Quality

You’re a what?” he asked over the noise of the passing Mardi Gras parade.

“I’m a hospitalist,” I replied.

“Oh.” There was an extended pause. I could tell he was searching his mental database to determine if he had a family member who was a hospitalist. Nope, nothing there. Then it came: “What is that exactly?” I followed with a general description of “what a hospitalist does,” but his response made it apparent that my description hadn’t stuck: “So you’re like a generalist, but you work in the hospital?”

I let it go. Mardi Gras wasn’t the time to launch into all that a hospitalist truly embodies: quality improvement, systems redesign, patient safety, effective transitions of care. And he probably wouldn’t remember it tomorrow anyway. But my reveler friend’s summary statement stayed with me through the night, for it returned me to a core philosophical tenet: Esse est percipi. We are who we appear to be.

There are 30,000 of us now, all facing the same problem: How do we match who we are perceived to be with who we are? The hospitalist is much more than a “generalist who works in a hospital,” but what is perceived to be is equally as important as what is. At the root of the problem is a question of accountability: How do we hold ourselves out to the public as a specialty that possesses the knowledge and skills necessary to advance quality and safety for the hospitalized patient?

This question of public accountability is not new to the profession. The heterogeneity of physicians in the early 1900s, from the authentic to the snake-oil salesmen, prompted the need for independent validation of physicians’ qualifications. Dr. Derrick Vail introduced the concept of a board certification in 1908, with the goal of “issuing credentials that would assure the public of the specialist’s qualifications.” The American Board of Medical Specialties was formed in 1933, and continues to this day to be the entity responsible for ensuring this accountability.

While there are no “snake-oil salesmen” in HM, there is heterogeneity. There are many of us answering the call to advance quality and patient safety, but there are many more of us who are not yet there. And there are some (i.e., those practicing medicine in the hospital while awaiting a subspecialty fellowship) who, while referred to as “hospitalists,” do not embrace the central tenets of the career hospitalist. Thirty-thousand hospitalists is a spectacular achievement, but with that growth comes the new problem of dilution: Without some measure of distinguishing those who are authentic in the value-added services of quality and patient safety from those who have not embraced these tenets, the perception of us all will be merely “physicians who practice in the hospital.”

To my mind, the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) Focused Practice in Hospital Medicine (FPHM) program answers this question of public accountability. This new MOC process provides an objective way of establishing that hospitalists who claim to be competent in their field have, in fact, demonstrated this competence. Paradoxically, it is even more compelling than a board certification following a residency or fellowship; skills and knowledge fade over time, and new knowledge consistently is added. The MOC certification assures the public that despite these challenges, the certified hospitalist has continued to maintain competence in the field.

Further, the components of the FPHM (www.abim.org/specialty/fphm.aspx) provide assurance that the certified hospitalist has the expertise to practice HM, and has the knowledge and skills necessary to offer the value-added services of quality, patient safety, and performance improvement.

Why Is It Important to Recertify?

Registration for the MOC in FPHM opened March 15, and more than 100 hospitalists enrolled in the program in the first two weeks. While exciting, this number is not enough; here I share with you my reflections on why this MOC is so important to our field.

As with all things SHM, the rationale begins with, “What is the best thing for the patient?” I completed my first recertification in 2008, and I can honestly say that this was the first “test” in my career that actually made me a better physician for my patients. I was skeptical at first, seeing the MOC as another bureaucratic hurdle for which I would have the opportunity to pay $1,000. But the reality was that it was much more than that; it made me a better physician. It alerted me to blind spots in my clinical repertoire: some topics I had never learned, some I had forgotten, and some that were new knowledge.

Preparing for the examination isn’t onerous, perhaps a couple extra hours a week of reading. Since the examination focused on the practical aspects of diagnosis and management, and not the basic- science minutiae that had characterized the earlier examinations in my career, I found that the preparation for the MOC exam improved my practice of medicine. The only downside was that I did not have the luxury of an HM-focused exam in 2008, and there were content areas on the standard internal medicine (IM) MOC that were not a part of my inpatient practice.

But it was the Practice Improvement Module (PIM) component of the MOC process, a shared feature of both the FPHM and the IM MOC processes, that most benefited my patients. As a hospitalist, this too was not onerous, as practice improvement is what I do on a daily basis. Moreover, it was the external discipline of completing the PIM that made it truly valuable: collecting data, reflecting on methods of improvement, enacting an intervention, and then reassessing the results. The process forced me to reflect on my practice, and it heightened my sensitivity to other parts of my practice, and the hospital system, that needed to be improved.

Further benefit came through collaboration with other physicians in my group, as encouraged by the ABIM, to complete the PIM. This teamwork fostered a heightened spirit of QI within our team, further augmenting quality of care and sensitivity to needed systems improvements. True, at the end of the process, I was $1,000 lighter … but my conscience was richer. I had improved as a physician, and I think it has translated into a benefit for my patients.

What Recertification Means to HM

Although the virtue of improving patient care is sufficient to justify participation in the MOC in FPHM, the passage of healthcare reform legislation raises the stakes for hospitalists. The Physician Quality Reporting Initiative (PQRI) is an ongoing reality, further voicing the public’s need for accountability.

The final impact will hinge on the Center for Medicare & Medicaid Services’ (CMS) interpretation and execution of the language in the final bill, but it is clear that physicians who participate in the PQRI (through claims-based or registry reporting) have the opportunity to receive an additional 0.5% bonus on their total allowable Medicare charges in 2011 through 2014, if they also meet MOC program requirements. (The health reform bill provides a 1.0% bonus in 2011 for PQRI participation and a 0.5% bonus through 2014.)

Subsequently, physicians who do not participate in the PQRI will face a 1.5% payment penalty in 2015, and a 2% payment penalty in 2016 and thereafter. With these incentives, it appears the day-to-day finances of practice will offset the cost of MOC participation.

The importance of FPHM extends to the remainder of the PQRI as well. Currently, HM is not recognized by CMS as its own specialty, which means that it does not have its own CMS specialty code. In turn, this means that the core measures CMS will apply to the hospitalist in fulfilling the PQRI standards will be those of the general internist, and these might or might not apply to HM practice. For those to whom the standards do not apply, PQRI becomes a practical impossibility, though the financial penalty remains an unfortunate reality.

The extent to which the core measures for general medicine do not apply to the inpatient environment is the extent to which PQRI will be less effective in incentivizing the advancement of inpatient healthcare quality. This is an opportunity missed. Preventing this systematic exclusion begins with recognizing HM as a specialty. In convincing CMS that HM is its own specialty, deserving of its own code and its own PQRI indices, I can think of no argument as compelling as pointing to 10,000 hospitalists certified in the MOC in FPHM program.

Financial incentives aside, the ultimate success of HM will be in our ability to change the healthcare system such that it provides safe, timely, equitable, efficient, and patient-centered care. We’ve spent more than 10 years trying to get into the conversation, and now we have a seat at the table. But to be effective in this audacious goal, we must speak with a stentorian voice—a timbre that comes only from the chords of the sincere. Society must know of our sincerity—not by our words, but by our actions.

As president of SHM, I am calling on you to join me in meeting this standard of public accountability. Let us prove to the world that our talk of quality and patient safety is much more than talk. Let us establish that we are willing to engage in the ongoing self-improvement necessary to reach this wished-for goal.

Esse est percipi. We are as we are perceived. Now is our time to make one with the other—fulfilling a covenant that promises that we will, eventually, close this quality chasm. TH

Dr. Wiese is president of SHM.

You’re a what?” he asked over the noise of the passing Mardi Gras parade.

“I’m a hospitalist,” I replied.

“Oh.” There was an extended pause. I could tell he was searching his mental database to determine if he had a family member who was a hospitalist. Nope, nothing there. Then it came: “What is that exactly?” I followed with a general description of “what a hospitalist does,” but his response made it apparent that my description hadn’t stuck: “So you’re like a generalist, but you work in the hospital?”

I let it go. Mardi Gras wasn’t the time to launch into all that a hospitalist truly embodies: quality improvement, systems redesign, patient safety, effective transitions of care. And he probably wouldn’t remember it tomorrow anyway. But my reveler friend’s summary statement stayed with me through the night, for it returned me to a core philosophical tenet: Esse est percipi. We are who we appear to be.

There are 30,000 of us now, all facing the same problem: How do we match who we are perceived to be with who we are? The hospitalist is much more than a “generalist who works in a hospital,” but what is perceived to be is equally as important as what is. At the root of the problem is a question of accountability: How do we hold ourselves out to the public as a specialty that possesses the knowledge and skills necessary to advance quality and safety for the hospitalized patient?

This question of public accountability is not new to the profession. The heterogeneity of physicians in the early 1900s, from the authentic to the snake-oil salesmen, prompted the need for independent validation of physicians’ qualifications. Dr. Derrick Vail introduced the concept of a board certification in 1908, with the goal of “issuing credentials that would assure the public of the specialist’s qualifications.” The American Board of Medical Specialties was formed in 1933, and continues to this day to be the entity responsible for ensuring this accountability.

While there are no “snake-oil salesmen” in HM, there is heterogeneity. There are many of us answering the call to advance quality and patient safety, but there are many more of us who are not yet there. And there are some (i.e., those practicing medicine in the hospital while awaiting a subspecialty fellowship) who, while referred to as “hospitalists,” do not embrace the central tenets of the career hospitalist. Thirty-thousand hospitalists is a spectacular achievement, but with that growth comes the new problem of dilution: Without some measure of distinguishing those who are authentic in the value-added services of quality and patient safety from those who have not embraced these tenets, the perception of us all will be merely “physicians who practice in the hospital.”

To my mind, the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) Focused Practice in Hospital Medicine (FPHM) program answers this question of public accountability. This new MOC process provides an objective way of establishing that hospitalists who claim to be competent in their field have, in fact, demonstrated this competence. Paradoxically, it is even more compelling than a board certification following a residency or fellowship; skills and knowledge fade over time, and new knowledge consistently is added. The MOC certification assures the public that despite these challenges, the certified hospitalist has continued to maintain competence in the field.

Further, the components of the FPHM (www.abim.org/specialty/fphm.aspx) provide assurance that the certified hospitalist has the expertise to practice HM, and has the knowledge and skills necessary to offer the value-added services of quality, patient safety, and performance improvement.

Why Is It Important to Recertify?

Registration for the MOC in FPHM opened March 15, and more than 100 hospitalists enrolled in the program in the first two weeks. While exciting, this number is not enough; here I share with you my reflections on why this MOC is so important to our field.

As with all things SHM, the rationale begins with, “What is the best thing for the patient?” I completed my first recertification in 2008, and I can honestly say that this was the first “test” in my career that actually made me a better physician for my patients. I was skeptical at first, seeing the MOC as another bureaucratic hurdle for which I would have the opportunity to pay $1,000. But the reality was that it was much more than that; it made me a better physician. It alerted me to blind spots in my clinical repertoire: some topics I had never learned, some I had forgotten, and some that were new knowledge.

Preparing for the examination isn’t onerous, perhaps a couple extra hours a week of reading. Since the examination focused on the practical aspects of diagnosis and management, and not the basic- science minutiae that had characterized the earlier examinations in my career, I found that the preparation for the MOC exam improved my practice of medicine. The only downside was that I did not have the luxury of an HM-focused exam in 2008, and there were content areas on the standard internal medicine (IM) MOC that were not a part of my inpatient practice.

But it was the Practice Improvement Module (PIM) component of the MOC process, a shared feature of both the FPHM and the IM MOC processes, that most benefited my patients. As a hospitalist, this too was not onerous, as practice improvement is what I do on a daily basis. Moreover, it was the external discipline of completing the PIM that made it truly valuable: collecting data, reflecting on methods of improvement, enacting an intervention, and then reassessing the results. The process forced me to reflect on my practice, and it heightened my sensitivity to other parts of my practice, and the hospital system, that needed to be improved.

Further benefit came through collaboration with other physicians in my group, as encouraged by the ABIM, to complete the PIM. This teamwork fostered a heightened spirit of QI within our team, further augmenting quality of care and sensitivity to needed systems improvements. True, at the end of the process, I was $1,000 lighter … but my conscience was richer. I had improved as a physician, and I think it has translated into a benefit for my patients.

What Recertification Means to HM

Although the virtue of improving patient care is sufficient to justify participation in the MOC in FPHM, the passage of healthcare reform legislation raises the stakes for hospitalists. The Physician Quality Reporting Initiative (PQRI) is an ongoing reality, further voicing the public’s need for accountability.

The final impact will hinge on the Center for Medicare & Medicaid Services’ (CMS) interpretation and execution of the language in the final bill, but it is clear that physicians who participate in the PQRI (through claims-based or registry reporting) have the opportunity to receive an additional 0.5% bonus on their total allowable Medicare charges in 2011 through 2014, if they also meet MOC program requirements. (The health reform bill provides a 1.0% bonus in 2011 for PQRI participation and a 0.5% bonus through 2014.)

Subsequently, physicians who do not participate in the PQRI will face a 1.5% payment penalty in 2015, and a 2% payment penalty in 2016 and thereafter. With these incentives, it appears the day-to-day finances of practice will offset the cost of MOC participation.

The importance of FPHM extends to the remainder of the PQRI as well. Currently, HM is not recognized by CMS as its own specialty, which means that it does not have its own CMS specialty code. In turn, this means that the core measures CMS will apply to the hospitalist in fulfilling the PQRI standards will be those of the general internist, and these might or might not apply to HM practice. For those to whom the standards do not apply, PQRI becomes a practical impossibility, though the financial penalty remains an unfortunate reality.

The extent to which the core measures for general medicine do not apply to the inpatient environment is the extent to which PQRI will be less effective in incentivizing the advancement of inpatient healthcare quality. This is an opportunity missed. Preventing this systematic exclusion begins with recognizing HM as a specialty. In convincing CMS that HM is its own specialty, deserving of its own code and its own PQRI indices, I can think of no argument as compelling as pointing to 10,000 hospitalists certified in the MOC in FPHM program.

Financial incentives aside, the ultimate success of HM will be in our ability to change the healthcare system such that it provides safe, timely, equitable, efficient, and patient-centered care. We’ve spent more than 10 years trying to get into the conversation, and now we have a seat at the table. But to be effective in this audacious goal, we must speak with a stentorian voice—a timbre that comes only from the chords of the sincere. Society must know of our sincerity—not by our words, but by our actions.

As president of SHM, I am calling on you to join me in meeting this standard of public accountability. Let us prove to the world that our talk of quality and patient safety is much more than talk. Let us establish that we are willing to engage in the ongoing self-improvement necessary to reach this wished-for goal.

Esse est percipi. We are as we are perceived. Now is our time to make one with the other—fulfilling a covenant that promises that we will, eventually, close this quality chasm. TH

Dr. Wiese is president of SHM.

You’re a what?” he asked over the noise of the passing Mardi Gras parade.

“I’m a hospitalist,” I replied.

“Oh.” There was an extended pause. I could tell he was searching his mental database to determine if he had a family member who was a hospitalist. Nope, nothing there. Then it came: “What is that exactly?” I followed with a general description of “what a hospitalist does,” but his response made it apparent that my description hadn’t stuck: “So you’re like a generalist, but you work in the hospital?”

I let it go. Mardi Gras wasn’t the time to launch into all that a hospitalist truly embodies: quality improvement, systems redesign, patient safety, effective transitions of care. And he probably wouldn’t remember it tomorrow anyway. But my reveler friend’s summary statement stayed with me through the night, for it returned me to a core philosophical tenet: Esse est percipi. We are who we appear to be.

There are 30,000 of us now, all facing the same problem: How do we match who we are perceived to be with who we are? The hospitalist is much more than a “generalist who works in a hospital,” but what is perceived to be is equally as important as what is. At the root of the problem is a question of accountability: How do we hold ourselves out to the public as a specialty that possesses the knowledge and skills necessary to advance quality and safety for the hospitalized patient?

This question of public accountability is not new to the profession. The heterogeneity of physicians in the early 1900s, from the authentic to the snake-oil salesmen, prompted the need for independent validation of physicians’ qualifications. Dr. Derrick Vail introduced the concept of a board certification in 1908, with the goal of “issuing credentials that would assure the public of the specialist’s qualifications.” The American Board of Medical Specialties was formed in 1933, and continues to this day to be the entity responsible for ensuring this accountability.

While there are no “snake-oil salesmen” in HM, there is heterogeneity. There are many of us answering the call to advance quality and patient safety, but there are many more of us who are not yet there. And there are some (i.e., those practicing medicine in the hospital while awaiting a subspecialty fellowship) who, while referred to as “hospitalists,” do not embrace the central tenets of the career hospitalist. Thirty-thousand hospitalists is a spectacular achievement, but with that growth comes the new problem of dilution: Without some measure of distinguishing those who are authentic in the value-added services of quality and patient safety from those who have not embraced these tenets, the perception of us all will be merely “physicians who practice in the hospital.”

To my mind, the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) Focused Practice in Hospital Medicine (FPHM) program answers this question of public accountability. This new MOC process provides an objective way of establishing that hospitalists who claim to be competent in their field have, in fact, demonstrated this competence. Paradoxically, it is even more compelling than a board certification following a residency or fellowship; skills and knowledge fade over time, and new knowledge consistently is added. The MOC certification assures the public that despite these challenges, the certified hospitalist has continued to maintain competence in the field.

Further, the components of the FPHM (www.abim.org/specialty/fphm.aspx) provide assurance that the certified hospitalist has the expertise to practice HM, and has the knowledge and skills necessary to offer the value-added services of quality, patient safety, and performance improvement.

Why Is It Important to Recertify?

Registration for the MOC in FPHM opened March 15, and more than 100 hospitalists enrolled in the program in the first two weeks. While exciting, this number is not enough; here I share with you my reflections on why this MOC is so important to our field.

As with all things SHM, the rationale begins with, “What is the best thing for the patient?” I completed my first recertification in 2008, and I can honestly say that this was the first “test” in my career that actually made me a better physician for my patients. I was skeptical at first, seeing the MOC as another bureaucratic hurdle for which I would have the opportunity to pay $1,000. But the reality was that it was much more than that; it made me a better physician. It alerted me to blind spots in my clinical repertoire: some topics I had never learned, some I had forgotten, and some that were new knowledge.

Preparing for the examination isn’t onerous, perhaps a couple extra hours a week of reading. Since the examination focused on the practical aspects of diagnosis and management, and not the basic- science minutiae that had characterized the earlier examinations in my career, I found that the preparation for the MOC exam improved my practice of medicine. The only downside was that I did not have the luxury of an HM-focused exam in 2008, and there were content areas on the standard internal medicine (IM) MOC that were not a part of my inpatient practice.

But it was the Practice Improvement Module (PIM) component of the MOC process, a shared feature of both the FPHM and the IM MOC processes, that most benefited my patients. As a hospitalist, this too was not onerous, as practice improvement is what I do on a daily basis. Moreover, it was the external discipline of completing the PIM that made it truly valuable: collecting data, reflecting on methods of improvement, enacting an intervention, and then reassessing the results. The process forced me to reflect on my practice, and it heightened my sensitivity to other parts of my practice, and the hospital system, that needed to be improved.

Further benefit came through collaboration with other physicians in my group, as encouraged by the ABIM, to complete the PIM. This teamwork fostered a heightened spirit of QI within our team, further augmenting quality of care and sensitivity to needed systems improvements. True, at the end of the process, I was $1,000 lighter … but my conscience was richer. I had improved as a physician, and I think it has translated into a benefit for my patients.

What Recertification Means to HM

Although the virtue of improving patient care is sufficient to justify participation in the MOC in FPHM, the passage of healthcare reform legislation raises the stakes for hospitalists. The Physician Quality Reporting Initiative (PQRI) is an ongoing reality, further voicing the public’s need for accountability.

The final impact will hinge on the Center for Medicare & Medicaid Services’ (CMS) interpretation and execution of the language in the final bill, but it is clear that physicians who participate in the PQRI (through claims-based or registry reporting) have the opportunity to receive an additional 0.5% bonus on their total allowable Medicare charges in 2011 through 2014, if they also meet MOC program requirements. (The health reform bill provides a 1.0% bonus in 2011 for PQRI participation and a 0.5% bonus through 2014.)

Subsequently, physicians who do not participate in the PQRI will face a 1.5% payment penalty in 2015, and a 2% payment penalty in 2016 and thereafter. With these incentives, it appears the day-to-day finances of practice will offset the cost of MOC participation.

The importance of FPHM extends to the remainder of the PQRI as well. Currently, HM is not recognized by CMS as its own specialty, which means that it does not have its own CMS specialty code. In turn, this means that the core measures CMS will apply to the hospitalist in fulfilling the PQRI standards will be those of the general internist, and these might or might not apply to HM practice. For those to whom the standards do not apply, PQRI becomes a practical impossibility, though the financial penalty remains an unfortunate reality.

The extent to which the core measures for general medicine do not apply to the inpatient environment is the extent to which PQRI will be less effective in incentivizing the advancement of inpatient healthcare quality. This is an opportunity missed. Preventing this systematic exclusion begins with recognizing HM as a specialty. In convincing CMS that HM is its own specialty, deserving of its own code and its own PQRI indices, I can think of no argument as compelling as pointing to 10,000 hospitalists certified in the MOC in FPHM program.

Financial incentives aside, the ultimate success of HM will be in our ability to change the healthcare system such that it provides safe, timely, equitable, efficient, and patient-centered care. We’ve spent more than 10 years trying to get into the conversation, and now we have a seat at the table. But to be effective in this audacious goal, we must speak with a stentorian voice—a timbre that comes only from the chords of the sincere. Society must know of our sincerity—not by our words, but by our actions.

As president of SHM, I am calling on you to join me in meeting this standard of public accountability. Let us prove to the world that our talk of quality and patient safety is much more than talk. Let us establish that we are willing to engage in the ongoing self-improvement necessary to reach this wished-for goal.

Esse est percipi. We are as we are perceived. Now is our time to make one with the other—fulfilling a covenant that promises that we will, eventually, close this quality chasm. TH

Dr. Wiese is president of SHM.

IT’S 11 MINUTES to 8 o’clock, and the sun is still climbing over the Potomac River just outside the Gaylord National Resort & Convention Center in National Harbor, Md. Day two of SHM’s annual meeting is about to begin.

Hospitalists file into a cavernous ballroom as the day kicks off with a panel discussion on healthcare reform and a speech by that rarest of breed: a popular hospital CEO. The back of the room fills quickly, but front and center, second row—that’s the seat for Nasim Afsarmanesh, MD, director of quality for HM and neurosurgery at Ronald Reagan UCLA Medical Center in Los Angeles.

“If I’m not in the front, I zone out,” she admits.

Dr. Afsarmanesh (who often adds a hyphen to her surname— Afsar-manesh—to help others pronounce it) knows herself and she knows how to plan ahead, from taking notes on her mini-laptop to knowing when to sit up front. And this day in her life is no different. Her schedule is a 12-hour dervish, yet it’s a simple roadmap of how to navigate HM10 and its scores of sessions, speeches, and seminars.

Innovator at Heart

Dr. Afsarmanesh did her residency in 2007 at UCLA. She stayed on to take a faculty position and is now assistant clinical professor of internal medicine (IM) and neurosurgery. Her days are split about 35% clinical practice, 40% on neurology quality issues, and 25% on hospital QI projects. In her free time, she’s an SHM activist and the incoming chair of its Hospital Quality and Patient Safety (HQPS) Committee.

“I get to be an innovator,” she boasts as she picks up a Danish, a chocolate pastry, and a cup of tea following two hours of listening to others talk. “I love that. You can’t really be an innovator when you’re [purely] practicing clinical medicine.”

Innovation requires preparation, though. Dr. Afsarmanesh spends countless hours creating PowerPoint presentations, so she hit a new feature at this year’s meeting: a limited-seating workshop on drawing up effective slides. The presentation is helpful, but she’s partially distracted. “Look up healthcare from talk,” she types as a note to herself for later. She follows that with “Look up Levy’s talk” (a nod to Paul Levy, the well-liked CEO of Beth Israel Deaconess in Boston).

Facial Recognition

The distraction ratchets up as she’s already looking forward to introducing herself to the editorial board of the Journal of Hospital Medicine, where she serves as an assistant editor. There are a few people she’d like to meet in person, so she gracefully sneaks out the side door a few minutes before noon. Handshakes, a box lunch, and a chat with 40 other journal editors ensue for the next hour.

“You can meet people you talk on the phone with for several years,” she says. “You can put a face to the name. That’s important.”

Hobnobbing at a board meeting is only a brief respite, however, before it’s back to professional development. At 1:15, there’s a 60-minute lesson on how to improve care from the patient perspective. Dr. Afsarmanesh, again, is distracted. She’s a first-time presenter in a few minutes, part of a four-woman panel on building a QI educational curriculum for medical students, residents, fellows, faculty, and other healthcare providers.

She scrolls through slides, rehearsing her thoughts. She wonders whether her PowerPoint presentation would have made the grade at this morning’s session.

She is smart enough not to judge her performance too soon—someone in an audience once reached out to her a year later—as she knows the impact of a training session is more than the round of applause at its end.

“You hope that you generate a discussion more than the traditional didactics,” she says. “These meetings are meant to start a discussion and, hopefully, create a network and a community where people can continue to [share ideas and learn from each other]. … I hope that along with some of the content that people take away, the bigger thing is those connections that they make.”

Work Never Ends

It’s 4:30 p.m. and Dr. Afsarmanesh still has a sales pitch to rehearse. This time, it’s self-promotion for her soon-to-begin poster presentation: “The ABCs of Hospitalized Patients: A Multi-Disciplinary Checklist for Improving Quality of Patient Care."

After umpteen repetitions of her spiel, the presentation doesn’t win a prize, but, once again, she showcases her attention to detail: A stack of 8.5”x 11” versions of her poster are available for handouts, a feature few others in the competition have.

Some 12 hours into her tour of this massive convention center, the day is coming to a close. But not before SHM CEO Larry Wellikson, MD, SFHM, drops by to say hello.

He points out how strong her research is. Unfortunately, he uses a pen in the process.

“Don’t poke a hole in my poster,” she jokes.

Moments later, it’s back to working the line queued up at her poster. “Hi, would you like to hear about my poster?” HM2010

Richard Quinn is a freelance writer based in New Jersey.

IT’S 11 MINUTES to 8 o’clock, and the sun is still climbing over the Potomac River just outside the Gaylord National Resort & Convention Center in National Harbor, Md. Day two of SHM’s annual meeting is about to begin.

Hospitalists file into a cavernous ballroom as the day kicks off with a panel discussion on healthcare reform and a speech by that rarest of breed: a popular hospital CEO. The back of the room fills quickly, but front and center, second row—that’s the seat for Nasim Afsarmanesh, MD, director of quality for HM and neurosurgery at Ronald Reagan UCLA Medical Center in Los Angeles.

“If I’m not in the front, I zone out,” she admits.

Dr. Afsarmanesh (who often adds a hyphen to her surname— Afsar-manesh—to help others pronounce it) knows herself and she knows how to plan ahead, from taking notes on her mini-laptop to knowing when to sit up front. And this day in her life is no different. Her schedule is a 12-hour dervish, yet it’s a simple roadmap of how to navigate HM10 and its scores of sessions, speeches, and seminars.

Innovator at Heart

Dr. Afsarmanesh did her residency in 2007 at UCLA. She stayed on to take a faculty position and is now assistant clinical professor of internal medicine (IM) and neurosurgery. Her days are split about 35% clinical practice, 40% on neurology quality issues, and 25% on hospital QI projects. In her free time, she’s an SHM activist and the incoming chair of its Hospital Quality and Patient Safety (HQPS) Committee.

“I get to be an innovator,” she boasts as she picks up a Danish, a chocolate pastry, and a cup of tea following two hours of listening to others talk. “I love that. You can’t really be an innovator when you’re [purely] practicing clinical medicine.”

Innovation requires preparation, though. Dr. Afsarmanesh spends countless hours creating PowerPoint presentations, so she hit a new feature at this year’s meeting: a limited-seating workshop on drawing up effective slides. The presentation is helpful, but she’s partially distracted. “Look up healthcare from talk,” she types as a note to herself for later. She follows that with “Look up Levy’s talk” (a nod to Paul Levy, the well-liked CEO of Beth Israel Deaconess in Boston).

Facial Recognition

The distraction ratchets up as she’s already looking forward to introducing herself to the editorial board of the Journal of Hospital Medicine, where she serves as an assistant editor. There are a few people she’d like to meet in person, so she gracefully sneaks out the side door a few minutes before noon. Handshakes, a box lunch, and a chat with 40 other journal editors ensue for the next hour.

“You can meet people you talk on the phone with for several years,” she says. “You can put a face to the name. That’s important.”

Hobnobbing at a board meeting is only a brief respite, however, before it’s back to professional development. At 1:15, there’s a 60-minute lesson on how to improve care from the patient perspective. Dr. Afsarmanesh, again, is distracted. She’s a first-time presenter in a few minutes, part of a four-woman panel on building a QI educational curriculum for medical students, residents, fellows, faculty, and other healthcare providers.

She scrolls through slides, rehearsing her thoughts. She wonders whether her PowerPoint presentation would have made the grade at this morning’s session.

She is smart enough not to judge her performance too soon—someone in an audience once reached out to her a year later—as she knows the impact of a training session is more than the round of applause at its end.

“You hope that you generate a discussion more than the traditional didactics,” she says. “These meetings are meant to start a discussion and, hopefully, create a network and a community where people can continue to [share ideas and learn from each other]. … I hope that along with some of the content that people take away, the bigger thing is those connections that they make.”

Work Never Ends

It’s 4:30 p.m. and Dr. Afsarmanesh still has a sales pitch to rehearse. This time, it’s self-promotion for her soon-to-begin poster presentation: “The ABCs of Hospitalized Patients: A Multi-Disciplinary Checklist for Improving Quality of Patient Care."

After umpteen repetitions of her spiel, the presentation doesn’t win a prize, but, once again, she showcases her attention to detail: A stack of 8.5”x 11” versions of her poster are available for handouts, a feature few others in the competition have.

Some 12 hours into her tour of this massive convention center, the day is coming to a close. But not before SHM CEO Larry Wellikson, MD, SFHM, drops by to say hello.

He points out how strong her research is. Unfortunately, he uses a pen in the process.

“Don’t poke a hole in my poster,” she jokes.

Moments later, it’s back to working the line queued up at her poster. “Hi, would you like to hear about my poster?” HM2010

Richard Quinn is a freelance writer based in New Jersey.

IT’S 11 MINUTES to 8 o’clock, and the sun is still climbing over the Potomac River just outside the Gaylord National Resort & Convention Center in National Harbor, Md. Day two of SHM’s annual meeting is about to begin.

Hospitalists file into a cavernous ballroom as the day kicks off with a panel discussion on healthcare reform and a speech by that rarest of breed: a popular hospital CEO. The back of the room fills quickly, but front and center, second row—that’s the seat for Nasim Afsarmanesh, MD, director of quality for HM and neurosurgery at Ronald Reagan UCLA Medical Center in Los Angeles.

“If I’m not in the front, I zone out,” she admits.

Dr. Afsarmanesh (who often adds a hyphen to her surname— Afsar-manesh—to help others pronounce it) knows herself and she knows how to plan ahead, from taking notes on her mini-laptop to knowing when to sit up front. And this day in her life is no different. Her schedule is a 12-hour dervish, yet it’s a simple roadmap of how to navigate HM10 and its scores of sessions, speeches, and seminars.

Innovator at Heart

Dr. Afsarmanesh did her residency in 2007 at UCLA. She stayed on to take a faculty position and is now assistant clinical professor of internal medicine (IM) and neurosurgery. Her days are split about 35% clinical practice, 40% on neurology quality issues, and 25% on hospital QI projects. In her free time, she’s an SHM activist and the incoming chair of its Hospital Quality and Patient Safety (HQPS) Committee.

“I get to be an innovator,” she boasts as she picks up a Danish, a chocolate pastry, and a cup of tea following two hours of listening to others talk. “I love that. You can’t really be an innovator when you’re [purely] practicing clinical medicine.”

Innovation requires preparation, though. Dr. Afsarmanesh spends countless hours creating PowerPoint presentations, so she hit a new feature at this year’s meeting: a limited-seating workshop on drawing up effective slides. The presentation is helpful, but she’s partially distracted. “Look up healthcare from talk,” she types as a note to herself for later. She follows that with “Look up Levy’s talk” (a nod to Paul Levy, the well-liked CEO of Beth Israel Deaconess in Boston).

Facial Recognition

The distraction ratchets up as she’s already looking forward to introducing herself to the editorial board of the Journal of Hospital Medicine, where she serves as an assistant editor. There are a few people she’d like to meet in person, so she gracefully sneaks out the side door a few minutes before noon. Handshakes, a box lunch, and a chat with 40 other journal editors ensue for the next hour.

“You can meet people you talk on the phone with for several years,” she says. “You can put a face to the name. That’s important.”

Hobnobbing at a board meeting is only a brief respite, however, before it’s back to professional development. At 1:15, there’s a 60-minute lesson on how to improve care from the patient perspective. Dr. Afsarmanesh, again, is distracted. She’s a first-time presenter in a few minutes, part of a four-woman panel on building a QI educational curriculum for medical students, residents, fellows, faculty, and other healthcare providers.

She scrolls through slides, rehearsing her thoughts. She wonders whether her PowerPoint presentation would have made the grade at this morning’s session.

She is smart enough not to judge her performance too soon—someone in an audience once reached out to her a year later—as she knows the impact of a training session is more than the round of applause at its end.

“You hope that you generate a discussion more than the traditional didactics,” she says. “These meetings are meant to start a discussion and, hopefully, create a network and a community where people can continue to [share ideas and learn from each other]. … I hope that along with some of the content that people take away, the bigger thing is those connections that they make.”

Work Never Ends

It’s 4:30 p.m. and Dr. Afsarmanesh still has a sales pitch to rehearse. This time, it’s self-promotion for her soon-to-begin poster presentation: “The ABCs of Hospitalized Patients: A Multi-Disciplinary Checklist for Improving Quality of Patient Care."

After umpteen repetitions of her spiel, the presentation doesn’t win a prize, but, once again, she showcases her attention to detail: A stack of 8.5”x 11” versions of her poster are available for handouts, a feature few others in the competition have.

Some 12 hours into her tour of this massive convention center, the day is coming to a close. But not before SHM CEO Larry Wellikson, MD, SFHM, drops by to say hello.

He points out how strong her research is. Unfortunately, he uses a pen in the process.

“Don’t poke a hole in my poster,” she jokes.

Moments later, it’s back to working the line queued up at her poster. “Hi, would you like to hear about my poster?” HM2010

Richard Quinn is a freelance writer based in New Jersey.

BUILDING QUALITY improvement (QI) into the healthcare process starts with education, but to date, standardized QI curriculums have not taken root across academic medical centers.

A quartet of academic hospitalists pushed the concept during an HM10 session titled “Quality Improvement Curriculum: How to Get Started and to Keep Going.” All four speakers agreed that QI “empowers providers to create change.”

The presentation was based on a 1998 book from first author David Kern, MD, MPH, FACP, professor at the Johns Hopkins University School of Medicine in Baltimore: “Curriculum Development for Medical Education: A Six-Step Process.” Some of the take-home points included:

• Problem identification and a general-needs assessment, followed by a targeted needs assessment. Combined, the two steps create a construct for an issue, such as “residents lack knowledge skills in QI,” and then hone in with such queries as “What is the baseline knowledge?”
• Goals and objectives. There is a difference between the two. Goals are broad-based with little specificity; objectives are measurable items that gauge progress.
• Educational strategies. Cognitive objectives can be taught via lectures or team-based projects; however, skill-based objectives traditionally are better taught via hands-on experience.
• Implementation, evaluation, and feedback. Many programs try to move too quickly and put something in place before fully planning out the curriculum.

“Take a step back,” said Arpana Vidyarthi, MD, assistant professor and director of quality University of California at San Francisco. “What you do in implementing your curriculum ought to be connected to what your goals and objectives are.” HM10

BUILDING QUALITY improvement (QI) into the healthcare process starts with education, but to date, standardized QI curriculums have not taken root across academic medical centers.

A quartet of academic hospitalists pushed the concept during an HM10 session titled “Quality Improvement Curriculum: How to Get Started and to Keep Going.” All four speakers agreed that QI “empowers providers to create change.”

The presentation was based on a 1998 book from first author David Kern, MD, MPH, FACP, professor at the Johns Hopkins University School of Medicine in Baltimore: “Curriculum Development for Medical Education: A Six-Step Process.” Some of the take-home points included:

• Problem identification and a general-needs assessment, followed by a targeted needs assessment. Combined, the two steps create a construct for an issue, such as “residents lack knowledge skills in QI,” and then hone in with such queries as “What is the baseline knowledge?”
• Goals and objectives. There is a difference between the two. Goals are broad-based with little specificity; objectives are measurable items that gauge progress.
• Educational strategies. Cognitive objectives can be taught via lectures or team-based projects; however, skill-based objectives traditionally are better taught via hands-on experience.
• Implementation, evaluation, and feedback. Many programs try to move too quickly and put something in place before fully planning out the curriculum.

“Take a step back,” said Arpana Vidyarthi, MD, assistant professor and director of quality University of California at San Francisco. “What you do in implementing your curriculum ought to be connected to what your goals and objectives are.” HM10

BUILDING QUALITY improvement (QI) into the healthcare process starts with education, but to date, standardized QI curriculums have not taken root across academic medical centers.

A quartet of academic hospitalists pushed the concept during an HM10 session titled “Quality Improvement Curriculum: How to Get Started and to Keep Going.” All four speakers agreed that QI “empowers providers to create change.”

The presentation was based on a 1998 book from first author David Kern, MD, MPH, FACP, professor at the Johns Hopkins University School of Medicine in Baltimore: “Curriculum Development for Medical Education: A Six-Step Process.” Some of the take-home points included:

• Problem identification and a general-needs assessment, followed by a targeted needs assessment. Combined, the two steps create a construct for an issue, such as “residents lack knowledge skills in QI,” and then hone in with such queries as “What is the baseline knowledge?”
• Goals and objectives. There is a difference between the two. Goals are broad-based with little specificity; objectives are measurable items that gauge progress.
• Educational strategies. Cognitive objectives can be taught via lectures or team-based projects; however, skill-based objectives traditionally are better taught via hands-on experience.
• Implementation, evaluation, and feedback. Many programs try to move too quickly and put something in place before fully planning out the curriculum.

“Take a step back,” said Arpana Vidyarthi, MD, assistant professor and director of quality University of California at San Francisco. “What you do in implementing your curriculum ought to be connected to what your goals and objectives are.” HM10

NATIONAL HARBOR, Md.—It’s happened to every hospitalist who has pushed for a quality improvement (QI) project in their hospital: A chief says no because there’s no money for it. Doesn’t matter if it was the chief medical officer, chief operating officer, or the chief financial officer—the answer is no, no, no.

The best way to change the answer? Change the question.

“Think like they do,” said Mahalakshmi K. Halasymani, MD, SFHM, vice president for quality and systems improvement
at Saint Joseph Mercy Health System in Ann Arbor, Mich. “Think about how healthcare is paid for. … [Administrators are] much more likely to release resources if it matters to the institution’s ability to collect money, or get a better survey next time.”

Dr. Halasymani, an SHM board member, co-led the session “The Value Proposition to C-Suites: Aligning Hospital Resources to Support Hospitalist QI” with hospitalist Mark Novotny, MD, FHM, who held several C-suite positions at Southwestern Vermont Medical Center in Bennington, Vt., before parting ways with the hospital in early April. Both physicians urge getting organized before taking any case to hospital or health system administrators. Some of their tips:

• Define the scope of your proposal. Tackling too many issues can appear over-reaching. Attain a reasonable goal and build on success; that works better than swinging and missing with loftier goals.
• Attack topic areas with metrics. QI projects are only as good as the data they produce.
• Be interactive. Bring a C-suite member along on daily rounds for a week to showcase the problem you hope to address. When an administrator sees a need for improvement in real time, the issue is personalized. If administrators won’t come to rounds, go to them wherever they are—medical executive committee meetings, patient safety sessions, etc.

“Create a compelling story so people can see you not as an enemy, but as an ally,” Dr. Halasymani said. “To do that, you have to be where the conversations take place.” HM10

NATIONAL HARBOR, Md.—It’s happened to every hospitalist who has pushed for a quality improvement (QI) project in their hospital: A chief says no because there’s no money for it. Doesn’t matter if it was the chief medical officer, chief operating officer, or the chief financial officer—the answer is no, no, no.

The best way to change the answer? Change the question.

“Think like they do,” said Mahalakshmi K. Halasymani, MD, SFHM, vice president for quality and systems improvement
at Saint Joseph Mercy Health System in Ann Arbor, Mich. “Think about how healthcare is paid for. … [Administrators are] much more likely to release resources if it matters to the institution’s ability to collect money, or get a better survey next time.”

Dr. Halasymani, an SHM board member, co-led the session “The Value Proposition to C-Suites: Aligning Hospital Resources to Support Hospitalist QI” with hospitalist Mark Novotny, MD, FHM, who held several C-suite positions at Southwestern Vermont Medical Center in Bennington, Vt., before parting ways with the hospital in early April. Both physicians urge getting organized before taking any case to hospital or health system administrators. Some of their tips:

• Define the scope of your proposal. Tackling too many issues can appear over-reaching. Attain a reasonable goal and build on success; that works better than swinging and missing with loftier goals.
• Attack topic areas with metrics. QI projects are only as good as the data they produce.
• Be interactive. Bring a C-suite member along on daily rounds for a week to showcase the problem you hope to address. When an administrator sees a need for improvement in real time, the issue is personalized. If administrators won’t come to rounds, go to them wherever they are—medical executive committee meetings, patient safety sessions, etc.

“Create a compelling story so people can see you not as an enemy, but as an ally,” Dr. Halasymani said. “To do that, you have to be where the conversations take place.” HM10

NATIONAL HARBOR, Md.—It’s happened to every hospitalist who has pushed for a quality improvement (QI) project in their hospital: A chief says no because there’s no money for it. Doesn’t matter if it was the chief medical officer, chief operating officer, or the chief financial officer—the answer is no, no, no.

The best way to change the answer? Change the question.

“Think like they do,” said Mahalakshmi K. Halasymani, MD, SFHM, vice president for quality and systems improvement
at Saint Joseph Mercy Health System in Ann Arbor, Mich. “Think about how healthcare is paid for. … [Administrators are] much more likely to release resources if it matters to the institution’s ability to collect money, or get a better survey next time.”

Dr. Halasymani, an SHM board member, co-led the session “The Value Proposition to C-Suites: Aligning Hospital Resources to Support Hospitalist QI” with hospitalist Mark Novotny, MD, FHM, who held several C-suite positions at Southwestern Vermont Medical Center in Bennington, Vt., before parting ways with the hospital in early April. Both physicians urge getting organized before taking any case to hospital or health system administrators. Some of their tips:

• Define the scope of your proposal. Tackling too many issues can appear over-reaching. Attain a reasonable goal and build on success; that works better than swinging and missing with loftier goals.
• Attack topic areas with metrics. QI projects are only as good as the data they produce.
• Be interactive. Bring a C-suite member along on daily rounds for a week to showcase the problem you hope to address. When an administrator sees a need for improvement in real time, the issue is personalized. If administrators won’t come to rounds, go to them wherever they are—medical executive committee meetings, patient safety sessions, etc.

“Create a compelling story so people can see you not as an enemy, but as an ally,” Dr. Halasymani said. “To do that, you have to be where the conversations take place.” HM10

Editor’s note: Third of a three-part series.

In the two monthly columns preceding this one, I’ve provided an overview of some ways hospitalist groups distribute new referrals among the providers. This month, I’ll review things that cause some groups to make exceptions to their typical method of distributing patients, and turn from how patients are distributed over 24 hours to thoughts about how they might be assigned over the course of consecutive days worked by a doctor.

Equitable Exceptions

There are a number of reasons groups decide to depart from their typical method of assigning patients. These include:

• “Bouncebacks”;
• One hospitalist is at the cap, others aren’t;
• Consult requested of a specific hospitalist;
• Hospitalists with unique skills (e.g., ICU expertise); and
• A patient “fires” the hospitalist.

There isn’t a standard “hospitalist way” of dealing with these issues, and each group will need to work out its own system. The most common of these issues is “bouncebacks.” Every group should try to have patients readmitted within three or four days of discharge go back to the discharging hospitalist. However, this proves difficult in many cases for several reasons, most commonly because the original discharging doctor might not be working when the patient returns.

The Alpha & Omega

Nearly every hospitalist practice makes some effort to maximize continuity between a single hospitalist and patient over the course of a hospital stay. But the effect of the method of patient assignment on continuity often is overlooked.

A reasonable way to think about or measure continuity is to estimate the portion of patients seen by the group that see the same hospitalist for each daytime visit over the course of their stay. (Assume that in most HM groups the same hospitalist can’t make both day and night visits over the course of the hospital stay. So, just for simplicity, I’ve intentionally left night visits, including an initial admission visit at night, out of the continuity calculation.) Plug the numbers for your practice into the formula (see Figure 1, right) and see what you get.

If a hospitalist always works seven consecutive day shifts (e.g., a seven-on/seven-off schedule) and the hospitalist’s patients have an average LOS of 4.2 days, then 54% of patients will see the same hospitalist for all daytime visits, and 46% will experience at least one handoff. (To keep things simple, I’m ignoring the effect on continuity of patients being admitted by an “admitter” or nocturnist who doesn’t see the patient subsequently.)

Changing the number of consecutive day shifts a hospitalist works has the most significant impact on continuity, but just how many consecutive days can one work routinely before fatigue and burnout—not too mention increased errors and decreased patient satisfaction—become a problem? (Many hospitalists make the mistake of trying to stuff what might be a reasonable annual workload into the smallest number of shifts possible with the goal of maximizing the number of days off. That means each worked day will be very busy, making it really hard to work many consecutive days. But you always have the option of titrating out that same annual workload over more days so that each day is less busy and it becomes easier to work more consecutive days.)

An often-overlooked way to improve continuity without having to work more consecutive day shifts is to have a hospitalist who is early in their series of worked days take on more new admissions and consults, and perhaps exempt that doctor from taking on new referrals for the last day or two he or she is on service. Eric Howell, MD, FHM, an SHM board member, calls this method “slam and dwindle.” This has been the approach I’ve experienced my whole career, and it is hard for me to imagine doing it any other way.

Here’s how it might work: Let’s say Dr. Petty always works seven consecutive day shifts, and on the first day he picks up a list of patients remaining from the doctor he’s replacing. To keep things simple, let’s assume he’s not in a large group, and during his first day of seven days on service he accepts and “keeps” all new referrals to the practice. On each successive day, he might assume the care of some new patients, but none on days six and seven. This means he takes on a disproportionately large number of new referrals at the beginning of his consecutive worked days, or “front-loads” new referrals. And because many of these patients will discharge before the end of his seven days and he takes on no new patients on days six and seven, his census will drop a lot before he rotates off, which in turn means there will be few patients who will have to get to know a new doctor on the first day Dr. Petty starts his seven-off schedule.

This system of patient distribution means continuity improved without requiring Dr. Petty to work more consecutive day shifts. Even though he works seven consecutive days and his average (or median) LOS is 4.2, as in the example above, his continuity will be much better than 54%. In fact, as many as 70% to 80% of Dr. Petty’s patients will see him for every daytime visit during their stay.

click for large version

Other benefits of assigning more patients early and none late in a series of worked days are that on his last day of service, he will have more time to “tee up” patients for the next doctor, including preparing for patients anticipated to discharge the next day (e.g., dictate discharge summary, complete paperwork, etc.), and might be able to wrap up a little earlier that day. And when rotating back on service, he will pick up a small list of patients left by Dr. Tench, maybe fewer than eight, rather than the group’s average daily load of 15 patients per doctor, so he will have the capacity to admit a lot of patients that day.

I think there are three main reasons this isn’t a more common approach:

1. Many HM groups just haven’t considered it.
2. HM groups might have a schedule that has all doctors rotate off/on the same days each week. For example, all doctors rotate off on Tuesdays and are replaced by new doctors on Wednesday. That makes it impossible to exempt a doctor from taking on new referrals on the last day of service because all of the group’s doctors have their last day on Tuesday. These groups could stagger the day each doctor rotates off—one on Monday, one on Tuesday, and so on.
3. Every doctor is so busy each day that it wouldn’t be feasible to exempt any individual doctor from taking on new patients, even if they are off the next day.

Despite the difficulties implementing a system of front-loading new referrals, I think most hospitalists would find that they like it. Because it reduces handoffs, it reduces, at least modestly, the group’s overall workload and probably benefits the group’s quality and patient satisfaction. TH

Dr. Nelson has been a practicing hospitalist since 1988 and is co-founder and past president of SHM. He is a principal in Nelson Flores Hospital Medicine Consultants, a national hospitalist practice management consulting firm (www.nelsonflores.com). He is also course co-director and faculty for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. This column represents his views and is not intended to reflect an official position of SHM.

Editor’s note: Third of a three-part series.

In the two monthly columns preceding this one, I’ve provided an overview of some ways hospitalist groups distribute new referrals among the providers. This month, I’ll review things that cause some groups to make exceptions to their typical method of distributing patients, and turn from how patients are distributed over 24 hours to thoughts about how they might be assigned over the course of consecutive days worked by a doctor.

Equitable Exceptions

There are a number of reasons groups decide to depart from their typical method of assigning patients. These include:

• “Bouncebacks”;
• One hospitalist is at the cap, others aren’t;
• Consult requested of a specific hospitalist;
• Hospitalists with unique skills (e.g., ICU expertise); and
• A patient “fires” the hospitalist.

There isn’t a standard “hospitalist way” of dealing with these issues, and each group will need to work out its own system. The most common of these issues is “bouncebacks.” Every group should try to have patients readmitted within three or four days of discharge go back to the discharging hospitalist. However, this proves difficult in many cases for several reasons, most commonly because the original discharging doctor might not be working when the patient returns.

The Alpha & Omega

Nearly every hospitalist practice makes some effort to maximize continuity between a single hospitalist and patient over the course of a hospital stay. But the effect of the method of patient assignment on continuity often is overlooked.

A reasonable way to think about or measure continuity is to estimate the portion of patients seen by the group that see the same hospitalist for each daytime visit over the course of their stay. (Assume that in most HM groups the same hospitalist can’t make both day and night visits over the course of the hospital stay. So, just for simplicity, I’ve intentionally left night visits, including an initial admission visit at night, out of the continuity calculation.) Plug the numbers for your practice into the formula (see Figure 1, right) and see what you get.

If a hospitalist always works seven consecutive day shifts (e.g., a seven-on/seven-off schedule) and the hospitalist’s patients have an average LOS of 4.2 days, then 54% of patients will see the same hospitalist for all daytime visits, and 46% will experience at least one handoff. (To keep things simple, I’m ignoring the effect on continuity of patients being admitted by an “admitter” or nocturnist who doesn’t see the patient subsequently.)

Changing the number of consecutive day shifts a hospitalist works has the most significant impact on continuity, but just how many consecutive days can one work routinely before fatigue and burnout—not too mention increased errors and decreased patient satisfaction—become a problem? (Many hospitalists make the mistake of trying to stuff what might be a reasonable annual workload into the smallest number of shifts possible with the goal of maximizing the number of days off. That means each worked day will be very busy, making it really hard to work many consecutive days. But you always have the option of titrating out that same annual workload over more days so that each day is less busy and it becomes easier to work more consecutive days.)

An often-overlooked way to improve continuity without having to work more consecutive day shifts is to have a hospitalist who is early in their series of worked days take on more new admissions and consults, and perhaps exempt that doctor from taking on new referrals for the last day or two he or she is on service. Eric Howell, MD, FHM, an SHM board member, calls this method “slam and dwindle.” This has been the approach I’ve experienced my whole career, and it is hard for me to imagine doing it any other way.

Here’s how it might work: Let’s say Dr. Petty always works seven consecutive day shifts, and on the first day he picks up a list of patients remaining from the doctor he’s replacing. To keep things simple, let’s assume he’s not in a large group, and during his first day of seven days on service he accepts and “keeps” all new referrals to the practice. On each successive day, he might assume the care of some new patients, but none on days six and seven. This means he takes on a disproportionately large number of new referrals at the beginning of his consecutive worked days, or “front-loads” new referrals. And because many of these patients will discharge before the end of his seven days and he takes on no new patients on days six and seven, his census will drop a lot before he rotates off, which in turn means there will be few patients who will have to get to know a new doctor on the first day Dr. Petty starts his seven-off schedule.

This system of patient distribution means continuity improved without requiring Dr. Petty to work more consecutive day shifts. Even though he works seven consecutive days and his average (or median) LOS is 4.2, as in the example above, his continuity will be much better than 54%. In fact, as many as 70% to 80% of Dr. Petty’s patients will see him for every daytime visit during their stay.

click for large version

Other benefits of assigning more patients early and none late in a series of worked days are that on his last day of service, he will have more time to “tee up” patients for the next doctor, including preparing for patients anticipated to discharge the next day (e.g., dictate discharge summary, complete paperwork, etc.), and might be able to wrap up a little earlier that day. And when rotating back on service, he will pick up a small list of patients left by Dr. Tench, maybe fewer than eight, rather than the group’s average daily load of 15 patients per doctor, so he will have the capacity to admit a lot of patients that day.

I think there are three main reasons this isn’t a more common approach:

1. Many HM groups just haven’t considered it.
2. HM groups might have a schedule that has all doctors rotate off/on the same days each week. For example, all doctors rotate off on Tuesdays and are replaced by new doctors on Wednesday. That makes it impossible to exempt a doctor from taking on new referrals on the last day of service because all of the group’s doctors have their last day on Tuesday. These groups could stagger the day each doctor rotates off—one on Monday, one on Tuesday, and so on.
3. Every doctor is so busy each day that it wouldn’t be feasible to exempt any individual doctor from taking on new patients, even if they are off the next day.

Despite the difficulties implementing a system of front-loading new referrals, I think most hospitalists would find that they like it. Because it reduces handoffs, it reduces, at least modestly, the group’s overall workload and probably benefits the group’s quality and patient satisfaction. TH

Dr. Nelson has been a practicing hospitalist since 1988 and is co-founder and past president of SHM. He is a principal in Nelson Flores Hospital Medicine Consultants, a national hospitalist practice management consulting firm (www.nelsonflores.com). He is also course co-director and faculty for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. This column represents his views and is not intended to reflect an official position of SHM.

Editor’s note: Third of a three-part series.

In the two monthly columns preceding this one, I’ve provided an overview of some ways hospitalist groups distribute new referrals among the providers. This month, I’ll review things that cause some groups to make exceptions to their typical method of distributing patients, and turn from how patients are distributed over 24 hours to thoughts about how they might be assigned over the course of consecutive days worked by a doctor.

Equitable Exceptions

There are a number of reasons groups decide to depart from their typical method of assigning patients. These include:

• “Bouncebacks”;
• One hospitalist is at the cap, others aren’t;
• Consult requested of a specific hospitalist;
• Hospitalists with unique skills (e.g., ICU expertise); and
• A patient “fires” the hospitalist.

There isn’t a standard “hospitalist way” of dealing with these issues, and each group will need to work out its own system. The most common of these issues is “bouncebacks.” Every group should try to have patients readmitted within three or four days of discharge go back to the discharging hospitalist. However, this proves difficult in many cases for several reasons, most commonly because the original discharging doctor might not be working when the patient returns.

The Alpha & Omega

Nearly every hospitalist practice makes some effort to maximize continuity between a single hospitalist and patient over the course of a hospital stay. But the effect of the method of patient assignment on continuity often is overlooked.

A reasonable way to think about or measure continuity is to estimate the portion of patients seen by the group that see the same hospitalist for each daytime visit over the course of their stay. (Assume that in most HM groups the same hospitalist can’t make both day and night visits over the course of the hospital stay. So, just for simplicity, I’ve intentionally left night visits, including an initial admission visit at night, out of the continuity calculation.) Plug the numbers for your practice into the formula (see Figure 1, right) and see what you get.

If a hospitalist always works seven consecutive day shifts (e.g., a seven-on/seven-off schedule) and the hospitalist’s patients have an average LOS of 4.2 days, then 54% of patients will see the same hospitalist for all daytime visits, and 46% will experience at least one handoff. (To keep things simple, I’m ignoring the effect on continuity of patients being admitted by an “admitter” or nocturnist who doesn’t see the patient subsequently.)

Changing the number of consecutive day shifts a hospitalist works has the most significant impact on continuity, but just how many consecutive days can one work routinely before fatigue and burnout—not too mention increased errors and decreased patient satisfaction—become a problem? (Many hospitalists make the mistake of trying to stuff what might be a reasonable annual workload into the smallest number of shifts possible with the goal of maximizing the number of days off. That means each worked day will be very busy, making it really hard to work many consecutive days. But you always have the option of titrating out that same annual workload over more days so that each day is less busy and it becomes easier to work more consecutive days.)

An often-overlooked way to improve continuity without having to work more consecutive day shifts is to have a hospitalist who is early in their series of worked days take on more new admissions and consults, and perhaps exempt that doctor from taking on new referrals for the last day or two he or she is on service. Eric Howell, MD, FHM, an SHM board member, calls this method “slam and dwindle.” This has been the approach I’ve experienced my whole career, and it is hard for me to imagine doing it any other way.

Here’s how it might work: Let’s say Dr. Petty always works seven consecutive day shifts, and on the first day he picks up a list of patients remaining from the doctor he’s replacing. To keep things simple, let’s assume he’s not in a large group, and during his first day of seven days on service he accepts and “keeps” all new referrals to the practice. On each successive day, he might assume the care of some new patients, but none on days six and seven. This means he takes on a disproportionately large number of new referrals at the beginning of his consecutive worked days, or “front-loads” new referrals. And because many of these patients will discharge before the end of his seven days and he takes on no new patients on days six and seven, his census will drop a lot before he rotates off, which in turn means there will be few patients who will have to get to know a new doctor on the first day Dr. Petty starts his seven-off schedule.

This system of patient distribution means continuity improved without requiring Dr. Petty to work more consecutive day shifts. Even though he works seven consecutive days and his average (or median) LOS is 4.2, as in the example above, his continuity will be much better than 54%. In fact, as many as 70% to 80% of Dr. Petty’s patients will see him for every daytime visit during their stay.

click for large version

Other benefits of assigning more patients early and none late in a series of worked days are that on his last day of service, he will have more time to “tee up” patients for the next doctor, including preparing for patients anticipated to discharge the next day (e.g., dictate discharge summary, complete paperwork, etc.), and might be able to wrap up a little earlier that day. And when rotating back on service, he will pick up a small list of patients left by Dr. Tench, maybe fewer than eight, rather than the group’s average daily load of 15 patients per doctor, so he will have the capacity to admit a lot of patients that day.

I think there are three main reasons this isn’t a more common approach:

1. Many HM groups just haven’t considered it.
2. HM groups might have a schedule that has all doctors rotate off/on the same days each week. For example, all doctors rotate off on Tuesdays and are replaced by new doctors on Wednesday. That makes it impossible to exempt a doctor from taking on new referrals on the last day of service because all of the group’s doctors have their last day on Tuesday. These groups could stagger the day each doctor rotates off—one on Monday, one on Tuesday, and so on.
3. Every doctor is so busy each day that it wouldn’t be feasible to exempt any individual doctor from taking on new patients, even if they are off the next day.

Despite the difficulties implementing a system of front-loading new referrals, I think most hospitalists would find that they like it. Because it reduces handoffs, it reduces, at least modestly, the group’s overall workload and probably benefits the group’s quality and patient satisfaction. TH

Dr. Nelson has been a practicing hospitalist since 1988 and is co-founder and past president of SHM. He is a principal in Nelson Flores Hospital Medicine Consultants, a national hospitalist practice management consulting firm (www.nelsonflores.com). He is also course co-director and faculty for SHM’s “Best Practices in Managing a Hospital Medicine Program” course. This column represents his views and is not intended to reflect an official position of SHM.

Pipeline Drugs

• Phentermine/topiramate (Qnexa) is an investigational drug for the treatment of obesity. This includes weight loss and weight-loss maintenance in patients who are obese or overweight with such comorbidities as hypertension, Type 2 diabetes, dyslipidemia, or central adiposity. A new drug application (NDA) was filed with the FDA for this agent late in 2009.1 Qnexa is a once-daily, oral, controlled-release formulation comprised of low-dose phentermine and topiramate, which works on both patient satiety and appetite. Clinical trials show the drug has led to significant weight loss, glycemic control, and improved cardiovascular risk factors. Common side effects in clinical trials were dry mouth, tingling, and constipation.
• Pirfenidone, a potential treatment for idiopathic pulmonary fibrosis (IPF), has been granted a priority review by the FDA.2 Idiopathic pulmonary fibrosis is a disabling and fatal disease characterized by lung inflammation and scarring. The median survival time from diagnosis is two to five years, with an approximate five-year survival rate of 20%. Patients usually are diagnosed between the ages of 20 and 70, with a median of 63 years. It affects slightly more men than women. There are no medications approved to treat this fatal disease. Pirfenidone has been shown to have both antifibrotic and anti-inflammatory properties. The most common side effects are photosensitivity rash and gastrointestinal symptoms.3 The FDA’s action date is expected to be May 4.
• FDA approval was requested for retigabine, a potential new adjunctive epilepsy treatment, on Dec. 30, 2009.4 Retigabine is a neuronal potassium channel opener for use in adults with partial-onset seizures. In Phase 3 clinical trials, common adverse effects (occurring in more than 5% of patients) were dizziness, fatigue, confused state, vertigo, tremor, abnormal coordination, diplopia, attention disturbance, asthenia, and visual blurring.

Safety Information

• Desipramine (Norpramin), a tricyclic antidepressant approved by the FDA for treating major depression in adults, has undergone a label change to reflect new safety information. The “Warnings” and “Overdosage” sections of the product label now include information stating that extreme caution needs to be used when desipramine is administered to patients with a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances. The information also states that seizures might precede cardiac dysrhythmias and death in some patients.5 In a related “Dear Healthcare Professional” letter, information related to this warning was included with regard to identifying patients who present with a desipramine overdose, managing gastrointestinal decontamination with activated charcoal, managing cardiovascular effects, and deletion of measuring plasma-concentration desipramine as a guide to patient monitoring.5
• Diclofenac gel (Voltaren gel), a topical NSAID indicated for the relief of osteoarthritis pain of joints amenable to topical treatment (e.g., knees and hands), has undergone a label change related to its hepatic effects section. The label has revised warnings and precautions about the potential for liver function test elevations while receiving treatment with all diclofenac-containing products.6 There have been post-marketing reports of drug-induced hepatotoxicity within the first month of treatment with this topical agent. However, this reaction can occur at any time during diclofenac treatment. Severe hepatic reactions have been reported, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these cases resulted in fatalities or liver transplantation. Oral diclofenac also is hepatotoxic; it’s one of the most hepatotoxic NSAIDs available. To monitor patients receiving topical diclofenac, you should, after obtaining baseline transaminases, periodically measure transaminases in patients receiving long-term therapy. The optimum times for measurement are unknown. Based on available data from clinical trials and other cases, transaminases should be monitored within four to eight weeks after initiating diclofenac treatment.
• Fosamprenavir (Lexiva) has undergone a label change in the “Warnings” and “Precautions” sections, which is related to a potential association between the agent and the occurrence of myocardial infarction and dyslipidemia in adults with HIV.7 The updated label notes that patient cholesterol levels might increase if treated with fosamprenavir, and that lipid monitoring prior to and after initiating the agent should occur.
• Valproate sodium, valproic acid, and divalproex sodium have been associated with an increased risk of neural tube defects and other major birth defects (e.g., craniofacial defects and cardiovascular malformations) in babies exposed to these agents during pregnancy.8 Healthcare providers need to inform women of childbearing potential about these risks and consider alternative therapies, especially if the use of valproate is considered to treat migraines or other conditions that are not considered life-threatening. Women who are not actively planning a pregnancy and require use of valproate for medical conditions should use contraception, as birth-defect risks are high during the first trimester of pregnancy. Pregnant women using valproate should be encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry (888-233-2334 or www.aedpregnancyregistry.org). A medication guide explaining the risk and benefits of such treatment is required to be distributed with each dispensed valproate prescription.9 TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. NDA submitted for Qnexa. Drugs.com Web site. Available at: http://www.drugs.com/nda/qnexa_091229.html. Accessed Jan. 7, 2010.
2. Todoruk M. InterMune’s pulmonary drug pirfenidone granted priority review by FDA. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=5C01296C0574469B9A67F3574353FB1E&logRowId=343385. Accessed Jan. 7, 2010.
3. FDA grants priority review of pirfenidone NDA for the treatment of patients with IPF. InterMune Web site. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-newsArticle&ID=1370133&highlight=. Accessed Jan. 7, 2010.
4. FDA accepts NDA filing for retigabine. Drugs.com Web site. Available at: http://www.drugs.com/nda/retigabine_091230.html. Accessed Jan. 7, 2010.
5. Norpramin (desipramine hydrochloride)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192655.htm. Accessed Jan. 7, 2010.
6. Voltaren gel (diclofenac sodium topical gel) 1%—hepatic effects labeling changes. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm193047.htm. Accessed Jan. 7, 2009.
7. Lexiva (fosamprenavir calcium)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192699.htm. Accessed Jan. 7, 2010.
8. FDA warns of birth defects with valproate sodium, valproic acid, and divalproex sodium. Monthly Prescribing Reference Web site. Available at: http://www.empr.com/fda-warns-of-birth-defects-with-valproate-sodium-valproic-acid-and-divalproex-sodium/article/159034/. Accessed Jan. 7, 2010.
9. Valproate sodium and related products (valproic acid and divalproex sodium): risk of birth defects. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htm. Accessed Jan. 7, 2009.

Pipeline Drugs

• Phentermine/topiramate (Qnexa) is an investigational drug for the treatment of obesity. This includes weight loss and weight-loss maintenance in patients who are obese or overweight with such comorbidities as hypertension, Type 2 diabetes, dyslipidemia, or central adiposity. A new drug application (NDA) was filed with the FDA for this agent late in 2009.1 Qnexa is a once-daily, oral, controlled-release formulation comprised of low-dose phentermine and topiramate, which works on both patient satiety and appetite. Clinical trials show the drug has led to significant weight loss, glycemic control, and improved cardiovascular risk factors. Common side effects in clinical trials were dry mouth, tingling, and constipation.
• Pirfenidone, a potential treatment for idiopathic pulmonary fibrosis (IPF), has been granted a priority review by the FDA.2 Idiopathic pulmonary fibrosis is a disabling and fatal disease characterized by lung inflammation and scarring. The median survival time from diagnosis is two to five years, with an approximate five-year survival rate of 20%. Patients usually are diagnosed between the ages of 20 and 70, with a median of 63 years. It affects slightly more men than women. There are no medications approved to treat this fatal disease. Pirfenidone has been shown to have both antifibrotic and anti-inflammatory properties. The most common side effects are photosensitivity rash and gastrointestinal symptoms.3 The FDA’s action date is expected to be May 4.
• FDA approval was requested for retigabine, a potential new adjunctive epilepsy treatment, on Dec. 30, 2009.4 Retigabine is a neuronal potassium channel opener for use in adults with partial-onset seizures. In Phase 3 clinical trials, common adverse effects (occurring in more than 5% of patients) were dizziness, fatigue, confused state, vertigo, tremor, abnormal coordination, diplopia, attention disturbance, asthenia, and visual blurring.

Safety Information

• Desipramine (Norpramin), a tricyclic antidepressant approved by the FDA for treating major depression in adults, has undergone a label change to reflect new safety information. The “Warnings” and “Overdosage” sections of the product label now include information stating that extreme caution needs to be used when desipramine is administered to patients with a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances. The information also states that seizures might precede cardiac dysrhythmias and death in some patients.5 In a related “Dear Healthcare Professional” letter, information related to this warning was included with regard to identifying patients who present with a desipramine overdose, managing gastrointestinal decontamination with activated charcoal, managing cardiovascular effects, and deletion of measuring plasma-concentration desipramine as a guide to patient monitoring.5
• Diclofenac gel (Voltaren gel), a topical NSAID indicated for the relief of osteoarthritis pain of joints amenable to topical treatment (e.g., knees and hands), has undergone a label change related to its hepatic effects section. The label has revised warnings and precautions about the potential for liver function test elevations while receiving treatment with all diclofenac-containing products.6 There have been post-marketing reports of drug-induced hepatotoxicity within the first month of treatment with this topical agent. However, this reaction can occur at any time during diclofenac treatment. Severe hepatic reactions have been reported, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these cases resulted in fatalities or liver transplantation. Oral diclofenac also is hepatotoxic; it’s one of the most hepatotoxic NSAIDs available. To monitor patients receiving topical diclofenac, you should, after obtaining baseline transaminases, periodically measure transaminases in patients receiving long-term therapy. The optimum times for measurement are unknown. Based on available data from clinical trials and other cases, transaminases should be monitored within four to eight weeks after initiating diclofenac treatment.
• Fosamprenavir (Lexiva) has undergone a label change in the “Warnings” and “Precautions” sections, which is related to a potential association between the agent and the occurrence of myocardial infarction and dyslipidemia in adults with HIV.7 The updated label notes that patient cholesterol levels might increase if treated with fosamprenavir, and that lipid monitoring prior to and after initiating the agent should occur.
• Valproate sodium, valproic acid, and divalproex sodium have been associated with an increased risk of neural tube defects and other major birth defects (e.g., craniofacial defects and cardiovascular malformations) in babies exposed to these agents during pregnancy.8 Healthcare providers need to inform women of childbearing potential about these risks and consider alternative therapies, especially if the use of valproate is considered to treat migraines or other conditions that are not considered life-threatening. Women who are not actively planning a pregnancy and require use of valproate for medical conditions should use contraception, as birth-defect risks are high during the first trimester of pregnancy. Pregnant women using valproate should be encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry (888-233-2334 or www.aedpregnancyregistry.org). A medication guide explaining the risk and benefits of such treatment is required to be distributed with each dispensed valproate prescription.9 TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. NDA submitted for Qnexa. Drugs.com Web site. Available at: http://www.drugs.com/nda/qnexa_091229.html. Accessed Jan. 7, 2010.
2. Todoruk M. InterMune’s pulmonary drug pirfenidone granted priority review by FDA. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=5C01296C0574469B9A67F3574353FB1E&logRowId=343385. Accessed Jan. 7, 2010.
3. FDA grants priority review of pirfenidone NDA for the treatment of patients with IPF. InterMune Web site. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-newsArticle&ID=1370133&highlight=. Accessed Jan. 7, 2010.
4. FDA accepts NDA filing for retigabine. Drugs.com Web site. Available at: http://www.drugs.com/nda/retigabine_091230.html. Accessed Jan. 7, 2010.
5. Norpramin (desipramine hydrochloride)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192655.htm. Accessed Jan. 7, 2010.
6. Voltaren gel (diclofenac sodium topical gel) 1%—hepatic effects labeling changes. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm193047.htm. Accessed Jan. 7, 2009.
7. Lexiva (fosamprenavir calcium)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192699.htm. Accessed Jan. 7, 2010.
8. FDA warns of birth defects with valproate sodium, valproic acid, and divalproex sodium. Monthly Prescribing Reference Web site. Available at: http://www.empr.com/fda-warns-of-birth-defects-with-valproate-sodium-valproic-acid-and-divalproex-sodium/article/159034/. Accessed Jan. 7, 2010.
9. Valproate sodium and related products (valproic acid and divalproex sodium): risk of birth defects. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htm. Accessed Jan. 7, 2009.

Pipeline Drugs

• Phentermine/topiramate (Qnexa) is an investigational drug for the treatment of obesity. This includes weight loss and weight-loss maintenance in patients who are obese or overweight with such comorbidities as hypertension, Type 2 diabetes, dyslipidemia, or central adiposity. A new drug application (NDA) was filed with the FDA for this agent late in 2009.1 Qnexa is a once-daily, oral, controlled-release formulation comprised of low-dose phentermine and topiramate, which works on both patient satiety and appetite. Clinical trials show the drug has led to significant weight loss, glycemic control, and improved cardiovascular risk factors. Common side effects in clinical trials were dry mouth, tingling, and constipation.
• Pirfenidone, a potential treatment for idiopathic pulmonary fibrosis (IPF), has been granted a priority review by the FDA.2 Idiopathic pulmonary fibrosis is a disabling and fatal disease characterized by lung inflammation and scarring. The median survival time from diagnosis is two to five years, with an approximate five-year survival rate of 20%. Patients usually are diagnosed between the ages of 20 and 70, with a median of 63 years. It affects slightly more men than women. There are no medications approved to treat this fatal disease. Pirfenidone has been shown to have both antifibrotic and anti-inflammatory properties. The most common side effects are photosensitivity rash and gastrointestinal symptoms.3 The FDA’s action date is expected to be May 4.
• FDA approval was requested for retigabine, a potential new adjunctive epilepsy treatment, on Dec. 30, 2009.4 Retigabine is a neuronal potassium channel opener for use in adults with partial-onset seizures. In Phase 3 clinical trials, common adverse effects (occurring in more than 5% of patients) were dizziness, fatigue, confused state, vertigo, tremor, abnormal coordination, diplopia, attention disturbance, asthenia, and visual blurring.

Safety Information

• Desipramine (Norpramin), a tricyclic antidepressant approved by the FDA for treating major depression in adults, has undergone a label change to reflect new safety information. The “Warnings” and “Overdosage” sections of the product label now include information stating that extreme caution needs to be used when desipramine is administered to patients with a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances. The information also states that seizures might precede cardiac dysrhythmias and death in some patients.5 In a related “Dear Healthcare Professional” letter, information related to this warning was included with regard to identifying patients who present with a desipramine overdose, managing gastrointestinal decontamination with activated charcoal, managing cardiovascular effects, and deletion of measuring plasma-concentration desipramine as a guide to patient monitoring.5
• Diclofenac gel (Voltaren gel), a topical NSAID indicated for the relief of osteoarthritis pain of joints amenable to topical treatment (e.g., knees and hands), has undergone a label change related to its hepatic effects section. The label has revised warnings and precautions about the potential for liver function test elevations while receiving treatment with all diclofenac-containing products.6 There have been post-marketing reports of drug-induced hepatotoxicity within the first month of treatment with this topical agent. However, this reaction can occur at any time during diclofenac treatment. Severe hepatic reactions have been reported, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these cases resulted in fatalities or liver transplantation. Oral diclofenac also is hepatotoxic; it’s one of the most hepatotoxic NSAIDs available. To monitor patients receiving topical diclofenac, you should, after obtaining baseline transaminases, periodically measure transaminases in patients receiving long-term therapy. The optimum times for measurement are unknown. Based on available data from clinical trials and other cases, transaminases should be monitored within four to eight weeks after initiating diclofenac treatment.
• Fosamprenavir (Lexiva) has undergone a label change in the “Warnings” and “Precautions” sections, which is related to a potential association between the agent and the occurrence of myocardial infarction and dyslipidemia in adults with HIV.7 The updated label notes that patient cholesterol levels might increase if treated with fosamprenavir, and that lipid monitoring prior to and after initiating the agent should occur.
• Valproate sodium, valproic acid, and divalproex sodium have been associated with an increased risk of neural tube defects and other major birth defects (e.g., craniofacial defects and cardiovascular malformations) in babies exposed to these agents during pregnancy.8 Healthcare providers need to inform women of childbearing potential about these risks and consider alternative therapies, especially if the use of valproate is considered to treat migraines or other conditions that are not considered life-threatening. Women who are not actively planning a pregnancy and require use of valproate for medical conditions should use contraception, as birth-defect risks are high during the first trimester of pregnancy. Pregnant women using valproate should be encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry (888-233-2334 or www.aedpregnancyregistry.org). A medication guide explaining the risk and benefits of such treatment is required to be distributed with each dispensed valproate prescription.9 TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. NDA submitted for Qnexa. Drugs.com Web site. Available at: http://www.drugs.com/nda/qnexa_091229.html. Accessed Jan. 7, 2010.
2. Todoruk M. InterMune’s pulmonary drug pirfenidone granted priority review by FDA. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=5C01296C0574469B9A67F3574353FB1E&logRowId=343385. Accessed Jan. 7, 2010.
3. FDA grants priority review of pirfenidone NDA for the treatment of patients with IPF. InterMune Web site. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-newsArticle&ID=1370133&highlight=. Accessed Jan. 7, 2010.
4. FDA accepts NDA filing for retigabine. Drugs.com Web site. Available at: http://www.drugs.com/nda/retigabine_091230.html. Accessed Jan. 7, 2010.
5. Norpramin (desipramine hydrochloride)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192655.htm. Accessed Jan. 7, 2010.
6. Voltaren gel (diclofenac sodium topical gel) 1%—hepatic effects labeling changes. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm193047.htm. Accessed Jan. 7, 2009.
7. Lexiva (fosamprenavir calcium)—Dear Healthcare Professional letter. Food and Drug Administration Web site. Available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192699.htm. Accessed Jan. 7, 2010.
8. FDA warns of birth defects with valproate sodium, valproic acid, and divalproex sodium. Monthly Prescribing Reference Web site. Available at: http://www.empr.com/fda-warns-of-birth-defects-with-valproate-sodium-valproic-acid-and-divalproex-sodium/article/159034/. Accessed Jan. 7, 2010.
9. Valproate sodium and related products (valproic acid and divalproex sodium): risk of birth defects. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htm. Accessed Jan. 7, 2009.

Thousands of Michigan residents will have a better chance of avoiding readmission to the hospital thanks to a groundbreaking new collaboration between three of the state’s healthcare leaders.

Based on SHM’s Project BOOST (Better Outcomes for Older Adults through Safe Transitions) model, the collaborative program will be managed by the University of Michigan in collaboration with Blue Cross Blue Shield of Michigan. The Michigan Blues provide and administer health benefits to 4.7 million Michigan residents.

Project BOOST helps hospitals reduce readmission rates by providing them with proven resources and expert mentoring to optimize the discharge transition process, enhance patient and family education practices, and improve the flow of information between inpatient and outpatient providers. Project BOOST was developed through a grant from the John A. Hartford Foundation. Earlier in the year, the program recruited 15 Michigan sites to participate. Training begins in May.

Each improvement team will be assigned a mentor to coach them through the process of planning, implementing, and evaluating Project BOOST at their site. Program participants will receive face-to-face training, monthly coaching sessions with their mentors, and a comprehensive toolkit to implement Project BOOST. Sites also participate in an online peer learning and collaboration network.

“This kind of innovative, targeted program benefits both the patient and the healthcare provider by establishing better communication between all parties,” says Scott Flanders, MD, FHM, associate professor and director of hospital medicine at the University of Michigan in Ann Arbor, and SHM president.

To Flanders, it’s no coincidence that hospitalists are taking the lead in improving hospital discharges. “Readmissions are a pervasive but preventable problem,” he says. “Hospitalists are uniquely positioned to provide leadership within the hospital, to promote positive, system-based changes that improve patient satisfaction, and promote collaboration between hospitalists and primary-care physicians.”

In addition to being preventable, readmissions are costly, draining the resources, time, and energy of the patient, PCPs, and hospitals. Research in the April 2009 New England Journal of Medicine indicates that 20% of hospitalized patients are readmitted to the hospital within a month of their discharge.1 Nationally, readmissions cost Medicare $17.4 billion each year.1

Collaborative Partnerships

Prior to the program’s launch in Michigan, SHM recruited and mentored Project BOOST sites independently. However, like many productive relationships in a hospital, Project BOOST in Michigan depends on collaboration between experts.

“Blue Cross Blue Shield of Michigan is confident that this project, like our other Value Partnership programs that focus on robust, statewide, data-driven quality-improvement (QI) partnerships, will have a positive impact on thousands of Michigan lives,” says David Share, MD, MPH, BCBS Michigan’s senior associate medical director of Healthcare Quality. “We look forward to helping hospitals, physicians, and patients work together to assure smooth transitions between inpatient and outpatient care, and to reduce readmissions and improve the patient experience.”

For University of Michigan hospitalist Christopher Kim, MD, MBA, FHM, Project BOOST is a chance to work with a diverse set of groups. “We are grateful for the opportunity to work with not just Blue Cross Blue Shield of Michigan, but also with the other physician organizations across our state to implement and share best-practice ideas in transitions of care,” says Kim, director of the statewide collaborative program on transitions of care.

Results and Reports

Having launched six pilot sites just two years ago, adding 24 additional sites in 2009, Project BOOST is still a relatively young QI program, which makes reliable quantitative data about its effectiveness tough to come by. The expansion into Michigan gives SHM and others the prospect of programwide measurement of how Project BOOST affects discharge and reduces readmissions.

“This is a tremendous opportunity to improve patient safety, reduce readmissions, and study the impact of Project BOOST interventions through patient-level data,” says Mark Williams, MD, FHM, Journal of Hospital Medicine editor, principal investigator for Project BOOST, and former SHM president. “We’re thrilled to be working with the state’s healthcare leaders to implement this critical program.”

Nonetheless, in the absence of comprehensive data, the early reports from Project BOOST sites are promising. At Piedmont Hospital in the Atlanta area, the rate of readmission among patients under the age of 70 participating in BOOST is 8.5%, compared with 25.5% among nonparticipants. The readmission rate among BOOST participants at Piedmont over the age of 70 was 22%, compared with 26% of nonparticipants. When SSM St. Mary’s Medical Center in St. Louis implemented BOOST at its 33-bed hospitalist unit, 30-day readmissions dropped to 7% from 12% within three months.

Patient satisfaction rates also increased markedly, to 68% from 52%. And in 2009, the University of Pennsylvania Health System awarded its annual Operational Quality and Safety Award to the Project BOOST implementation team at the hospital.

BOOST’s Reach Expands

Project BOOST leaders are planning an aggressive expansion in the near future. In addition to the potential for new program sites, SHM has made materials available to hospitalists through the Project BOOST Resource Room at SHM’s newly redesigned Web site (see “The New Face of HospitalMedicine.org,” p. 12), www.hospitalmedicine.org/boost.

In addition to free resources, new BOOST materials are for sale through SHM’s online store. The Project BOOST Implementation Guide—available electronically for free through the resource room—is now available for sale as a hard copy. The online store also features a new Project BOOST instructional DVD for hospitalists, “Using Teach Back to Improve Communication with Patients.” TH

Brendon Shank is a freelance writer based in Philadelphia.

Reference

1. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009;360(14): 1418-1428.

Chapter Updates

The Historic Main Street Trolley in Memphis, Tenn.

Memphis

The Memphis chapter held its quarterly meeting Feb. 4 at Erling Jensen in Memphis, Tenn. Dr. William Edmonson of the North Mississippi Medical Center in Tupelo, Miss., discussed “Updates on COPD.” Boehringer Engelheim sponsored the dinner meeting, which was attended by hospitalists and physicians in the area as well as hospital nurses and administration.

Milwaukee/Southeast Wisconsin

The Milwaukee/Southeast Wisconsin chapter’s Feb. 27 meeting in the Columbia Hospital Auditorium brought together hospitalists, nurse practitioners, pharmacists, and others from the Milwaukee area. Attendees were able to obtain CME credit on topics including acute coronary syndrome, hyponatremia, and sepsis. The meeting highlight was a presentation from Dr. Alpesh Amin, interim chair of the Department of Medicine at the University of California at Irvine. Dr. Amin discussed how to start up a local SHM chapter. Sponsorship from CME University helped make the chapter’s first HM symposium a success.

Nebraska Area

Lincoln HM group Bryan LGH hosted the Nebraska Area chapter quarterly meeting Feb. 23. Dr. Tamer Mahrous gave an overview of coding issues for hospitalists. A copy of the presentation will be sent to all of the chapter members.

The chapter elected officers to serve terms through 2012. They include: Dr. Eric Rice, president; Russ Cowles, vice president; Alissa Clough, secretary; and Jay Snow, officer at large.

Several additional items were discussed, including topics for upcoming meetings, how the chapter can best take advantage of opportunities at HM10, the possibility of launching a chapter newsletter, and organizational issues.

Thousands of Michigan residents will have a better chance of avoiding readmission to the hospital thanks to a groundbreaking new collaboration between three of the state’s healthcare leaders.

Based on SHM’s Project BOOST (Better Outcomes for Older Adults through Safe Transitions) model, the collaborative program will be managed by the University of Michigan in collaboration with Blue Cross Blue Shield of Michigan. The Michigan Blues provide and administer health benefits to 4.7 million Michigan residents.

Project BOOST helps hospitals reduce readmission rates by providing them with proven resources and expert mentoring to optimize the discharge transition process, enhance patient and family education practices, and improve the flow of information between inpatient and outpatient providers. Project BOOST was developed through a grant from the John A. Hartford Foundation. Earlier in the year, the program recruited 15 Michigan sites to participate. Training begins in May.

Each improvement team will be assigned a mentor to coach them through the process of planning, implementing, and evaluating Project BOOST at their site. Program participants will receive face-to-face training, monthly coaching sessions with their mentors, and a comprehensive toolkit to implement Project BOOST. Sites also participate in an online peer learning and collaboration network.

“This kind of innovative, targeted program benefits both the patient and the healthcare provider by establishing better communication between all parties,” says Scott Flanders, MD, FHM, associate professor and director of hospital medicine at the University of Michigan in Ann Arbor, and SHM president.

To Flanders, it’s no coincidence that hospitalists are taking the lead in improving hospital discharges. “Readmissions are a pervasive but preventable problem,” he says. “Hospitalists are uniquely positioned to provide leadership within the hospital, to promote positive, system-based changes that improve patient satisfaction, and promote collaboration between hospitalists and primary-care physicians.”

In addition to being preventable, readmissions are costly, draining the resources, time, and energy of the patient, PCPs, and hospitals. Research in the April 2009 New England Journal of Medicine indicates that 20% of hospitalized patients are readmitted to the hospital within a month of their discharge.1 Nationally, readmissions cost Medicare $17.4 billion each year.1

Collaborative Partnerships

Prior to the program’s launch in Michigan, SHM recruited and mentored Project BOOST sites independently. However, like many productive relationships in a hospital, Project BOOST in Michigan depends on collaboration between experts.

“Blue Cross Blue Shield of Michigan is confident that this project, like our other Value Partnership programs that focus on robust, statewide, data-driven quality-improvement (QI) partnerships, will have a positive impact on thousands of Michigan lives,” says David Share, MD, MPH, BCBS Michigan’s senior associate medical director of Healthcare Quality. “We look forward to helping hospitals, physicians, and patients work together to assure smooth transitions between inpatient and outpatient care, and to reduce readmissions and improve the patient experience.”

For University of Michigan hospitalist Christopher Kim, MD, MBA, FHM, Project BOOST is a chance to work with a diverse set of groups. “We are grateful for the opportunity to work with not just Blue Cross Blue Shield of Michigan, but also with the other physician organizations across our state to implement and share best-practice ideas in transitions of care,” says Kim, director of the statewide collaborative program on transitions of care.

Results and Reports

Having launched six pilot sites just two years ago, adding 24 additional sites in 2009, Project BOOST is still a relatively young QI program, which makes reliable quantitative data about its effectiveness tough to come by. The expansion into Michigan gives SHM and others the prospect of programwide measurement of how Project BOOST affects discharge and reduces readmissions.

“This is a tremendous opportunity to improve patient safety, reduce readmissions, and study the impact of Project BOOST interventions through patient-level data,” says Mark Williams, MD, FHM, Journal of Hospital Medicine editor, principal investigator for Project BOOST, and former SHM president. “We’re thrilled to be working with the state’s healthcare leaders to implement this critical program.”

Nonetheless, in the absence of comprehensive data, the early reports from Project BOOST sites are promising. At Piedmont Hospital in the Atlanta area, the rate of readmission among patients under the age of 70 participating in BOOST is 8.5%, compared with 25.5% among nonparticipants. The readmission rate among BOOST participants at Piedmont over the age of 70 was 22%, compared with 26% of nonparticipants. When SSM St. Mary’s Medical Center in St. Louis implemented BOOST at its 33-bed hospitalist unit, 30-day readmissions dropped to 7% from 12% within three months.

Patient satisfaction rates also increased markedly, to 68% from 52%. And in 2009, the University of Pennsylvania Health System awarded its annual Operational Quality and Safety Award to the Project BOOST implementation team at the hospital.

BOOST’s Reach Expands

Project BOOST leaders are planning an aggressive expansion in the near future. In addition to the potential for new program sites, SHM has made materials available to hospitalists through the Project BOOST Resource Room at SHM’s newly redesigned Web site (see “The New Face of HospitalMedicine.org,” p. 12), www.hospitalmedicine.org/boost.

In addition to free resources, new BOOST materials are for sale through SHM’s online store. The Project BOOST Implementation Guide—available electronically for free through the resource room—is now available for sale as a hard copy. The online store also features a new Project BOOST instructional DVD for hospitalists, “Using Teach Back to Improve Communication with Patients.” TH

Brendon Shank is a freelance writer based in Philadelphia.

Reference

1. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009;360(14): 1418-1428.

Chapter Updates

The Historic Main Street Trolley in Memphis, Tenn.

Memphis

The Memphis chapter held its quarterly meeting Feb. 4 at Erling Jensen in Memphis, Tenn. Dr. William Edmonson of the North Mississippi Medical Center in Tupelo, Miss., discussed “Updates on COPD.” Boehringer Engelheim sponsored the dinner meeting, which was attended by hospitalists and physicians in the area as well as hospital nurses and administration.

Milwaukee/Southeast Wisconsin

The Milwaukee/Southeast Wisconsin chapter’s Feb. 27 meeting in the Columbia Hospital Auditorium brought together hospitalists, nurse practitioners, pharmacists, and others from the Milwaukee area. Attendees were able to obtain CME credit on topics including acute coronary syndrome, hyponatremia, and sepsis. The meeting highlight was a presentation from Dr. Alpesh Amin, interim chair of the Department of Medicine at the University of California at Irvine. Dr. Amin discussed how to start up a local SHM chapter. Sponsorship from CME University helped make the chapter’s first HM symposium a success.

Nebraska Area

Lincoln HM group Bryan LGH hosted the Nebraska Area chapter quarterly meeting Feb. 23. Dr. Tamer Mahrous gave an overview of coding issues for hospitalists. A copy of the presentation will be sent to all of the chapter members.

The chapter elected officers to serve terms through 2012. They include: Dr. Eric Rice, president; Russ Cowles, vice president; Alissa Clough, secretary; and Jay Snow, officer at large.

Several additional items were discussed, including topics for upcoming meetings, how the chapter can best take advantage of opportunities at HM10, the possibility of launching a chapter newsletter, and organizational issues.

Thousands of Michigan residents will have a better chance of avoiding readmission to the hospital thanks to a groundbreaking new collaboration between three of the state’s healthcare leaders.

Based on SHM’s Project BOOST (Better Outcomes for Older Adults through Safe Transitions) model, the collaborative program will be managed by the University of Michigan in collaboration with Blue Cross Blue Shield of Michigan. The Michigan Blues provide and administer health benefits to 4.7 million Michigan residents.

Project BOOST helps hospitals reduce readmission rates by providing them with proven resources and expert mentoring to optimize the discharge transition process, enhance patient and family education practices, and improve the flow of information between inpatient and outpatient providers. Project BOOST was developed through a grant from the John A. Hartford Foundation. Earlier in the year, the program recruited 15 Michigan sites to participate. Training begins in May.

Each improvement team will be assigned a mentor to coach them through the process of planning, implementing, and evaluating Project BOOST at their site. Program participants will receive face-to-face training, monthly coaching sessions with their mentors, and a comprehensive toolkit to implement Project BOOST. Sites also participate in an online peer learning and collaboration network.

“This kind of innovative, targeted program benefits both the patient and the healthcare provider by establishing better communication between all parties,” says Scott Flanders, MD, FHM, associate professor and director of hospital medicine at the University of Michigan in Ann Arbor, and SHM president.

To Flanders, it’s no coincidence that hospitalists are taking the lead in improving hospital discharges. “Readmissions are a pervasive but preventable problem,” he says. “Hospitalists are uniquely positioned to provide leadership within the hospital, to promote positive, system-based changes that improve patient satisfaction, and promote collaboration between hospitalists and primary-care physicians.”

In addition to being preventable, readmissions are costly, draining the resources, time, and energy of the patient, PCPs, and hospitals. Research in the April 2009 New England Journal of Medicine indicates that 20% of hospitalized patients are readmitted to the hospital within a month of their discharge.1 Nationally, readmissions cost Medicare $17.4 billion each year.1

Collaborative Partnerships

Prior to the program’s launch in Michigan, SHM recruited and mentored Project BOOST sites independently. However, like many productive relationships in a hospital, Project BOOST in Michigan depends on collaboration between experts.

“Blue Cross Blue Shield of Michigan is confident that this project, like our other Value Partnership programs that focus on robust, statewide, data-driven quality-improvement (QI) partnerships, will have a positive impact on thousands of Michigan lives,” says David Share, MD, MPH, BCBS Michigan’s senior associate medical director of Healthcare Quality. “We look forward to helping hospitals, physicians, and patients work together to assure smooth transitions between inpatient and outpatient care, and to reduce readmissions and improve the patient experience.”

For University of Michigan hospitalist Christopher Kim, MD, MBA, FHM, Project BOOST is a chance to work with a diverse set of groups. “We are grateful for the opportunity to work with not just Blue Cross Blue Shield of Michigan, but also with the other physician organizations across our state to implement and share best-practice ideas in transitions of care,” says Kim, director of the statewide collaborative program on transitions of care.

Results and Reports

Having launched six pilot sites just two years ago, adding 24 additional sites in 2009, Project BOOST is still a relatively young QI program, which makes reliable quantitative data about its effectiveness tough to come by. The expansion into Michigan gives SHM and others the prospect of programwide measurement of how Project BOOST affects discharge and reduces readmissions.

“This is a tremendous opportunity to improve patient safety, reduce readmissions, and study the impact of Project BOOST interventions through patient-level data,” says Mark Williams, MD, FHM, Journal of Hospital Medicine editor, principal investigator for Project BOOST, and former SHM president. “We’re thrilled to be working with the state’s healthcare leaders to implement this critical program.”

Nonetheless, in the absence of comprehensive data, the early reports from Project BOOST sites are promising. At Piedmont Hospital in the Atlanta area, the rate of readmission among patients under the age of 70 participating in BOOST is 8.5%, compared with 25.5% among nonparticipants. The readmission rate among BOOST participants at Piedmont over the age of 70 was 22%, compared with 26% of nonparticipants. When SSM St. Mary’s Medical Center in St. Louis implemented BOOST at its 33-bed hospitalist unit, 30-day readmissions dropped to 7% from 12% within three months.

Patient satisfaction rates also increased markedly, to 68% from 52%. And in 2009, the University of Pennsylvania Health System awarded its annual Operational Quality and Safety Award to the Project BOOST implementation team at the hospital.

BOOST’s Reach Expands

Project BOOST leaders are planning an aggressive expansion in the near future. In addition to the potential for new program sites, SHM has made materials available to hospitalists through the Project BOOST Resource Room at SHM’s newly redesigned Web site (see “The New Face of HospitalMedicine.org,” p. 12), www.hospitalmedicine.org/boost.

In addition to free resources, new BOOST materials are for sale through SHM’s online store. The Project BOOST Implementation Guide—available electronically for free through the resource room—is now available for sale as a hard copy. The online store also features a new Project BOOST instructional DVD for hospitalists, “Using Teach Back to Improve Communication with Patients.” TH

Brendon Shank is a freelance writer based in Philadelphia.

Reference

1. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009;360(14): 1418-1428.

Chapter Updates

The Historic Main Street Trolley in Memphis, Tenn.

Memphis

The Memphis chapter held its quarterly meeting Feb. 4 at Erling Jensen in Memphis, Tenn. Dr. William Edmonson of the North Mississippi Medical Center in Tupelo, Miss., discussed “Updates on COPD.” Boehringer Engelheim sponsored the dinner meeting, which was attended by hospitalists and physicians in the area as well as hospital nurses and administration.

Milwaukee/Southeast Wisconsin

The Milwaukee/Southeast Wisconsin chapter’s Feb. 27 meeting in the Columbia Hospital Auditorium brought together hospitalists, nurse practitioners, pharmacists, and others from the Milwaukee area. Attendees were able to obtain CME credit on topics including acute coronary syndrome, hyponatremia, and sepsis. The meeting highlight was a presentation from Dr. Alpesh Amin, interim chair of the Department of Medicine at the University of California at Irvine. Dr. Amin discussed how to start up a local SHM chapter. Sponsorship from CME University helped make the chapter’s first HM symposium a success.

Nebraska Area

Lincoln HM group Bryan LGH hosted the Nebraska Area chapter quarterly meeting Feb. 23. Dr. Tamer Mahrous gave an overview of coding issues for hospitalists. A copy of the presentation will be sent to all of the chapter members.

The chapter elected officers to serve terms through 2012. They include: Dr. Eric Rice, president; Russ Cowles, vice president; Alissa Clough, secretary; and Jay Snow, officer at large.

Several additional items were discussed, including topics for upcoming meetings, how the chapter can best take advantage of opportunities at HM10, the possibility of launching a chapter newsletter, and organizational issues.

Case

A 67-year-old man with a history of hypertension presents with a swollen right lower extremity. An ultrasound reveals a DVT, and he is commenced on low-molecular-weight heparin and warfarin. Two days later, he develops slurred speech and right-sided weakness. A head CT reveals an intracranial hemorrhage. When should an inferior vena cava (IVC) filter be utilized for treatment of DVT?

Overview

It is estimated that 350,000 to 600,000 Americans develop a VTE each year.1 Patients with a DVT are at high risk of developing a pulmonary embolism (PE). In a multicenter study, nearly 40% of patients admitted with a DVT had evidence of a PE on ventilation perfusion scan.2 Treatment of a DVT is aimed at preventing the extension of the DVT and embolization.3 The American College of Chest Physicians (ACCP) recommends anticoagulation as the primary DVT treatment (Grade 1A).4 However, IVC filters might be considered when anticoagulation is contraindicated.

In 1868, Trousseau created the conceptual model of surgical interruption of the IVC to prevent PE. However, it wasn’t until 1959 by Bottini that the surgical interruption was successfully performed.5 The Mobin-Uddin filter was introduced in 1967 as the first mechanical IVC filter.6 IVC filters mechanically trap the DVT, preventing emboli from traveling into the pulmonary vasculature.7

There are two classes of IVC filters: permanent filters and removable filters. Removable filters include both temporary filters and retrievable filters. Temporary filters are attached to a catheter that exits the skin and therefore must be removed due to the risk of infection and embolization.7 Retrievable filters are similar in design to permanent filters but are designed to be removed. However, this must be done with caution, as neointimal hyperplasia can prevent removal or cause vessel wall damage upon removal.8

IVC filters are inserted into the vena cava percutaneously via the femoral or jugular approach under fluoroscopy or ultrasound guidance (see Figure 1, p. 16). The filters typically are placed infrarenally, unless there is an indication for a suprarenal filter (e.g., renal vein thrombosis or IVC thrombus extending above the renal veins).7 Complete IVC thrombosis is an absolute contraindication to IVC filter placement, and the relative contraindications include significant coagulopathy and bacteremia.9

The incidence of complications related to IVC filter placement is 4% to 11%. Complications include:

• Insertion-site thrombosis;
• IVC thrombosis;
• Recurrent DVT postphlebitic syndrome;
• Filter migration;
• Erosion of the filter through the vessel wall; and
• Vena caval obstruction.10

A review of the National Hospital Discharge Survey database for trends in IVC filter use in the U.S. found a dramatic increase in the use of IVC filters from 1979 to 1999—to 49,000 patients from 2,000 patients with IVC filters in place. The indications for IVC filter use vary such that it is imperative there are well-designed trials and guidelines to guide appropriate use.11

MEDICAL-ON-LINE/ALAMY

The Evidence

The 2008 ACCP guidelines on VTE management follow a grading system that classifies recommendations as Grade 1 (strong) or Grade 2 (weak), and classifies the quality of evidence as A (high), B (moderate), or C (low).12 The ACCP guidelines’ recommended first-line treatment for a confirmed DVT is anticoagulation with subcutaneous low-molecular-weight heparin, intravenous unfractionated heparin, monitored subcutaneous heparin, fixed-dose subcutaneous unfractionated heparin, or subcutaneous fondaparinux (all Grade 1A recommendations). The ACCP recommends against the routine use of an IVC filter in addition to anticoagulants (Grade 1A). However, for patients with acute proximal DVT, if anticoagulant therapy is not possible because of the risk of bleeding, IVC filter placement is recommended (Grade 1C). If a patient requires an IVC filter for treatment of an acute DVT as an alternative to anticoagulation, it is recommended to start anticoagulant therapy once the risk of bleeding resolves (Grade 1C).4

click for large version

The 2008 ACCP guidelines for IVC filter use have a few important changes from the 2004 version. First, the IVC filter placement recommendation for patients with contraindications to anticoagulation was strengthened from Grade 2C to Grade 1C. Second, the 2008 guidelines omitted the early recommendation of IVC filter use for recurrent VTE, despite adequate anticoagulation (Grade 2C).13

Only one randomized study has evaluated the efficacy of IVC filters. All other studies of IVC filters are retrospective or prospective case series.

The PREPIC study randomized 400 patients with proximal DVT considered to be at high risk for PE to receive either an IVC filter or no IVC filter. Additionally, patients were randomized to receive enoxaparin or unfractionated heparin as a bridge to warfarin therapy, which was continued for at least three months. The primary endpoints were recurrent DVT, PE, major bleeding, or death. The patients were followed up at day 12, two years, and then annually up to eight years following randomization.14 At day 12, there were fewer PEs in the group that received filters (OR 0.22, 95% CI, 0.05-0.90). However, at year two, there was no significant difference in PE development in the filter group compared with the no-filter group (OR 0.50, 95% CI, 0.19-1.33).

click for large version

Additionally, at year two, the filter group was more likely to develop recurrent DVT (OR 1.87, 95% CI, 1.10-3.20). At year eight, there was a significant reduction in the number of PEs in the filter group versus the no-filter group (6.2% vs.15.1%, P=0.008). However, at eight-year followup, IVC filter use was associated with increased DVT (35.7% vs. 27.5%, P=0.042). There was no difference in mortality between the two groups.

In summary, the use of IVC filters was associated with decreased incidence of PE at eight years, offset by higher rates of recurrent DVT and no overall mortality benefit.14,15 Importantly, the indications for IVC filter use in this study differ from the current ACCP guidelines; all patients were given concomitant anticoagulation for at least three months, which might not be possible in patients for whom the ACCP recommends IVC filters.

There are no randomized studies to compare the efficacy of permanent IVC filters and retrievable filters for PE prevention. A retrospective study comparing the clinical effectiveness of the two filter types reported no difference in the rates of symptomatic PE (permanent filter 4% vs. retrievable filter 4.7%, P=0.67) or DVT (11.3% vs. 12.6%, P=0.59). In addition, the frequency of symptomatic IVC thrombosis was similar (1.1% vs. 0.5%, p=0.39).16 A paper reviewing the efficacy of IVC filters reported that permanent filters were associated with a 0%-6.2% rate of PE versus a 0%-1.9% rate with retrievable filters.7 Notably, these studies were not randomized controlled trials—rather, case series—and the indications for IVC filters were not necessarily those currently recommended by the ACCP.

Due to the long-term complications of permanent IVC filters, it is suggested that a retrievable IVC filter be used for patients with temporary contraindications to anticoagulation.17 Comerata et al created a clinical decision-making tool for picking the type of filter to employ. If the duration of contraindication to anticoagulation is short or uncertain, a retrievable filter is recommended.18 Table 1 (p. 15) outlines the recommendations for IVC filter placement.

click for large version

There are no randomized controlled trials to guide the use of concomitant anticoagulation after filter insertion, although this intervention may be beneficial to prevent DVT propagation, recurrence, or IVC filter thrombosis.5 A meta-analysis of 14 studies evaluating the rates of VTE after IVC filter placement demonstrated a non-statistically significant trend toward fewer VTE events in the patients with an IVC filter and concomitant anticoagulation in comparison with those who solely had an IVC filter (OR 0.64, 95% CI, 0.35-1.2). The duration and degree of anticoagulation was not presented in all of the studies in the meta-analysis, therefore limiting the analysis.19

In addition to the ACCP guidelines, there have been other proposed indications for IVC filter use, including recurrent VTE despite anticoagulation, chronic recurrent PE with pulmonary hypertension, extensive free-floating iliofemoral thrombus, and thrombolysis of ilio-caval thrombus.20 The ACCP guidelines do not specifically address these individual indications, and at this time there are no randomized controlled trials to guide IVC filter use in these cases.

Back to the Case

Our patient developed a significant complication from anticoagulation. Current ACCP guidelines recommend an IVC filter if anticoagulant therapy is contraindicated (Grade 1C). The anticoagulation was discontinued and a retrievable IVC filter was placed. Once a patient no longer has a contraindication for anticoagulation, the ACCP recommends restarting a conventional course of anticoagulation. Thus, once the patient can tolerate anticoagulation, consideration will be given to removal of the retrievable filter.

Bottom Line

An IVC filter should be considered in patients with a DVT who have a contraindication to anticoagulation. Other indications for IVC filter use are not supported by the current literature. TH

Drs. Bhogal and Eid are hospitalist fellows and instructors at Johns Hopkins Bayview Medical Center in Baltimore. Dr. Kantsiper is a hospitalist and assistant professor at Bayview Medical Center.

References

1. The Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. U.S. Department of Health & Human Services Web site. Available at: www.surgeongeneral.gov/topics/deepvein/. Accessed Jan. 25, 2010.
2. Moser KM, Fedullo PR, LitteJohn JK, Crawford R. Frequent asymptomatic pulmonary embolism in patients with deep venous thrombosis. JAMA. 1994;271(3):223-225.
3. Bates SM, Ginsberg JS. Treatment of deep vein thrombosis. N Engl J Med. 2004;351:268-277.
4. Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ, American College of Chest Physicians. Antithrombotic therapy for venous theomboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133(6 Suppl):454S-545S.
5. Becker DM, Philbrick JT, Selby JB. Inferior vena cava filters. Indications, safety, effectiveness. Arch Intern Med. 1992;152(10):1985-1994.
6. Streiff MB. Vena caval filters: a comprehensive review. Blood. 2000;95(12):3669-3677.
7. Chung J, Owen RJ. Using inferior vena cava filters to prevent pulmonary embolism. Can Fam Physician. 2008;54(1):49-55.
8. Ku GH. Billett HH. Long lives, short indications. The case for removable inferior cava filters. Thromb Haemost. 2005;93(1):17-22.
9. Stavropoulos WS. Inferior vena cava filters. Tech Vasc Interv Radiol. 2004;7(2):91-95.
10. Crowther MA. Inferior vena cava filters in the management of venous thromboembolism. Am J Med. 2007;120(10 Suppl 2):S13–S17.
11. Stein PD, Kayali F, Olson RE. Twenty-one-year trends in the use of inferior vena cava filters. Arch Intern Med. 2004;164(14):1541-1545.
12. Guyatt G, Gutterman D, Baumann MH, et al. Grading strength of recommendations and quality of evidence in clinical guidelines: report from an American College of Chest Physicians task force. Chest. 2006;129(1):174-181.
13. Büller HR, Agnelli G, Hull RD, Hyers TM, Prins MH, Raskob GE. Antithrombotic therapy for venous thromboembolic disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126(3 Suppl):401S-428S.
14. Decousus H, Leizorovicz A, Parent F, et al. A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis. Prévention du Risque d’Embolie Pulmonaire par Interruption Cave Study Group. N Engl J Med. 1998;338(7):409-415.
15. Decousus H, Barral F, Buchmuller-Cordier A, et al. Participating centers eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism: the PREPIC randomization croup. Circulation. 2005;112:416-422.
16. Kim HS, Young MJ, Narayan AK, Liddell RP, Streiff MB. A comparison of clinical outcomes with retrievable and permanent inferior vena cava filters. J Vasc Interv Radiol. 2008:19(3):393-399.
17. Houman Fekrazad M, Lopes RD, Stashenko GJ, Alexander JH, Garcia D. Treatment of venous thromboembolism: guidelines translated for the clinician. J Thromb Thrombolysis. 2009; 28(3):270–275.
18. Comerota AJ. Retrievable IVC filters: a decision matrix for appropriate utilization. Perspect Vasc Surg Endovasc Ther. 2006;18(1):11-17.
19. Ray CE Jr, Prochazka A. The need for anticoagulation following inferior vena cava filter placement: systematic review. Cardiovasc Intervent Radiol. 2008; 31(2):316-324.
20. Hajduk B, Tomkowski WZ, Malek G, Davidson BL. Vena cava filter occlusion and venous thromboembolism risk in persistently anticoagulated patients: A prospective, observational cohort study. Chest. 2009.

Case

A 67-year-old man with a history of hypertension presents with a swollen right lower extremity. An ultrasound reveals a DVT, and he is commenced on low-molecular-weight heparin and warfarin. Two days later, he develops slurred speech and right-sided weakness. A head CT reveals an intracranial hemorrhage. When should an inferior vena cava (IVC) filter be utilized for treatment of DVT?

Overview

It is estimated that 350,000 to 600,000 Americans develop a VTE each year.1 Patients with a DVT are at high risk of developing a pulmonary embolism (PE). In a multicenter study, nearly 40% of patients admitted with a DVT had evidence of a PE on ventilation perfusion scan.2 Treatment of a DVT is aimed at preventing the extension of the DVT and embolization.3 The American College of Chest Physicians (ACCP) recommends anticoagulation as the primary DVT treatment (Grade 1A).4 However, IVC filters might be considered when anticoagulation is contraindicated.

In 1868, Trousseau created the conceptual model of surgical interruption of the IVC to prevent PE. However, it wasn’t until 1959 by Bottini that the surgical interruption was successfully performed.5 The Mobin-Uddin filter was introduced in 1967 as the first mechanical IVC filter.6 IVC filters mechanically trap the DVT, preventing emboli from traveling into the pulmonary vasculature.7

There are two classes of IVC filters: permanent filters and removable filters. Removable filters include both temporary filters and retrievable filters. Temporary filters are attached to a catheter that exits the skin and therefore must be removed due to the risk of infection and embolization.7 Retrievable filters are similar in design to permanent filters but are designed to be removed. However, this must be done with caution, as neointimal hyperplasia can prevent removal or cause vessel wall damage upon removal.8

IVC filters are inserted into the vena cava percutaneously via the femoral or jugular approach under fluoroscopy or ultrasound guidance (see Figure 1, p. 16). The filters typically are placed infrarenally, unless there is an indication for a suprarenal filter (e.g., renal vein thrombosis or IVC thrombus extending above the renal veins).7 Complete IVC thrombosis is an absolute contraindication to IVC filter placement, and the relative contraindications include significant coagulopathy and bacteremia.9

The incidence of complications related to IVC filter placement is 4% to 11%. Complications include:

• Insertion-site thrombosis;
• IVC thrombosis;
• Recurrent DVT postphlebitic syndrome;
• Filter migration;
• Erosion of the filter through the vessel wall; and
• Vena caval obstruction.10

A review of the National Hospital Discharge Survey database for trends in IVC filter use in the U.S. found a dramatic increase in the use of IVC filters from 1979 to 1999—to 49,000 patients from 2,000 patients with IVC filters in place. The indications for IVC filter use vary such that it is imperative there are well-designed trials and guidelines to guide appropriate use.11

MEDICAL-ON-LINE/ALAMY

The Evidence

The 2008 ACCP guidelines on VTE management follow a grading system that classifies recommendations as Grade 1 (strong) or Grade 2 (weak), and classifies the quality of evidence as A (high), B (moderate), or C (low).12 The ACCP guidelines’ recommended first-line treatment for a confirmed DVT is anticoagulation with subcutaneous low-molecular-weight heparin, intravenous unfractionated heparin, monitored subcutaneous heparin, fixed-dose subcutaneous unfractionated heparin, or subcutaneous fondaparinux (all Grade 1A recommendations). The ACCP recommends against the routine use of an IVC filter in addition to anticoagulants (Grade 1A). However, for patients with acute proximal DVT, if anticoagulant therapy is not possible because of the risk of bleeding, IVC filter placement is recommended (Grade 1C). If a patient requires an IVC filter for treatment of an acute DVT as an alternative to anticoagulation, it is recommended to start anticoagulant therapy once the risk of bleeding resolves (Grade 1C).4

click for large version

The 2008 ACCP guidelines for IVC filter use have a few important changes from the 2004 version. First, the IVC filter placement recommendation for patients with contraindications to anticoagulation was strengthened from Grade 2C to Grade 1C. Second, the 2008 guidelines omitted the early recommendation of IVC filter use for recurrent VTE, despite adequate anticoagulation (Grade 2C).13

Only one randomized study has evaluated the efficacy of IVC filters. All other studies of IVC filters are retrospective or prospective case series.

The PREPIC study randomized 400 patients with proximal DVT considered to be at high risk for PE to receive either an IVC filter or no IVC filter. Additionally, patients were randomized to receive enoxaparin or unfractionated heparin as a bridge to warfarin therapy, which was continued for at least three months. The primary endpoints were recurrent DVT, PE, major bleeding, or death. The patients were followed up at day 12, two years, and then annually up to eight years following randomization.14 At day 12, there were fewer PEs in the group that received filters (OR 0.22, 95% CI, 0.05-0.90). However, at year two, there was no significant difference in PE development in the filter group compared with the no-filter group (OR 0.50, 95% CI, 0.19-1.33).

click for large version

Additionally, at year two, the filter group was more likely to develop recurrent DVT (OR 1.87, 95% CI, 1.10-3.20). At year eight, there was a significant reduction in the number of PEs in the filter group versus the no-filter group (6.2% vs.15.1%, P=0.008). However, at eight-year followup, IVC filter use was associated with increased DVT (35.7% vs. 27.5%, P=0.042). There was no difference in mortality between the two groups.

In summary, the use of IVC filters was associated with decreased incidence of PE at eight years, offset by higher rates of recurrent DVT and no overall mortality benefit.14,15 Importantly, the indications for IVC filter use in this study differ from the current ACCP guidelines; all patients were given concomitant anticoagulation for at least three months, which might not be possible in patients for whom the ACCP recommends IVC filters.

There are no randomized studies to compare the efficacy of permanent IVC filters and retrievable filters for PE prevention. A retrospective study comparing the clinical effectiveness of the two filter types reported no difference in the rates of symptomatic PE (permanent filter 4% vs. retrievable filter 4.7%, P=0.67) or DVT (11.3% vs. 12.6%, P=0.59). In addition, the frequency of symptomatic IVC thrombosis was similar (1.1% vs. 0.5%, p=0.39).16 A paper reviewing the efficacy of IVC filters reported that permanent filters were associated with a 0%-6.2% rate of PE versus a 0%-1.9% rate with retrievable filters.7 Notably, these studies were not randomized controlled trials—rather, case series—and the indications for IVC filters were not necessarily those currently recommended by the ACCP.

Due to the long-term complications of permanent IVC filters, it is suggested that a retrievable IVC filter be used for patients with temporary contraindications to anticoagulation.17 Comerata et al created a clinical decision-making tool for picking the type of filter to employ. If the duration of contraindication to anticoagulation is short or uncertain, a retrievable filter is recommended.18 Table 1 (p. 15) outlines the recommendations for IVC filter placement.

click for large version

There are no randomized controlled trials to guide the use of concomitant anticoagulation after filter insertion, although this intervention may be beneficial to prevent DVT propagation, recurrence, or IVC filter thrombosis.5 A meta-analysis of 14 studies evaluating the rates of VTE after IVC filter placement demonstrated a non-statistically significant trend toward fewer VTE events in the patients with an IVC filter and concomitant anticoagulation in comparison with those who solely had an IVC filter (OR 0.64, 95% CI, 0.35-1.2). The duration and degree of anticoagulation was not presented in all of the studies in the meta-analysis, therefore limiting the analysis.19

In addition to the ACCP guidelines, there have been other proposed indications for IVC filter use, including recurrent VTE despite anticoagulation, chronic recurrent PE with pulmonary hypertension, extensive free-floating iliofemoral thrombus, and thrombolysis of ilio-caval thrombus.20 The ACCP guidelines do not specifically address these individual indications, and at this time there are no randomized controlled trials to guide IVC filter use in these cases.

Back to the Case

Our patient developed a significant complication from anticoagulation. Current ACCP guidelines recommend an IVC filter if anticoagulant therapy is contraindicated (Grade 1C). The anticoagulation was discontinued and a retrievable IVC filter was placed. Once a patient no longer has a contraindication for anticoagulation, the ACCP recommends restarting a conventional course of anticoagulation. Thus, once the patient can tolerate anticoagulation, consideration will be given to removal of the retrievable filter.

Bottom Line

An IVC filter should be considered in patients with a DVT who have a contraindication to anticoagulation. Other indications for IVC filter use are not supported by the current literature. TH

Drs. Bhogal and Eid are hospitalist fellows and instructors at Johns Hopkins Bayview Medical Center in Baltimore. Dr. Kantsiper is a hospitalist and assistant professor at Bayview Medical Center.

References

1. The Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. U.S. Department of Health & Human Services Web site. Available at: www.surgeongeneral.gov/topics/deepvein/. Accessed Jan. 25, 2010.
2. Moser KM, Fedullo PR, LitteJohn JK, Crawford R. Frequent asymptomatic pulmonary embolism in patients with deep venous thrombosis. JAMA. 1994;271(3):223-225.
3. Bates SM, Ginsberg JS. Treatment of deep vein thrombosis. N Engl J Med. 2004;351:268-277.
4. Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ, American College of Chest Physicians. Antithrombotic therapy for venous theomboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133(6 Suppl):454S-545S.
5. Becker DM, Philbrick JT, Selby JB. Inferior vena cava filters. Indications, safety, effectiveness. Arch Intern Med. 1992;152(10):1985-1994.
6. Streiff MB. Vena caval filters: a comprehensive review. Blood. 2000;95(12):3669-3677.
7. Chung J, Owen RJ. Using inferior vena cava filters to prevent pulmonary embolism. Can Fam Physician. 2008;54(1):49-55.
8. Ku GH. Billett HH. Long lives, short indications. The case for removable inferior cava filters. Thromb Haemost. 2005;93(1):17-22.
9. Stavropoulos WS. Inferior vena cava filters. Tech Vasc Interv Radiol. 2004;7(2):91-95.
10. Crowther MA. Inferior vena cava filters in the management of venous thromboembolism. Am J Med. 2007;120(10 Suppl 2):S13–S17.
11. Stein PD, Kayali F, Olson RE. Twenty-one-year trends in the use of inferior vena cava filters. Arch Intern Med. 2004;164(14):1541-1545.
12. Guyatt G, Gutterman D, Baumann MH, et al. Grading strength of recommendations and quality of evidence in clinical guidelines: report from an American College of Chest Physicians task force. Chest. 2006;129(1):174-181.
13. Büller HR, Agnelli G, Hull RD, Hyers TM, Prins MH, Raskob GE. Antithrombotic therapy for venous thromboembolic disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126(3 Suppl):401S-428S.
14. Decousus H, Leizorovicz A, Parent F, et al. A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis. Prévention du Risque d’Embolie Pulmonaire par Interruption Cave Study Group. N Engl J Med. 1998;338(7):409-415.
15. Decousus H, Barral F, Buchmuller-Cordier A, et al. Participating centers eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism: the PREPIC randomization croup. Circulation. 2005;112:416-422.
16. Kim HS, Young MJ, Narayan AK, Liddell RP, Streiff MB. A comparison of clinical outcomes with retrievable and permanent inferior vena cava filters. J Vasc Interv Radiol. 2008:19(3):393-399.
17. Houman Fekrazad M, Lopes RD, Stashenko GJ, Alexander JH, Garcia D. Treatment of venous thromboembolism: guidelines translated for the clinician. J Thromb Thrombolysis. 2009; 28(3):270–275.
18. Comerota AJ. Retrievable IVC filters: a decision matrix for appropriate utilization. Perspect Vasc Surg Endovasc Ther. 2006;18(1):11-17.
19. Ray CE Jr, Prochazka A. The need for anticoagulation following inferior vena cava filter placement: systematic review. Cardiovasc Intervent Radiol. 2008; 31(2):316-324.
20. Hajduk B, Tomkowski WZ, Malek G, Davidson BL. Vena cava filter occlusion and venous thromboembolism risk in persistently anticoagulated patients: A prospective, observational cohort study. Chest. 2009.

Case

A 67-year-old man with a history of hypertension presents with a swollen right lower extremity. An ultrasound reveals a DVT, and he is commenced on low-molecular-weight heparin and warfarin. Two days later, he develops slurred speech and right-sided weakness. A head CT reveals an intracranial hemorrhage. When should an inferior vena cava (IVC) filter be utilized for treatment of DVT?

Overview

It is estimated that 350,000 to 600,000 Americans develop a VTE each year.1 Patients with a DVT are at high risk of developing a pulmonary embolism (PE). In a multicenter study, nearly 40% of patients admitted with a DVT had evidence of a PE on ventilation perfusion scan.2 Treatment of a DVT is aimed at preventing the extension of the DVT and embolization.3 The American College of Chest Physicians (ACCP) recommends anticoagulation as the primary DVT treatment (Grade 1A).4 However, IVC filters might be considered when anticoagulation is contraindicated.

In 1868, Trousseau created the conceptual model of surgical interruption of the IVC to prevent PE. However, it wasn’t until 1959 by Bottini that the surgical interruption was successfully performed.5 The Mobin-Uddin filter was introduced in 1967 as the first mechanical IVC filter.6 IVC filters mechanically trap the DVT, preventing emboli from traveling into the pulmonary vasculature.7

There are two classes of IVC filters: permanent filters and removable filters. Removable filters include both temporary filters and retrievable filters. Temporary filters are attached to a catheter that exits the skin and therefore must be removed due to the risk of infection and embolization.7 Retrievable filters are similar in design to permanent filters but are designed to be removed. However, this must be done with caution, as neointimal hyperplasia can prevent removal or cause vessel wall damage upon removal.8

IVC filters are inserted into the vena cava percutaneously via the femoral or jugular approach under fluoroscopy or ultrasound guidance (see Figure 1, p. 16). The filters typically are placed infrarenally, unless there is an indication for a suprarenal filter (e.g., renal vein thrombosis or IVC thrombus extending above the renal veins).7 Complete IVC thrombosis is an absolute contraindication to IVC filter placement, and the relative contraindications include significant coagulopathy and bacteremia.9

The incidence of complications related to IVC filter placement is 4% to 11%. Complications include:

• Insertion-site thrombosis;
• IVC thrombosis;
• Recurrent DVT postphlebitic syndrome;
• Filter migration;
• Erosion of the filter through the vessel wall; and
• Vena caval obstruction.10

A review of the National Hospital Discharge Survey database for trends in IVC filter use in the U.S. found a dramatic increase in the use of IVC filters from 1979 to 1999—to 49,000 patients from 2,000 patients with IVC filters in place. The indications for IVC filter use vary such that it is imperative there are well-designed trials and guidelines to guide appropriate use.11

MEDICAL-ON-LINE/ALAMY

The Evidence

The 2008 ACCP guidelines on VTE management follow a grading system that classifies recommendations as Grade 1 (strong) or Grade 2 (weak), and classifies the quality of evidence as A (high), B (moderate), or C (low).12 The ACCP guidelines’ recommended first-line treatment for a confirmed DVT is anticoagulation with subcutaneous low-molecular-weight heparin, intravenous unfractionated heparin, monitored subcutaneous heparin, fixed-dose subcutaneous unfractionated heparin, or subcutaneous fondaparinux (all Grade 1A recommendations). The ACCP recommends against the routine use of an IVC filter in addition to anticoagulants (Grade 1A). However, for patients with acute proximal DVT, if anticoagulant therapy is not possible because of the risk of bleeding, IVC filter placement is recommended (Grade 1C). If a patient requires an IVC filter for treatment of an acute DVT as an alternative to anticoagulation, it is recommended to start anticoagulant therapy once the risk of bleeding resolves (Grade 1C).4

click for large version

The 2008 ACCP guidelines for IVC filter use have a few important changes from the 2004 version. First, the IVC filter placement recommendation for patients with contraindications to anticoagulation was strengthened from Grade 2C to Grade 1C. Second, the 2008 guidelines omitted the early recommendation of IVC filter use for recurrent VTE, despite adequate anticoagulation (Grade 2C).13

Only one randomized study has evaluated the efficacy of IVC filters. All other studies of IVC filters are retrospective or prospective case series.

The PREPIC study randomized 400 patients with proximal DVT considered to be at high risk for PE to receive either an IVC filter or no IVC filter. Additionally, patients were randomized to receive enoxaparin or unfractionated heparin as a bridge to warfarin therapy, which was continued for at least three months. The primary endpoints were recurrent DVT, PE, major bleeding, or death. The patients were followed up at day 12, two years, and then annually up to eight years following randomization.14 At day 12, there were fewer PEs in the group that received filters (OR 0.22, 95% CI, 0.05-0.90). However, at year two, there was no significant difference in PE development in the filter group compared with the no-filter group (OR 0.50, 95% CI, 0.19-1.33).

click for large version

Additionally, at year two, the filter group was more likely to develop recurrent DVT (OR 1.87, 95% CI, 1.10-3.20). At year eight, there was a significant reduction in the number of PEs in the filter group versus the no-filter group (6.2% vs.15.1%, P=0.008). However, at eight-year followup, IVC filter use was associated with increased DVT (35.7% vs. 27.5%, P=0.042). There was no difference in mortality between the two groups.

In summary, the use of IVC filters was associated with decreased incidence of PE at eight years, offset by higher rates of recurrent DVT and no overall mortality benefit.14,15 Importantly, the indications for IVC filter use in this study differ from the current ACCP guidelines; all patients were given concomitant anticoagulation for at least three months, which might not be possible in patients for whom the ACCP recommends IVC filters.

There are no randomized studies to compare the efficacy of permanent IVC filters and retrievable filters for PE prevention. A retrospective study comparing the clinical effectiveness of the two filter types reported no difference in the rates of symptomatic PE (permanent filter 4% vs. retrievable filter 4.7%, P=0.67) or DVT (11.3% vs. 12.6%, P=0.59). In addition, the frequency of symptomatic IVC thrombosis was similar (1.1% vs. 0.5%, p=0.39).16 A paper reviewing the efficacy of IVC filters reported that permanent filters were associated with a 0%-6.2% rate of PE versus a 0%-1.9% rate with retrievable filters.7 Notably, these studies were not randomized controlled trials—rather, case series—and the indications for IVC filters were not necessarily those currently recommended by the ACCP.

Due to the long-term complications of permanent IVC filters, it is suggested that a retrievable IVC filter be used for patients with temporary contraindications to anticoagulation.17 Comerata et al created a clinical decision-making tool for picking the type of filter to employ. If the duration of contraindication to anticoagulation is short or uncertain, a retrievable filter is recommended.18 Table 1 (p. 15) outlines the recommendations for IVC filter placement.

click for large version

There are no randomized controlled trials to guide the use of concomitant anticoagulation after filter insertion, although this intervention may be beneficial to prevent DVT propagation, recurrence, or IVC filter thrombosis.5 A meta-analysis of 14 studies evaluating the rates of VTE after IVC filter placement demonstrated a non-statistically significant trend toward fewer VTE events in the patients with an IVC filter and concomitant anticoagulation in comparison with those who solely had an IVC filter (OR 0.64, 95% CI, 0.35-1.2). The duration and degree of anticoagulation was not presented in all of the studies in the meta-analysis, therefore limiting the analysis.19

In addition to the ACCP guidelines, there have been other proposed indications for IVC filter use, including recurrent VTE despite anticoagulation, chronic recurrent PE with pulmonary hypertension, extensive free-floating iliofemoral thrombus, and thrombolysis of ilio-caval thrombus.20 The ACCP guidelines do not specifically address these individual indications, and at this time there are no randomized controlled trials to guide IVC filter use in these cases.

Back to the Case

Our patient developed a significant complication from anticoagulation. Current ACCP guidelines recommend an IVC filter if anticoagulant therapy is contraindicated (Grade 1C). The anticoagulation was discontinued and a retrievable IVC filter was placed. Once a patient no longer has a contraindication for anticoagulation, the ACCP recommends restarting a conventional course of anticoagulation. Thus, once the patient can tolerate anticoagulation, consideration will be given to removal of the retrievable filter.

Bottom Line

An IVC filter should be considered in patients with a DVT who have a contraindication to anticoagulation. Other indications for IVC filter use are not supported by the current literature. TH

Drs. Bhogal and Eid are hospitalist fellows and instructors at Johns Hopkins Bayview Medical Center in Baltimore. Dr. Kantsiper is a hospitalist and assistant professor at Bayview Medical Center.

References

1. The Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. U.S. Department of Health & Human Services Web site. Available at: www.surgeongeneral.gov/topics/deepvein/. Accessed Jan. 25, 2010.
2. Moser KM, Fedullo PR, LitteJohn JK, Crawford R. Frequent asymptomatic pulmonary embolism in patients with deep venous thrombosis. JAMA. 1994;271(3):223-225.
3. Bates SM, Ginsberg JS. Treatment of deep vein thrombosis. N Engl J Med. 2004;351:268-277.
4. Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ, American College of Chest Physicians. Antithrombotic therapy for venous theomboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133(6 Suppl):454S-545S.
5. Becker DM, Philbrick JT, Selby JB. Inferior vena cava filters. Indications, safety, effectiveness. Arch Intern Med. 1992;152(10):1985-1994.
6. Streiff MB. Vena caval filters: a comprehensive review. Blood. 2000;95(12):3669-3677.
7. Chung J, Owen RJ. Using inferior vena cava filters to prevent pulmonary embolism. Can Fam Physician. 2008;54(1):49-55.
8. Ku GH. Billett HH. Long lives, short indications. The case for removable inferior cava filters. Thromb Haemost. 2005;93(1):17-22.
9. Stavropoulos WS. Inferior vena cava filters. Tech Vasc Interv Radiol. 2004;7(2):91-95.
10. Crowther MA. Inferior vena cava filters in the management of venous thromboembolism. Am J Med. 2007;120(10 Suppl 2):S13–S17.
11. Stein PD, Kayali F, Olson RE. Twenty-one-year trends in the use of inferior vena cava filters. Arch Intern Med. 2004;164(14):1541-1545.
12. Guyatt G, Gutterman D, Baumann MH, et al. Grading strength of recommendations and quality of evidence in clinical guidelines: report from an American College of Chest Physicians task force. Chest. 2006;129(1):174-181.
13. Büller HR, Agnelli G, Hull RD, Hyers TM, Prins MH, Raskob GE. Antithrombotic therapy for venous thromboembolic disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126(3 Suppl):401S-428S.
14. Decousus H, Leizorovicz A, Parent F, et al. A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis. Prévention du Risque d’Embolie Pulmonaire par Interruption Cave Study Group. N Engl J Med. 1998;338(7):409-415.
15. Decousus H, Barral F, Buchmuller-Cordier A, et al. Participating centers eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism: the PREPIC randomization croup. Circulation. 2005;112:416-422.
16. Kim HS, Young MJ, Narayan AK, Liddell RP, Streiff MB. A comparison of clinical outcomes with retrievable and permanent inferior vena cava filters. J Vasc Interv Radiol. 2008:19(3):393-399.
17. Houman Fekrazad M, Lopes RD, Stashenko GJ, Alexander JH, Garcia D. Treatment of venous thromboembolism: guidelines translated for the clinician. J Thromb Thrombolysis. 2009; 28(3):270–275.
18. Comerota AJ. Retrievable IVC filters: a decision matrix for appropriate utilization. Perspect Vasc Surg Endovasc Ther. 2006;18(1):11-17.
19. Ray CE Jr, Prochazka A. The need for anticoagulation following inferior vena cava filter placement: systematic review. Cardiovasc Intervent Radiol. 2008; 31(2):316-324.
20. Hajduk B, Tomkowski WZ, Malek G, Davidson BL. Vena cava filter occlusion and venous thromboembolism risk in persistently anticoagulated patients: A prospective, observational cohort study. Chest. 2009.

New Generics

• Donepezil orally disintegrating tablets (generic Aricept ODT)1
• Nizatadine oral solution (generic Axid oral solution), 15mg/mL.2 It is available in peppermint flavor.

New Drugs, Indications, and Dosage Forms

• Clonidine ER tablets and suspension (Clonidine ER suspension and Clonidine ER tablets) have been approved by the FDA.3
• Estradiol 10 mcg vaginal (Vagifem) low-dose tablets have been approved by the FDA for treating atrophic vaginitis due to menopause.4
• Olanzapine (Zyprexa) has been approved by the FDA to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder in patients aged 13 to 17 years old.5 Prescribers must consider the potential for weight gain and hyperlipidemia, as well as other long-term risks that might occur in adolescents compared with adult patients.
• Olanzapine injection (Zyprexa Relprevv) has been approved by the FDA for treating schizophrenia in adults.6 A risk-evaluation and mitigation strategy (REMS) will be implemented with this agent. It is a long-acting, intramuscular depot injection given every two to four weeks, depending on the dose.7
• Quetiapine extended-release (Zyprexa) has been approved by the FDA as add-on therapy to antidepressants in managing adults with major depressive disorder.8 AstraZeneca, the drug manufacturer, also is seeking approval for a monotherapy indication to manage depression in the acute and maintenance phases.
• Sildenafil intravenous (Revatio IV) has been approved by the FDA for treating pulmonary arterial hypertension for patients who are temporarily unable to take the oral medication.9 The injection is administered as a single-dose of 10 mg up to three times daily. According to the manufacturer, this is bioequivalent to 20 mg three times a day for the oral formulation.
• Tiotropium bromide inhalation powder (Spiriva HandiHaler) has been approved by the FDA for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).10

Pipeline

• Approval is pending for Aztreonam lysine inhaled (Cayston) for the treatment of Pseudomonas aeruginosa infections in patients with cystic fibrosis.11 The FDA’s Anti-Infectives Drugs Advisory Committee voted 15-2 in favor of the drug’s safety and effectiveness, and 17-0 in favor of a regimen of 75 mg three times a day. The FDA usually approves drugs recommended by its panels.
• Darapladib, a selective and orally active LpPLA2 inhibitor, has begun Phase 3 clinical trials in the management of acute coronary syndrome (ACS).12 The study will include 11,500 male and female patients from 40 countries. It is a double-blind, randomized, placebo-controlled clinical efficacy trial of the long-term use of darapladib when added to standard of care. The study will test whether darapladib affects the chances of having a cardiovascular event, such as a myocardial infarction or a stroke, when treatment is started within 30 days after an ACS.
• Denosumab has received a positive opinion from the European Union for treating osteoporosis in postmenopausal women at increased risk of fractures, and also for treating bone loss in men with prostate cancer who are at increased risk of fractures.13 In the U.S., approval by the FDA is pending for management of osteoporosis in postmenopausal women.14 The FDA’s reproductive health advisory committee, which evaluated the agent, voted 12-1 to require the drug to carry a REMS.
• Ocrelizumab, a Phase 3 humanized anti-CD20 monoclonal antibody for treating rheumatoid arthritis (RA), recently reported positive results when given in combination with methotrexate (MTX) in an international, randomized, multicenter, double-blind trial.15 Ocrelizumab or placebo administered by intravenous infusion on days one and 15 met the primary endpoint of improving the signs and symptoms of RA in patients with an inadequate response to MTX.
• A response to an FDA complete response letter dated May 2009 was expected for rivaroxaban, an oral, direct Factor Xa inhibitor for preventing DVT and pulmonary embolism in patients undergoing hip or knee surgery. Complete review of rivaroxaban data was deferred by its manufacturers until February.16,17
• The FDA is considering a new indication for rosuvastatin (Crestor), following recommendations of the Endocrinologic and Metabolic Drugs Advisory Committee on Dec. 15, 2009.18

Safety Information

Pay attention to two agents manufactured by AstraZeneca: Dexlansoprazole (Kapidex), a new formulation of the proton-pump inhibitor lansoprazole, and bicalutamide (Casodex), which is used in combination with a hormone treatment for prostate cancer, have had medication mixups. The agent names look alike and sound alike when written and verbalized. Both written and verbal prescriptions have been dispensed in error. Bicalutamide is available as 50-mg tablets; dexlansoprazole is available as 30-mg and 60-mg capsules. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Walsh S. FDA Approves Generic Aricept to Treat Dementia Related to Alzheimer’s Disease. U.S. Food and Drug Administration Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm194173.htm. Accessed Dec. 28, 2009.
2. Amenal Receives FDA Approval For Nizatidine Oral Solution, the First Oral Solution for Axid in the Market. Medical News Today Web site. Available at: www.medicalnewstoday.com/articles/173591.php. Accessed Dec. 28, 2009.
3. Clonidine ER Suspension and Clonidine ER Tablets approved. Monthly Prescribing Reference Web site. Available at: www.empr.com/clonidine-er-suspension-and-clonidine-er-tablets-approved/article/159148/. Accessed Dec. 28, 2009.
4. FDA Approves Mcg Dose of Vagifem For the Treatment of Atrophic Vaginitis Due to Menopause. Medical News Today Web site. Available at: www.medicalnewstoday.com/articles/172804.php. Accessed Dec. 28, 2009.
5. Todoruk M. Eli Lilly’s Zyprexa approved in US for adolescents. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=B5699B38AADB46AF85E7B34F508DB943&logRowId=340534. Accessed Dec. 28, 2009.
6. Dennis M. FDA approves Eli Lilly’s long-acting Zyprexa injection. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=30C504823E42425FA0C3B9BB8490D5AA&logRowId=341775. Accessed Dec. 28, 2009.
7. Gever J. FDA Approves Long-Acting Olanzapine. MedPage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/17539. Accessed Dec. 28, 2009.
8. Dennis M. FDA approves AstraZeneca’s Seroquel XR as add-on therapy; requires more data as monotherapy. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=0530A906ABCB44B5A32EC05E148E0220&logRowId=340531. Accessed Dec. 28, 2009.
9. Petrochko C. FDA Approves IV Sildenafil for Hypertension. MedPage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/17296. Accessed Dec. 28, 2009.
10. FDA Approves Spiriva HandiHaler for the Reduction of COPD Exacerbations. Pfizer Web site. Available at: mediaroom.pfizer.com/portal/site/pfizer/?ndmViewId=news_view&newsId=20091217006384&newsLang=en. Accessed Dec. 28, 2009.
11. Leuty R. Gilead wins panel OK for cystic fibrosis drug. San Francisco Business Times Web site. Available at: sanfrancisco.bizjournals.com/sanfrancisco/stories/2009/12/07/daily59.html?surround=etf&ana=e_article. Accessed Dec. 28, 2009.
12. GSK initiates second pivotal Phase III trial for investigational cardiovascular medication Darapladib. GlaxoSmithKline Web site. Available at: www.gsk.com/media/pressreleases/2009/2009_pressrelease_10141.htm. Accessed Dec. 29, 2009.
13. Todoruk M. EU panel issues positive opinion for Amgen’s Prolia. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=A9F30DD044A14893899DF7D880FB8AB0&logRowId=342650. Accessed Dec. 29, 2009.
14. Walker EP. FDA Panel Backs Denosumab for Osteoporosis, But Not Osteopenia. MedPage Web site. Available at: www.medpagetoday.com/Endocrinology/Osteoporosis/15530. Accessed Dec. 29, 2009.
15. Phase 3 study of ocrelizumab for rheumatoid arthritis (RA). Monthly Prescribing Reference Web site. Available at: www.empr.com/phase-3-study-of-ocrelizumab-for-rheumatoid-arthritis-ra/article/159474/. Accessed Dec. 29, 2009.
16. Phase III EINSTEIN-Extension Study of Bayer’s Rivaroxaban Shows Significant Benefit in the Prevention of Secondary Symptomatic VTE. Bayer Web site. Available at: www.bayer.com/en/News-Detail.aspx?id=12554. Accessed Dec. 20, 2009.
17. Todoruk M. Bayer, Johnson & Johnson provide update on Xarelto complete response to FDA. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=8F8AEC62E7DB46C3809C1E77A8384F30&logRowId=340535. Accessed Dec. 29, 2009.
18. O’Riordan M. FDA advisory panel votes in favor of broadened rosuvastatin indication. TheHeart.org Web site. Available at: www.theheart.org/article/1035155/print.do. Accessed Dec. 29, 2009.
19. Kapidex-Casodex confusion. Institute for Safe Medication Practices Web site. Available at: www.ismp.org/newsletters/ambulatory/archives/200907_1.asp. Accessed Dec. 28, 2009.

New Generics

• Donepezil orally disintegrating tablets (generic Aricept ODT)1
• Nizatadine oral solution (generic Axid oral solution), 15mg/mL.2 It is available in peppermint flavor.

New Drugs, Indications, and Dosage Forms

• Clonidine ER tablets and suspension (Clonidine ER suspension and Clonidine ER tablets) have been approved by the FDA.3
• Estradiol 10 mcg vaginal (Vagifem) low-dose tablets have been approved by the FDA for treating atrophic vaginitis due to menopause.4
• Olanzapine (Zyprexa) has been approved by the FDA to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder in patients aged 13 to 17 years old.5 Prescribers must consider the potential for weight gain and hyperlipidemia, as well as other long-term risks that might occur in adolescents compared with adult patients.
• Olanzapine injection (Zyprexa Relprevv) has been approved by the FDA for treating schizophrenia in adults.6 A risk-evaluation and mitigation strategy (REMS) will be implemented with this agent. It is a long-acting, intramuscular depot injection given every two to four weeks, depending on the dose.7
• Quetiapine extended-release (Zyprexa) has been approved by the FDA as add-on therapy to antidepressants in managing adults with major depressive disorder.8 AstraZeneca, the drug manufacturer, also is seeking approval for a monotherapy indication to manage depression in the acute and maintenance phases.
• Sildenafil intravenous (Revatio IV) has been approved by the FDA for treating pulmonary arterial hypertension for patients who are temporarily unable to take the oral medication.9 The injection is administered as a single-dose of 10 mg up to three times daily. According to the manufacturer, this is bioequivalent to 20 mg three times a day for the oral formulation.
• Tiotropium bromide inhalation powder (Spiriva HandiHaler) has been approved by the FDA for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).10

Pipeline

• Approval is pending for Aztreonam lysine inhaled (Cayston) for the treatment of Pseudomonas aeruginosa infections in patients with cystic fibrosis.11 The FDA’s Anti-Infectives Drugs Advisory Committee voted 15-2 in favor of the drug’s safety and effectiveness, and 17-0 in favor of a regimen of 75 mg three times a day. The FDA usually approves drugs recommended by its panels.
• Darapladib, a selective and orally active LpPLA2 inhibitor, has begun Phase 3 clinical trials in the management of acute coronary syndrome (ACS).12 The study will include 11,500 male and female patients from 40 countries. It is a double-blind, randomized, placebo-controlled clinical efficacy trial of the long-term use of darapladib when added to standard of care. The study will test whether darapladib affects the chances of having a cardiovascular event, such as a myocardial infarction or a stroke, when treatment is started within 30 days after an ACS.
• Denosumab has received a positive opinion from the European Union for treating osteoporosis in postmenopausal women at increased risk of fractures, and also for treating bone loss in men with prostate cancer who are at increased risk of fractures.13 In the U.S., approval by the FDA is pending for management of osteoporosis in postmenopausal women.14 The FDA’s reproductive health advisory committee, which evaluated the agent, voted 12-1 to require the drug to carry a REMS.
• Ocrelizumab, a Phase 3 humanized anti-CD20 monoclonal antibody for treating rheumatoid arthritis (RA), recently reported positive results when given in combination with methotrexate (MTX) in an international, randomized, multicenter, double-blind trial.15 Ocrelizumab or placebo administered by intravenous infusion on days one and 15 met the primary endpoint of improving the signs and symptoms of RA in patients with an inadequate response to MTX.
• A response to an FDA complete response letter dated May 2009 was expected for rivaroxaban, an oral, direct Factor Xa inhibitor for preventing DVT and pulmonary embolism in patients undergoing hip or knee surgery. Complete review of rivaroxaban data was deferred by its manufacturers until February.16,17
• The FDA is considering a new indication for rosuvastatin (Crestor), following recommendations of the Endocrinologic and Metabolic Drugs Advisory Committee on Dec. 15, 2009.18

Safety Information

Pay attention to two agents manufactured by AstraZeneca: Dexlansoprazole (Kapidex), a new formulation of the proton-pump inhibitor lansoprazole, and bicalutamide (Casodex), which is used in combination with a hormone treatment for prostate cancer, have had medication mixups. The agent names look alike and sound alike when written and verbalized. Both written and verbal prescriptions have been dispensed in error. Bicalutamide is available as 50-mg tablets; dexlansoprazole is available as 30-mg and 60-mg capsules. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Walsh S. FDA Approves Generic Aricept to Treat Dementia Related to Alzheimer’s Disease. U.S. Food and Drug Administration Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm194173.htm. Accessed Dec. 28, 2009.
2. Amenal Receives FDA Approval For Nizatidine Oral Solution, the First Oral Solution for Axid in the Market. Medical News Today Web site. Available at: www.medicalnewstoday.com/articles/173591.php. Accessed Dec. 28, 2009.
3. Clonidine ER Suspension and Clonidine ER Tablets approved. Monthly Prescribing Reference Web site. Available at: www.empr.com/clonidine-er-suspension-and-clonidine-er-tablets-approved/article/159148/. Accessed Dec. 28, 2009.
4. FDA Approves Mcg Dose of Vagifem For the Treatment of Atrophic Vaginitis Due to Menopause. Medical News Today Web site. Available at: www.medicalnewstoday.com/articles/172804.php. Accessed Dec. 28, 2009.
5. Todoruk M. Eli Lilly’s Zyprexa approved in US for adolescents. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=B5699B38AADB46AF85E7B34F508DB943&logRowId=340534. Accessed Dec. 28, 2009.
6. Dennis M. FDA approves Eli Lilly’s long-acting Zyprexa injection. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=30C504823E42425FA0C3B9BB8490D5AA&logRowId=341775. Accessed Dec. 28, 2009.
7. Gever J. FDA Approves Long-Acting Olanzapine. MedPage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/17539. Accessed Dec. 28, 2009.
8. Dennis M. FDA approves AstraZeneca’s Seroquel XR as add-on therapy; requires more data as monotherapy. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=0530A906ABCB44B5A32EC05E148E0220&logRowId=340531. Accessed Dec. 28, 2009.
9. Petrochko C. FDA Approves IV Sildenafil for Hypertension. MedPage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/17296. Accessed Dec. 28, 2009.
10. FDA Approves Spiriva HandiHaler for the Reduction of COPD Exacerbations. Pfizer Web site. Available at: mediaroom.pfizer.com/portal/site/pfizer/?ndmViewId=news_view&newsId=20091217006384&newsLang=en. Accessed Dec. 28, 2009.
11. Leuty R. Gilead wins panel OK for cystic fibrosis drug. San Francisco Business Times Web site. Available at: sanfrancisco.bizjournals.com/sanfrancisco/stories/2009/12/07/daily59.html?surround=etf&ana=e_article. Accessed Dec. 28, 2009.
12. GSK initiates second pivotal Phase III trial for investigational cardiovascular medication Darapladib. GlaxoSmithKline Web site. Available at: www.gsk.com/media/pressreleases/2009/2009_pressrelease_10141.htm. Accessed Dec. 29, 2009.
13. Todoruk M. EU panel issues positive opinion for Amgen’s Prolia. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=A9F30DD044A14893899DF7D880FB8AB0&logRowId=342650. Accessed Dec. 29, 2009.
14. Walker EP. FDA Panel Backs Denosumab for Osteoporosis, But Not Osteopenia. MedPage Web site. Available at: www.medpagetoday.com/Endocrinology/Osteoporosis/15530. Accessed Dec. 29, 2009.
15. Phase 3 study of ocrelizumab for rheumatoid arthritis (RA). Monthly Prescribing Reference Web site. Available at: www.empr.com/phase-3-study-of-ocrelizumab-for-rheumatoid-arthritis-ra/article/159474/. Accessed Dec. 29, 2009.
16. Phase III EINSTEIN-Extension Study of Bayer’s Rivaroxaban Shows Significant Benefit in the Prevention of Secondary Symptomatic VTE. Bayer Web site. Available at: www.bayer.com/en/News-Detail.aspx?id=12554. Accessed Dec. 20, 2009.
17. Todoruk M. Bayer, Johnson & Johnson provide update on Xarelto complete response to FDA. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=8F8AEC62E7DB46C3809C1E77A8384F30&logRowId=340535. Accessed Dec. 29, 2009.
18. O’Riordan M. FDA advisory panel votes in favor of broadened rosuvastatin indication. TheHeart.org Web site. Available at: www.theheart.org/article/1035155/print.do. Accessed Dec. 29, 2009.
19. Kapidex-Casodex confusion. Institute for Safe Medication Practices Web site. Available at: www.ismp.org/newsletters/ambulatory/archives/200907_1.asp. Accessed Dec. 28, 2009.

New Generics

• Donepezil orally disintegrating tablets (generic Aricept ODT)1
• Nizatadine oral solution (generic Axid oral solution), 15mg/mL.2 It is available in peppermint flavor.

New Drugs, Indications, and Dosage Forms

• Clonidine ER tablets and suspension (Clonidine ER suspension and Clonidine ER tablets) have been approved by the FDA.3
• Estradiol 10 mcg vaginal (Vagifem) low-dose tablets have been approved by the FDA for treating atrophic vaginitis due to menopause.4
• Olanzapine (Zyprexa) has been approved by the FDA to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder in patients aged 13 to 17 years old.5 Prescribers must consider the potential for weight gain and hyperlipidemia, as well as other long-term risks that might occur in adolescents compared with adult patients.
• Olanzapine injection (Zyprexa Relprevv) has been approved by the FDA for treating schizophrenia in adults.6 A risk-evaluation and mitigation strategy (REMS) will be implemented with this agent. It is a long-acting, intramuscular depot injection given every two to four weeks, depending on the dose.7
• Quetiapine extended-release (Zyprexa) has been approved by the FDA as add-on therapy to antidepressants in managing adults with major depressive disorder.8 AstraZeneca, the drug manufacturer, also is seeking approval for a monotherapy indication to manage depression in the acute and maintenance phases.
• Sildenafil intravenous (Revatio IV) has been approved by the FDA for treating pulmonary arterial hypertension for patients who are temporarily unable to take the oral medication.9 The injection is administered as a single-dose of 10 mg up to three times daily. According to the manufacturer, this is bioequivalent to 20 mg three times a day for the oral formulation.
• Tiotropium bromide inhalation powder (Spiriva HandiHaler) has been approved by the FDA for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).10

Pipeline

• Approval is pending for Aztreonam lysine inhaled (Cayston) for the treatment of Pseudomonas aeruginosa infections in patients with cystic fibrosis.11 The FDA’s Anti-Infectives Drugs Advisory Committee voted 15-2 in favor of the drug’s safety and effectiveness, and 17-0 in favor of a regimen of 75 mg three times a day. The FDA usually approves drugs recommended by its panels.
• Darapladib, a selective and orally active LpPLA2 inhibitor, has begun Phase 3 clinical trials in the management of acute coronary syndrome (ACS).12 The study will include 11,500 male and female patients from 40 countries. It is a double-blind, randomized, placebo-controlled clinical efficacy trial of the long-term use of darapladib when added to standard of care. The study will test whether darapladib affects the chances of having a cardiovascular event, such as a myocardial infarction or a stroke, when treatment is started within 30 days after an ACS.
• Denosumab has received a positive opinion from the European Union for treating osteoporosis in postmenopausal women at increased risk of fractures, and also for treating bone loss in men with prostate cancer who are at increased risk of fractures.13 In the U.S., approval by the FDA is pending for management of osteoporosis in postmenopausal women.14 The FDA’s reproductive health advisory committee, which evaluated the agent, voted 12-1 to require the drug to carry a REMS.
• Ocrelizumab, a Phase 3 humanized anti-CD20 monoclonal antibody for treating rheumatoid arthritis (RA), recently reported positive results when given in combination with methotrexate (MTX) in an international, randomized, multicenter, double-blind trial.15 Ocrelizumab or placebo administered by intravenous infusion on days one and 15 met the primary endpoint of improving the signs and symptoms of RA in patients with an inadequate response to MTX.
• A response to an FDA complete response letter dated May 2009 was expected for rivaroxaban, an oral, direct Factor Xa inhibitor for preventing DVT and pulmonary embolism in patients undergoing hip or knee surgery. Complete review of rivaroxaban data was deferred by its manufacturers until February.16,17
• The FDA is considering a new indication for rosuvastatin (Crestor), following recommendations of the Endocrinologic and Metabolic Drugs Advisory Committee on Dec. 15, 2009.18

Safety Information

Pay attention to two agents manufactured by AstraZeneca: Dexlansoprazole (Kapidex), a new formulation of the proton-pump inhibitor lansoprazole, and bicalutamide (Casodex), which is used in combination with a hormone treatment for prostate cancer, have had medication mixups. The agent names look alike and sound alike when written and verbalized. Both written and verbal prescriptions have been dispensed in error. Bicalutamide is available as 50-mg tablets; dexlansoprazole is available as 30-mg and 60-mg capsules. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Walsh S. FDA Approves Generic Aricept to Treat Dementia Related to Alzheimer’s Disease. U.S. Food and Drug Administration Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm194173.htm. Accessed Dec. 28, 2009.
2. Amenal Receives FDA Approval For Nizatidine Oral Solution, the First Oral Solution for Axid in the Market. Medical News Today Web site. Available at: www.medicalnewstoday.com/articles/173591.php. Accessed Dec. 28, 2009.
3. Clonidine ER Suspension and Clonidine ER Tablets approved. Monthly Prescribing Reference Web site. Available at: www.empr.com/clonidine-er-suspension-and-clonidine-er-tablets-approved/article/159148/. Accessed Dec. 28, 2009.
4. FDA Approves Mcg Dose of Vagifem For the Treatment of Atrophic Vaginitis Due to Menopause. Medical News Today Web site. Available at: www.medicalnewstoday.com/articles/172804.php. Accessed Dec. 28, 2009.
5. Todoruk M. Eli Lilly’s Zyprexa approved in US for adolescents. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=B5699B38AADB46AF85E7B34F508DB943&logRowId=340534. Accessed Dec. 28, 2009.
6. Dennis M. FDA approves Eli Lilly’s long-acting Zyprexa injection. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=30C504823E42425FA0C3B9BB8490D5AA&logRowId=341775. Accessed Dec. 28, 2009.
7. Gever J. FDA Approves Long-Acting Olanzapine. MedPage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/17539. Accessed Dec. 28, 2009.
8. Dennis M. FDA approves AstraZeneca’s Seroquel XR as add-on therapy; requires more data as monotherapy. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=0530A906ABCB44B5A32EC05E148E0220&logRowId=340531. Accessed Dec. 28, 2009.
9. Petrochko C. FDA Approves IV Sildenafil for Hypertension. MedPage Today Web site. Available at: www.medpagetoday.com/ProductAlert/Prescriptions/17296. Accessed Dec. 28, 2009.
10. FDA Approves Spiriva HandiHaler for the Reduction of COPD Exacerbations. Pfizer Web site. Available at: mediaroom.pfizer.com/portal/site/pfizer/?ndmViewId=news_view&newsId=20091217006384&newsLang=en. Accessed Dec. 28, 2009.
11. Leuty R. Gilead wins panel OK for cystic fibrosis drug. San Francisco Business Times Web site. Available at: sanfrancisco.bizjournals.com/sanfrancisco/stories/2009/12/07/daily59.html?surround=etf&ana=e_article. Accessed Dec. 28, 2009.
12. GSK initiates second pivotal Phase III trial for investigational cardiovascular medication Darapladib. GlaxoSmithKline Web site. Available at: www.gsk.com/media/pressreleases/2009/2009_pressrelease_10141.htm. Accessed Dec. 29, 2009.
13. Todoruk M. EU panel issues positive opinion for Amgen’s Prolia. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=A9F30DD044A14893899DF7D880FB8AB0&logRowId=342650. Accessed Dec. 29, 2009.
14. Walker EP. FDA Panel Backs Denosumab for Osteoporosis, But Not Osteopenia. MedPage Web site. Available at: www.medpagetoday.com/Endocrinology/Osteoporosis/15530. Accessed Dec. 29, 2009.
15. Phase 3 study of ocrelizumab for rheumatoid arthritis (RA). Monthly Prescribing Reference Web site. Available at: www.empr.com/phase-3-study-of-ocrelizumab-for-rheumatoid-arthritis-ra/article/159474/. Accessed Dec. 29, 2009.
16. Phase III EINSTEIN-Extension Study of Bayer’s Rivaroxaban Shows Significant Benefit in the Prevention of Secondary Symptomatic VTE. Bayer Web site. Available at: www.bayer.com/en/News-Detail.aspx?id=12554. Accessed Dec. 20, 2009.
17. Todoruk M. Bayer, Johnson & Johnson provide update on Xarelto complete response to FDA. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=8F8AEC62E7DB46C3809C1E77A8384F30&logRowId=340535. Accessed Dec. 29, 2009.
18. O’Riordan M. FDA advisory panel votes in favor of broadened rosuvastatin indication. TheHeart.org Web site. Available at: www.theheart.org/article/1035155/print.do. Accessed Dec. 29, 2009.
19. Kapidex-Casodex confusion. Institute for Safe Medication Practices Web site. Available at: www.ismp.org/newsletters/ambulatory/archives/200907_1.asp. Accessed Dec. 28, 2009.

In This Edition

Literature at a Glance

A guide to this month’s studies

• Statins and postoperative cardiac outcomes
• Cardiac resynchronization therapy in patients with mild CHF symptoms
• Oral direct thrombin inhibitor versus warfarin for stroke prevention in atrial fibrillation
• Association of fatigue and medical error
• Effects of chronic inhaled steroid and beta-agonist use in COPD
• Dialysis and functional status in nursing home patients
• Outcomes with different insulin-dosing regimens
• Understanding of disease severity and outcomes in advanced dementia

Fluvastatin Improves Postoperative Cardiac Outcomes in Patients Undergoing Vascular Surgery

Clinical question: Does perioperative fluvastatin decrease adverse cardiac events after vascular surgery?

Background: Patients with atherosclerotic vascular disease who undergo vascular surgery are at high risk for postoperative cardiac events. Studies in nonsurgical populations have shown the beneficial effects of statin therapy on cardiac outcomes. However, no placebo-controlled trials have addressed the effect of statins on postoperative cardiac outcomes.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Single large academic medical center in the Netherlands.

Synopsis: The study looked at 497 statin-naïve patients 40 years or older undergoing non-cardiac vascular surgery. The patients were randomized to 80 mg of extended-release fluvastatin versus placebo; all patients received a beta-blocker. Therapy began preoperatively (median of 37 days) and continued for at least 30 days after surgery. Outcomes were assessed at 30 days post-surgery.

Postoperative myocardial infarction (MI) was significantly less common in the fluvastatin group than with placebo (10.8% vs. 19%, hazard ratio (HR) 0.55, P=0.01). In addition, the treatment group had a lower frequency of death from cardiovascular causes (4.8% vs. 10.1%, HR 0.47, P=0.03). Statin therapy was not associated with an increased rate of adverse events.

Notably, all of the patients enrolled in this study were high-risk patients undergoing high-risk (vascular) surgery. Patients already on statins were excluded.

Further studies are needed to determine whether the findings can be extrapolated to other populations, including nonvascular surgery patients.

Bottom line: Perioperative statin therapy resulted in a significant decrease in postoperative MI and death within 30 days of vascular surgery.

Citation: Schouten O, Boersma E, Hoeks SE, et al. Fluvastatin and perioperative events in patients undergoing vascular surgery. N Engl J Med. 2009;361(10):980-989.

Cardiac Resynchronization Therapy with Implantable Cardioverter Defibrillator Placement Decreases Heart Failure

Clinical question: Does cardiac resynchronization therapy (CRT) with biventricular pacing decrease cardiac events in patients with reduced ejection fraction (EF) and wide QRS complex but only mild cardiac symptoms?

Background: In patients with severely reduced EF, implantable cardioverter defibrillators (ICDs) have been shown to improve survival. Meanwhile, CRT decreases heart-failure-related hospitalizations for patients with advanced heart-failure symptoms, EF less than 35%, and intraventricular conduction delay. It is not as clear whether patients with less-severe symptoms benefit from CRT.

Study design: Randomized, controlled trial.

Setting: 110 medical centers in the U.S., Canada, and Europe.

Synopsis: This Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) study randomly assigned 1,820 adults with EF less than 30%, New York Health Association Class I or II congestive heart failure, and in sinus rhythm with QRS greater than 130 msec to receive ICD with CRT or ICD alone. The primary endpoint was all-cause mortality or nonfatal heart-failure events. Average followup was 2.4 years.

A 34% reduction in the primary endpoint was found in the ICD-CRT group when compared with the ICD-only group, primarily due to a 41% reduction in heart-failure events. In a subgroup analysis, women and patients with QRS greater than 150 msec experienced particular benefit. Echocardiography one year after device implantation demonstrated significant reductions in left ventricular end-systolic and end-diastolic volume, and a significant increase in EF with ICD-CRT versus ICD-only (P<0.001).

Bottom line: Compared with ICD alone, CRT in combination with ICD prevented heart-failure events in relatively asymptomatic heart-failure patients with low EF and prolonged QRS.

Citation: Moss AJ, Hall WJ, Cannom DS, et al. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009;361(14):1329-1338.

Dabigatran Is Not Inferior to Warfarin in Atrial Fibrillation

Clinical question: Is dabigatran, an oral thrombin inhibitor, an effective and safe alternative to warfarin in patients with atrial fibrillation?

Background: Warfarin reduces the risk of stroke among patients with atrial fibrillation (AF) but requires frequent laboratory monitoring. Dabigatran is an oral direct thrombin inhibitor given in fixed dosages without laboratory monitoring.

Study design: Randomized, multicenter, open-label, noninferiority trial.

Setting: 951 clinical centers in 44 countries.

Synopsis: More than 18,000 patients 65 and older with AF and at least one stroke risk factor were enrolled. The average CHADS2 score was 2.1. Patients were randomized to receive fixed doses of dabigatran (110 mg or 150 mg, twice daily) or warfarin adjusted to an INR of 2.0-3.0. The primary outcomes were a) stroke or systemic embolism and b) major hemorrhage. Median followup was two years.

The annual rates of stroke or systemic embolism for both doses of dabigatran were noninferior to warfarin (P<0.001); higher-dose dabigatran was statistically superior to warfarin (relative risk (RR)=0.66, P<0.001). The annual rate of major hemorrhage was lowest in the lower-dose dabigatran group (RR=0.80, P=0.003 compared with warfarin); the higher-dose dabigatran and warfarin groups had equivalent rates of major bleeding. No increased risk of liver function abnormalities was noted.

Bottom line: Dabigatran appears to be an effective and safe alternative to warfarin in AF patients. If the drug were to be FDA-approved, appropriate patient selection and cost will need to be established.

Citation: Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-1151.

Resident Fatigue and Distress Contribute to Perceived Medical Errors

Clinical question: Do resident fatigue and distress contribute to medical errors?

Background: In recent years, such measures as work-hour limitations have been implemented to decrease resident fatigue and, it is presumed, medical errors. However, few studies address the relationship between residents’ well-being and self-reported medical errors.

Study design: Prospective six-year longitudinal cohort study.

Setting: Single academic medical center.

Synopsis: The authors had 380 internal-medicine residents complete quarterly surveys to assess fatigue, quality of life, burnout, symptoms of depression, and frequency of perceived medical errors. In a univariate analysis, fatigue/sleepiness, burnout, depression, and overall quality of life measures correlated significantly with self-reported major medical errors. Fatigue/sleepiness and measures of distress additively increased the risk of self-reported errors. Increases in one or both domains were estimated to increase the risk of self-reported errors by as much as 15% to 28%.

The authors studied only self-reported medical errors. It is difficult to know whether these errors directly affected patient outcomes. Additionally, results of this single-site study might not be able to be generalized.

Bottom line: Fatigue and distress contribute to self-perceived medical errors among residents.

Citation: West CP, Tan AD, Habermann TM, Sloan JA, Shanafelt TD. Association of resident fatigue and distress with perceived medical errors. JAMA. 2009;302(12):1294-1300.

Inhaled Corticosteroids Decrease Inflammation in Moderate to Severe COPD

Clinical question: Does long-term inhaled corticosteroid therapy, with and without long-acting beta-agonists, decrease airway inflammation and improve lung function in patients with moderate to severe chronic obstructive pulmonary disease (COPD)?

Background: Guideline-recommended treatment of COPD with inhaled corticosteroids and long-acting beta-agonists improves symptoms and exacerbation rates; little is known about the impact of these therapies on inflammation and long-term lung function.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Two university medical centers in the Netherlands.

Synopsis: One hundred one steroid-naïve patients, ages 45 to 75 who were current or former smokers with moderate to severe COPD, were randomized to one of four regimens: 1) fluticasone for six months, then placebo for 24 months; 2) fluticasone for 30 months; 3) fluticasone and salmeterol for 30 months; or 4) placebo for 30 months. The primary outcome was inflammatory cell counts in bronchial biopsies/induced sputum. Secondary outcomes included postbronchodilator spirometry, methacholine hyperresponsiveness, and self-reported symptoms and health status. Patients with asthma were excluded.

Short-term fluticasone therapy decreased inflammation and improved forced expiratory volume in one second (FEV1). Long-term therapy also decreased the rate of FEV1 decline, reduced dyspnea, and improved health status. Discontinuation of therapy at six months led to inflammation relapse with worsened symptoms and increased rate of FEV1 decline. The addition of long-acting beta-agonists did not provide additional anti-inflammatory benefits, but it did improve FEV1 and dyspnea at six months.

Additional studies are needed to further define clinical outcomes and assess the cost benefit of these therapies.

Bottom line: Inhaled corticosteroids decrease inflammation in steroid-naïve patients with moderate to severe COPD and might decrease the rate of lung function decline. Long-acting beta-agonists do not offer additional anti-inflammatory benefit.

Citation: Lapperre TS, Snoeck-Stroband JB, Gosman MM, et al. Effect of fluticasone with and without salmeterol on pulmonary outcomes in chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. 2009;151(8):517-527.

Initiation of Dialysis Does Not Help Maintain Functional Status in Elderly

Clinical question: Is functional status in the elderly maintained over time after initiating long-term dialysis?

Background: Quality-of-life maintenance often is used as a goal when initiating long-term dialysis in elderly patients with end-stage renal disease. More elderly patients are being offered long-term dialysis treatment. Little is known about the functional status of elderly patients on long-term dialysis.

Study design: Retrospective cohort study.

Setting: U.S. nursing homes.

Synopsis: By cross-linking data from two population-based administrative datasets, this study identified 3,702 nursing home patients (mean 73.4 years) who had started long-term dialysis and whose functional status had been assessed. Activities of daily living assessments before and at three-month intervals after dialysis initiation were compared to see if functional status was maintained.

Within three months of starting dialysis, 61% of patients had a decline in functional status or had died. By one year, only 1 in 8 patients had maintained their pre-dialysis functional status.

Decline in functional status cannot be attributed solely to dialysis because study patients were not compared to patients with chronic kidney disease who were not dialyzed. In addition, these results might not apply to all elderly patients on dialysis, as the functional status of elderly nursing home patients might differ significantly from those living at home.

Bottom line: Functional status is not maintained in most elderly nursing home patients in the first 12 months after long-term dialysis is initiated. Elderly patients considering dialysis treatment should be aware that dialysis might not help maintain functional status and quality of life.

Citation: Kurella Tamura MK, Covinsky KE, Chertow GM, Yaffe C, Landefeld CS, McCulloch CE. Functional status of elderly adults before and after initiation of dialysis. N Engl J Med. 2009;361(16):1539-1547.

Adding Basal Insulin to Oral Agents in Type 2 Diabetes Might Offer Best Glycemic Control

Clinical question: When added to oral diabetic agents, which insulin regimen (biphasic, prandial or basal) best achieves glycemic control in patients with Type 2 diabetes?

Background: Most patients with Type 2 diabetes mellitus (DM2) require insulin when oral agents provide suboptimal glycemic control. Little is known about which insulin regimen is most effective.

Study design: Three-year, open-label, multicenter trial.

Setting: Fifty-eight clinical centers in the United Kingdom and Ireland.

Synopsis: The authors randomized 708 insulin-naïve DM2 patients (median age 62 years) with HgbA1c 7% to 10% on maximum-dose metformin or sulfonylurea to one of three regimens: biphasic insulin twice daily; prandial insulin three times daily; or basal insulin once daily. Outcomes were HgbA1c, hypoglycemia rates, and weight gain. Sulfonylureas were replaced by another insulin if glycemic control was unacceptable.

The patients were mostly Caucasian and overweight. At three years of followup, median HgbA1c was similar in all groups (7.1% biphasic, 6.8% prandial, 6.9% basal); however, more patients who received prandial or basal insulin achieved HgbA1c less than 6.5% (45% and 43%, respectively) than in the biphasic group (32%).

Hypoglycemia was significantly less frequent in the basal insulin group (1.7 per patient per year versus 3.0 and 5.5 with biphasic and prandial, respectively). Patients gained weight in all groups; the greatest gain was with prandial insulin. At three years, there were no significant between-group differences in blood pressure, cholesterol, albuminuria, or quality of life.

Bottom line: Adding insulin to oral diabetic regimens improves glycemic control. Basal or prandial insulin regimens achieve glycemic targets more frequently than biphasic dosing.

Citation: Holman RR, Farmer AJ, Davies MJ, et al. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med. 2009;361(18):1736-1747.

Advanced Dementia Is a Terminal Illness with High Morbidity and Mortality

Clinical question: Does understanding the expected clinical course of advanced dementia influence end-of-life decisions by proxy decision-makers?

Background: Advanced dementia is a leading cause of death in the United States, but the clinical course of advanced dementia has not been described in a rigorous, prospective manner. The lack of information might cause risk to be underestimated, and patients might receive suboptimal palliative care.

Study design: Multicenter prospective cohort study.

Setting: Twenty-two nursing homes in a single U.S. city.

Synopsis: The survey examined 323 nursing home residents with advanced dementia. The patients were clinically assessed at baseline and quarterly for 18 months through chart reviews, nursing interviews, and physical examinations. Additionally, their proxies were surveyed regarding their understanding of the subjects’ prognoses.

During the survey period, 41.1% of patients developed pneumonia, 52.6% of patients experienced a febrile episode, and 85.8% of patients developed an eating problem; cumulative all-cause mortality was 54.8%. Adjusted for age, sex, and disease duration, the six-month mortality rate for subjects who had pneumonia was 46.7%; a febrile episode, 44.5%; and an eating problem, 38.6%.

Distressing symptoms, including dyspnea (46.0%) and pain (39.1%), were common. In the last three months of life, 40.7% of subjects underwent at least one burdensome intervention (defined as hospitalization, ED visit, parenteral therapy, or tube feeding).

Subjects whose proxies reported an understanding of the poor prognosis and expected clinical complications of advanced dementia underwent significantly fewer burdensome interventions (adjusted odds ratio 0.12).

Bottom line: Advanced dementia is associated with frequent complications, including infections and eating problems, with high six-month mortality and significant associated morbidity. Patients whose healthcare proxies have a good understanding of the expected clinical course and prognosis receive less-aggressive end-of-life care.

Citation: Mitchell SL, Teno JM, Kiely DK, et al. The clinical course of advanced dementia. N Engl J Med. 2009;361(16):1529-1538. TH

PEDIATRIC HM LITerature

By Mark Shen, MD

Antibiotic Prophylaxis Might Prevent Recurrent UTIs

Reviewed by Pediatric Editor Mark Shen, MD, medical director of hospital medicine at Dell Children’s Medical Center, Austin, Texas.

Clinical question: Does antibiotic prophylaxis prevent future episodes of urinary tract infections?

Background: Recurrent urinary tract infections (UTI) in children might be associated with renal scarring and subsequent clinical consequences associated with long-term morbidity. Historically, antibiotic prophylaxis has been recommended for children who might have risk factors for recurrent infection, most commonly vesicoureteral reflux. However, scars may be present in the absence of known risk factors and upon first UTI. The efficacy of antibiotic prophylaxis in preventing recurrent UTIs is unclear.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Four centers in Australia.

Synopsis: The study looked at 576 children under the age of 18 with a history of at least one symptomatic UTI. The patients were randomized to receive trimethoprim-sulfamethoxazole (TMP-SMX) or placebo for 12 months. Children with vesicoureteral reflux were included, but those with known neurologic, skeletal, or urologic predispositions were excluded.

Thirteen percent of patients in the antibiotic group developed a UTI compared with 19% of patients in the placebo group (P=0.02). The authors calculate that at 12 months, 14 patients would need to be treated to prevent one UTI.

This study was unable to enroll the planned number of children but remained adequately powered to show a reduction in the primary outcome (rate of symptomatic UTI). However, a significant number of patients (approximately 28%) in each arm stopped taking the medication, the majority for undisclosed reasons. Despite an intention-to-treat analysis, this degree of dropout raises questions about the true effect size. Additionally, this study does not answer the more important clinical question regarding the effect of prophylaxis on potential future renal damage, specifically in children with vesicoureteral reflux.

Bottom line: Antibiotic prophylaxis might be modestly effective in preventing recurrent UTIs.

Citation: Craig JC, Simpson JM, Williams GJ, et al. Antibiotic prophylaxis and recurrent urinary tract infection in children. N Engl J Med. 2009;361(18):1748-1759.

In This Edition

Literature at a Glance

A guide to this month’s studies

• Statins and postoperative cardiac outcomes
• Cardiac resynchronization therapy in patients with mild CHF symptoms
• Oral direct thrombin inhibitor versus warfarin for stroke prevention in atrial fibrillation
• Association of fatigue and medical error
• Effects of chronic inhaled steroid and beta-agonist use in COPD
• Dialysis and functional status in nursing home patients
• Outcomes with different insulin-dosing regimens
• Understanding of disease severity and outcomes in advanced dementia

Fluvastatin Improves Postoperative Cardiac Outcomes in Patients Undergoing Vascular Surgery

Clinical question: Does perioperative fluvastatin decrease adverse cardiac events after vascular surgery?

Background: Patients with atherosclerotic vascular disease who undergo vascular surgery are at high risk for postoperative cardiac events. Studies in nonsurgical populations have shown the beneficial effects of statin therapy on cardiac outcomes. However, no placebo-controlled trials have addressed the effect of statins on postoperative cardiac outcomes.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Single large academic medical center in the Netherlands.

Synopsis: The study looked at 497 statin-naïve patients 40 years or older undergoing non-cardiac vascular surgery. The patients were randomized to 80 mg of extended-release fluvastatin versus placebo; all patients received a beta-blocker. Therapy began preoperatively (median of 37 days) and continued for at least 30 days after surgery. Outcomes were assessed at 30 days post-surgery.

Postoperative myocardial infarction (MI) was significantly less common in the fluvastatin group than with placebo (10.8% vs. 19%, hazard ratio (HR) 0.55, P=0.01). In addition, the treatment group had a lower frequency of death from cardiovascular causes (4.8% vs. 10.1%, HR 0.47, P=0.03). Statin therapy was not associated with an increased rate of adverse events.

Notably, all of the patients enrolled in this study were high-risk patients undergoing high-risk (vascular) surgery. Patients already on statins were excluded.

Further studies are needed to determine whether the findings can be extrapolated to other populations, including nonvascular surgery patients.

Bottom line: Perioperative statin therapy resulted in a significant decrease in postoperative MI and death within 30 days of vascular surgery.

Citation: Schouten O, Boersma E, Hoeks SE, et al. Fluvastatin and perioperative events in patients undergoing vascular surgery. N Engl J Med. 2009;361(10):980-989.

Cardiac Resynchronization Therapy with Implantable Cardioverter Defibrillator Placement Decreases Heart Failure

Clinical question: Does cardiac resynchronization therapy (CRT) with biventricular pacing decrease cardiac events in patients with reduced ejection fraction (EF) and wide QRS complex but only mild cardiac symptoms?

Background: In patients with severely reduced EF, implantable cardioverter defibrillators (ICDs) have been shown to improve survival. Meanwhile, CRT decreases heart-failure-related hospitalizations for patients with advanced heart-failure symptoms, EF less than 35%, and intraventricular conduction delay. It is not as clear whether patients with less-severe symptoms benefit from CRT.

Study design: Randomized, controlled trial.

Setting: 110 medical centers in the U.S., Canada, and Europe.

Synopsis: This Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) study randomly assigned 1,820 adults with EF less than 30%, New York Health Association Class I or II congestive heart failure, and in sinus rhythm with QRS greater than 130 msec to receive ICD with CRT or ICD alone. The primary endpoint was all-cause mortality or nonfatal heart-failure events. Average followup was 2.4 years.

A 34% reduction in the primary endpoint was found in the ICD-CRT group when compared with the ICD-only group, primarily due to a 41% reduction in heart-failure events. In a subgroup analysis, women and patients with QRS greater than 150 msec experienced particular benefit. Echocardiography one year after device implantation demonstrated significant reductions in left ventricular end-systolic and end-diastolic volume, and a significant increase in EF with ICD-CRT versus ICD-only (P<0.001).

Bottom line: Compared with ICD alone, CRT in combination with ICD prevented heart-failure events in relatively asymptomatic heart-failure patients with low EF and prolonged QRS.

Citation: Moss AJ, Hall WJ, Cannom DS, et al. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009;361(14):1329-1338.

Dabigatran Is Not Inferior to Warfarin in Atrial Fibrillation

Clinical question: Is dabigatran, an oral thrombin inhibitor, an effective and safe alternative to warfarin in patients with atrial fibrillation?

Background: Warfarin reduces the risk of stroke among patients with atrial fibrillation (AF) but requires frequent laboratory monitoring. Dabigatran is an oral direct thrombin inhibitor given in fixed dosages without laboratory monitoring.

Study design: Randomized, multicenter, open-label, noninferiority trial.

Setting: 951 clinical centers in 44 countries.

Synopsis: More than 18,000 patients 65 and older with AF and at least one stroke risk factor were enrolled. The average CHADS2 score was 2.1. Patients were randomized to receive fixed doses of dabigatran (110 mg or 150 mg, twice daily) or warfarin adjusted to an INR of 2.0-3.0. The primary outcomes were a) stroke or systemic embolism and b) major hemorrhage. Median followup was two years.

The annual rates of stroke or systemic embolism for both doses of dabigatran were noninferior to warfarin (P<0.001); higher-dose dabigatran was statistically superior to warfarin (relative risk (RR)=0.66, P<0.001). The annual rate of major hemorrhage was lowest in the lower-dose dabigatran group (RR=0.80, P=0.003 compared with warfarin); the higher-dose dabigatran and warfarin groups had equivalent rates of major bleeding. No increased risk of liver function abnormalities was noted.

Bottom line: Dabigatran appears to be an effective and safe alternative to warfarin in AF patients. If the drug were to be FDA-approved, appropriate patient selection and cost will need to be established.

Citation: Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-1151.

Resident Fatigue and Distress Contribute to Perceived Medical Errors

Clinical question: Do resident fatigue and distress contribute to medical errors?

Background: In recent years, such measures as work-hour limitations have been implemented to decrease resident fatigue and, it is presumed, medical errors. However, few studies address the relationship between residents’ well-being and self-reported medical errors.

Study design: Prospective six-year longitudinal cohort study.

Setting: Single academic medical center.

Synopsis: The authors had 380 internal-medicine residents complete quarterly surveys to assess fatigue, quality of life, burnout, symptoms of depression, and frequency of perceived medical errors. In a univariate analysis, fatigue/sleepiness, burnout, depression, and overall quality of life measures correlated significantly with self-reported major medical errors. Fatigue/sleepiness and measures of distress additively increased the risk of self-reported errors. Increases in one or both domains were estimated to increase the risk of self-reported errors by as much as 15% to 28%.

The authors studied only self-reported medical errors. It is difficult to know whether these errors directly affected patient outcomes. Additionally, results of this single-site study might not be able to be generalized.

Bottom line: Fatigue and distress contribute to self-perceived medical errors among residents.

Citation: West CP, Tan AD, Habermann TM, Sloan JA, Shanafelt TD. Association of resident fatigue and distress with perceived medical errors. JAMA. 2009;302(12):1294-1300.

Inhaled Corticosteroids Decrease Inflammation in Moderate to Severe COPD

Clinical question: Does long-term inhaled corticosteroid therapy, with and without long-acting beta-agonists, decrease airway inflammation and improve lung function in patients with moderate to severe chronic obstructive pulmonary disease (COPD)?

Background: Guideline-recommended treatment of COPD with inhaled corticosteroids and long-acting beta-agonists improves symptoms and exacerbation rates; little is known about the impact of these therapies on inflammation and long-term lung function.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Two university medical centers in the Netherlands.

Synopsis: One hundred one steroid-naïve patients, ages 45 to 75 who were current or former smokers with moderate to severe COPD, were randomized to one of four regimens: 1) fluticasone for six months, then placebo for 24 months; 2) fluticasone for 30 months; 3) fluticasone and salmeterol for 30 months; or 4) placebo for 30 months. The primary outcome was inflammatory cell counts in bronchial biopsies/induced sputum. Secondary outcomes included postbronchodilator spirometry, methacholine hyperresponsiveness, and self-reported symptoms and health status. Patients with asthma were excluded.

Short-term fluticasone therapy decreased inflammation and improved forced expiratory volume in one second (FEV1). Long-term therapy also decreased the rate of FEV1 decline, reduced dyspnea, and improved health status. Discontinuation of therapy at six months led to inflammation relapse with worsened symptoms and increased rate of FEV1 decline. The addition of long-acting beta-agonists did not provide additional anti-inflammatory benefits, but it did improve FEV1 and dyspnea at six months.

Additional studies are needed to further define clinical outcomes and assess the cost benefit of these therapies.

Bottom line: Inhaled corticosteroids decrease inflammation in steroid-naïve patients with moderate to severe COPD and might decrease the rate of lung function decline. Long-acting beta-agonists do not offer additional anti-inflammatory benefit.

Citation: Lapperre TS, Snoeck-Stroband JB, Gosman MM, et al. Effect of fluticasone with and without salmeterol on pulmonary outcomes in chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. 2009;151(8):517-527.

Initiation of Dialysis Does Not Help Maintain Functional Status in Elderly

Clinical question: Is functional status in the elderly maintained over time after initiating long-term dialysis?

Background: Quality-of-life maintenance often is used as a goal when initiating long-term dialysis in elderly patients with end-stage renal disease. More elderly patients are being offered long-term dialysis treatment. Little is known about the functional status of elderly patients on long-term dialysis.

Study design: Retrospective cohort study.

Setting: U.S. nursing homes.

Synopsis: By cross-linking data from two population-based administrative datasets, this study identified 3,702 nursing home patients (mean 73.4 years) who had started long-term dialysis and whose functional status had been assessed. Activities of daily living assessments before and at three-month intervals after dialysis initiation were compared to see if functional status was maintained.

Within three months of starting dialysis, 61% of patients had a decline in functional status or had died. By one year, only 1 in 8 patients had maintained their pre-dialysis functional status.

Decline in functional status cannot be attributed solely to dialysis because study patients were not compared to patients with chronic kidney disease who were not dialyzed. In addition, these results might not apply to all elderly patients on dialysis, as the functional status of elderly nursing home patients might differ significantly from those living at home.

Bottom line: Functional status is not maintained in most elderly nursing home patients in the first 12 months after long-term dialysis is initiated. Elderly patients considering dialysis treatment should be aware that dialysis might not help maintain functional status and quality of life.

Citation: Kurella Tamura MK, Covinsky KE, Chertow GM, Yaffe C, Landefeld CS, McCulloch CE. Functional status of elderly adults before and after initiation of dialysis. N Engl J Med. 2009;361(16):1539-1547.

Adding Basal Insulin to Oral Agents in Type 2 Diabetes Might Offer Best Glycemic Control

Clinical question: When added to oral diabetic agents, which insulin regimen (biphasic, prandial or basal) best achieves glycemic control in patients with Type 2 diabetes?

Background: Most patients with Type 2 diabetes mellitus (DM2) require insulin when oral agents provide suboptimal glycemic control. Little is known about which insulin regimen is most effective.

Study design: Three-year, open-label, multicenter trial.

Setting: Fifty-eight clinical centers in the United Kingdom and Ireland.

Synopsis: The authors randomized 708 insulin-naïve DM2 patients (median age 62 years) with HgbA1c 7% to 10% on maximum-dose metformin or sulfonylurea to one of three regimens: biphasic insulin twice daily; prandial insulin three times daily; or basal insulin once daily. Outcomes were HgbA1c, hypoglycemia rates, and weight gain. Sulfonylureas were replaced by another insulin if glycemic control was unacceptable.

The patients were mostly Caucasian and overweight. At three years of followup, median HgbA1c was similar in all groups (7.1% biphasic, 6.8% prandial, 6.9% basal); however, more patients who received prandial or basal insulin achieved HgbA1c less than 6.5% (45% and 43%, respectively) than in the biphasic group (32%).

Hypoglycemia was significantly less frequent in the basal insulin group (1.7 per patient per year versus 3.0 and 5.5 with biphasic and prandial, respectively). Patients gained weight in all groups; the greatest gain was with prandial insulin. At three years, there were no significant between-group differences in blood pressure, cholesterol, albuminuria, or quality of life.

Bottom line: Adding insulin to oral diabetic regimens improves glycemic control. Basal or prandial insulin regimens achieve glycemic targets more frequently than biphasic dosing.

Citation: Holman RR, Farmer AJ, Davies MJ, et al. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med. 2009;361(18):1736-1747.

Advanced Dementia Is a Terminal Illness with High Morbidity and Mortality

Clinical question: Does understanding the expected clinical course of advanced dementia influence end-of-life decisions by proxy decision-makers?

Background: Advanced dementia is a leading cause of death in the United States, but the clinical course of advanced dementia has not been described in a rigorous, prospective manner. The lack of information might cause risk to be underestimated, and patients might receive suboptimal palliative care.

Study design: Multicenter prospective cohort study.

Setting: Twenty-two nursing homes in a single U.S. city.

Synopsis: The survey examined 323 nursing home residents with advanced dementia. The patients were clinically assessed at baseline and quarterly for 18 months through chart reviews, nursing interviews, and physical examinations. Additionally, their proxies were surveyed regarding their understanding of the subjects’ prognoses.

During the survey period, 41.1% of patients developed pneumonia, 52.6% of patients experienced a febrile episode, and 85.8% of patients developed an eating problem; cumulative all-cause mortality was 54.8%. Adjusted for age, sex, and disease duration, the six-month mortality rate for subjects who had pneumonia was 46.7%; a febrile episode, 44.5%; and an eating problem, 38.6%.

Distressing symptoms, including dyspnea (46.0%) and pain (39.1%), were common. In the last three months of life, 40.7% of subjects underwent at least one burdensome intervention (defined as hospitalization, ED visit, parenteral therapy, or tube feeding).

Subjects whose proxies reported an understanding of the poor prognosis and expected clinical complications of advanced dementia underwent significantly fewer burdensome interventions (adjusted odds ratio 0.12).

Bottom line: Advanced dementia is associated with frequent complications, including infections and eating problems, with high six-month mortality and significant associated morbidity. Patients whose healthcare proxies have a good understanding of the expected clinical course and prognosis receive less-aggressive end-of-life care.

Citation: Mitchell SL, Teno JM, Kiely DK, et al. The clinical course of advanced dementia. N Engl J Med. 2009;361(16):1529-1538. TH

PEDIATRIC HM LITerature

By Mark Shen, MD

Antibiotic Prophylaxis Might Prevent Recurrent UTIs

Reviewed by Pediatric Editor Mark Shen, MD, medical director of hospital medicine at Dell Children’s Medical Center, Austin, Texas.

Clinical question: Does antibiotic prophylaxis prevent future episodes of urinary tract infections?

Background: Recurrent urinary tract infections (UTI) in children might be associated with renal scarring and subsequent clinical consequences associated with long-term morbidity. Historically, antibiotic prophylaxis has been recommended for children who might have risk factors for recurrent infection, most commonly vesicoureteral reflux. However, scars may be present in the absence of known risk factors and upon first UTI. The efficacy of antibiotic prophylaxis in preventing recurrent UTIs is unclear.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Four centers in Australia.

Synopsis: The study looked at 576 children under the age of 18 with a history of at least one symptomatic UTI. The patients were randomized to receive trimethoprim-sulfamethoxazole (TMP-SMX) or placebo for 12 months. Children with vesicoureteral reflux were included, but those with known neurologic, skeletal, or urologic predispositions were excluded.

Thirteen percent of patients in the antibiotic group developed a UTI compared with 19% of patients in the placebo group (P=0.02). The authors calculate that at 12 months, 14 patients would need to be treated to prevent one UTI.

This study was unable to enroll the planned number of children but remained adequately powered to show a reduction in the primary outcome (rate of symptomatic UTI). However, a significant number of patients (approximately 28%) in each arm stopped taking the medication, the majority for undisclosed reasons. Despite an intention-to-treat analysis, this degree of dropout raises questions about the true effect size. Additionally, this study does not answer the more important clinical question regarding the effect of prophylaxis on potential future renal damage, specifically in children with vesicoureteral reflux.

Bottom line: Antibiotic prophylaxis might be modestly effective in preventing recurrent UTIs.

Citation: Craig JC, Simpson JM, Williams GJ, et al. Antibiotic prophylaxis and recurrent urinary tract infection in children. N Engl J Med. 2009;361(18):1748-1759.

In This Edition

Literature at a Glance

A guide to this month’s studies

• Statins and postoperative cardiac outcomes
• Cardiac resynchronization therapy in patients with mild CHF symptoms
• Oral direct thrombin inhibitor versus warfarin for stroke prevention in atrial fibrillation
• Association of fatigue and medical error
• Effects of chronic inhaled steroid and beta-agonist use in COPD
• Dialysis and functional status in nursing home patients
• Outcomes with different insulin-dosing regimens
• Understanding of disease severity and outcomes in advanced dementia

Fluvastatin Improves Postoperative Cardiac Outcomes in Patients Undergoing Vascular Surgery

Clinical question: Does perioperative fluvastatin decrease adverse cardiac events after vascular surgery?

Background: Patients with atherosclerotic vascular disease who undergo vascular surgery are at high risk for postoperative cardiac events. Studies in nonsurgical populations have shown the beneficial effects of statin therapy on cardiac outcomes. However, no placebo-controlled trials have addressed the effect of statins on postoperative cardiac outcomes.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Single large academic medical center in the Netherlands.

Synopsis: The study looked at 497 statin-naïve patients 40 years or older undergoing non-cardiac vascular surgery. The patients were randomized to 80 mg of extended-release fluvastatin versus placebo; all patients received a beta-blocker. Therapy began preoperatively (median of 37 days) and continued for at least 30 days after surgery. Outcomes were assessed at 30 days post-surgery.

Postoperative myocardial infarction (MI) was significantly less common in the fluvastatin group than with placebo (10.8% vs. 19%, hazard ratio (HR) 0.55, P=0.01). In addition, the treatment group had a lower frequency of death from cardiovascular causes (4.8% vs. 10.1%, HR 0.47, P=0.03). Statin therapy was not associated with an increased rate of adverse events.

Notably, all of the patients enrolled in this study were high-risk patients undergoing high-risk (vascular) surgery. Patients already on statins were excluded.

Further studies are needed to determine whether the findings can be extrapolated to other populations, including nonvascular surgery patients.

Bottom line: Perioperative statin therapy resulted in a significant decrease in postoperative MI and death within 30 days of vascular surgery.

Citation: Schouten O, Boersma E, Hoeks SE, et al. Fluvastatin and perioperative events in patients undergoing vascular surgery. N Engl J Med. 2009;361(10):980-989.

Cardiac Resynchronization Therapy with Implantable Cardioverter Defibrillator Placement Decreases Heart Failure

Clinical question: Does cardiac resynchronization therapy (CRT) with biventricular pacing decrease cardiac events in patients with reduced ejection fraction (EF) and wide QRS complex but only mild cardiac symptoms?

Background: In patients with severely reduced EF, implantable cardioverter defibrillators (ICDs) have been shown to improve survival. Meanwhile, CRT decreases heart-failure-related hospitalizations for patients with advanced heart-failure symptoms, EF less than 35%, and intraventricular conduction delay. It is not as clear whether patients with less-severe symptoms benefit from CRT.

Study design: Randomized, controlled trial.

Setting: 110 medical centers in the U.S., Canada, and Europe.

Synopsis: This Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) study randomly assigned 1,820 adults with EF less than 30%, New York Health Association Class I or II congestive heart failure, and in sinus rhythm with QRS greater than 130 msec to receive ICD with CRT or ICD alone. The primary endpoint was all-cause mortality or nonfatal heart-failure events. Average followup was 2.4 years.

A 34% reduction in the primary endpoint was found in the ICD-CRT group when compared with the ICD-only group, primarily due to a 41% reduction in heart-failure events. In a subgroup analysis, women and patients with QRS greater than 150 msec experienced particular benefit. Echocardiography one year after device implantation demonstrated significant reductions in left ventricular end-systolic and end-diastolic volume, and a significant increase in EF with ICD-CRT versus ICD-only (P<0.001).

Bottom line: Compared with ICD alone, CRT in combination with ICD prevented heart-failure events in relatively asymptomatic heart-failure patients with low EF and prolonged QRS.

Citation: Moss AJ, Hall WJ, Cannom DS, et al. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009;361(14):1329-1338.

Dabigatran Is Not Inferior to Warfarin in Atrial Fibrillation

Clinical question: Is dabigatran, an oral thrombin inhibitor, an effective and safe alternative to warfarin in patients with atrial fibrillation?

Background: Warfarin reduces the risk of stroke among patients with atrial fibrillation (AF) but requires frequent laboratory monitoring. Dabigatran is an oral direct thrombin inhibitor given in fixed dosages without laboratory monitoring.

Study design: Randomized, multicenter, open-label, noninferiority trial.

Setting: 951 clinical centers in 44 countries.

Synopsis: More than 18,000 patients 65 and older with AF and at least one stroke risk factor were enrolled. The average CHADS2 score was 2.1. Patients were randomized to receive fixed doses of dabigatran (110 mg or 150 mg, twice daily) or warfarin adjusted to an INR of 2.0-3.0. The primary outcomes were a) stroke or systemic embolism and b) major hemorrhage. Median followup was two years.

The annual rates of stroke or systemic embolism for both doses of dabigatran were noninferior to warfarin (P<0.001); higher-dose dabigatran was statistically superior to warfarin (relative risk (RR)=0.66, P<0.001). The annual rate of major hemorrhage was lowest in the lower-dose dabigatran group (RR=0.80, P=0.003 compared with warfarin); the higher-dose dabigatran and warfarin groups had equivalent rates of major bleeding. No increased risk of liver function abnormalities was noted.

Bottom line: Dabigatran appears to be an effective and safe alternative to warfarin in AF patients. If the drug were to be FDA-approved, appropriate patient selection and cost will need to be established.

Citation: Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-1151.

Resident Fatigue and Distress Contribute to Perceived Medical Errors

Clinical question: Do resident fatigue and distress contribute to medical errors?

Background: In recent years, such measures as work-hour limitations have been implemented to decrease resident fatigue and, it is presumed, medical errors. However, few studies address the relationship between residents’ well-being and self-reported medical errors.

Study design: Prospective six-year longitudinal cohort study.

Setting: Single academic medical center.

Synopsis: The authors had 380 internal-medicine residents complete quarterly surveys to assess fatigue, quality of life, burnout, symptoms of depression, and frequency of perceived medical errors. In a univariate analysis, fatigue/sleepiness, burnout, depression, and overall quality of life measures correlated significantly with self-reported major medical errors. Fatigue/sleepiness and measures of distress additively increased the risk of self-reported errors. Increases in one or both domains were estimated to increase the risk of self-reported errors by as much as 15% to 28%.

The authors studied only self-reported medical errors. It is difficult to know whether these errors directly affected patient outcomes. Additionally, results of this single-site study might not be able to be generalized.

Bottom line: Fatigue and distress contribute to self-perceived medical errors among residents.

Citation: West CP, Tan AD, Habermann TM, Sloan JA, Shanafelt TD. Association of resident fatigue and distress with perceived medical errors. JAMA. 2009;302(12):1294-1300.

Inhaled Corticosteroids Decrease Inflammation in Moderate to Severe COPD

Clinical question: Does long-term inhaled corticosteroid therapy, with and without long-acting beta-agonists, decrease airway inflammation and improve lung function in patients with moderate to severe chronic obstructive pulmonary disease (COPD)?

Background: Guideline-recommended treatment of COPD with inhaled corticosteroids and long-acting beta-agonists improves symptoms and exacerbation rates; little is known about the impact of these therapies on inflammation and long-term lung function.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Two university medical centers in the Netherlands.

Synopsis: One hundred one steroid-naïve patients, ages 45 to 75 who were current or former smokers with moderate to severe COPD, were randomized to one of four regimens: 1) fluticasone for six months, then placebo for 24 months; 2) fluticasone for 30 months; 3) fluticasone and salmeterol for 30 months; or 4) placebo for 30 months. The primary outcome was inflammatory cell counts in bronchial biopsies/induced sputum. Secondary outcomes included postbronchodilator spirometry, methacholine hyperresponsiveness, and self-reported symptoms and health status. Patients with asthma were excluded.

Short-term fluticasone therapy decreased inflammation and improved forced expiratory volume in one second (FEV1). Long-term therapy also decreased the rate of FEV1 decline, reduced dyspnea, and improved health status. Discontinuation of therapy at six months led to inflammation relapse with worsened symptoms and increased rate of FEV1 decline. The addition of long-acting beta-agonists did not provide additional anti-inflammatory benefits, but it did improve FEV1 and dyspnea at six months.

Additional studies are needed to further define clinical outcomes and assess the cost benefit of these therapies.

Bottom line: Inhaled corticosteroids decrease inflammation in steroid-naïve patients with moderate to severe COPD and might decrease the rate of lung function decline. Long-acting beta-agonists do not offer additional anti-inflammatory benefit.

Citation: Lapperre TS, Snoeck-Stroband JB, Gosman MM, et al. Effect of fluticasone with and without salmeterol on pulmonary outcomes in chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. 2009;151(8):517-527.

Initiation of Dialysis Does Not Help Maintain Functional Status in Elderly

Clinical question: Is functional status in the elderly maintained over time after initiating long-term dialysis?

Background: Quality-of-life maintenance often is used as a goal when initiating long-term dialysis in elderly patients with end-stage renal disease. More elderly patients are being offered long-term dialysis treatment. Little is known about the functional status of elderly patients on long-term dialysis.

Study design: Retrospective cohort study.

Setting: U.S. nursing homes.

Synopsis: By cross-linking data from two population-based administrative datasets, this study identified 3,702 nursing home patients (mean 73.4 years) who had started long-term dialysis and whose functional status had been assessed. Activities of daily living assessments before and at three-month intervals after dialysis initiation were compared to see if functional status was maintained.

Within three months of starting dialysis, 61% of patients had a decline in functional status or had died. By one year, only 1 in 8 patients had maintained their pre-dialysis functional status.

Decline in functional status cannot be attributed solely to dialysis because study patients were not compared to patients with chronic kidney disease who were not dialyzed. In addition, these results might not apply to all elderly patients on dialysis, as the functional status of elderly nursing home patients might differ significantly from those living at home.

Bottom line: Functional status is not maintained in most elderly nursing home patients in the first 12 months after long-term dialysis is initiated. Elderly patients considering dialysis treatment should be aware that dialysis might not help maintain functional status and quality of life.

Citation: Kurella Tamura MK, Covinsky KE, Chertow GM, Yaffe C, Landefeld CS, McCulloch CE. Functional status of elderly adults before and after initiation of dialysis. N Engl J Med. 2009;361(16):1539-1547.

Adding Basal Insulin to Oral Agents in Type 2 Diabetes Might Offer Best Glycemic Control

Clinical question: When added to oral diabetic agents, which insulin regimen (biphasic, prandial or basal) best achieves glycemic control in patients with Type 2 diabetes?

Background: Most patients with Type 2 diabetes mellitus (DM2) require insulin when oral agents provide suboptimal glycemic control. Little is known about which insulin regimen is most effective.

Study design: Three-year, open-label, multicenter trial.

Setting: Fifty-eight clinical centers in the United Kingdom and Ireland.

Synopsis: The authors randomized 708 insulin-naïve DM2 patients (median age 62 years) with HgbA1c 7% to 10% on maximum-dose metformin or sulfonylurea to one of three regimens: biphasic insulin twice daily; prandial insulin three times daily; or basal insulin once daily. Outcomes were HgbA1c, hypoglycemia rates, and weight gain. Sulfonylureas were replaced by another insulin if glycemic control was unacceptable.

The patients were mostly Caucasian and overweight. At three years of followup, median HgbA1c was similar in all groups (7.1% biphasic, 6.8% prandial, 6.9% basal); however, more patients who received prandial or basal insulin achieved HgbA1c less than 6.5% (45% and 43%, respectively) than in the biphasic group (32%).

Hypoglycemia was significantly less frequent in the basal insulin group (1.7 per patient per year versus 3.0 and 5.5 with biphasic and prandial, respectively). Patients gained weight in all groups; the greatest gain was with prandial insulin. At three years, there were no significant between-group differences in blood pressure, cholesterol, albuminuria, or quality of life.

Bottom line: Adding insulin to oral diabetic regimens improves glycemic control. Basal or prandial insulin regimens achieve glycemic targets more frequently than biphasic dosing.

Citation: Holman RR, Farmer AJ, Davies MJ, et al. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med. 2009;361(18):1736-1747.

Advanced Dementia Is a Terminal Illness with High Morbidity and Mortality

Clinical question: Does understanding the expected clinical course of advanced dementia influence end-of-life decisions by proxy decision-makers?

Background: Advanced dementia is a leading cause of death in the United States, but the clinical course of advanced dementia has not been described in a rigorous, prospective manner. The lack of information might cause risk to be underestimated, and patients might receive suboptimal palliative care.

Study design: Multicenter prospective cohort study.

Setting: Twenty-two nursing homes in a single U.S. city.

Synopsis: The survey examined 323 nursing home residents with advanced dementia. The patients were clinically assessed at baseline and quarterly for 18 months through chart reviews, nursing interviews, and physical examinations. Additionally, their proxies were surveyed regarding their understanding of the subjects’ prognoses.

During the survey period, 41.1% of patients developed pneumonia, 52.6% of patients experienced a febrile episode, and 85.8% of patients developed an eating problem; cumulative all-cause mortality was 54.8%. Adjusted for age, sex, and disease duration, the six-month mortality rate for subjects who had pneumonia was 46.7%; a febrile episode, 44.5%; and an eating problem, 38.6%.

Distressing symptoms, including dyspnea (46.0%) and pain (39.1%), were common. In the last three months of life, 40.7% of subjects underwent at least one burdensome intervention (defined as hospitalization, ED visit, parenteral therapy, or tube feeding).

Subjects whose proxies reported an understanding of the poor prognosis and expected clinical complications of advanced dementia underwent significantly fewer burdensome interventions (adjusted odds ratio 0.12).

Bottom line: Advanced dementia is associated with frequent complications, including infections and eating problems, with high six-month mortality and significant associated morbidity. Patients whose healthcare proxies have a good understanding of the expected clinical course and prognosis receive less-aggressive end-of-life care.

Citation: Mitchell SL, Teno JM, Kiely DK, et al. The clinical course of advanced dementia. N Engl J Med. 2009;361(16):1529-1538. TH

PEDIATRIC HM LITerature

By Mark Shen, MD

Antibiotic Prophylaxis Might Prevent Recurrent UTIs

Reviewed by Pediatric Editor Mark Shen, MD, medical director of hospital medicine at Dell Children’s Medical Center, Austin, Texas.

Clinical question: Does antibiotic prophylaxis prevent future episodes of urinary tract infections?

Background: Recurrent urinary tract infections (UTI) in children might be associated with renal scarring and subsequent clinical consequences associated with long-term morbidity. Historically, antibiotic prophylaxis has been recommended for children who might have risk factors for recurrent infection, most commonly vesicoureteral reflux. However, scars may be present in the absence of known risk factors and upon first UTI. The efficacy of antibiotic prophylaxis in preventing recurrent UTIs is unclear.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Four centers in Australia.

Synopsis: The study looked at 576 children under the age of 18 with a history of at least one symptomatic UTI. The patients were randomized to receive trimethoprim-sulfamethoxazole (TMP-SMX) or placebo for 12 months. Children with vesicoureteral reflux were included, but those with known neurologic, skeletal, or urologic predispositions were excluded.

Thirteen percent of patients in the antibiotic group developed a UTI compared with 19% of patients in the placebo group (P=0.02). The authors calculate that at 12 months, 14 patients would need to be treated to prevent one UTI.

This study was unable to enroll the planned number of children but remained adequately powered to show a reduction in the primary outcome (rate of symptomatic UTI). However, a significant number of patients (approximately 28%) in each arm stopped taking the medication, the majority for undisclosed reasons. Despite an intention-to-treat analysis, this degree of dropout raises questions about the true effect size. Additionally, this study does not answer the more important clinical question regarding the effect of prophylaxis on potential future renal damage, specifically in children with vesicoureteral reflux.

Bottom line: Antibiotic prophylaxis might be modestly effective in preventing recurrent UTIs.

Citation: Craig JC, Simpson JM, Williams GJ, et al. Antibiotic prophylaxis and recurrent urinary tract infection in children. N Engl J Med. 2009;361(18):1748-1759.