patients, so alternative therapies should be considered, the FDA said in its statement announcing the approval.

Sivextro is marketed by Cubist Pharmaceuticals.

[email protected]

Tedizolid, an oxazolidinone antibacterial drug, has been approved as an intravenous and oral treatment for acute bacterial skin and skin structure infections caused by gram positive bacteria, the Food and Drug Administration announced on June 20.

Tedizolid (Sivextro) is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by methicillin-resistant and methicillin-susceptible strains of Staphylococcus aureus, various streptococcus species, and Enterococcus faecalis.

At a meeting in March, the FDA’s Anti-infective Drugs Advisory Committee unanimously recommended that tedizolid be approved. The drug is the second new antibacterial drug to be approved by the FDA in the past month to treat ABSSSI. On May 23, the agency approved dalbavancin (Dalvance) to treat patients with ABSSSI caused by Staphylococcus aureus and various streptococcus species. Both drugs were designated as qualified infectious disease products, allowing them an additional 5 years of marketing exclusivity.

Tedizolid’s safety and efficacy were evaluated and shown to be as effective as linezolid in two clinical trials with 1,315 adults randomly assigned to receive tedizolid or linezolid.

One of the phase III studies, the ESTABLISH-2 study, an international, randomized study, compared 6 days of treatment with intravenous tedizolid to 10 days of treatment with IV linezolid in 666 patients with acute bacterial skin and skin structure infections, with the option of switching to oral treatment. The lesions were at least 75 cm² in size, and were known to be or were suspected to be associated with gram-positive bacteria. Half the patients had cellulitis, 20% had a major cutaneous abscess, and about 30% had an infected wound; about 27% had MRSA.

The primary endpoint, an early clinical response (at least a 20% reduction in the lesion area 48-72 hours after starting treatment), was achieved by 85% of those treated with tedizolid and by 83% of those treated with linezolid, a difference that met the non-inferiority margin. Clinical responses were also similar at 7-14 days. At late follow-up, 18-25 days after the end of treatment, outcomes of MRSA infections "matched the overall results," according to the study, which was published online in the Lancet Infectious Diseases.

Fewer patients on tedizolid (16%) developed gastrointestinal-related adverse events than those on linezolid (20%); otherwise, treatment- associated adverse events were similar in the two groups.

Tedizolid has not been evaluated in neutropenic patients, so alternative therapies should be considered, the FDA said in its statement announcing the approval.

Sivextro is marketed by Cubist Pharmaceuticals.

[email protected]

Tedizolid, an oxazolidinone antibacterial drug, has been approved as an intravenous and oral treatment for acute bacterial skin and skin structure infections caused by gram positive bacteria, the Food and Drug Administration announced on June 20.

Tedizolid (Sivextro) is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by methicillin-resistant and methicillin-susceptible strains of Staphylococcus aureus, various streptococcus species, and Enterococcus faecalis.

At a meeting in March, the FDA’s Anti-infective Drugs Advisory Committee unanimously recommended that tedizolid be approved. The drug is the second new antibacterial drug to be approved by the FDA in the past month to treat ABSSSI. On May 23, the agency approved dalbavancin (Dalvance) to treat patients with ABSSSI caused by Staphylococcus aureus and various streptococcus species. Both drugs were designated as qualified infectious disease products, allowing them an additional 5 years of marketing exclusivity.

Tedizolid’s safety and efficacy were evaluated and shown to be as effective as linezolid in two clinical trials with 1,315 adults randomly assigned to receive tedizolid or linezolid.

One of the phase III studies, the ESTABLISH-2 study, an international, randomized study, compared 6 days of treatment with intravenous tedizolid to 10 days of treatment with IV linezolid in 666 patients with acute bacterial skin and skin structure infections, with the option of switching to oral treatment. The lesions were at least 75 cm² in size, and were known to be or were suspected to be associated with gram-positive bacteria. Half the patients had cellulitis, 20% had a major cutaneous abscess, and about 30% had an infected wound; about 27% had MRSA.

The primary endpoint, an early clinical response (at least a 20% reduction in the lesion area 48-72 hours after starting treatment), was achieved by 85% of those treated with tedizolid and by 83% of those treated with linezolid, a difference that met the non-inferiority margin. Clinical responses were also similar at 7-14 days. At late follow-up, 18-25 days after the end of treatment, outcomes of MRSA infections "matched the overall results," according to the study, which was published online in the Lancet Infectious Diseases.

Fewer patients on tedizolid (16%) developed gastrointestinal-related adverse events than those on linezolid (20%); otherwise, treatment- associated adverse events were similar in the two groups.

Tedizolid has not been evaluated in neutropenic patients, so alternative therapies should be considered, the FDA said in its statement announcing the approval.

Sivextro is marketed by Cubist Pharmaceuticals.

[email protected]

Yes: Accreditation is why bariatric surgery outcomes are so good.

In the early days of bariatric surgery, there were very high mortality rates, up to 21% at 1 year in some studies. Because of that level of risk to patients, accreditation was implemented. Currently, mortality rates for bariatric surgery are at 0.15%, an extraordinary achievement in less than a decade. There are now 729 accredited hospitals in the United States, and that number says much about the level of access for patients. It is not unfettered access to bariatric surgery that is important, but rather access by patients to quality care. That’s what matters at the end of the day.

Accreditation isn’t keeping patients from gaining access to bariatric surgery. The bigger problem in access is making sure the federal and state health exchanges provide coverage for bariatric surgery among the essential health benefits. Fewer than half the states have this coverage.

Since accreditation started, there have been six studies with findings supporting it and three with findings that did not. Among the papers supporting it, Flum et al. is most persuasive because it looks at the Medicare population before and after the implementation of accreditation. It shows a big improvement in deaths, complications, and readmissions after the accreditation mandate despite an increase in the number of patients undergoing bariatric surgery (Ann. Surg. 2011;254:860-5).

The question that always comes up is whether it is volume (the number of cases you’re doing) or accreditation that matters for outcomes. A 2013 study found that accreditation status rendered a benefit independent of volume (Surg. Endosc. 2013;27:4539-46).

If we look at the three papers that found against accreditation, I would dismiss one study because it preceded the accreditation movement (Arch. Surg. 2009;144:319-25).

A study of Michigan patients reported similar complication rates at Centers of Excellence (COEs) and non-COEs (JAMA 2010;304:435-42). The problem with that study is that all of the hospitals in the study essentially are COEs, with the same components that come out of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). They have a registry. They have volume requirements. They have quality improvement. So, essentially, they’re all COEs, and I’m glad that they embrace the same concepts that we espouse.

The final paper, by Dr. Dimick, takes an econometric approach using differences within differences analysis, which means you look at the differential rate of change to see if the experimental group (in this case, the Medicare population) is different in some way from the control group (non-Medicare). Here’s the problem: That is not a true control. Non-Medicare patients were exposed to accreditation. All of the major insurers embraced accreditation then and continue to do so.

The paper didn’t look at mortality and failure to rescue patients from complications (JAMA 2013;309:792-9). Even though mortality may be low, it still matters. It’s what I would call a sentinel event. It’s become so rare that when it happens, it’s a signal of an issue around quality. We see improvements in both the Medicare and non-Medicare populations. Do two rights make a wrong? Does that mean that accreditation doesn’t work? I think it points out that we’re seeing important changes for the better for all groups.

We presented findings at the American Surgical Association this year showing that accredited hospitals had lower total charges with lower rates of complications, mortality, and failure to rescue. What accreditation provides is a safety net. If something goes wrong, the difference is the ability to recover from complications. There was not a big difference between accredited and non-accredited hospitals in complications in general, but a bigger difference in mortality. Mortality still counts. Failure to rescue is a very important metric that we all need to pay attention to.

Some of our other data show a halo effect from accreditation. In the accredited centers, outcomes were better for non-bariatric procedures. Why? Because they had more experience with obese patients. It’s a collateral benefit.

Without accreditation, I wonder what will happen at hospitals that aren’t required to be accredited. Will they still have the registry? Will they still have the resources they need? Not everybody has the advantages that Michigan has with major insurer support to pay for accreditation efforts. And it’s critical that we have those data. You can’t manage what you don’t measure. Accreditation is vital for bariatric surgery.

Dr. Morton is director of both bariatric surgery and surgical quality at Stanford (Calif.) University Medical Center. He disclosed financial associations with Vivus, Covidien, and Ethicon.

No: The data do not show that outcomes are better in COEs.

The Centers of Excellence has evolved into the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), which is an outcomes benchmarking and quality improvement program. So we are, in many ways, looking in the rear-view mirror when we talk about whether or not the historical accreditation process improved outcomes.

I’m going to make two arguments against the historical way it was done. The first argument is that limiting care to Centers of Excellence (COEs) as they were defined had very little benefit on outcomes and may have caused some harm.

A lot of the data out there to evaluate the COE program are a little misleading. They looked at Medicare data for outcomes before and after the Medicare COE mandate was put in place requiring that bariatric surgery be performed in a COE to qualify for coverage. The problem with that is the outcomes are improving so quickly that you can’t just do a before and after study. You need to adjust for that time frame to make sure you’re not getting a spurious finding.

We did a study comparing improvement trends for any complications, serious complications, and reoperations before and after Medicare implemented its coverage decision. Surgeons were already getting better before that. There was no change in the trajectory of improvements when the policy was implemented. We concluded that the policy that selectively referred patients to Centers of Excellence didn’t have any benefit (JAMA 2013;309:792-9). We originally included mortality in our analysis but deaths were so rare that it didn’t meet power specifications set by the journal.

In that paper, we did a head-to-head comparison of COEs vs. non-COEs in 12 large states. It’s hard to do a randomized controlled trial for this, so we did an instrumental variable analysis, a sophisticated analysis that takes out a lot of the unmeasured confounding in selection bias. We found that there was no benefit to having bariatric surgery in a COE.

We noticed that many hospitals that traditionally served minorities did not achieve accreditation. One can assume that’s because they probably didn’t have the resources to participate in the program. After the policy was implemented, the rate of bariatric surgery in minorities dropped substantially, whereas it went up in non-minority patients (JAMA 2013;310:1399-1400). So, there’s potential evidence of harm with these policies.

Medicare eliminated their facility accreditation requirement for bariatric surgery last September.

My second argument is that we could be doing something so much better than accreditation to improve bariatric surgery outcomes. Michigan’s approach is a large quality improvement collaborative funded by Blue Cross Blue Shield. We’re using lessons learned in Michigan to implement change on a broader scale without the involvement of payers. We have 70 surgeons and 32 bariatric surgery programs benchmarking outcomes and using those in strategic ways to learn from each other, hopefully improving everybody’s outcomes.

We standardized venous thromboembolism (VTE) prophylaxis across the state and implemented decision support. VTE rates fell by half. We saw a 90% improvement in mortality and a 24% drop in overall complications. Yes, bariatric surgery centers everywhere were improving at that same time, but when we compared Michigan hospitals participating in our collaborative to non-Michigan hospitals, we saw steeper declines in adverse outcomes in Michigan. That’s very robust evidence that this approach is effective for improving perioperative care.

We have launched a technical skill initiative in which surgeons participating in the collaborative give us a video of a typical procedure that gets rated in a blinded fashion by their peers. We just got funded to use these videos in a coaching program to help surgeons in Michigan improve our technique.

Doing this kind of collaborative work doesn’t take a ton of money. It does take time, strategy, and social capital – developing networks of surgeons that work together and learn together. The historical Centers of Excellence program wasn’t a bad idea, but it wasn’t correlated with perioperative outcomes, and it did have harms.

Dr. Dimick is chief of minimally invasive surgery at the University of Michigan Health System, Ann Arbor. He disclosed being a stockholder in ArborMetrix.

Yes: Accreditation is why bariatric surgery outcomes are so good.

In the early days of bariatric surgery, there were very high mortality rates, up to 21% at 1 year in some studies. Because of that level of risk to patients, accreditation was implemented. Currently, mortality rates for bariatric surgery are at 0.15%, an extraordinary achievement in less than a decade. There are now 729 accredited hospitals in the United States, and that number says much about the level of access for patients. It is not unfettered access to bariatric surgery that is important, but rather access by patients to quality care. That’s what matters at the end of the day.

Accreditation isn’t keeping patients from gaining access to bariatric surgery. The bigger problem in access is making sure the federal and state health exchanges provide coverage for bariatric surgery among the essential health benefits. Fewer than half the states have this coverage.

Since accreditation started, there have been six studies with findings supporting it and three with findings that did not. Among the papers supporting it, Flum et al. is most persuasive because it looks at the Medicare population before and after the implementation of accreditation. It shows a big improvement in deaths, complications, and readmissions after the accreditation mandate despite an increase in the number of patients undergoing bariatric surgery (Ann. Surg. 2011;254:860-5).

The question that always comes up is whether it is volume (the number of cases you’re doing) or accreditation that matters for outcomes. A 2013 study found that accreditation status rendered a benefit independent of volume (Surg. Endosc. 2013;27:4539-46).

If we look at the three papers that found against accreditation, I would dismiss one study because it preceded the accreditation movement (Arch. Surg. 2009;144:319-25).

A study of Michigan patients reported similar complication rates at Centers of Excellence (COEs) and non-COEs (JAMA 2010;304:435-42). The problem with that study is that all of the hospitals in the study essentially are COEs, with the same components that come out of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). They have a registry. They have volume requirements. They have quality improvement. So, essentially, they’re all COEs, and I’m glad that they embrace the same concepts that we espouse.

The final paper, by Dr. Dimick, takes an econometric approach using differences within differences analysis, which means you look at the differential rate of change to see if the experimental group (in this case, the Medicare population) is different in some way from the control group (non-Medicare). Here’s the problem: That is not a true control. Non-Medicare patients were exposed to accreditation. All of the major insurers embraced accreditation then and continue to do so.

The paper didn’t look at mortality and failure to rescue patients from complications (JAMA 2013;309:792-9). Even though mortality may be low, it still matters. It’s what I would call a sentinel event. It’s become so rare that when it happens, it’s a signal of an issue around quality. We see improvements in both the Medicare and non-Medicare populations. Do two rights make a wrong? Does that mean that accreditation doesn’t work? I think it points out that we’re seeing important changes for the better for all groups.

We presented findings at the American Surgical Association this year showing that accredited hospitals had lower total charges with lower rates of complications, mortality, and failure to rescue. What accreditation provides is a safety net. If something goes wrong, the difference is the ability to recover from complications. There was not a big difference between accredited and non-accredited hospitals in complications in general, but a bigger difference in mortality. Mortality still counts. Failure to rescue is a very important metric that we all need to pay attention to.

Some of our other data show a halo effect from accreditation. In the accredited centers, outcomes were better for non-bariatric procedures. Why? Because they had more experience with obese patients. It’s a collateral benefit.

Without accreditation, I wonder what will happen at hospitals that aren’t required to be accredited. Will they still have the registry? Will they still have the resources they need? Not everybody has the advantages that Michigan has with major insurer support to pay for accreditation efforts. And it’s critical that we have those data. You can’t manage what you don’t measure. Accreditation is vital for bariatric surgery.

Dr. Morton is director of both bariatric surgery and surgical quality at Stanford (Calif.) University Medical Center. He disclosed financial associations with Vivus, Covidien, and Ethicon.

No: The data do not show that outcomes are better in COEs.

The Centers of Excellence has evolved into the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), which is an outcomes benchmarking and quality improvement program. So we are, in many ways, looking in the rear-view mirror when we talk about whether or not the historical accreditation process improved outcomes.

I’m going to make two arguments against the historical way it was done. The first argument is that limiting care to Centers of Excellence (COEs) as they were defined had very little benefit on outcomes and may have caused some harm.

A lot of the data out there to evaluate the COE program are a little misleading. They looked at Medicare data for outcomes before and after the Medicare COE mandate was put in place requiring that bariatric surgery be performed in a COE to qualify for coverage. The problem with that is the outcomes are improving so quickly that you can’t just do a before and after study. You need to adjust for that time frame to make sure you’re not getting a spurious finding.

We did a study comparing improvement trends for any complications, serious complications, and reoperations before and after Medicare implemented its coverage decision. Surgeons were already getting better before that. There was no change in the trajectory of improvements when the policy was implemented. We concluded that the policy that selectively referred patients to Centers of Excellence didn’t have any benefit (JAMA 2013;309:792-9). We originally included mortality in our analysis but deaths were so rare that it didn’t meet power specifications set by the journal.

In that paper, we did a head-to-head comparison of COEs vs. non-COEs in 12 large states. It’s hard to do a randomized controlled trial for this, so we did an instrumental variable analysis, a sophisticated analysis that takes out a lot of the unmeasured confounding in selection bias. We found that there was no benefit to having bariatric surgery in a COE.

We noticed that many hospitals that traditionally served minorities did not achieve accreditation. One can assume that’s because they probably didn’t have the resources to participate in the program. After the policy was implemented, the rate of bariatric surgery in minorities dropped substantially, whereas it went up in non-minority patients (JAMA 2013;310:1399-1400). So, there’s potential evidence of harm with these policies.

Medicare eliminated their facility accreditation requirement for bariatric surgery last September.

My second argument is that we could be doing something so much better than accreditation to improve bariatric surgery outcomes. Michigan’s approach is a large quality improvement collaborative funded by Blue Cross Blue Shield. We’re using lessons learned in Michigan to implement change on a broader scale without the involvement of payers. We have 70 surgeons and 32 bariatric surgery programs benchmarking outcomes and using those in strategic ways to learn from each other, hopefully improving everybody’s outcomes.

We standardized venous thromboembolism (VTE) prophylaxis across the state and implemented decision support. VTE rates fell by half. We saw a 90% improvement in mortality and a 24% drop in overall complications. Yes, bariatric surgery centers everywhere were improving at that same time, but when we compared Michigan hospitals participating in our collaborative to non-Michigan hospitals, we saw steeper declines in adverse outcomes in Michigan. That’s very robust evidence that this approach is effective for improving perioperative care.

We have launched a technical skill initiative in which surgeons participating in the collaborative give us a video of a typical procedure that gets rated in a blinded fashion by their peers. We just got funded to use these videos in a coaching program to help surgeons in Michigan improve our technique.

Doing this kind of collaborative work doesn’t take a ton of money. It does take time, strategy, and social capital – developing networks of surgeons that work together and learn together. The historical Centers of Excellence program wasn’t a bad idea, but it wasn’t correlated with perioperative outcomes, and it did have harms.

Dr. Dimick is chief of minimally invasive surgery at the University of Michigan Health System, Ann Arbor. He disclosed being a stockholder in ArborMetrix.

Yes: Accreditation is why bariatric surgery outcomes are so good.

In the early days of bariatric surgery, there were very high mortality rates, up to 21% at 1 year in some studies. Because of that level of risk to patients, accreditation was implemented. Currently, mortality rates for bariatric surgery are at 0.15%, an extraordinary achievement in less than a decade. There are now 729 accredited hospitals in the United States, and that number says much about the level of access for patients. It is not unfettered access to bariatric surgery that is important, but rather access by patients to quality care. That’s what matters at the end of the day.

Accreditation isn’t keeping patients from gaining access to bariatric surgery. The bigger problem in access is making sure the federal and state health exchanges provide coverage for bariatric surgery among the essential health benefits. Fewer than half the states have this coverage.

Since accreditation started, there have been six studies with findings supporting it and three with findings that did not. Among the papers supporting it, Flum et al. is most persuasive because it looks at the Medicare population before and after the implementation of accreditation. It shows a big improvement in deaths, complications, and readmissions after the accreditation mandate despite an increase in the number of patients undergoing bariatric surgery (Ann. Surg. 2011;254:860-5).

The question that always comes up is whether it is volume (the number of cases you’re doing) or accreditation that matters for outcomes. A 2013 study found that accreditation status rendered a benefit independent of volume (Surg. Endosc. 2013;27:4539-46).

If we look at the three papers that found against accreditation, I would dismiss one study because it preceded the accreditation movement (Arch. Surg. 2009;144:319-25).

A study of Michigan patients reported similar complication rates at Centers of Excellence (COEs) and non-COEs (JAMA 2010;304:435-42). The problem with that study is that all of the hospitals in the study essentially are COEs, with the same components that come out of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). They have a registry. They have volume requirements. They have quality improvement. So, essentially, they’re all COEs, and I’m glad that they embrace the same concepts that we espouse.

The final paper, by Dr. Dimick, takes an econometric approach using differences within differences analysis, which means you look at the differential rate of change to see if the experimental group (in this case, the Medicare population) is different in some way from the control group (non-Medicare). Here’s the problem: That is not a true control. Non-Medicare patients were exposed to accreditation. All of the major insurers embraced accreditation then and continue to do so.

The paper didn’t look at mortality and failure to rescue patients from complications (JAMA 2013;309:792-9). Even though mortality may be low, it still matters. It’s what I would call a sentinel event. It’s become so rare that when it happens, it’s a signal of an issue around quality. We see improvements in both the Medicare and non-Medicare populations. Do two rights make a wrong? Does that mean that accreditation doesn’t work? I think it points out that we’re seeing important changes for the better for all groups.

We presented findings at the American Surgical Association this year showing that accredited hospitals had lower total charges with lower rates of complications, mortality, and failure to rescue. What accreditation provides is a safety net. If something goes wrong, the difference is the ability to recover from complications. There was not a big difference between accredited and non-accredited hospitals in complications in general, but a bigger difference in mortality. Mortality still counts. Failure to rescue is a very important metric that we all need to pay attention to.

Some of our other data show a halo effect from accreditation. In the accredited centers, outcomes were better for non-bariatric procedures. Why? Because they had more experience with obese patients. It’s a collateral benefit.

Without accreditation, I wonder what will happen at hospitals that aren’t required to be accredited. Will they still have the registry? Will they still have the resources they need? Not everybody has the advantages that Michigan has with major insurer support to pay for accreditation efforts. And it’s critical that we have those data. You can’t manage what you don’t measure. Accreditation is vital for bariatric surgery.

Dr. Morton is director of both bariatric surgery and surgical quality at Stanford (Calif.) University Medical Center. He disclosed financial associations with Vivus, Covidien, and Ethicon.

No: The data do not show that outcomes are better in COEs.

The Centers of Excellence has evolved into the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), which is an outcomes benchmarking and quality improvement program. So we are, in many ways, looking in the rear-view mirror when we talk about whether or not the historical accreditation process improved outcomes.

I’m going to make two arguments against the historical way it was done. The first argument is that limiting care to Centers of Excellence (COEs) as they were defined had very little benefit on outcomes and may have caused some harm.

A lot of the data out there to evaluate the COE program are a little misleading. They looked at Medicare data for outcomes before and after the Medicare COE mandate was put in place requiring that bariatric surgery be performed in a COE to qualify for coverage. The problem with that is the outcomes are improving so quickly that you can’t just do a before and after study. You need to adjust for that time frame to make sure you’re not getting a spurious finding.

We did a study comparing improvement trends for any complications, serious complications, and reoperations before and after Medicare implemented its coverage decision. Surgeons were already getting better before that. There was no change in the trajectory of improvements when the policy was implemented. We concluded that the policy that selectively referred patients to Centers of Excellence didn’t have any benefit (JAMA 2013;309:792-9). We originally included mortality in our analysis but deaths were so rare that it didn’t meet power specifications set by the journal.

In that paper, we did a head-to-head comparison of COEs vs. non-COEs in 12 large states. It’s hard to do a randomized controlled trial for this, so we did an instrumental variable analysis, a sophisticated analysis that takes out a lot of the unmeasured confounding in selection bias. We found that there was no benefit to having bariatric surgery in a COE.

We noticed that many hospitals that traditionally served minorities did not achieve accreditation. One can assume that’s because they probably didn’t have the resources to participate in the program. After the policy was implemented, the rate of bariatric surgery in minorities dropped substantially, whereas it went up in non-minority patients (JAMA 2013;310:1399-1400). So, there’s potential evidence of harm with these policies.

Medicare eliminated their facility accreditation requirement for bariatric surgery last September.

My second argument is that we could be doing something so much better than accreditation to improve bariatric surgery outcomes. Michigan’s approach is a large quality improvement collaborative funded by Blue Cross Blue Shield. We’re using lessons learned in Michigan to implement change on a broader scale without the involvement of payers. We have 70 surgeons and 32 bariatric surgery programs benchmarking outcomes and using those in strategic ways to learn from each other, hopefully improving everybody’s outcomes.

We standardized venous thromboembolism (VTE) prophylaxis across the state and implemented decision support. VTE rates fell by half. We saw a 90% improvement in mortality and a 24% drop in overall complications. Yes, bariatric surgery centers everywhere were improving at that same time, but when we compared Michigan hospitals participating in our collaborative to non-Michigan hospitals, we saw steeper declines in adverse outcomes in Michigan. That’s very robust evidence that this approach is effective for improving perioperative care.

We have launched a technical skill initiative in which surgeons participating in the collaborative give us a video of a typical procedure that gets rated in a blinded fashion by their peers. We just got funded to use these videos in a coaching program to help surgeons in Michigan improve our technique.

Doing this kind of collaborative work doesn’t take a ton of money. It does take time, strategy, and social capital – developing networks of surgeons that work together and learn together. The historical Centers of Excellence program wasn’t a bad idea, but it wasn’t correlated with perioperative outcomes, and it did have harms.

Dr. Dimick is chief of minimally invasive surgery at the University of Michigan Health System, Ann Arbor. He disclosed being a stockholder in ArborMetrix.

SAN FRANCISCO – Bariatric surgery appears to have a preventive effect on the incidence of atrial fibrillation in patients who are morbidly obese, results from a study of more than 400 patients showed.

"Bariatric surgery is a preventative measure that obese patients may choose to take and our study shows that the surgery helps them not only lose weight, but also reduces their risk of developing a serious cardiac condition, like AF," Dr. Yong-Mei Cha, professor of medicine at Mayo Clinic, Rochester, Minn., said in a prepared statement.

In an interview at the annual scientific sessions of the Heart Rhythm Society, Dr. John D. Day, a Murray, Utah–based electrophysiologist and cardiologist who was not involved in the research, characterized the findings as "a message of hope. Too often here in the United States people get a diagnosis of AF and they feel like it’s going to be with them the rest of their lives. The message of hope is that AF – if aggressive lifestyle changes are made early on – is a potentially reversible condition. This study showed that point. And this was just by eliminating the weight. How much more powerful would it be if they made comprehensive lifestyle changes that include more physical activity, dietary changes, and stress reduction?"

Dr. Cha and her associates retrospectively evaluated data from 438 patients in Olmsted County, Minn., who had a body mass index of 40 kg/m² or higher and were considered good candidates for bariatric surgery. One electrophysiologist reviewed the medical records and the diagnosis of AF was documented by ECG or ambulatory monitors. The researchers collected metabolic profiles at baseline and at follow-up.

Of the 438 patients, 326 (74%) underwent bariatric surgery while the remaining 112 were managed medically and served as the control group. At baseline, BMI was significantly greater in the surgery group compared with the control group (a mean of 46.9 vs. 43.2 kg/m², respectively), but the prevalence of AF was similar between the two groups (3.7 vs. 4.5%).

After a mean follow-up of 7.2 years, new onset of AF occurred in 3.1% of the surgery group, compared with 12.5% in the control group, a difference that reached statistical significance. The surgery group also had a significant reduction in BMI and improvements in their metabolic profiles, compared with the control group.

Dr. Day said that the study’s single-center, retrospective design is a limitation, as is the fact that bariatric surgery "is pretty extreme; you can’t offer it to everybody. But [the findings] fit in line with current data. We know that obesity is a powerful risk factor for atrial fibrillation."

The researchers reported no financial conflicts of interest.

[email protected]

SAN FRANCISCO – Bariatric surgery appears to have a preventive effect on the incidence of atrial fibrillation in patients who are morbidly obese, results from a study of more than 400 patients showed.

"Bariatric surgery is a preventative measure that obese patients may choose to take and our study shows that the surgery helps them not only lose weight, but also reduces their risk of developing a serious cardiac condition, like AF," Dr. Yong-Mei Cha, professor of medicine at Mayo Clinic, Rochester, Minn., said in a prepared statement.

In an interview at the annual scientific sessions of the Heart Rhythm Society, Dr. John D. Day, a Murray, Utah–based electrophysiologist and cardiologist who was not involved in the research, characterized the findings as "a message of hope. Too often here in the United States people get a diagnosis of AF and they feel like it’s going to be with them the rest of their lives. The message of hope is that AF – if aggressive lifestyle changes are made early on – is a potentially reversible condition. This study showed that point. And this was just by eliminating the weight. How much more powerful would it be if they made comprehensive lifestyle changes that include more physical activity, dietary changes, and stress reduction?"

Dr. Cha and her associates retrospectively evaluated data from 438 patients in Olmsted County, Minn., who had a body mass index of 40 kg/m² or higher and were considered good candidates for bariatric surgery. One electrophysiologist reviewed the medical records and the diagnosis of AF was documented by ECG or ambulatory monitors. The researchers collected metabolic profiles at baseline and at follow-up.

Of the 438 patients, 326 (74%) underwent bariatric surgery while the remaining 112 were managed medically and served as the control group. At baseline, BMI was significantly greater in the surgery group compared with the control group (a mean of 46.9 vs. 43.2 kg/m², respectively), but the prevalence of AF was similar between the two groups (3.7 vs. 4.5%).

After a mean follow-up of 7.2 years, new onset of AF occurred in 3.1% of the surgery group, compared with 12.5% in the control group, a difference that reached statistical significance. The surgery group also had a significant reduction in BMI and improvements in their metabolic profiles, compared with the control group.

Dr. Day said that the study’s single-center, retrospective design is a limitation, as is the fact that bariatric surgery "is pretty extreme; you can’t offer it to everybody. But [the findings] fit in line with current data. We know that obesity is a powerful risk factor for atrial fibrillation."

The researchers reported no financial conflicts of interest.

[email protected]

SAN FRANCISCO – Bariatric surgery appears to have a preventive effect on the incidence of atrial fibrillation in patients who are morbidly obese, results from a study of more than 400 patients showed.

"Bariatric surgery is a preventative measure that obese patients may choose to take and our study shows that the surgery helps them not only lose weight, but also reduces their risk of developing a serious cardiac condition, like AF," Dr. Yong-Mei Cha, professor of medicine at Mayo Clinic, Rochester, Minn., said in a prepared statement.

In an interview at the annual scientific sessions of the Heart Rhythm Society, Dr. John D. Day, a Murray, Utah–based electrophysiologist and cardiologist who was not involved in the research, characterized the findings as "a message of hope. Too often here in the United States people get a diagnosis of AF and they feel like it’s going to be with them the rest of their lives. The message of hope is that AF – if aggressive lifestyle changes are made early on – is a potentially reversible condition. This study showed that point. And this was just by eliminating the weight. How much more powerful would it be if they made comprehensive lifestyle changes that include more physical activity, dietary changes, and stress reduction?"

Dr. Cha and her associates retrospectively evaluated data from 438 patients in Olmsted County, Minn., who had a body mass index of 40 kg/m² or higher and were considered good candidates for bariatric surgery. One electrophysiologist reviewed the medical records and the diagnosis of AF was documented by ECG or ambulatory monitors. The researchers collected metabolic profiles at baseline and at follow-up.

Of the 438 patients, 326 (74%) underwent bariatric surgery while the remaining 112 were managed medically and served as the control group. At baseline, BMI was significantly greater in the surgery group compared with the control group (a mean of 46.9 vs. 43.2 kg/m², respectively), but the prevalence of AF was similar between the two groups (3.7 vs. 4.5%).

After a mean follow-up of 7.2 years, new onset of AF occurred in 3.1% of the surgery group, compared with 12.5% in the control group, a difference that reached statistical significance. The surgery group also had a significant reduction in BMI and improvements in their metabolic profiles, compared with the control group.

Dr. Day said that the study’s single-center, retrospective design is a limitation, as is the fact that bariatric surgery "is pretty extreme; you can’t offer it to everybody. But [the findings] fit in line with current data. We know that obesity is a powerful risk factor for atrial fibrillation."

The researchers reported no financial conflicts of interest.

[email protected]

Treatment with opioid receptor-antagonist naloxegol significantly improved opioid-associated constipation, compared with placebo, without affecting pain scores or daily opioid requirements, according to data from two identical double-blind studies.

Outpatients with noncancer pain who were given 25 mg of naloxegol showed a significantly shorter time to first spontaneous bowel movement after treatment, compared with those given placebo – a median time of 5.9 hours and 12 hours in the two studies, compared with 35.8 hours and 37.2 hours with placebo, according to a study published online June 4 in the New England Journal of Medicine.

Treatment with naloxegol was also associated with a significantly greater number of spontaneous bowel movements over the course of the 12-week study period, compared with placebo, and an increase in the mean number of days per week with one or more spontaneous bowel movements.

The Food and Drug Administration is currently considering whether to approve naloxegol; the agency is expected to decide by Sept. 16, 2014.

The two phase III randomized, controlled studies were nearly identical in size – one including 652 individuals with opioid-induced constipation, and the other including 700 – and entirely identical in design: Participants were randomized to receive either 25 mg or 12.5 mg of naloxegol daily, or placebo.

"In both studies, naloxegol at a dose of 25 mg was associated with an increased rate of response (10-15 percentage points higher than the response with placebo) over a period of 12 weeks," wrote Dr. William D. Chey of the University of Michigan Health System, Ann Arbor, and his colleagues.

The higher dose of naloxegol also was associated with more significant improvements in severity of straining, stool consistency, and the frequency of days with complete, spontaneous bowel movements.

Naloxegol’s benefits were even greater among individuals who had previously failed to respond to laxatives before study enrollment, which accounted for 71% of participants, a prespecified subgroup analysis showed (N. Engl. J. Med. 2014 June 4 [doi:10.1056/NEJMoa1310246]).

"In clinical practice, osmotic and stimulant laxatives are likely to be used before more expensive prescription medications," the researchers wrote. "Thus, the finding that naloxegol proved beneficial in patients who had persistent symptoms of opioid-induced constipation despite using standard laxatives is of potential importance."

There were some dose-related side effects observed in the naloxegol group, including abdominal pain, nausea, diarrhea, and vomiting, occurring soon after initiation of treatment. But most of these effects were mild to moderate.

There had been concern about potential cardiovascular side effects, which had been observed previously with alvimopan, another peripherally-acting mu-opioid antagonist. However the incidence of major cardiovascular events was rare and similar across both active and placebo groups.

Researchers found no significant interaction between naloxegol treatment and daily opioid dose, and there also were no significant differences in the mean change from baseline in pain scores.

Around half of the patients enrolled were taking opioids for back pain, while other reasons included arthritis, joint pain, or fibromyalgia. On average, participants had been taking opioids for 3.65 years.

AstraZeneca supported the study, and the authors declared a range of grants, consultancies, and other financial relationships with several pharmaceutical companies, including AstraZeneca.

Treatment with opioid receptor-antagonist naloxegol significantly improved opioid-associated constipation, compared with placebo, without affecting pain scores or daily opioid requirements, according to data from two identical double-blind studies.

Outpatients with noncancer pain who were given 25 mg of naloxegol showed a significantly shorter time to first spontaneous bowel movement after treatment, compared with those given placebo – a median time of 5.9 hours and 12 hours in the two studies, compared with 35.8 hours and 37.2 hours with placebo, according to a study published online June 4 in the New England Journal of Medicine.

Treatment with naloxegol was also associated with a significantly greater number of spontaneous bowel movements over the course of the 12-week study period, compared with placebo, and an increase in the mean number of days per week with one or more spontaneous bowel movements.

The Food and Drug Administration is currently considering whether to approve naloxegol; the agency is expected to decide by Sept. 16, 2014.

The two phase III randomized, controlled studies were nearly identical in size – one including 652 individuals with opioid-induced constipation, and the other including 700 – and entirely identical in design: Participants were randomized to receive either 25 mg or 12.5 mg of naloxegol daily, or placebo.

"In both studies, naloxegol at a dose of 25 mg was associated with an increased rate of response (10-15 percentage points higher than the response with placebo) over a period of 12 weeks," wrote Dr. William D. Chey of the University of Michigan Health System, Ann Arbor, and his colleagues.

The higher dose of naloxegol also was associated with more significant improvements in severity of straining, stool consistency, and the frequency of days with complete, spontaneous bowel movements.

Naloxegol’s benefits were even greater among individuals who had previously failed to respond to laxatives before study enrollment, which accounted for 71% of participants, a prespecified subgroup analysis showed (N. Engl. J. Med. 2014 June 4 [doi:10.1056/NEJMoa1310246]).

"In clinical practice, osmotic and stimulant laxatives are likely to be used before more expensive prescription medications," the researchers wrote. "Thus, the finding that naloxegol proved beneficial in patients who had persistent symptoms of opioid-induced constipation despite using standard laxatives is of potential importance."

There were some dose-related side effects observed in the naloxegol group, including abdominal pain, nausea, diarrhea, and vomiting, occurring soon after initiation of treatment. But most of these effects were mild to moderate.

There had been concern about potential cardiovascular side effects, which had been observed previously with alvimopan, another peripherally-acting mu-opioid antagonist. However the incidence of major cardiovascular events was rare and similar across both active and placebo groups.

Researchers found no significant interaction between naloxegol treatment and daily opioid dose, and there also were no significant differences in the mean change from baseline in pain scores.

Around half of the patients enrolled were taking opioids for back pain, while other reasons included arthritis, joint pain, or fibromyalgia. On average, participants had been taking opioids for 3.65 years.

AstraZeneca supported the study, and the authors declared a range of grants, consultancies, and other financial relationships with several pharmaceutical companies, including AstraZeneca.

Treatment with opioid receptor-antagonist naloxegol significantly improved opioid-associated constipation, compared with placebo, without affecting pain scores or daily opioid requirements, according to data from two identical double-blind studies.

Outpatients with noncancer pain who were given 25 mg of naloxegol showed a significantly shorter time to first spontaneous bowel movement after treatment, compared with those given placebo – a median time of 5.9 hours and 12 hours in the two studies, compared with 35.8 hours and 37.2 hours with placebo, according to a study published online June 4 in the New England Journal of Medicine.

Treatment with naloxegol was also associated with a significantly greater number of spontaneous bowel movements over the course of the 12-week study period, compared with placebo, and an increase in the mean number of days per week with one or more spontaneous bowel movements.

The Food and Drug Administration is currently considering whether to approve naloxegol; the agency is expected to decide by Sept. 16, 2014.

The two phase III randomized, controlled studies were nearly identical in size – one including 652 individuals with opioid-induced constipation, and the other including 700 – and entirely identical in design: Participants were randomized to receive either 25 mg or 12.5 mg of naloxegol daily, or placebo.

"In both studies, naloxegol at a dose of 25 mg was associated with an increased rate of response (10-15 percentage points higher than the response with placebo) over a period of 12 weeks," wrote Dr. William D. Chey of the University of Michigan Health System, Ann Arbor, and his colleagues.

The higher dose of naloxegol also was associated with more significant improvements in severity of straining, stool consistency, and the frequency of days with complete, spontaneous bowel movements.

Naloxegol’s benefits were even greater among individuals who had previously failed to respond to laxatives before study enrollment, which accounted for 71% of participants, a prespecified subgroup analysis showed (N. Engl. J. Med. 2014 June 4 [doi:10.1056/NEJMoa1310246]).

"In clinical practice, osmotic and stimulant laxatives are likely to be used before more expensive prescription medications," the researchers wrote. "Thus, the finding that naloxegol proved beneficial in patients who had persistent symptoms of opioid-induced constipation despite using standard laxatives is of potential importance."

There were some dose-related side effects observed in the naloxegol group, including abdominal pain, nausea, diarrhea, and vomiting, occurring soon after initiation of treatment. But most of these effects were mild to moderate.

There had been concern about potential cardiovascular side effects, which had been observed previously with alvimopan, another peripherally-acting mu-opioid antagonist. However the incidence of major cardiovascular events was rare and similar across both active and placebo groups.

Researchers found no significant interaction between naloxegol treatment and daily opioid dose, and there also were no significant differences in the mean change from baseline in pain scores.

Around half of the patients enrolled were taking opioids for back pain, while other reasons included arthritis, joint pain, or fibromyalgia. On average, participants had been taking opioids for 3.65 years.

AstraZeneca supported the study, and the authors declared a range of grants, consultancies, and other financial relationships with several pharmaceutical companies, including AstraZeneca.

In a group of moderately obese patients with type 2 diabetes, Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding resulted in complete disease remission in 17% and 23%, respectively.

Partial remission was significantly more common among the Roux-en-Y patients, with 50% achieving it, compared with 27% of the gastric banding patients, Dr. Anita Courcoulas and her colleagues reported in the June 4 online issue of JAMA Surgery (JAMA Surg. 2014 [doi:10.1001/jamasurg.2014.467]). There were no partial or complete remissions in the study’s third arm – a year-long intensive lifestyle-management program.

The results are encouraging, but because the study had only 69 patients with just 1 year of follow-up, "no definitive conclusions can be drawn," about the durability of disease remission, Dr. Courcoulas, a bariatric surgeon at the University of Pittsburgh Medical Center, and her associates wrote.

"Nevertheless, the [lifestyle management arm] had no remission, so these results suggest that the gastric banding procedure – low risk and potentially reversible – may have a place as a treatment option for patients with low body mass index and type 2 diabetes. Further studies will be needed to confirm these results," the investigators wrote.

The patients were an average of 47 years old, with a mean body mass index (BMI) of 35 kg/m². The mean duration of type 2 diabetes was 6 years. The average HbA1_c was 8%. Almost all were taking some kind of antidiabetic medication; 40 were on oral drugs, and 26 were taking insulin.

By 1 year, there were no cases of partial or complete remission in the lifestyle intervention group. In the Roux-en-Y group, 50% experienced a partial remission and 17% a complete remission. In the gastric banding group, 27% experienced a partial remission and 23% a complete remission.

Patients in the Roux-en-Y group lost significantly more weight than those in the banding or lifestyle groups (27% vs. 17% and 10% respectively). HbA1_c improved significantly more in the Roux-en-Y group than in the banding or lifestyle groups as well. Significantly more surgical patients than lifestyle patients were able to be off all antidiabetic medications (58% vs. 36% and 4%, respectively).

Surgical safety was good, with six patients needing one additional hospital night for nausea or glucose management. One banding patient needed a port replacement, and three others had minor clinical problems. There were three serious adverse events, including an anastomotic ulcer in one Roux-en-Y patient and dehydration requiring a hospital stay in two gastric banding patients.

The study also highlighted some of the problems with accruing and retaining patients in weight loss trials, the investigators noted. Of 667 screened patients, 69 (10%) were randomized. Of these, seven refused their assigned treatment, and one was excluded from treatment on the procedure day. Six had incomplete follow-up and five – all in the lifestyle intervention arm – withdrew by 6 months.

Because the planned 12-month follow-up was too short to allow any conclusions about the stability of diabetes remission in treated patients, longer follow-up is crucial and will require considerable financial investments.

"These important feasibility issues – the need for targeted screening, the thorough assessment of clinical equipoise to reduce the likelihood of postrandomization dropout, the challenging retention in the [lifestyle] arm, and funding – raise a number of concerns for the scalability of this type of study to a larger multicenter trial. For this reason, pursuing alternative methods to obtain high-order evidence regarding outcomes of surgical vs. nonsurgical treatment may be more reasonable for people with a relatively low BMI," they said.

The study was funded by the National Institutes of Health. Dr. Courcoulas disclosed financial relationships with Covidien, EndoGastric Solutions, Nutrisystem, and Ethicon J&J Healthcare. Some of the other authors disclosed financial relationships with a variety of pharmaceutical companies.

[email protected]

In a group of moderately obese patients with type 2 diabetes, Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding resulted in complete disease remission in 17% and 23%, respectively.

Partial remission was significantly more common among the Roux-en-Y patients, with 50% achieving it, compared with 27% of the gastric banding patients, Dr. Anita Courcoulas and her colleagues reported in the June 4 online issue of JAMA Surgery (JAMA Surg. 2014 [doi:10.1001/jamasurg.2014.467]). There were no partial or complete remissions in the study’s third arm – a year-long intensive lifestyle-management program.

The results are encouraging, but because the study had only 69 patients with just 1 year of follow-up, "no definitive conclusions can be drawn," about the durability of disease remission, Dr. Courcoulas, a bariatric surgeon at the University of Pittsburgh Medical Center, and her associates wrote.

"Nevertheless, the [lifestyle management arm] had no remission, so these results suggest that the gastric banding procedure – low risk and potentially reversible – may have a place as a treatment option for patients with low body mass index and type 2 diabetes. Further studies will be needed to confirm these results," the investigators wrote.

The patients were an average of 47 years old, with a mean body mass index (BMI) of 35 kg/m². The mean duration of type 2 diabetes was 6 years. The average HbA1_c was 8%. Almost all were taking some kind of antidiabetic medication; 40 were on oral drugs, and 26 were taking insulin.

By 1 year, there were no cases of partial or complete remission in the lifestyle intervention group. In the Roux-en-Y group, 50% experienced a partial remission and 17% a complete remission. In the gastric banding group, 27% experienced a partial remission and 23% a complete remission.

Patients in the Roux-en-Y group lost significantly more weight than those in the banding or lifestyle groups (27% vs. 17% and 10% respectively). HbA1_c improved significantly more in the Roux-en-Y group than in the banding or lifestyle groups as well. Significantly more surgical patients than lifestyle patients were able to be off all antidiabetic medications (58% vs. 36% and 4%, respectively).

Surgical safety was good, with six patients needing one additional hospital night for nausea or glucose management. One banding patient needed a port replacement, and three others had minor clinical problems. There were three serious adverse events, including an anastomotic ulcer in one Roux-en-Y patient and dehydration requiring a hospital stay in two gastric banding patients.

The study also highlighted some of the problems with accruing and retaining patients in weight loss trials, the investigators noted. Of 667 screened patients, 69 (10%) were randomized. Of these, seven refused their assigned treatment, and one was excluded from treatment on the procedure day. Six had incomplete follow-up and five – all in the lifestyle intervention arm – withdrew by 6 months.

Because the planned 12-month follow-up was too short to allow any conclusions about the stability of diabetes remission in treated patients, longer follow-up is crucial and will require considerable financial investments.

"These important feasibility issues – the need for targeted screening, the thorough assessment of clinical equipoise to reduce the likelihood of postrandomization dropout, the challenging retention in the [lifestyle] arm, and funding – raise a number of concerns for the scalability of this type of study to a larger multicenter trial. For this reason, pursuing alternative methods to obtain high-order evidence regarding outcomes of surgical vs. nonsurgical treatment may be more reasonable for people with a relatively low BMI," they said.

The study was funded by the National Institutes of Health. Dr. Courcoulas disclosed financial relationships with Covidien, EndoGastric Solutions, Nutrisystem, and Ethicon J&J Healthcare. Some of the other authors disclosed financial relationships with a variety of pharmaceutical companies.

[email protected]

In a group of moderately obese patients with type 2 diabetes, Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding resulted in complete disease remission in 17% and 23%, respectively.

Partial remission was significantly more common among the Roux-en-Y patients, with 50% achieving it, compared with 27% of the gastric banding patients, Dr. Anita Courcoulas and her colleagues reported in the June 4 online issue of JAMA Surgery (JAMA Surg. 2014 [doi:10.1001/jamasurg.2014.467]). There were no partial or complete remissions in the study’s third arm – a year-long intensive lifestyle-management program.

The results are encouraging, but because the study had only 69 patients with just 1 year of follow-up, "no definitive conclusions can be drawn," about the durability of disease remission, Dr. Courcoulas, a bariatric surgeon at the University of Pittsburgh Medical Center, and her associates wrote.

"Nevertheless, the [lifestyle management arm] had no remission, so these results suggest that the gastric banding procedure – low risk and potentially reversible – may have a place as a treatment option for patients with low body mass index and type 2 diabetes. Further studies will be needed to confirm these results," the investigators wrote.

The patients were an average of 47 years old, with a mean body mass index (BMI) of 35 kg/m². The mean duration of type 2 diabetes was 6 years. The average HbA1_c was 8%. Almost all were taking some kind of antidiabetic medication; 40 were on oral drugs, and 26 were taking insulin.

By 1 year, there were no cases of partial or complete remission in the lifestyle intervention group. In the Roux-en-Y group, 50% experienced a partial remission and 17% a complete remission. In the gastric banding group, 27% experienced a partial remission and 23% a complete remission.

Patients in the Roux-en-Y group lost significantly more weight than those in the banding or lifestyle groups (27% vs. 17% and 10% respectively). HbA1_c improved significantly more in the Roux-en-Y group than in the banding or lifestyle groups as well. Significantly more surgical patients than lifestyle patients were able to be off all antidiabetic medications (58% vs. 36% and 4%, respectively).

Surgical safety was good, with six patients needing one additional hospital night for nausea or glucose management. One banding patient needed a port replacement, and three others had minor clinical problems. There were three serious adverse events, including an anastomotic ulcer in one Roux-en-Y patient and dehydration requiring a hospital stay in two gastric banding patients.

The study also highlighted some of the problems with accruing and retaining patients in weight loss trials, the investigators noted. Of 667 screened patients, 69 (10%) were randomized. Of these, seven refused their assigned treatment, and one was excluded from treatment on the procedure day. Six had incomplete follow-up and five – all in the lifestyle intervention arm – withdrew by 6 months.

Because the planned 12-month follow-up was too short to allow any conclusions about the stability of diabetes remission in treated patients, longer follow-up is crucial and will require considerable financial investments.

"These important feasibility issues – the need for targeted screening, the thorough assessment of clinical equipoise to reduce the likelihood of postrandomization dropout, the challenging retention in the [lifestyle] arm, and funding – raise a number of concerns for the scalability of this type of study to a larger multicenter trial. For this reason, pursuing alternative methods to obtain high-order evidence regarding outcomes of surgical vs. nonsurgical treatment may be more reasonable for people with a relatively low BMI," they said.

The study was funded by the National Institutes of Health. Dr. Courcoulas disclosed financial relationships with Covidien, EndoGastric Solutions, Nutrisystem, and Ethicon J&J Healthcare. Some of the other authors disclosed financial relationships with a variety of pharmaceutical companies.

[email protected]

The first generic versions of celecoxib received approval May 30 by the Food and Drug Administration.

Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 mg, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals received approval to market 50 mg celecoxib capsules.

Citing the importance of "affordable treatment options for chronic conditions," Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, added in a written statement, the assurance "that these FDA-approved generic drugs have met our rigorous approval standards." Generic prescription drugs approved by the FDA are of the same strength as brand-name drugs, and generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

As with its trade version Celebrex and all nonsteroidal anti-inflammatory drugs, the two new generics will carry a boxed warning in their prescribing information regarding the risks of heart attack or stroke and serious gastrointestinal bleeding. These labels also will note that risk is increased for patients who have heart disease or heart disease risk factors, as it is for patients who take NSAIDs for prolonged periods of time.

Information about the availability of generic celecoxib is available from the companies.

[email protected]

On Twitter @maryjodales

The first generic versions of celecoxib received approval May 30 by the Food and Drug Administration.

Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 mg, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals received approval to market 50 mg celecoxib capsules.

Citing the importance of "affordable treatment options for chronic conditions," Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, added in a written statement, the assurance "that these FDA-approved generic drugs have met our rigorous approval standards." Generic prescription drugs approved by the FDA are of the same strength as brand-name drugs, and generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

As with its trade version Celebrex and all nonsteroidal anti-inflammatory drugs, the two new generics will carry a boxed warning in their prescribing information regarding the risks of heart attack or stroke and serious gastrointestinal bleeding. These labels also will note that risk is increased for patients who have heart disease or heart disease risk factors, as it is for patients who take NSAIDs for prolonged periods of time.

Information about the availability of generic celecoxib is available from the companies.

[email protected]

On Twitter @maryjodales

The first generic versions of celecoxib received approval May 30 by the Food and Drug Administration.

Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 mg, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals received approval to market 50 mg celecoxib capsules.

Citing the importance of "affordable treatment options for chronic conditions," Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, added in a written statement, the assurance "that these FDA-approved generic drugs have met our rigorous approval standards." Generic prescription drugs approved by the FDA are of the same strength as brand-name drugs, and generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

As with its trade version Celebrex and all nonsteroidal anti-inflammatory drugs, the two new generics will carry a boxed warning in their prescribing information regarding the risks of heart attack or stroke and serious gastrointestinal bleeding. These labels also will note that risk is increased for patients who have heart disease or heart disease risk factors, as it is for patients who take NSAIDs for prolonged periods of time.

Information about the availability of generic celecoxib is available from the companies.

[email protected]

On Twitter @maryjodales

BALTIMORE – Implementing a bundle of preventive interventions led to a significant drop in pressure ulcers acquired during hospitalization among high-risk surgical patients, according to a prospective study.

Moreover, the beneficial effect of the program was sustained for more than a year after the program was implemented, reported Dr. Sylvia Martinez of Baylor College of Medicine and the Michael E. DeBakey VA Medical Center in Houston.

Elizabeth Mechcatie/Frontline Medical News

Dr. Martinez pointed out that strategies used to prevent hospital-acquired pressure ulcers are not standardized, and that in an effort to improve quality of care, save money, and reduce mortality, the Centers for Medicare & Medicaid Services no longer reimburses medical facilities for stage III and IV hospital-acquired pressure ulcers.

More than 7,000 high-risk patients were included in the study. During the 6 months before the plan was implemented at the medical center, the mean pressure ulcer rate overall was 3.37, dropping to 1.45 during the 6 months after implementation, a significant difference (P = .004). At 18 months, the rate was 0.89. During this time, the mean rates of hospital-acquired pressure ulcers in the entire VA system did not significantly change, ranging from 1.68 to 1.85, Dr. Martinez reported at the annual meeting of the Surgical Infection Society.

The study was done to address the relatively high rate of pressure ulcers in the medical center’s surgical service. Dr. Martinez and her associates evaluated the impact of an evidence-based hospital-acquired pressure ulcer prevention bundle, developed by an interdisciplinary team.

Patients were classified as high risk if they met at least two of four criteria (age greater than 62 years, albumin less than 3.5 g/dL, ASA score greater than 3, and surgery lasting for more than 3 hours).

The components of the program included:

• Comprehensive skin assessment and documentation and identification of any ulcers on admission, transfer, and discharge.

• Use of operating room beds with pressure redistributing mattresses, with careful positioning and padding of pressure points.

• Turning of patients every 2 hours with pressure point relief via wedges, heel pads, and pillows, as well as massages of bony prominences.

• Assessment of patients for pressure ulcers on daily rounds (led by the unit nurse manager) and use of daily checklists in high-risk patients.

The pressure ulcer rate was calculated by the number of discharged acute-care patients with a stage II or greater hospital-acquired pressure ulcer, divided by number patient days in the hospital (the discharge date minus the admission date for all discharged acute-care patients who were hospitalized for at least 48 hours).

During the period studied, 21,377 operations were performed. Almost 5,000 (4,692) were during the 6-month period prior to implementation of the program, from January to June 2012, and 16,685 were done in the 18 months after implementation (including 4,461 during the first 6 months). Overall, 34% of the patients were determined to be at high risk.

The rates dropped significantly in different parts of the surgical service: In the surgical intensive care unit, the rate dropped from 2.93 before implementation to 1.25 at 6 months and 0.86 at 18 months post implementation. In the surgical wards, the rate dropped from 2.93 to 0.83 at 6 months, and was 0.86 at 18 months.

Implementation of this bundle "may decrease hospital-acquired pressure ulcer rates in high risk surgical patients," with sustained lower rates, which "can lead to decreased costs, complications, and length of stay, and improved quality of life for our patients," Dr. Martinez concluded.

Among the study’s limitations were that it was conducted at one hospital and it did not evaluate which elements of the prevention bundle were most important, she said.

Dr. Martinez had no disclosures. The study was funded by the U.S. Department of Veterans Affairs.

[email protected]

BALTIMORE – Implementing a bundle of preventive interventions led to a significant drop in pressure ulcers acquired during hospitalization among high-risk surgical patients, according to a prospective study.

Moreover, the beneficial effect of the program was sustained for more than a year after the program was implemented, reported Dr. Sylvia Martinez of Baylor College of Medicine and the Michael E. DeBakey VA Medical Center in Houston.

Elizabeth Mechcatie/Frontline Medical News

Dr. Martinez pointed out that strategies used to prevent hospital-acquired pressure ulcers are not standardized, and that in an effort to improve quality of care, save money, and reduce mortality, the Centers for Medicare & Medicaid Services no longer reimburses medical facilities for stage III and IV hospital-acquired pressure ulcers.

More than 7,000 high-risk patients were included in the study. During the 6 months before the plan was implemented at the medical center, the mean pressure ulcer rate overall was 3.37, dropping to 1.45 during the 6 months after implementation, a significant difference (P = .004). At 18 months, the rate was 0.89. During this time, the mean rates of hospital-acquired pressure ulcers in the entire VA system did not significantly change, ranging from 1.68 to 1.85, Dr. Martinez reported at the annual meeting of the Surgical Infection Society.

The study was done to address the relatively high rate of pressure ulcers in the medical center’s surgical service. Dr. Martinez and her associates evaluated the impact of an evidence-based hospital-acquired pressure ulcer prevention bundle, developed by an interdisciplinary team.

Patients were classified as high risk if they met at least two of four criteria (age greater than 62 years, albumin less than 3.5 g/dL, ASA score greater than 3, and surgery lasting for more than 3 hours).

The components of the program included:

• Comprehensive skin assessment and documentation and identification of any ulcers on admission, transfer, and discharge.

• Use of operating room beds with pressure redistributing mattresses, with careful positioning and padding of pressure points.

• Turning of patients every 2 hours with pressure point relief via wedges, heel pads, and pillows, as well as massages of bony prominences.

• Assessment of patients for pressure ulcers on daily rounds (led by the unit nurse manager) and use of daily checklists in high-risk patients.

The pressure ulcer rate was calculated by the number of discharged acute-care patients with a stage II or greater hospital-acquired pressure ulcer, divided by number patient days in the hospital (the discharge date minus the admission date for all discharged acute-care patients who were hospitalized for at least 48 hours).

During the period studied, 21,377 operations were performed. Almost 5,000 (4,692) were during the 6-month period prior to implementation of the program, from January to June 2012, and 16,685 were done in the 18 months after implementation (including 4,461 during the first 6 months). Overall, 34% of the patients were determined to be at high risk.

The rates dropped significantly in different parts of the surgical service: In the surgical intensive care unit, the rate dropped from 2.93 before implementation to 1.25 at 6 months and 0.86 at 18 months post implementation. In the surgical wards, the rate dropped from 2.93 to 0.83 at 6 months, and was 0.86 at 18 months.

Implementation of this bundle "may decrease hospital-acquired pressure ulcer rates in high risk surgical patients," with sustained lower rates, which "can lead to decreased costs, complications, and length of stay, and improved quality of life for our patients," Dr. Martinez concluded.

Among the study’s limitations were that it was conducted at one hospital and it did not evaluate which elements of the prevention bundle were most important, she said.

Dr. Martinez had no disclosures. The study was funded by the U.S. Department of Veterans Affairs.

[email protected]

BALTIMORE – Implementing a bundle of preventive interventions led to a significant drop in pressure ulcers acquired during hospitalization among high-risk surgical patients, according to a prospective study.

Moreover, the beneficial effect of the program was sustained for more than a year after the program was implemented, reported Dr. Sylvia Martinez of Baylor College of Medicine and the Michael E. DeBakey VA Medical Center in Houston.

Elizabeth Mechcatie/Frontline Medical News

Dr. Martinez pointed out that strategies used to prevent hospital-acquired pressure ulcers are not standardized, and that in an effort to improve quality of care, save money, and reduce mortality, the Centers for Medicare & Medicaid Services no longer reimburses medical facilities for stage III and IV hospital-acquired pressure ulcers.

More than 7,000 high-risk patients were included in the study. During the 6 months before the plan was implemented at the medical center, the mean pressure ulcer rate overall was 3.37, dropping to 1.45 during the 6 months after implementation, a significant difference (P = .004). At 18 months, the rate was 0.89. During this time, the mean rates of hospital-acquired pressure ulcers in the entire VA system did not significantly change, ranging from 1.68 to 1.85, Dr. Martinez reported at the annual meeting of the Surgical Infection Society.

The study was done to address the relatively high rate of pressure ulcers in the medical center’s surgical service. Dr. Martinez and her associates evaluated the impact of an evidence-based hospital-acquired pressure ulcer prevention bundle, developed by an interdisciplinary team.

Patients were classified as high risk if they met at least two of four criteria (age greater than 62 years, albumin less than 3.5 g/dL, ASA score greater than 3, and surgery lasting for more than 3 hours).

The components of the program included:

• Comprehensive skin assessment and documentation and identification of any ulcers on admission, transfer, and discharge.

• Use of operating room beds with pressure redistributing mattresses, with careful positioning and padding of pressure points.

• Turning of patients every 2 hours with pressure point relief via wedges, heel pads, and pillows, as well as massages of bony prominences.

• Assessment of patients for pressure ulcers on daily rounds (led by the unit nurse manager) and use of daily checklists in high-risk patients.

The pressure ulcer rate was calculated by the number of discharged acute-care patients with a stage II or greater hospital-acquired pressure ulcer, divided by number patient days in the hospital (the discharge date minus the admission date for all discharged acute-care patients who were hospitalized for at least 48 hours).

During the period studied, 21,377 operations were performed. Almost 5,000 (4,692) were during the 6-month period prior to implementation of the program, from January to June 2012, and 16,685 were done in the 18 months after implementation (including 4,461 during the first 6 months). Overall, 34% of the patients were determined to be at high risk.

The rates dropped significantly in different parts of the surgical service: In the surgical intensive care unit, the rate dropped from 2.93 before implementation to 1.25 at 6 months and 0.86 at 18 months post implementation. In the surgical wards, the rate dropped from 2.93 to 0.83 at 6 months, and was 0.86 at 18 months.

Implementation of this bundle "may decrease hospital-acquired pressure ulcer rates in high risk surgical patients," with sustained lower rates, which "can lead to decreased costs, complications, and length of stay, and improved quality of life for our patients," Dr. Martinez concluded.

Among the study’s limitations were that it was conducted at one hospital and it did not evaluate which elements of the prevention bundle were most important, she said.

Dr. Martinez had no disclosures. The study was funded by the U.S. Department of Veterans Affairs.

[email protected]

Dalbavancin is the first drug with a Qualified Infectious Disease Product designation to be approved by the Food and Drug Administration.

On May 23, the agency approved dalbavancin (Dalvance) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus. The drug, which is given intravenously, is effective for methicillin-susceptible and methicillin-resistant strains as well as Streptococcus pyogenes.

Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, dalbavancin was granted Qualified Infectious Disease Product designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections, according to a statement issued by the FDA.

As part of its QIDP designation, dalbavancin was given priority review and qualifies for an additional 5 years of marketing exclusivity, in addition to the exclusivity period already provided by the Food, Drug and Cosmetic Act.

Dalbavancin was shown to be as safe and effective as vancomycin for the treatment of ABSSSI in two clinical trials with a total of 1,289 adults who had ABSSSI and were randomly assigned to one of the two drugs.

The most common side effects identified in the clinical trials were nausea, headache and diarrhea. More participants in the dalbavancin group had elevated liver enzymes.

Dalvance is marketed by Durata Therapeutics.

[email protected]

Dalbavancin is the first drug with a Qualified Infectious Disease Product designation to be approved by the Food and Drug Administration.

On May 23, the agency approved dalbavancin (Dalvance) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus. The drug, which is given intravenously, is effective for methicillin-susceptible and methicillin-resistant strains as well as Streptococcus pyogenes.

Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, dalbavancin was granted Qualified Infectious Disease Product designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections, according to a statement issued by the FDA.

As part of its QIDP designation, dalbavancin was given priority review and qualifies for an additional 5 years of marketing exclusivity, in addition to the exclusivity period already provided by the Food, Drug and Cosmetic Act.

Dalbavancin was shown to be as safe and effective as vancomycin for the treatment of ABSSSI in two clinical trials with a total of 1,289 adults who had ABSSSI and were randomly assigned to one of the two drugs.

The most common side effects identified in the clinical trials were nausea, headache and diarrhea. More participants in the dalbavancin group had elevated liver enzymes.

Dalvance is marketed by Durata Therapeutics.

[email protected]

Dalbavancin is the first drug with a Qualified Infectious Disease Product designation to be approved by the Food and Drug Administration.

On May 23, the agency approved dalbavancin (Dalvance) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus. The drug, which is given intravenously, is effective for methicillin-susceptible and methicillin-resistant strains as well as Streptococcus pyogenes.

Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, dalbavancin was granted Qualified Infectious Disease Product designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections, according to a statement issued by the FDA.

As part of its QIDP designation, dalbavancin was given priority review and qualifies for an additional 5 years of marketing exclusivity, in addition to the exclusivity period already provided by the Food, Drug and Cosmetic Act.

Dalbavancin was shown to be as safe and effective as vancomycin for the treatment of ABSSSI in two clinical trials with a total of 1,289 adults who had ABSSSI and were randomly assigned to one of the two drugs.

The most common side effects identified in the clinical trials were nausea, headache and diarrhea. More participants in the dalbavancin group had elevated liver enzymes.

Dalvance is marketed by Durata Therapeutics.

[email protected]

SAN DIEGO – Subsyndromal delirium was present in 86% of critically ill patients, results from a large observational study demonstrated. In addition, the duration of delirium was associated with increased odds of institutionalization, an association that was modified by the duration of delirium.

"In patients with less delirium, the effect of subsyndromal delirium on institutionalization was actually stronger," lead author Dr. Nathan E. Brummel said in an interview at an international conference of the American Thoracic Society, where the research was presented. "This identifies a cohort of people who previously were considered to have normal brain function, but it appears that this has long-term implications for their lives.

"Screening for delirium should occur not only in the ICU but on the wards as well. Patients who have delirium or delirium symptoms may benefit from measures used to prevent and treat this syndrome, such as the Hospital Elder Life Program, routine mobilization, and frequent reorientation through the use of nursing staff or even family members," he later added. This study data may help clinicians discuss long-term outcomes of critical illness with patients and their family members," he said.

For the study, Dr. Brummel, an instructor in medicine in the division of allergy, pulmonary and critical care medicine at Vanderbilt University Medical Center, Nashville, Tenn., and his associates evaluated 821 medical or surgical ICU patients with respiratory failure and/or shock who were enrolled in the BRAIN-ICU observational cohort study (N. Engl. J. Med. 2013;369:1306-16).

They used the Confusion Assessment Method for the ICU (CAM-ICU) to screen for delirium symptoms twice daily in the ICU and daily thereafter. The researchers considered delirium to be present if the CAM-ICU was positive. If the CAM-ICU was negative, they considered subsyndromal delirium (SSD) to be present if any delirium features were present or if inattention was present with or without other features of delirium.

SSD "is said to be present when a patient exhibits some delirium symptoms but does not meet the full delirium diagnostic criteria," the researchers wrote in their poster. "In patients without critical illness, SSD is associated with institutionalization, mortality, and cognitive decline, but these associations remain unclear in the critically ill."

The researchers tracked discharge location, mortality after hospital discharge and assessed for cognitive impairment at 3 and 12 months follow-up and used multivariate regression to determine the relationship between days of SSD and outcomes.

The mean age of the 821 patients was 61 years and their mean APACHE II score was 25. In all, 702 patients (86%) had SSD that lasted an average of 3 days. The most common SSU pattern based on the CAM-ICU was fluctuation of mental status (which occurred in 50% of assessments) and fluctuation in mental status plus altered level of consciousness (which occurred in 22% of assessments).

Dr. Brummel and his associates also found that the duration of SSD was independently associated with increased odds of institutionalization (odds ratio, 1.90), but SSD did not predict mortality or long-term cognitive impairment at 3 or 12 months. "We don’t yet understand the mechanism behind why subsyndromal delirium and institutionalization are associated," Dr. Brummel said. "It probably relates to an association between SSD and factors that drive institutionalization, such as physical disability and cognitive impairment. Once patients survived the hospital stay, subsyndromal delirium wasn’t associated with an increased risk of mortality. It may be the fact that this less severe form of brain dysfunction in the ICU does not have the same effect as the full syndrome of delirium."

He acknowledged certain limitations of the study, including the fact that the CAM-ICU only measures four features of delirium and that no assessments of cognitive or physical function were conducted at hospital discharge.

The study was supported by the National Institutes of Health, the Vanderbilt Clinical and Translational Scholars Program, and the Veterans Affairs Tennessee Valley Healthcare System Geriatric Research Education and Clinical Centers. Dr. Brummel said that he had no relevant financial conflicts to disclose.

[email protected]

SAN DIEGO – Subsyndromal delirium was present in 86% of critically ill patients, results from a large observational study demonstrated. In addition, the duration of delirium was associated with increased odds of institutionalization, an association that was modified by the duration of delirium.

"In patients with less delirium, the effect of subsyndromal delirium on institutionalization was actually stronger," lead author Dr. Nathan E. Brummel said in an interview at an international conference of the American Thoracic Society, where the research was presented. "This identifies a cohort of people who previously were considered to have normal brain function, but it appears that this has long-term implications for their lives.

"Screening for delirium should occur not only in the ICU but on the wards as well. Patients who have delirium or delirium symptoms may benefit from measures used to prevent and treat this syndrome, such as the Hospital Elder Life Program, routine mobilization, and frequent reorientation through the use of nursing staff or even family members," he later added. This study data may help clinicians discuss long-term outcomes of critical illness with patients and their family members," he said.

For the study, Dr. Brummel, an instructor in medicine in the division of allergy, pulmonary and critical care medicine at Vanderbilt University Medical Center, Nashville, Tenn., and his associates evaluated 821 medical or surgical ICU patients with respiratory failure and/or shock who were enrolled in the BRAIN-ICU observational cohort study (N. Engl. J. Med. 2013;369:1306-16).

They used the Confusion Assessment Method for the ICU (CAM-ICU) to screen for delirium symptoms twice daily in the ICU and daily thereafter. The researchers considered delirium to be present if the CAM-ICU was positive. If the CAM-ICU was negative, they considered subsyndromal delirium (SSD) to be present if any delirium features were present or if inattention was present with or without other features of delirium.

SSD "is said to be present when a patient exhibits some delirium symptoms but does not meet the full delirium diagnostic criteria," the researchers wrote in their poster. "In patients without critical illness, SSD is associated with institutionalization, mortality, and cognitive decline, but these associations remain unclear in the critically ill."

The researchers tracked discharge location, mortality after hospital discharge and assessed for cognitive impairment at 3 and 12 months follow-up and used multivariate regression to determine the relationship between days of SSD and outcomes.

The mean age of the 821 patients was 61 years and their mean APACHE II score was 25. In all, 702 patients (86%) had SSD that lasted an average of 3 days. The most common SSU pattern based on the CAM-ICU was fluctuation of mental status (which occurred in 50% of assessments) and fluctuation in mental status plus altered level of consciousness (which occurred in 22% of assessments).

Dr. Brummel and his associates also found that the duration of SSD was independently associated with increased odds of institutionalization (odds ratio, 1.90), but SSD did not predict mortality or long-term cognitive impairment at 3 or 12 months. "We don’t yet understand the mechanism behind why subsyndromal delirium and institutionalization are associated," Dr. Brummel said. "It probably relates to an association between SSD and factors that drive institutionalization, such as physical disability and cognitive impairment. Once patients survived the hospital stay, subsyndromal delirium wasn’t associated with an increased risk of mortality. It may be the fact that this less severe form of brain dysfunction in the ICU does not have the same effect as the full syndrome of delirium."

He acknowledged certain limitations of the study, including the fact that the CAM-ICU only measures four features of delirium and that no assessments of cognitive or physical function were conducted at hospital discharge.

The study was supported by the National Institutes of Health, the Vanderbilt Clinical and Translational Scholars Program, and the Veterans Affairs Tennessee Valley Healthcare System Geriatric Research Education and Clinical Centers. Dr. Brummel said that he had no relevant financial conflicts to disclose.

[email protected]

SAN DIEGO – Subsyndromal delirium was present in 86% of critically ill patients, results from a large observational study demonstrated. In addition, the duration of delirium was associated with increased odds of institutionalization, an association that was modified by the duration of delirium.

"In patients with less delirium, the effect of subsyndromal delirium on institutionalization was actually stronger," lead author Dr. Nathan E. Brummel said in an interview at an international conference of the American Thoracic Society, where the research was presented. "This identifies a cohort of people who previously were considered to have normal brain function, but it appears that this has long-term implications for their lives.

"Screening for delirium should occur not only in the ICU but on the wards as well. Patients who have delirium or delirium symptoms may benefit from measures used to prevent and treat this syndrome, such as the Hospital Elder Life Program, routine mobilization, and frequent reorientation through the use of nursing staff or even family members," he later added. This study data may help clinicians discuss long-term outcomes of critical illness with patients and their family members," he said.

For the study, Dr. Brummel, an instructor in medicine in the division of allergy, pulmonary and critical care medicine at Vanderbilt University Medical Center, Nashville, Tenn., and his associates evaluated 821 medical or surgical ICU patients with respiratory failure and/or shock who were enrolled in the BRAIN-ICU observational cohort study (N. Engl. J. Med. 2013;369:1306-16).

They used the Confusion Assessment Method for the ICU (CAM-ICU) to screen for delirium symptoms twice daily in the ICU and daily thereafter. The researchers considered delirium to be present if the CAM-ICU was positive. If the CAM-ICU was negative, they considered subsyndromal delirium (SSD) to be present if any delirium features were present or if inattention was present with or without other features of delirium.

SSD "is said to be present when a patient exhibits some delirium symptoms but does not meet the full delirium diagnostic criteria," the researchers wrote in their poster. "In patients without critical illness, SSD is associated with institutionalization, mortality, and cognitive decline, but these associations remain unclear in the critically ill."

The researchers tracked discharge location, mortality after hospital discharge and assessed for cognitive impairment at 3 and 12 months follow-up and used multivariate regression to determine the relationship between days of SSD and outcomes.

The mean age of the 821 patients was 61 years and their mean APACHE II score was 25. In all, 702 patients (86%) had SSD that lasted an average of 3 days. The most common SSU pattern based on the CAM-ICU was fluctuation of mental status (which occurred in 50% of assessments) and fluctuation in mental status plus altered level of consciousness (which occurred in 22% of assessments).

Dr. Brummel and his associates also found that the duration of SSD was independently associated with increased odds of institutionalization (odds ratio, 1.90), but SSD did not predict mortality or long-term cognitive impairment at 3 or 12 months. "We don’t yet understand the mechanism behind why subsyndromal delirium and institutionalization are associated," Dr. Brummel said. "It probably relates to an association between SSD and factors that drive institutionalization, such as physical disability and cognitive impairment. Once patients survived the hospital stay, subsyndromal delirium wasn’t associated with an increased risk of mortality. It may be the fact that this less severe form of brain dysfunction in the ICU does not have the same effect as the full syndrome of delirium."

He acknowledged certain limitations of the study, including the fact that the CAM-ICU only measures four features of delirium and that no assessments of cognitive or physical function were conducted at hospital discharge.

The study was supported by the National Institutes of Health, the Vanderbilt Clinical and Translational Scholars Program, and the Veterans Affairs Tennessee Valley Healthcare System Geriatric Research Education and Clinical Centers. Dr. Brummel said that he had no relevant financial conflicts to disclose.

[email protected]