Ever since the International Human GenomeSequencing Consortium unveiled its “working draft” of the human genome sequence in 2000, the scientific community has eagerly discussed and speculated on the potential of genomic medicine. Patients, clinicians, and scientists were—and still are—excited about the possibilities of targeted therapies such as imatinib (Gleevec) for chronic myeloid leukemias and gastrointestinal stromal tumors and trastuzumab (Herceptin) for HER2/neu-positive breast cancer. There has been significant progress in the development of these and other targeted therapies, and they remain part of an intriguing and promising work in progress. However, for patients with lung cancer and melanoma, both of which are highly refractory diseases, the therapeutic choices other than chemotherapy have been limited and the commensurate outcomes discouraging.

In the early 2000s, we were excited about targeted therapies such as gefitinib (Iressa), which blocks epidermal growth factor receptor (EGFR)- tyrosine kinase activity in non-small cell lung cancer (NSCLC), but its clinical benefit was still limited. We have since gained a better understanding of lung cancer as a molecularly heterogeneous disease and have adjusted our approach to its treatment, based on new data showing that all lung cancer patients cannot be treated with the same drug regimen and achieve the same outcomes. With those insights, the implications of targeted therapies came into sharper focus in 2004 with the US Food and Drug Administration (FDA) approval of erlotinib (Tarceva) for the 10%–15% of patients with NSCLC (adenocarcinoma) who have the EGFR gene mutation. At around the same time, scientists identified BRAF gene mutations in about 40%– 60% of patients with melanoma, and the quest for therapies for that disease was redirected to the cellular level as well. ...

* For a PDF of the full article, click in the link to the left of this introduction.

Ever since the International Human GenomeSequencing Consortium unveiled its “working draft” of the human genome sequence in 2000, the scientific community has eagerly discussed and speculated on the potential of genomic medicine. Patients, clinicians, and scientists were—and still are—excited about the possibilities of targeted therapies such as imatinib (Gleevec) for chronic myeloid leukemias and gastrointestinal stromal tumors and trastuzumab (Herceptin) for HER2/neu-positive breast cancer. There has been significant progress in the development of these and other targeted therapies, and they remain part of an intriguing and promising work in progress. However, for patients with lung cancer and melanoma, both of which are highly refractory diseases, the therapeutic choices other than chemotherapy have been limited and the commensurate outcomes discouraging.

In the early 2000s, we were excited about targeted therapies such as gefitinib (Iressa), which blocks epidermal growth factor receptor (EGFR)- tyrosine kinase activity in non-small cell lung cancer (NSCLC), but its clinical benefit was still limited. We have since gained a better understanding of lung cancer as a molecularly heterogeneous disease and have adjusted our approach to its treatment, based on new data showing that all lung cancer patients cannot be treated with the same drug regimen and achieve the same outcomes. With those insights, the implications of targeted therapies came into sharper focus in 2004 with the US Food and Drug Administration (FDA) approval of erlotinib (Tarceva) for the 10%–15% of patients with NSCLC (adenocarcinoma) who have the EGFR gene mutation. At around the same time, scientists identified BRAF gene mutations in about 40%– 60% of patients with melanoma, and the quest for therapies for that disease was redirected to the cellular level as well. ...

* For a PDF of the full article, click in the link to the left of this introduction.

Ever since the International Human GenomeSequencing Consortium unveiled its “working draft” of the human genome sequence in 2000, the scientific community has eagerly discussed and speculated on the potential of genomic medicine. Patients, clinicians, and scientists were—and still are—excited about the possibilities of targeted therapies such as imatinib (Gleevec) for chronic myeloid leukemias and gastrointestinal stromal tumors and trastuzumab (Herceptin) for HER2/neu-positive breast cancer. There has been significant progress in the development of these and other targeted therapies, and they remain part of an intriguing and promising work in progress. However, for patients with lung cancer and melanoma, both of which are highly refractory diseases, the therapeutic choices other than chemotherapy have been limited and the commensurate outcomes discouraging.

In the early 2000s, we were excited about targeted therapies such as gefitinib (Iressa), which blocks epidermal growth factor receptor (EGFR)- tyrosine kinase activity in non-small cell lung cancer (NSCLC), but its clinical benefit was still limited. We have since gained a better understanding of lung cancer as a molecularly heterogeneous disease and have adjusted our approach to its treatment, based on new data showing that all lung cancer patients cannot be treated with the same drug regimen and achieve the same outcomes. With those insights, the implications of targeted therapies came into sharper focus in 2004 with the US Food and Drug Administration (FDA) approval of erlotinib (Tarceva) for the 10%–15% of patients with NSCLC (adenocarcinoma) who have the EGFR gene mutation. At around the same time, scientists identified BRAF gene mutations in about 40%– 60% of patients with melanoma, and the quest for therapies for that disease was redirected to the cellular level as well. ...

* For a PDF of the full article, click in the link to the left of this introduction.

The recent Registry on Cardiac Rhythm Disorders Assessing the Control of Atrial Fibrillation (RECORD AF) provides further data to belie our obsession with obtaining or maintaining normal sinus rhythm in patients with intermittent or paroxysmal AF (J. Am. Coll. Cardiol. 2011;58:493-501).

Registry studies fail to provide the randomized data that we demand in control trials, but can often yield data about real-world therapy. This registry, which included 5,604 patients from around the world and whose authors were either consultants or employees of Sanofi-Aventis, the makers of dronedarone, confirms much of what has already been said on the issue. There is little or no benefit associated with the rhythm control therapy compared to a heart rate strategy when examined in this community-based unselected population.

Because patients in this study were not randomized to a particular therapy, participating doctors could use either strategy. Unfortunately, patients in the rate control arm were older and more often had AF, heart failure, and valvular heart disease at baseline. Despite this imbalance, the heart rate strategy was as good as rhythm control. Both groups experienced an 18% incidence of adverse clinical events that were determined by the clinical characteristics of the patient and not the therapeutic strategy used or heart rate achieved. Success was measured by the presence of normal sinus rhythm in the rhythm-controlled patients or a heart rate of less than 80 bpm in the rate-controlled patients at 1 year follow-up, which was achieved in 60% and 47%, respectively. If the heart rate target was below 85 bpm, the success was achieved in 60% vs. 52%, respectively. These observations are consistent with previous studies comparing rhythm and rate control strategies.

This obsession with the maintenance of normal sinus rhythm in patients with AF has spawned a whole industry associated with the technology and application of catheter ablation, atrial defibrillation, left atrial occlusive devices, and the continued development of anti-arrhythmic drugs. All of these interventions have achieved some success but have been associated with significant drug and device adverse events.

The most recently approved anti-arrhythmic drug, dronedarone (Multaq), has been extensively studied in AF. Three major clinical trials have examined the drug in paroxysmal, persistent, and permanent AF. The most recent trial, Permanent Atrial Fibrillation Outcome Study Using Dronedarone (PALLAS), compared dronedarone to placebo in 3,000 patients with permanent AF and who also had a number of comorbidities, including symptomatic heart failure and a decrease in ejection fraction, but excluded New York Heart Association class III heart failure. Only an electrophysiologist is able to make the distinction between these two clinical heart failure settings. The study was prematurely stopped because of a significant increase in cardiovascular events, including mortality (

Dronedarone was approved in 2009 for patients with paroxysmal and persistent AF and atrial flutter by the Food and Drug Administration based on the ATHENA trial, which reported a decrease in recurrent AF in patients treated with the drug. In addition, dronedarone decreased the combined cardiovascular end point of mortality and rehospitalization, achieved mostly by a decrease in rehospitalization. However, its approval included a boxed warning that it is “contraindicated in patients with NYHA Class IV heart failure or NYHA Class II-III heart failure with a recent decompensation requiring hospitalization,” because of the increased risks observed in the previous Trial with Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease (ANDROMEDA). That trial, which included mostly patients with NYHA class III-IV, was stopped prematurely because of the increase in heart failure mortality.

Dr. Stuart Connolly, the co–primary investigator of PALLAS, emphasized the difference between ATHENA, which randomized patients with nonpermanent AF, and PALLAS, which randomized patients with permanent AF. He thought that it was “reasonable” for patients with nonpermanent AF to continue with dronedarone, because “they will still benefit from it in terms of reduced CV hospitalization.”

Although there are surely some patients in whom AF causes significant symptoms that warrant aggressive therapy, the vast majority of patients, as indicated in RECORD AF, tolerate AF quite well. Much of the quest for rhythm control is related to the need to prevent systemic emboli and the requirement for anticoagulation therapy using vitamin K derivatives. The development of new antithrombotic drugs and factor Xa inhibitors now provides a safer and more effective alternative. It is time to relax our obsessive approach to atrial fibrillation therapy and become more realistic about our long-term goals for its therapy.

The recent Registry on Cardiac Rhythm Disorders Assessing the Control of Atrial Fibrillation (RECORD AF) provides further data to belie our obsession with obtaining or maintaining normal sinus rhythm in patients with intermittent or paroxysmal AF (J. Am. Coll. Cardiol. 2011;58:493-501).

Registry studies fail to provide the randomized data that we demand in control trials, but can often yield data about real-world therapy. This registry, which included 5,604 patients from around the world and whose authors were either consultants or employees of Sanofi-Aventis, the makers of dronedarone, confirms much of what has already been said on the issue. There is little or no benefit associated with the rhythm control therapy compared to a heart rate strategy when examined in this community-based unselected population.

Because patients in this study were not randomized to a particular therapy, participating doctors could use either strategy. Unfortunately, patients in the rate control arm were older and more often had AF, heart failure, and valvular heart disease at baseline. Despite this imbalance, the heart rate strategy was as good as rhythm control. Both groups experienced an 18% incidence of adverse clinical events that were determined by the clinical characteristics of the patient and not the therapeutic strategy used or heart rate achieved. Success was measured by the presence of normal sinus rhythm in the rhythm-controlled patients or a heart rate of less than 80 bpm in the rate-controlled patients at 1 year follow-up, which was achieved in 60% and 47%, respectively. If the heart rate target was below 85 bpm, the success was achieved in 60% vs. 52%, respectively. These observations are consistent with previous studies comparing rhythm and rate control strategies.

This obsession with the maintenance of normal sinus rhythm in patients with AF has spawned a whole industry associated with the technology and application of catheter ablation, atrial defibrillation, left atrial occlusive devices, and the continued development of anti-arrhythmic drugs. All of these interventions have achieved some success but have been associated with significant drug and device adverse events.

The most recently approved anti-arrhythmic drug, dronedarone (Multaq), has been extensively studied in AF. Three major clinical trials have examined the drug in paroxysmal, persistent, and permanent AF. The most recent trial, Permanent Atrial Fibrillation Outcome Study Using Dronedarone (PALLAS), compared dronedarone to placebo in 3,000 patients with permanent AF and who also had a number of comorbidities, including symptomatic heart failure and a decrease in ejection fraction, but excluded New York Heart Association class III heart failure. Only an electrophysiologist is able to make the distinction between these two clinical heart failure settings. The study was prematurely stopped because of a significant increase in cardiovascular events, including mortality (

Dronedarone was approved in 2009 for patients with paroxysmal and persistent AF and atrial flutter by the Food and Drug Administration based on the ATHENA trial, which reported a decrease in recurrent AF in patients treated with the drug. In addition, dronedarone decreased the combined cardiovascular end point of mortality and rehospitalization, achieved mostly by a decrease in rehospitalization. However, its approval included a boxed warning that it is “contraindicated in patients with NYHA Class IV heart failure or NYHA Class II-III heart failure with a recent decompensation requiring hospitalization,” because of the increased risks observed in the previous Trial with Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease (ANDROMEDA). That trial, which included mostly patients with NYHA class III-IV, was stopped prematurely because of the increase in heart failure mortality.

Dr. Stuart Connolly, the co–primary investigator of PALLAS, emphasized the difference between ATHENA, which randomized patients with nonpermanent AF, and PALLAS, which randomized patients with permanent AF. He thought that it was “reasonable” for patients with nonpermanent AF to continue with dronedarone, because “they will still benefit from it in terms of reduced CV hospitalization.”

Although there are surely some patients in whom AF causes significant symptoms that warrant aggressive therapy, the vast majority of patients, as indicated in RECORD AF, tolerate AF quite well. Much of the quest for rhythm control is related to the need to prevent systemic emboli and the requirement for anticoagulation therapy using vitamin K derivatives. The development of new antithrombotic drugs and factor Xa inhibitors now provides a safer and more effective alternative. It is time to relax our obsessive approach to atrial fibrillation therapy and become more realistic about our long-term goals for its therapy.

The recent Registry on Cardiac Rhythm Disorders Assessing the Control of Atrial Fibrillation (RECORD AF) provides further data to belie our obsession with obtaining or maintaining normal sinus rhythm in patients with intermittent or paroxysmal AF (J. Am. Coll. Cardiol. 2011;58:493-501).

Registry studies fail to provide the randomized data that we demand in control trials, but can often yield data about real-world therapy. This registry, which included 5,604 patients from around the world and whose authors were either consultants or employees of Sanofi-Aventis, the makers of dronedarone, confirms much of what has already been said on the issue. There is little or no benefit associated with the rhythm control therapy compared to a heart rate strategy when examined in this community-based unselected population.

Because patients in this study were not randomized to a particular therapy, participating doctors could use either strategy. Unfortunately, patients in the rate control arm were older and more often had AF, heart failure, and valvular heart disease at baseline. Despite this imbalance, the heart rate strategy was as good as rhythm control. Both groups experienced an 18% incidence of adverse clinical events that were determined by the clinical characteristics of the patient and not the therapeutic strategy used or heart rate achieved. Success was measured by the presence of normal sinus rhythm in the rhythm-controlled patients or a heart rate of less than 80 bpm in the rate-controlled patients at 1 year follow-up, which was achieved in 60% and 47%, respectively. If the heart rate target was below 85 bpm, the success was achieved in 60% vs. 52%, respectively. These observations are consistent with previous studies comparing rhythm and rate control strategies.

This obsession with the maintenance of normal sinus rhythm in patients with AF has spawned a whole industry associated with the technology and application of catheter ablation, atrial defibrillation, left atrial occlusive devices, and the continued development of anti-arrhythmic drugs. All of these interventions have achieved some success but have been associated with significant drug and device adverse events.

The most recently approved anti-arrhythmic drug, dronedarone (Multaq), has been extensively studied in AF. Three major clinical trials have examined the drug in paroxysmal, persistent, and permanent AF. The most recent trial, Permanent Atrial Fibrillation Outcome Study Using Dronedarone (PALLAS), compared dronedarone to placebo in 3,000 patients with permanent AF and who also had a number of comorbidities, including symptomatic heart failure and a decrease in ejection fraction, but excluded New York Heart Association class III heart failure. Only an electrophysiologist is able to make the distinction between these two clinical heart failure settings. The study was prematurely stopped because of a significant increase in cardiovascular events, including mortality (

Dronedarone was approved in 2009 for patients with paroxysmal and persistent AF and atrial flutter by the Food and Drug Administration based on the ATHENA trial, which reported a decrease in recurrent AF in patients treated with the drug. In addition, dronedarone decreased the combined cardiovascular end point of mortality and rehospitalization, achieved mostly by a decrease in rehospitalization. However, its approval included a boxed warning that it is “contraindicated in patients with NYHA Class IV heart failure or NYHA Class II-III heart failure with a recent decompensation requiring hospitalization,” because of the increased risks observed in the previous Trial with Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease (ANDROMEDA). That trial, which included mostly patients with NYHA class III-IV, was stopped prematurely because of the increase in heart failure mortality.

Dr. Stuart Connolly, the co–primary investigator of PALLAS, emphasized the difference between ATHENA, which randomized patients with nonpermanent AF, and PALLAS, which randomized patients with permanent AF. He thought that it was “reasonable” for patients with nonpermanent AF to continue with dronedarone, because “they will still benefit from it in terms of reduced CV hospitalization.”

Although there are surely some patients in whom AF causes significant symptoms that warrant aggressive therapy, the vast majority of patients, as indicated in RECORD AF, tolerate AF quite well. Much of the quest for rhythm control is related to the need to prevent systemic emboli and the requirement for anticoagulation therapy using vitamin K derivatives. The development of new antithrombotic drugs and factor Xa inhibitors now provides a safer and more effective alternative. It is time to relax our obsessive approach to atrial fibrillation therapy and become more realistic about our long-term goals for its therapy.

A new study that shows cumulative antibiotic exposures appear to be associated with Clostridium difficile infections (CDI) should be seen as another reason to reduce the use of antibiotics to minimum levels, according to the paper's lead author.

"In terms of prevention, it's really important for us to start delineating [shortened antibiotic courses] in treating the primary infection," says Vanessa Stevens, PhD, a fellow at the Center for Health Outcomes, Pharmacoinformatics, and Epidemiology at the State University of New York at Buffalo. "What are the minimums that are necessary to accomplish the job?"

Dr. Stevens says CDI's growing incidence is clear; however, there is little research linking the risk to the total dose, duration, or number of antibiotics a patient receives. So her team set out to provide one of the first links. They found that compared to patients who received one antibiotic, the adjusted hazard ratios for those receiving two to five antibiotics were 2.5 (95% confidence interval [CI] 1.6-4.0), 3.3 (CI 2.2-5.2), and 9.6 (CI 6.1-15.1), respectively (Clin Infect Dis. 2011;53(1):42-48). Patients exposed to fluoroquinolones were associated with higher risk, while those given metronidazole saw reduced risk.

Dr. Stevens says she expected the research would confirm her suspicions that continued exposure to antibiotics increased risk of infection. Still, she says, the more difficult question is when to balance a minimalistic approach to antibiotic use with the need to aggressively deal with more acute primary infections.

"The risk of C. diff might be an acceptable risk in a case where you're treating a life-threatening infection," Dr. Stevens adds. "If you're treating acne or something that isn't a life-threatening condition to the patient, there has to be a balance."

A new study that shows cumulative antibiotic exposures appear to be associated with Clostridium difficile infections (CDI) should be seen as another reason to reduce the use of antibiotics to minimum levels, according to the paper's lead author.

"In terms of prevention, it's really important for us to start delineating [shortened antibiotic courses] in treating the primary infection," says Vanessa Stevens, PhD, a fellow at the Center for Health Outcomes, Pharmacoinformatics, and Epidemiology at the State University of New York at Buffalo. "What are the minimums that are necessary to accomplish the job?"

Dr. Stevens says CDI's growing incidence is clear; however, there is little research linking the risk to the total dose, duration, or number of antibiotics a patient receives. So her team set out to provide one of the first links. They found that compared to patients who received one antibiotic, the adjusted hazard ratios for those receiving two to five antibiotics were 2.5 (95% confidence interval [CI] 1.6-4.0), 3.3 (CI 2.2-5.2), and 9.6 (CI 6.1-15.1), respectively (Clin Infect Dis. 2011;53(1):42-48). Patients exposed to fluoroquinolones were associated with higher risk, while those given metronidazole saw reduced risk.

Dr. Stevens says she expected the research would confirm her suspicions that continued exposure to antibiotics increased risk of infection. Still, she says, the more difficult question is when to balance a minimalistic approach to antibiotic use with the need to aggressively deal with more acute primary infections.

"The risk of C. diff might be an acceptable risk in a case where you're treating a life-threatening infection," Dr. Stevens adds. "If you're treating acne or something that isn't a life-threatening condition to the patient, there has to be a balance."

A new study that shows cumulative antibiotic exposures appear to be associated with Clostridium difficile infections (CDI) should be seen as another reason to reduce the use of antibiotics to minimum levels, according to the paper's lead author.

"In terms of prevention, it's really important for us to start delineating [shortened antibiotic courses] in treating the primary infection," says Vanessa Stevens, PhD, a fellow at the Center for Health Outcomes, Pharmacoinformatics, and Epidemiology at the State University of New York at Buffalo. "What are the minimums that are necessary to accomplish the job?"

Dr. Stevens says CDI's growing incidence is clear; however, there is little research linking the risk to the total dose, duration, or number of antibiotics a patient receives. So her team set out to provide one of the first links. They found that compared to patients who received one antibiotic, the adjusted hazard ratios for those receiving two to five antibiotics were 2.5 (95% confidence interval [CI] 1.6-4.0), 3.3 (CI 2.2-5.2), and 9.6 (CI 6.1-15.1), respectively (Clin Infect Dis. 2011;53(1):42-48). Patients exposed to fluoroquinolones were associated with higher risk, while those given metronidazole saw reduced risk.

Dr. Stevens says she expected the research would confirm her suspicions that continued exposure to antibiotics increased risk of infection. Still, she says, the more difficult question is when to balance a minimalistic approach to antibiotic use with the need to aggressively deal with more acute primary infections.

"The risk of C. diff might be an acceptable risk in a case where you're treating a life-threatening infection," Dr. Stevens adds. "If you're treating acne or something that isn't a life-threatening condition to the patient, there has to be a balance."

Bassett Medical Center in Cooperstown, N.Y., received a Pinnacle Award for Quality and Patient Safety from the Health Care Association of New York State in June, honoring Bassett's program for improving care transitions and reducing hospital readmissions.

Bassett used an evidence-based approach that incorporated readmission screening tools and risk-reduction strategies, a patient services coordinator to make post-discharge follow-up phone calls, and a toll-free number for patients to call any time prior to their first post-discharge medical appointment. The result was a readmission rate that was reduced by 25%, from 17% in 2009 to 13% in 2010. Thirty-day readmissions for high-risk patients fell 70% for the hospital, which is a mentored site in SHM's Project BOOST (Better Outcomes for Older Adults through Safe Transitions).

Hospitalist Komron Ostovar, MD, FHM, and Lorraine Stubley, RN, MS, the hospital's senior director of care coordination, led a multidisciplinary quality group that included primary-care providers and representatives from community settings. They worked to strengthen information flow between inpatient and outpatient providers. One of the most helpful tools, Stubley says, was Project BOOST's "8 Ps" for risk assessment, which identified high-risk patients consistently.

The care-transitions initiative also lays the groundwork for implementing a "geographical care model" at Bassett, with a universal bed unit staffed by nurses who are able to provide for all of the patient's needs for the entire hospitalization, she says.

The facility's hospitalists led daily rounds, emphasized teach-back education, and helped to refine discharge instructions in patient-friendly terms. "Our group of hospitalists understands that we now 'own' the complexity of care transitions," Dr. Ostovar says. "If we, as professionals, don't make every effort to get it right, then who will?"

Bassett Medical Center in Cooperstown, N.Y., received a Pinnacle Award for Quality and Patient Safety from the Health Care Association of New York State in June, honoring Bassett's program for improving care transitions and reducing hospital readmissions.

Bassett used an evidence-based approach that incorporated readmission screening tools and risk-reduction strategies, a patient services coordinator to make post-discharge follow-up phone calls, and a toll-free number for patients to call any time prior to their first post-discharge medical appointment. The result was a readmission rate that was reduced by 25%, from 17% in 2009 to 13% in 2010. Thirty-day readmissions for high-risk patients fell 70% for the hospital, which is a mentored site in SHM's Project BOOST (Better Outcomes for Older Adults through Safe Transitions).

Hospitalist Komron Ostovar, MD, FHM, and Lorraine Stubley, RN, MS, the hospital's senior director of care coordination, led a multidisciplinary quality group that included primary-care providers and representatives from community settings. They worked to strengthen information flow between inpatient and outpatient providers. One of the most helpful tools, Stubley says, was Project BOOST's "8 Ps" for risk assessment, which identified high-risk patients consistently.

The care-transitions initiative also lays the groundwork for implementing a "geographical care model" at Bassett, with a universal bed unit staffed by nurses who are able to provide for all of the patient's needs for the entire hospitalization, she says.

The facility's hospitalists led daily rounds, emphasized teach-back education, and helped to refine discharge instructions in patient-friendly terms. "Our group of hospitalists understands that we now 'own' the complexity of care transitions," Dr. Ostovar says. "If we, as professionals, don't make every effort to get it right, then who will?"

Bassett Medical Center in Cooperstown, N.Y., received a Pinnacle Award for Quality and Patient Safety from the Health Care Association of New York State in June, honoring Bassett's program for improving care transitions and reducing hospital readmissions.

Bassett used an evidence-based approach that incorporated readmission screening tools and risk-reduction strategies, a patient services coordinator to make post-discharge follow-up phone calls, and a toll-free number for patients to call any time prior to their first post-discharge medical appointment. The result was a readmission rate that was reduced by 25%, from 17% in 2009 to 13% in 2010. Thirty-day readmissions for high-risk patients fell 70% for the hospital, which is a mentored site in SHM's Project BOOST (Better Outcomes for Older Adults through Safe Transitions).

Hospitalist Komron Ostovar, MD, FHM, and Lorraine Stubley, RN, MS, the hospital's senior director of care coordination, led a multidisciplinary quality group that included primary-care providers and representatives from community settings. They worked to strengthen information flow between inpatient and outpatient providers. One of the most helpful tools, Stubley says, was Project BOOST's "8 Ps" for risk assessment, which identified high-risk patients consistently.

The care-transitions initiative also lays the groundwork for implementing a "geographical care model" at Bassett, with a universal bed unit staffed by nurses who are able to provide for all of the patient's needs for the entire hospitalization, she says.

The facility's hospitalists led daily rounds, emphasized teach-back education, and helped to refine discharge instructions in patient-friendly terms. "Our group of hospitalists understands that we now 'own' the complexity of care transitions," Dr. Ostovar says. "If we, as professionals, don't make every effort to get it right, then who will?"

A large-scale trial showed that the anticoagulant apixaban was more effective than warfarin in preventing stroke and systemic embolism in patients with atrial fibrillation. Moreover, apixaban resulted in substantially less bleeding and lower mortality.

These results were presented at the European Society of Cardiology Congress in Paris on August 28 and published simultaneously online in The New England Journal of Medicine.

The study was funded by the makers of apixaban, Bristol-Myers Squibb, Co. and Pfizer Inc.

The trial, called ARISTOTLE, included 18,201 patients from 1034 clinical sites in 39 countries. Patients were randomized to receive either apixaban or warfarin at 5 mg twice daily for an average of 1.8 years.

“[W]hen compared to warfarin..., apixaban resulted in an additional 21% relative reduction in stroke or systemic embolism,” said lead study author Christopher B. Granger, MD, of Duke University. “It also resulted in a 31% relative reduction in major bleeding, as well as an 11% relative reduction in overall mortality.”

The improvement in stroke prevention was statistically significant (P = 0.011), as was the lower rate of major bleeding (P < 0.001) and the lower mortality (P = 0.047). Hemorrhagic stroke was reduced by about 50%.

The benefits of stroke reduction and lower rates of bleeding were consistent across all major subgroups and despite the heterogeneity that exists in the quality of warfarin use across the world, according to John Alexander, MD, a study co-author and Duke cardiologist.

The number of events prevented per 1000 people, which indicate absolute risk reduction, was also impressive, Dr Alexander said. Apixaban prevented 6 patients from having a stroke, 15 patients from having major bleeding, and 8 patients from dying.

“There is an enormous unmet need for treatment of patients at risk for stroke associated with atrial fibrillation,” Dr Granger said. “Only about half of patients who should be treated are being treated. The disparity exists because warfarin treatment has several limitations.”

These limitations include regular blood tests to monitor and adjust warfarin dose, as well as the need to avoid certain foods and medications that interfere with warfarin's efficacy. Warfarin has also been shown to increase bleeding risk, including intracranial hemorrhage.

“Our study indicates treatment with apixaban is more effective than warfarin in preventing stroke, without the need for anticoagulation monitoring,” said the study committee's co-chair Lars Wallentin, MD, of the Uppsala Clinical Research Center University Hospital in Sweden.

The study also shows apixaban is safer than warfarin, Dr Wallentin said. “Our findings show a single dose of apixaban accomplishes the same stroke prevention goal as adjusted-dose warfarin, with a substantially lower risk of all types of bleeding across different ages and with lower rates of discontinuation.”

Though these results suggest apixaban is a promising drug, it is important to note that other studies of apixaban have produced mixed results.

A study published in The New England Journal of Medicine on July 24 showed that apixaban increased major bleeding in patients with acute coronary syndrome, without reducing recurrent ischemic events.

A study presented at the American Stroke Association’s International Stroke Conference 2011 found apixaban to be “far superior” to aspirin at preventing stroke in atrial fibrillation patients who could not use vitamin K antagonists.

The ADVANCE-2 study suggested apixaban was more effective at preventing venous thromboembolism than enoxaparin in patients who had elective total knee replacement surgery. However, the earlier ADVANCE study indicated apixaban was not more effective than enoxaparin.

And a study presented at the European Society of Cardiology Conference in 2008 found that apixaban lowered the incidence of heart attack, stroke, chest pain, or death from cardiovascular problems when compared to placebo. However, the drug did not lower the incidence significantly, and it caused major bleeding when administered at high doses.

A large-scale trial showed that the anticoagulant apixaban was more effective than warfarin in preventing stroke and systemic embolism in patients with atrial fibrillation. Moreover, apixaban resulted in substantially less bleeding and lower mortality.

These results were presented at the European Society of Cardiology Congress in Paris on August 28 and published simultaneously online in The New England Journal of Medicine.

The study was funded by the makers of apixaban, Bristol-Myers Squibb, Co. and Pfizer Inc.

The trial, called ARISTOTLE, included 18,201 patients from 1034 clinical sites in 39 countries. Patients were randomized to receive either apixaban or warfarin at 5 mg twice daily for an average of 1.8 years.

“[W]hen compared to warfarin..., apixaban resulted in an additional 21% relative reduction in stroke or systemic embolism,” said lead study author Christopher B. Granger, MD, of Duke University. “It also resulted in a 31% relative reduction in major bleeding, as well as an 11% relative reduction in overall mortality.”

The improvement in stroke prevention was statistically significant (P = 0.011), as was the lower rate of major bleeding (P < 0.001) and the lower mortality (P = 0.047). Hemorrhagic stroke was reduced by about 50%.

The benefits of stroke reduction and lower rates of bleeding were consistent across all major subgroups and despite the heterogeneity that exists in the quality of warfarin use across the world, according to John Alexander, MD, a study co-author and Duke cardiologist.

The number of events prevented per 1000 people, which indicate absolute risk reduction, was also impressive, Dr Alexander said. Apixaban prevented 6 patients from having a stroke, 15 patients from having major bleeding, and 8 patients from dying.

“There is an enormous unmet need for treatment of patients at risk for stroke associated with atrial fibrillation,” Dr Granger said. “Only about half of patients who should be treated are being treated. The disparity exists because warfarin treatment has several limitations.”

These limitations include regular blood tests to monitor and adjust warfarin dose, as well as the need to avoid certain foods and medications that interfere with warfarin's efficacy. Warfarin has also been shown to increase bleeding risk, including intracranial hemorrhage.

“Our study indicates treatment with apixaban is more effective than warfarin in preventing stroke, without the need for anticoagulation monitoring,” said the study committee's co-chair Lars Wallentin, MD, of the Uppsala Clinical Research Center University Hospital in Sweden.

The study also shows apixaban is safer than warfarin, Dr Wallentin said. “Our findings show a single dose of apixaban accomplishes the same stroke prevention goal as adjusted-dose warfarin, with a substantially lower risk of all types of bleeding across different ages and with lower rates of discontinuation.”

Though these results suggest apixaban is a promising drug, it is important to note that other studies of apixaban have produced mixed results.

A study published in The New England Journal of Medicine on July 24 showed that apixaban increased major bleeding in patients with acute coronary syndrome, without reducing recurrent ischemic events.

A study presented at the American Stroke Association’s International Stroke Conference 2011 found apixaban to be “far superior” to aspirin at preventing stroke in atrial fibrillation patients who could not use vitamin K antagonists.

The ADVANCE-2 study suggested apixaban was more effective at preventing venous thromboembolism than enoxaparin in patients who had elective total knee replacement surgery. However, the earlier ADVANCE study indicated apixaban was not more effective than enoxaparin.

And a study presented at the European Society of Cardiology Conference in 2008 found that apixaban lowered the incidence of heart attack, stroke, chest pain, or death from cardiovascular problems when compared to placebo. However, the drug did not lower the incidence significantly, and it caused major bleeding when administered at high doses.

A large-scale trial showed that the anticoagulant apixaban was more effective than warfarin in preventing stroke and systemic embolism in patients with atrial fibrillation. Moreover, apixaban resulted in substantially less bleeding and lower mortality.

These results were presented at the European Society of Cardiology Congress in Paris on August 28 and published simultaneously online in The New England Journal of Medicine.

The study was funded by the makers of apixaban, Bristol-Myers Squibb, Co. and Pfizer Inc.

The trial, called ARISTOTLE, included 18,201 patients from 1034 clinical sites in 39 countries. Patients were randomized to receive either apixaban or warfarin at 5 mg twice daily for an average of 1.8 years.

“[W]hen compared to warfarin..., apixaban resulted in an additional 21% relative reduction in stroke or systemic embolism,” said lead study author Christopher B. Granger, MD, of Duke University. “It also resulted in a 31% relative reduction in major bleeding, as well as an 11% relative reduction in overall mortality.”

The improvement in stroke prevention was statistically significant (P = 0.011), as was the lower rate of major bleeding (P < 0.001) and the lower mortality (P = 0.047). Hemorrhagic stroke was reduced by about 50%.

The benefits of stroke reduction and lower rates of bleeding were consistent across all major subgroups and despite the heterogeneity that exists in the quality of warfarin use across the world, according to John Alexander, MD, a study co-author and Duke cardiologist.

The number of events prevented per 1000 people, which indicate absolute risk reduction, was also impressive, Dr Alexander said. Apixaban prevented 6 patients from having a stroke, 15 patients from having major bleeding, and 8 patients from dying.

“There is an enormous unmet need for treatment of patients at risk for stroke associated with atrial fibrillation,” Dr Granger said. “Only about half of patients who should be treated are being treated. The disparity exists because warfarin treatment has several limitations.”

These limitations include regular blood tests to monitor and adjust warfarin dose, as well as the need to avoid certain foods and medications that interfere with warfarin's efficacy. Warfarin has also been shown to increase bleeding risk, including intracranial hemorrhage.

“Our study indicates treatment with apixaban is more effective than warfarin in preventing stroke, without the need for anticoagulation monitoring,” said the study committee's co-chair Lars Wallentin, MD, of the Uppsala Clinical Research Center University Hospital in Sweden.

The study also shows apixaban is safer than warfarin, Dr Wallentin said. “Our findings show a single dose of apixaban accomplishes the same stroke prevention goal as adjusted-dose warfarin, with a substantially lower risk of all types of bleeding across different ages and with lower rates of discontinuation.”

Though these results suggest apixaban is a promising drug, it is important to note that other studies of apixaban have produced mixed results.

A study published in The New England Journal of Medicine on July 24 showed that apixaban increased major bleeding in patients with acute coronary syndrome, without reducing recurrent ischemic events.

A study presented at the American Stroke Association’s International Stroke Conference 2011 found apixaban to be “far superior” to aspirin at preventing stroke in atrial fibrillation patients who could not use vitamin K antagonists.

The ADVANCE-2 study suggested apixaban was more effective at preventing venous thromboembolism than enoxaparin in patients who had elective total knee replacement surgery. However, the earlier ADVANCE study indicated apixaban was not more effective than enoxaparin.

And a study presented at the European Society of Cardiology Conference in 2008 found that apixaban lowered the incidence of heart attack, stroke, chest pain, or death from cardiovascular problems when compared to placebo. However, the drug did not lower the incidence significantly, and it caused major bleeding when administered at high doses.

Crizotinib has been approved to treat locally advanced and metastatic non–small cell lung cancers that express an abnormal anaplastic lymphoma kinase gene, the Food and Drug Administration announced on Aug. 26.

Crizotinib (Xalkori, Pfizer) was approved for the indication in concert with a companion diagnostic test for ALK gene abnormality, called the Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.). Up to 7% of those with NSCLC – typically patients without a history of smoking – have the ALK gene abnormality. Crizotinib, a kinase inhibitor, is a single-agent oral therapy.

"The approval of Xalkori with a specific test allows the selection of patients who are more likely to respond to the drug," Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in a press release announcing the approval. "Targeted therapies such as Xalkori are important options for treating patients with this disease and may ultimately result in fewer side effects."

Crizotinib’s safety and effectiveness were established in two multicenter, single-arm studies enrolling a total of 255 patients with late-stage ALK-positive NSCLC. The studies were designed to measure the percentage of patients who experienced complete or partial cancer shrinkage. Most patients in the studies had received prior chemotherapy.

In one study, the objective response rate was 50% with a median response duration of 42 weeks. In another, the objective response rate was 61% with a median response duration of 48 weeks.

Crizotinib was approved under the FDA’s accelerated approval program, which allows approvals based on clinical data showing a drug’s effect on an end point that is reasonably likely to predict clinical benefit. Further studies will confirm the drug’s clinical benefit.

The most common side effects reported in patients receiving crizotinib included vision disorders, nausea, diarrhea, vomiting, edema, and constipation. Crizotinib has also been associated with potentially life-threatening pneumonitis, which necessitates discontinuation of the drug. Pregnancy also is a contraindication for crizotinib use.

Crizotinib has been approved to treat locally advanced and metastatic non–small cell lung cancers that express an abnormal anaplastic lymphoma kinase gene, the Food and Drug Administration announced on Aug. 26.

Crizotinib (Xalkori, Pfizer) was approved for the indication in concert with a companion diagnostic test for ALK gene abnormality, called the Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.). Up to 7% of those with NSCLC – typically patients without a history of smoking – have the ALK gene abnormality. Crizotinib, a kinase inhibitor, is a single-agent oral therapy.

"The approval of Xalkori with a specific test allows the selection of patients who are more likely to respond to the drug," Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in a press release announcing the approval. "Targeted therapies such as Xalkori are important options for treating patients with this disease and may ultimately result in fewer side effects."

Crizotinib’s safety and effectiveness were established in two multicenter, single-arm studies enrolling a total of 255 patients with late-stage ALK-positive NSCLC. The studies were designed to measure the percentage of patients who experienced complete or partial cancer shrinkage. Most patients in the studies had received prior chemotherapy.

In one study, the objective response rate was 50% with a median response duration of 42 weeks. In another, the objective response rate was 61% with a median response duration of 48 weeks.

Crizotinib was approved under the FDA’s accelerated approval program, which allows approvals based on clinical data showing a drug’s effect on an end point that is reasonably likely to predict clinical benefit. Further studies will confirm the drug’s clinical benefit.

The most common side effects reported in patients receiving crizotinib included vision disorders, nausea, diarrhea, vomiting, edema, and constipation. Crizotinib has also been associated with potentially life-threatening pneumonitis, which necessitates discontinuation of the drug. Pregnancy also is a contraindication for crizotinib use.

Crizotinib has been approved to treat locally advanced and metastatic non–small cell lung cancers that express an abnormal anaplastic lymphoma kinase gene, the Food and Drug Administration announced on Aug. 26.

Crizotinib (Xalkori, Pfizer) was approved for the indication in concert with a companion diagnostic test for ALK gene abnormality, called the Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.). Up to 7% of those with NSCLC – typically patients without a history of smoking – have the ALK gene abnormality. Crizotinib, a kinase inhibitor, is a single-agent oral therapy.

"The approval of Xalkori with a specific test allows the selection of patients who are more likely to respond to the drug," Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in a press release announcing the approval. "Targeted therapies such as Xalkori are important options for treating patients with this disease and may ultimately result in fewer side effects."

Crizotinib’s safety and effectiveness were established in two multicenter, single-arm studies enrolling a total of 255 patients with late-stage ALK-positive NSCLC. The studies were designed to measure the percentage of patients who experienced complete or partial cancer shrinkage. Most patients in the studies had received prior chemotherapy.

In one study, the objective response rate was 50% with a median response duration of 42 weeks. In another, the objective response rate was 61% with a median response duration of 48 weeks.

Crizotinib was approved under the FDA’s accelerated approval program, which allows approvals based on clinical data showing a drug’s effect on an end point that is reasonably likely to predict clinical benefit. Further studies will confirm the drug’s clinical benefit.

The most common side effects reported in patients receiving crizotinib included vision disorders, nausea, diarrhea, vomiting, edema, and constipation. Crizotinib has also been associated with potentially life-threatening pneumonitis, which necessitates discontinuation of the drug. Pregnancy also is a contraindication for crizotinib use.

Section 10332 of the Affordable Care Act (ACA) allows the Centers for Medicare & Medicaid Services (CMS) to provide Medicare claims data to “qualified” private organizations for the purpose of reporting provider performance information. On June 8, CMS issued a proposed rule that includes tight parameters on who qualifies to receive the data, beneficiary privacy protections, and the rights of providers to correct errors before reports are made public. CMS also included estimates of the fees to receive the claims data: $275,000.

The fees are not a price as much as an effort to recoup the expense associated with providing the data. CMS has interpreted expenses to include the cost of providing technical assistance, processing qualified entities’ applications, and monitoring of qualified entities to ensure appropriate use of the data and appropriate adherence to data privacy and security standards.

For hospitalists, the opportunity to access this data presents both positives and negatives. On the positive side, research and QI data sources will be greatly expanded. Currently, it is not unheard of to receive multiple, sometimes contradictory, reports from different sources because they are based on different data from piecemeal claims or measures. This initiative grants the ability to combine private sector data with the enormous amount of data at CMS, which should result in the more useful quality reports. This broad pool of data also will allow for a new level of accuracy when it comes to analyzing quality, efficiency, and resource use.

On the negative side, the expense of obtaining this data could be cost-prohibitive for smaller organizations, and access could end up being limited to those with deeper pockets. Additionally, it will be critical to identify errors and inaccuracies in reports. As a result, hospitalists could be forced to spend time and resources reviewing privately produced performance reports before they are made public.

There is potential in this initiative to change the quality measurement landscape. If done well, the opportunity to combine claims data from both Medicare and the private sector will produce a wealth of information related to how providers and suppliers are performing.

SHM will be voicing support for the concept because it serves to increase performance transparency, not just for hospitalists but for all stakeholders.

Ready to Lead Hospital Medicine?

Join an SHM Committee

Dr. Li

When Kim Dickinson, MD, joined SHM’s Administrators Committee, it expanded her network of HM professionals. It also gave her an opportunity to take some of the best practices in the specialty to others within her company.

For other hospitalists interested in flexing leadership muscles and growing their network of hospitalists, now is the time to apply for positions on more than 30 of SHM’s committees and task forces. Potential applicants are encouraged to apply before January 2012.

Committee information and applications are available at www.hospitalmedicine.org/committees.

“SHM’s committees and task forces are the engines that drive SHM toward a vision of transforming healthcare and revolutionizing patient care in the hospital,” says SHM president Joseph Li, MD, SFHM. “And the broad span of issues covered by our committees gives every aspiring hospitalist an opportunity to channel their energy into something meaningful.”

Dr. Dickinson sees committee participation as a way to learn and grow.

“I always tell people about being on committees,” she says. “It’s a good learning experience for people, and it exposes you to a wide variety of people and different perspectives. What applies to a four-member group is very different than what applies to 40-member group.

“A lot of learning that can come from that.”

SHM’s Atchley Leadership Fund Supports the Next Generation of Hospitalist Leaders

Dr. Atchley

Hospitalist Bill Atchley, MD, SFHM, was there at the beginning of SHM’s Leadership Academy. Now, he’s helping it to endure.

After participating in the first Leadership Academy, he was hooked on the concept and later became a course facilitator.

As much as Bill has been a fixture at Leadership Academy, so has his wife, Anne. There, she saw firsthand her husband’s passion not only for the specialty, but also his passion for helping groom the next generation of hospitalist leaders. The academies also were the place where many got to see Bill and Anne together after hours, a scene that reminds hospitalists that leadership is not a solitary journey, but one to embark on with both colleagues and those closest to us.

When Anne passed in December 2009, following a valiant fight against cancer, Bill worked with SHM to create the Atchley Leadership Fund. The fund honors Anne’s memory by providing partial scholarships for Leadership Academy participants.

Hospitalists can join Bill in paying tribute to Anne and paving the way for new hospitalist leaders in healthcare by making a tax-free donation to the Atchley Leadership Fund. For more information, visit www.hospitalmedicine.org/atchley.

Section 10332 of the Affordable Care Act (ACA) allows the Centers for Medicare & Medicaid Services (CMS) to provide Medicare claims data to “qualified” private organizations for the purpose of reporting provider performance information. On June 8, CMS issued a proposed rule that includes tight parameters on who qualifies to receive the data, beneficiary privacy protections, and the rights of providers to correct errors before reports are made public. CMS also included estimates of the fees to receive the claims data: $275,000.

The fees are not a price as much as an effort to recoup the expense associated with providing the data. CMS has interpreted expenses to include the cost of providing technical assistance, processing qualified entities’ applications, and monitoring of qualified entities to ensure appropriate use of the data and appropriate adherence to data privacy and security standards.

For hospitalists, the opportunity to access this data presents both positives and negatives. On the positive side, research and QI data sources will be greatly expanded. Currently, it is not unheard of to receive multiple, sometimes contradictory, reports from different sources because they are based on different data from piecemeal claims or measures. This initiative grants the ability to combine private sector data with the enormous amount of data at CMS, which should result in the more useful quality reports. This broad pool of data also will allow for a new level of accuracy when it comes to analyzing quality, efficiency, and resource use.

On the negative side, the expense of obtaining this data could be cost-prohibitive for smaller organizations, and access could end up being limited to those with deeper pockets. Additionally, it will be critical to identify errors and inaccuracies in reports. As a result, hospitalists could be forced to spend time and resources reviewing privately produced performance reports before they are made public.

There is potential in this initiative to change the quality measurement landscape. If done well, the opportunity to combine claims data from both Medicare and the private sector will produce a wealth of information related to how providers and suppliers are performing.

SHM will be voicing support for the concept because it serves to increase performance transparency, not just for hospitalists but for all stakeholders.

Ready to Lead Hospital Medicine?

Join an SHM Committee

Dr. Li

When Kim Dickinson, MD, joined SHM’s Administrators Committee, it expanded her network of HM professionals. It also gave her an opportunity to take some of the best practices in the specialty to others within her company.

For other hospitalists interested in flexing leadership muscles and growing their network of hospitalists, now is the time to apply for positions on more than 30 of SHM’s committees and task forces. Potential applicants are encouraged to apply before January 2012.

Committee information and applications are available at www.hospitalmedicine.org/committees.

“SHM’s committees and task forces are the engines that drive SHM toward a vision of transforming healthcare and revolutionizing patient care in the hospital,” says SHM president Joseph Li, MD, SFHM. “And the broad span of issues covered by our committees gives every aspiring hospitalist an opportunity to channel their energy into something meaningful.”

Dr. Dickinson sees committee participation as a way to learn and grow.

“I always tell people about being on committees,” she says. “It’s a good learning experience for people, and it exposes you to a wide variety of people and different perspectives. What applies to a four-member group is very different than what applies to 40-member group.

“A lot of learning that can come from that.”

SHM’s Atchley Leadership Fund Supports the Next Generation of Hospitalist Leaders

Dr. Atchley

Hospitalist Bill Atchley, MD, SFHM, was there at the beginning of SHM’s Leadership Academy. Now, he’s helping it to endure.

After participating in the first Leadership Academy, he was hooked on the concept and later became a course facilitator.

As much as Bill has been a fixture at Leadership Academy, so has his wife, Anne. There, she saw firsthand her husband’s passion not only for the specialty, but also his passion for helping groom the next generation of hospitalist leaders. The academies also were the place where many got to see Bill and Anne together after hours, a scene that reminds hospitalists that leadership is not a solitary journey, but one to embark on with both colleagues and those closest to us.

When Anne passed in December 2009, following a valiant fight against cancer, Bill worked with SHM to create the Atchley Leadership Fund. The fund honors Anne’s memory by providing partial scholarships for Leadership Academy participants.

Hospitalists can join Bill in paying tribute to Anne and paving the way for new hospitalist leaders in healthcare by making a tax-free donation to the Atchley Leadership Fund. For more information, visit www.hospitalmedicine.org/atchley.

Section 10332 of the Affordable Care Act (ACA) allows the Centers for Medicare & Medicaid Services (CMS) to provide Medicare claims data to “qualified” private organizations for the purpose of reporting provider performance information. On June 8, CMS issued a proposed rule that includes tight parameters on who qualifies to receive the data, beneficiary privacy protections, and the rights of providers to correct errors before reports are made public. CMS also included estimates of the fees to receive the claims data: $275,000.

The fees are not a price as much as an effort to recoup the expense associated with providing the data. CMS has interpreted expenses to include the cost of providing technical assistance, processing qualified entities’ applications, and monitoring of qualified entities to ensure appropriate use of the data and appropriate adherence to data privacy and security standards.

For hospitalists, the opportunity to access this data presents both positives and negatives. On the positive side, research and QI data sources will be greatly expanded. Currently, it is not unheard of to receive multiple, sometimes contradictory, reports from different sources because they are based on different data from piecemeal claims or measures. This initiative grants the ability to combine private sector data with the enormous amount of data at CMS, which should result in the more useful quality reports. This broad pool of data also will allow for a new level of accuracy when it comes to analyzing quality, efficiency, and resource use.

On the negative side, the expense of obtaining this data could be cost-prohibitive for smaller organizations, and access could end up being limited to those with deeper pockets. Additionally, it will be critical to identify errors and inaccuracies in reports. As a result, hospitalists could be forced to spend time and resources reviewing privately produced performance reports before they are made public.

There is potential in this initiative to change the quality measurement landscape. If done well, the opportunity to combine claims data from both Medicare and the private sector will produce a wealth of information related to how providers and suppliers are performing.

SHM will be voicing support for the concept because it serves to increase performance transparency, not just for hospitalists but for all stakeholders.

Ready to Lead Hospital Medicine?

Join an SHM Committee

Dr. Li

When Kim Dickinson, MD, joined SHM’s Administrators Committee, it expanded her network of HM professionals. It also gave her an opportunity to take some of the best practices in the specialty to others within her company.

For other hospitalists interested in flexing leadership muscles and growing their network of hospitalists, now is the time to apply for positions on more than 30 of SHM’s committees and task forces. Potential applicants are encouraged to apply before January 2012.

Committee information and applications are available at www.hospitalmedicine.org/committees.

“SHM’s committees and task forces are the engines that drive SHM toward a vision of transforming healthcare and revolutionizing patient care in the hospital,” says SHM president Joseph Li, MD, SFHM. “And the broad span of issues covered by our committees gives every aspiring hospitalist an opportunity to channel their energy into something meaningful.”

Dr. Dickinson sees committee participation as a way to learn and grow.

“I always tell people about being on committees,” she says. “It’s a good learning experience for people, and it exposes you to a wide variety of people and different perspectives. What applies to a four-member group is very different than what applies to 40-member group.

“A lot of learning that can come from that.”

SHM’s Atchley Leadership Fund Supports the Next Generation of Hospitalist Leaders

Dr. Atchley

Hospitalist Bill Atchley, MD, SFHM, was there at the beginning of SHM’s Leadership Academy. Now, he’s helping it to endure.

After participating in the first Leadership Academy, he was hooked on the concept and later became a course facilitator.

As much as Bill has been a fixture at Leadership Academy, so has his wife, Anne. There, she saw firsthand her husband’s passion not only for the specialty, but also his passion for helping groom the next generation of hospitalist leaders. The academies also were the place where many got to see Bill and Anne together after hours, a scene that reminds hospitalists that leadership is not a solitary journey, but one to embark on with both colleagues and those closest to us.

When Anne passed in December 2009, following a valiant fight against cancer, Bill worked with SHM to create the Atchley Leadership Fund. The fund honors Anne’s memory by providing partial scholarships for Leadership Academy participants.

Hospitalists can join Bill in paying tribute to Anne and paving the way for new hospitalist leaders in healthcare by making a tax-free donation to the Atchley Leadership Fund. For more information, visit www.hospitalmedicine.org/atchley.

A new risk prediction model for venous thromboembolism (VTE) that was validated in a recent study in England may portend a quicker way to test patients in the U.S.

A research team from the University of Nottingham in England developed an algorithm to measure a patient’s risk for VTE using data points often already collected by hospitalists, including information about chronic renal disease, heart failure, and body mass index. In the study, the risk prediction equation explained 33% of the variation in women and 34% in men in the validation cohort evaluated at five years (BMJ. 2011;343:d4656). The report added that the D statistic was 1.43 for women and 1.45 for men, while the receiver operating curve statistic was 0.75 for both sexes.

The researchers then created a website where physicians can input a set of data points on patients and generate a risk profile.

"The algorithm should be validated in the U.S., though we have no reason to think it won’t work in the U.S.," senior author Julia Hippisley-Cox, MD, FRCGP, MRCP, professor of clinical epidemiology and general practice at the University of Nottingham wrote in an email. "And assuming it performs well, then it could be used by hospital doctors to systematically risk assess patients for VTE risk on admission. Patients at high risk could be given prophylaxis."

Dr. Hippisley-Cox says it's too early to tell if the site will become a popular reference tool.

"The algorithm is published as open-source software, so anyone can use it for research," she writes. It "would be ... interesting to have a team of academics in the U.S. use it in a research project."

A new risk prediction model for venous thromboembolism (VTE) that was validated in a recent study in England may portend a quicker way to test patients in the U.S.

A research team from the University of Nottingham in England developed an algorithm to measure a patient’s risk for VTE using data points often already collected by hospitalists, including information about chronic renal disease, heart failure, and body mass index. In the study, the risk prediction equation explained 33% of the variation in women and 34% in men in the validation cohort evaluated at five years (BMJ. 2011;343:d4656). The report added that the D statistic was 1.43 for women and 1.45 for men, while the receiver operating curve statistic was 0.75 for both sexes.

The researchers then created a website where physicians can input a set of data points on patients and generate a risk profile.

"The algorithm should be validated in the U.S., though we have no reason to think it won’t work in the U.S.," senior author Julia Hippisley-Cox, MD, FRCGP, MRCP, professor of clinical epidemiology and general practice at the University of Nottingham wrote in an email. "And assuming it performs well, then it could be used by hospital doctors to systematically risk assess patients for VTE risk on admission. Patients at high risk could be given prophylaxis."

Dr. Hippisley-Cox says it's too early to tell if the site will become a popular reference tool.

"The algorithm is published as open-source software, so anyone can use it for research," she writes. It "would be ... interesting to have a team of academics in the U.S. use it in a research project."

A new risk prediction model for venous thromboembolism (VTE) that was validated in a recent study in England may portend a quicker way to test patients in the U.S.

A research team from the University of Nottingham in England developed an algorithm to measure a patient’s risk for VTE using data points often already collected by hospitalists, including information about chronic renal disease, heart failure, and body mass index. In the study, the risk prediction equation explained 33% of the variation in women and 34% in men in the validation cohort evaluated at five years (BMJ. 2011;343:d4656). The report added that the D statistic was 1.43 for women and 1.45 for men, while the receiver operating curve statistic was 0.75 for both sexes.

The researchers then created a website where physicians can input a set of data points on patients and generate a risk profile.

"The algorithm should be validated in the U.S., though we have no reason to think it won’t work in the U.S.," senior author Julia Hippisley-Cox, MD, FRCGP, MRCP, professor of clinical epidemiology and general practice at the University of Nottingham wrote in an email. "And assuming it performs well, then it could be used by hospital doctors to systematically risk assess patients for VTE risk on admission. Patients at high risk could be given prophylaxis."

Dr. Hippisley-Cox says it's too early to tell if the site will become a popular reference tool.

"The algorithm is published as open-source software, so anyone can use it for research," she writes. It "would be ... interesting to have a team of academics in the U.S. use it in a research project."

Clinical question: Is dalteparin better than unfractionated heparin at preventing venous thromboembolism (VTE) in ICU patients?

Background: VTE is an important health problem for critically ill patients, but prevention is possible, with both unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) superior to placebo in previous studies. Studies comparing UFH and LMWH in ICU patients have been inconclusive thus far.

Study design: Randomized controlled trial.

Setting: Sixty-seven ICUs in six countries from 2006 to 2010.

Synopsis: Researchers randomized 3,746 patients who met the enrollment criteria to either the LMWH dalteparin 5,000 units daily or UFH 5,000 IU twice daily. The drug was held if major bleeding occurred or the patient developed thrombocytopenia concerning heparin-induced thrombocytopenia (HIT). Patients were followed until discharge or death. VTE was evaluated by ultrasound two days after ICU admission and then twice weekly.

There was no difference in incidence of VTE in patients receiving dalteparin versus UFH [5.1% vs. 5.8%, HR 0.92 (CI 0.68-1.23), P=0.57]. Fewer pulmonary emboli occurred in the dalteparin group (1.3% vs. 2.3%, HR 0.51, P=0.01). There was no difference in major bleeding or HIT between groups.

Bottom line: Dalteparin and UFH were equally effective at preventing proximal VTE in ICU patients, but dalteparin prevented more pulmonary emboli.

Citation: The PROTECT investigators for the Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Dalteparin versus unfractionated heparin in critically ill patients. N Engl J Med. 2010;364(14):1305-1314.

For more physician reviews of HM-related research, visit our website.

Clinical question: Is dalteparin better than unfractionated heparin at preventing venous thromboembolism (VTE) in ICU patients?

Background: VTE is an important health problem for critically ill patients, but prevention is possible, with both unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) superior to placebo in previous studies. Studies comparing UFH and LMWH in ICU patients have been inconclusive thus far.

Study design: Randomized controlled trial.

Setting: Sixty-seven ICUs in six countries from 2006 to 2010.

Synopsis: Researchers randomized 3,746 patients who met the enrollment criteria to either the LMWH dalteparin 5,000 units daily or UFH 5,000 IU twice daily. The drug was held if major bleeding occurred or the patient developed thrombocytopenia concerning heparin-induced thrombocytopenia (HIT). Patients were followed until discharge or death. VTE was evaluated by ultrasound two days after ICU admission and then twice weekly.

There was no difference in incidence of VTE in patients receiving dalteparin versus UFH [5.1% vs. 5.8%, HR 0.92 (CI 0.68-1.23), P=0.57]. Fewer pulmonary emboli occurred in the dalteparin group (1.3% vs. 2.3%, HR 0.51, P=0.01). There was no difference in major bleeding or HIT between groups.

Bottom line: Dalteparin and UFH were equally effective at preventing proximal VTE in ICU patients, but dalteparin prevented more pulmonary emboli.

Citation: The PROTECT investigators for the Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Dalteparin versus unfractionated heparin in critically ill patients. N Engl J Med. 2010;364(14):1305-1314.

For more physician reviews of HM-related research, visit our website.

Clinical question: Is dalteparin better than unfractionated heparin at preventing venous thromboembolism (VTE) in ICU patients?

Background: VTE is an important health problem for critically ill patients, but prevention is possible, with both unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) superior to placebo in previous studies. Studies comparing UFH and LMWH in ICU patients have been inconclusive thus far.

Study design: Randomized controlled trial.

Setting: Sixty-seven ICUs in six countries from 2006 to 2010.

Synopsis: Researchers randomized 3,746 patients who met the enrollment criteria to either the LMWH dalteparin 5,000 units daily or UFH 5,000 IU twice daily. The drug was held if major bleeding occurred or the patient developed thrombocytopenia concerning heparin-induced thrombocytopenia (HIT). Patients were followed until discharge or death. VTE was evaluated by ultrasound two days after ICU admission and then twice weekly.

There was no difference in incidence of VTE in patients receiving dalteparin versus UFH [5.1% vs. 5.8%, HR 0.92 (CI 0.68-1.23), P=0.57]. Fewer pulmonary emboli occurred in the dalteparin group (1.3% vs. 2.3%, HR 0.51, P=0.01). There was no difference in major bleeding or HIT between groups.

Bottom line: Dalteparin and UFH were equally effective at preventing proximal VTE in ICU patients, but dalteparin prevented more pulmonary emboli.

Citation: The PROTECT investigators for the Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Dalteparin versus unfractionated heparin in critically ill patients. N Engl J Med. 2010;364(14):1305-1314.

For more physician reviews of HM-related research, visit our website.

Micrograph showing HL

The US Food and Drug Administration (FDA) has granted accelerated approval for brentuximab vedotin (Adcetris) to treat patients with Hodgkin lymphoma (HL) and systemic anaplastic large-cell lymphoma (sALCL).

The drug can now be used to treat HL patients after the failure of autologous stem cell transplant (ASCT) or, in patients who are not ASCT candidates, after they fail at least 2 prior multiagent chemotherapy regimens.

Brentuximab vedotin can also be used to treat patients with sALCL after the failure of at least 1 prior multiagent chemotherapy regimen.

About accelerated approval

The FDA instituted its accelerated approval program to allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need. The approval is based on a surrogate endpoint that is not a measure of clinical benefit.

Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. If these confirmatory trials suggest the drug actually provides a clinical benefit, the FDA grants traditional approval for the drug. If the confirmatory trial does not show a clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.

Brentuximab vedotin in HL

Accelerated approval for the HL indication was based on a single-arm, multicenter trial to evaluate the objective response rate of brentuximab vedotin as a single agent. The 102 patients enrolled in the trial had CD30-positive HL that relapsed following ASCT.

Brentuximab vedotin prompted an overall response rate in these patients of 73%, with a median response duration of 6.7 months.

Thirty-two percent of patients achieved a complete remission, with a median duration of 20.5 months. Forty percent of patients achieved a partial remission, with a median duration of 3.5 months.

Brentuximab vedotin in sALCL

Accelerated approval for the treatment of sALCL was based on a single-arm, multicenter trial as well. The study included 58 patients with CD30-positive sALCL who had previously received frontline, multiagent chemotherapy treatment.

The primary efficacy endpoint of overall response rate was achieved in 86% of sALCL patients, with a median duration of 12.6 months.

Fifty-seven percent of patients achieved a complete remission, with a median duration of 13.2 months. Twenty-nine percent of patients achieved a partial response, with a median duration of 2.1 months.

The recommended dose and schedule for both indications is 1.8 mg/kg given intravenously over 30 minutes every 3 weeks. Treatment may last a total of 16 cycles, or until disease progresses or toxicity becomes unacceptable.

The agent, manufactured by Seattle Genetics under the trade name Adcetris, is the first new treatment for HL to be approved by the FDA since 1977 and the first to be indicated for sALCL.

Micrograph showing HL

The US Food and Drug Administration (FDA) has granted accelerated approval for brentuximab vedotin (Adcetris) to treat patients with Hodgkin lymphoma (HL) and systemic anaplastic large-cell lymphoma (sALCL).

The drug can now be used to treat HL patients after the failure of autologous stem cell transplant (ASCT) or, in patients who are not ASCT candidates, after they fail at least 2 prior multiagent chemotherapy regimens.

Brentuximab vedotin can also be used to treat patients with sALCL after the failure of at least 1 prior multiagent chemotherapy regimen.

About accelerated approval

The FDA instituted its accelerated approval program to allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need. The approval is based on a surrogate endpoint that is not a measure of clinical benefit.

Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. If these confirmatory trials suggest the drug actually provides a clinical benefit, the FDA grants traditional approval for the drug. If the confirmatory trial does not show a clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.

Brentuximab vedotin in HL

Accelerated approval for the HL indication was based on a single-arm, multicenter trial to evaluate the objective response rate of brentuximab vedotin as a single agent. The 102 patients enrolled in the trial had CD30-positive HL that relapsed following ASCT.

Brentuximab vedotin prompted an overall response rate in these patients of 73%, with a median response duration of 6.7 months.

Thirty-two percent of patients achieved a complete remission, with a median duration of 20.5 months. Forty percent of patients achieved a partial remission, with a median duration of 3.5 months.

Brentuximab vedotin in sALCL

Accelerated approval for the treatment of sALCL was based on a single-arm, multicenter trial as well. The study included 58 patients with CD30-positive sALCL who had previously received frontline, multiagent chemotherapy treatment.

The primary efficacy endpoint of overall response rate was achieved in 86% of sALCL patients, with a median duration of 12.6 months.

Fifty-seven percent of patients achieved a complete remission, with a median duration of 13.2 months. Twenty-nine percent of patients achieved a partial response, with a median duration of 2.1 months.

The recommended dose and schedule for both indications is 1.8 mg/kg given intravenously over 30 minutes every 3 weeks. Treatment may last a total of 16 cycles, or until disease progresses or toxicity becomes unacceptable.

The agent, manufactured by Seattle Genetics under the trade name Adcetris, is the first new treatment for HL to be approved by the FDA since 1977 and the first to be indicated for sALCL.

Micrograph showing HL

The US Food and Drug Administration (FDA) has granted accelerated approval for brentuximab vedotin (Adcetris) to treat patients with Hodgkin lymphoma (HL) and systemic anaplastic large-cell lymphoma (sALCL).

The drug can now be used to treat HL patients after the failure of autologous stem cell transplant (ASCT) or, in patients who are not ASCT candidates, after they fail at least 2 prior multiagent chemotherapy regimens.

Brentuximab vedotin can also be used to treat patients with sALCL after the failure of at least 1 prior multiagent chemotherapy regimen.

About accelerated approval

The FDA instituted its accelerated approval program to allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need. The approval is based on a surrogate endpoint that is not a measure of clinical benefit.

Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. If these confirmatory trials suggest the drug actually provides a clinical benefit, the FDA grants traditional approval for the drug. If the confirmatory trial does not show a clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.

Brentuximab vedotin in HL

Accelerated approval for the HL indication was based on a single-arm, multicenter trial to evaluate the objective response rate of brentuximab vedotin as a single agent. The 102 patients enrolled in the trial had CD30-positive HL that relapsed following ASCT.

Brentuximab vedotin prompted an overall response rate in these patients of 73%, with a median response duration of 6.7 months.

Thirty-two percent of patients achieved a complete remission, with a median duration of 20.5 months. Forty percent of patients achieved a partial remission, with a median duration of 3.5 months.

Brentuximab vedotin in sALCL

Accelerated approval for the treatment of sALCL was based on a single-arm, multicenter trial as well. The study included 58 patients with CD30-positive sALCL who had previously received frontline, multiagent chemotherapy treatment.

The primary efficacy endpoint of overall response rate was achieved in 86% of sALCL patients, with a median duration of 12.6 months.

Fifty-seven percent of patients achieved a complete remission, with a median duration of 13.2 months. Twenty-nine percent of patients achieved a partial response, with a median duration of 2.1 months.

The recommended dose and schedule for both indications is 1.8 mg/kg given intravenously over 30 minutes every 3 weeks. Treatment may last a total of 16 cycles, or until disease progresses or toxicity becomes unacceptable.

The agent, manufactured by Seattle Genetics under the trade name Adcetris, is the first new treatment for HL to be approved by the FDA since 1977 and the first to be indicated for sALCL.