ORLANDO, FLA. — Early angiography is associated with improved survival in women presenting with acute coronary syndrome, Rasha N. Bazari, M.D., reported at an international conference on women, heart disease, and stroke.

Women who underwent coronary angiography within 2 days of presenting with ACS had a significantly lower 3-year mortality rates than did those who had later procedures (a difference of 7% vs. 20%), said Dr. Bazari of the Henry Ford Heart and Vascular Institute, Detroit.

Angiography beyond 48 hours after presentation was the most significant predictor of mortality, after adjustment for confounding variables (odds ratio 3.7).

Marginal predictors of mortality included older age and lower diastolic blood pressure, she said.

Dr. Bazari and associates reviewed the records of 836 patients (350 women and 486 men) admitted to the hospital during 1997–2000 who underwent angiography during their stay.

The study also showed that fewer women than men admitted during the study period underwent early coronary angiography (63% vs. 74%), she noted.

“Gender should not be a reason to delay early angiography” Dr. Bazari said.

ORLANDO, FLA. — Early angiography is associated with improved survival in women presenting with acute coronary syndrome, Rasha N. Bazari, M.D., reported at an international conference on women, heart disease, and stroke.

Women who underwent coronary angiography within 2 days of presenting with ACS had a significantly lower 3-year mortality rates than did those who had later procedures (a difference of 7% vs. 20%), said Dr. Bazari of the Henry Ford Heart and Vascular Institute, Detroit.

Angiography beyond 48 hours after presentation was the most significant predictor of mortality, after adjustment for confounding variables (odds ratio 3.7).

Marginal predictors of mortality included older age and lower diastolic blood pressure, she said.

Dr. Bazari and associates reviewed the records of 836 patients (350 women and 486 men) admitted to the hospital during 1997–2000 who underwent angiography during their stay.

The study also showed that fewer women than men admitted during the study period underwent early coronary angiography (63% vs. 74%), she noted.

“Gender should not be a reason to delay early angiography” Dr. Bazari said.

ORLANDO, FLA. — Early angiography is associated with improved survival in women presenting with acute coronary syndrome, Rasha N. Bazari, M.D., reported at an international conference on women, heart disease, and stroke.

Women who underwent coronary angiography within 2 days of presenting with ACS had a significantly lower 3-year mortality rates than did those who had later procedures (a difference of 7% vs. 20%), said Dr. Bazari of the Henry Ford Heart and Vascular Institute, Detroit.

Angiography beyond 48 hours after presentation was the most significant predictor of mortality, after adjustment for confounding variables (odds ratio 3.7).

Marginal predictors of mortality included older age and lower diastolic blood pressure, she said.

Dr. Bazari and associates reviewed the records of 836 patients (350 women and 486 men) admitted to the hospital during 1997–2000 who underwent angiography during their stay.

The study also showed that fewer women than men admitted during the study period underwent early coronary angiography (63% vs. 74%), she noted.

“Gender should not be a reason to delay early angiography” Dr. Bazari said.

ORLANDO, FLA. — Women presenting with myocardial infarction continue to receive less intensive treatment and have higher mortality than men with similar presentations, but the gender gap in medical interventions prescribed at hospital discharge may be narrowing, according to studies presented at an international conference on women, heart disease, and stroke.

One retrospective study included nearly 26,700 Swedish patients who were treated for ST-elevation myocardial infarction (STEMI) at cardiac intensive care units during 1997–2001. Reperfusion therapy was administered to 71% of the 17,243 men in the study, compared with 62% of the 9,455 women who participated in the study, Sofia Sederholm Lavesson, M.D., reported.

Men, compared with women, had lower in-hospital mortality (9% vs. 16%), 30-day mortality (11% vs. 18%), and 1-year mortality (16% vs. 25%), said Dr. Lavesson of Linköping (Sweden) University.

After adjustment for numerous confounding factors, women remained significantly less likely than men to receive reperfusion therapy (odds ratio 0.83) and to survive while in the hospital (OR 1.23), she said, noting that the differences between men and women cannot be fully explained by differences in age and comorbidities. “[Greater] age is the main explanation for the higher mortality in women, but less intensive treatment also appears to contribute,” she said.

A similar conclusion was reached in a study of more than 55,000 patients who were admitted to any of 153 different hospitals with a primary diagnosis of Q-wave acute MI during January 2000-June 2004.

Mortality was 13% in the 19,034 women in the study, compared with 7% in the 35,969 men.

Even after adjustment for a total of 24 variables, including age, various comorbidities, and the type of hospital setting that provided the treatment (heart surgery hospital, cath lab hospital, or a hospital with neither a heart surgery or cath lab), men were still shown to be less likely than women to die (OR 0.71).

Additionally, men were more likely than women to be transferred for further treatment (OR 1.24), receive thrombolytics (OR 1.16), receive percutaneous coronary intervention (OR 1.12), and/or receive coronary artery bypass grafting (OR 1.64), reported Allan L. Anderson, M.D., a cardiologist at the Medical City Dallas Hospital.

“Women with Q-wave acute MI continue to have significantly worse mortality rates and receive less revascularization than men,” he concluded, noting that additional research is needed to determine how women with MI can obtain clinical parity with men.

But such parity is being achieved when it comes to the prescribing of medical interventions at hospital discharge in patients who present with heart attack or chest pain, a third study suggests.

That ongoing study showed such men and women are being prescribed appropriate drug interventions at the about the same frequency.

The subanalysis of a National Institutes of Health-funded study of 177 men and 35 women with acute coronary syndrome showed that women were prescribed aspirin, β-blockers, and statins as frequently as men.

However, it also showed that 10% of women with acute coronary syndrome didn't receive aspirin or β-blockers and that more than 30% didn't receive statins, Shu-Fen Wung, Ph.D., and Heather Hiscox of the University of Arizona, Tucson, reported in a poster.

Also, women in this study lived significantly longer than men following their hospitalization (179 days vs. 156 days), with both age and gender showing a significant association with 6-month survival, the investigators noted.

The findings suggest that more people are following the guidelines of the American Heart Association and American College of Cardiology, and that progress is being made in the treatment of both men and women, Dr. Wung said in a statement.

ORLANDO, FLA. — Women presenting with myocardial infarction continue to receive less intensive treatment and have higher mortality than men with similar presentations, but the gender gap in medical interventions prescribed at hospital discharge may be narrowing, according to studies presented at an international conference on women, heart disease, and stroke.

One retrospective study included nearly 26,700 Swedish patients who were treated for ST-elevation myocardial infarction (STEMI) at cardiac intensive care units during 1997–2001. Reperfusion therapy was administered to 71% of the 17,243 men in the study, compared with 62% of the 9,455 women who participated in the study, Sofia Sederholm Lavesson, M.D., reported.

Men, compared with women, had lower in-hospital mortality (9% vs. 16%), 30-day mortality (11% vs. 18%), and 1-year mortality (16% vs. 25%), said Dr. Lavesson of Linköping (Sweden) University.

After adjustment for numerous confounding factors, women remained significantly less likely than men to receive reperfusion therapy (odds ratio 0.83) and to survive while in the hospital (OR 1.23), she said, noting that the differences between men and women cannot be fully explained by differences in age and comorbidities. “[Greater] age is the main explanation for the higher mortality in women, but less intensive treatment also appears to contribute,” she said.

A similar conclusion was reached in a study of more than 55,000 patients who were admitted to any of 153 different hospitals with a primary diagnosis of Q-wave acute MI during January 2000-June 2004.

Mortality was 13% in the 19,034 women in the study, compared with 7% in the 35,969 men.

Even after adjustment for a total of 24 variables, including age, various comorbidities, and the type of hospital setting that provided the treatment (heart surgery hospital, cath lab hospital, or a hospital with neither a heart surgery or cath lab), men were still shown to be less likely than women to die (OR 0.71).

Additionally, men were more likely than women to be transferred for further treatment (OR 1.24), receive thrombolytics (OR 1.16), receive percutaneous coronary intervention (OR 1.12), and/or receive coronary artery bypass grafting (OR 1.64), reported Allan L. Anderson, M.D., a cardiologist at the Medical City Dallas Hospital.

“Women with Q-wave acute MI continue to have significantly worse mortality rates and receive less revascularization than men,” he concluded, noting that additional research is needed to determine how women with MI can obtain clinical parity with men.

But such parity is being achieved when it comes to the prescribing of medical interventions at hospital discharge in patients who present with heart attack or chest pain, a third study suggests.

That ongoing study showed such men and women are being prescribed appropriate drug interventions at the about the same frequency.

The subanalysis of a National Institutes of Health-funded study of 177 men and 35 women with acute coronary syndrome showed that women were prescribed aspirin, β-blockers, and statins as frequently as men.

However, it also showed that 10% of women with acute coronary syndrome didn't receive aspirin or β-blockers and that more than 30% didn't receive statins, Shu-Fen Wung, Ph.D., and Heather Hiscox of the University of Arizona, Tucson, reported in a poster.

Also, women in this study lived significantly longer than men following their hospitalization (179 days vs. 156 days), with both age and gender showing a significant association with 6-month survival, the investigators noted.

The findings suggest that more people are following the guidelines of the American Heart Association and American College of Cardiology, and that progress is being made in the treatment of both men and women, Dr. Wung said in a statement.

ORLANDO, FLA. — Women presenting with myocardial infarction continue to receive less intensive treatment and have higher mortality than men with similar presentations, but the gender gap in medical interventions prescribed at hospital discharge may be narrowing, according to studies presented at an international conference on women, heart disease, and stroke.

One retrospective study included nearly 26,700 Swedish patients who were treated for ST-elevation myocardial infarction (STEMI) at cardiac intensive care units during 1997–2001. Reperfusion therapy was administered to 71% of the 17,243 men in the study, compared with 62% of the 9,455 women who participated in the study, Sofia Sederholm Lavesson, M.D., reported.

Men, compared with women, had lower in-hospital mortality (9% vs. 16%), 30-day mortality (11% vs. 18%), and 1-year mortality (16% vs. 25%), said Dr. Lavesson of Linköping (Sweden) University.

After adjustment for numerous confounding factors, women remained significantly less likely than men to receive reperfusion therapy (odds ratio 0.83) and to survive while in the hospital (OR 1.23), she said, noting that the differences between men and women cannot be fully explained by differences in age and comorbidities. “[Greater] age is the main explanation for the higher mortality in women, but less intensive treatment also appears to contribute,” she said.

A similar conclusion was reached in a study of more than 55,000 patients who were admitted to any of 153 different hospitals with a primary diagnosis of Q-wave acute MI during January 2000-June 2004.

Mortality was 13% in the 19,034 women in the study, compared with 7% in the 35,969 men.

Even after adjustment for a total of 24 variables, including age, various comorbidities, and the type of hospital setting that provided the treatment (heart surgery hospital, cath lab hospital, or a hospital with neither a heart surgery or cath lab), men were still shown to be less likely than women to die (OR 0.71).

Additionally, men were more likely than women to be transferred for further treatment (OR 1.24), receive thrombolytics (OR 1.16), receive percutaneous coronary intervention (OR 1.12), and/or receive coronary artery bypass grafting (OR 1.64), reported Allan L. Anderson, M.D., a cardiologist at the Medical City Dallas Hospital.

“Women with Q-wave acute MI continue to have significantly worse mortality rates and receive less revascularization than men,” he concluded, noting that additional research is needed to determine how women with MI can obtain clinical parity with men.

But such parity is being achieved when it comes to the prescribing of medical interventions at hospital discharge in patients who present with heart attack or chest pain, a third study suggests.

That ongoing study showed such men and women are being prescribed appropriate drug interventions at the about the same frequency.

The subanalysis of a National Institutes of Health-funded study of 177 men and 35 women with acute coronary syndrome showed that women were prescribed aspirin, β-blockers, and statins as frequently as men.

However, it also showed that 10% of women with acute coronary syndrome didn't receive aspirin or β-blockers and that more than 30% didn't receive statins, Shu-Fen Wung, Ph.D., and Heather Hiscox of the University of Arizona, Tucson, reported in a poster.

Also, women in this study lived significantly longer than men following their hospitalization (179 days vs. 156 days), with both age and gender showing a significant association with 6-month survival, the investigators noted.

The findings suggest that more people are following the guidelines of the American Heart Association and American College of Cardiology, and that progress is being made in the treatment of both men and women, Dr. Wung said in a statement.

ORLANDO, FLA. — One in 12 patients with acute MI presents with a concomitant acute potentially life-threatening noncardiac condition at admission, Judith H. Lichtman, Ph.D., reported at the annual meeting of the American College of Cardiology.

None of the current risk-adjustment models for MI patients that are widely used to guide clinical care and benchmark hospital and physician performance take account of these life-threatening noncardiac conditions.

Instead, the prognostic models are restricted to variables that are directly related to the patient's cardiovascular disease. That's largely because the models were developed using data from randomized clinical trials from which patients with significant comorbidities are generally excluded.

As a consequence, the risk-adjustment models fail to account for much of the variation in short-term outcomes in MI patients, explained Dr. Lichtman of Yale University, New Haven.

This is a glaring oversight, she stressed, because those 1 in 12 MI patients who have a dueling potentially life-threatening acute noncardiac condition account for a disproportionate share of total inpatient deaths.

Indeed, in the Prospective Registry Evaluating Outcomes After Myocardial Infarction: Events and Recovery (PREMIER) study such patients had an in-hospital mortality of 20%, compared with 3% in MI patients without such comorbidities.

“We feel that in this study we've identified a very important subgroup of acute MI patients at increased risk for mortality that have really not been previously described in the literature,” Dr. Lichtman added.

The PREMIER registry involved 3,948 acute myocardial infarction patients prospectively enrolled at 19 participating U.S. medical centers during 2003–2004. Chart review showed that 8% of these patients enrolled had an acute potentially life-threatening noncardiac condition present at the time of their admission.

These were not chronic conditions such as arthritis or seizure disorders. The most common of these conditions included severe pneumonia requiring intubation, trauma, stroke, sepsis, severe GI bleeding, and hip fracture.

Patients who present with one of these conditions in addition to an acute MI typically have been found to require care from multiple specialists, including both cardiovascular and noncardiovascular.

The MI patients with acute potentially life-threatening noncardiac conditions in PREMIER presented differently from those with MI alone. They were older—a mean age of 62 years compared with 56—and more likely to be women and nonwhite.

They also were more likely to have diabetes and hypertension and less likely to present with ST-elevation MI. And they were less likely to receive early therapy with aspirin, fibrinolytic agents, and β-blockers, as recommended in national guidelines.

After adjustment for the lesser use of guideline-based initial therapies for MI in the patients with potentially life-threatening comorbid conditions, along with differences in demographics, prior history, and clinical presentation, the patients still had a 4.9-fold increased risk of in-hospital mortality.

“I think this underscores a strong need to adopt a broader perspective of the clinical factors that contribute to the initial assessment, process of care, and outcomes for acute MI patients. … These factors need to be put on the radar of these risk-adjustment models,” Dr. Lichtman concluded.

Session cochair Eric D. Peterson, M.D., of Duke University in Durham, N.C., who was a coinvestigator in the PREMIER registry, said that while most MI patients with an acute potentially life-threatening noncardiac condition are routinely admitted to coronary care units, it might make more sense for them to go directly to the intensive care unit, where the caregivers are experienced in managing a wider array of very serious medical conditions.

ORLANDO, FLA. — One in 12 patients with acute MI presents with a concomitant acute potentially life-threatening noncardiac condition at admission, Judith H. Lichtman, Ph.D., reported at the annual meeting of the American College of Cardiology.

None of the current risk-adjustment models for MI patients that are widely used to guide clinical care and benchmark hospital and physician performance take account of these life-threatening noncardiac conditions.

Instead, the prognostic models are restricted to variables that are directly related to the patient's cardiovascular disease. That's largely because the models were developed using data from randomized clinical trials from which patients with significant comorbidities are generally excluded.

As a consequence, the risk-adjustment models fail to account for much of the variation in short-term outcomes in MI patients, explained Dr. Lichtman of Yale University, New Haven.

This is a glaring oversight, she stressed, because those 1 in 12 MI patients who have a dueling potentially life-threatening acute noncardiac condition account for a disproportionate share of total inpatient deaths.

Indeed, in the Prospective Registry Evaluating Outcomes After Myocardial Infarction: Events and Recovery (PREMIER) study such patients had an in-hospital mortality of 20%, compared with 3% in MI patients without such comorbidities.

“We feel that in this study we've identified a very important subgroup of acute MI patients at increased risk for mortality that have really not been previously described in the literature,” Dr. Lichtman added.

The PREMIER registry involved 3,948 acute myocardial infarction patients prospectively enrolled at 19 participating U.S. medical centers during 2003–2004. Chart review showed that 8% of these patients enrolled had an acute potentially life-threatening noncardiac condition present at the time of their admission.

These were not chronic conditions such as arthritis or seizure disorders. The most common of these conditions included severe pneumonia requiring intubation, trauma, stroke, sepsis, severe GI bleeding, and hip fracture.

Patients who present with one of these conditions in addition to an acute MI typically have been found to require care from multiple specialists, including both cardiovascular and noncardiovascular.

The MI patients with acute potentially life-threatening noncardiac conditions in PREMIER presented differently from those with MI alone. They were older—a mean age of 62 years compared with 56—and more likely to be women and nonwhite.

They also were more likely to have diabetes and hypertension and less likely to present with ST-elevation MI. And they were less likely to receive early therapy with aspirin, fibrinolytic agents, and β-blockers, as recommended in national guidelines.

After adjustment for the lesser use of guideline-based initial therapies for MI in the patients with potentially life-threatening comorbid conditions, along with differences in demographics, prior history, and clinical presentation, the patients still had a 4.9-fold increased risk of in-hospital mortality.

“I think this underscores a strong need to adopt a broader perspective of the clinical factors that contribute to the initial assessment, process of care, and outcomes for acute MI patients. … These factors need to be put on the radar of these risk-adjustment models,” Dr. Lichtman concluded.

Session cochair Eric D. Peterson, M.D., of Duke University in Durham, N.C., who was a coinvestigator in the PREMIER registry, said that while most MI patients with an acute potentially life-threatening noncardiac condition are routinely admitted to coronary care units, it might make more sense for them to go directly to the intensive care unit, where the caregivers are experienced in managing a wider array of very serious medical conditions.

ORLANDO, FLA. — One in 12 patients with acute MI presents with a concomitant acute potentially life-threatening noncardiac condition at admission, Judith H. Lichtman, Ph.D., reported at the annual meeting of the American College of Cardiology.

None of the current risk-adjustment models for MI patients that are widely used to guide clinical care and benchmark hospital and physician performance take account of these life-threatening noncardiac conditions.

Instead, the prognostic models are restricted to variables that are directly related to the patient's cardiovascular disease. That's largely because the models were developed using data from randomized clinical trials from which patients with significant comorbidities are generally excluded.

As a consequence, the risk-adjustment models fail to account for much of the variation in short-term outcomes in MI patients, explained Dr. Lichtman of Yale University, New Haven.

This is a glaring oversight, she stressed, because those 1 in 12 MI patients who have a dueling potentially life-threatening acute noncardiac condition account for a disproportionate share of total inpatient deaths.

Indeed, in the Prospective Registry Evaluating Outcomes After Myocardial Infarction: Events and Recovery (PREMIER) study such patients had an in-hospital mortality of 20%, compared with 3% in MI patients without such comorbidities.

“We feel that in this study we've identified a very important subgroup of acute MI patients at increased risk for mortality that have really not been previously described in the literature,” Dr. Lichtman added.

The PREMIER registry involved 3,948 acute myocardial infarction patients prospectively enrolled at 19 participating U.S. medical centers during 2003–2004. Chart review showed that 8% of these patients enrolled had an acute potentially life-threatening noncardiac condition present at the time of their admission.

These were not chronic conditions such as arthritis or seizure disorders. The most common of these conditions included severe pneumonia requiring intubation, trauma, stroke, sepsis, severe GI bleeding, and hip fracture.

Patients who present with one of these conditions in addition to an acute MI typically have been found to require care from multiple specialists, including both cardiovascular and noncardiovascular.

The MI patients with acute potentially life-threatening noncardiac conditions in PREMIER presented differently from those with MI alone. They were older—a mean age of 62 years compared with 56—and more likely to be women and nonwhite.

They also were more likely to have diabetes and hypertension and less likely to present with ST-elevation MI. And they were less likely to receive early therapy with aspirin, fibrinolytic agents, and β-blockers, as recommended in national guidelines.

After adjustment for the lesser use of guideline-based initial therapies for MI in the patients with potentially life-threatening comorbid conditions, along with differences in demographics, prior history, and clinical presentation, the patients still had a 4.9-fold increased risk of in-hospital mortality.

“I think this underscores a strong need to adopt a broader perspective of the clinical factors that contribute to the initial assessment, process of care, and outcomes for acute MI patients. … These factors need to be put on the radar of these risk-adjustment models,” Dr. Lichtman concluded.

Session cochair Eric D. Peterson, M.D., of Duke University in Durham, N.C., who was a coinvestigator in the PREMIER registry, said that while most MI patients with an acute potentially life-threatening noncardiac condition are routinely admitted to coronary care units, it might make more sense for them to go directly to the intensive care unit, where the caregivers are experienced in managing a wider array of very serious medical conditions.

NEW ORLEANS — The benefits of emboli protection devices clearly outweigh the risks, with most major centers and trials reporting a 50% reduction in strokes during carotid artery stenting, Alex Abou-Chebl, M.D., reported during the joint annual meeting of the American Association of Neurological Surgeons and the American Society of Interventional and Therapeutic Neuroradiology.

Further, newer generation devices are easier to use, said Dr. Abou-Chebl, an interventional neurologist with the Cleveland Clinic department of neurology.

Transcranial Doppler studies have shown that all patients who undergo angioplasty or stenting of the carotid arteries have emboli. The greatest number of emboli is during the actual intervention, and not during guidewire placement.

Since the filter device is the first to pass through the lesion, it has the potential to trap many emboli and thereby reduce intraoperative events, Dr. Abou-Chebl said. The 30-day stroke rate in most stenting and angioplasty trials before the filter devices were available was quite high, between 5% and 8%.

“We use these devices not because we are going to cause stroke in 100% of patients, but because we are going to cause stroke in 5%–8% of patients, and in these patients we want to have these devices there to help us out,” Dr. Abou-Chebl said.

Newer-generation devices are smaller and generally better tolerated. But the devices can be difficult to deliver in some lesions, increase the complexity of surgery, cause vasospasm and dissection, and fail. Vasospasm discontinues when the device is removed, and although serious, dissection occurs in less than 1% of patients and can be treated, Dr. Abou-Chebl said.

Critics have argued that the devices catch only platelet aggregation and thrombus formation on top of the device. Clinical experience suggests that the majority of particles are thrombotically formed from the carotid plaque, and range in size from 1.1 μm to 5 mm, Dr. Abou-Chebl said.

Dr. Abou-Chebl has placed stents in 187 patients with a filter device and captured particles as large as 4.5 by 5 mm.

Large particles are trapped, but it's the smaller particles that come out of the plaque that mandate the use of some protection device, Lee R. Guterman, M.D., of the department of neurosurgery at the State University of New York at Buffalo said during the same scientific session.

“They cause either permanent or transient neurologic deficit,” said Dr. Guterman, who has participated in all of the major stenting trials.

Emboli protection devices have been added to major angioplasty and stenting trials with consistently better results, with the exception of the Acculink for Revascularization of Carotids in High-Risk Patients (ARCHER) trial.

Dr. Abou-Chebl said he could not explain the ARCHER results, which showed a 30-day all-stroke rate of 7.6% in the first phase without protection, 8.6% in the second phase with embolic protection, and 8.3% in the third phase using the rapid exchange versions of the devices.

Comparatively, data from the Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial showed a 98.6% successful placement rate for the device and an overall stroke and death rate of 3.7% in a high-risk population.

The filter captures particles as large as 4.5 by 5 mm and reduces intraoperative events. Courtesy Dr. Alex Abou-Chebl

NEW ORLEANS — The benefits of emboli protection devices clearly outweigh the risks, with most major centers and trials reporting a 50% reduction in strokes during carotid artery stenting, Alex Abou-Chebl, M.D., reported during the joint annual meeting of the American Association of Neurological Surgeons and the American Society of Interventional and Therapeutic Neuroradiology.

Further, newer generation devices are easier to use, said Dr. Abou-Chebl, an interventional neurologist with the Cleveland Clinic department of neurology.

Transcranial Doppler studies have shown that all patients who undergo angioplasty or stenting of the carotid arteries have emboli. The greatest number of emboli is during the actual intervention, and not during guidewire placement.

Since the filter device is the first to pass through the lesion, it has the potential to trap many emboli and thereby reduce intraoperative events, Dr. Abou-Chebl said. The 30-day stroke rate in most stenting and angioplasty trials before the filter devices were available was quite high, between 5% and 8%.

“We use these devices not because we are going to cause stroke in 100% of patients, but because we are going to cause stroke in 5%–8% of patients, and in these patients we want to have these devices there to help us out,” Dr. Abou-Chebl said.

Newer-generation devices are smaller and generally better tolerated. But the devices can be difficult to deliver in some lesions, increase the complexity of surgery, cause vasospasm and dissection, and fail. Vasospasm discontinues when the device is removed, and although serious, dissection occurs in less than 1% of patients and can be treated, Dr. Abou-Chebl said.

Critics have argued that the devices catch only platelet aggregation and thrombus formation on top of the device. Clinical experience suggests that the majority of particles are thrombotically formed from the carotid plaque, and range in size from 1.1 μm to 5 mm, Dr. Abou-Chebl said.

Dr. Abou-Chebl has placed stents in 187 patients with a filter device and captured particles as large as 4.5 by 5 mm.

Large particles are trapped, but it's the smaller particles that come out of the plaque that mandate the use of some protection device, Lee R. Guterman, M.D., of the department of neurosurgery at the State University of New York at Buffalo said during the same scientific session.

“They cause either permanent or transient neurologic deficit,” said Dr. Guterman, who has participated in all of the major stenting trials.

Emboli protection devices have been added to major angioplasty and stenting trials with consistently better results, with the exception of the Acculink for Revascularization of Carotids in High-Risk Patients (ARCHER) trial.

Dr. Abou-Chebl said he could not explain the ARCHER results, which showed a 30-day all-stroke rate of 7.6% in the first phase without protection, 8.6% in the second phase with embolic protection, and 8.3% in the third phase using the rapid exchange versions of the devices.

Comparatively, data from the Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial showed a 98.6% successful placement rate for the device and an overall stroke and death rate of 3.7% in a high-risk population.

The filter captures particles as large as 4.5 by 5 mm and reduces intraoperative events. Courtesy Dr. Alex Abou-Chebl

NEW ORLEANS — The benefits of emboli protection devices clearly outweigh the risks, with most major centers and trials reporting a 50% reduction in strokes during carotid artery stenting, Alex Abou-Chebl, M.D., reported during the joint annual meeting of the American Association of Neurological Surgeons and the American Society of Interventional and Therapeutic Neuroradiology.

Further, newer generation devices are easier to use, said Dr. Abou-Chebl, an interventional neurologist with the Cleveland Clinic department of neurology.

Transcranial Doppler studies have shown that all patients who undergo angioplasty or stenting of the carotid arteries have emboli. The greatest number of emboli is during the actual intervention, and not during guidewire placement.

Since the filter device is the first to pass through the lesion, it has the potential to trap many emboli and thereby reduce intraoperative events, Dr. Abou-Chebl said. The 30-day stroke rate in most stenting and angioplasty trials before the filter devices were available was quite high, between 5% and 8%.

“We use these devices not because we are going to cause stroke in 100% of patients, but because we are going to cause stroke in 5%–8% of patients, and in these patients we want to have these devices there to help us out,” Dr. Abou-Chebl said.

Newer-generation devices are smaller and generally better tolerated. But the devices can be difficult to deliver in some lesions, increase the complexity of surgery, cause vasospasm and dissection, and fail. Vasospasm discontinues when the device is removed, and although serious, dissection occurs in less than 1% of patients and can be treated, Dr. Abou-Chebl said.

Critics have argued that the devices catch only platelet aggregation and thrombus formation on top of the device. Clinical experience suggests that the majority of particles are thrombotically formed from the carotid plaque, and range in size from 1.1 μm to 5 mm, Dr. Abou-Chebl said.

Dr. Abou-Chebl has placed stents in 187 patients with a filter device and captured particles as large as 4.5 by 5 mm.

Large particles are trapped, but it's the smaller particles that come out of the plaque that mandate the use of some protection device, Lee R. Guterman, M.D., of the department of neurosurgery at the State University of New York at Buffalo said during the same scientific session.

“They cause either permanent or transient neurologic deficit,” said Dr. Guterman, who has participated in all of the major stenting trials.

Emboli protection devices have been added to major angioplasty and stenting trials with consistently better results, with the exception of the Acculink for Revascularization of Carotids in High-Risk Patients (ARCHER) trial.

Dr. Abou-Chebl said he could not explain the ARCHER results, which showed a 30-day all-stroke rate of 7.6% in the first phase without protection, 8.6% in the second phase with embolic protection, and 8.3% in the third phase using the rapid exchange versions of the devices.

Comparatively, data from the Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial showed a 98.6% successful placement rate for the device and an overall stroke and death rate of 3.7% in a high-risk population.

The filter captures particles as large as 4.5 by 5 mm and reduces intraoperative events. Courtesy Dr. Alex Abou-Chebl

1. Esper F, Shapiro ED, Weibel C, et al. Association between a novel human coronavirus and Kawasaki disease. J Infect Dis. 2005;191:499-502.

Kawasaki disease, a systemic vasculitis of childhood, is the most common cause of childhood acquired heart disease in developed countries and frequently a diagnosis made in the inpatient setting. Although the etiology of Kawasaki disease is not known, there is evidence to suggest the disease may be triggered by an infectious agent. This evidence includes wavelike spread in countries, seasonal epidemics, and the rarity of Kawasaki disease in adults and infants less than 3 months old. Even more compelling is the recent identification by Rowley et al. Of an antigen of unknown origin in respiratory epithelial cells and macrophages from children with Kawasaki disease (1).

Despite suggestion that retroviruses, Epstein–Barr virus, parvovirus B19, or chlamydia may be important in the pathogenesis of Kawasaki disease, no infectious etiology has been proven. In this brief report, Esper et al. document the interesting finding of a novel human coronavirus, “New Haven coronavirus” (HCoVNH), in the respiratory secretions of a 6-month old infant diagnosed with Kawasaki disease. Subsequently, the authors performed a retrospective, case-controlled study of 11 Kawasaki disease patients less than 5 years of age from whom respiratory secretions were archived but had tested negative for respiratory syncytial virus, influenza viruses A and B, parainfluenza viruses 1–3, and adenovirus by direct fluorescent antibody assay. These patients were matched with 2 control subjects. Eight (72.7%) of 11 case subjects and 1 (4.5%) of the 22 control subjects tested positive for HCoVNH by reverse transcriptase polymerase chain reaction (p=.0015). Further studies are needed to determine the precise role this, or other infectious pathogens, may have in the pathogenesis of the disease.

Reference

1. Rowley AH, Baker SC, Shulman ST, et al. Detection of antigen in bronchial epithelium and macrophages in acute Kawasaki disease by use of synthetic antibody. J Infect Dis. 2004;190:856-65.

2. Eyaid WM, AlNouri DM, Rashed MS, et al. An inborn error of metabolism presenting as hypoxicischemic insult. Pediatr Neurol. 2005;32:134-6.

Inborn error of metabolism is frequently on the “bottom” of many differential diagnoses lists for common pediatric presenting complaints. Relative infrequency coupled with the occasional difficulty of making an accurate diagnosis presents unique challenges. Nonetheless, the importance of making this diagnosis is essential, given the frequent opportunity for pharmacologic and/ or dietary intervention to be therapeutic.

These authors present an interesting case of siblings presenting with seizures and central nervous system imaging consistent with hypoxicischemic insult who were subsequently diagnosed with isolated sulfite oxidase deficiency.

1. Esper F, Shapiro ED, Weibel C, et al. Association between a novel human coronavirus and Kawasaki disease. J Infect Dis. 2005;191:499-502.

Kawasaki disease, a systemic vasculitis of childhood, is the most common cause of childhood acquired heart disease in developed countries and frequently a diagnosis made in the inpatient setting. Although the etiology of Kawasaki disease is not known, there is evidence to suggest the disease may be triggered by an infectious agent. This evidence includes wavelike spread in countries, seasonal epidemics, and the rarity of Kawasaki disease in adults and infants less than 3 months old. Even more compelling is the recent identification by Rowley et al. Of an antigen of unknown origin in respiratory epithelial cells and macrophages from children with Kawasaki disease (1).

Despite suggestion that retroviruses, Epstein–Barr virus, parvovirus B19, or chlamydia may be important in the pathogenesis of Kawasaki disease, no infectious etiology has been proven. In this brief report, Esper et al. document the interesting finding of a novel human coronavirus, “New Haven coronavirus” (HCoVNH), in the respiratory secretions of a 6-month old infant diagnosed with Kawasaki disease. Subsequently, the authors performed a retrospective, case-controlled study of 11 Kawasaki disease patients less than 5 years of age from whom respiratory secretions were archived but had tested negative for respiratory syncytial virus, influenza viruses A and B, parainfluenza viruses 1–3, and adenovirus by direct fluorescent antibody assay. These patients were matched with 2 control subjects. Eight (72.7%) of 11 case subjects and 1 (4.5%) of the 22 control subjects tested positive for HCoVNH by reverse transcriptase polymerase chain reaction (p=.0015). Further studies are needed to determine the precise role this, or other infectious pathogens, may have in the pathogenesis of the disease.

Reference

1. Rowley AH, Baker SC, Shulman ST, et al. Detection of antigen in bronchial epithelium and macrophages in acute Kawasaki disease by use of synthetic antibody. J Infect Dis. 2004;190:856-65.

2. Eyaid WM, AlNouri DM, Rashed MS, et al. An inborn error of metabolism presenting as hypoxicischemic insult. Pediatr Neurol. 2005;32:134-6.

Inborn error of metabolism is frequently on the “bottom” of many differential diagnoses lists for common pediatric presenting complaints. Relative infrequency coupled with the occasional difficulty of making an accurate diagnosis presents unique challenges. Nonetheless, the importance of making this diagnosis is essential, given the frequent opportunity for pharmacologic and/ or dietary intervention to be therapeutic.

These authors present an interesting case of siblings presenting with seizures and central nervous system imaging consistent with hypoxicischemic insult who were subsequently diagnosed with isolated sulfite oxidase deficiency.

1. Esper F, Shapiro ED, Weibel C, et al. Association between a novel human coronavirus and Kawasaki disease. J Infect Dis. 2005;191:499-502.

Kawasaki disease, a systemic vasculitis of childhood, is the most common cause of childhood acquired heart disease in developed countries and frequently a diagnosis made in the inpatient setting. Although the etiology of Kawasaki disease is not known, there is evidence to suggest the disease may be triggered by an infectious agent. This evidence includes wavelike spread in countries, seasonal epidemics, and the rarity of Kawasaki disease in adults and infants less than 3 months old. Even more compelling is the recent identification by Rowley et al. Of an antigen of unknown origin in respiratory epithelial cells and macrophages from children with Kawasaki disease (1).

Despite suggestion that retroviruses, Epstein–Barr virus, parvovirus B19, or chlamydia may be important in the pathogenesis of Kawasaki disease, no infectious etiology has been proven. In this brief report, Esper et al. document the interesting finding of a novel human coronavirus, “New Haven coronavirus” (HCoVNH), in the respiratory secretions of a 6-month old infant diagnosed with Kawasaki disease. Subsequently, the authors performed a retrospective, case-controlled study of 11 Kawasaki disease patients less than 5 years of age from whom respiratory secretions were archived but had tested negative for respiratory syncytial virus, influenza viruses A and B, parainfluenza viruses 1–3, and adenovirus by direct fluorescent antibody assay. These patients were matched with 2 control subjects. Eight (72.7%) of 11 case subjects and 1 (4.5%) of the 22 control subjects tested positive for HCoVNH by reverse transcriptase polymerase chain reaction (p=.0015). Further studies are needed to determine the precise role this, or other infectious pathogens, may have in the pathogenesis of the disease.

Reference

1. Rowley AH, Baker SC, Shulman ST, et al. Detection of antigen in bronchial epithelium and macrophages in acute Kawasaki disease by use of synthetic antibody. J Infect Dis. 2004;190:856-65.

2. Eyaid WM, AlNouri DM, Rashed MS, et al. An inborn error of metabolism presenting as hypoxicischemic insult. Pediatr Neurol. 2005;32:134-6.

Inborn error of metabolism is frequently on the “bottom” of many differential diagnoses lists for common pediatric presenting complaints. Relative infrequency coupled with the occasional difficulty of making an accurate diagnosis presents unique challenges. Nonetheless, the importance of making this diagnosis is essential, given the frequent opportunity for pharmacologic and/ or dietary intervention to be therapeutic.

These authors present an interesting case of siblings presenting with seizures and central nervous system imaging consistent with hypoxicischemic insult who were subsequently diagnosed with isolated sulfite oxidase deficiency.

Calicitonin Precusors and IL-8 as a Screen Panel for Bacterial Sepsis

Stryjewski GR, Nylen ES, Bell MJ, et al. Interleukin-6, interleukin-8, and a rapid and sensitive assay for calcitonin precursors for the determination of bacterial sepsis in febrile neutropenic children. Pediatr Crit Care Med. 2005;6:129-35.

Identification of sensitive and specific markers for serious bacterial infection (SBI) in children has commanded significant attention in recent literature. These researchers present a prospective cohort study of 56 children aged 5 months to 17 years (median 6.7 years) with fever (axillary temperature ≥37.5°C or oral temperature ≥38°C) and neutropenia (absolute neutrophil count ≤500/mm³) admitted to Children’s National Medical Center during a 15-month period. Researchers hypothesized that a highly sensitive assay for calcitonin precursors (CTpr) would detect levels of CTpr early in the course of illness, and that these levels in conjunction with measured levels of the cytokines interleukin (IL)-6 and IL-8 would provide a sensitive and specific set of markers for diagnosing bacterial sepsis in the study population. Markers were measured at admission, at 24 hours and at 48 hours. CTpr at 24 hours (adjusted odds ratio [95% confidence interval], 1.8 [1.2–2.8], p=.001) and IL8 (at 48 hours 1.08 [1.2–2.8], p=.02) were found to have association with bacterial sepsis. The authors conclude that based on the data generated, using cutoff values of 500 pg/mL for CTpr at 24 hours and 20 pg/mL for IL-8 at 48 hours would provide a sensitivity of 94% and specificity of 90%. Reliable biochemical markers that are highly associated with SBI and/or sepsis will likely improve the care of pediatric patients by guiding more specific therapy and potentially limiting exposure to unnecessary antibiotic . The results of this study cannot be generalized to all pediatric patients with fever and risk for SBI, due to the unique attributes of the study population. However, the study does provide information for future research into the development of markers and/or scoring systems to aid in the early diagnosis of SBI/sepsis in the general pediatric population.

Which Tests are Helpful and Cost-Effective in the Evaluation of Pediatric Syncope?

Steinberg LA, Knilans TK. Syncope in children: diagnostic tests have a high cost and low yield. J Pediatr. 2005;146:355-8.

Evaluation of syncope in children is not uncommon. This evaluation can often include multiple expensive tests, and evidence defining the most efficacious and cost-effective course of evaluation is lacking. Researchers from the Children’s Heart Center at St. Vincent Hospital in Indianapolis and the Division of Cardiology at Children’s Hospital Medical Center in Cincinnati present a retrospective review of 169 patients aged 4.5 to 18.7 years (mean, 13.1 ± 3.6) presenting to a tertiary care center for evaluation of transient loss of consciousness associated with loss of postural tone to describe the cost and utility of testing used to make a diagnosis. Costs were based on hospital costs for 1999 and did not include professional fees, the cost of clinic evaluations, or hospital admissions. There are significant limitations in the study design, and these are adequately discussed by the authors. A diagnosis was established in 128 patients (76%), and neurocardiogenic syncope was the most common diagnosis occurring in 116 patients (68%). Other diagnoses included seizure disorder (3 patients), pseudoseizure (2), anxiety disorder (2), psychogenic syncope (2) and 1 patient each with breathholding spells, long QT syndrome, and exertonal ventricular tachycardia. Tilt-testing had the highest diagnostic yield, although the researchers aptly point out that in the literature the specificity of tilt-testing ranges from 48 to 100% and that this test is rarely required to diagnose neurocardiogenic syncope, the most frequent diagnosis in this review. Loop memory cardiac monitoring had the lowest cost per diagnostic result. Electrocardiography had the lowest diagnostic yield and highest cost per test. Echocardiogram, chest radiograph, cardiac catheterization, electrophysiology studies, and evaluation of serum and body fluids were not diagnostic in this series. This respective review highlights the need for a consistent, evidence-based approach to this common presenting problem while emphasizing the importance of judicious testing guided by a thorough history and physical exam.

An Increase in Severe Community Acquired MRSA Infections in Texas

Gonzales BE, Martinez-Aguilar G, Hulten KG, et al. Severe staphylococcal sepsis in adolescents in the era of community-acquired methicillin-resistant Staphylococcus aureus. Pediatrics. 2005;115:642-8.

Gonzales et al. describe data prospectively gathered since August 1, 2001, showing an increase in the number of severely ill patients with community acquired (CA) Staphylococcus aureus infections. Fourteen patients with a mean age of 12.9 years (range: 10–15 years) were admitted to the PICU with sepsis. Twelve patients had CA methicillin-resistant S. aureus (CAMRSA). Thirteen patients (93%) had bone and joint infections. Thirteen patients had pulmonary involvement. Acute prerenal failure and peripheral vascular thrombosis were present in 50% and 29% of patients, respectively. Thirteen patients were bacteremic. All CAMRSA isolates were resistant to erythromycin, without inducible resistance to clindamycin. The review is interesting in light of the other literature reviewed by the authors suggesting a trend toward more severe infections caused by CAMRSA.

TheoPhylline vs. Terubutaline in Critically III Asthmatics

Wheeler DS, Jacobs BR, Kenreigh CA, et al. Theophylline versus terbutaline in treating critically ill children with status asthmaticus: A prospective, randomized, controlled trial. Pediatr Crit Care Med. 2005;6:142-7.

Status asthmaticus is a common diagnosis on the pediatric inpatient unit and in the pediatric intensive care unit (PICU). Inhaled beta-2 agonists, systemic corticosteroids, and supplemental oxygen are accepted as the standard of care for children with status asthmaticus who require admission. For critically ill children who are poorly responsive to the aforementioned triad of therapy, both theophylline and terbutaline are considered possible adjunctive therapies. Wheeler et al. suggest that the many studies failing to demonstrate added benefit of theophylline in non–critically ill patients has decreased the use of theophylline in the critical care setting, but point out that recent studies involving critically ill populations with status asthmaticus treated with theophylline have suggested benefit with comparison to placebo. Therefore, these researchers present a randomized, prospective, controlled, double-blind trial comparing the efficacy of theophylline alone, terbutaline alone, and theophylline and terbutaline together in critically ill pediatric patients receiving continuous nebulized albuterol and intravenous steroids. Forty patients with impending respiratory failure between the ages of 3 and 15 years were randomized to 1 of 3 groups: theophylline plus placebo (group 1), terbutaline plus placebo (group 2), or theophylline and terbutaline together (group 3). Thirty-six patients completed the study; 3 patients from group 1 were withdrawn due to parental request secondary to agitation (2 patients) and being inadvertently placed on a terbutaline infusion (1 patient). One patient from group 3 was withdrawn by the treating physician due to lack of improvement. All study participants, with the exception of the study pharmacist, were blinded to group assignment. Adjunctive therapies, including magnesium, ipatropium bromide and ketamine, were utilized at the discretion of the treating physician and were not controlled for. The primary outcome variable was change in a clinical scoring tool. Secondary outcomes variables included time to a specific clinical score, length of stay in the PICU, progression to mechanical ventilation, and incidence of adverse events. In addition, a cost analysis was performed isolating the 3 groups based on fiscal year 2003 cost estimates for theophylline and terbutaline. Results demonstrated no difference in the primary or secondary clinical outcome measures, with the exception of a higher incidence of nausea in group 3. The hospital costs were significantly lower in group 1 compared with groups 2 and 3 ($280 vs. $3,908 vs. $4,045, respectively, p<.0001). Significant limitations to the study include the lack of control of adjunctive therapies, a small sample size that confounds the ability to conclude no clinical difference between groups, and a baseline Pediatric Risk of Mortality (PRISM) Score in group 3 compared with groups 1 and 2. Despite these limitations the researchers suggest that the addition of intravenous theophylline to continuous nebulized albuterol and corticosteroids in the management of critically ill children with status asthmaticus is as safe and effective as adding intravenous terbutaline while being more cost-effective. Subsequent larger, well-controlled studies are required to support this conclusion.

Can Computerized Physician Ordering Create Errors?

Koppel R, Metlay JP, Cohen A, et al. Role of computerized physician order entry systems in facilitating medication errors. JAMA. 2005;293:1197-203.

Adverse drug events are a frequent etiology of inpatient morbidity and prescribing errors are the most frequent source. Computerized physician order entry (CPOE) is touted as a potential remedy for some types of adverse drug events. Few studies have investigated the potential for novel medication errors generated by a change to CPOE from conventional ordering. Koppel et al. present a quantitative and qualitative study of medication errors caused or exacerbated by a CPOE system. Interviews, surveys, and focus groups were the primary means of data collection. Housestaff who typically enter more than 9 orders per month were the primary study population, but data collection also included pharmacists, nursing staff , information technology managers, and attending physicians. The study was conducted in a tertiary-care teaching hospital between 2002 and 2004 utilizing a CPOE system in place since 1997. The CPOE system utilized is described as “monochromatic” and having “pre-Windows interfaces.” While not integrated with all hospital functions, the system was integrated with pharmacy and nursing medication lists. Researchers grouped errors into two broad categories: (1) information errors (fragmentation and systems integration failure) and (2) human-machine interface flaws (machine rules that do not correspond to work organization or usual behaviors). In total, 22 types of errors were recorded.

An example of an “information error” is assumed and incorrect dose information based on viewing doses intended only to describe pharmacy stocking practice―i.e. assuming that because the pharmacy stocks a 10mg dose of a medication, 10mg is an appropriate “minimally effective” dose. A “human-machine interface error” example is selecting an incorrect patient for ordering due to properties of the CPOE screen, such as the patient name not appearing on all screens. There are several important limitations to this study, but perhaps most important is the inability to generalize this data to other settings with potentially different physician users and software. Also important is a lack of description regarding physician user training and/or correlation of errors with amount of training or frequency of use, considering that the study population was defined as housestaff who may only use the system for 9 orders each . Despite these limitations, the study represents a requisite component to the growing trend toward the complete electronic record―namely, the use of objective investigations to study the safety and effectiveness of CPOE and the electronic record to promote the most optimal implementation and evolution of this new clinical tool.

Single-Dose Azithromycin for Acute Otitis Media

Arguedas A, Emparanza P, Schwartz RH, et al. A randomized, multicenter, double blind, double dummy trial of single dose azithromycin versus high dose amoxicillin for treatment of uncomplicated acute otitis media. Pediatr Infect Dis J. 2005;24: 153-61.

Acute otitis media is a common comorbid condition in pediatric inpatients. Patients at risk of having AOM with drug-resistant Streptococcus pneumoniae can be treated with high-dose amoxicillin as a first-line therapy according to recent American Academy of Pediatrics (AAP) recommendations. Despite this recommendation, there is evidence of reduced in vitro activity of amoxicillin against β-lactamase-producing Haemophilus influenzae and Moraxella catarrhalis, as well as a lack of data from controlled and blinded studies demonstrating efficacy, adverse events and compliance for high-dose regimens. Azithromycin has in vitro activity against the 4 pathogens of clinical significance in AOM, and studies have shown that a single-dose regimen of azithromycin by the oral route is pharmacokinetically feasible, safe, and comparable in success rate to 3- and 5-day azithromycin regimens. With these considerations in mind, Arguedas et al. designed this study to compare single-dose (30 mg/kg) azithromycin with high-dose (90 mg/kg/day) amoxicillin in uncomplicated AOM.

In this double-blind, double-dummy, multinational, clinical trial, children between the ages of 6 and 30 months with uncomplicated AOM were randomized to treatment with single-dose azithromycin or high-dose amoxicillin (90 mg/kg/day, in 2 div doses) for 10 days. The primary outcome measure was clinical efficacy assessed at the end of treatment on the basis of a modified intent-to-treat (MITT) population. Secondary outcomes were analyses of safety and compliance. Three hundred thirteen patients were enrolled, of whom 83% were <2 years old, with 158 patients randomized to receive azithromycin and 154 to receive amoxicillin. Tympanocentesis was performed at baseline, and clinical responses were assessed at days 12–14 (end of therapy) and 25–28 (end of study). A middle-ear pathogen was detected in 212 patients (68%). H. Influenzae was the most common pathogen isolated (96 cases), followed by S. pneumoniae (92), M. catarrhalis (23), and S. pyogenes (23). At the end of therapy, clinical success rates for azithromycin and amoxicillin were comparable for all patients (84% and 84%, respectively) and for children <2 years of age (82% and 82%, respectively). At the end of the study, clinical efficacies among all microbiologic modified intent-to-treat evaluable subjects were comparable for patients treated with azithro(80%) and patients treated with amoxicillin (83%). The rates of adverse events for azithromycin and amoxicillin were 20% and 29%, respectively (p=.064). Diarrhea was more common in the amoxicillin group (17.5%) as compared to the azithromycin group (8.2%) (p=.017). Compliance, defined as completion of >80% of the study medications, was higher in the azithromycin group (100%) then in the amoxicillin group (90%) (p=.001). For practitioners ordering medications, compliance and efficacy are uppermost considerations. Single-dose azithromycin ensured 100% compliance, decreased adverse reactions, and equal efficacy, compared to high-dose amoxicillin in this well designed, randomized, controlled trial. (Jadad Score = 4/5) all patients (84% and 84%, respectively) and for children <2 years of age (82% and 82%, respectively). At the end of the study, clinical efficacies among all microbiologic modified intent-to-treat evaluable subjects were comparable for patients treated with azithromycin (80%) and patients treated with amoxicillin (83%). The rates of adverse events for azithromycin and amoxicillin were 20% and 29%, respectively

(p=.064). Diarrhea was more common in the amoxicillin group (17.5%) as compared to the azithromycin group (8.2%) (p=.017). Compliance, defined as completion of >80% of the study medications, was higher in the azithromycin group (100%) then in the amoxicillin group (90%) (p=.001). For practitioners ordering medications, compliance and efficacy are uppermost considerations. Single-dose azithromycin ensured 100% compliance, decreased adverse reactions, and equal efficacy, compared to high-dose amoxicillin in this well-designed, randomized, controlled trial. (Jadad Score = 4/5)

Calicitonin Precusors and IL-8 as a Screen Panel for Bacterial Sepsis

Stryjewski GR, Nylen ES, Bell MJ, et al. Interleukin-6, interleukin-8, and a rapid and sensitive assay for calcitonin precursors for the determination of bacterial sepsis in febrile neutropenic children. Pediatr Crit Care Med. 2005;6:129-35.

Identification of sensitive and specific markers for serious bacterial infection (SBI) in children has commanded significant attention in recent literature. These researchers present a prospective cohort study of 56 children aged 5 months to 17 years (median 6.7 years) with fever (axillary temperature ≥37.5°C or oral temperature ≥38°C) and neutropenia (absolute neutrophil count ≤500/mm³) admitted to Children’s National Medical Center during a 15-month period. Researchers hypothesized that a highly sensitive assay for calcitonin precursors (CTpr) would detect levels of CTpr early in the course of illness, and that these levels in conjunction with measured levels of the cytokines interleukin (IL)-6 and IL-8 would provide a sensitive and specific set of markers for diagnosing bacterial sepsis in the study population. Markers were measured at admission, at 24 hours and at 48 hours. CTpr at 24 hours (adjusted odds ratio [95% confidence interval], 1.8 [1.2–2.8], p=.001) and IL8 (at 48 hours 1.08 [1.2–2.8], p=.02) were found to have association with bacterial sepsis. The authors conclude that based on the data generated, using cutoff values of 500 pg/mL for CTpr at 24 hours and 20 pg/mL for IL-8 at 48 hours would provide a sensitivity of 94% and specificity of 90%. Reliable biochemical markers that are highly associated with SBI and/or sepsis will likely improve the care of pediatric patients by guiding more specific therapy and potentially limiting exposure to unnecessary antibiotic . The results of this study cannot be generalized to all pediatric patients with fever and risk for SBI, due to the unique attributes of the study population. However, the study does provide information for future research into the development of markers and/or scoring systems to aid in the early diagnosis of SBI/sepsis in the general pediatric population.

Which Tests are Helpful and Cost-Effective in the Evaluation of Pediatric Syncope?

Steinberg LA, Knilans TK. Syncope in children: diagnostic tests have a high cost and low yield. J Pediatr. 2005;146:355-8.

Evaluation of syncope in children is not uncommon. This evaluation can often include multiple expensive tests, and evidence defining the most efficacious and cost-effective course of evaluation is lacking. Researchers from the Children’s Heart Center at St. Vincent Hospital in Indianapolis and the Division of Cardiology at Children’s Hospital Medical Center in Cincinnati present a retrospective review of 169 patients aged 4.5 to 18.7 years (mean, 13.1 ± 3.6) presenting to a tertiary care center for evaluation of transient loss of consciousness associated with loss of postural tone to describe the cost and utility of testing used to make a diagnosis. Costs were based on hospital costs for 1999 and did not include professional fees, the cost of clinic evaluations, or hospital admissions. There are significant limitations in the study design, and these are adequately discussed by the authors. A diagnosis was established in 128 patients (76%), and neurocardiogenic syncope was the most common diagnosis occurring in 116 patients (68%). Other diagnoses included seizure disorder (3 patients), pseudoseizure (2), anxiety disorder (2), psychogenic syncope (2) and 1 patient each with breathholding spells, long QT syndrome, and exertonal ventricular tachycardia. Tilt-testing had the highest diagnostic yield, although the researchers aptly point out that in the literature the specificity of tilt-testing ranges from 48 to 100% and that this test is rarely required to diagnose neurocardiogenic syncope, the most frequent diagnosis in this review. Loop memory cardiac monitoring had the lowest cost per diagnostic result. Electrocardiography had the lowest diagnostic yield and highest cost per test. Echocardiogram, chest radiograph, cardiac catheterization, electrophysiology studies, and evaluation of serum and body fluids were not diagnostic in this series. This respective review highlights the need for a consistent, evidence-based approach to this common presenting problem while emphasizing the importance of judicious testing guided by a thorough history and physical exam.

An Increase in Severe Community Acquired MRSA Infections in Texas

Gonzales BE, Martinez-Aguilar G, Hulten KG, et al. Severe staphylococcal sepsis in adolescents in the era of community-acquired methicillin-resistant Staphylococcus aureus. Pediatrics. 2005;115:642-8.

Gonzales et al. describe data prospectively gathered since August 1, 2001, showing an increase in the number of severely ill patients with community acquired (CA) Staphylococcus aureus infections. Fourteen patients with a mean age of 12.9 years (range: 10–15 years) were admitted to the PICU with sepsis. Twelve patients had CA methicillin-resistant S. aureus (CAMRSA). Thirteen patients (93%) had bone and joint infections. Thirteen patients had pulmonary involvement. Acute prerenal failure and peripheral vascular thrombosis were present in 50% and 29% of patients, respectively. Thirteen patients were bacteremic. All CAMRSA isolates were resistant to erythromycin, without inducible resistance to clindamycin. The review is interesting in light of the other literature reviewed by the authors suggesting a trend toward more severe infections caused by CAMRSA.

TheoPhylline vs. Terubutaline in Critically III Asthmatics

Wheeler DS, Jacobs BR, Kenreigh CA, et al. Theophylline versus terbutaline in treating critically ill children with status asthmaticus: A prospective, randomized, controlled trial. Pediatr Crit Care Med. 2005;6:142-7.

Status asthmaticus is a common diagnosis on the pediatric inpatient unit and in the pediatric intensive care unit (PICU). Inhaled beta-2 agonists, systemic corticosteroids, and supplemental oxygen are accepted as the standard of care for children with status asthmaticus who require admission. For critically ill children who are poorly responsive to the aforementioned triad of therapy, both theophylline and terbutaline are considered possible adjunctive therapies. Wheeler et al. suggest that the many studies failing to demonstrate added benefit of theophylline in non–critically ill patients has decreased the use of theophylline in the critical care setting, but point out that recent studies involving critically ill populations with status asthmaticus treated with theophylline have suggested benefit with comparison to placebo. Therefore, these researchers present a randomized, prospective, controlled, double-blind trial comparing the efficacy of theophylline alone, terbutaline alone, and theophylline and terbutaline together in critically ill pediatric patients receiving continuous nebulized albuterol and intravenous steroids. Forty patients with impending respiratory failure between the ages of 3 and 15 years were randomized to 1 of 3 groups: theophylline plus placebo (group 1), terbutaline plus placebo (group 2), or theophylline and terbutaline together (group 3). Thirty-six patients completed the study; 3 patients from group 1 were withdrawn due to parental request secondary to agitation (2 patients) and being inadvertently placed on a terbutaline infusion (1 patient). One patient from group 3 was withdrawn by the treating physician due to lack of improvement. All study participants, with the exception of the study pharmacist, were blinded to group assignment. Adjunctive therapies, including magnesium, ipatropium bromide and ketamine, were utilized at the discretion of the treating physician and were not controlled for. The primary outcome variable was change in a clinical scoring tool. Secondary outcomes variables included time to a specific clinical score, length of stay in the PICU, progression to mechanical ventilation, and incidence of adverse events. In addition, a cost analysis was performed isolating the 3 groups based on fiscal year 2003 cost estimates for theophylline and terbutaline. Results demonstrated no difference in the primary or secondary clinical outcome measures, with the exception of a higher incidence of nausea in group 3. The hospital costs were significantly lower in group 1 compared with groups 2 and 3 ($280 vs. $3,908 vs. $4,045, respectively, p<.0001). Significant limitations to the study include the lack of control of adjunctive therapies, a small sample size that confounds the ability to conclude no clinical difference between groups, and a baseline Pediatric Risk of Mortality (PRISM) Score in group 3 compared with groups 1 and 2. Despite these limitations the researchers suggest that the addition of intravenous theophylline to continuous nebulized albuterol and corticosteroids in the management of critically ill children with status asthmaticus is as safe and effective as adding intravenous terbutaline while being more cost-effective. Subsequent larger, well-controlled studies are required to support this conclusion.

Can Computerized Physician Ordering Create Errors?

Koppel R, Metlay JP, Cohen A, et al. Role of computerized physician order entry systems in facilitating medication errors. JAMA. 2005;293:1197-203.

Adverse drug events are a frequent etiology of inpatient morbidity and prescribing errors are the most frequent source. Computerized physician order entry (CPOE) is touted as a potential remedy for some types of adverse drug events. Few studies have investigated the potential for novel medication errors generated by a change to CPOE from conventional ordering. Koppel et al. present a quantitative and qualitative study of medication errors caused or exacerbated by a CPOE system. Interviews, surveys, and focus groups were the primary means of data collection. Housestaff who typically enter more than 9 orders per month were the primary study population, but data collection also included pharmacists, nursing staff , information technology managers, and attending physicians. The study was conducted in a tertiary-care teaching hospital between 2002 and 2004 utilizing a CPOE system in place since 1997. The CPOE system utilized is described as “monochromatic” and having “pre-Windows interfaces.” While not integrated with all hospital functions, the system was integrated with pharmacy and nursing medication lists. Researchers grouped errors into two broad categories: (1) information errors (fragmentation and systems integration failure) and (2) human-machine interface flaws (machine rules that do not correspond to work organization or usual behaviors). In total, 22 types of errors were recorded.

An example of an “information error” is assumed and incorrect dose information based on viewing doses intended only to describe pharmacy stocking practice―i.e. assuming that because the pharmacy stocks a 10mg dose of a medication, 10mg is an appropriate “minimally effective” dose. A “human-machine interface error” example is selecting an incorrect patient for ordering due to properties of the CPOE screen, such as the patient name not appearing on all screens. There are several important limitations to this study, but perhaps most important is the inability to generalize this data to other settings with potentially different physician users and software. Also important is a lack of description regarding physician user training and/or correlation of errors with amount of training or frequency of use, considering that the study population was defined as housestaff who may only use the system for 9 orders each . Despite these limitations, the study represents a requisite component to the growing trend toward the complete electronic record―namely, the use of objective investigations to study the safety and effectiveness of CPOE and the electronic record to promote the most optimal implementation and evolution of this new clinical tool.

Single-Dose Azithromycin for Acute Otitis Media

Arguedas A, Emparanza P, Schwartz RH, et al. A randomized, multicenter, double blind, double dummy trial of single dose azithromycin versus high dose amoxicillin for treatment of uncomplicated acute otitis media. Pediatr Infect Dis J. 2005;24: 153-61.

Acute otitis media is a common comorbid condition in pediatric inpatients. Patients at risk of having AOM with drug-resistant Streptococcus pneumoniae can be treated with high-dose amoxicillin as a first-line therapy according to recent American Academy of Pediatrics (AAP) recommendations. Despite this recommendation, there is evidence of reduced in vitro activity of amoxicillin against β-lactamase-producing Haemophilus influenzae and Moraxella catarrhalis, as well as a lack of data from controlled and blinded studies demonstrating efficacy, adverse events and compliance for high-dose regimens. Azithromycin has in vitro activity against the 4 pathogens of clinical significance in AOM, and studies have shown that a single-dose regimen of azithromycin by the oral route is pharmacokinetically feasible, safe, and comparable in success rate to 3- and 5-day azithromycin regimens. With these considerations in mind, Arguedas et al. designed this study to compare single-dose (30 mg/kg) azithromycin with high-dose (90 mg/kg/day) amoxicillin in uncomplicated AOM.

In this double-blind, double-dummy, multinational, clinical trial, children between the ages of 6 and 30 months with uncomplicated AOM were randomized to treatment with single-dose azithromycin or high-dose amoxicillin (90 mg/kg/day, in 2 div doses) for 10 days. The primary outcome measure was clinical efficacy assessed at the end of treatment on the basis of a modified intent-to-treat (MITT) population. Secondary outcomes were analyses of safety and compliance. Three hundred thirteen patients were enrolled, of whom 83% were <2 years old, with 158 patients randomized to receive azithromycin and 154 to receive amoxicillin. Tympanocentesis was performed at baseline, and clinical responses were assessed at days 12–14 (end of therapy) and 25–28 (end of study). A middle-ear pathogen was detected in 212 patients (68%). H. Influenzae was the most common pathogen isolated (96 cases), followed by S. pneumoniae (92), M. catarrhalis (23), and S. pyogenes (23). At the end of therapy, clinical success rates for azithromycin and amoxicillin were comparable for all patients (84% and 84%, respectively) and for children <2 years of age (82% and 82%, respectively). At the end of the study, clinical efficacies among all microbiologic modified intent-to-treat evaluable subjects were comparable for patients treated with azithro(80%) and patients treated with amoxicillin (83%). The rates of adverse events for azithromycin and amoxicillin were 20% and 29%, respectively (p=.064). Diarrhea was more common in the amoxicillin group (17.5%) as compared to the azithromycin group (8.2%) (p=.017). Compliance, defined as completion of >80% of the study medications, was higher in the azithromycin group (100%) then in the amoxicillin group (90%) (p=.001). For practitioners ordering medications, compliance and efficacy are uppermost considerations. Single-dose azithromycin ensured 100% compliance, decreased adverse reactions, and equal efficacy, compared to high-dose amoxicillin in this well designed, randomized, controlled trial. (Jadad Score = 4/5) all patients (84% and 84%, respectively) and for children <2 years of age (82% and 82%, respectively). At the end of the study, clinical efficacies among all microbiologic modified intent-to-treat evaluable subjects were comparable for patients treated with azithromycin (80%) and patients treated with amoxicillin (83%). The rates of adverse events for azithromycin and amoxicillin were 20% and 29%, respectively

(p=.064). Diarrhea was more common in the amoxicillin group (17.5%) as compared to the azithromycin group (8.2%) (p=.017). Compliance, defined as completion of >80% of the study medications, was higher in the azithromycin group (100%) then in the amoxicillin group (90%) (p=.001). For practitioners ordering medications, compliance and efficacy are uppermost considerations. Single-dose azithromycin ensured 100% compliance, decreased adverse reactions, and equal efficacy, compared to high-dose amoxicillin in this well-designed, randomized, controlled trial. (Jadad Score = 4/5)

Calicitonin Precusors and IL-8 as a Screen Panel for Bacterial Sepsis

Stryjewski GR, Nylen ES, Bell MJ, et al. Interleukin-6, interleukin-8, and a rapid and sensitive assay for calcitonin precursors for the determination of bacterial sepsis in febrile neutropenic children. Pediatr Crit Care Med. 2005;6:129-35.

Identification of sensitive and specific markers for serious bacterial infection (SBI) in children has commanded significant attention in recent literature. These researchers present a prospective cohort study of 56 children aged 5 months to 17 years (median 6.7 years) with fever (axillary temperature ≥37.5°C or oral temperature ≥38°C) and neutropenia (absolute neutrophil count ≤500/mm³) admitted to Children’s National Medical Center during a 15-month period. Researchers hypothesized that a highly sensitive assay for calcitonin precursors (CTpr) would detect levels of CTpr early in the course of illness, and that these levels in conjunction with measured levels of the cytokines interleukin (IL)-6 and IL-8 would provide a sensitive and specific set of markers for diagnosing bacterial sepsis in the study population. Markers were measured at admission, at 24 hours and at 48 hours. CTpr at 24 hours (adjusted odds ratio [95% confidence interval], 1.8 [1.2–2.8], p=.001) and IL8 (at 48 hours 1.08 [1.2–2.8], p=.02) were found to have association with bacterial sepsis. The authors conclude that based on the data generated, using cutoff values of 500 pg/mL for CTpr at 24 hours and 20 pg/mL for IL-8 at 48 hours would provide a sensitivity of 94% and specificity of 90%. Reliable biochemical markers that are highly associated with SBI and/or sepsis will likely improve the care of pediatric patients by guiding more specific therapy and potentially limiting exposure to unnecessary antibiotic . The results of this study cannot be generalized to all pediatric patients with fever and risk for SBI, due to the unique attributes of the study population. However, the study does provide information for future research into the development of markers and/or scoring systems to aid in the early diagnosis of SBI/sepsis in the general pediatric population.

Which Tests are Helpful and Cost-Effective in the Evaluation of Pediatric Syncope?

Steinberg LA, Knilans TK. Syncope in children: diagnostic tests have a high cost and low yield. J Pediatr. 2005;146:355-8.

Evaluation of syncope in children is not uncommon. This evaluation can often include multiple expensive tests, and evidence defining the most efficacious and cost-effective course of evaluation is lacking. Researchers from the Children’s Heart Center at St. Vincent Hospital in Indianapolis and the Division of Cardiology at Children’s Hospital Medical Center in Cincinnati present a retrospective review of 169 patients aged 4.5 to 18.7 years (mean, 13.1 ± 3.6) presenting to a tertiary care center for evaluation of transient loss of consciousness associated with loss of postural tone to describe the cost and utility of testing used to make a diagnosis. Costs were based on hospital costs for 1999 and did not include professional fees, the cost of clinic evaluations, or hospital admissions. There are significant limitations in the study design, and these are adequately discussed by the authors. A diagnosis was established in 128 patients (76%), and neurocardiogenic syncope was the most common diagnosis occurring in 116 patients (68%). Other diagnoses included seizure disorder (3 patients), pseudoseizure (2), anxiety disorder (2), psychogenic syncope (2) and 1 patient each with breathholding spells, long QT syndrome, and exertonal ventricular tachycardia. Tilt-testing had the highest diagnostic yield, although the researchers aptly point out that in the literature the specificity of tilt-testing ranges from 48 to 100% and that this test is rarely required to diagnose neurocardiogenic syncope, the most frequent diagnosis in this review. Loop memory cardiac monitoring had the lowest cost per diagnostic result. Electrocardiography had the lowest diagnostic yield and highest cost per test. Echocardiogram, chest radiograph, cardiac catheterization, electrophysiology studies, and evaluation of serum and body fluids were not diagnostic in this series. This respective review highlights the need for a consistent, evidence-based approach to this common presenting problem while emphasizing the importance of judicious testing guided by a thorough history and physical exam.

An Increase in Severe Community Acquired MRSA Infections in Texas

Gonzales BE, Martinez-Aguilar G, Hulten KG, et al. Severe staphylococcal sepsis in adolescents in the era of community-acquired methicillin-resistant Staphylococcus aureus. Pediatrics. 2005;115:642-8.

Gonzales et al. describe data prospectively gathered since August 1, 2001, showing an increase in the number of severely ill patients with community acquired (CA) Staphylococcus aureus infections. Fourteen patients with a mean age of 12.9 years (range: 10–15 years) were admitted to the PICU with sepsis. Twelve patients had CA methicillin-resistant S. aureus (CAMRSA). Thirteen patients (93%) had bone and joint infections. Thirteen patients had pulmonary involvement. Acute prerenal failure and peripheral vascular thrombosis were present in 50% and 29% of patients, respectively. Thirteen patients were bacteremic. All CAMRSA isolates were resistant to erythromycin, without inducible resistance to clindamycin. The review is interesting in light of the other literature reviewed by the authors suggesting a trend toward more severe infections caused by CAMRSA.

TheoPhylline vs. Terubutaline in Critically III Asthmatics

Wheeler DS, Jacobs BR, Kenreigh CA, et al. Theophylline versus terbutaline in treating critically ill children with status asthmaticus: A prospective, randomized, controlled trial. Pediatr Crit Care Med. 2005;6:142-7.

Status asthmaticus is a common diagnosis on the pediatric inpatient unit and in the pediatric intensive care unit (PICU). Inhaled beta-2 agonists, systemic corticosteroids, and supplemental oxygen are accepted as the standard of care for children with status asthmaticus who require admission. For critically ill children who are poorly responsive to the aforementioned triad of therapy, both theophylline and terbutaline are considered possible adjunctive therapies. Wheeler et al. suggest that the many studies failing to demonstrate added benefit of theophylline in non–critically ill patients has decreased the use of theophylline in the critical care setting, but point out that recent studies involving critically ill populations with status asthmaticus treated with theophylline have suggested benefit with comparison to placebo. Therefore, these researchers present a randomized, prospective, controlled, double-blind trial comparing the efficacy of theophylline alone, terbutaline alone, and theophylline and terbutaline together in critically ill pediatric patients receiving continuous nebulized albuterol and intravenous steroids. Forty patients with impending respiratory failure between the ages of 3 and 15 years were randomized to 1 of 3 groups: theophylline plus placebo (group 1), terbutaline plus placebo (group 2), or theophylline and terbutaline together (group 3). Thirty-six patients completed the study; 3 patients from group 1 were withdrawn due to parental request secondary to agitation (2 patients) and being inadvertently placed on a terbutaline infusion (1 patient). One patient from group 3 was withdrawn by the treating physician due to lack of improvement. All study participants, with the exception of the study pharmacist, were blinded to group assignment. Adjunctive therapies, including magnesium, ipatropium bromide and ketamine, were utilized at the discretion of the treating physician and were not controlled for. The primary outcome variable was change in a clinical scoring tool. Secondary outcomes variables included time to a specific clinical score, length of stay in the PICU, progression to mechanical ventilation, and incidence of adverse events. In addition, a cost analysis was performed isolating the 3 groups based on fiscal year 2003 cost estimates for theophylline and terbutaline. Results demonstrated no difference in the primary or secondary clinical outcome measures, with the exception of a higher incidence of nausea in group 3. The hospital costs were significantly lower in group 1 compared with groups 2 and 3 ($280 vs. $3,908 vs. $4,045, respectively, p<.0001). Significant limitations to the study include the lack of control of adjunctive therapies, a small sample size that confounds the ability to conclude no clinical difference between groups, and a baseline Pediatric Risk of Mortality (PRISM) Score in group 3 compared with groups 1 and 2. Despite these limitations the researchers suggest that the addition of intravenous theophylline to continuous nebulized albuterol and corticosteroids in the management of critically ill children with status asthmaticus is as safe and effective as adding intravenous terbutaline while being more cost-effective. Subsequent larger, well-controlled studies are required to support this conclusion.

Can Computerized Physician Ordering Create Errors?

Koppel R, Metlay JP, Cohen A, et al. Role of computerized physician order entry systems in facilitating medication errors. JAMA. 2005;293:1197-203.

Adverse drug events are a frequent etiology of inpatient morbidity and prescribing errors are the most frequent source. Computerized physician order entry (CPOE) is touted as a potential remedy for some types of adverse drug events. Few studies have investigated the potential for novel medication errors generated by a change to CPOE from conventional ordering. Koppel et al. present a quantitative and qualitative study of medication errors caused or exacerbated by a CPOE system. Interviews, surveys, and focus groups were the primary means of data collection. Housestaff who typically enter more than 9 orders per month were the primary study population, but data collection also included pharmacists, nursing staff , information technology managers, and attending physicians. The study was conducted in a tertiary-care teaching hospital between 2002 and 2004 utilizing a CPOE system in place since 1997. The CPOE system utilized is described as “monochromatic” and having “pre-Windows interfaces.” While not integrated with all hospital functions, the system was integrated with pharmacy and nursing medication lists. Researchers grouped errors into two broad categories: (1) information errors (fragmentation and systems integration failure) and (2) human-machine interface flaws (machine rules that do not correspond to work organization or usual behaviors). In total, 22 types of errors were recorded.

An example of an “information error” is assumed and incorrect dose information based on viewing doses intended only to describe pharmacy stocking practice―i.e. assuming that because the pharmacy stocks a 10mg dose of a medication, 10mg is an appropriate “minimally effective” dose. A “human-machine interface error” example is selecting an incorrect patient for ordering due to properties of the CPOE screen, such as the patient name not appearing on all screens. There are several important limitations to this study, but perhaps most important is the inability to generalize this data to other settings with potentially different physician users and software. Also important is a lack of description regarding physician user training and/or correlation of errors with amount of training or frequency of use, considering that the study population was defined as housestaff who may only use the system for 9 orders each . Despite these limitations, the study represents a requisite component to the growing trend toward the complete electronic record―namely, the use of objective investigations to study the safety and effectiveness of CPOE and the electronic record to promote the most optimal implementation and evolution of this new clinical tool.

Single-Dose Azithromycin for Acute Otitis Media

Arguedas A, Emparanza P, Schwartz RH, et al. A randomized, multicenter, double blind, double dummy trial of single dose azithromycin versus high dose amoxicillin for treatment of uncomplicated acute otitis media. Pediatr Infect Dis J. 2005;24: 153-61.

Acute otitis media is a common comorbid condition in pediatric inpatients. Patients at risk of having AOM with drug-resistant Streptococcus pneumoniae can be treated with high-dose amoxicillin as a first-line therapy according to recent American Academy of Pediatrics (AAP) recommendations. Despite this recommendation, there is evidence of reduced in vitro activity of amoxicillin against β-lactamase-producing Haemophilus influenzae and Moraxella catarrhalis, as well as a lack of data from controlled and blinded studies demonstrating efficacy, adverse events and compliance for high-dose regimens. Azithromycin has in vitro activity against the 4 pathogens of clinical significance in AOM, and studies have shown that a single-dose regimen of azithromycin by the oral route is pharmacokinetically feasible, safe, and comparable in success rate to 3- and 5-day azithromycin regimens. With these considerations in mind, Arguedas et al. designed this study to compare single-dose (30 mg/kg) azithromycin with high-dose (90 mg/kg/day) amoxicillin in uncomplicated AOM.

In this double-blind, double-dummy, multinational, clinical trial, children between the ages of 6 and 30 months with uncomplicated AOM were randomized to treatment with single-dose azithromycin or high-dose amoxicillin (90 mg/kg/day, in 2 div doses) for 10 days. The primary outcome measure was clinical efficacy assessed at the end of treatment on the basis of a modified intent-to-treat (MITT) population. Secondary outcomes were analyses of safety and compliance. Three hundred thirteen patients were enrolled, of whom 83% were <2 years old, with 158 patients randomized to receive azithromycin and 154 to receive amoxicillin. Tympanocentesis was performed at baseline, and clinical responses were assessed at days 12–14 (end of therapy) and 25–28 (end of study). A middle-ear pathogen was detected in 212 patients (68%). H. Influenzae was the most common pathogen isolated (96 cases), followed by S. pneumoniae (92), M. catarrhalis (23), and S. pyogenes (23). At the end of therapy, clinical success rates for azithromycin and amoxicillin were comparable for all patients (84% and 84%, respectively) and for children <2 years of age (82% and 82%, respectively). At the end of the study, clinical efficacies among all microbiologic modified intent-to-treat evaluable subjects were comparable for patients treated with azithro(80%) and patients treated with amoxicillin (83%). The rates of adverse events for azithromycin and amoxicillin were 20% and 29%, respectively (p=.064). Diarrhea was more common in the amoxicillin group (17.5%) as compared to the azithromycin group (8.2%) (p=.017). Compliance, defined as completion of >80% of the study medications, was higher in the azithromycin group (100%) then in the amoxicillin group (90%) (p=.001). For practitioners ordering medications, compliance and efficacy are uppermost considerations. Single-dose azithromycin ensured 100% compliance, decreased adverse reactions, and equal efficacy, compared to high-dose amoxicillin in this well designed, randomized, controlled trial. (Jadad Score = 4/5) all patients (84% and 84%, respectively) and for children <2 years of age (82% and 82%, respectively). At the end of the study, clinical efficacies among all microbiologic modified intent-to-treat evaluable subjects were comparable for patients treated with azithromycin (80%) and patients treated with amoxicillin (83%). The rates of adverse events for azithromycin and amoxicillin were 20% and 29%, respectively

(p=.064). Diarrhea was more common in the amoxicillin group (17.5%) as compared to the azithromycin group (8.2%) (p=.017). Compliance, defined as completion of >80% of the study medications, was higher in the azithromycin group (100%) then in the amoxicillin group (90%) (p=.001). For practitioners ordering medications, compliance and efficacy are uppermost considerations. Single-dose azithromycin ensured 100% compliance, decreased adverse reactions, and equal efficacy, compared to high-dose amoxicillin in this well-designed, randomized, controlled trial. (Jadad Score = 4/5)

Coronary-Artery Revascularization Before Elective Major Vascular Sugery

McFalls EO, Ward HB, Moritz TE, et al. Coronary-artery revascularization before elective major vascular surgery. N Engl J Med. 2004;351:2861-3.

Cardiac risk stratification and treatment prior to non-cardiac surgery is a frequent reason for medical consultation, and yet the optimal approach to managing these patients remains controversial. National guidelines, based on expert opinion and inferred from published data, suggest that preoperative cardiac revascularization be reserved for patients with unstable coronary syndromes or for whom coronary artery bypass grad ing has been shown to improve mortality. Despite these recommendations, there remains considerable variability in clinical practice, which is compounded by a paucity of prospective randomized trials to validate one approach over another.

In this multicenter randomized controlled trial, McFalls et al. studied whether coronary artery revascularization prior to elective vascular surgery would reduce mortality among a cohort of patients with angiographically documented stable coronary artery disease. The investigators evaluated 5859 patients from 18 centers scheduled for abdominal aortic aneurysm or lower extremity vascular surgery. Patients felt to be at high risk for perioperative cardiac complications based on cardiology consultation, established clinical criteria, or the presence of ischemia on stress imaging studies were referred for coronary angiography. Of this cohort, 4669 (80%) were excluded due to subsequent determination of insufficient cardiac risk (28%), urgent need for vascular surgery (18%), severe comorbid illness (13%), patient preference (11%), or prior revascularization without new ischemia (11%). Of the 1190 patients who underwent angiography, 680 were excluded due to protocol criteria including: the absence of obstructive coronary artery disease (54%), coronary disease not amenable to revascularization (32%), led main artery stenosis ≥ 50% (8%), led ventricular ejection fraction <20% (2%), or severe aortic stenosis (AVA<1.0 cm²) (1%).

Of the 510 patients who remained, 252 were randomized to proceed with vascular surgery with optimal medical management, of which 9 crossed over due to the need for urgent cardiac revascularization. Two hundred fifty-eight patients were randomized to elective preoperative revascularization; 99 underwent CABG, 141 underwent PCI, and 18 were excluded due to need for urgent vascular surgery, patient preference, or in one case, stroke. Both groups were similar with respect to baseline clinical variables, including the incidence of previous myocardial infarction, congestive heart failure, diabetes mellitus, led ventricular ejection fraction, and 3vessel coronary artery disease. They were also similar in the use of perioperative betablockers (~ 85%), statins, and aspirin.

At 2.7 years after randomization, mortality was 22% in the revascularization group and 22% in the medical management group, the relative risk was 0.98 (95% CI 0.7-1.37; p=.92), which was not statistically significant. The median time from randomization to vascular surgery was 54 days in the revascularization group and 18 days in the medical management group not undergoing revascularization (p<.001). Although not designed to address short-term outcomes, there were no differences in the rates of early postoperative myocardial infarction, death, or hospital length of stay. It is also worth noting that 316 of the 510 patients who were ultimately randomized had undergone nuclear imaging studies, of which 226 (72%) had moderate to large reversible perfusion defects detected. These outcome data suggest that the presence of reversible perfusions defects is not in itself a reason for preoperative revascularization.

This well-designed study demonstrates that in the absence of unstable coronary syndromes, led main disease, severe aortic stenosis, or severely depressed led ventricular ejection fraction, there is no morbidity or mortality benefit to revascularization among patients with stable coronary artery disease prior to vascular surgery. Because vascular surgery is the highest risk category among non-cardiac procedures, it may be reasonable to extend these findings to lower risk surgeries as well, and in this sense this study is particularly relevant to consultative practice. While this study provides clear evidence on how to manage this cohort of patients, it remains unclear what the optimal strategy is to identify and manage those patients who were excluded from the trial. (DF)

Amiodarone or a Implantable Cardioverter-Defibrilator for Congestive Heart Failure

Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 20;352:225-37.

Ventricular arrhythmias are the leading cause of sudden cardiac death in patients with systolic heart failure. Treatment with antiarrhythmic drug therapy has failed to improve survival in these patients, due to their proarrhythmic effects. Unlike other antiarrhythmics, amiodarone is a drug with low proarrhythmic effects. Some studies have suggested that amiodarone may be beneficial in patients with systolic heart failure. Conversely, several primary and secondary prevention trials have demonstrated that placement of an implantable cardioverter-defibrillator (ICD) confers a survival benefit in patients with ischemic cardiomyopathy. However, the role of ICDs in nonischemic heart failure remained unproven.

Bardy and colleagues developed the Sudden Cardiac Death in Heart Failure Trial (SCDHeFT) to evaluate the hypothesis that treatment with amiodarone or a shock-only, single-lead ICD would decrease death from any cause in a population of patients with mild to moderate heart failure. They randomly assigned 2521 patients with New York Heart Association (NYHA) class II or II heart failure (and a led ventricular ejection fraction (LVEF) of 35% or less to conventional medical therapy plus placebo, conventional therapy plus treatment with amiodarone or conventional therapy plus a conservatively programmed, shock-only, single-lead ICD.

Fifty-two percent of patients had ischemic heart failure and 48% had nonischemic heart failure. Placebo and amiodarone were given in double-blind fashion. The primary endpoint was death from any cause with a median followup of 45.5 months. The results were as follows:

Placebo Group - 244 deaths (29% Death Rate)

Amiodarone Group - 240 deaths (28% Death Rate)

ICD Group - 182 deaths (22% Death Rate)

Patients treated with amiodarone had a similar risk of death as those who received placebo (hazard ratio, 1.06; 97.5% CI: 0.86–1.30; p=0.53). Patients implanted with an ICD had a 23% decreased risk of death when compared with those who received placebo (0.77; 97.5% CI: 0.62–0.96; p=.007). This resulted in an absolute risk reduction of 7.2% at 5 years. The authors concluded that in patients with NYHA class II or III heart failure and a LVEF of 35% or less, implantation of a single-lead, shock-only ICD reduced overall mortality by 23%, while treatment with amiodarone had no effect on survival. The benefit of ICD placement reached or approached significance in both the ischemic (hazard ratio .79, CI: 0.60–1.04, p= .05) and nonischemic (hazard ratio 0.73, CI: 0.50–1.07, p= 0.06) subgroups.

It is important to note that an additional subgroup analysis showed that ICD therapy had a significant survival benefit only in NYHA class II patients but not in NYHA class III patients. Amiodarone therapy had no benefit in class II patients and actually decreased survival in class III patients compared to those receiving placebo. In light of results from previous trials that demonstrated a greater survival benefit from ICD placement with worsening ejection fraction in patients with ischemic heart failure, the authors were unable to explain whether the differences in subclasses were biologically plausible.

This study is important for several reasons. First, it suggested that patients with systolic heart failure due to either ischemic or non ischemic causes would benefit from placement of an ICD. Second, these results support the conclusions of previous trials that demonstrate a survival advantage of ICD placement in patients with ischemic heart failure. Finally, this study also demonstrates that amiodarone therapy offers no survival benefit in this population of patients. (JL)

Clopidogrel versus Aspirin and Esomeprazole to Prevent Recurrent Ulcer Bleeding

Chan F, Ching J, Hung L, et al. Clopidogrel versus aspirin and esomeprazole to prevent recurrent ulcer bleeding. N Engl J Med. 2005;352:238-44.

The optimal choice of antiplatelet therapy for patients with coronary heart disease who have had a recent upper gastrointestinal hemorrhage has not been well studied. Clopidogrel has been shown to cause fewer episodes of gastrointestinal hemorrhage than aspirin, but it is unknown whether clopidogrel monotherapy is in fact superior to aspirin plus a protonpump inhibitor. In this prospective, randomized, doubleblind trial, Chan and colleagues hypothesize that clopidogrel monotherapy would “not be inferior” to aspirin plus esomeprazole in a population of patients who had recovered from aspirin-induced hemorrhagic ulcers.

The study population was drawn from patients taking aspirin who were evaluated for an upper gastrointestinal bleed and had ulcer disease documented on endoscopy. Patients with documented Helicobacter pylori infection were treated with a 1-week course of a standard triple-drug regimen. All subjects, regardless of H. pylori status, were treated with an 8-week course of proton-pump inhibitors (PPI). Inclusion criteria included endoscopic confirmation of ulcer healing and successful eradication of H. pylori, if it was present. The location of the ulcers was not specified in the study.

Exclusion criteria included use of nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 inhibitors, anticoagulant drugs, corticosteroids, or other anti-platelet agents; history of gastric surgery; presence of erosive esophagitis; gastric outlet obstruction; cancer; need for dialysis; or terminal illness.

Subjects who met the inclusion criteria were randomized to receive either 75 mg of clopidogrel and placebo or 80 mg of aspirin daily plus 20 mg of esomeprazole twice a day for a 12 months. Patients returned for evaluation every 3 months during the 1-year study period. The primary endpoint was recurrence of ulcer bleeding, which was predefined as clinical or laboratory evidence of gastrointestinal hemorrhage with a documented recurrence of ulcers on endoscopy. Lower gastrointestinal bleeding was a secondary endpoint.

Of 492 consecutive patients who were evaluated, 320 met inclusion criteria and were evenly divided into the clopidogrel plus placebo or the aspirin plus esomeprazole arms. Only 3 patients were lost to followup. During the study period, 34 cases of suspected gastrointestinal hemorrhage (defined as hematemesis, melena, or 2 g/dL decrease of hemoglobin) were identified. During endoscopy,14 cases were confirmed to be due to recurrent ulcer bleeding. Of these, 13 ulcers were in the clopidogrel arm (6 gastric ulcers, 5 duodenal, and 2 both) and 1 ulcer (duodenal) in the aspirin plus esomeprazole arm, a statistically significant difference (p=.001).

Fourteen patients were determined to have a lower gastrointestinal hemorrhage. Interestingly, these cases were evenly divided between the clopidogrel group (7 cases) and the aspirin plus esomeprazole (7 cases). This finding suggests the effect of esomeprazole in this study may be specific in preventing recurrent upper gastrointestinal ulcer formation and hemorrhage. The 2 groups had equivalent rates of recurrent ischemic events.

This study addresses an important clinical question, frequently encountered by hospitalists. The recommendation that clopidogrel be used instead of aspirin in patients who require antiplatelet therapy but have a history of upper gastrointestinal hemorrhage is based on studies using high-dose (325 mg) aspirin and excluded patients on acid-suppressing therapy. However, this study failed to prove noninferiority of clopidogrel to aspirin and esomeprazole for this indication. Although this study was not designed to show superiority of aspirin and esomeprazole over clopidogrel, these results indicate that this may be the case, and such a study would be timely. (CG)

Coronary-Artery Revascularization Before Elective Major Vascular Sugery

McFalls EO, Ward HB, Moritz TE, et al. Coronary-artery revascularization before elective major vascular surgery. N Engl J Med. 2004;351:2861-3.

Cardiac risk stratification and treatment prior to non-cardiac surgery is a frequent reason for medical consultation, and yet the optimal approach to managing these patients remains controversial. National guidelines, based on expert opinion and inferred from published data, suggest that preoperative cardiac revascularization be reserved for patients with unstable coronary syndromes or for whom coronary artery bypass grad ing has been shown to improve mortality. Despite these recommendations, there remains considerable variability in clinical practice, which is compounded by a paucity of prospective randomized trials to validate one approach over another.

In this multicenter randomized controlled trial, McFalls et al. studied whether coronary artery revascularization prior to elective vascular surgery would reduce mortality among a cohort of patients with angiographically documented stable coronary artery disease. The investigators evaluated 5859 patients from 18 centers scheduled for abdominal aortic aneurysm or lower extremity vascular surgery. Patients felt to be at high risk for perioperative cardiac complications based on cardiology consultation, established clinical criteria, or the presence of ischemia on stress imaging studies were referred for coronary angiography. Of this cohort, 4669 (80%) were excluded due to subsequent determination of insufficient cardiac risk (28%), urgent need for vascular surgery (18%), severe comorbid illness (13%), patient preference (11%), or prior revascularization without new ischemia (11%). Of the 1190 patients who underwent angiography, 680 were excluded due to protocol criteria including: the absence of obstructive coronary artery disease (54%), coronary disease not amenable to revascularization (32%), led main artery stenosis ≥ 50% (8%), led ventricular ejection fraction <20% (2%), or severe aortic stenosis (AVA<1.0 cm²) (1%).

Of the 510 patients who remained, 252 were randomized to proceed with vascular surgery with optimal medical management, of which 9 crossed over due to the need for urgent cardiac revascularization. Two hundred fifty-eight patients were randomized to elective preoperative revascularization; 99 underwent CABG, 141 underwent PCI, and 18 were excluded due to need for urgent vascular surgery, patient preference, or in one case, stroke. Both groups were similar with respect to baseline clinical variables, including the incidence of previous myocardial infarction, congestive heart failure, diabetes mellitus, led ventricular ejection fraction, and 3vessel coronary artery disease. They were also similar in the use of perioperative betablockers (~ 85%), statins, and aspirin.

At 2.7 years after randomization, mortality was 22% in the revascularization group and 22% in the medical management group, the relative risk was 0.98 (95% CI 0.7-1.37; p=.92), which was not statistically significant. The median time from randomization to vascular surgery was 54 days in the revascularization group and 18 days in the medical management group not undergoing revascularization (p<.001). Although not designed to address short-term outcomes, there were no differences in the rates of early postoperative myocardial infarction, death, or hospital length of stay. It is also worth noting that 316 of the 510 patients who were ultimately randomized had undergone nuclear imaging studies, of which 226 (72%) had moderate to large reversible perfusion defects detected. These outcome data suggest that the presence of reversible perfusions defects is not in itself a reason for preoperative revascularization.

This well-designed study demonstrates that in the absence of unstable coronary syndromes, led main disease, severe aortic stenosis, or severely depressed led ventricular ejection fraction, there is no morbidity or mortality benefit to revascularization among patients with stable coronary artery disease prior to vascular surgery. Because vascular surgery is the highest risk category among non-cardiac procedures, it may be reasonable to extend these findings to lower risk surgeries as well, and in this sense this study is particularly relevant to consultative practice. While this study provides clear evidence on how to manage this cohort of patients, it remains unclear what the optimal strategy is to identify and manage those patients who were excluded from the trial. (DF)

Amiodarone or a Implantable Cardioverter-Defibrilator for Congestive Heart Failure

Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 20;352:225-37.

Ventricular arrhythmias are the leading cause of sudden cardiac death in patients with systolic heart failure. Treatment with antiarrhythmic drug therapy has failed to improve survival in these patients, due to their proarrhythmic effects. Unlike other antiarrhythmics, amiodarone is a drug with low proarrhythmic effects. Some studies have suggested that amiodarone may be beneficial in patients with systolic heart failure. Conversely, several primary and secondary prevention trials have demonstrated that placement of an implantable cardioverter-defibrillator (ICD) confers a survival benefit in patients with ischemic cardiomyopathy. However, the role of ICDs in nonischemic heart failure remained unproven.

Bardy and colleagues developed the Sudden Cardiac Death in Heart Failure Trial (SCDHeFT) to evaluate the hypothesis that treatment with amiodarone or a shock-only, single-lead ICD would decrease death from any cause in a population of patients with mild to moderate heart failure. They randomly assigned 2521 patients with New York Heart Association (NYHA) class II or II heart failure (and a led ventricular ejection fraction (LVEF) of 35% or less to conventional medical therapy plus placebo, conventional therapy plus treatment with amiodarone or conventional therapy plus a conservatively programmed, shock-only, single-lead ICD.

Fifty-two percent of patients had ischemic heart failure and 48% had nonischemic heart failure. Placebo and amiodarone were given in double-blind fashion. The primary endpoint was death from any cause with a median followup of 45.5 months. The results were as follows:

Placebo Group - 244 deaths (29% Death Rate)

Amiodarone Group - 240 deaths (28% Death Rate)

ICD Group - 182 deaths (22% Death Rate)

Patients treated with amiodarone had a similar risk of death as those who received placebo (hazard ratio, 1.06; 97.5% CI: 0.86–1.30; p=0.53). Patients implanted with an ICD had a 23% decreased risk of death when compared with those who received placebo (0.77; 97.5% CI: 0.62–0.96; p=.007). This resulted in an absolute risk reduction of 7.2% at 5 years. The authors concluded that in patients with NYHA class II or III heart failure and a LVEF of 35% or less, implantation of a single-lead, shock-only ICD reduced overall mortality by 23%, while treatment with amiodarone had no effect on survival. The benefit of ICD placement reached or approached significance in both the ischemic (hazard ratio .79, CI: 0.60–1.04, p= .05) and nonischemic (hazard ratio 0.73, CI: 0.50–1.07, p= 0.06) subgroups.

It is important to note that an additional subgroup analysis showed that ICD therapy had a significant survival benefit only in NYHA class II patients but not in NYHA class III patients. Amiodarone therapy had no benefit in class II patients and actually decreased survival in class III patients compared to those receiving placebo. In light of results from previous trials that demonstrated a greater survival benefit from ICD placement with worsening ejection fraction in patients with ischemic heart failure, the authors were unable to explain whether the differences in subclasses were biologically plausible.

This study is important for several reasons. First, it suggested that patients with systolic heart failure due to either ischemic or non ischemic causes would benefit from placement of an ICD. Second, these results support the conclusions of previous trials that demonstrate a survival advantage of ICD placement in patients with ischemic heart failure. Finally, this study also demonstrates that amiodarone therapy offers no survival benefit in this population of patients. (JL)

Clopidogrel versus Aspirin and Esomeprazole to Prevent Recurrent Ulcer Bleeding

Chan F, Ching J, Hung L, et al. Clopidogrel versus aspirin and esomeprazole to prevent recurrent ulcer bleeding. N Engl J Med. 2005;352:238-44.

The optimal choice of antiplatelet therapy for patients with coronary heart disease who have had a recent upper gastrointestinal hemorrhage has not been well studied. Clopidogrel has been shown to cause fewer episodes of gastrointestinal hemorrhage than aspirin, but it is unknown whether clopidogrel monotherapy is in fact superior to aspirin plus a protonpump inhibitor. In this prospective, randomized, doubleblind trial, Chan and colleagues hypothesize that clopidogrel monotherapy would “not be inferior” to aspirin plus esomeprazole in a population of patients who had recovered from aspirin-induced hemorrhagic ulcers.

The study population was drawn from patients taking aspirin who were evaluated for an upper gastrointestinal bleed and had ulcer disease documented on endoscopy. Patients with documented Helicobacter pylori infection were treated with a 1-week course of a standard triple-drug regimen. All subjects, regardless of H. pylori status, were treated with an 8-week course of proton-pump inhibitors (PPI). Inclusion criteria included endoscopic confirmation of ulcer healing and successful eradication of H. pylori, if it was present. The location of the ulcers was not specified in the study.

Exclusion criteria included use of nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 inhibitors, anticoagulant drugs, corticosteroids, or other anti-platelet agents; history of gastric surgery; presence of erosive esophagitis; gastric outlet obstruction; cancer; need for dialysis; or terminal illness.

Subjects who met the inclusion criteria were randomized to receive either 75 mg of clopidogrel and placebo or 80 mg of aspirin daily plus 20 mg of esomeprazole twice a day for a 12 months. Patients returned for evaluation every 3 months during the 1-year study period. The primary endpoint was recurrence of ulcer bleeding, which was predefined as clinical or laboratory evidence of gastrointestinal hemorrhage with a documented recurrence of ulcers on endoscopy. Lower gastrointestinal bleeding was a secondary endpoint.

Of 492 consecutive patients who were evaluated, 320 met inclusion criteria and were evenly divided into the clopidogrel plus placebo or the aspirin plus esomeprazole arms. Only 3 patients were lost to followup. During the study period, 34 cases of suspected gastrointestinal hemorrhage (defined as hematemesis, melena, or 2 g/dL decrease of hemoglobin) were identified. During endoscopy,14 cases were confirmed to be due to recurrent ulcer bleeding. Of these, 13 ulcers were in the clopidogrel arm (6 gastric ulcers, 5 duodenal, and 2 both) and 1 ulcer (duodenal) in the aspirin plus esomeprazole arm, a statistically significant difference (p=.001).

Fourteen patients were determined to have a lower gastrointestinal hemorrhage. Interestingly, these cases were evenly divided between the clopidogrel group (7 cases) and the aspirin plus esomeprazole (7 cases). This finding suggests the effect of esomeprazole in this study may be specific in preventing recurrent upper gastrointestinal ulcer formation and hemorrhage. The 2 groups had equivalent rates of recurrent ischemic events.

This study addresses an important clinical question, frequently encountered by hospitalists. The recommendation that clopidogrel be used instead of aspirin in patients who require antiplatelet therapy but have a history of upper gastrointestinal hemorrhage is based on studies using high-dose (325 mg) aspirin and excluded patients on acid-suppressing therapy. However, this study failed to prove noninferiority of clopidogrel to aspirin and esomeprazole for this indication. Although this study was not designed to show superiority of aspirin and esomeprazole over clopidogrel, these results indicate that this may be the case, and such a study would be timely. (CG)

Coronary-Artery Revascularization Before Elective Major Vascular Sugery

McFalls EO, Ward HB, Moritz TE, et al. Coronary-artery revascularization before elective major vascular surgery. N Engl J Med. 2004;351:2861-3.

Cardiac risk stratification and treatment prior to non-cardiac surgery is a frequent reason for medical consultation, and yet the optimal approach to managing these patients remains controversial. National guidelines, based on expert opinion and inferred from published data, suggest that preoperative cardiac revascularization be reserved for patients with unstable coronary syndromes or for whom coronary artery bypass grad ing has been shown to improve mortality. Despite these recommendations, there remains considerable variability in clinical practice, which is compounded by a paucity of prospective randomized trials to validate one approach over another.

In this multicenter randomized controlled trial, McFalls et al. studied whether coronary artery revascularization prior to elective vascular surgery would reduce mortality among a cohort of patients with angiographically documented stable coronary artery disease. The investigators evaluated 5859 patients from 18 centers scheduled for abdominal aortic aneurysm or lower extremity vascular surgery. Patients felt to be at high risk for perioperative cardiac complications based on cardiology consultation, established clinical criteria, or the presence of ischemia on stress imaging studies were referred for coronary angiography. Of this cohort, 4669 (80%) were excluded due to subsequent determination of insufficient cardiac risk (28%), urgent need for vascular surgery (18%), severe comorbid illness (13%), patient preference (11%), or prior revascularization without new ischemia (11%). Of the 1190 patients who underwent angiography, 680 were excluded due to protocol criteria including: the absence of obstructive coronary artery disease (54%), coronary disease not amenable to revascularization (32%), led main artery stenosis ≥ 50% (8%), led ventricular ejection fraction <20% (2%), or severe aortic stenosis (AVA<1.0 cm²) (1%).

Of the 510 patients who remained, 252 were randomized to proceed with vascular surgery with optimal medical management, of which 9 crossed over due to the need for urgent cardiac revascularization. Two hundred fifty-eight patients were randomized to elective preoperative revascularization; 99 underwent CABG, 141 underwent PCI, and 18 were excluded due to need for urgent vascular surgery, patient preference, or in one case, stroke. Both groups were similar with respect to baseline clinical variables, including the incidence of previous myocardial infarction, congestive heart failure, diabetes mellitus, led ventricular ejection fraction, and 3vessel coronary artery disease. They were also similar in the use of perioperative betablockers (~ 85%), statins, and aspirin.

At 2.7 years after randomization, mortality was 22% in the revascularization group and 22% in the medical management group, the relative risk was 0.98 (95% CI 0.7-1.37; p=.92), which was not statistically significant. The median time from randomization to vascular surgery was 54 days in the revascularization group and 18 days in the medical management group not undergoing revascularization (p<.001). Although not designed to address short-term outcomes, there were no differences in the rates of early postoperative myocardial infarction, death, or hospital length of stay. It is also worth noting that 316 of the 510 patients who were ultimately randomized had undergone nuclear imaging studies, of which 226 (72%) had moderate to large reversible perfusion defects detected. These outcome data suggest that the presence of reversible perfusions defects is not in itself a reason for preoperative revascularization.

This well-designed study demonstrates that in the absence of unstable coronary syndromes, led main disease, severe aortic stenosis, or severely depressed led ventricular ejection fraction, there is no morbidity or mortality benefit to revascularization among patients with stable coronary artery disease prior to vascular surgery. Because vascular surgery is the highest risk category among non-cardiac procedures, it may be reasonable to extend these findings to lower risk surgeries as well, and in this sense this study is particularly relevant to consultative practice. While this study provides clear evidence on how to manage this cohort of patients, it remains unclear what the optimal strategy is to identify and manage those patients who were excluded from the trial. (DF)

Amiodarone or a Implantable Cardioverter-Defibrilator for Congestive Heart Failure

Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 20;352:225-37.

Ventricular arrhythmias are the leading cause of sudden cardiac death in patients with systolic heart failure. Treatment with antiarrhythmic drug therapy has failed to improve survival in these patients, due to their proarrhythmic effects. Unlike other antiarrhythmics, amiodarone is a drug with low proarrhythmic effects. Some studies have suggested that amiodarone may be beneficial in patients with systolic heart failure. Conversely, several primary and secondary prevention trials have demonstrated that placement of an implantable cardioverter-defibrillator (ICD) confers a survival benefit in patients with ischemic cardiomyopathy. However, the role of ICDs in nonischemic heart failure remained unproven.

Bardy and colleagues developed the Sudden Cardiac Death in Heart Failure Trial (SCDHeFT) to evaluate the hypothesis that treatment with amiodarone or a shock-only, single-lead ICD would decrease death from any cause in a population of patients with mild to moderate heart failure. They randomly assigned 2521 patients with New York Heart Association (NYHA) class II or II heart failure (and a led ventricular ejection fraction (LVEF) of 35% or less to conventional medical therapy plus placebo, conventional therapy plus treatment with amiodarone or conventional therapy plus a conservatively programmed, shock-only, single-lead ICD.

Fifty-two percent of patients had ischemic heart failure and 48% had nonischemic heart failure. Placebo and amiodarone were given in double-blind fashion. The primary endpoint was death from any cause with a median followup of 45.5 months. The results were as follows:

Placebo Group - 244 deaths (29% Death Rate)

Amiodarone Group - 240 deaths (28% Death Rate)

ICD Group - 182 deaths (22% Death Rate)

Patients treated with amiodarone had a similar risk of death as those who received placebo (hazard ratio, 1.06; 97.5% CI: 0.86–1.30; p=0.53). Patients implanted with an ICD had a 23% decreased risk of death when compared with those who received placebo (0.77; 97.5% CI: 0.62–0.96; p=.007). This resulted in an absolute risk reduction of 7.2% at 5 years. The authors concluded that in patients with NYHA class II or III heart failure and a LVEF of 35% or less, implantation of a single-lead, shock-only ICD reduced overall mortality by 23%, while treatment with amiodarone had no effect on survival. The benefit of ICD placement reached or approached significance in both the ischemic (hazard ratio .79, CI: 0.60–1.04, p= .05) and nonischemic (hazard ratio 0.73, CI: 0.50–1.07, p= 0.06) subgroups.

It is important to note that an additional subgroup analysis showed that ICD therapy had a significant survival benefit only in NYHA class II patients but not in NYHA class III patients. Amiodarone therapy had no benefit in class II patients and actually decreased survival in class III patients compared to those receiving placebo. In light of results from previous trials that demonstrated a greater survival benefit from ICD placement with worsening ejection fraction in patients with ischemic heart failure, the authors were unable to explain whether the differences in subclasses were biologically plausible.

This study is important for several reasons. First, it suggested that patients with systolic heart failure due to either ischemic or non ischemic causes would benefit from placement of an ICD. Second, these results support the conclusions of previous trials that demonstrate a survival advantage of ICD placement in patients with ischemic heart failure. Finally, this study also demonstrates that amiodarone therapy offers no survival benefit in this population of patients. (JL)

Clopidogrel versus Aspirin and Esomeprazole to Prevent Recurrent Ulcer Bleeding

Chan F, Ching J, Hung L, et al. Clopidogrel versus aspirin and esomeprazole to prevent recurrent ulcer bleeding. N Engl J Med. 2005;352:238-44.

The optimal choice of antiplatelet therapy for patients with coronary heart disease who have had a recent upper gastrointestinal hemorrhage has not been well studied. Clopidogrel has been shown to cause fewer episodes of gastrointestinal hemorrhage than aspirin, but it is unknown whether clopidogrel monotherapy is in fact superior to aspirin plus a protonpump inhibitor. In this prospective, randomized, doubleblind trial, Chan and colleagues hypothesize that clopidogrel monotherapy would “not be inferior” to aspirin plus esomeprazole in a population of patients who had recovered from aspirin-induced hemorrhagic ulcers.

The study population was drawn from patients taking aspirin who were evaluated for an upper gastrointestinal bleed and had ulcer disease documented on endoscopy. Patients with documented Helicobacter pylori infection were treated with a 1-week course of a standard triple-drug regimen. All subjects, regardless of H. pylori status, were treated with an 8-week course of proton-pump inhibitors (PPI). Inclusion criteria included endoscopic confirmation of ulcer healing and successful eradication of H. pylori, if it was present. The location of the ulcers was not specified in the study.

Exclusion criteria included use of nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 inhibitors, anticoagulant drugs, corticosteroids, or other anti-platelet agents; history of gastric surgery; presence of erosive esophagitis; gastric outlet obstruction; cancer; need for dialysis; or terminal illness.

Subjects who met the inclusion criteria were randomized to receive either 75 mg of clopidogrel and placebo or 80 mg of aspirin daily plus 20 mg of esomeprazole twice a day for a 12 months. Patients returned for evaluation every 3 months during the 1-year study period. The primary endpoint was recurrence of ulcer bleeding, which was predefined as clinical or laboratory evidence of gastrointestinal hemorrhage with a documented recurrence of ulcers on endoscopy. Lower gastrointestinal bleeding was a secondary endpoint.

Of 492 consecutive patients who were evaluated, 320 met inclusion criteria and were evenly divided into the clopidogrel plus placebo or the aspirin plus esomeprazole arms. Only 3 patients were lost to followup. During the study period, 34 cases of suspected gastrointestinal hemorrhage (defined as hematemesis, melena, or 2 g/dL decrease of hemoglobin) were identified. During endoscopy,14 cases were confirmed to be due to recurrent ulcer bleeding. Of these, 13 ulcers were in the clopidogrel arm (6 gastric ulcers, 5 duodenal, and 2 both) and 1 ulcer (duodenal) in the aspirin plus esomeprazole arm, a statistically significant difference (p=.001).

Fourteen patients were determined to have a lower gastrointestinal hemorrhage. Interestingly, these cases were evenly divided between the clopidogrel group (7 cases) and the aspirin plus esomeprazole (7 cases). This finding suggests the effect of esomeprazole in this study may be specific in preventing recurrent upper gastrointestinal ulcer formation and hemorrhage. The 2 groups had equivalent rates of recurrent ischemic events.

This study addresses an important clinical question, frequently encountered by hospitalists. The recommendation that clopidogrel be used instead of aspirin in patients who require antiplatelet therapy but have a history of upper gastrointestinal hemorrhage is based on studies using high-dose (325 mg) aspirin and excluded patients on acid-suppressing therapy. However, this study failed to prove noninferiority of clopidogrel to aspirin and esomeprazole for this indication. Although this study was not designed to show superiority of aspirin and esomeprazole over clopidogrel, these results indicate that this may be the case, and such a study would be timely. (CG)

Contact

Mark Kulaga, MD

Associate Program Director

Internal Medicine Residency

Norwalk Hospital

Norwalk, CT 06856

[email protected]

Physician Staff

Pamela Charney, MD

Joseph Cleary, MD

Mark Kulaga, MD

Eric Mazur, MD

Stephen O’Mahony, MD

Jason Orlinick, MD, PhD

Andrea Peterson, MD

Other Staff

Michael Marotta, PA

Start Up

July 1999

Hospital Setting

Norwalk Hospital, Norwalk, CT

Academic Community Hospital with 250 beds

Affiliated with Yale University

Patient Population

Our patient population is wonderfully diverse, both economically and socially. Located in the heart of affluent Fairfield County, Norwalk is nevertheless a true small city and home to vibrant communities of African Americans, Latinos, and multiple other immigrant groups. The Hospitalist Clinician-Educator program was originally created to provide inpatient care for indigent patients (who predominantly attend the Norwalk Community Health Center) and for those patients without a local primary care physician. In recent years, as more community internists have chosen to use the hospital medicine service, our payer mix has substantially changed to include many more patients with private insurance and/or Medicare.

Employer

All physicians are general internists employed by the Norwalk Hospital.

Organization/Management

Dr. Eric Mazur, Chairman of the Department of Internal Medicine, is the program founder and administrative leader. He serves as the primary liaison between the hospitalists and the Chief Executive and Operating Officers of the hospital.

Total Number of Patients Served Each Year

On average, each hospitalist admits 350 patients per year. When this threshold is exceeded, a new hospitalist has been added to the group. In the first few years of service, our hospitalists covered 20-25% of the total number of medical admissions to the Norwalk Hospital. As use of the service by local internists has increased, this percentage has grown to 40–45%. It is projected that the Norwalk Hospital hospital medicine service will admit over 2200 patients this year.

Compensation/Schedules

All hospitalists receive a fixed annual salary. The hospital subsidizes 50% of each Hospitalist Clinician Educator position and bills the faculty practice income for the remaining 50%. Faculty practice income is generated through direct patient billing facilitated by a billing agency not affiliated with the hospital. The hospital also provides an annual stipend to the faculty practice for the indigent care supplied by the hospital medicine group. Our compensation model does not utilize an incentive bonus system, although yearly bonuses derived from surplus faculty practice revenue are provided at the discretion of the Chairman.

All hospitalists admit and co-manage patients with resident teams who provide 24/7 in-house coverage. Each hospitalist typically works Monday through Friday from approximately 7–8 a.m. until 5:30–6:30 p.m. depending on patient census. Hospitalists, along with other members of the full time faculty, provide nighttime backup coverage from home for the residents. Weekend coverage responsibilities are also shared with other members of the teaching faculty. Weekend moonlighters, all of whom are board-certified or board-eligible internists from nearby communities, assist full-time faculty members with coverage on Saturdays and Sundays.

Communication Strategies/Role in Education

All of our hospitalists are highly rated by medical residents for their effectiveness as teachers and supervisors. For many, they also serve as important mentors and role models. In addition to traditional educational roles on the inpatient service, our hospitalists have developed several innovative teaching conferences, which include: teaching skills workshops; weekly medical informatics sessions; a monthly medical quiz game incorporating content from core educational conferences; a multidisciplinary Morbidity and Mortality Conference in which residents from the internal medicine and radiology departments are key participants; and a series of conferences in which end-of-life issues and physician professional development are explored in great depth.

Our hospitalists have also established a formal medical consultation service with a specially designed curriculum for the residents. We have also developed a hospital medicine elective where medical residents experience what being a hospitalist is “really like.” This elective has also been used to remediate struggling residents. Our hospitalists also have prominent administrative hospital roles; one is the Director of Graduate Medical Education, and 2 others serve as Associate Program Directors for the Internal Medicine residency. In addition, they have presented their academic work at regional and national meetings of the American College of Physicians and the Society of General Internal Medicine.

Challenges Now and in the Future

Our biggest challenge can be summed up with one word: growth. Up to this point in time, a major strength of our program is that it has been able to grow incrementally and deliberately. We have never “rushed” the hiring of new hospitalists and thus have been able to recruit physicians with similar academic backgrounds and career goals. This has resulted in a cohesive group of hospitalists who support each other in every way and work extremely well together.

A major concern in hospitalist medicine is the concept of “hospitalist burnout.” We have successfully addressed this issue by limiting the number of hospitalist admissions and weekends on call, actively participating in medical education with resident physicians, and serving in important administrative roles within the hospital. As we expand to meet the growing demand for our inpatient care services by primary care physicians, we are finding it more difficult to strike a balance between our service duties and academic interests. We are working closely with our department chairman, who is a true advocate of “hospitalist career building,” to find creative ways to achieve this goal. We believe that it is the balance between service and education that has allowed us to attain a hospitalist retention rate of 100% since the inception of the group.

Goals of Hospital Medicine Group

In addition to providing outstanding patient care and resident teaching, the goals of our group are commensurate with many of the current trends affecting the field of medicine and include:

1. Quality. As quality moves to the forefront of medicine, we believe that hospitalists are the logical champions and effectors of inpatient quality care. Our hospitalists have been involved in a number of quality improvement projects, such as the establishment of multidisciplinary patient rounds, which serve to advance care and achieve high levels of core measure compliance; stroke center development; and the design of inpatient diabetes management protocols. Our hospitalists have also been heavily involved in the implementation of computerized physician order entry at the Norwalk Hospital and have written numerous order sets for specific diagnoses. We expect these projects to result in demonstrably improved quality beyond the improvements in length-of-stay and core-measures adherence already achieved. We believe that our involvement in quality, both now and in the future, adds value to our role as hospitalists from the point of view of hospital administrators. It also provides us with enhanced job satisfaction and multiple opportunities for career development.
2. Patient safety. This is another “hot topic” in the field of medicine where we feel that hospitalists can and should have a substantial impact. As mentioned before, our hospitalists have played prominent roles in the successful implementation of computerized physician order entry, a process that has been shown to result in major improvements in patient safety. Our hospitalists also serve on the patient safety committee and are an important link between residents and ancillary staff when housestaff raise safety concerns. In the future, our hospitalists hope to have an even greater role in such important safety areas as infection control, management of delirium in the elderly, venous thromboembolism prophylaxis in the medical inpatient, and the prevention of patient falls.
3. Research. Clinically and educationally oriented research is encouraged among all full-time hospitalist faculty. We recently published data on the financial and educational benefits of our hospitalist model in the April 2004 issue of the Journal of General Internal Medicine, but we feel that more needs to be done. In particular, we plan to better quantify how hospitalists achieve the reported cost-saving benefits. We also plan to further assess the roles of hospitalists in the education of medical residents in the community setting, a topic that is vastly underrepresented in the medical literature. Hospitalist faculty will also participate in a formal evaluation of the Multidisciplinary Rounds Process and will mentor residents in their personal research projects.

Contact

Mark Kulaga, MD

Associate Program Director

Internal Medicine Residency

Norwalk Hospital

Norwalk, CT 06856

[email protected]

Physician Staff

Pamela Charney, MD

Joseph Cleary, MD

Mark Kulaga, MD

Eric Mazur, MD

Stephen O’Mahony, MD

Jason Orlinick, MD, PhD

Andrea Peterson, MD

Other Staff

Michael Marotta, PA

Start Up

July 1999

Hospital Setting

Norwalk Hospital, Norwalk, CT

Academic Community Hospital with 250 beds

Affiliated with Yale University

Patient Population

Our patient population is wonderfully diverse, both economically and socially. Located in the heart of affluent Fairfield County, Norwalk is nevertheless a true small city and home to vibrant communities of African Americans, Latinos, and multiple other immigrant groups. The Hospitalist Clinician-Educator program was originally created to provide inpatient care for indigent patients (who predominantly attend the Norwalk Community Health Center) and for those patients without a local primary care physician. In recent years, as more community internists have chosen to use the hospital medicine service, our payer mix has substantially changed to include many more patients with private insurance and/or Medicare.

Employer

All physicians are general internists employed by the Norwalk Hospital.

Organization/Management

Dr. Eric Mazur, Chairman of the Department of Internal Medicine, is the program founder and administrative leader. He serves as the primary liaison between the hospitalists and the Chief Executive and Operating Officers of the hospital.

Total Number of Patients Served Each Year

On average, each hospitalist admits 350 patients per year. When this threshold is exceeded, a new hospitalist has been added to the group. In the first few years of service, our hospitalists covered 20-25% of the total number of medical admissions to the Norwalk Hospital. As use of the service by local internists has increased, this percentage has grown to 40–45%. It is projected that the Norwalk Hospital hospital medicine service will admit over 2200 patients this year.

Compensation/Schedules

All hospitalists receive a fixed annual salary. The hospital subsidizes 50% of each Hospitalist Clinician Educator position and bills the faculty practice income for the remaining 50%. Faculty practice income is generated through direct patient billing facilitated by a billing agency not affiliated with the hospital. The hospital also provides an annual stipend to the faculty practice for the indigent care supplied by the hospital medicine group. Our compensation model does not utilize an incentive bonus system, although yearly bonuses derived from surplus faculty practice revenue are provided at the discretion of the Chairman.

All hospitalists admit and co-manage patients with resident teams who provide 24/7 in-house coverage. Each hospitalist typically works Monday through Friday from approximately 7–8 a.m. until 5:30–6:30 p.m. depending on patient census. Hospitalists, along with other members of the full time faculty, provide nighttime backup coverage from home for the residents. Weekend coverage responsibilities are also shared with other members of the teaching faculty. Weekend moonlighters, all of whom are board-certified or board-eligible internists from nearby communities, assist full-time faculty members with coverage on Saturdays and Sundays.

Communication Strategies/Role in Education

All of our hospitalists are highly rated by medical residents for their effectiveness as teachers and supervisors. For many, they also serve as important mentors and role models. In addition to traditional educational roles on the inpatient service, our hospitalists have developed several innovative teaching conferences, which include: teaching skills workshops; weekly medical informatics sessions; a monthly medical quiz game incorporating content from core educational conferences; a multidisciplinary Morbidity and Mortality Conference in which residents from the internal medicine and radiology departments are key participants; and a series of conferences in which end-of-life issues and physician professional development are explored in great depth.

Our hospitalists have also established a formal medical consultation service with a specially designed curriculum for the residents. We have also developed a hospital medicine elective where medical residents experience what being a hospitalist is “really like.” This elective has also been used to remediate struggling residents. Our hospitalists also have prominent administrative hospital roles; one is the Director of Graduate Medical Education, and 2 others serve as Associate Program Directors for the Internal Medicine residency. In addition, they have presented their academic work at regional and national meetings of the American College of Physicians and the Society of General Internal Medicine.

Challenges Now and in the Future

Our biggest challenge can be summed up with one word: growth. Up to this point in time, a major strength of our program is that it has been able to grow incrementally and deliberately. We have never “rushed” the hiring of new hospitalists and thus have been able to recruit physicians with similar academic backgrounds and career goals. This has resulted in a cohesive group of hospitalists who support each other in every way and work extremely well together.

A major concern in hospitalist medicine is the concept of “hospitalist burnout.” We have successfully addressed this issue by limiting the number of hospitalist admissions and weekends on call, actively participating in medical education with resident physicians, and serving in important administrative roles within the hospital. As we expand to meet the growing demand for our inpatient care services by primary care physicians, we are finding it more difficult to strike a balance between our service duties and academic interests. We are working closely with our department chairman, who is a true advocate of “hospitalist career building,” to find creative ways to achieve this goal. We believe that it is the balance between service and education that has allowed us to attain a hospitalist retention rate of 100% since the inception of the group.

Goals of Hospital Medicine Group

In addition to providing outstanding patient care and resident teaching, the goals of our group are commensurate with many of the current trends affecting the field of medicine and include:

1. Quality. As quality moves to the forefront of medicine, we believe that hospitalists are the logical champions and effectors of inpatient quality care. Our hospitalists have been involved in a number of quality improvement projects, such as the establishment of multidisciplinary patient rounds, which serve to advance care and achieve high levels of core measure compliance; stroke center development; and the design of inpatient diabetes management protocols. Our hospitalists have also been heavily involved in the implementation of computerized physician order entry at the Norwalk Hospital and have written numerous order sets for specific diagnoses. We expect these projects to result in demonstrably improved quality beyond the improvements in length-of-stay and core-measures adherence already achieved. We believe that our involvement in quality, both now and in the future, adds value to our role as hospitalists from the point of view of hospital administrators. It also provides us with enhanced job satisfaction and multiple opportunities for career development.
2. Patient safety. This is another “hot topic” in the field of medicine where we feel that hospitalists can and should have a substantial impact. As mentioned before, our hospitalists have played prominent roles in the successful implementation of computerized physician order entry, a process that has been shown to result in major improvements in patient safety. Our hospitalists also serve on the patient safety committee and are an important link between residents and ancillary staff when housestaff raise safety concerns. In the future, our hospitalists hope to have an even greater role in such important safety areas as infection control, management of delirium in the elderly, venous thromboembolism prophylaxis in the medical inpatient, and the prevention of patient falls.
3. Research. Clinically and educationally oriented research is encouraged among all full-time hospitalist faculty. We recently published data on the financial and educational benefits of our hospitalist model in the April 2004 issue of the Journal of General Internal Medicine, but we feel that more needs to be done. In particular, we plan to better quantify how hospitalists achieve the reported cost-saving benefits. We also plan to further assess the roles of hospitalists in the education of medical residents in the community setting, a topic that is vastly underrepresented in the medical literature. Hospitalist faculty will also participate in a formal evaluation of the Multidisciplinary Rounds Process and will mentor residents in their personal research projects.

Contact

Mark Kulaga, MD

Associate Program Director

Internal Medicine Residency

Norwalk Hospital

Norwalk, CT 06856

[email protected]

Physician Staff

Pamela Charney, MD

Joseph Cleary, MD

Mark Kulaga, MD

Eric Mazur, MD

Stephen O’Mahony, MD

Jason Orlinick, MD, PhD

Andrea Peterson, MD

Other Staff

Michael Marotta, PA

Start Up

July 1999

Hospital Setting

Norwalk Hospital, Norwalk, CT

Academic Community Hospital with 250 beds

Affiliated with Yale University

Patient Population

Our patient population is wonderfully diverse, both economically and socially. Located in the heart of affluent Fairfield County, Norwalk is nevertheless a true small city and home to vibrant communities of African Americans, Latinos, and multiple other immigrant groups. The Hospitalist Clinician-Educator program was originally created to provide inpatient care for indigent patients (who predominantly attend the Norwalk Community Health Center) and for those patients without a local primary care physician. In recent years, as more community internists have chosen to use the hospital medicine service, our payer mix has substantially changed to include many more patients with private insurance and/or Medicare.

Employer

All physicians are general internists employed by the Norwalk Hospital.

Organization/Management

Dr. Eric Mazur, Chairman of the Department of Internal Medicine, is the program founder and administrative leader. He serves as the primary liaison between the hospitalists and the Chief Executive and Operating Officers of the hospital.

Total Number of Patients Served Each Year

On average, each hospitalist admits 350 patients per year. When this threshold is exceeded, a new hospitalist has been added to the group. In the first few years of service, our hospitalists covered 20-25% of the total number of medical admissions to the Norwalk Hospital. As use of the service by local internists has increased, this percentage has grown to 40–45%. It is projected that the Norwalk Hospital hospital medicine service will admit over 2200 patients this year.

Compensation/Schedules

All hospitalists receive a fixed annual salary. The hospital subsidizes 50% of each Hospitalist Clinician Educator position and bills the faculty practice income for the remaining 50%. Faculty practice income is generated through direct patient billing facilitated by a billing agency not affiliated with the hospital. The hospital also provides an annual stipend to the faculty practice for the indigent care supplied by the hospital medicine group. Our compensation model does not utilize an incentive bonus system, although yearly bonuses derived from surplus faculty practice revenue are provided at the discretion of the Chairman.

All hospitalists admit and co-manage patients with resident teams who provide 24/7 in-house coverage. Each hospitalist typically works Monday through Friday from approximately 7–8 a.m. until 5:30–6:30 p.m. depending on patient census. Hospitalists, along with other members of the full time faculty, provide nighttime backup coverage from home for the residents. Weekend coverage responsibilities are also shared with other members of the teaching faculty. Weekend moonlighters, all of whom are board-certified or board-eligible internists from nearby communities, assist full-time faculty members with coverage on Saturdays and Sundays.

Communication Strategies/Role in Education

All of our hospitalists are highly rated by medical residents for their effectiveness as teachers and supervisors. For many, they also serve as important mentors and role models. In addition to traditional educational roles on the inpatient service, our hospitalists have developed several innovative teaching conferences, which include: teaching skills workshops; weekly medical informatics sessions; a monthly medical quiz game incorporating content from core educational conferences; a multidisciplinary Morbidity and Mortality Conference in which residents from the internal medicine and radiology departments are key participants; and a series of conferences in which end-of-life issues and physician professional development are explored in great depth.

Our hospitalists have also established a formal medical consultation service with a specially designed curriculum for the residents. We have also developed a hospital medicine elective where medical residents experience what being a hospitalist is “really like.” This elective has also been used to remediate struggling residents. Our hospitalists also have prominent administrative hospital roles; one is the Director of Graduate Medical Education, and 2 others serve as Associate Program Directors for the Internal Medicine residency. In addition, they have presented their academic work at regional and national meetings of the American College of Physicians and the Society of General Internal Medicine.

Challenges Now and in the Future

Our biggest challenge can be summed up with one word: growth. Up to this point in time, a major strength of our program is that it has been able to grow incrementally and deliberately. We have never “rushed” the hiring of new hospitalists and thus have been able to recruit physicians with similar academic backgrounds and career goals. This has resulted in a cohesive group of hospitalists who support each other in every way and work extremely well together.

A major concern in hospitalist medicine is the concept of “hospitalist burnout.” We have successfully addressed this issue by limiting the number of hospitalist admissions and weekends on call, actively participating in medical education with resident physicians, and serving in important administrative roles within the hospital. As we expand to meet the growing demand for our inpatient care services by primary care physicians, we are finding it more difficult to strike a balance between our service duties and academic interests. We are working closely with our department chairman, who is a true advocate of “hospitalist career building,” to find creative ways to achieve this goal. We believe that it is the balance between service and education that has allowed us to attain a hospitalist retention rate of 100% since the inception of the group.

Goals of Hospital Medicine Group

In addition to providing outstanding patient care and resident teaching, the goals of our group are commensurate with many of the current trends affecting the field of medicine and include:

1. Quality. As quality moves to the forefront of medicine, we believe that hospitalists are the logical champions and effectors of inpatient quality care. Our hospitalists have been involved in a number of quality improvement projects, such as the establishment of multidisciplinary patient rounds, which serve to advance care and achieve high levels of core measure compliance; stroke center development; and the design of inpatient diabetes management protocols. Our hospitalists have also been heavily involved in the implementation of computerized physician order entry at the Norwalk Hospital and have written numerous order sets for specific diagnoses. We expect these projects to result in demonstrably improved quality beyond the improvements in length-of-stay and core-measures adherence already achieved. We believe that our involvement in quality, both now and in the future, adds value to our role as hospitalists from the point of view of hospital administrators. It also provides us with enhanced job satisfaction and multiple opportunities for career development.
2. Patient safety. This is another “hot topic” in the field of medicine where we feel that hospitalists can and should have a substantial impact. As mentioned before, our hospitalists have played prominent roles in the successful implementation of computerized physician order entry, a process that has been shown to result in major improvements in patient safety. Our hospitalists also serve on the patient safety committee and are an important link between residents and ancillary staff when housestaff raise safety concerns. In the future, our hospitalists hope to have an even greater role in such important safety areas as infection control, management of delirium in the elderly, venous thromboembolism prophylaxis in the medical inpatient, and the prevention of patient falls.
3. Research. Clinically and educationally oriented research is encouraged among all full-time hospitalist faculty. We recently published data on the financial and educational benefits of our hospitalist model in the April 2004 issue of the Journal of General Internal Medicine, but we feel that more needs to be done. In particular, we plan to better quantify how hospitalists achieve the reported cost-saving benefits. We also plan to further assess the roles of hospitalists in the education of medical residents in the community setting, a topic that is vastly underrepresented in the medical literature. Hospitalist faculty will also participate in a formal evaluation of the Multidisciplinary Rounds Process and will mentor residents in their personal research projects.

Jackson Memorial Hospital is an accredited, nonprofit, tertiary care hospital and the major teaching facility for the University of Miami School of Medicine. Jackson Memorial Hospital is one of the busiest centers in the country, with approximately 1500 licensed beds, 225,000 emergency and urgent care visits, and nearly 60,000 admissions to the hospital each year. Furthermore, JMH is the only full-service provider for the uninsured and medically indigent in Miami-Dade County, Florida.

Jackson Memorial Hospital has a broad range of tertiary services and clinical programs designed to serve the entire community. Its medical staff is recognized nationally for the quality of its patient care, teaching, and research. The hospital has over 11,000 full-time employees, approximately 1000 house staff, and nearly 700 clinical attending physicians from the University of Miami School of Medicine alone.

Our medicine department is composed of the following inpatient services: eight general medical teaching teams, three HIV/AIDS teams, one cardiology team, an acute care for the elderly (ACE) unit, one oncology team, and a hospitalist run (non-teaching) service.

Over the last several years a combination of the pressures from outside regulatory agencies and an increasing number of patient admissions brought the admitting process to a breaking point. Teaching services were being held to the admission cap guidelines by the Residency Review Committee (RRC). Furthermore, the Accreditation Council for Graduate Medical Education (ACGME) began to enforce strict work-hour rules for all training programs. With these restrictions a fixed number of admissions were admitted to a fixed number of services within a shorter period of the day. In fact, many patients were being held in the emergency department (ED) for as long as 15 hours before an internal medicine service saw the patient or wrote admission orders. We had concerns about safety and the provision of high quality of care for these patients. One of the concerns was that ED physicians were caring for patients who were essentially inpatients while continuing to treat new ED cases.

In an attempt to provide excellent care to our patients, we developed the Emergency Medical Hospitalist Service (EMHS), a nocturnist service. The goals of this service are to: (1) provide attendinglevel care to patients requiring admission, (2) allow the hospital to operate within the admission cap guideline set forth by the RRC, (3) function during the time in which the ACGME work hour limits were affecting the hospital, and (4) operate in a manner that would be at least cost neutral for the institution. We hired two internists (myself and Dr. Roshan K. Rao) to admit patients overnight and begin their inpatient work-up. During this shift, we admit and initiate the inpatient care of all medical admissions for the inpatient services, including the housestaff covered teams. During a typical 12-hour shift, we will admit an average of 10–12 new patients from the ED. In addition to this, there is one resident on each night (termed “night relief”), who provides cross-coverage of existing medical inpatients. We also work in close concert with the newly developed “Patient Placement Coordinator,” who facilitates prompt bed assignments and movement of these patients to in-house beds.

Currently there are two of us, so we make our own schedule depending on each others’ needs. We currently work one week on/one week off, from 8 p.m. To 8 a.m. Towards the end of the shift, we sign out the newly admitted patients to the appropriate services. Typically, the resident will come into the ED and take their sign-out from one of us. The geriatrics fellows and non-teaching hospitalists usually take sign-out over the phone. The entire sign-out process occurs anytime from 6:00 a.m. to 8:00 a.m. We also reserve this part of the shift to follow up laboratory studies and other diagnostic procedures. Occasionally, we are able to discharge some patients by the end of the shift as well.

On occasion, we will call in the other nocturnist to help out when admissions are too numerous for one physician to handle. This typically occurs towards the end of the work week. We usually require “double coverage” approximately 6–8 nights per month.

Since we instituted the nocturnist program 2 years ago, we have seen great improvements in ED throughput, inpatient bed utilization, patient satisfaction, average length of stay (both in the ED and inpatient), and quality of care. As soon as the emergency physician makes their decision to admit the patient, one of us is already interviewing, examining, and writing admission orders on the patient. This speeds up the process of the patient’s evaluation and allows the patient to be immediately transferred to a quiet room. Furthermore, this allows us to develop a rapport with the patient in the middle of the night, instead of feeling rushed in the morning to round on as many as 20 new patients. This also ensures a good night’s rest for the patient and improves the bed utilization. Moving patients to the floor in a timely fashion also allows for the ED to treat more patients.

Having a nocturnist in the hospital throughout the night allows for a more precise and accurate physical exam, formulation of an impression, and execution of a treatment plan. Physicians who are on-call at home often do not get the complete or correct story from the ED, which can lead to incomplete admission orders and delayed treatment plans. This can lead to unnecessary increases in length of stay. For example, I often admit “chest pain” patients, who by morning have already “ruled out” for an acute coronary event, had a stress test, and are ready for discharge before the “daytime” physician has seen the patient. Another example is diabetic ketoacidosis. I am able to be very aggressive with the treatment plan throughout the night, again decreasing length of stay and hospital costs.

Nocturnism is not only advantageous to the hospital and patients, but also to the nocturnist himself/herself. Dedicated nocturnists have less fatigue and stress. I work only nights, so I do not become excessively tired. My sleep schedule is completely reversed from the norm. This also has many advantages to my personal life. One of these is that I never miss a package delivered to my home!

Indeed, developing this program was a challenge. Initially we sold the idea through a combination of patient safety and revenue. The hospital cannot bill for holding patients in the ED. If we admit patients and move them to an inpatient bed, the hospital can generate this otherwise lost revenue. As with any new idea, we did meet resistance and opposition along the way. However, we were able to overcome these obstacles and build upon them. Once the administration saw the improvements and our productivity, they were immensely pleased. In fact, the administration is already looking at expanding our staffing and our services. Our billing and collections have shown we pay for our cost and generate additional funds for the hospital, despite a poor payer mix. I am excited to see what the future holds for nocturnists, not only in our institution, but across the country. Groups that employ nocturnists probably wonder how they ever survived without them in the past.

Dr. Sabharwal can be contacted at [email protected].

Jackson Memorial Hospital is an accredited, nonprofit, tertiary care hospital and the major teaching facility for the University of Miami School of Medicine. Jackson Memorial Hospital is one of the busiest centers in the country, with approximately 1500 licensed beds, 225,000 emergency and urgent care visits, and nearly 60,000 admissions to the hospital each year. Furthermore, JMH is the only full-service provider for the uninsured and medically indigent in Miami-Dade County, Florida.

Jackson Memorial Hospital has a broad range of tertiary services and clinical programs designed to serve the entire community. Its medical staff is recognized nationally for the quality of its patient care, teaching, and research. The hospital has over 11,000 full-time employees, approximately 1000 house staff, and nearly 700 clinical attending physicians from the University of Miami School of Medicine alone.

Our medicine department is composed of the following inpatient services: eight general medical teaching teams, three HIV/AIDS teams, one cardiology team, an acute care for the elderly (ACE) unit, one oncology team, and a hospitalist run (non-teaching) service.

Over the last several years a combination of the pressures from outside regulatory agencies and an increasing number of patient admissions brought the admitting process to a breaking point. Teaching services were being held to the admission cap guidelines by the Residency Review Committee (RRC). Furthermore, the Accreditation Council for Graduate Medical Education (ACGME) began to enforce strict work-hour rules for all training programs. With these restrictions a fixed number of admissions were admitted to a fixed number of services within a shorter period of the day. In fact, many patients were being held in the emergency department (ED) for as long as 15 hours before an internal medicine service saw the patient or wrote admission orders. We had concerns about safety and the provision of high quality of care for these patients. One of the concerns was that ED physicians were caring for patients who were essentially inpatients while continuing to treat new ED cases.

In an attempt to provide excellent care to our patients, we developed the Emergency Medical Hospitalist Service (EMHS), a nocturnist service. The goals of this service are to: (1) provide attendinglevel care to patients requiring admission, (2) allow the hospital to operate within the admission cap guideline set forth by the RRC, (3) function during the time in which the ACGME work hour limits were affecting the hospital, and (4) operate in a manner that would be at least cost neutral for the institution. We hired two internists (myself and Dr. Roshan K. Rao) to admit patients overnight and begin their inpatient work-up. During this shift, we admit and initiate the inpatient care of all medical admissions for the inpatient services, including the housestaff covered teams. During a typical 12-hour shift, we will admit an average of 10–12 new patients from the ED. In addition to this, there is one resident on each night (termed “night relief”), who provides cross-coverage of existing medical inpatients. We also work in close concert with the newly developed “Patient Placement Coordinator,” who facilitates prompt bed assignments and movement of these patients to in-house beds.

Currently there are two of us, so we make our own schedule depending on each others’ needs. We currently work one week on/one week off, from 8 p.m. To 8 a.m. Towards the end of the shift, we sign out the newly admitted patients to the appropriate services. Typically, the resident will come into the ED and take their sign-out from one of us. The geriatrics fellows and non-teaching hospitalists usually take sign-out over the phone. The entire sign-out process occurs anytime from 6:00 a.m. to 8:00 a.m. We also reserve this part of the shift to follow up laboratory studies and other diagnostic procedures. Occasionally, we are able to discharge some patients by the end of the shift as well.

On occasion, we will call in the other nocturnist to help out when admissions are too numerous for one physician to handle. This typically occurs towards the end of the work week. We usually require “double coverage” approximately 6–8 nights per month.

Since we instituted the nocturnist program 2 years ago, we have seen great improvements in ED throughput, inpatient bed utilization, patient satisfaction, average length of stay (both in the ED and inpatient), and quality of care. As soon as the emergency physician makes their decision to admit the patient, one of us is already interviewing, examining, and writing admission orders on the patient. This speeds up the process of the patient’s evaluation and allows the patient to be immediately transferred to a quiet room. Furthermore, this allows us to develop a rapport with the patient in the middle of the night, instead of feeling rushed in the morning to round on as many as 20 new patients. This also ensures a good night’s rest for the patient and improves the bed utilization. Moving patients to the floor in a timely fashion also allows for the ED to treat more patients.

Having a nocturnist in the hospital throughout the night allows for a more precise and accurate physical exam, formulation of an impression, and execution of a treatment plan. Physicians who are on-call at home often do not get the complete or correct story from the ED, which can lead to incomplete admission orders and delayed treatment plans. This can lead to unnecessary increases in length of stay. For example, I often admit “chest pain” patients, who by morning have already “ruled out” for an acute coronary event, had a stress test, and are ready for discharge before the “daytime” physician has seen the patient. Another example is diabetic ketoacidosis. I am able to be very aggressive with the treatment plan throughout the night, again decreasing length of stay and hospital costs.

Nocturnism is not only advantageous to the hospital and patients, but also to the nocturnist himself/herself. Dedicated nocturnists have less fatigue and stress. I work only nights, so I do not become excessively tired. My sleep schedule is completely reversed from the norm. This also has many advantages to my personal life. One of these is that I never miss a package delivered to my home!

Indeed, developing this program was a challenge. Initially we sold the idea through a combination of patient safety and revenue. The hospital cannot bill for holding patients in the ED. If we admit patients and move them to an inpatient bed, the hospital can generate this otherwise lost revenue. As with any new idea, we did meet resistance and opposition along the way. However, we were able to overcome these obstacles and build upon them. Once the administration saw the improvements and our productivity, they were immensely pleased. In fact, the administration is already looking at expanding our staffing and our services. Our billing and collections have shown we pay for our cost and generate additional funds for the hospital, despite a poor payer mix. I am excited to see what the future holds for nocturnists, not only in our institution, but across the country. Groups that employ nocturnists probably wonder how they ever survived without them in the past.

Dr. Sabharwal can be contacted at [email protected].

Jackson Memorial Hospital is an accredited, nonprofit, tertiary care hospital and the major teaching facility for the University of Miami School of Medicine. Jackson Memorial Hospital is one of the busiest centers in the country, with approximately 1500 licensed beds, 225,000 emergency and urgent care visits, and nearly 60,000 admissions to the hospital each year. Furthermore, JMH is the only full-service provider for the uninsured and medically indigent in Miami-Dade County, Florida.

Jackson Memorial Hospital has a broad range of tertiary services and clinical programs designed to serve the entire community. Its medical staff is recognized nationally for the quality of its patient care, teaching, and research. The hospital has over 11,000 full-time employees, approximately 1000 house staff, and nearly 700 clinical attending physicians from the University of Miami School of Medicine alone.

Our medicine department is composed of the following inpatient services: eight general medical teaching teams, three HIV/AIDS teams, one cardiology team, an acute care for the elderly (ACE) unit, one oncology team, and a hospitalist run (non-teaching) service.

Over the last several years a combination of the pressures from outside regulatory agencies and an increasing number of patient admissions brought the admitting process to a breaking point. Teaching services were being held to the admission cap guidelines by the Residency Review Committee (RRC). Furthermore, the Accreditation Council for Graduate Medical Education (ACGME) began to enforce strict work-hour rules for all training programs. With these restrictions a fixed number of admissions were admitted to a fixed number of services within a shorter period of the day. In fact, many patients were being held in the emergency department (ED) for as long as 15 hours before an internal medicine service saw the patient or wrote admission orders. We had concerns about safety and the provision of high quality of care for these patients. One of the concerns was that ED physicians were caring for patients who were essentially inpatients while continuing to treat new ED cases.

In an attempt to provide excellent care to our patients, we developed the Emergency Medical Hospitalist Service (EMHS), a nocturnist service. The goals of this service are to: (1) provide attendinglevel care to patients requiring admission, (2) allow the hospital to operate within the admission cap guideline set forth by the RRC, (3) function during the time in which the ACGME work hour limits were affecting the hospital, and (4) operate in a manner that would be at least cost neutral for the institution. We hired two internists (myself and Dr. Roshan K. Rao) to admit patients overnight and begin their inpatient work-up. During this shift, we admit and initiate the inpatient care of all medical admissions for the inpatient services, including the housestaff covered teams. During a typical 12-hour shift, we will admit an average of 10–12 new patients from the ED. In addition to this, there is one resident on each night (termed “night relief”), who provides cross-coverage of existing medical inpatients. We also work in close concert with the newly developed “Patient Placement Coordinator,” who facilitates prompt bed assignments and movement of these patients to in-house beds.

Currently there are two of us, so we make our own schedule depending on each others’ needs. We currently work one week on/one week off, from 8 p.m. To 8 a.m. Towards the end of the shift, we sign out the newly admitted patients to the appropriate services. Typically, the resident will come into the ED and take their sign-out from one of us. The geriatrics fellows and non-teaching hospitalists usually take sign-out over the phone. The entire sign-out process occurs anytime from 6:00 a.m. to 8:00 a.m. We also reserve this part of the shift to follow up laboratory studies and other diagnostic procedures. Occasionally, we are able to discharge some patients by the end of the shift as well.

On occasion, we will call in the other nocturnist to help out when admissions are too numerous for one physician to handle. This typically occurs towards the end of the work week. We usually require “double coverage” approximately 6–8 nights per month.

Since we instituted the nocturnist program 2 years ago, we have seen great improvements in ED throughput, inpatient bed utilization, patient satisfaction, average length of stay (both in the ED and inpatient), and quality of care. As soon as the emergency physician makes their decision to admit the patient, one of us is already interviewing, examining, and writing admission orders on the patient. This speeds up the process of the patient’s evaluation and allows the patient to be immediately transferred to a quiet room. Furthermore, this allows us to develop a rapport with the patient in the middle of the night, instead of feeling rushed in the morning to round on as many as 20 new patients. This also ensures a good night’s rest for the patient and improves the bed utilization. Moving patients to the floor in a timely fashion also allows for the ED to treat more patients.

Having a nocturnist in the hospital throughout the night allows for a more precise and accurate physical exam, formulation of an impression, and execution of a treatment plan. Physicians who are on-call at home often do not get the complete or correct story from the ED, which can lead to incomplete admission orders and delayed treatment plans. This can lead to unnecessary increases in length of stay. For example, I often admit “chest pain” patients, who by morning have already “ruled out” for an acute coronary event, had a stress test, and are ready for discharge before the “daytime” physician has seen the patient. Another example is diabetic ketoacidosis. I am able to be very aggressive with the treatment plan throughout the night, again decreasing length of stay and hospital costs.

Nocturnism is not only advantageous to the hospital and patients, but also to the nocturnist himself/herself. Dedicated nocturnists have less fatigue and stress. I work only nights, so I do not become excessively tired. My sleep schedule is completely reversed from the norm. This also has many advantages to my personal life. One of these is that I never miss a package delivered to my home!

Indeed, developing this program was a challenge. Initially we sold the idea through a combination of patient safety and revenue. The hospital cannot bill for holding patients in the ED. If we admit patients and move them to an inpatient bed, the hospital can generate this otherwise lost revenue. As with any new idea, we did meet resistance and opposition along the way. However, we were able to overcome these obstacles and build upon them. Once the administration saw the improvements and our productivity, they were immensely pleased. In fact, the administration is already looking at expanding our staffing and our services. Our billing and collections have shown we pay for our cost and generate additional funds for the hospital, despite a poor payer mix. I am excited to see what the future holds for nocturnists, not only in our institution, but across the country. Groups that employ nocturnists probably wonder how they ever survived without them in the past.

Dr. Sabharwal can be contacted at [email protected].

At many academic institutions, hospitalists are increasingly acting as the teaching attendings on inpatient general medicine rotations. There have been multiple studies demonstrating perceived benefits of hospitalist faculty on housestaff education in academic and community hospitals (1-6). Measured benefits have included improved trainee satisfaction with the educational experience, improved teaching, and higher quality of attending rounds (3,4). There is growing evidence that hospitalist physicians attending on medicine wards provide educational advantages for medical students as well (5-7).

The majority of published studies thus far have focused on trainee education on a traditional medicine ward rotation, with a team including housestaff and medical students. A few medical centers have developed a resident or medical student rotation on a primary hospitalist service (8). With recent restrictions on resident work hours, many more academic programs are developing a “non-covered” hospitalist service similar to the community model (9). While the outcomes of many such programs are not yet entirely clear, this type of service may provide opportunities for an alternative learning experience for medical students. The author is not aware of any published accounts of the medical student experience on such rotations.

Barnes-Jewish Hospital is an urban, 904-bed academic center. The hospitalist program at our institution was initiated as a community model in 2000, with a private service managing patients independent of the internal medicine teaching service. Since then, members of the group have become integrally involved in multiple other teaching roles throughout the institution. The private inpatient service has remained a portion of the practice. During this time period, fourth-year medical students have had the opportunity to participate in a 4-week clinical elective on our primary hospitalist service as a substitute for, or in addition to, the traditional internal medicine sub-internship.

This rotation differs from the traditional medicine rotation in that students have the opportunity to be exposed to more patients, as multiple patients are admitted each day, rather than on a rotating call schedule. Students work directly with hospitalists on the service without the involvement of housestaff. They are not assigned to a specific attending, and therefore work with several attendings over the course of the rotation. A single student rotates on any given 4-week block. There are no other support staff involved in patient care, such as physician assistants or nurse practitioners. Over the last 4 years, over 30 students have participated in this rotation.

In 4 years, students have enrolled in approximately 75% of the elective block rotations available. Overall, written feedback has been obtained from 21 students. Students have been asked to rate the quality of teaching, meaningful participation in patient care, and overall satisfaction with the rotation, as well as to provide additional comments on their experience. Ratings were on a five-point scale, ranging from poor to excellent. Review of student evaluations of this rotation over the past 4 years reveals a majority rating of excellent or very good in all three categories (17/21).

In the students’ narrative comments, several themes were predominant. Positive feedback included the opportunity for one-on-one interactions with several attendings. Students valued the exposure to multiple role models with unique patient care styles. In addition, many students appreciated the opportunity to see a larger number of patients, given the multiple daily admissions. Students see an average of 16 new admissions during the rotation compared to an average of 10 patients on the traditional sub-internship over the course of 4 weeks.

Students also commented on the diversity of patients seen. Given the high patient census on the service (an average of 30 each day), we are able to be selective and choose learning cases with interesting and varied diagnoses. Several students appreciated the opportunity to perform more procedures, which may be preferentially performed by the housestaff on a traditional medicine rotation.

Many students noted an increased level of independence experienced on this rotation compared with traditional teaching rotations. In other studies, concerns have been voiced regarding resident lack of autonomy while working with a hospitalist attending, who tends to have a more visible presence on the inpatient medicine floors (1,4). These concerns have not been validated by resident or medical student feedback of actual experiences (1,4). At the training level of a third- or fourth-year medical student, not having a resident intermediary may lead to more perceived autonomy, adding to the overall learning experience.

The main reservation expressed by students pertained to the challenge of scheduling dedicated teaching time while attending physicians are busy with patient care. Serving as the primary inpatient caregiver for patients can often lead to an unpredictable daily schedule. This year our hospital has instituted a designated floor for patients on the< hospitalist service. This has allowed centralization of most patient care, providing more time for teaching and more visibility of attending physicians to medical students on the rotation. Another solution may involve the increased use of non-physician practitioners, as are being incorporated into many hospital medicine practices. This could allow the physicians to focus on teaching and on patients with more complex medical issues.

From the physician perspective, having medical students rotate on the service is consistent with our mission as clinician educators. Hospitalists choose a position at an academic institution in part because teaching is a priority. For community hospitalists, working with medical students may offer an option to incorporate teaching into clinical patient care. For academic hospitalists facing more “nonteaching” duties, a similar rotation may allow physicians to incorporate an additional teaching role into such duties. Based on the limited experience at this institution, a hospitalist rotation appears to offer a distinct and positive learning experience for medical students compared with a traditional medicine rotation. More extensive experience in the future may support this as a viable option at more centers. Further study will be necessary to identify an optimal curriculum for such a rotation and to evaluate the impact on students’ career choices and perceptions of the field of internal medicine.

Dr. Quartarolo can be contacted at [email protected].

References

1. Wachter RM, Katz P, Showstack J, Bindman AB, Goldman L. Reorganizing an academic medical service: impact on cost, quality, patient satisfaction, and education. JAMA. 1998;279:1560-5.
2. Kulaga ME, Charney P, O’Mahony SP. The positive impact of initiation of hospitalist clinician educators. J Gen Intern Med. 2004;19:293-301.
3. Hauer KE, Wachter RM, McCulloch CE, Woo GA, Auerbach AD. Effects of hospitalist attending physicians on trainee satisfaction with teaching and with internal medicine rotations. Arch Intern Med. 2004;164:1866-71.
4. Chung P, Morrison J, Jin L, Levinson W. Humphrey H. Meltzer D. Resident satisfaction on an academic hospitalist service: Time to teach. Am J Med. 2002;112: 597-601.
5. Kripalani S, Pope AC, Rask K. Hospitalists as teachers. J Gen Intern Med. 2004;19:8-15.
6. Hunter AJ, Desai SS, Harrison RA, Chan BK. Medical student evaluation of the quality of hospitalist and non-hospitalist teaching faculty on inpatient medicine rotations. Acad Med. 2004;79:78-82.
7. Hauer KE and Wachter RM. Implications of the hospitalist model for medical students’ education. Acad Med. 2001;76:324-330.
8. Amin AN. A successful hospitalist rotation for senior medicine residents. Med Educ. 2003;37:1042.
9. Saint S, Flanders SA. Hospitalists in teaching hospitals: opportunities but not without danger. J Gen Intern Med. 2004;19:392-3.

At many academic institutions, hospitalists are increasingly acting as the teaching attendings on inpatient general medicine rotations. There have been multiple studies demonstrating perceived benefits of hospitalist faculty on housestaff education in academic and community hospitals (1-6). Measured benefits have included improved trainee satisfaction with the educational experience, improved teaching, and higher quality of attending rounds (3,4). There is growing evidence that hospitalist physicians attending on medicine wards provide educational advantages for medical students as well (5-7).

The majority of published studies thus far have focused on trainee education on a traditional medicine ward rotation, with a team including housestaff and medical students. A few medical centers have developed a resident or medical student rotation on a primary hospitalist service (8). With recent restrictions on resident work hours, many more academic programs are developing a “non-covered” hospitalist service similar to the community model (9). While the outcomes of many such programs are not yet entirely clear, this type of service may provide opportunities for an alternative learning experience for medical students. The author is not aware of any published accounts of the medical student experience on such rotations.

Barnes-Jewish Hospital is an urban, 904-bed academic center. The hospitalist program at our institution was initiated as a community model in 2000, with a private service managing patients independent of the internal medicine teaching service. Since then, members of the group have become integrally involved in multiple other teaching roles throughout the institution. The private inpatient service has remained a portion of the practice. During this time period, fourth-year medical students have had the opportunity to participate in a 4-week clinical elective on our primary hospitalist service as a substitute for, or in addition to, the traditional internal medicine sub-internship.

This rotation differs from the traditional medicine rotation in that students have the opportunity to be exposed to more patients, as multiple patients are admitted each day, rather than on a rotating call schedule. Students work directly with hospitalists on the service without the involvement of housestaff. They are not assigned to a specific attending, and therefore work with several attendings over the course of the rotation. A single student rotates on any given 4-week block. There are no other support staff involved in patient care, such as physician assistants or nurse practitioners. Over the last 4 years, over 30 students have participated in this rotation.

In 4 years, students have enrolled in approximately 75% of the elective block rotations available. Overall, written feedback has been obtained from 21 students. Students have been asked to rate the quality of teaching, meaningful participation in patient care, and overall satisfaction with the rotation, as well as to provide additional comments on their experience. Ratings were on a five-point scale, ranging from poor to excellent. Review of student evaluations of this rotation over the past 4 years reveals a majority rating of excellent or very good in all three categories (17/21).

In the students’ narrative comments, several themes were predominant. Positive feedback included the opportunity for one-on-one interactions with several attendings. Students valued the exposure to multiple role models with unique patient care styles. In addition, many students appreciated the opportunity to see a larger number of patients, given the multiple daily admissions. Students see an average of 16 new admissions during the rotation compared to an average of 10 patients on the traditional sub-internship over the course of 4 weeks.

Students also commented on the diversity of patients seen. Given the high patient census on the service (an average of 30 each day), we are able to be selective and choose learning cases with interesting and varied diagnoses. Several students appreciated the opportunity to perform more procedures, which may be preferentially performed by the housestaff on a traditional medicine rotation.

Many students noted an increased level of independence experienced on this rotation compared with traditional teaching rotations. In other studies, concerns have been voiced regarding resident lack of autonomy while working with a hospitalist attending, who tends to have a more visible presence on the inpatient medicine floors (1,4). These concerns have not been validated by resident or medical student feedback of actual experiences (1,4). At the training level of a third- or fourth-year medical student, not having a resident intermediary may lead to more perceived autonomy, adding to the overall learning experience.

The main reservation expressed by students pertained to the challenge of scheduling dedicated teaching time while attending physicians are busy with patient care. Serving as the primary inpatient caregiver for patients can often lead to an unpredictable daily schedule. This year our hospital has instituted a designated floor for patients on the< hospitalist service. This has allowed centralization of most patient care, providing more time for teaching and more visibility of attending physicians to medical students on the rotation. Another solution may involve the increased use of non-physician practitioners, as are being incorporated into many hospital medicine practices. This could allow the physicians to focus on teaching and on patients with more complex medical issues.

From the physician perspective, having medical students rotate on the service is consistent with our mission as clinician educators. Hospitalists choose a position at an academic institution in part because teaching is a priority. For community hospitalists, working with medical students may offer an option to incorporate teaching into clinical patient care. For academic hospitalists facing more “nonteaching” duties, a similar rotation may allow physicians to incorporate an additional teaching role into such duties. Based on the limited experience at this institution, a hospitalist rotation appears to offer a distinct and positive learning experience for medical students compared with a traditional medicine rotation. More extensive experience in the future may support this as a viable option at more centers. Further study will be necessary to identify an optimal curriculum for such a rotation and to evaluate the impact on students’ career choices and perceptions of the field of internal medicine.

Dr. Quartarolo can be contacted at [email protected].

References

1. Wachter RM, Katz P, Showstack J, Bindman AB, Goldman L. Reorganizing an academic medical service: impact on cost, quality, patient satisfaction, and education. JAMA. 1998;279:1560-5.
2. Kulaga ME, Charney P, O’Mahony SP. The positive impact of initiation of hospitalist clinician educators. J Gen Intern Med. 2004;19:293-301.
3. Hauer KE, Wachter RM, McCulloch CE, Woo GA, Auerbach AD. Effects of hospitalist attending physicians on trainee satisfaction with teaching and with internal medicine rotations. Arch Intern Med. 2004;164:1866-71.
4. Chung P, Morrison J, Jin L, Levinson W. Humphrey H. Meltzer D. Resident satisfaction on an academic hospitalist service: Time to teach. Am J Med. 2002;112: 597-601.
5. Kripalani S, Pope AC, Rask K. Hospitalists as teachers. J Gen Intern Med. 2004;19:8-15.
6. Hunter AJ, Desai SS, Harrison RA, Chan BK. Medical student evaluation of the quality of hospitalist and non-hospitalist teaching faculty on inpatient medicine rotations. Acad Med. 2004;79:78-82.
7. Hauer KE and Wachter RM. Implications of the hospitalist model for medical students’ education. Acad Med. 2001;76:324-330.
8. Amin AN. A successful hospitalist rotation for senior medicine residents. Med Educ. 2003;37:1042.
9. Saint S, Flanders SA. Hospitalists in teaching hospitals: opportunities but not without danger. J Gen Intern Med. 2004;19:392-3.

At many academic institutions, hospitalists are increasingly acting as the teaching attendings on inpatient general medicine rotations. There have been multiple studies demonstrating perceived benefits of hospitalist faculty on housestaff education in academic and community hospitals (1-6). Measured benefits have included improved trainee satisfaction with the educational experience, improved teaching, and higher quality of attending rounds (3,4). There is growing evidence that hospitalist physicians attending on medicine wards provide educational advantages for medical students as well (5-7).

The majority of published studies thus far have focused on trainee education on a traditional medicine ward rotation, with a team including housestaff and medical students. A few medical centers have developed a resident or medical student rotation on a primary hospitalist service (8). With recent restrictions on resident work hours, many more academic programs are developing a “non-covered” hospitalist service similar to the community model (9). While the outcomes of many such programs are not yet entirely clear, this type of service may provide opportunities for an alternative learning experience for medical students. The author is not aware of any published accounts of the medical student experience on such rotations.

Barnes-Jewish Hospital is an urban, 904-bed academic center. The hospitalist program at our institution was initiated as a community model in 2000, with a private service managing patients independent of the internal medicine teaching service. Since then, members of the group have become integrally involved in multiple other teaching roles throughout the institution. The private inpatient service has remained a portion of the practice. During this time period, fourth-year medical students have had the opportunity to participate in a 4-week clinical elective on our primary hospitalist service as a substitute for, or in addition to, the traditional internal medicine sub-internship.

This rotation differs from the traditional medicine rotation in that students have the opportunity to be exposed to more patients, as multiple patients are admitted each day, rather than on a rotating call schedule. Students work directly with hospitalists on the service without the involvement of housestaff. They are not assigned to a specific attending, and therefore work with several attendings over the course of the rotation. A single student rotates on any given 4-week block. There are no other support staff involved in patient care, such as physician assistants or nurse practitioners. Over the last 4 years, over 30 students have participated in this rotation.

In 4 years, students have enrolled in approximately 75% of the elective block rotations available. Overall, written feedback has been obtained from 21 students. Students have been asked to rate the quality of teaching, meaningful participation in patient care, and overall satisfaction with the rotation, as well as to provide additional comments on their experience. Ratings were on a five-point scale, ranging from poor to excellent. Review of student evaluations of this rotation over the past 4 years reveals a majority rating of excellent or very good in all three categories (17/21).

In the students’ narrative comments, several themes were predominant. Positive feedback included the opportunity for one-on-one interactions with several attendings. Students valued the exposure to multiple role models with unique patient care styles. In addition, many students appreciated the opportunity to see a larger number of patients, given the multiple daily admissions. Students see an average of 16 new admissions during the rotation compared to an average of 10 patients on the traditional sub-internship over the course of 4 weeks.

Students also commented on the diversity of patients seen. Given the high patient census on the service (an average of 30 each day), we are able to be selective and choose learning cases with interesting and varied diagnoses. Several students appreciated the opportunity to perform more procedures, which may be preferentially performed by the housestaff on a traditional medicine rotation.

Many students noted an increased level of independence experienced on this rotation compared with traditional teaching rotations. In other studies, concerns have been voiced regarding resident lack of autonomy while working with a hospitalist attending, who tends to have a more visible presence on the inpatient medicine floors (1,4). These concerns have not been validated by resident or medical student feedback of actual experiences (1,4). At the training level of a third- or fourth-year medical student, not having a resident intermediary may lead to more perceived autonomy, adding to the overall learning experience.

The main reservation expressed by students pertained to the challenge of scheduling dedicated teaching time while attending physicians are busy with patient care. Serving as the primary inpatient caregiver for patients can often lead to an unpredictable daily schedule. This year our hospital has instituted a designated floor for patients on the< hospitalist service. This has allowed centralization of most patient care, providing more time for teaching and more visibility of attending physicians to medical students on the rotation. Another solution may involve the increased use of non-physician practitioners, as are being incorporated into many hospital medicine practices. This could allow the physicians to focus on teaching and on patients with more complex medical issues.

From the physician perspective, having medical students rotate on the service is consistent with our mission as clinician educators. Hospitalists choose a position at an academic institution in part because teaching is a priority. For community hospitalists, working with medical students may offer an option to incorporate teaching into clinical patient care. For academic hospitalists facing more “nonteaching” duties, a similar rotation may allow physicians to incorporate an additional teaching role into such duties. Based on the limited experience at this institution, a hospitalist rotation appears to offer a distinct and positive learning experience for medical students compared with a traditional medicine rotation. More extensive experience in the future may support this as a viable option at more centers. Further study will be necessary to identify an optimal curriculum for such a rotation and to evaluate the impact on students’ career choices and perceptions of the field of internal medicine.

Dr. Quartarolo can be contacted at [email protected].

References

1. Wachter RM, Katz P, Showstack J, Bindman AB, Goldman L. Reorganizing an academic medical service: impact on cost, quality, patient satisfaction, and education. JAMA. 1998;279:1560-5.
2. Kulaga ME, Charney P, O’Mahony SP. The positive impact of initiation of hospitalist clinician educators. J Gen Intern Med. 2004;19:293-301.
3. Hauer KE, Wachter RM, McCulloch CE, Woo GA, Auerbach AD. Effects of hospitalist attending physicians on trainee satisfaction with teaching and with internal medicine rotations. Arch Intern Med. 2004;164:1866-71.
4. Chung P, Morrison J, Jin L, Levinson W. Humphrey H. Meltzer D. Resident satisfaction on an academic hospitalist service: Time to teach. Am J Med. 2002;112: 597-601.
5. Kripalani S, Pope AC, Rask K. Hospitalists as teachers. J Gen Intern Med. 2004;19:8-15.
6. Hunter AJ, Desai SS, Harrison RA, Chan BK. Medical student evaluation of the quality of hospitalist and non-hospitalist teaching faculty on inpatient medicine rotations. Acad Med. 2004;79:78-82.
7. Hauer KE and Wachter RM. Implications of the hospitalist model for medical students’ education. Acad Med. 2001;76:324-330.
8. Amin AN. A successful hospitalist rotation for senior medicine residents. Med Educ. 2003;37:1042.
9. Saint S, Flanders SA. Hospitalists in teaching hospitals: opportunities but not without danger. J Gen Intern Med. 2004;19:392-3.