“The box is locked, the lights are on. It’s robot fighting time. Sewer Snake charges first. He’s lifting Ragin Scotsman high in the air. Ragin Scotsman manages to escape his death grip and slams Sewer Snake against the wall. Oh no! His front wheel just fell off!”

Jim Yeh, DO, has better things to do with his spare time than watch TV or play golf. For the past dozen years, he has been designing and building robots that fight other robots at events that attract techies nationwide.

It all started harmlessly, when he and his six-year-old son, Forrest, were watching a comedy sketch on TV featuring battling robots. When Forrest suggested they build robots together, Dr. Yeh reluctantly agreed.

Since then, he has enjoyed crushing his opponents. Destroying them, actually. He’s entered his robots in more than 20 events and has placed 10 times, winning ribbons, medals, and international recognition.

“We’d always heard of these secret robot fights that go on in local warehouses,” says Dr. Yeh, president at Alameda Inpatient Medical, a 10-hospitalist group in Alameda, Calif. “I’ve always been interested in building things you can destroy.”

Sounds a bit ironic for a physician who has dedicated his life to healing people. But when it comes to nuts, bolts, and titanium, let the fights begin.

Big, Bad, and Bold

Over the past decade, Dr. Yeh has designed and built five robots in his garage, learning his newfound trade from books, other builders, and more recently, the Internet. His first robot took six months to build, he says. Named Robo Master by his son, it had a titanium shell, four-wheel drive, and was strong enough to lift 300 pounds.

Unfortunately, Robo Master made the ultimate sacrifice. During its very first fight, it was slammed against a wall. Its death was premature but quick. It did not suffer. Its body parts were later donated to science—actually, to other robots built by Dr. Yeh.

Several of Dr. Yeh’s robots are still very much alive, however.

At 30 pounds, “The Bully” is considered a featherweight and ranked second in its weight class in the world by BotRank.com. With help from his dad, Forrest drives the robot during events, controlling it remotely.

To encourage his wife, Buffy, to join in the family fun, Dr. Yeh built a 60-pound robot for her in 2004; named “Come To Mama,” the robot is now ranked 22nd in the world in its weight class. It features a drum that spins about 2,000 RPMs and has placed first, second, and third in various competitions.

“She tried driving it but didn’t like it,” says Dr. Yeh, explaining that a robot’s performance in the ring is based 10% on robot, 90% on driver. “But how else was I going to convince my wife to let me build a big toy?”

Building such toys isn’t exactly cheap. While Dr. Yeh says the price of each of his robots was in the four-figure range, he knows other builders who equate their cost to a college education.

Dr. Yeh’s latest prodigy is called “Ragin Scotsman.” At 220 pounds, this heavyweight stands about 10 inches tall and is roughly 2.5 square feet. When his son was a member of his high school’s robotics club, he grew tired of the featherweight division and wanted to fight a bigger robot.

 

Ragin Scotsman is, indeed, bigger and badder. Built in 2011, its superpowers would intimidate Ironman. According to Dr. Yeh, it has the “acceleration of a race car and the aggressiveness of a bulldog.” It can get under its opponents and forcibly throw them against the wall. Not to mention its flame thrower, which can melt their electronics.

At one 2012 event, the Science Channel was filming fights for a new show called “Killer Robots.” Initially, Ragin Scotsman wasn’t one of the stars; however, after the producer watched its aggressiveness and, of course, its flame-throwing ability, Ragin Scotsman was filmed fighting other robots.

Despite its toughness, Dr. Yeh says this robot rarely beats top-ranked rivals, “Sewer Snake” and “Original Sin.”

“These robots are very talented,” he says, adding that they have fought over 100 times. “Ragin Scotsman probably has 40 fights under its belt. Every time we fight, we will win one out of four fights against them.”

He says drivers must learn to anticipate the other drivers’ moves, which takes practice. Some of his friends analyze each fight, studying driver habits so they can predict maneuvers. For example, after every hit, one driver may always signal his robot to turn left.

For the most part, he believes good drivers are able to “negotiate that sweet [vulnerable] spot” before destroying the other robot. He refers to some robots as one-hit wonders. After performing the single task they were designed to do, they have nothing new to offer and end up losing.

Break ‘Em, Build ‘Em

Win or lose, what attracts Dr. Yeh to the hobby is the engineering, building, and camaraderie. He says the robotics community is one big, happy family. Even if his robot gets destroyed, friends will help him rebuild it so it can later fight other robots, including their own.

There may be one more robot in Dr. Yeh’s future. Although he hasn’t made any commitments, he envisions that it would involve pneumatics, using pressurized gas to lift or flip challenging robots on their heads or vault them against walls.

Until then, Dr. Yeh keeps asking himself one question—how can he use his mechanical, engineering, and electrical talent in medicine?

“I’m still trying to figure out if there’s a connection between the two,” he says. “Where’s the bridge?”

Regardless of the outcome, he’ll continue enjoying this hobby. Unlike his day job, he says this is one activity where no one demands anything from him.

---

Carol Patton is a freelance writer in Las Vegas.

“The box is locked, the lights are on. It’s robot fighting time. Sewer Snake charges first. He’s lifting Ragin Scotsman high in the air. Ragin Scotsman manages to escape his death grip and slams Sewer Snake against the wall. Oh no! His front wheel just fell off!”

Jim Yeh, DO, has better things to do with his spare time than watch TV or play golf. For the past dozen years, he has been designing and building robots that fight other robots at events that attract techies nationwide.

It all started harmlessly, when he and his six-year-old son, Forrest, were watching a comedy sketch on TV featuring battling robots. When Forrest suggested they build robots together, Dr. Yeh reluctantly agreed.

Since then, he has enjoyed crushing his opponents. Destroying them, actually. He’s entered his robots in more than 20 events and has placed 10 times, winning ribbons, medals, and international recognition.

“We’d always heard of these secret robot fights that go on in local warehouses,” says Dr. Yeh, president at Alameda Inpatient Medical, a 10-hospitalist group in Alameda, Calif. “I’ve always been interested in building things you can destroy.”

Sounds a bit ironic for a physician who has dedicated his life to healing people. But when it comes to nuts, bolts, and titanium, let the fights begin.

Big, Bad, and Bold

Over the past decade, Dr. Yeh has designed and built five robots in his garage, learning his newfound trade from books, other builders, and more recently, the Internet. His first robot took six months to build, he says. Named Robo Master by his son, it had a titanium shell, four-wheel drive, and was strong enough to lift 300 pounds.

Unfortunately, Robo Master made the ultimate sacrifice. During its very first fight, it was slammed against a wall. Its death was premature but quick. It did not suffer. Its body parts were later donated to science—actually, to other robots built by Dr. Yeh.

Several of Dr. Yeh’s robots are still very much alive, however.

At 30 pounds, “The Bully” is considered a featherweight and ranked second in its weight class in the world by BotRank.com. With help from his dad, Forrest drives the robot during events, controlling it remotely.

To encourage his wife, Buffy, to join in the family fun, Dr. Yeh built a 60-pound robot for her in 2004; named “Come To Mama,” the robot is now ranked 22nd in the world in its weight class. It features a drum that spins about 2,000 RPMs and has placed first, second, and third in various competitions.

“She tried driving it but didn’t like it,” says Dr. Yeh, explaining that a robot’s performance in the ring is based 10% on robot, 90% on driver. “But how else was I going to convince my wife to let me build a big toy?”

Building such toys isn’t exactly cheap. While Dr. Yeh says the price of each of his robots was in the four-figure range, he knows other builders who equate their cost to a college education.

Dr. Yeh’s latest prodigy is called “Ragin Scotsman.” At 220 pounds, this heavyweight stands about 10 inches tall and is roughly 2.5 square feet. When his son was a member of his high school’s robotics club, he grew tired of the featherweight division and wanted to fight a bigger robot.

 

Ragin Scotsman is, indeed, bigger and badder. Built in 2011, its superpowers would intimidate Ironman. According to Dr. Yeh, it has the “acceleration of a race car and the aggressiveness of a bulldog.” It can get under its opponents and forcibly throw them against the wall. Not to mention its flame thrower, which can melt their electronics.

At one 2012 event, the Science Channel was filming fights for a new show called “Killer Robots.” Initially, Ragin Scotsman wasn’t one of the stars; however, after the producer watched its aggressiveness and, of course, its flame-throwing ability, Ragin Scotsman was filmed fighting other robots.

Despite its toughness, Dr. Yeh says this robot rarely beats top-ranked rivals, “Sewer Snake” and “Original Sin.”

“These robots are very talented,” he says, adding that they have fought over 100 times. “Ragin Scotsman probably has 40 fights under its belt. Every time we fight, we will win one out of four fights against them.”

He says drivers must learn to anticipate the other drivers’ moves, which takes practice. Some of his friends analyze each fight, studying driver habits so they can predict maneuvers. For example, after every hit, one driver may always signal his robot to turn left.

For the most part, he believes good drivers are able to “negotiate that sweet [vulnerable] spot” before destroying the other robot. He refers to some robots as one-hit wonders. After performing the single task they were designed to do, they have nothing new to offer and end up losing.

Break ‘Em, Build ‘Em

Win or lose, what attracts Dr. Yeh to the hobby is the engineering, building, and camaraderie. He says the robotics community is one big, happy family. Even if his robot gets destroyed, friends will help him rebuild it so it can later fight other robots, including their own.

There may be one more robot in Dr. Yeh’s future. Although he hasn’t made any commitments, he envisions that it would involve pneumatics, using pressurized gas to lift or flip challenging robots on their heads or vault them against walls.

Until then, Dr. Yeh keeps asking himself one question—how can he use his mechanical, engineering, and electrical talent in medicine?

“I’m still trying to figure out if there’s a connection between the two,” he says. “Where’s the bridge?”

Regardless of the outcome, he’ll continue enjoying this hobby. Unlike his day job, he says this is one activity where no one demands anything from him.

---

Carol Patton is a freelance writer in Las Vegas.

“The box is locked, the lights are on. It’s robot fighting time. Sewer Snake charges first. He’s lifting Ragin Scotsman high in the air. Ragin Scotsman manages to escape his death grip and slams Sewer Snake against the wall. Oh no! His front wheel just fell off!”

Jim Yeh, DO, has better things to do with his spare time than watch TV or play golf. For the past dozen years, he has been designing and building robots that fight other robots at events that attract techies nationwide.

It all started harmlessly, when he and his six-year-old son, Forrest, were watching a comedy sketch on TV featuring battling robots. When Forrest suggested they build robots together, Dr. Yeh reluctantly agreed.

Since then, he has enjoyed crushing his opponents. Destroying them, actually. He’s entered his robots in more than 20 events and has placed 10 times, winning ribbons, medals, and international recognition.

“We’d always heard of these secret robot fights that go on in local warehouses,” says Dr. Yeh, president at Alameda Inpatient Medical, a 10-hospitalist group in Alameda, Calif. “I’ve always been interested in building things you can destroy.”

Sounds a bit ironic for a physician who has dedicated his life to healing people. But when it comes to nuts, bolts, and titanium, let the fights begin.

Big, Bad, and Bold

Over the past decade, Dr. Yeh has designed and built five robots in his garage, learning his newfound trade from books, other builders, and more recently, the Internet. His first robot took six months to build, he says. Named Robo Master by his son, it had a titanium shell, four-wheel drive, and was strong enough to lift 300 pounds.

Unfortunately, Robo Master made the ultimate sacrifice. During its very first fight, it was slammed against a wall. Its death was premature but quick. It did not suffer. Its body parts were later donated to science—actually, to other robots built by Dr. Yeh.

Several of Dr. Yeh’s robots are still very much alive, however.

At 30 pounds, “The Bully” is considered a featherweight and ranked second in its weight class in the world by BotRank.com. With help from his dad, Forrest drives the robot during events, controlling it remotely.

To encourage his wife, Buffy, to join in the family fun, Dr. Yeh built a 60-pound robot for her in 2004; named “Come To Mama,” the robot is now ranked 22nd in the world in its weight class. It features a drum that spins about 2,000 RPMs and has placed first, second, and third in various competitions.

“She tried driving it but didn’t like it,” says Dr. Yeh, explaining that a robot’s performance in the ring is based 10% on robot, 90% on driver. “But how else was I going to convince my wife to let me build a big toy?”

Building such toys isn’t exactly cheap. While Dr. Yeh says the price of each of his robots was in the four-figure range, he knows other builders who equate their cost to a college education.

Dr. Yeh’s latest prodigy is called “Ragin Scotsman.” At 220 pounds, this heavyweight stands about 10 inches tall and is roughly 2.5 square feet. When his son was a member of his high school’s robotics club, he grew tired of the featherweight division and wanted to fight a bigger robot.

 

Ragin Scotsman is, indeed, bigger and badder. Built in 2011, its superpowers would intimidate Ironman. According to Dr. Yeh, it has the “acceleration of a race car and the aggressiveness of a bulldog.” It can get under its opponents and forcibly throw them against the wall. Not to mention its flame thrower, which can melt their electronics.

At one 2012 event, the Science Channel was filming fights for a new show called “Killer Robots.” Initially, Ragin Scotsman wasn’t one of the stars; however, after the producer watched its aggressiveness and, of course, its flame-throwing ability, Ragin Scotsman was filmed fighting other robots.

Despite its toughness, Dr. Yeh says this robot rarely beats top-ranked rivals, “Sewer Snake” and “Original Sin.”

“These robots are very talented,” he says, adding that they have fought over 100 times. “Ragin Scotsman probably has 40 fights under its belt. Every time we fight, we will win one out of four fights against them.”

He says drivers must learn to anticipate the other drivers’ moves, which takes practice. Some of his friends analyze each fight, studying driver habits so they can predict maneuvers. For example, after every hit, one driver may always signal his robot to turn left.

For the most part, he believes good drivers are able to “negotiate that sweet [vulnerable] spot” before destroying the other robot. He refers to some robots as one-hit wonders. After performing the single task they were designed to do, they have nothing new to offer and end up losing.

Break ‘Em, Build ‘Em

Win or lose, what attracts Dr. Yeh to the hobby is the engineering, building, and camaraderie. He says the robotics community is one big, happy family. Even if his robot gets destroyed, friends will help him rebuild it so it can later fight other robots, including their own.

There may be one more robot in Dr. Yeh’s future. Although he hasn’t made any commitments, he envisions that it would involve pneumatics, using pressurized gas to lift or flip challenging robots on their heads or vault them against walls.

Until then, Dr. Yeh keeps asking himself one question—how can he use his mechanical, engineering, and electrical talent in medicine?

“I’m still trying to figure out if there’s a connection between the two,” he says. “Where’s the bridge?”

Regardless of the outcome, he’ll continue enjoying this hobby. Unlike his day job, he says this is one activity where no one demands anything from him.

---

Carol Patton is a freelance writer in Las Vegas.

The 2014 State of Hospital Medicine report (SOHM), published by SHM in the fall of even years, is unquestionably the most robust and informative data available to understand the hospitalist workforce marketplace. And if you are the person who returned a completed survey for your practice, you get a free copy of the report mailed to you.

Keep in mind that the Medical Group Management Association (MGMA) surveys and reports data on hospitalist productivity and compensation every year. And the data acquired by MGMA in even years is simply folded into the SOHM, along with a ton of additional information added by a separate SHM survey, including things like the amount of financial support provided to hospitalist groups by hospitals (now up to a median of $156, 063 per full-time equivalent, or FTE).

I’ve written previously about some of the ways that the data reported in both of these surveys can be tricky to interpret (September 2013 and October 2013), and in this column I’ll go a little deeper into how to use the data reported on number of shifts worked and productivity.

A Common Question

Assume that, to address a staffing shortage or simply as a way to boost their income, some of the doctors in your group are willing to work more shifts than required for full-time status. And, in your group, some portion of a doctor’s compensation is a function of their individual work relevant value unit (wRVU) productivity—for example, a bonus for wRVUs above a certain threshold. You want to know whether the wRVU productivity generated by a doctor on their extra shifts should factor into compensation the same way it does for “regular” shifts.

You might turn to the MGMA and SOHM surveys to see how other groups handle this issue. But here is where it gets tricky.

First, you need to realize that the MGMA surveys, and similar ones from the American Medical Group Association and others, report wRVUs and compensation per physician, not per FTE. So wRVUs generated by these doctors on extra shifts are included, and you can’t tell from the aggregate data what portion of wRVUs came from regular shifts and what portion came from extra shifts.

And it is critical to keep in mind that any doctor who works at least 0.8 FTE as defined by that particular practice is reported as full time. Those working 79% or less of full time are counted by MGMA as part time.

To summarize: The MGMA and similar surveys don’t provide data on wRVU productivity per FTE, even though in most cases that is how everyone describes the data. Instead, the surveys provide data per individual doctor, many of whom work more or less than 1.0 FTE. So, despite the fact that most people, including me, tend to quote data from the surveys as though it is per FTE, as in “The 2014 MGMA data shows median hospitalist compensation is $253,977 per FTE,” we should say “per doctor” instead.

Theoretically, doctors working slightly less than 1.0 FTE should offset the doctors working slightly more than 1.0 FTE. But, while I think that’s a reasonable assumption for most specialties, such a significant portion of hospitalist groups have had chronic staffing shortages that a lot of hospitalists across the country are working extra shifts, probably more than are working between 0.8 and 1.0 FTE. So the hospitalist survey wRVU data is probably at least a little higher than it would be if it were reported per FTE.

 

Unfortunately, there is no way to confirm my suspicion, because MGMA doesn’t allow any individual doctor to be reported as more than 1.0 FTE, even if he works far more shifts than the number that defines full time for that practice. In other words, extra shifts just aren’t accounted for in the MGMA survey.

Implications of Individual vs. FTE

For most purposes, it probably doesn’t make any difference if you are erroneously thinking about the compensation and productivity survey numbers on a per FTE basis. But, for some purposes, and for those who work significantly more shifts than most hospitalists, it can start to matter.

Now back to the original question. You’re thinking about whether wRVUs generated by the doctors in your group on extra shifts should count toward the wRVU bonus just like those generated on regular shifts. You’d like to handle this the same way as other groups, but, unfortunately, survey data just isn’t helpful here. You’ll have to decide this for yourself.

I think some, but probably not all, extra shift productivity should count toward your wRVU bonus. You might, for example, say that productivity for somewhere between three or five extra shifts per quarter—that’s totally arbitrary, and of course this would be a negotiation between you and hospital leadership—should count toward the productivity target, and the rest wouldn’t, or that those extra shifts above an agreed-upon number would result in an increase in the wRVU target. The biggest problem with this is that it would be a nightmare to administer—essentially impossible for many practices. But you could accomplish the same thing by including the first few shifts per quarter in the “base” FTE calculation and then, after that, adjusting each person’s FTE value up as they work more shifts.

One more thing about productivity targets…

It’s also important to remember that productivity targets make the most sense at the group—not the individual—level. The MGMA data includes hospitalists who work night shifts (including nocturnists) and doctors who work low-production shifts (i.e., pager or ED triage shifts), as well as daytime rounding doctors. So, if you have a doctor who only works days, you would expect him to generate wRVUs in excess of the global target of wRVUs per FTE to make up for the low-productivity shifts that other doctors have to work.

For example, your practice might decide the group as a whole is expected to generate the MGMA yearly median 4,298 wRVUs per doctor, multiplied by the number of FTEs in the group. But the nocturnists would be expected to generate fewer, while those who work most or all of their shifts in a daytime rounder would be expected to generate more. So the threshold to begin paying the wRVU bonus for daytime rounding doctors might be adjusted up to something like 4,500 wRVUs.

The above example is just as an illustration, of course, and there are all kinds of reasons it might be more appropriate to choose different thresholds for your practice. But it’s a good place to start the thinking.

---

Dr. Nelson has been a practicing hospitalist since 1988. He is co-founder and past president of SHM, and principal in Nelson Flores Hospital Medicine Consultants. He is co-director for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. Write to him at [email protected].

The 2014 State of Hospital Medicine report (SOHM), published by SHM in the fall of even years, is unquestionably the most robust and informative data available to understand the hospitalist workforce marketplace. And if you are the person who returned a completed survey for your practice, you get a free copy of the report mailed to you.

Keep in mind that the Medical Group Management Association (MGMA) surveys and reports data on hospitalist productivity and compensation every year. And the data acquired by MGMA in even years is simply folded into the SOHM, along with a ton of additional information added by a separate SHM survey, including things like the amount of financial support provided to hospitalist groups by hospitals (now up to a median of $156, 063 per full-time equivalent, or FTE).

I’ve written previously about some of the ways that the data reported in both of these surveys can be tricky to interpret (September 2013 and October 2013), and in this column I’ll go a little deeper into how to use the data reported on number of shifts worked and productivity.

A Common Question

Assume that, to address a staffing shortage or simply as a way to boost their income, some of the doctors in your group are willing to work more shifts than required for full-time status. And, in your group, some portion of a doctor’s compensation is a function of their individual work relevant value unit (wRVU) productivity—for example, a bonus for wRVUs above a certain threshold. You want to know whether the wRVU productivity generated by a doctor on their extra shifts should factor into compensation the same way it does for “regular” shifts.

You might turn to the MGMA and SOHM surveys to see how other groups handle this issue. But here is where it gets tricky.

First, you need to realize that the MGMA surveys, and similar ones from the American Medical Group Association and others, report wRVUs and compensation per physician, not per FTE. So wRVUs generated by these doctors on extra shifts are included, and you can’t tell from the aggregate data what portion of wRVUs came from regular shifts and what portion came from extra shifts.

And it is critical to keep in mind that any doctor who works at least 0.8 FTE as defined by that particular practice is reported as full time. Those working 79% or less of full time are counted by MGMA as part time.

To summarize: The MGMA and similar surveys don’t provide data on wRVU productivity per FTE, even though in most cases that is how everyone describes the data. Instead, the surveys provide data per individual doctor, many of whom work more or less than 1.0 FTE. So, despite the fact that most people, including me, tend to quote data from the surveys as though it is per FTE, as in “The 2014 MGMA data shows median hospitalist compensation is $253,977 per FTE,” we should say “per doctor” instead.

Theoretically, doctors working slightly less than 1.0 FTE should offset the doctors working slightly more than 1.0 FTE. But, while I think that’s a reasonable assumption for most specialties, such a significant portion of hospitalist groups have had chronic staffing shortages that a lot of hospitalists across the country are working extra shifts, probably more than are working between 0.8 and 1.0 FTE. So the hospitalist survey wRVU data is probably at least a little higher than it would be if it were reported per FTE.

 

Unfortunately, there is no way to confirm my suspicion, because MGMA doesn’t allow any individual doctor to be reported as more than 1.0 FTE, even if he works far more shifts than the number that defines full time for that practice. In other words, extra shifts just aren’t accounted for in the MGMA survey.

Implications of Individual vs. FTE

For most purposes, it probably doesn’t make any difference if you are erroneously thinking about the compensation and productivity survey numbers on a per FTE basis. But, for some purposes, and for those who work significantly more shifts than most hospitalists, it can start to matter.

Now back to the original question. You’re thinking about whether wRVUs generated by the doctors in your group on extra shifts should count toward the wRVU bonus just like those generated on regular shifts. You’d like to handle this the same way as other groups, but, unfortunately, survey data just isn’t helpful here. You’ll have to decide this for yourself.

I think some, but probably not all, extra shift productivity should count toward your wRVU bonus. You might, for example, say that productivity for somewhere between three or five extra shifts per quarter—that’s totally arbitrary, and of course this would be a negotiation between you and hospital leadership—should count toward the productivity target, and the rest wouldn’t, or that those extra shifts above an agreed-upon number would result in an increase in the wRVU target. The biggest problem with this is that it would be a nightmare to administer—essentially impossible for many practices. But you could accomplish the same thing by including the first few shifts per quarter in the “base” FTE calculation and then, after that, adjusting each person’s FTE value up as they work more shifts.

One more thing about productivity targets…

It’s also important to remember that productivity targets make the most sense at the group—not the individual—level. The MGMA data includes hospitalists who work night shifts (including nocturnists) and doctors who work low-production shifts (i.e., pager or ED triage shifts), as well as daytime rounding doctors. So, if you have a doctor who only works days, you would expect him to generate wRVUs in excess of the global target of wRVUs per FTE to make up for the low-productivity shifts that other doctors have to work.

For example, your practice might decide the group as a whole is expected to generate the MGMA yearly median 4,298 wRVUs per doctor, multiplied by the number of FTEs in the group. But the nocturnists would be expected to generate fewer, while those who work most or all of their shifts in a daytime rounder would be expected to generate more. So the threshold to begin paying the wRVU bonus for daytime rounding doctors might be adjusted up to something like 4,500 wRVUs.

The above example is just as an illustration, of course, and there are all kinds of reasons it might be more appropriate to choose different thresholds for your practice. But it’s a good place to start the thinking.

---

Dr. Nelson has been a practicing hospitalist since 1988. He is co-founder and past president of SHM, and principal in Nelson Flores Hospital Medicine Consultants. He is co-director for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. Write to him at [email protected].

The 2014 State of Hospital Medicine report (SOHM), published by SHM in the fall of even years, is unquestionably the most robust and informative data available to understand the hospitalist workforce marketplace. And if you are the person who returned a completed survey for your practice, you get a free copy of the report mailed to you.

Keep in mind that the Medical Group Management Association (MGMA) surveys and reports data on hospitalist productivity and compensation every year. And the data acquired by MGMA in even years is simply folded into the SOHM, along with a ton of additional information added by a separate SHM survey, including things like the amount of financial support provided to hospitalist groups by hospitals (now up to a median of $156, 063 per full-time equivalent, or FTE).

I’ve written previously about some of the ways that the data reported in both of these surveys can be tricky to interpret (September 2013 and October 2013), and in this column I’ll go a little deeper into how to use the data reported on number of shifts worked and productivity.

A Common Question

Assume that, to address a staffing shortage or simply as a way to boost their income, some of the doctors in your group are willing to work more shifts than required for full-time status. And, in your group, some portion of a doctor’s compensation is a function of their individual work relevant value unit (wRVU) productivity—for example, a bonus for wRVUs above a certain threshold. You want to know whether the wRVU productivity generated by a doctor on their extra shifts should factor into compensation the same way it does for “regular” shifts.

You might turn to the MGMA and SOHM surveys to see how other groups handle this issue. But here is where it gets tricky.

First, you need to realize that the MGMA surveys, and similar ones from the American Medical Group Association and others, report wRVUs and compensation per physician, not per FTE. So wRVUs generated by these doctors on extra shifts are included, and you can’t tell from the aggregate data what portion of wRVUs came from regular shifts and what portion came from extra shifts.

And it is critical to keep in mind that any doctor who works at least 0.8 FTE as defined by that particular practice is reported as full time. Those working 79% or less of full time are counted by MGMA as part time.

To summarize: The MGMA and similar surveys don’t provide data on wRVU productivity per FTE, even though in most cases that is how everyone describes the data. Instead, the surveys provide data per individual doctor, many of whom work more or less than 1.0 FTE. So, despite the fact that most people, including me, tend to quote data from the surveys as though it is per FTE, as in “The 2014 MGMA data shows median hospitalist compensation is $253,977 per FTE,” we should say “per doctor” instead.

Theoretically, doctors working slightly less than 1.0 FTE should offset the doctors working slightly more than 1.0 FTE. But, while I think that’s a reasonable assumption for most specialties, such a significant portion of hospitalist groups have had chronic staffing shortages that a lot of hospitalists across the country are working extra shifts, probably more than are working between 0.8 and 1.0 FTE. So the hospitalist survey wRVU data is probably at least a little higher than it would be if it were reported per FTE.

 

Unfortunately, there is no way to confirm my suspicion, because MGMA doesn’t allow any individual doctor to be reported as more than 1.0 FTE, even if he works far more shifts than the number that defines full time for that practice. In other words, extra shifts just aren’t accounted for in the MGMA survey.

Implications of Individual vs. FTE

For most purposes, it probably doesn’t make any difference if you are erroneously thinking about the compensation and productivity survey numbers on a per FTE basis. But, for some purposes, and for those who work significantly more shifts than most hospitalists, it can start to matter.

Now back to the original question. You’re thinking about whether wRVUs generated by the doctors in your group on extra shifts should count toward the wRVU bonus just like those generated on regular shifts. You’d like to handle this the same way as other groups, but, unfortunately, survey data just isn’t helpful here. You’ll have to decide this for yourself.

I think some, but probably not all, extra shift productivity should count toward your wRVU bonus. You might, for example, say that productivity for somewhere between three or five extra shifts per quarter—that’s totally arbitrary, and of course this would be a negotiation between you and hospital leadership—should count toward the productivity target, and the rest wouldn’t, or that those extra shifts above an agreed-upon number would result in an increase in the wRVU target. The biggest problem with this is that it would be a nightmare to administer—essentially impossible for many practices. But you could accomplish the same thing by including the first few shifts per quarter in the “base” FTE calculation and then, after that, adjusting each person’s FTE value up as they work more shifts.

One more thing about productivity targets…

It’s also important to remember that productivity targets make the most sense at the group—not the individual—level. The MGMA data includes hospitalists who work night shifts (including nocturnists) and doctors who work low-production shifts (i.e., pager or ED triage shifts), as well as daytime rounding doctors. So, if you have a doctor who only works days, you would expect him to generate wRVUs in excess of the global target of wRVUs per FTE to make up for the low-productivity shifts that other doctors have to work.

For example, your practice might decide the group as a whole is expected to generate the MGMA yearly median 4,298 wRVUs per doctor, multiplied by the number of FTEs in the group. But the nocturnists would be expected to generate fewer, while those who work most or all of their shifts in a daytime rounder would be expected to generate more. So the threshold to begin paying the wRVU bonus for daytime rounding doctors might be adjusted up to something like 4,500 wRVUs.

The above example is just as an illustration, of course, and there are all kinds of reasons it might be more appropriate to choose different thresholds for your practice. But it’s a good place to start the thinking.

---

Dr. Nelson has been a practicing hospitalist since 1988. He is co-founder and past president of SHM, and principal in Nelson Flores Hospital Medicine Consultants. He is co-director for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. Write to him at [email protected].

EDITOR’S NOTE: Third in an occasional series of reviews of the Hospital Medicine: Current Concepts series by members of Team Hospitalist.

Summary

Older patients comprise an increasingly large part of the population we serve as hospitalists. We are all very familiar with the standard medical problems—congestive heart failure, COPD, or stroke—that these individuals present to us in the inpatient setting; however, this patient population has special needs and challenges that often are inadequately covered in textbooks and treatment guidelines.

The Hospitalists’ Guide to the Care of Older Patients serves as an excellent guide for the day-to-day management of geriatric patients. All 13 of its chapters are written in a concise, to-the-point style. The authors have a sound understanding of the needs and challenges of today’s practicing hospitalists.

The authors focus entire chapters on geriatric assessment and exam and communication with older patients. They remind hospitalists to be aware that these patients need a thoughtful approach in our interactions, because vision, hearing, or cognition might be impaired.

The 269-page book provides a great overview on decision making and decision-making capacity (DMC). Patients might have partial DMC, in spite of cognitive impairment or neurological or psychiatric illness. Surrogate decision makers and their limitations also are discussed.

One chapter is dedicated to end-of-life care, with special attention to debility and dementia.

Another major focus is geriatric pharmacotherapy and polypharmacy in the elderly. Attention is given to the fact that drug studies frequently fail to include the elderly and that pharmacokinetics may be significantly altered in this population. The chapter includes a table of “high-risk meds” prescribed by hospitalists.

Delirium and management of behavioral disturbances are described in two chapters and include very helpful tables to guide in its treatment.

The authors also review nutrition management, including a customized approach to patients with dysphagia at risk for aspiration and managing complex medical patients with hip fractures, including pre-op evaluation, post-op care, pain management, and delirium. Narcotic pain medications are of obvious concern in the elderly, but it is pointed out that uncontrolled pain in itself can cause delirium.

Special attention is given to mobility and fall risk, as well as prevention strategies, in hospitalized patients.

Pressure ulcers are a concern in all patients but especially the elderly. This guide outlines mechanisms of ulcer formation, staging, and treatment options.

The book concludes with a chapter on transitional care planning for a safe discharge. It describes potential risks for errors and poor handoffs, including failure to adequately communicate complex discharge plans to elderly patients.

Analysis

The Hospitalists’ Guide to the Care of Older Patients is an excellent, hands-on manual for managing elderly patients. It describes standard situations frequently encountered by hospitalists and provides pertinent information that can be acted upon.

Written with a genuine understanding of what matters most for hospitalists in their daily practice, the chapters are focused and concise enough to serve as a quick reference, yet detailed enough to supply the hospitalist with sufficient information to be able to put a patient management plan into action.

After reading this book, hospitalists will have a solid and rational basis for the thoughtful and effective management of elderly patients.

---

Dr. Suehler is a hospitalist with Midwest Internal Medicine Hospitalists at Mercy Hospital in Coon Rapids, Minn., and a member of Team Hospitalist since 2013.

EDITOR’S NOTE: Third in an occasional series of reviews of the Hospital Medicine: Current Concepts series by members of Team Hospitalist.

Summary

Older patients comprise an increasingly large part of the population we serve as hospitalists. We are all very familiar with the standard medical problems—congestive heart failure, COPD, or stroke—that these individuals present to us in the inpatient setting; however, this patient population has special needs and challenges that often are inadequately covered in textbooks and treatment guidelines.

The Hospitalists’ Guide to the Care of Older Patients serves as an excellent guide for the day-to-day management of geriatric patients. All 13 of its chapters are written in a concise, to-the-point style. The authors have a sound understanding of the needs and challenges of today’s practicing hospitalists.

The authors focus entire chapters on geriatric assessment and exam and communication with older patients. They remind hospitalists to be aware that these patients need a thoughtful approach in our interactions, because vision, hearing, or cognition might be impaired.

The 269-page book provides a great overview on decision making and decision-making capacity (DMC). Patients might have partial DMC, in spite of cognitive impairment or neurological or psychiatric illness. Surrogate decision makers and their limitations also are discussed.

One chapter is dedicated to end-of-life care, with special attention to debility and dementia.

Another major focus is geriatric pharmacotherapy and polypharmacy in the elderly. Attention is given to the fact that drug studies frequently fail to include the elderly and that pharmacokinetics may be significantly altered in this population. The chapter includes a table of “high-risk meds” prescribed by hospitalists.

Delirium and management of behavioral disturbances are described in two chapters and include very helpful tables to guide in its treatment.

The authors also review nutrition management, including a customized approach to patients with dysphagia at risk for aspiration and managing complex medical patients with hip fractures, including pre-op evaluation, post-op care, pain management, and delirium. Narcotic pain medications are of obvious concern in the elderly, but it is pointed out that uncontrolled pain in itself can cause delirium.

Special attention is given to mobility and fall risk, as well as prevention strategies, in hospitalized patients.

Pressure ulcers are a concern in all patients but especially the elderly. This guide outlines mechanisms of ulcer formation, staging, and treatment options.

The book concludes with a chapter on transitional care planning for a safe discharge. It describes potential risks for errors and poor handoffs, including failure to adequately communicate complex discharge plans to elderly patients.

Analysis

The Hospitalists’ Guide to the Care of Older Patients is an excellent, hands-on manual for managing elderly patients. It describes standard situations frequently encountered by hospitalists and provides pertinent information that can be acted upon.

Written with a genuine understanding of what matters most for hospitalists in their daily practice, the chapters are focused and concise enough to serve as a quick reference, yet detailed enough to supply the hospitalist with sufficient information to be able to put a patient management plan into action.

After reading this book, hospitalists will have a solid and rational basis for the thoughtful and effective management of elderly patients.

---

Dr. Suehler is a hospitalist with Midwest Internal Medicine Hospitalists at Mercy Hospital in Coon Rapids, Minn., and a member of Team Hospitalist since 2013.

EDITOR’S NOTE: Third in an occasional series of reviews of the Hospital Medicine: Current Concepts series by members of Team Hospitalist.

Summary

Older patients comprise an increasingly large part of the population we serve as hospitalists. We are all very familiar with the standard medical problems—congestive heart failure, COPD, or stroke—that these individuals present to us in the inpatient setting; however, this patient population has special needs and challenges that often are inadequately covered in textbooks and treatment guidelines.

The Hospitalists’ Guide to the Care of Older Patients serves as an excellent guide for the day-to-day management of geriatric patients. All 13 of its chapters are written in a concise, to-the-point style. The authors have a sound understanding of the needs and challenges of today’s practicing hospitalists.

The authors focus entire chapters on geriatric assessment and exam and communication with older patients. They remind hospitalists to be aware that these patients need a thoughtful approach in our interactions, because vision, hearing, or cognition might be impaired.

The 269-page book provides a great overview on decision making and decision-making capacity (DMC). Patients might have partial DMC, in spite of cognitive impairment or neurological or psychiatric illness. Surrogate decision makers and their limitations also are discussed.

One chapter is dedicated to end-of-life care, with special attention to debility and dementia.

Another major focus is geriatric pharmacotherapy and polypharmacy in the elderly. Attention is given to the fact that drug studies frequently fail to include the elderly and that pharmacokinetics may be significantly altered in this population. The chapter includes a table of “high-risk meds” prescribed by hospitalists.

Delirium and management of behavioral disturbances are described in two chapters and include very helpful tables to guide in its treatment.

The authors also review nutrition management, including a customized approach to patients with dysphagia at risk for aspiration and managing complex medical patients with hip fractures, including pre-op evaluation, post-op care, pain management, and delirium. Narcotic pain medications are of obvious concern in the elderly, but it is pointed out that uncontrolled pain in itself can cause delirium.

Special attention is given to mobility and fall risk, as well as prevention strategies, in hospitalized patients.

Pressure ulcers are a concern in all patients but especially the elderly. This guide outlines mechanisms of ulcer formation, staging, and treatment options.

The book concludes with a chapter on transitional care planning for a safe discharge. It describes potential risks for errors and poor handoffs, including failure to adequately communicate complex discharge plans to elderly patients.

Analysis

The Hospitalists’ Guide to the Care of Older Patients is an excellent, hands-on manual for managing elderly patients. It describes standard situations frequently encountered by hospitalists and provides pertinent information that can be acted upon.

Written with a genuine understanding of what matters most for hospitalists in their daily practice, the chapters are focused and concise enough to serve as a quick reference, yet detailed enough to supply the hospitalist with sufficient information to be able to put a patient management plan into action.

After reading this book, hospitalists will have a solid and rational basis for the thoughtful and effective management of elderly patients.

---

Dr. Suehler is a hospitalist with Midwest Internal Medicine Hospitalists at Mercy Hospital in Coon Rapids, Minn., and a member of Team Hospitalist since 2013.

SAN FRANCISCO—Patients with HIV-related lymphoma (HRL) should not be excluded from clinical trials of autologous stem cell transplant (ASCT) due to their HIV status, new research suggests.

Investigators found no significant difference in rates of treatment failure, disease progression, or survival between transplant-treated historical controls who had lymphoma but not HIV and patients with HRL who received the modified BEAM regimen followed by ASCT on a phase 2 trial.

This suggests patients with chemotherapy-sensitive, relapsed/refractory HRL can be treated successfully with the modified BEAM regimen, said study investigator Joseph Alvarnas, MD, of City of Hope National Medical Center in Duarte, California.

“Patients with treatment-responsive HIV infection and HIV-related lymphoma should be considered candidates for autologous transplant if they meet standard transplant criteria,” he added. “And we would argue that exclusion from clinical trials on the basis of HIV infection alone is no longer justified.”

Dr Alvarnas presented this viewpoint and the research to support it at the 2014 ASH Annual Meeting as abstract 674.

The trial enrolled 43 patients with treatable HIV-1 infection, adequate organ function, and aggressive lymphoma. Three patients were excluded because they could not undergo transplant due to lymphoma progression.

Of the 40 remaining patients, 5 were female, and their median age was 46.9 years (range, 22.5-62.2). They had diffuse large B-cell lymphoma (n=16), plasmablastic lymphoma (n=2), Burkitt/Burkitt-like lymphoma (n=7), and Hodgkin lymphoma (n=15).

The pre-ASCT HIV viral load was undetectable in 31 patients. In the patients with detectable HIV, the median viral load pre-ASCT was 84 copies/μL (range, 50-17,455). The median CD4 count was 250.5/µL (range, 39-797).

Before transplant, 30 patients (75%) were in complete remission, 8 (20%) were in partial remission, and 2 (5%) had relapsed/progressive disease.

The patients underwent ASCT after conditioning with the modified BEAM regimen—carmustine at 300 mg/m² (day -6), etoposide at 100 mg/m² twice daily (days -5 to -2), cytarabine at 100 mg/m² (days -5 to -2), and melphalan at 140 mg/m² (day -1).

Combination antiretroviral therapy (cART) was held during the preparative regimen and resumed after the resolution of gastrointestinal toxicity. The investigators switched efavirenz to an alternative agent 2 or more weeks prior to the planned interruption of cART, as the drug has a long half-life. And AZT was prohibited due to its myelosuppressive effects.

Treatment results

The median follow-up was 24 months. At 100 days post-transplant, the investigators assessed 39 patients for response. One patient was not evaluable due to early death.

Thirty-six of the patients (92.3%) were in complete remission, 1 (2.6%) was in partial remission, and 2 (5.1%) had relapsed or progressive disease.

Fifteen patients reported grade 3 or higher toxicities within a year of transplant. Of the 13 unexpected grade 3-5 adverse events (reported in 9 patients), 5 were infection/sepsis, 1 was acute appendicitis, 1 was acute coronary syndrome, 2 were deep vein thromboses, 2 were gastrointestinal toxicities, and 2 were metabolic abnormalities.

Seventeen patients reported at least 1 infectious episode, 42 events in total, 9 of which were severe. Fourteen patients required readmission to the hospital after transplant.

Within a year of transplant, 5 patients had died—3 from recurrent/persistent disease, 1 due to a fungal infection, and 1 from cardiac arrest. Two additional patients died after the 1-year mark—1 of recurrent/persistent disease and 1 of heart failure.

At 12 months, the rate of overall survival was 86.6%, progression-free survival was 82.3%, progression was 12.5%, and non-relapse mortality was 5.2%.

“In order to place this within context, we had the opportunity to compare our patient experience with 151 matched controls [without HIV] from CIBMTR,” Dr Alvarnas said. “Ninety-three percent of these patients were actually transplanted within 2 years so that they were the time-concordant group, and they were matched for performance score, disease, and disease stage.”

 

The investigators found no significant difference between their patient group and the HIV-free controls with regard to overall mortality (P=0.56), treatment failure (P=0.10), progression (P=0.06), and treatment-related mortality (P=0.97).

Likewise, there was no significant difference in overall survival between the HRL patients and controls—86.6% and 87.7%, respectively (P=0.56). And the same was true of progression-free survival—82.3% and 69.5%, respectively (P=0.10).

SAN FRANCISCO—Patients with HIV-related lymphoma (HRL) should not be excluded from clinical trials of autologous stem cell transplant (ASCT) due to their HIV status, new research suggests.

Investigators found no significant difference in rates of treatment failure, disease progression, or survival between transplant-treated historical controls who had lymphoma but not HIV and patients with HRL who received the modified BEAM regimen followed by ASCT on a phase 2 trial.

This suggests patients with chemotherapy-sensitive, relapsed/refractory HRL can be treated successfully with the modified BEAM regimen, said study investigator Joseph Alvarnas, MD, of City of Hope National Medical Center in Duarte, California.

“Patients with treatment-responsive HIV infection and HIV-related lymphoma should be considered candidates for autologous transplant if they meet standard transplant criteria,” he added. “And we would argue that exclusion from clinical trials on the basis of HIV infection alone is no longer justified.”

Dr Alvarnas presented this viewpoint and the research to support it at the 2014 ASH Annual Meeting as abstract 674.

The trial enrolled 43 patients with treatable HIV-1 infection, adequate organ function, and aggressive lymphoma. Three patients were excluded because they could not undergo transplant due to lymphoma progression.

Of the 40 remaining patients, 5 were female, and their median age was 46.9 years (range, 22.5-62.2). They had diffuse large B-cell lymphoma (n=16), plasmablastic lymphoma (n=2), Burkitt/Burkitt-like lymphoma (n=7), and Hodgkin lymphoma (n=15).

The pre-ASCT HIV viral load was undetectable in 31 patients. In the patients with detectable HIV, the median viral load pre-ASCT was 84 copies/μL (range, 50-17,455). The median CD4 count was 250.5/µL (range, 39-797).

Before transplant, 30 patients (75%) were in complete remission, 8 (20%) were in partial remission, and 2 (5%) had relapsed/progressive disease.

The patients underwent ASCT after conditioning with the modified BEAM regimen—carmustine at 300 mg/m² (day -6), etoposide at 100 mg/m² twice daily (days -5 to -2), cytarabine at 100 mg/m² (days -5 to -2), and melphalan at 140 mg/m² (day -1).

Combination antiretroviral therapy (cART) was held during the preparative regimen and resumed after the resolution of gastrointestinal toxicity. The investigators switched efavirenz to an alternative agent 2 or more weeks prior to the planned interruption of cART, as the drug has a long half-life. And AZT was prohibited due to its myelosuppressive effects.

Treatment results

The median follow-up was 24 months. At 100 days post-transplant, the investigators assessed 39 patients for response. One patient was not evaluable due to early death.

Thirty-six of the patients (92.3%) were in complete remission, 1 (2.6%) was in partial remission, and 2 (5.1%) had relapsed or progressive disease.

Fifteen patients reported grade 3 or higher toxicities within a year of transplant. Of the 13 unexpected grade 3-5 adverse events (reported in 9 patients), 5 were infection/sepsis, 1 was acute appendicitis, 1 was acute coronary syndrome, 2 were deep vein thromboses, 2 were gastrointestinal toxicities, and 2 were metabolic abnormalities.

Seventeen patients reported at least 1 infectious episode, 42 events in total, 9 of which were severe. Fourteen patients required readmission to the hospital after transplant.

Within a year of transplant, 5 patients had died—3 from recurrent/persistent disease, 1 due to a fungal infection, and 1 from cardiac arrest. Two additional patients died after the 1-year mark—1 of recurrent/persistent disease and 1 of heart failure.

At 12 months, the rate of overall survival was 86.6%, progression-free survival was 82.3%, progression was 12.5%, and non-relapse mortality was 5.2%.

“In order to place this within context, we had the opportunity to compare our patient experience with 151 matched controls [without HIV] from CIBMTR,” Dr Alvarnas said. “Ninety-three percent of these patients were actually transplanted within 2 years so that they were the time-concordant group, and they were matched for performance score, disease, and disease stage.”

 

The investigators found no significant difference between their patient group and the HIV-free controls with regard to overall mortality (P=0.56), treatment failure (P=0.10), progression (P=0.06), and treatment-related mortality (P=0.97).

Likewise, there was no significant difference in overall survival between the HRL patients and controls—86.6% and 87.7%, respectively (P=0.56). And the same was true of progression-free survival—82.3% and 69.5%, respectively (P=0.10).

SAN FRANCISCO—Patients with HIV-related lymphoma (HRL) should not be excluded from clinical trials of autologous stem cell transplant (ASCT) due to their HIV status, new research suggests.

Investigators found no significant difference in rates of treatment failure, disease progression, or survival between transplant-treated historical controls who had lymphoma but not HIV and patients with HRL who received the modified BEAM regimen followed by ASCT on a phase 2 trial.

This suggests patients with chemotherapy-sensitive, relapsed/refractory HRL can be treated successfully with the modified BEAM regimen, said study investigator Joseph Alvarnas, MD, of City of Hope National Medical Center in Duarte, California.

“Patients with treatment-responsive HIV infection and HIV-related lymphoma should be considered candidates for autologous transplant if they meet standard transplant criteria,” he added. “And we would argue that exclusion from clinical trials on the basis of HIV infection alone is no longer justified.”

Dr Alvarnas presented this viewpoint and the research to support it at the 2014 ASH Annual Meeting as abstract 674.

The trial enrolled 43 patients with treatable HIV-1 infection, adequate organ function, and aggressive lymphoma. Three patients were excluded because they could not undergo transplant due to lymphoma progression.

Of the 40 remaining patients, 5 were female, and their median age was 46.9 years (range, 22.5-62.2). They had diffuse large B-cell lymphoma (n=16), plasmablastic lymphoma (n=2), Burkitt/Burkitt-like lymphoma (n=7), and Hodgkin lymphoma (n=15).

The pre-ASCT HIV viral load was undetectable in 31 patients. In the patients with detectable HIV, the median viral load pre-ASCT was 84 copies/μL (range, 50-17,455). The median CD4 count was 250.5/µL (range, 39-797).

Before transplant, 30 patients (75%) were in complete remission, 8 (20%) were in partial remission, and 2 (5%) had relapsed/progressive disease.

The patients underwent ASCT after conditioning with the modified BEAM regimen—carmustine at 300 mg/m² (day -6), etoposide at 100 mg/m² twice daily (days -5 to -2), cytarabine at 100 mg/m² (days -5 to -2), and melphalan at 140 mg/m² (day -1).

Combination antiretroviral therapy (cART) was held during the preparative regimen and resumed after the resolution of gastrointestinal toxicity. The investigators switched efavirenz to an alternative agent 2 or more weeks prior to the planned interruption of cART, as the drug has a long half-life. And AZT was prohibited due to its myelosuppressive effects.

Treatment results

The median follow-up was 24 months. At 100 days post-transplant, the investigators assessed 39 patients for response. One patient was not evaluable due to early death.

Thirty-six of the patients (92.3%) were in complete remission, 1 (2.6%) was in partial remission, and 2 (5.1%) had relapsed or progressive disease.

Fifteen patients reported grade 3 or higher toxicities within a year of transplant. Of the 13 unexpected grade 3-5 adverse events (reported in 9 patients), 5 were infection/sepsis, 1 was acute appendicitis, 1 was acute coronary syndrome, 2 were deep vein thromboses, 2 were gastrointestinal toxicities, and 2 were metabolic abnormalities.

Seventeen patients reported at least 1 infectious episode, 42 events in total, 9 of which were severe. Fourteen patients required readmission to the hospital after transplant.

Within a year of transplant, 5 patients had died—3 from recurrent/persistent disease, 1 due to a fungal infection, and 1 from cardiac arrest. Two additional patients died after the 1-year mark—1 of recurrent/persistent disease and 1 of heart failure.

At 12 months, the rate of overall survival was 86.6%, progression-free survival was 82.3%, progression was 12.5%, and non-relapse mortality was 5.2%.

“In order to place this within context, we had the opportunity to compare our patient experience with 151 matched controls [without HIV] from CIBMTR,” Dr Alvarnas said. “Ninety-three percent of these patients were actually transplanted within 2 years so that they were the time-concordant group, and they were matched for performance score, disease, and disease stage.”

 

The investigators found no significant difference between their patient group and the HIV-free controls with regard to overall mortality (P=0.56), treatment failure (P=0.10), progression (P=0.06), and treatment-related mortality (P=0.97).

Likewise, there was no significant difference in overall survival between the HRL patients and controls—86.6% and 87.7%, respectively (P=0.56). And the same was true of progression-free survival—82.3% and 69.5%, respectively (P=0.10).

 

SAN FRANCISCO—Maintenance therapy with the anti-CD20 monoclonal antibody ofatumumab improves progression-free survival (PFS), but not overall survival (OS), in patients with relapsed chronic lymphocytic leukemia (CLL), according to an interim analysis of the PROLONG study.

 

The median PFS was about 29 months in patients who received ofatumumab and about 15 months for patients who did not receive maintenance (P<0.0001).

 

But there was no significant difference in the median OS, which was not reached in either treatment arm.

 

Marinus H.J. van Oers, MD, PhD, of the Academisch Medisch Centrum and HOVON in Amsterdam, The Netherlands, reported these results at the 2014 ASH Annual Meeting (abstract 21*). The study was sponsored by GlaxoSmithKline, makers of ofatumumab.

 

“[A]s of 2014, still we cannot say that we are able to cure CLL,” Dr van Oers noted. “And CLL is characterized by decreasing response duration with subsequent lines of treatment. In this respect, but also a number of other respects, there are similarities in biological behavior between CLL and follicular lymphoma.”

 

“There is definitely a role—although it’s somewhat debated—for maintenance treatment in follicular lymphoma. Therefore, it is rational to explore safe and effective maintenance treatment in CLL as well.”

 

To that end, Dr van Oers and his colleagues compared ofatumumab maintenance to observation in patients who were in remission after induction treatment for relapsed CLL. The team enrolled 474 patients who were in complete or partial remission after their 2nd- or 3rd-line treatment for CLL.

 

Patients were randomized to observation (n=236) or to receive ofatumumab (n=238) at 300 mg, followed 1 week later by 1000 mg every 8 weeks for up to 2 years. Patients on ofatumumab also received premedication with acetaminophen, antihistamine, and glucocorticoid.

 

The patients were stratified by the number and type of prior therapy, as well as remission status after induction treatment, and baseline characteristics were similar between the two treatment arms.

 

“The median age was about 65, and about 30% of patients were older than 70 years,” Dr van Oers noted. “[There was] a male preponderance, as you would expect, and the time since diagnosis was somewhere between 5 and 6 years.”

 

“Most patients were in [partial response], actually 80%, and most patients had received 2 prior regimens, about 70%. As for prior treatments, 80% of patients had received effective immuno-chemotherapy.”

 

“In both arms, there were only a few patients with unfavorable cytogenetics—11q and 17p deletion. [As for] β2 microglobulin, two-thirds [of patients in both arms] had low levels. And, in both arms, there were almost twice as many IGVH-mutated as unmutated patients.”

 

Patient outcomes

 

The median follow-up was 19.1 months. The study’s primary endpoint was PFS, which was defined as the time from randomization to the date of disease progression or death from any cause.

 

The median PFS was significantly longer in the ofatumumab arm than in the observation arm, at 29.4 months and 15.2 months, respectively (hazard ratio [HR]=0.50; P<0.0001).

 

Similarly, the time to the start of patients’ next therapy was significantly longer in the ofatumumab arm than in the in observation arm—a median of 38 months and 31.1 months, respectively (HR=0.66, P=0.108).

 

However, there was no significant difference in OS, which was not reached in either arm (HR=0.85, P=0.4877).

 

Adverse events (AEs) occurred in 86% of patients in the ofatumumab arm and 72% of patients in the observation arm (P<0.001). Sixty percent of AEs were considered related to ofatumumab. None of the AEs led to study withdrawal.

 

Grade 3 or higher AEs occurred in 46% of patients in the ofatumumab arm and 28% in the observation arm. They included neutropenia (24% and 10%, respectively; P<0.001), infections (13% and 8%, respectively), thrombocytopenia (2% and 3%, respectively), and infusion-related reactions (1% and 0%, respectively).

 

 

There were 5 deaths in the observation arm—1 due to progression and 4 due to causes other than progression, infection, or secondary malignancy. There were 2 deaths in the ofatumumab arm—1 due to infection/sepsis and 1 due to an “other” cause.

 

“So based on this planned interim analysis, we can conclude that ofatumumab maintenance in relapsed CLL results in a highly significant and clinically meaningful improvement of progression-free survival,” Dr van Oers said in closing.

 

“It significantly prolongs time to next treatment, it’s well-tolerated, and it’s associated with an adverse event profile which is quite characteristic of anti-CD20 monoclonal antibodies.”

 

*Information in the abstract differs from that presented at the meeting.

 

SAN FRANCISCO—Maintenance therapy with the anti-CD20 monoclonal antibody ofatumumab improves progression-free survival (PFS), but not overall survival (OS), in patients with relapsed chronic lymphocytic leukemia (CLL), according to an interim analysis of the PROLONG study.

 

The median PFS was about 29 months in patients who received ofatumumab and about 15 months for patients who did not receive maintenance (P<0.0001).

 

But there was no significant difference in the median OS, which was not reached in either treatment arm.

 

Marinus H.J. van Oers, MD, PhD, of the Academisch Medisch Centrum and HOVON in Amsterdam, The Netherlands, reported these results at the 2014 ASH Annual Meeting (abstract 21*). The study was sponsored by GlaxoSmithKline, makers of ofatumumab.

 

“[A]s of 2014, still we cannot say that we are able to cure CLL,” Dr van Oers noted. “And CLL is characterized by decreasing response duration with subsequent lines of treatment. In this respect, but also a number of other respects, there are similarities in biological behavior between CLL and follicular lymphoma.”

 

“There is definitely a role—although it’s somewhat debated—for maintenance treatment in follicular lymphoma. Therefore, it is rational to explore safe and effective maintenance treatment in CLL as well.”

 

To that end, Dr van Oers and his colleagues compared ofatumumab maintenance to observation in patients who were in remission after induction treatment for relapsed CLL. The team enrolled 474 patients who were in complete or partial remission after their 2nd- or 3rd-line treatment for CLL.

 

Patients were randomized to observation (n=236) or to receive ofatumumab (n=238) at 300 mg, followed 1 week later by 1000 mg every 8 weeks for up to 2 years. Patients on ofatumumab also received premedication with acetaminophen, antihistamine, and glucocorticoid.

 

The patients were stratified by the number and type of prior therapy, as well as remission status after induction treatment, and baseline characteristics were similar between the two treatment arms.

 

“The median age was about 65, and about 30% of patients were older than 70 years,” Dr van Oers noted. “[There was] a male preponderance, as you would expect, and the time since diagnosis was somewhere between 5 and 6 years.”

 

“Most patients were in [partial response], actually 80%, and most patients had received 2 prior regimens, about 70%. As for prior treatments, 80% of patients had received effective immuno-chemotherapy.”

 

“In both arms, there were only a few patients with unfavorable cytogenetics—11q and 17p deletion. [As for] β2 microglobulin, two-thirds [of patients in both arms] had low levels. And, in both arms, there were almost twice as many IGVH-mutated as unmutated patients.”

 

Patient outcomes

 

The median follow-up was 19.1 months. The study’s primary endpoint was PFS, which was defined as the time from randomization to the date of disease progression or death from any cause.

 

The median PFS was significantly longer in the ofatumumab arm than in the observation arm, at 29.4 months and 15.2 months, respectively (hazard ratio [HR]=0.50; P<0.0001).

 

Similarly, the time to the start of patients’ next therapy was significantly longer in the ofatumumab arm than in the in observation arm—a median of 38 months and 31.1 months, respectively (HR=0.66, P=0.108).

 

However, there was no significant difference in OS, which was not reached in either arm (HR=0.85, P=0.4877).

 

Adverse events (AEs) occurred in 86% of patients in the ofatumumab arm and 72% of patients in the observation arm (P<0.001). Sixty percent of AEs were considered related to ofatumumab. None of the AEs led to study withdrawal.

 

Grade 3 or higher AEs occurred in 46% of patients in the ofatumumab arm and 28% in the observation arm. They included neutropenia (24% and 10%, respectively; P<0.001), infections (13% and 8%, respectively), thrombocytopenia (2% and 3%, respectively), and infusion-related reactions (1% and 0%, respectively).

 

 

There were 5 deaths in the observation arm—1 due to progression and 4 due to causes other than progression, infection, or secondary malignancy. There were 2 deaths in the ofatumumab arm—1 due to infection/sepsis and 1 due to an “other” cause.

 

“So based on this planned interim analysis, we can conclude that ofatumumab maintenance in relapsed CLL results in a highly significant and clinically meaningful improvement of progression-free survival,” Dr van Oers said in closing.

 

“It significantly prolongs time to next treatment, it’s well-tolerated, and it’s associated with an adverse event profile which is quite characteristic of anti-CD20 monoclonal antibodies.”

 

*Information in the abstract differs from that presented at the meeting.

 

SAN FRANCISCO—Maintenance therapy with the anti-CD20 monoclonal antibody ofatumumab improves progression-free survival (PFS), but not overall survival (OS), in patients with relapsed chronic lymphocytic leukemia (CLL), according to an interim analysis of the PROLONG study.

 

The median PFS was about 29 months in patients who received ofatumumab and about 15 months for patients who did not receive maintenance (P<0.0001).

 

But there was no significant difference in the median OS, which was not reached in either treatment arm.

 

Marinus H.J. van Oers, MD, PhD, of the Academisch Medisch Centrum and HOVON in Amsterdam, The Netherlands, reported these results at the 2014 ASH Annual Meeting (abstract 21*). The study was sponsored by GlaxoSmithKline, makers of ofatumumab.

 

“[A]s of 2014, still we cannot say that we are able to cure CLL,” Dr van Oers noted. “And CLL is characterized by decreasing response duration with subsequent lines of treatment. In this respect, but also a number of other respects, there are similarities in biological behavior between CLL and follicular lymphoma.”

 

“There is definitely a role—although it’s somewhat debated—for maintenance treatment in follicular lymphoma. Therefore, it is rational to explore safe and effective maintenance treatment in CLL as well.”

 

To that end, Dr van Oers and his colleagues compared ofatumumab maintenance to observation in patients who were in remission after induction treatment for relapsed CLL. The team enrolled 474 patients who were in complete or partial remission after their 2nd- or 3rd-line treatment for CLL.

 

Patients were randomized to observation (n=236) or to receive ofatumumab (n=238) at 300 mg, followed 1 week later by 1000 mg every 8 weeks for up to 2 years. Patients on ofatumumab also received premedication with acetaminophen, antihistamine, and glucocorticoid.

 

The patients were stratified by the number and type of prior therapy, as well as remission status after induction treatment, and baseline characteristics were similar between the two treatment arms.

 

“The median age was about 65, and about 30% of patients were older than 70 years,” Dr van Oers noted. “[There was] a male preponderance, as you would expect, and the time since diagnosis was somewhere between 5 and 6 years.”

 

“Most patients were in [partial response], actually 80%, and most patients had received 2 prior regimens, about 70%. As for prior treatments, 80% of patients had received effective immuno-chemotherapy.”

 

“In both arms, there were only a few patients with unfavorable cytogenetics—11q and 17p deletion. [As for] β2 microglobulin, two-thirds [of patients in both arms] had low levels. And, in both arms, there were almost twice as many IGVH-mutated as unmutated patients.”

 

Patient outcomes

 

The median follow-up was 19.1 months. The study’s primary endpoint was PFS, which was defined as the time from randomization to the date of disease progression or death from any cause.

 

The median PFS was significantly longer in the ofatumumab arm than in the observation arm, at 29.4 months and 15.2 months, respectively (hazard ratio [HR]=0.50; P<0.0001).

 

Similarly, the time to the start of patients’ next therapy was significantly longer in the ofatumumab arm than in the in observation arm—a median of 38 months and 31.1 months, respectively (HR=0.66, P=0.108).

 

However, there was no significant difference in OS, which was not reached in either arm (HR=0.85, P=0.4877).

 

Adverse events (AEs) occurred in 86% of patients in the ofatumumab arm and 72% of patients in the observation arm (P<0.001). Sixty percent of AEs were considered related to ofatumumab. None of the AEs led to study withdrawal.

 

Grade 3 or higher AEs occurred in 46% of patients in the ofatumumab arm and 28% in the observation arm. They included neutropenia (24% and 10%, respectively; P<0.001), infections (13% and 8%, respectively), thrombocytopenia (2% and 3%, respectively), and infusion-related reactions (1% and 0%, respectively).

 

 

There were 5 deaths in the observation arm—1 due to progression and 4 due to causes other than progression, infection, or secondary malignancy. There were 2 deaths in the ofatumumab arm—1 due to infection/sepsis and 1 due to an “other” cause.

 

“So based on this planned interim analysis, we can conclude that ofatumumab maintenance in relapsed CLL results in a highly significant and clinically meaningful improvement of progression-free survival,” Dr van Oers said in closing.

 

“It significantly prolongs time to next treatment, it’s well-tolerated, and it’s associated with an adverse event profile which is quite characteristic of anti-CD20 monoclonal antibodies.”

 

*Information in the abstract differs from that presented at the meeting.

Sepsis may have an Achilles heel that would allow for more effective treatment of the condition, according to research published in The FASEB Journal.

The study showed that CD39, an enzyme capable of clearing high levels of adenosine triphosphate (ATP) from the bloodstream, significantly improved survival of mice with severe sepsis.

Based on this finding, the researchers speculate that CD39 may also be used in other diseases associated with inflammation.

“Although we have come a long way in the treatment of sepsis since it was first described by Hippocrates in the fourth century BC, about 250,000 Americans still die from sepsis each year,” said study author Gyorgy Hasko, PhD, of Rutgers New Jersey Medical School in Newark.

“A drug that could cure patients with sepsis would not only save the lives of many, it would also decrease the enormous costs associated with treating septic patients in the intensive care unit and would help unburden the healthcare system.”

To make their discovery, Dr Hasko and his colleagues compared mice lacking the CD39 gene to wild-type mice. When sepsis was induced in both sets of mice, those without CD39 had worse survival.

With this information in hand, the researchers then performed another experiment with two more groups of normal mice that were septic.

The first group was injected with CD39 and the other with placebo. The mice that received CD39 had improved survival compared to those injected with placebo.

“Finding a more effective treatment for sepsis would be a major step forward since far too many people still die from overwhelming microbial infection,” said Gerald Weissmann, MD, Editor-in-Chief of The FASEB Journal. “If CD39 proves to be as critical a factor in humans as in mice, this is a major discovery.”

Sepsis may have an Achilles heel that would allow for more effective treatment of the condition, according to research published in The FASEB Journal.

The study showed that CD39, an enzyme capable of clearing high levels of adenosine triphosphate (ATP) from the bloodstream, significantly improved survival of mice with severe sepsis.

Based on this finding, the researchers speculate that CD39 may also be used in other diseases associated with inflammation.

“Although we have come a long way in the treatment of sepsis since it was first described by Hippocrates in the fourth century BC, about 250,000 Americans still die from sepsis each year,” said study author Gyorgy Hasko, PhD, of Rutgers New Jersey Medical School in Newark.

“A drug that could cure patients with sepsis would not only save the lives of many, it would also decrease the enormous costs associated with treating septic patients in the intensive care unit and would help unburden the healthcare system.”

To make their discovery, Dr Hasko and his colleagues compared mice lacking the CD39 gene to wild-type mice. When sepsis was induced in both sets of mice, those without CD39 had worse survival.

With this information in hand, the researchers then performed another experiment with two more groups of normal mice that were septic.

The first group was injected with CD39 and the other with placebo. The mice that received CD39 had improved survival compared to those injected with placebo.

“Finding a more effective treatment for sepsis would be a major step forward since far too many people still die from overwhelming microbial infection,” said Gerald Weissmann, MD, Editor-in-Chief of The FASEB Journal. “If CD39 proves to be as critical a factor in humans as in mice, this is a major discovery.”

Sepsis may have an Achilles heel that would allow for more effective treatment of the condition, according to research published in The FASEB Journal.

The study showed that CD39, an enzyme capable of clearing high levels of adenosine triphosphate (ATP) from the bloodstream, significantly improved survival of mice with severe sepsis.

Based on this finding, the researchers speculate that CD39 may also be used in other diseases associated with inflammation.

“Although we have come a long way in the treatment of sepsis since it was first described by Hippocrates in the fourth century BC, about 250,000 Americans still die from sepsis each year,” said study author Gyorgy Hasko, PhD, of Rutgers New Jersey Medical School in Newark.

“A drug that could cure patients with sepsis would not only save the lives of many, it would also decrease the enormous costs associated with treating septic patients in the intensive care unit and would help unburden the healthcare system.”

To make their discovery, Dr Hasko and his colleagues compared mice lacking the CD39 gene to wild-type mice. When sepsis was induced in both sets of mice, those without CD39 had worse survival.

With this information in hand, the researchers then performed another experiment with two more groups of normal mice that were septic.

The first group was injected with CD39 and the other with placebo. The mice that received CD39 had improved survival compared to those injected with placebo.

“Finding a more effective treatment for sepsis would be a major step forward since far too many people still die from overwhelming microbial infection,” said Gerald Weissmann, MD, Editor-in-Chief of The FASEB Journal. “If CD39 proves to be as critical a factor in humans as in mice, this is a major discovery.”

The process of pathogen inactivation does not compromise the quality of red blood cells (RBCs), results of a phase 3 study suggest.

Researchers compared untreated RBCs and RBCs treated with the INTERCEPT Blood System, a pathogen inactivation system.

The two sets of RBCs, which were given to cardiovascular surgery patients with acute anemia, had comparable hemoglobin content and in vitro quality, according to Cerus Corporation, makers of the INTERCEPT system.

Cerus recently announced these results, and the researchers plan to submit data from this study for presentation at upcoming scientific congresses.

“In our prior US phase 3 study in a similar patient population, INTERCEPT red cells were shown to be noninferior to control red cells in 148 patients based on a composite endpoint of myocardial infarction, renal failure, and death,” said Laurence Corash, MD, Cerus’s chief medical officer.

“The data from the recent phase 3 study met the European criteria for red blood cell components for transfusion and demonstrated sufficient hemoglobin content and in vitro quality compared to untreated red cells. We believe that the successful results from this study, combined with data from the prior phase 3 study, support the safety and efficacy of the INTERCEPT RBC system for CE Mark registration.”

In the current trial, researchers evaluated the efficacy of the INTERCEPT system to process RBCs with quality and mean hemoglobin content (> 40 g) suitable to support transfusion according to the European Directorate for the Quality of Medicines.

The blood components were transfused in 51 cardiovascular surgery patients at 2 German trial sites. Patients undergoing procedures for coronary artery bypass grafting, valve repair, or combined procedures received transfusions during a 7-day treatment period that included the day of surgery and 6 days post-operatively.

The patients received either INTERCEPT-treated RBCs or control RBCs not treated for pathogen inactivation. RBC components for both clinical sites were manufactured at the German Red Cross blood center in Frankfurt, and the RBCs were stored for up to 35 days prior to transfusion.

The primary endpoint was the equivalence of mean hemoglobin content between INTERCEPT-treated RBCs and conventional RBCs. The mean hemoglobin content of INTERCEPT-treated RBCs on day 35 of storage (53.1 g) fell within the protocol-specified 5g equivalence margin, when compared to control RBCs (55.8 g).

The secondary efficacy endpoints also suggested INTERCEPT-treated RBCs were suitable for transfusion based on mean hematocrit of 60.4% (acceptance range: 55%-70%) and mean end-of-storage hemolysis rate of 0.28% (acceptance range < 0.8%).

There were no statistical differences in the adverse event rates between recipients of INTERCEPT-treated RBCs and control RBCs. There were no clinically relevant trends in severe or serious treatment-related adverse events by system organ class.

The observed adverse events were within the expected spectrum of comorbidity and mortality for patients of similar age and with advanced cardiovascular diseases undergoing cardiovascular surgery requiring RBC transfusion. And none of the patients exhibited an immune response to INTERCEPT-treated RBCs.

The process of pathogen inactivation does not compromise the quality of red blood cells (RBCs), results of a phase 3 study suggest.

Researchers compared untreated RBCs and RBCs treated with the INTERCEPT Blood System, a pathogen inactivation system.

The two sets of RBCs, which were given to cardiovascular surgery patients with acute anemia, had comparable hemoglobin content and in vitro quality, according to Cerus Corporation, makers of the INTERCEPT system.

Cerus recently announced these results, and the researchers plan to submit data from this study for presentation at upcoming scientific congresses.

“In our prior US phase 3 study in a similar patient population, INTERCEPT red cells were shown to be noninferior to control red cells in 148 patients based on a composite endpoint of myocardial infarction, renal failure, and death,” said Laurence Corash, MD, Cerus’s chief medical officer.

“The data from the recent phase 3 study met the European criteria for red blood cell components for transfusion and demonstrated sufficient hemoglobin content and in vitro quality compared to untreated red cells. We believe that the successful results from this study, combined with data from the prior phase 3 study, support the safety and efficacy of the INTERCEPT RBC system for CE Mark registration.”

In the current trial, researchers evaluated the efficacy of the INTERCEPT system to process RBCs with quality and mean hemoglobin content (> 40 g) suitable to support transfusion according to the European Directorate for the Quality of Medicines.

The blood components were transfused in 51 cardiovascular surgery patients at 2 German trial sites. Patients undergoing procedures for coronary artery bypass grafting, valve repair, or combined procedures received transfusions during a 7-day treatment period that included the day of surgery and 6 days post-operatively.

The patients received either INTERCEPT-treated RBCs or control RBCs not treated for pathogen inactivation. RBC components for both clinical sites were manufactured at the German Red Cross blood center in Frankfurt, and the RBCs were stored for up to 35 days prior to transfusion.

The primary endpoint was the equivalence of mean hemoglobin content between INTERCEPT-treated RBCs and conventional RBCs. The mean hemoglobin content of INTERCEPT-treated RBCs on day 35 of storage (53.1 g) fell within the protocol-specified 5g equivalence margin, when compared to control RBCs (55.8 g).

The secondary efficacy endpoints also suggested INTERCEPT-treated RBCs were suitable for transfusion based on mean hematocrit of 60.4% (acceptance range: 55%-70%) and mean end-of-storage hemolysis rate of 0.28% (acceptance range < 0.8%).

There were no statistical differences in the adverse event rates between recipients of INTERCEPT-treated RBCs and control RBCs. There were no clinically relevant trends in severe or serious treatment-related adverse events by system organ class.

The observed adverse events were within the expected spectrum of comorbidity and mortality for patients of similar age and with advanced cardiovascular diseases undergoing cardiovascular surgery requiring RBC transfusion. And none of the patients exhibited an immune response to INTERCEPT-treated RBCs.

The process of pathogen inactivation does not compromise the quality of red blood cells (RBCs), results of a phase 3 study suggest.

Researchers compared untreated RBCs and RBCs treated with the INTERCEPT Blood System, a pathogen inactivation system.

The two sets of RBCs, which were given to cardiovascular surgery patients with acute anemia, had comparable hemoglobin content and in vitro quality, according to Cerus Corporation, makers of the INTERCEPT system.

Cerus recently announced these results, and the researchers plan to submit data from this study for presentation at upcoming scientific congresses.

“In our prior US phase 3 study in a similar patient population, INTERCEPT red cells were shown to be noninferior to control red cells in 148 patients based on a composite endpoint of myocardial infarction, renal failure, and death,” said Laurence Corash, MD, Cerus’s chief medical officer.

“The data from the recent phase 3 study met the European criteria for red blood cell components for transfusion and demonstrated sufficient hemoglobin content and in vitro quality compared to untreated red cells. We believe that the successful results from this study, combined with data from the prior phase 3 study, support the safety and efficacy of the INTERCEPT RBC system for CE Mark registration.”

In the current trial, researchers evaluated the efficacy of the INTERCEPT system to process RBCs with quality and mean hemoglobin content (> 40 g) suitable to support transfusion according to the European Directorate for the Quality of Medicines.

The blood components were transfused in 51 cardiovascular surgery patients at 2 German trial sites. Patients undergoing procedures for coronary artery bypass grafting, valve repair, or combined procedures received transfusions during a 7-day treatment period that included the day of surgery and 6 days post-operatively.

The patients received either INTERCEPT-treated RBCs or control RBCs not treated for pathogen inactivation. RBC components for both clinical sites were manufactured at the German Red Cross blood center in Frankfurt, and the RBCs were stored for up to 35 days prior to transfusion.

The primary endpoint was the equivalence of mean hemoglobin content between INTERCEPT-treated RBCs and conventional RBCs. The mean hemoglobin content of INTERCEPT-treated RBCs on day 35 of storage (53.1 g) fell within the protocol-specified 5g equivalence margin, when compared to control RBCs (55.8 g).

The secondary efficacy endpoints also suggested INTERCEPT-treated RBCs were suitable for transfusion based on mean hematocrit of 60.4% (acceptance range: 55%-70%) and mean end-of-storage hemolysis rate of 0.28% (acceptance range < 0.8%).

There were no statistical differences in the adverse event rates between recipients of INTERCEPT-treated RBCs and control RBCs. There were no clinically relevant trends in severe or serious treatment-related adverse events by system organ class.

The observed adverse events were within the expected spectrum of comorbidity and mortality for patients of similar age and with advanced cardiovascular diseases undergoing cardiovascular surgery requiring RBC transfusion. And none of the patients exhibited an immune response to INTERCEPT-treated RBCs.

CHICAGO – Patients with atrial fibrillation who frequently have a supratherapeutic international normalized ratio are at sharply increased risk for developing dementia, according to a large observational study.

“We postulate that the mechanism is an accumulation of microbleeds in the brain,” Dr. T. Jared Bunch said at the American Heart Association Scientific Sessions.

“In patients with hypertension, a condition that’s extremely common with atrial fibrillation, these repetitive small bleeds are preferentially in the hippocampus, where memory is stored,” added Dr. Bunch, who is medical director for heart rhythm services at the Intermountain Medical Center Heart Institute in Salt Lake City.

He presented a study of 1,031 patients with atrial fibrillation (AF) in Intermountain’s centralized anticoagulation service. All were on dual therapy with warfarin plus aspirin or, much less commonly, another antiplatelet agent. At baseline, their average age was in the early- to mid-70s, and none of the subjects had a history of stroke or any notes in their medical record suggestive of early cognitive decline. At this dedicated anticoagulation center, their INR was measured on a weekly or biweekly basis, as a result of which their average time spent in the therapeutic range of 2.0-3.0 was relatively high at nearly 70%.

The increased risk of dementia in patients with AF has previously been recognized. The association is stronger in patients under age 75 than in those who are older. But the mechanism has been unknown. Dr. Bunch and coinvestigators decided to test their hypothesis that the mechanism involves microbleeds secondary to long-term overanticoagulation by dividing the patients into three groups based upon their percentage of INR measurements above 3.0 during a mean follow-up of more than 4 and up to a maximum of 10 years: 240 patients had a supratherapeutic INR 25% of the time or more; 374 did so less than 10% of the time; and 417 had an elevated INR 10%-24% of the time.

 

The incidence of dementia diagnosed by a consultant neurologist during follow-up was 5.8% in the group with an INR above 3.0 at least 25% of the time, more than twice the 2.7% rate in patients with a high INR less than 10% of the time. In the middle group, the incidence of dementia was 4.1%. In a multivariate Cox regression analysis, having an INR above 3.0 on at least 25% of occasions was independently associated with a 2.59-fold increased risk of developing dementia, making it by far the most potent risk factor in their analysis.

The next step in their research will be to perform serial brain imaging and volumetric scans, Dr. Bunch said. Also, he and his coworkers are 3 years into an ongoing study looking at the incidence of dementia in AF patients on the various novel oral anticoagulants, where INR is a nonissue. Their hypothesis is the dementia risk will be lower than in patients on warfarin. Dr. Bunch has particularly high hopes for AF patients on apixaban (Eliquis) because it’s known to have a reduced risk of large bleeds, stroke, and GI bleeding; the hope is it will cause fewer cerebral microbleeds as well.

In an interview, the cardiologist said he believes his study showing an increased risk of dementia in AF patients with supratherapeutic INRs on warfarin plus antiplatelet therapy holds several important lessons for AF patients and physicians alike.

For patients, the message is don’t just start taking aspirin on your own because you’ve read it’s good for your heart or may reduce cancer risk; consult your physician.

And for physicians, it’s important to ask all patients on warfarin if they’re using aspirin; many don’t ask. Also, periodically reconsider the need for dual therapy with warfarin and aspirin.

“We find the risks of stroke and bleeding change dynamically over time, so the initial therapy for stroke prevention may not be the ideal therapy after 5-10 years,” Dr. Bunch said.

Lastly, for patients who are overanticoagulated on a substantial percentage of their INR measurements, it’s essential to consider a change in strategy. Either follow their INRs more closely and adjust warfarin dosing accordingly, or switch to one of the novel, more predictable oral anticoagulants, he concluded.

This study was funded internally by Intermountain Healthcare. Dr. Bunch reported having no financial conflicts.

[email protected]

CHICAGO – Patients with atrial fibrillation who frequently have a supratherapeutic international normalized ratio are at sharply increased risk for developing dementia, according to a large observational study.

“We postulate that the mechanism is an accumulation of microbleeds in the brain,” Dr. T. Jared Bunch said at the American Heart Association Scientific Sessions.

“In patients with hypertension, a condition that’s extremely common with atrial fibrillation, these repetitive small bleeds are preferentially in the hippocampus, where memory is stored,” added Dr. Bunch, who is medical director for heart rhythm services at the Intermountain Medical Center Heart Institute in Salt Lake City.

He presented a study of 1,031 patients with atrial fibrillation (AF) in Intermountain’s centralized anticoagulation service. All were on dual therapy with warfarin plus aspirin or, much less commonly, another antiplatelet agent. At baseline, their average age was in the early- to mid-70s, and none of the subjects had a history of stroke or any notes in their medical record suggestive of early cognitive decline. At this dedicated anticoagulation center, their INR was measured on a weekly or biweekly basis, as a result of which their average time spent in the therapeutic range of 2.0-3.0 was relatively high at nearly 70%.

The increased risk of dementia in patients with AF has previously been recognized. The association is stronger in patients under age 75 than in those who are older. But the mechanism has been unknown. Dr. Bunch and coinvestigators decided to test their hypothesis that the mechanism involves microbleeds secondary to long-term overanticoagulation by dividing the patients into three groups based upon their percentage of INR measurements above 3.0 during a mean follow-up of more than 4 and up to a maximum of 10 years: 240 patients had a supratherapeutic INR 25% of the time or more; 374 did so less than 10% of the time; and 417 had an elevated INR 10%-24% of the time.

 

The incidence of dementia diagnosed by a consultant neurologist during follow-up was 5.8% in the group with an INR above 3.0 at least 25% of the time, more than twice the 2.7% rate in patients with a high INR less than 10% of the time. In the middle group, the incidence of dementia was 4.1%. In a multivariate Cox regression analysis, having an INR above 3.0 on at least 25% of occasions was independently associated with a 2.59-fold increased risk of developing dementia, making it by far the most potent risk factor in their analysis.

The next step in their research will be to perform serial brain imaging and volumetric scans, Dr. Bunch said. Also, he and his coworkers are 3 years into an ongoing study looking at the incidence of dementia in AF patients on the various novel oral anticoagulants, where INR is a nonissue. Their hypothesis is the dementia risk will be lower than in patients on warfarin. Dr. Bunch has particularly high hopes for AF patients on apixaban (Eliquis) because it’s known to have a reduced risk of large bleeds, stroke, and GI bleeding; the hope is it will cause fewer cerebral microbleeds as well.

In an interview, the cardiologist said he believes his study showing an increased risk of dementia in AF patients with supratherapeutic INRs on warfarin plus antiplatelet therapy holds several important lessons for AF patients and physicians alike.

For patients, the message is don’t just start taking aspirin on your own because you’ve read it’s good for your heart or may reduce cancer risk; consult your physician.

And for physicians, it’s important to ask all patients on warfarin if they’re using aspirin; many don’t ask. Also, periodically reconsider the need for dual therapy with warfarin and aspirin.

“We find the risks of stroke and bleeding change dynamically over time, so the initial therapy for stroke prevention may not be the ideal therapy after 5-10 years,” Dr. Bunch said.

Lastly, for patients who are overanticoagulated on a substantial percentage of their INR measurements, it’s essential to consider a change in strategy. Either follow their INRs more closely and adjust warfarin dosing accordingly, or switch to one of the novel, more predictable oral anticoagulants, he concluded.

This study was funded internally by Intermountain Healthcare. Dr. Bunch reported having no financial conflicts.

[email protected]

CHICAGO – Patients with atrial fibrillation who frequently have a supratherapeutic international normalized ratio are at sharply increased risk for developing dementia, according to a large observational study.

“We postulate that the mechanism is an accumulation of microbleeds in the brain,” Dr. T. Jared Bunch said at the American Heart Association Scientific Sessions.

“In patients with hypertension, a condition that’s extremely common with atrial fibrillation, these repetitive small bleeds are preferentially in the hippocampus, where memory is stored,” added Dr. Bunch, who is medical director for heart rhythm services at the Intermountain Medical Center Heart Institute in Salt Lake City.

He presented a study of 1,031 patients with atrial fibrillation (AF) in Intermountain’s centralized anticoagulation service. All were on dual therapy with warfarin plus aspirin or, much less commonly, another antiplatelet agent. At baseline, their average age was in the early- to mid-70s, and none of the subjects had a history of stroke or any notes in their medical record suggestive of early cognitive decline. At this dedicated anticoagulation center, their INR was measured on a weekly or biweekly basis, as a result of which their average time spent in the therapeutic range of 2.0-3.0 was relatively high at nearly 70%.

The increased risk of dementia in patients with AF has previously been recognized. The association is stronger in patients under age 75 than in those who are older. But the mechanism has been unknown. Dr. Bunch and coinvestigators decided to test their hypothesis that the mechanism involves microbleeds secondary to long-term overanticoagulation by dividing the patients into three groups based upon their percentage of INR measurements above 3.0 during a mean follow-up of more than 4 and up to a maximum of 10 years: 240 patients had a supratherapeutic INR 25% of the time or more; 374 did so less than 10% of the time; and 417 had an elevated INR 10%-24% of the time.

 

The incidence of dementia diagnosed by a consultant neurologist during follow-up was 5.8% in the group with an INR above 3.0 at least 25% of the time, more than twice the 2.7% rate in patients with a high INR less than 10% of the time. In the middle group, the incidence of dementia was 4.1%. In a multivariate Cox regression analysis, having an INR above 3.0 on at least 25% of occasions was independently associated with a 2.59-fold increased risk of developing dementia, making it by far the most potent risk factor in their analysis.

The next step in their research will be to perform serial brain imaging and volumetric scans, Dr. Bunch said. Also, he and his coworkers are 3 years into an ongoing study looking at the incidence of dementia in AF patients on the various novel oral anticoagulants, where INR is a nonissue. Their hypothesis is the dementia risk will be lower than in patients on warfarin. Dr. Bunch has particularly high hopes for AF patients on apixaban (Eliquis) because it’s known to have a reduced risk of large bleeds, stroke, and GI bleeding; the hope is it will cause fewer cerebral microbleeds as well.

In an interview, the cardiologist said he believes his study showing an increased risk of dementia in AF patients with supratherapeutic INRs on warfarin plus antiplatelet therapy holds several important lessons for AF patients and physicians alike.

For patients, the message is don’t just start taking aspirin on your own because you’ve read it’s good for your heart or may reduce cancer risk; consult your physician.

And for physicians, it’s important to ask all patients on warfarin if they’re using aspirin; many don’t ask. Also, periodically reconsider the need for dual therapy with warfarin and aspirin.

“We find the risks of stroke and bleeding change dynamically over time, so the initial therapy for stroke prevention may not be the ideal therapy after 5-10 years,” Dr. Bunch said.

Lastly, for patients who are overanticoagulated on a substantial percentage of their INR measurements, it’s essential to consider a change in strategy. Either follow their INRs more closely and adjust warfarin dosing accordingly, or switch to one of the novel, more predictable oral anticoagulants, he concluded.

This study was funded internally by Intermountain Healthcare. Dr. Bunch reported having no financial conflicts.

[email protected]

In this podcast, two hospitalists who’ve seen the flip side of their practice as hospital patients talk about their experience as doctor-patients. Dr. Brett Hendel-Paterson of Health Partners Regional in St. Paul  shares how his diagnosis with chronic lymphocytic leukemia has impacted his practice. Dr. Matthew Dudley, a hospitalist with the Alaska Hospitalist Group in Anchorage and a patient with acute myelogenous leukemia, tells how the experience has deepened his conviction in the value of hospitalists.

[audio mp3="http://www.the-hospitalist.org/wp-content/uploads/2015/01/Doctor-As-Patient.mp3"][/audio]

In this podcast, two hospitalists who’ve seen the flip side of their practice as hospital patients talk about their experience as doctor-patients. Dr. Brett Hendel-Paterson of Health Partners Regional in St. Paul  shares how his diagnosis with chronic lymphocytic leukemia has impacted his practice. Dr. Matthew Dudley, a hospitalist with the Alaska Hospitalist Group in Anchorage and a patient with acute myelogenous leukemia, tells how the experience has deepened his conviction in the value of hospitalists.

[audio mp3="http://www.the-hospitalist.org/wp-content/uploads/2015/01/Doctor-As-Patient.mp3"][/audio]

In this podcast, two hospitalists who’ve seen the flip side of their practice as hospital patients talk about their experience as doctor-patients. Dr. Brett Hendel-Paterson of Health Partners Regional in St. Paul  shares how his diagnosis with chronic lymphocytic leukemia has impacted his practice. Dr. Matthew Dudley, a hospitalist with the Alaska Hospitalist Group in Anchorage and a patient with acute myelogenous leukemia, tells how the experience has deepened his conviction in the value of hospitalists.

[audio mp3="http://www.the-hospitalist.org/wp-content/uploads/2015/01/Doctor-As-Patient.mp3"][/audio]

This month in our issue, one of our cover stories looks to answer the question, “Do You Really Need an MBA?” if your career goals include a leadership role. In a news brief, we cover the long-awaited confirmation of Dr. Vivek Murthy to the post of U.S. Surgeon General. We also launch "After Seven," a column profiling hospitalists' hobbies, starting with a feature on part-time robot-builder, Dr. Jim Yeh. Our book review addresses caring for older patients, and we profile the newest member of Team Hospitalist, Dr. Joshua Allen-Dicker. We also feature the latest in clinical literature, and our Key Clinical Question asks who should be tested for HIV in the hospital.

[audio mp3="http://www.the-hospitalist.org/wp-content/uploads/2015/01/2015-January-Highlights.mp3"][/audio]

This month in our issue, one of our cover stories looks to answer the question, “Do You Really Need an MBA?” if your career goals include a leadership role. In a news brief, we cover the long-awaited confirmation of Dr. Vivek Murthy to the post of U.S. Surgeon General. We also launch "After Seven," a column profiling hospitalists' hobbies, starting with a feature on part-time robot-builder, Dr. Jim Yeh. Our book review addresses caring for older patients, and we profile the newest member of Team Hospitalist, Dr. Joshua Allen-Dicker. We also feature the latest in clinical literature, and our Key Clinical Question asks who should be tested for HIV in the hospital.

[audio mp3="http://www.the-hospitalist.org/wp-content/uploads/2015/01/2015-January-Highlights.mp3"][/audio]

This month in our issue, one of our cover stories looks to answer the question, “Do You Really Need an MBA?” if your career goals include a leadership role. In a news brief, we cover the long-awaited confirmation of Dr. Vivek Murthy to the post of U.S. Surgeon General. We also launch "After Seven," a column profiling hospitalists' hobbies, starting with a feature on part-time robot-builder, Dr. Jim Yeh. Our book review addresses caring for older patients, and we profile the newest member of Team Hospitalist, Dr. Joshua Allen-Dicker. We also feature the latest in clinical literature, and our Key Clinical Question asks who should be tested for HIV in the hospital.

[audio mp3="http://www.the-hospitalist.org/wp-content/uploads/2015/01/2015-January-Highlights.mp3"][/audio]