Guidelines

Let’s examine a documentation case for hospitalists providing daily care: A 65-year-old male patient is admitted with a left hip fracture. The patient also has hypertension and Type 2 diabetes, which might complicate his care. The orthopedic surgeon manages the patient’s perioperative course for the fracture while the hospitalist provides daily post-op care for hypertension and diabetes.

A common scenario is the hospitalist will provide concurrent care, along with a varying number of specialists, depending on the complexity of the patient’s presenting problems and existing comorbidities. Payors define concurrent care as more than one physician providing care to the same patient on the same date, or during the same hospitalization. Payors often consider two key principles before reimbursing concurrent care:

• Does the patient’s condition warrant more than one physician? and
• Are the services provided by each physician reasonable and necessary?¹

When more than one medical condition exists and each physician actively treats the condition related to their expertise, each physician can demonstrate medical necessity. As in the above example, the orthopedic surgeon cares for the patient’s fracture while the hospitalist oversees diabetes and hypertension management. Claim submission follows the same logic. Report each subsequent hospital care code (99231-99233) with the corresponding diagnosis each physician primarily manages (i.e., orthopedic surgeon: 9923x with 820.8; hospitalist: 9923x with 250.00, 401.1).

When each physician assigns a different primary diagnosis code to the visit code, each is more likely to receive payment. Because each of these physicians are in different specialties and different provider groups, most payors do not require modifier 25 (separately identifiable E/M service on the same day as a procedure or other service) appended to the visit code. However, some managed-care payors require each physician to append modifier 25 to the concurrent E/M visit code (i.e., 99232-25) despite claim submission under different tax identification numbers.

Unfortunately, the physicians might not realize this until a claim rejection has been issued. Furthermore, payors might want to see the proof before rendering payment. In other words, they pay the first claim received and deny any subsequent claim in order to confirm medical necessity of the concurrent visit. Appeal denied such claims rejections with supporting documentation that distinguishes each physician visit, if possible. This assists the payors in understanding each physician’s contribution to care.

Reasons for Denial

Concurrent care services are more easily distinguished when separate diagnoses are reported with each service. Conversely, payors are likely to deny services that are hard to differentiate. Furthermore, payors frequently deny concurrent care services for the following reasons:

• Services exceed normal frequency or duration for a given condition without documented circumstances requiring additional care; or
• Services by one physician duplicate or overlap those of another provider without recognizable distinction.²

For example, a hospitalist might be involved in the post-op care of patients with fractures and no other identifiable chronic or acute conditions or complications. In these cases, the hospitalist’s continued involvement might constitute a facility policy (e.g., quality of care, risk reduction, etc.) rather than active clinical management. Claim submission could erroneously occur with each physician reporting 9923x for 820.8. Payors deny medically unnecessary services, or request refunds for inappropriate payments.

Hospitalists might attempt to negotiate other terms with the facility to account for the unpaid time and effort directed toward these types of cases.

Group Practice

Physicians in the same group practice with the same specialty designation must report, and are paid, as a single physician. Multiple visits to the same patient can occur on the same day by members of the same group (e.g., hospitalist A evaluates the patient in the morning, and hospitalist B reviews test results and the resulting course of treatment in the afternoon). However, only one subsequent hospital care service can be reported for the day.

The hospitalists should select the visit level representative of the combined services and submit one appropriately determined code (e.g., 99233), thereby capturing the medically necessary efforts of each physician. To complicate matters, the hospitalists must determine which name to report on the claim: the physician who provided the first encounter, or the physician who provided the most extensive or best-documented encounter.

Tracking productivity for these cases proves challenging. Some practices develop an internal accounting system and credit each physician for their medically necessary efforts (a labor-intensive task for administrators and physicians). TH

Carol Pohlig is a billing and coding expert with the University of Pennsylvania Medical Center in Philadelphia. She is faculty for SHM’s inpatient coding course.

References

1. Medicare Benefit Policy Manual: Concurrent Care. Chapter 15, Section 30.E. CMS website. Available at: www.cms.gov/manuals/Downloads/bp102c15.pdf. Accessed July 9, 2010.
2. Medicare Claims Processing Manual: Physicians in Group Practice. Chapter 12, Section 30.6.5. CMS website. Available at: www.cms.gov/manuals/downloads/clm104c12.pdf. Accessed July 9, 2010.
3. Pohlig, C. Daily care conundrums. The Hospitalist website. Available at: www.the-hospitalist.org/details/article/188735/Daily_Care_Conundrums_.html. Accessed July 9, 2010.
4. Medicare Claims Processing Manual: Hospital Visits Same Day But by Different Physicians. Chapter 12, Section 30.6.9.C. CMS website. Available at: www.cms.gov/manuals/downloads/clm104c12.pdf. Accessed July 9, 2010.
5. Abraham M, Beebe M, Dalton J, Evans D, Glenn R. Current Procedural Terminology Professional Edition. Chicago: American Medical Association Press; 2010:15.

Let’s examine a documentation case for hospitalists providing daily care: A 65-year-old male patient is admitted with a left hip fracture. The patient also has hypertension and Type 2 diabetes, which might complicate his care. The orthopedic surgeon manages the patient’s perioperative course for the fracture while the hospitalist provides daily post-op care for hypertension and diabetes.

A common scenario is the hospitalist will provide concurrent care, along with a varying number of specialists, depending on the complexity of the patient’s presenting problems and existing comorbidities. Payors define concurrent care as more than one physician providing care to the same patient on the same date, or during the same hospitalization. Payors often consider two key principles before reimbursing concurrent care:

• Does the patient’s condition warrant more than one physician? and
• Are the services provided by each physician reasonable and necessary?¹

When more than one medical condition exists and each physician actively treats the condition related to their expertise, each physician can demonstrate medical necessity. As in the above example, the orthopedic surgeon cares for the patient’s fracture while the hospitalist oversees diabetes and hypertension management. Claim submission follows the same logic. Report each subsequent hospital care code (99231-99233) with the corresponding diagnosis each physician primarily manages (i.e., orthopedic surgeon: 9923x with 820.8; hospitalist: 9923x with 250.00, 401.1).

When each physician assigns a different primary diagnosis code to the visit code, each is more likely to receive payment. Because each of these physicians are in different specialties and different provider groups, most payors do not require modifier 25 (separately identifiable E/M service on the same day as a procedure or other service) appended to the visit code. However, some managed-care payors require each physician to append modifier 25 to the concurrent E/M visit code (i.e., 99232-25) despite claim submission under different tax identification numbers.

Unfortunately, the physicians might not realize this until a claim rejection has been issued. Furthermore, payors might want to see the proof before rendering payment. In other words, they pay the first claim received and deny any subsequent claim in order to confirm medical necessity of the concurrent visit. Appeal denied such claims rejections with supporting documentation that distinguishes each physician visit, if possible. This assists the payors in understanding each physician’s contribution to care.

Reasons for Denial

Concurrent care services are more easily distinguished when separate diagnoses are reported with each service. Conversely, payors are likely to deny services that are hard to differentiate. Furthermore, payors frequently deny concurrent care services for the following reasons:

• Services exceed normal frequency or duration for a given condition without documented circumstances requiring additional care; or
• Services by one physician duplicate or overlap those of another provider without recognizable distinction.²

For example, a hospitalist might be involved in the post-op care of patients with fractures and no other identifiable chronic or acute conditions or complications. In these cases, the hospitalist’s continued involvement might constitute a facility policy (e.g., quality of care, risk reduction, etc.) rather than active clinical management. Claim submission could erroneously occur with each physician reporting 9923x for 820.8. Payors deny medically unnecessary services, or request refunds for inappropriate payments.

Hospitalists might attempt to negotiate other terms with the facility to account for the unpaid time and effort directed toward these types of cases.

Group Practice

Physicians in the same group practice with the same specialty designation must report, and are paid, as a single physician. Multiple visits to the same patient can occur on the same day by members of the same group (e.g., hospitalist A evaluates the patient in the morning, and hospitalist B reviews test results and the resulting course of treatment in the afternoon). However, only one subsequent hospital care service can be reported for the day.

The hospitalists should select the visit level representative of the combined services and submit one appropriately determined code (e.g., 99233), thereby capturing the medically necessary efforts of each physician. To complicate matters, the hospitalists must determine which name to report on the claim: the physician who provided the first encounter, or the physician who provided the most extensive or best-documented encounter.

Tracking productivity for these cases proves challenging. Some practices develop an internal accounting system and credit each physician for their medically necessary efforts (a labor-intensive task for administrators and physicians). TH

Carol Pohlig is a billing and coding expert with the University of Pennsylvania Medical Center in Philadelphia. She is faculty for SHM’s inpatient coding course.

References

1. Medicare Benefit Policy Manual: Concurrent Care. Chapter 15, Section 30.E. CMS website. Available at: www.cms.gov/manuals/Downloads/bp102c15.pdf. Accessed July 9, 2010.
2. Medicare Claims Processing Manual: Physicians in Group Practice. Chapter 12, Section 30.6.5. CMS website. Available at: www.cms.gov/manuals/downloads/clm104c12.pdf. Accessed July 9, 2010.
3. Pohlig, C. Daily care conundrums. The Hospitalist website. Available at: www.the-hospitalist.org/details/article/188735/Daily_Care_Conundrums_.html. Accessed July 9, 2010.
4. Medicare Claims Processing Manual: Hospital Visits Same Day But by Different Physicians. Chapter 12, Section 30.6.9.C. CMS website. Available at: www.cms.gov/manuals/downloads/clm104c12.pdf. Accessed July 9, 2010.
5. Abraham M, Beebe M, Dalton J, Evans D, Glenn R. Current Procedural Terminology Professional Edition. Chicago: American Medical Association Press; 2010:15.

Let’s examine a documentation case for hospitalists providing daily care: A 65-year-old male patient is admitted with a left hip fracture. The patient also has hypertension and Type 2 diabetes, which might complicate his care. The orthopedic surgeon manages the patient’s perioperative course for the fracture while the hospitalist provides daily post-op care for hypertension and diabetes.

A common scenario is the hospitalist will provide concurrent care, along with a varying number of specialists, depending on the complexity of the patient’s presenting problems and existing comorbidities. Payors define concurrent care as more than one physician providing care to the same patient on the same date, or during the same hospitalization. Payors often consider two key principles before reimbursing concurrent care:

• Does the patient’s condition warrant more than one physician? and
• Are the services provided by each physician reasonable and necessary?¹

When more than one medical condition exists and each physician actively treats the condition related to their expertise, each physician can demonstrate medical necessity. As in the above example, the orthopedic surgeon cares for the patient’s fracture while the hospitalist oversees diabetes and hypertension management. Claim submission follows the same logic. Report each subsequent hospital care code (99231-99233) with the corresponding diagnosis each physician primarily manages (i.e., orthopedic surgeon: 9923x with 820.8; hospitalist: 9923x with 250.00, 401.1).

When each physician assigns a different primary diagnosis code to the visit code, each is more likely to receive payment. Because each of these physicians are in different specialties and different provider groups, most payors do not require modifier 25 (separately identifiable E/M service on the same day as a procedure or other service) appended to the visit code. However, some managed-care payors require each physician to append modifier 25 to the concurrent E/M visit code (i.e., 99232-25) despite claim submission under different tax identification numbers.

Unfortunately, the physicians might not realize this until a claim rejection has been issued. Furthermore, payors might want to see the proof before rendering payment. In other words, they pay the first claim received and deny any subsequent claim in order to confirm medical necessity of the concurrent visit. Appeal denied such claims rejections with supporting documentation that distinguishes each physician visit, if possible. This assists the payors in understanding each physician’s contribution to care.

Reasons for Denial

Concurrent care services are more easily distinguished when separate diagnoses are reported with each service. Conversely, payors are likely to deny services that are hard to differentiate. Furthermore, payors frequently deny concurrent care services for the following reasons:

• Services exceed normal frequency or duration for a given condition without documented circumstances requiring additional care; or
• Services by one physician duplicate or overlap those of another provider without recognizable distinction.²

For example, a hospitalist might be involved in the post-op care of patients with fractures and no other identifiable chronic or acute conditions or complications. In these cases, the hospitalist’s continued involvement might constitute a facility policy (e.g., quality of care, risk reduction, etc.) rather than active clinical management. Claim submission could erroneously occur with each physician reporting 9923x for 820.8. Payors deny medically unnecessary services, or request refunds for inappropriate payments.

Hospitalists might attempt to negotiate other terms with the facility to account for the unpaid time and effort directed toward these types of cases.

Group Practice

Physicians in the same group practice with the same specialty designation must report, and are paid, as a single physician. Multiple visits to the same patient can occur on the same day by members of the same group (e.g., hospitalist A evaluates the patient in the morning, and hospitalist B reviews test results and the resulting course of treatment in the afternoon). However, only one subsequent hospital care service can be reported for the day.

The hospitalists should select the visit level representative of the combined services and submit one appropriately determined code (e.g., 99233), thereby capturing the medically necessary efforts of each physician. To complicate matters, the hospitalists must determine which name to report on the claim: the physician who provided the first encounter, or the physician who provided the most extensive or best-documented encounter.

Tracking productivity for these cases proves challenging. Some practices develop an internal accounting system and credit each physician for their medically necessary efforts (a labor-intensive task for administrators and physicians). TH

Carol Pohlig is a billing and coding expert with the University of Pennsylvania Medical Center in Philadelphia. She is faculty for SHM’s inpatient coding course.

References

1. Medicare Benefit Policy Manual: Concurrent Care. Chapter 15, Section 30.E. CMS website. Available at: www.cms.gov/manuals/Downloads/bp102c15.pdf. Accessed July 9, 2010.
2. Medicare Claims Processing Manual: Physicians in Group Practice. Chapter 12, Section 30.6.5. CMS website. Available at: www.cms.gov/manuals/downloads/clm104c12.pdf. Accessed July 9, 2010.
3. Pohlig, C. Daily care conundrums. The Hospitalist website. Available at: www.the-hospitalist.org/details/article/188735/Daily_Care_Conundrums_.html. Accessed July 9, 2010.
4. Medicare Claims Processing Manual: Hospital Visits Same Day But by Different Physicians. Chapter 12, Section 30.6.9.C. CMS website. Available at: www.cms.gov/manuals/downloads/clm104c12.pdf. Accessed July 9, 2010.
5. Abraham M, Beebe M, Dalton J, Evans D, Glenn R. Current Procedural Terminology Professional Edition. Chicago: American Medical Association Press; 2010:15.

How many people have to die before you’ll pay attention? Like many of you, I read the article but it didn’t really stick. Rather, I filed it in the “interesting tidbits” folder on my brain’s hard drive. Somehow 29,000 people with cancer just didn’t register as a big number.

Until I thought I could be one of them.

The Number

I was harried, running late for a meeting, questioning my decision to try to shoehorn a PCP appointment into my lunch break. Then again, this was a routine follow-up of some labs and I, of course, am the picture of health. Well, I am if you exclude my LDL. It turns out that on a check 12 months earlier, my LDL was found to be running a few heart attacks higher than normal. I took this as a sign, combined with my ballooning waist, middle-ish age, and nagging wife, that I needed to do something.

Still, I wasn’t ready for “something” to include an anticholesterol medication. Instead, I chose the masochistic route and hit the treadmill. And the bike. And a little less of the dinner plate. As a result, I had lost 30 pounds, a handful of pant sizes and, while I wasn’t exactly “in shape,” I did find myself shaped a little less like the Michelin Man.

Triumphantly, I was returning to vanquish my tormentor—the PCP who foolhardily recommended I start a medication.

Sitting in the office awaiting the news of my post-weight-loss cholesterol, my grin was wide and smug—and apparently still overflowing with LDL. I was devastated. 259? I lose weight and my LDL actually goes up!?! I could feel the foam cells in my coronary plaques twitch with delight as they mockingly gorged on chylomicrons.

Undeterred, I inquired what my options were, secretly hoping the answer would be more red wine. Emboldened by my supersaturated serum, my PCP declared it was time for a statin. Alternatively, he noted that I could get a CT angiogram of my coronaries and, if they were clean, I potentially could bypass drug therapy. Thoughts of avoided myalgias happily flittered across my mind until they stumbled onto the number 29,000. It was then that I recalled the recent Archives of Internal Medicine paper.¹

The Study

Using risk models based on the known biological effects of radiation, researchers estimated that approximately 29,000 people would develop cancer from the radiation associated with CT scans in 2007 alone. To arrive at this number, the authors used data showing that 1.5% to 2% of all U.S. cancers could be traced to the radiation from CT scans.

Not surprisingly, the most commonly utilized CT scans—namely, abdominal (14,000 a year), chest (4,100 a year), and head (4,000 a year)—accounted for the most morbidity. However, CT angiography, with its super-high dose of radiation, was projected to contribute 2,700 cancers a year. Apparently, my PCP didn’t read this article.

In terms of types of malignancy, lung cancer leads the list with 6,200 projected CT-induced cancers per year, followed by colon cancer (3,500 a year) and leukemia (2,800 a year).

The Names

If the numbers from this study hold, then about 1 in every 2,000 CT scans results in a new cancer. That would mean that I’ve dished out several cancers during my practice. In fact, I’ve ordered many thousand CT scans over my career—give or take a cancer. So my pen has, statistically, caused approximately three cancers.

I wondered which three patients it was. Was it Mr. Reynolds, who would’ve very likely died had we not diagnosed his post-operative abdominal abscess? Perhaps it was Mr. Jenson, who surely would have fared poorly if his pulmonary embolism had not been diagnosed and treated. Maybe it was Mrs. Hernandez, who wouldn’t have received thrombolytics for her stroke without a head CT.

Yes, I might have played a role in causing cancer in these three patients, but I did so knowing that I also saved, or at least improved, their lives. Most patients would accept that calculus.

But what if it were a different three? What if my cancer was that head CT I ordered for Mr. Davidson’s confusion, even though I know that head scans are rarely helpful in the evaluation of delirium? Perhaps my cancer-causer was that abdominal CT scan for Mrs. Ramirez’s chronic pain, which was clearly referable to her irritable bowel syndrome. Maybe it will be that CT scan I ordered last week because the patient insisted it be done, even though I strongly suspected, correctly, that it wouldn’t alter my management.

Which three would it be?

The Questions

This triggered more questions. How many of the 70 million-plus CT scans we order every year really are necessary? How many could be avoided by a robust physical examination, crisper clinical reasoning, or an alternate test? Do our patients really know the risk of these “innocuous” tests? Do we?

And, more personally, what if my PCP was still sitting on two? Would I be his number three?

Moving forward, I vow to remember 29,000. It will remain in the forefront of my mind, constantly badgering me about the next CT scan I order. To be sure, I will continue to order CTs—a lot of CTs. However, I will do so through the prism of the following query. If a patient developed a cancer from the CT scan I was about to order, could I sincerely look them in the eye and tell them I would do the test again?

And I’m agitated by one final question. How is that it took my own carcinogenic brush with CT scans for me to realize the gravity of 29,000? It’s not that 29,000 is not a big number. In fact, it’s precisely because it is a big number that we miss its importance. It’s too easy to hide behind the anonymity of the number. Because in the end, numbers don’t have names until the name is yours. TH

Dr. Glasheen is associate professor of medicine at the University of Colorado Denver, where he serves as director of the Hospital Medicine Program and the Hospitalist Training Program, and as associate program director of the Internal Medicine Residency Program.

Reference

1. Berrington de González A, Mahesh M, Kim KP, et al. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med. 2009;169(22):2071-2077.

How many people have to die before you’ll pay attention? Like many of you, I read the article but it didn’t really stick. Rather, I filed it in the “interesting tidbits” folder on my brain’s hard drive. Somehow 29,000 people with cancer just didn’t register as a big number.

Until I thought I could be one of them.

The Number

I was harried, running late for a meeting, questioning my decision to try to shoehorn a PCP appointment into my lunch break. Then again, this was a routine follow-up of some labs and I, of course, am the picture of health. Well, I am if you exclude my LDL. It turns out that on a check 12 months earlier, my LDL was found to be running a few heart attacks higher than normal. I took this as a sign, combined with my ballooning waist, middle-ish age, and nagging wife, that I needed to do something.

Still, I wasn’t ready for “something” to include an anticholesterol medication. Instead, I chose the masochistic route and hit the treadmill. And the bike. And a little less of the dinner plate. As a result, I had lost 30 pounds, a handful of pant sizes and, while I wasn’t exactly “in shape,” I did find myself shaped a little less like the Michelin Man.

Triumphantly, I was returning to vanquish my tormentor—the PCP who foolhardily recommended I start a medication.

Sitting in the office awaiting the news of my post-weight-loss cholesterol, my grin was wide and smug—and apparently still overflowing with LDL. I was devastated. 259? I lose weight and my LDL actually goes up!?! I could feel the foam cells in my coronary plaques twitch with delight as they mockingly gorged on chylomicrons.

Undeterred, I inquired what my options were, secretly hoping the answer would be more red wine. Emboldened by my supersaturated serum, my PCP declared it was time for a statin. Alternatively, he noted that I could get a CT angiogram of my coronaries and, if they were clean, I potentially could bypass drug therapy. Thoughts of avoided myalgias happily flittered across my mind until they stumbled onto the number 29,000. It was then that I recalled the recent Archives of Internal Medicine paper.¹

The Study

Using risk models based on the known biological effects of radiation, researchers estimated that approximately 29,000 people would develop cancer from the radiation associated with CT scans in 2007 alone. To arrive at this number, the authors used data showing that 1.5% to 2% of all U.S. cancers could be traced to the radiation from CT scans.

Not surprisingly, the most commonly utilized CT scans—namely, abdominal (14,000 a year), chest (4,100 a year), and head (4,000 a year)—accounted for the most morbidity. However, CT angiography, with its super-high dose of radiation, was projected to contribute 2,700 cancers a year. Apparently, my PCP didn’t read this article.

In terms of types of malignancy, lung cancer leads the list with 6,200 projected CT-induced cancers per year, followed by colon cancer (3,500 a year) and leukemia (2,800 a year).

The Names

If the numbers from this study hold, then about 1 in every 2,000 CT scans results in a new cancer. That would mean that I’ve dished out several cancers during my practice. In fact, I’ve ordered many thousand CT scans over my career—give or take a cancer. So my pen has, statistically, caused approximately three cancers.

I wondered which three patients it was. Was it Mr. Reynolds, who would’ve very likely died had we not diagnosed his post-operative abdominal abscess? Perhaps it was Mr. Jenson, who surely would have fared poorly if his pulmonary embolism had not been diagnosed and treated. Maybe it was Mrs. Hernandez, who wouldn’t have received thrombolytics for her stroke without a head CT.

Yes, I might have played a role in causing cancer in these three patients, but I did so knowing that I also saved, or at least improved, their lives. Most patients would accept that calculus.

But what if it were a different three? What if my cancer was that head CT I ordered for Mr. Davidson’s confusion, even though I know that head scans are rarely helpful in the evaluation of delirium? Perhaps my cancer-causer was that abdominal CT scan for Mrs. Ramirez’s chronic pain, which was clearly referable to her irritable bowel syndrome. Maybe it will be that CT scan I ordered last week because the patient insisted it be done, even though I strongly suspected, correctly, that it wouldn’t alter my management.

Which three would it be?

The Questions

This triggered more questions. How many of the 70 million-plus CT scans we order every year really are necessary? How many could be avoided by a robust physical examination, crisper clinical reasoning, or an alternate test? Do our patients really know the risk of these “innocuous” tests? Do we?

And, more personally, what if my PCP was still sitting on two? Would I be his number three?

Moving forward, I vow to remember 29,000. It will remain in the forefront of my mind, constantly badgering me about the next CT scan I order. To be sure, I will continue to order CTs—a lot of CTs. However, I will do so through the prism of the following query. If a patient developed a cancer from the CT scan I was about to order, could I sincerely look them in the eye and tell them I would do the test again?

And I’m agitated by one final question. How is that it took my own carcinogenic brush with CT scans for me to realize the gravity of 29,000? It’s not that 29,000 is not a big number. In fact, it’s precisely because it is a big number that we miss its importance. It’s too easy to hide behind the anonymity of the number. Because in the end, numbers don’t have names until the name is yours. TH

Dr. Glasheen is associate professor of medicine at the University of Colorado Denver, where he serves as director of the Hospital Medicine Program and the Hospitalist Training Program, and as associate program director of the Internal Medicine Residency Program.

Reference

1. Berrington de González A, Mahesh M, Kim KP, et al. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med. 2009;169(22):2071-2077.

How many people have to die before you’ll pay attention? Like many of you, I read the article but it didn’t really stick. Rather, I filed it in the “interesting tidbits” folder on my brain’s hard drive. Somehow 29,000 people with cancer just didn’t register as a big number.

Until I thought I could be one of them.

The Number

I was harried, running late for a meeting, questioning my decision to try to shoehorn a PCP appointment into my lunch break. Then again, this was a routine follow-up of some labs and I, of course, am the picture of health. Well, I am if you exclude my LDL. It turns out that on a check 12 months earlier, my LDL was found to be running a few heart attacks higher than normal. I took this as a sign, combined with my ballooning waist, middle-ish age, and nagging wife, that I needed to do something.

Still, I wasn’t ready for “something” to include an anticholesterol medication. Instead, I chose the masochistic route and hit the treadmill. And the bike. And a little less of the dinner plate. As a result, I had lost 30 pounds, a handful of pant sizes and, while I wasn’t exactly “in shape,” I did find myself shaped a little less like the Michelin Man.

Triumphantly, I was returning to vanquish my tormentor—the PCP who foolhardily recommended I start a medication.

Sitting in the office awaiting the news of my post-weight-loss cholesterol, my grin was wide and smug—and apparently still overflowing with LDL. I was devastated. 259? I lose weight and my LDL actually goes up!?! I could feel the foam cells in my coronary plaques twitch with delight as they mockingly gorged on chylomicrons.

Undeterred, I inquired what my options were, secretly hoping the answer would be more red wine. Emboldened by my supersaturated serum, my PCP declared it was time for a statin. Alternatively, he noted that I could get a CT angiogram of my coronaries and, if they were clean, I potentially could bypass drug therapy. Thoughts of avoided myalgias happily flittered across my mind until they stumbled onto the number 29,000. It was then that I recalled the recent Archives of Internal Medicine paper.¹

The Study

Using risk models based on the known biological effects of radiation, researchers estimated that approximately 29,000 people would develop cancer from the radiation associated with CT scans in 2007 alone. To arrive at this number, the authors used data showing that 1.5% to 2% of all U.S. cancers could be traced to the radiation from CT scans.

Not surprisingly, the most commonly utilized CT scans—namely, abdominal (14,000 a year), chest (4,100 a year), and head (4,000 a year)—accounted for the most morbidity. However, CT angiography, with its super-high dose of radiation, was projected to contribute 2,700 cancers a year. Apparently, my PCP didn’t read this article.

In terms of types of malignancy, lung cancer leads the list with 6,200 projected CT-induced cancers per year, followed by colon cancer (3,500 a year) and leukemia (2,800 a year).

The Names

If the numbers from this study hold, then about 1 in every 2,000 CT scans results in a new cancer. That would mean that I’ve dished out several cancers during my practice. In fact, I’ve ordered many thousand CT scans over my career—give or take a cancer. So my pen has, statistically, caused approximately three cancers.

I wondered which three patients it was. Was it Mr. Reynolds, who would’ve very likely died had we not diagnosed his post-operative abdominal abscess? Perhaps it was Mr. Jenson, who surely would have fared poorly if his pulmonary embolism had not been diagnosed and treated. Maybe it was Mrs. Hernandez, who wouldn’t have received thrombolytics for her stroke without a head CT.

Yes, I might have played a role in causing cancer in these three patients, but I did so knowing that I also saved, or at least improved, their lives. Most patients would accept that calculus.

But what if it were a different three? What if my cancer was that head CT I ordered for Mr. Davidson’s confusion, even though I know that head scans are rarely helpful in the evaluation of delirium? Perhaps my cancer-causer was that abdominal CT scan for Mrs. Ramirez’s chronic pain, which was clearly referable to her irritable bowel syndrome. Maybe it will be that CT scan I ordered last week because the patient insisted it be done, even though I strongly suspected, correctly, that it wouldn’t alter my management.

Which three would it be?

The Questions

This triggered more questions. How many of the 70 million-plus CT scans we order every year really are necessary? How many could be avoided by a robust physical examination, crisper clinical reasoning, or an alternate test? Do our patients really know the risk of these “innocuous” tests? Do we?

And, more personally, what if my PCP was still sitting on two? Would I be his number three?

Moving forward, I vow to remember 29,000. It will remain in the forefront of my mind, constantly badgering me about the next CT scan I order. To be sure, I will continue to order CTs—a lot of CTs. However, I will do so through the prism of the following query. If a patient developed a cancer from the CT scan I was about to order, could I sincerely look them in the eye and tell them I would do the test again?

And I’m agitated by one final question. How is that it took my own carcinogenic brush with CT scans for me to realize the gravity of 29,000? It’s not that 29,000 is not a big number. In fact, it’s precisely because it is a big number that we miss its importance. It’s too easy to hide behind the anonymity of the number. Because in the end, numbers don’t have names until the name is yours. TH

Dr. Glasheen is associate professor of medicine at the University of Colorado Denver, where he serves as director of the Hospital Medicine Program and the Hospitalist Training Program, and as associate program director of the Internal Medicine Residency Program.

Reference

1. Berrington de González A, Mahesh M, Kim KP, et al. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med. 2009;169(22):2071-2077.

Did you happen to read a recent New York Times article (www.nytimes.com/2010/05/27/us/27hosp.html) about hospitalists? I thought the article was great, but I was surprised by some of the negative reader feedback. What did you think?

George Eppley, MD

Reed, Ga.

Dr. Hospitalist responds: I read the NYT article by Jane Gross, “New Breed of Specialist Steps in for Family Doctor,” which was published May 26. The accompanying reader comment section is available at http://newoldage.blogs.nytimes.com/2010/05/26/in-hospitals-new-fingers -on-the-pulse/?ref=us.

The article provides the statistics that all of us in HM have come to know: HM is the fastest-growing medical specialty in the U.S. and, over the past decade, the number of hospitalists in the U.S. has grown from hundreds to 30,000. Gross talks about the care a hospitalist at the Hospital of the University of Pennsylvania provides for her patient. She highlights the challenges of transitions of care and references the work being done by hospitalists and SHM to make sure patients are making safe transitions. While the article was largely supportive of HM, she does provide a shade of balance when she mentions the risks to the patient when hospitalists fail to do their job when it comes to communication.

As a practicing hospitalist, I kind of wished I had stopped reading at the end of the article. I honestly did not like most of what I read in the reader comment section. Although the article was a feel-good story, I think it is fair to say the reader comments were largely negative. I understand that readers with negative experiences with hospitalists might be more likely to post a comment; nevertheless, some of the comments are hard to ignore—mainly because I suspect some of it is true.

One reader from Raleigh, N.C., wrote, “Hospitalists proved inept at contacting the patients’ existing doctors or even talking to the patients. Then, on discharge to nursing homes for further recovery, the ball was dropped further, with very poor communication of medication dosages, etc.” Yikes! What happened to the communication and the medication reconciliation process?

A reader from Massachusetts wrote about “the hospitalist … (who) ordered five blood draws in the space of several hours to replicate tests that had already been taken by the primary-care physician before admission.” So, not only are hospitalists poor communicators and do not do a good job with transitions of care, but their care is also driving up the cost of healthcare needlessly?

The most positive comments seem to come from outpatient providers and, quite honestly, I found them lukewarm at best. A PCP from Charleston, S.C., wrote, “I no longer have to cancel the appointments of the patients at the last minute in order to attend to an emergency occurring outside my office. It is a very efficient system.” Glad to hear the hospitalist relationship is working out for you, Dr. PCP, but as a patient in the hospital, I am worried more about the competency of this doctor, whom I have never met before this hospitalization, as opposed to how this doctor is going to make you more “efficient” in your office practice.

I came away with several thoughts after reading the article and the comments.

First, we need to set the right expectations. Is this the equivalent of the star athlete who makes a brash statement followed shortly thereafter by the statement, “I was misquoted”? Well … maybe. Are we who we say we are? The headline is “New Breed of Specialist Steps in for Family Doctor.”

As a practicing hospitalist, I never describe myself as replacing the family doctor, because this is the worst position I could put myself in. A patient might have a relationship with a family doctor for three or four decades. This family doctor might not only care for this patient, but also his children and grandchildren. The patient visits the family doctor at least once a year for a checkup. But when the patient is as sick as they have ever been in their life and needs their family doctor whom they trust, I am supposed to “step in” for this family doctor? Good luck trying to meet that standard. It’s like putting me next to Justin Timberlake on stage at a teenybopper concert. Who do you think is going to look better in that sort of comparison?

We, as hospitalists, should never allow anyone to think we are replacing their family doctor. We are here to work with the family doctor to provide the best care possible. Do surgeons, medical subspecialists, or ED doctors “replace” the family doctor? No way! They are working with the family doctor. Perhaps the problem here is that we have not set the appropriate expectations for our patients.

Next, we need to be clear in saying what we say we do or doing we what we say we do. A line in this article bothers me more than any of the reader comments: “The most compelling argument in favor of hospitalists, who are now in 5,000 institutions, from academic giants like the Hospital of the University of Pennsylvania to small community hospitals to innovators like the Mayo and Cleveland Clinics—is that they are there all the time.”

Why does it bother me so much? It is troubling because it is misleading and might simply be untrue. Many hospitalists are not there “all the time.” While many of our hospitalist programs have providers in the hospital 24 hours a day, many do not. I know a number of hospitalists who make rounds at multiple hospitals throughout the day. Are they really hospitalists or are they inpatient rounders?

Hospitalists are physicians defined by their location, not unlike ED physicians. Do we have ED doctors going from hospital to hospital, leaving nurses alone to care for patients when they are at another hospital? So what do we expect from our hospitalists? Should they be in the hospital 24/7? That would seem to be more consistent with the thought that “they are there all the time.” Remember, Gross did not say hospitalists are “reachable” all the time. She did say hospitalists are “on top of everything that happens to a patient—from entry through treatment and discharge.” It is time that we, as hospitalists, uniformly meet those expectations. Patients all over the country are figuring out that not all hospitalists are doing what they are supposed to do when it comes to communications and establishing safe transitions of care. Remember the adage: It does not take many rotten apples to spoil the barrel.

Last, let us talk more about how hospitalists can provide patient-centric care, as opposed to cost savings and carrying out President Obama’s marching orders. The article describes how a study published in the Journal of the American Medical Association found that patients have a reduced length of stay in the hospital when cared for by hospitalists; how hospitalists are being viewed as leaders in healthcare reform; and how the hospitalist spends her nonclinical time “design(ing) computer programs to contain costs.” Do not get me wrong. I am supportive as anyone of the notion that hospitalists should provide cost-effective care. But the reality is that our patients’ No. 1 priority is to believe that their doctor is providing the best care possible. They do not want to feel someone is short-changing them.

Talk all you want to insurers and hospitals about cost savings, but when speaking with patients, I think it makes more sense to discuss the quality as opposed to cost of care. Ask your next patient whether they give a hoot what you do when you are not caring for them. TH

Did you happen to read a recent New York Times article (www.nytimes.com/2010/05/27/us/27hosp.html) about hospitalists? I thought the article was great, but I was surprised by some of the negative reader feedback. What did you think?

George Eppley, MD

Reed, Ga.

Dr. Hospitalist responds: I read the NYT article by Jane Gross, “New Breed of Specialist Steps in for Family Doctor,” which was published May 26. The accompanying reader comment section is available at http://newoldage.blogs.nytimes.com/2010/05/26/in-hospitals-new-fingers -on-the-pulse/?ref=us.

The article provides the statistics that all of us in HM have come to know: HM is the fastest-growing medical specialty in the U.S. and, over the past decade, the number of hospitalists in the U.S. has grown from hundreds to 30,000. Gross talks about the care a hospitalist at the Hospital of the University of Pennsylvania provides for her patient. She highlights the challenges of transitions of care and references the work being done by hospitalists and SHM to make sure patients are making safe transitions. While the article was largely supportive of HM, she does provide a shade of balance when she mentions the risks to the patient when hospitalists fail to do their job when it comes to communication.

As a practicing hospitalist, I kind of wished I had stopped reading at the end of the article. I honestly did not like most of what I read in the reader comment section. Although the article was a feel-good story, I think it is fair to say the reader comments were largely negative. I understand that readers with negative experiences with hospitalists might be more likely to post a comment; nevertheless, some of the comments are hard to ignore—mainly because I suspect some of it is true.

One reader from Raleigh, N.C., wrote, “Hospitalists proved inept at contacting the patients’ existing doctors or even talking to the patients. Then, on discharge to nursing homes for further recovery, the ball was dropped further, with very poor communication of medication dosages, etc.” Yikes! What happened to the communication and the medication reconciliation process?

A reader from Massachusetts wrote about “the hospitalist … (who) ordered five blood draws in the space of several hours to replicate tests that had already been taken by the primary-care physician before admission.” So, not only are hospitalists poor communicators and do not do a good job with transitions of care, but their care is also driving up the cost of healthcare needlessly?

The most positive comments seem to come from outpatient providers and, quite honestly, I found them lukewarm at best. A PCP from Charleston, S.C., wrote, “I no longer have to cancel the appointments of the patients at the last minute in order to attend to an emergency occurring outside my office. It is a very efficient system.” Glad to hear the hospitalist relationship is working out for you, Dr. PCP, but as a patient in the hospital, I am worried more about the competency of this doctor, whom I have never met before this hospitalization, as opposed to how this doctor is going to make you more “efficient” in your office practice.

I came away with several thoughts after reading the article and the comments.

First, we need to set the right expectations. Is this the equivalent of the star athlete who makes a brash statement followed shortly thereafter by the statement, “I was misquoted”? Well … maybe. Are we who we say we are? The headline is “New Breed of Specialist Steps in for Family Doctor.”

As a practicing hospitalist, I never describe myself as replacing the family doctor, because this is the worst position I could put myself in. A patient might have a relationship with a family doctor for three or four decades. This family doctor might not only care for this patient, but also his children and grandchildren. The patient visits the family doctor at least once a year for a checkup. But when the patient is as sick as they have ever been in their life and needs their family doctor whom they trust, I am supposed to “step in” for this family doctor? Good luck trying to meet that standard. It’s like putting me next to Justin Timberlake on stage at a teenybopper concert. Who do you think is going to look better in that sort of comparison?

We, as hospitalists, should never allow anyone to think we are replacing their family doctor. We are here to work with the family doctor to provide the best care possible. Do surgeons, medical subspecialists, or ED doctors “replace” the family doctor? No way! They are working with the family doctor. Perhaps the problem here is that we have not set the appropriate expectations for our patients.

Next, we need to be clear in saying what we say we do or doing we what we say we do. A line in this article bothers me more than any of the reader comments: “The most compelling argument in favor of hospitalists, who are now in 5,000 institutions, from academic giants like the Hospital of the University of Pennsylvania to small community hospitals to innovators like the Mayo and Cleveland Clinics—is that they are there all the time.”

Why does it bother me so much? It is troubling because it is misleading and might simply be untrue. Many hospitalists are not there “all the time.” While many of our hospitalist programs have providers in the hospital 24 hours a day, many do not. I know a number of hospitalists who make rounds at multiple hospitals throughout the day. Are they really hospitalists or are they inpatient rounders?

Hospitalists are physicians defined by their location, not unlike ED physicians. Do we have ED doctors going from hospital to hospital, leaving nurses alone to care for patients when they are at another hospital? So what do we expect from our hospitalists? Should they be in the hospital 24/7? That would seem to be more consistent with the thought that “they are there all the time.” Remember, Gross did not say hospitalists are “reachable” all the time. She did say hospitalists are “on top of everything that happens to a patient—from entry through treatment and discharge.” It is time that we, as hospitalists, uniformly meet those expectations. Patients all over the country are figuring out that not all hospitalists are doing what they are supposed to do when it comes to communications and establishing safe transitions of care. Remember the adage: It does not take many rotten apples to spoil the barrel.

Last, let us talk more about how hospitalists can provide patient-centric care, as opposed to cost savings and carrying out President Obama’s marching orders. The article describes how a study published in the Journal of the American Medical Association found that patients have a reduced length of stay in the hospital when cared for by hospitalists; how hospitalists are being viewed as leaders in healthcare reform; and how the hospitalist spends her nonclinical time “design(ing) computer programs to contain costs.” Do not get me wrong. I am supportive as anyone of the notion that hospitalists should provide cost-effective care. But the reality is that our patients’ No. 1 priority is to believe that their doctor is providing the best care possible. They do not want to feel someone is short-changing them.

Talk all you want to insurers and hospitals about cost savings, but when speaking with patients, I think it makes more sense to discuss the quality as opposed to cost of care. Ask your next patient whether they give a hoot what you do when you are not caring for them. TH

Did you happen to read a recent New York Times article (www.nytimes.com/2010/05/27/us/27hosp.html) about hospitalists? I thought the article was great, but I was surprised by some of the negative reader feedback. What did you think?

George Eppley, MD

Reed, Ga.

Dr. Hospitalist responds: I read the NYT article by Jane Gross, “New Breed of Specialist Steps in for Family Doctor,” which was published May 26. The accompanying reader comment section is available at http://newoldage.blogs.nytimes.com/2010/05/26/in-hospitals-new-fingers -on-the-pulse/?ref=us.

The article provides the statistics that all of us in HM have come to know: HM is the fastest-growing medical specialty in the U.S. and, over the past decade, the number of hospitalists in the U.S. has grown from hundreds to 30,000. Gross talks about the care a hospitalist at the Hospital of the University of Pennsylvania provides for her patient. She highlights the challenges of transitions of care and references the work being done by hospitalists and SHM to make sure patients are making safe transitions. While the article was largely supportive of HM, she does provide a shade of balance when she mentions the risks to the patient when hospitalists fail to do their job when it comes to communication.

As a practicing hospitalist, I kind of wished I had stopped reading at the end of the article. I honestly did not like most of what I read in the reader comment section. Although the article was a feel-good story, I think it is fair to say the reader comments were largely negative. I understand that readers with negative experiences with hospitalists might be more likely to post a comment; nevertheless, some of the comments are hard to ignore—mainly because I suspect some of it is true.

One reader from Raleigh, N.C., wrote, “Hospitalists proved inept at contacting the patients’ existing doctors or even talking to the patients. Then, on discharge to nursing homes for further recovery, the ball was dropped further, with very poor communication of medication dosages, etc.” Yikes! What happened to the communication and the medication reconciliation process?

A reader from Massachusetts wrote about “the hospitalist … (who) ordered five blood draws in the space of several hours to replicate tests that had already been taken by the primary-care physician before admission.” So, not only are hospitalists poor communicators and do not do a good job with transitions of care, but their care is also driving up the cost of healthcare needlessly?

The most positive comments seem to come from outpatient providers and, quite honestly, I found them lukewarm at best. A PCP from Charleston, S.C., wrote, “I no longer have to cancel the appointments of the patients at the last minute in order to attend to an emergency occurring outside my office. It is a very efficient system.” Glad to hear the hospitalist relationship is working out for you, Dr. PCP, but as a patient in the hospital, I am worried more about the competency of this doctor, whom I have never met before this hospitalization, as opposed to how this doctor is going to make you more “efficient” in your office practice.

I came away with several thoughts after reading the article and the comments.

First, we need to set the right expectations. Is this the equivalent of the star athlete who makes a brash statement followed shortly thereafter by the statement, “I was misquoted”? Well … maybe. Are we who we say we are? The headline is “New Breed of Specialist Steps in for Family Doctor.”

As a practicing hospitalist, I never describe myself as replacing the family doctor, because this is the worst position I could put myself in. A patient might have a relationship with a family doctor for three or four decades. This family doctor might not only care for this patient, but also his children and grandchildren. The patient visits the family doctor at least once a year for a checkup. But when the patient is as sick as they have ever been in their life and needs their family doctor whom they trust, I am supposed to “step in” for this family doctor? Good luck trying to meet that standard. It’s like putting me next to Justin Timberlake on stage at a teenybopper concert. Who do you think is going to look better in that sort of comparison?

We, as hospitalists, should never allow anyone to think we are replacing their family doctor. We are here to work with the family doctor to provide the best care possible. Do surgeons, medical subspecialists, or ED doctors “replace” the family doctor? No way! They are working with the family doctor. Perhaps the problem here is that we have not set the appropriate expectations for our patients.

Next, we need to be clear in saying what we say we do or doing we what we say we do. A line in this article bothers me more than any of the reader comments: “The most compelling argument in favor of hospitalists, who are now in 5,000 institutions, from academic giants like the Hospital of the University of Pennsylvania to small community hospitals to innovators like the Mayo and Cleveland Clinics—is that they are there all the time.”

Why does it bother me so much? It is troubling because it is misleading and might simply be untrue. Many hospitalists are not there “all the time.” While many of our hospitalist programs have providers in the hospital 24 hours a day, many do not. I know a number of hospitalists who make rounds at multiple hospitals throughout the day. Are they really hospitalists or are they inpatient rounders?

Hospitalists are physicians defined by their location, not unlike ED physicians. Do we have ED doctors going from hospital to hospital, leaving nurses alone to care for patients when they are at another hospital? So what do we expect from our hospitalists? Should they be in the hospital 24/7? That would seem to be more consistent with the thought that “they are there all the time.” Remember, Gross did not say hospitalists are “reachable” all the time. She did say hospitalists are “on top of everything that happens to a patient—from entry through treatment and discharge.” It is time that we, as hospitalists, uniformly meet those expectations. Patients all over the country are figuring out that not all hospitalists are doing what they are supposed to do when it comes to communications and establishing safe transitions of care. Remember the adage: It does not take many rotten apples to spoil the barrel.

Last, let us talk more about how hospitalists can provide patient-centric care, as opposed to cost savings and carrying out President Obama’s marching orders. The article describes how a study published in the Journal of the American Medical Association found that patients have a reduced length of stay in the hospital when cared for by hospitalists; how hospitalists are being viewed as leaders in healthcare reform; and how the hospitalist spends her nonclinical time “design(ing) computer programs to contain costs.” Do not get me wrong. I am supportive as anyone of the notion that hospitalists should provide cost-effective care. But the reality is that our patients’ No. 1 priority is to believe that their doctor is providing the best care possible. They do not want to feel someone is short-changing them.

Talk all you want to insurers and hospitals about cost savings, but when speaking with patients, I think it makes more sense to discuss the quality as opposed to cost of care. Ask your next patient whether they give a hoot what you do when you are not caring for them. TH

As the field of HM continues to mature, branch out, and is called upon to lead in the care of a larger cross-section of hospitalized patients, it is only natural that this includes the critically ill patient. Hospitalists already care for—and are the attending of record for—this patient population in most U.S. hospitals. It is my position that a technically proficient hospitalist service, which is facility-exclusive and offers 24/7 coverage, is able to offer the same quality of care as an intensivist group. An important feature of this model is the inclusion and “buy in” from community pulmonologists in order to provide backup and consultative assistance when warranted.

Our program at Westside Regional Medical Center in Plantation, Fla., has made great strides as we continue to integrate this model in the hospital. We are actively tracking ICU length of stay and throughput, incidence of ventilator-associated pneumonia (VAP), central-line infection rates, and ICU mortality.

I believe that a clinically competent and aggressive HM service is able to drive down costs and generate revenue by establishing clinically beneficial quality-improvement (QI) protocols; drive down ICU length of stay; provide effective and timely procedural services; and incur a lower cost burden (i.e., hospitalists cost less than intensivists). And I believe all of these benefits are available without sacrificing quality or patient care.

Leadership from medical staff and administration is imperative to establish the appropriate vision and drive toward hospitalist/intensivist implementation. Finding the right supporting physicians who bring excitement and energy is equally as important. Establishing expectations for skill sets, as well as the opportunity and mechanism by which these skill sets might be acquired and refined, is a must. The following technical skills should be required of hospitalist/intensivists:

• Ultrasound-guided central line insertion;
• PICC line insertion;
• Endotracheal intubation;
• Advanced airway management;
• Thoracostomy tube insertion;
• Arterial-line insertion;
• Transvenous pacing wire insertion;
• Lumbar puncture;
• Thoracentesis; and
• Paracentesis.

An important starting point is the identification of skill sets for each hospitalist. Once this information is ascertained, the next step is to understand what the credentialing requirements for the individual procedures are. This usually consists of a certain number of “logged” cases, which must be put forward for review by the medical staff leadership. Most physicians completing residency are required to keep a procedural log where cases are documented. Any deficiencies within the log can be supplemented by establishing a practice log where proctored cases are documented until the recommended number of cases are completed and put forward for credentialing.

Obtaining buy-in from the medical staff is important. They can serve as allies in many areas, specifically as proctors in the credentialing process. The key to successful interface is in awakening them to the beneficial impact a service such as this can have on patients and on the lifestyle of providers.

As an example, before our group started the hybrid model at Westside, the nursing staff would call anesthesia to evaluate patients for endotracheal intubation. This system took anesthesia away from its OR cases, causing delays and frustration. After a conversation, the anesthesia director realized the benefits that would come with assisting the hospitalists in becoming more proficient with intubations. This same scenario has been true in our experience with ED physicians, cardiothoracic surgeons (chest tubes), and so on.

Other resources for hospitalists include the National Procedure Institute, which offers CME credit and certification toward “Hospitalist Procedures.” Additionally, difficult airway or advanced airway courses provide certification.

Hospitalists have long been called on to provide emergency services for unstable patients via rapid response or codes. In many facilities hospitalists serve as the lead physicians in the management of critically ill patients. Our hospitalist model serves as a great launching pad for the development and evolution of this new breed of physician.

There exists no clinical evidence to assert inferiority between the care provided by an in-house, 24/7 hospitalist group with assistance from pulmonary medicine versus an intensivist group. It is my belief that if the appropriate infrastructure, fostered skill sets, pulmonologist partnership, and QI protocols are implemented, there will be no measurable difference in scope of care or outcomes.

The inpatient management of critically ill and unstable patients continues to be a significant and important subgroup of hospital patient populations. As patients continue to live longer with debilitating chronic diseases, the fallout from decompensation can be devastating. Many facilities have hospitalists leading the charge in the care of these patients. It is undeniable that the next evolution in HM will require a more proactive inpatient physician, with both the clinical and technical acumen to manage all patients across the hospital spectrum.

Ulises A. Perez, MD,

medical director, hospitalist division,

Westside Regional Medical Center, Plantation, Fla.,

Kendall Regional Medical Center, Miami

As the field of HM continues to mature, branch out, and is called upon to lead in the care of a larger cross-section of hospitalized patients, it is only natural that this includes the critically ill patient. Hospitalists already care for—and are the attending of record for—this patient population in most U.S. hospitals. It is my position that a technically proficient hospitalist service, which is facility-exclusive and offers 24/7 coverage, is able to offer the same quality of care as an intensivist group. An important feature of this model is the inclusion and “buy in” from community pulmonologists in order to provide backup and consultative assistance when warranted.

Our program at Westside Regional Medical Center in Plantation, Fla., has made great strides as we continue to integrate this model in the hospital. We are actively tracking ICU length of stay and throughput, incidence of ventilator-associated pneumonia (VAP), central-line infection rates, and ICU mortality.

I believe that a clinically competent and aggressive HM service is able to drive down costs and generate revenue by establishing clinically beneficial quality-improvement (QI) protocols; drive down ICU length of stay; provide effective and timely procedural services; and incur a lower cost burden (i.e., hospitalists cost less than intensivists). And I believe all of these benefits are available without sacrificing quality or patient care.

Leadership from medical staff and administration is imperative to establish the appropriate vision and drive toward hospitalist/intensivist implementation. Finding the right supporting physicians who bring excitement and energy is equally as important. Establishing expectations for skill sets, as well as the opportunity and mechanism by which these skill sets might be acquired and refined, is a must. The following technical skills should be required of hospitalist/intensivists:

• Ultrasound-guided central line insertion;
• PICC line insertion;
• Endotracheal intubation;
• Advanced airway management;
• Thoracostomy tube insertion;
• Arterial-line insertion;
• Transvenous pacing wire insertion;
• Lumbar puncture;
• Thoracentesis; and
• Paracentesis.

An important starting point is the identification of skill sets for each hospitalist. Once this information is ascertained, the next step is to understand what the credentialing requirements for the individual procedures are. This usually consists of a certain number of “logged” cases, which must be put forward for review by the medical staff leadership. Most physicians completing residency are required to keep a procedural log where cases are documented. Any deficiencies within the log can be supplemented by establishing a practice log where proctored cases are documented until the recommended number of cases are completed and put forward for credentialing.

Obtaining buy-in from the medical staff is important. They can serve as allies in many areas, specifically as proctors in the credentialing process. The key to successful interface is in awakening them to the beneficial impact a service such as this can have on patients and on the lifestyle of providers.

As an example, before our group started the hybrid model at Westside, the nursing staff would call anesthesia to evaluate patients for endotracheal intubation. This system took anesthesia away from its OR cases, causing delays and frustration. After a conversation, the anesthesia director realized the benefits that would come with assisting the hospitalists in becoming more proficient with intubations. This same scenario has been true in our experience with ED physicians, cardiothoracic surgeons (chest tubes), and so on.

Other resources for hospitalists include the National Procedure Institute, which offers CME credit and certification toward “Hospitalist Procedures.” Additionally, difficult airway or advanced airway courses provide certification.

Hospitalists have long been called on to provide emergency services for unstable patients via rapid response or codes. In many facilities hospitalists serve as the lead physicians in the management of critically ill patients. Our hospitalist model serves as a great launching pad for the development and evolution of this new breed of physician.

There exists no clinical evidence to assert inferiority between the care provided by an in-house, 24/7 hospitalist group with assistance from pulmonary medicine versus an intensivist group. It is my belief that if the appropriate infrastructure, fostered skill sets, pulmonologist partnership, and QI protocols are implemented, there will be no measurable difference in scope of care or outcomes.

The inpatient management of critically ill and unstable patients continues to be a significant and important subgroup of hospital patient populations. As patients continue to live longer with debilitating chronic diseases, the fallout from decompensation can be devastating. Many facilities have hospitalists leading the charge in the care of these patients. It is undeniable that the next evolution in HM will require a more proactive inpatient physician, with both the clinical and technical acumen to manage all patients across the hospital spectrum.

Ulises A. Perez, MD,

medical director, hospitalist division,

Westside Regional Medical Center, Plantation, Fla.,

Kendall Regional Medical Center, Miami

As the field of HM continues to mature, branch out, and is called upon to lead in the care of a larger cross-section of hospitalized patients, it is only natural that this includes the critically ill patient. Hospitalists already care for—and are the attending of record for—this patient population in most U.S. hospitals. It is my position that a technically proficient hospitalist service, which is facility-exclusive and offers 24/7 coverage, is able to offer the same quality of care as an intensivist group. An important feature of this model is the inclusion and “buy in” from community pulmonologists in order to provide backup and consultative assistance when warranted.

Our program at Westside Regional Medical Center in Plantation, Fla., has made great strides as we continue to integrate this model in the hospital. We are actively tracking ICU length of stay and throughput, incidence of ventilator-associated pneumonia (VAP), central-line infection rates, and ICU mortality.

I believe that a clinically competent and aggressive HM service is able to drive down costs and generate revenue by establishing clinically beneficial quality-improvement (QI) protocols; drive down ICU length of stay; provide effective and timely procedural services; and incur a lower cost burden (i.e., hospitalists cost less than intensivists). And I believe all of these benefits are available without sacrificing quality or patient care.

Leadership from medical staff and administration is imperative to establish the appropriate vision and drive toward hospitalist/intensivist implementation. Finding the right supporting physicians who bring excitement and energy is equally as important. Establishing expectations for skill sets, as well as the opportunity and mechanism by which these skill sets might be acquired and refined, is a must. The following technical skills should be required of hospitalist/intensivists:

• Ultrasound-guided central line insertion;
• PICC line insertion;
• Endotracheal intubation;
• Advanced airway management;
• Thoracostomy tube insertion;
• Arterial-line insertion;
• Transvenous pacing wire insertion;
• Lumbar puncture;
• Thoracentesis; and
• Paracentesis.

An important starting point is the identification of skill sets for each hospitalist. Once this information is ascertained, the next step is to understand what the credentialing requirements for the individual procedures are. This usually consists of a certain number of “logged” cases, which must be put forward for review by the medical staff leadership. Most physicians completing residency are required to keep a procedural log where cases are documented. Any deficiencies within the log can be supplemented by establishing a practice log where proctored cases are documented until the recommended number of cases are completed and put forward for credentialing.

Obtaining buy-in from the medical staff is important. They can serve as allies in many areas, specifically as proctors in the credentialing process. The key to successful interface is in awakening them to the beneficial impact a service such as this can have on patients and on the lifestyle of providers.

As an example, before our group started the hybrid model at Westside, the nursing staff would call anesthesia to evaluate patients for endotracheal intubation. This system took anesthesia away from its OR cases, causing delays and frustration. After a conversation, the anesthesia director realized the benefits that would come with assisting the hospitalists in becoming more proficient with intubations. This same scenario has been true in our experience with ED physicians, cardiothoracic surgeons (chest tubes), and so on.

Other resources for hospitalists include the National Procedure Institute, which offers CME credit and certification toward “Hospitalist Procedures.” Additionally, difficult airway or advanced airway courses provide certification.

Hospitalists have long been called on to provide emergency services for unstable patients via rapid response or codes. In many facilities hospitalists serve as the lead physicians in the management of critically ill patients. Our hospitalist model serves as a great launching pad for the development and evolution of this new breed of physician.

There exists no clinical evidence to assert inferiority between the care provided by an in-house, 24/7 hospitalist group with assistance from pulmonary medicine versus an intensivist group. It is my belief that if the appropriate infrastructure, fostered skill sets, pulmonologist partnership, and QI protocols are implemented, there will be no measurable difference in scope of care or outcomes.

The inpatient management of critically ill and unstable patients continues to be a significant and important subgroup of hospital patient populations. As patients continue to live longer with debilitating chronic diseases, the fallout from decompensation can be devastating. Many facilities have hospitalists leading the charge in the care of these patients. It is undeniable that the next evolution in HM will require a more proactive inpatient physician, with both the clinical and technical acumen to manage all patients across the hospital spectrum.

Ulises A. Perez, MD,

medical director, hospitalist division,

Westside Regional Medical Center, Plantation, Fla.,

Kendall Regional Medical Center, Miami

In This Edition

Literature at a Glance

A guide to this month’s studies

• Antibiotics after drainage of uncomplicated skin abscesses
• Clopidogrel vs. combined aspirin-dipyridamole for acute ischemic stroke
• BNP-guided therapy in chronic heart failure outpatients
• Cognitive decline and dementia after hospitalization
• Clopidogrel delays up risks for DES implantation patients
• Clinical score identifies prolonged length of stay
• Time to therapy reduces mortality in sepsis patients
• PEEP associated with lower mortality for ARDS patients

Antibiotics Might Be Unnecessary after Drainage of Uncomplicated Skin Abscesses

Clinical question: Does trimethoprim/sulfamethoxazole (TMP/SMX) treatment after drainage of a skin abscess reduce treatment failure at seven days or development of new lesions at 30 days?

Background: Community ac-quired methicillin-resistant Staphylococcus aureus (MRSA) skin abscesses are increasing in frequency. The benefit of antibiotic treatment after incision and drainage is not clear, as there is a high cure rate without antibiotics.

Study design: Multicenter, double-blinded, randomized, placebo-controlled trial.

Setting: Four military EDs treating civilians and military patients.

Synopsis: The study enrolled a convenience sample of 220 patients, each of whom presented to EDs with uncomplicated skin abscesses from November 2007 to June 2009. Abscesses were drained in the ED, then patients were randomized to either placebo or to TMP/SMX (two DS tablets twice daily) for seven days. Re-evaluation for wound checks occurred at two days and seven days.

Treatment failure at seven days, defined as worsening infection, new lesions, or absence of clinical improvement, occurred in 26% of placebo patients and 17% of patients in the treatment arm, a nonsignificant difference (P=0.12). Fewer patients in the treatment arm had new lesions at 30 days (28% vs. 9%, P=0.02). MRSA was cultured from 53% of patients overall; all samples were sensitive to TMP/SMX.

The study was limited by the fact that only 69% of patients were evaluated at 30 days.

Bottom line: TMP/SMX treatment of uncomplicated skin abscess after drainage in EDs does not decrease treatment failure at seven days, but might decrease the development of new lesions.

Citation: Schmitz GR, Bruner D, Pitotti R, et al. Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection [published online ahead of print March 29, 2010]. Ann Emerg Med. doi:10.1016/j.annemerg med.2010.03.002.

Clopidogrel and Combined Aspirin-Dipyridamole Have Similar Safety and Efficacy Profiles for Acute Ischemic Stroke

Clinical question: What is the efficacy and safety of combined aspirin and extended-release dipyridamole (Asp/ER-DP) compared to clopidogrel in patients with acute ischemic stroke?

Background: Long-term antiplatelet therapy is effective at reducing recurrence after ischemic stroke. However, the relative safety and efficacy of Asp/ER-DP or clopidogrel is not known in patients with acute ischemic stroke.

Study design: Randomized, controlled trial.

Setting: A multicenter trial involving 695 sites in 35 countries.

Synopsis: This post-hoc subgroup analysis of the PRoFESS (Prevention Regimen for Effectively Avoiding Second Strokes) trial assessed the relative safety and efficacy of Asp/ER-DP versus clopidogrel administered within 72 hours of stroke onset in 1,360 patients. The primary endpoint was functional outcome at 30 days.

Secondary outcomes included symptomatic hemorrhagic transformation of the infarct, cerebral edema, recurrent stroke, myocardial infarction (MI), composite vascular events (combination of nonfatal stroke, nonfatal MI, and vascular death), death, cognition, bleeding, and serious adverse events studied at seven, 30, and 90 days.

Combined death or dependency did not differ between treatment groups. Nonsignificant trends to reduced recurrence and vascular events were present with Asp/ER-DP. Rates of death, major bleeding, and serious adverse events did not differ between treatment groups.

Bottom line: Either clopidogrel or combined aspirin and extended-release dipyridamole can be used to treat acute ischemic stroke, with similar outcomes and safety profiles.

Citation: Bath PM, Cotton D, Martin RH, et al. Effect of combined aspirin and extended-release dipyridamole versus clopidogrel on functional outcome and recurrence in acute, mild ischemic stroke: PRoFESS subgroup analysis. Stroke. 2010;41(4):732-738.

BNP-Guided Therapy Reduces All-Cause Mortality in Outpatients with Chronic Heart Failure

Clinical question: Is there a clinical benefit in using B-type natriuretic peptide (BNP) to guide adjustment of proven medications in chronic heart failure?

Background: BNP is secreted by the heart in response to increased volume. It has been shown to be useful in the diagnosis of decompensated heart failure, and it can be decreased by treatment with proven heart failure medications. It is unclear if this effect provides clinical benefit on mortality and hospitalization.

Study design: Meta-analysis of prospective randomized controlled trials.

Setting: Eight studies involving 1,726 patients, published internationally from 2005-2009.

Synopsis: Study sizes ranged from 41 to 499 patients, with three- to 24-month follow-up. Patients had New York Heart Association (NYHA) class II or greater heart failure, with ejection fractions <50%.

All-cause mortality was significantly lower in BNP-guided therapy compared with clinical-guided therapy (RR=0.76; 95% CI, 0.63-0.91; P=0.003), specifically in patients younger than 75 years old (RR=0.52; 95% CI, 0.33-0.82; P=0.005).

A proposed mechanism for this result was a statistically significant increase in adjustment of most heart failure medications for BNP-guided therapy compared with clinical-guided therapy (75% vs. 58%, P<0.001 in diuretics; 49.6% vs. 30.9%, P<0.001 in ACE inhibitors or Angiotensin II receptor blockers (ARBs); and 51.1% vs. 41.6%, P=0.02 in beta-blockers) and a higher percentage reaching target doses in the BNP-guided therapy group. However, there was no significant decrease in all-cause hospitalization or survival free of hospitalization.

The study limitations include: Hospitalization for heart failure was not meta-analyzed, the pooled data were weighted toward one study, and BNP-guided titration parameters varied across studies.

Bottom line: BNP-guided therapy reduces all-cause mortality in chronic heart failure patients younger than 75 years old, but not all-cause hospitalization or survival free of hospitalization.

Citation: Porapakkham P, Porapakkham P, Zimmet H, Billah B, Krum H. B-type natriuretic peptide-guided heart failure therapy: A meta-analysis. Arch Intern Med. 2010;170(6):507-514.

Hospitalization Is Associated with Cognitive Decline and Subsequent Risk for Dementia in the Elderly

Clinical question: Is critical illness in patients 65 and older associated with long-term cognitive impairment, and does it affect the incidence of dementia?

Background: There is literature suggesting that survivors of critical illness suffer long-term cognitive impairment, but premorbid measures of cognitive function have not been researched. No studies have evaluated the risk of incident dementia among this patient population.

Study design: Prospective cohort study.

Setting: Group Health Cooperative in Seattle.

Synopsis: This study analyzed data from 2,929 community-dwelling adults older than 65 without baseline dementia. From 1994 to 2007, the individuals were screened with the Cognitive Abilities Screening Instrument (CASI) at follow-up visits every two years. CASI scores lower than 86 (out of 100) led to an examination for dementia; the diagnosis of dementia was an outcome measure. Scores were adjusted for baseline cognitive scores, age, and other risk factors.

For patients following acute-care hospitalization, adjusted CASI scores were 1.01 points lower on average than for those not hospitalized. For patients following critical-illness hospitalization, scores were 2.14 points lower. The dementia rate was 14.6 cases per 1,000 person-years among patients not hospitalized, and 33.6 among those admitted for noncritical illness.

As suspected, hospitalization might be a marker for cognitive decline in the elderly after adjusting for premorbid CASI scores and comorbid illness. Some factors in acute illness—and moreso in critical illness—might be causally related to cognitive decline.

Bottom line: In elderly patients without dementia at baseline, hospitalization for acute care and critical illness increases the likelihood of cognitive decline compared with patients who were not hospitalized. Only noncritical-illness hospitalization was not associated with the development of dementia.

Citation: Ehlenbach WJ, Hough CL, Crane PK, et al. Association between acute care and critical illness hospitalization and cognitive function in older adults. JAMA. 2010;303(8): 763-770.

Increased Risk of Death and Myocardial Infarction in Patients Who Delay Filling Clopidogrel Prescription after Drug-Eluting Stent Implantation

Clinical question: Is there an increased risk of death or myocardial infarction (MI) in patients with recent drug-eluting stent (DES) implantation who delayed filling their clopidogrel prescription compared with those who filled their prescription on the day of hospital discharge?

Background: Filling an initial prescription of clopidogrel on the day of discharge is important after DES implantation, as prior studies suggest that lack of thienopyridine therapy is a risk factor for early stent thrombosis.

Study design: Retrospective cohort study.

Setting: Three large, integrated healthcare systems.

Synopsis: The cohort included 7,042 patients discharged after DES implantation. Filling of a clopidogrel prescription was based on pharmacy dispensing data. Primary analysis divided patients based on whether they filled the prescription on the day of discharge or any time after discharge. Secondary analysis further characterized delays as >1 day, >3 days, or >5 days after discharge.

One in 6 patients delayed filling the initial prescription. Patients with any degree of delay had significantly higher death and MI rates during follow-up (14.2% vs. 7.9%, P<0.001), as well as an increased risk of death/MI (hazard ratio 1.53; 95% CI, 1.25-1.87). Factors associated with a delay in filling clopidogrel included older age, prior MI, diabetes, renal dysfunction, prior revascularization, cardiogenic shock, in-hospital bleeding, and use of clopidogrel upon admission.

The study was limited in that data were based on pharmacy records, and that patients might have received medication at discharge or outside the healthcare system.

Bottom line: The delay in filling a clopidogrel prescription is associated with an increased risk of death and MI in patients with recent DES implantation.

Citation: Ho PM, Tsai TT, Maddox TM, et al. Delays in filling clopidogrel prescription after hospital discharge and adverse outcomes after drug-eluting stent implantation: implications for transitions of care. Circ Cardiovasc Qual Outcomes. 2010;3(3):261-266.

Predicting Length of Stay after Stroke

Clinical question: Does a clinical score accurately predict prolonged length of stay after stroke?

Background: Stroke is a costly health problem, and length of stay is the most prominent factor contributing to the high costs. The factors leading to prolonged length of stay are varied, and there are no established tools to predict length of stay.

Study design: Prospective cohort study.

Setting: All 28 Israeli hospitals that admit stroke patients.

Synopsis: All patients admitted to Israeli hospitals during established two-month periods in 2004 (1,700 patients) and 2007 (1,648 patients) were included in the National Acute Stroke Israeli Survey (NASIS), and served as the derivation and validation cohort for development of a Prolonged Length of Stay (PLOS) score.

Using the 2004 data, investigators identified stroke severity using the National Institutes of Health Stroke Scale (NIHSS), history of congestive heart failure (CHF), history of atrial fibrillation, decreased level of consciousness on presentation, and intracerebral hemorrhage (as opposed to ischemic stroke) as predictors of prolonged length of stay. Four of these factors were expressed as dichotomous variables, whereas the stroke severity by NIHSS class was incorporated as a range; all were incorporated into a PLOS score.

Higher PLOS score correlated with longer length of stay. In the derivation cohort, 22% of patients with a PLOS score of 0 had a prolonged length of stay, whereas 85% of patients with PLOS scores of 6 or 7 had a prolonged length of stay. In the validation cohort, the corresponding figures were 19% and 72%.

Bottom line: Use of a simple score can predict risk of prolonged length of stay after stroke.

Citation: Koton S, Bornstein NM, Tsabari R, Tanne D, NASIS Investigators. Derivation and validation of the prolonged length of stay score in acute stroke patients. Neurology. 2010;74(19);1511-1516.

Earlier Administration of Appropriate Antimicrobials Decreases Mortality in Patients with Severe Sepsis and Septic Shock

Clinical question: Is the timing of antimicrobial administration an important determinant of survival in patients diagnosed with severe sepsis and septic shock?

Background: Severe sepsis and septic shock are associated with a 25% to 50% mortality rate. Early goal-directed therapy has been shown to increase survival in these patients. Antimicrobial treatment is a mainstay of this therapy, but the most effective timing of this treatment remains unclear.

Study design: Retrospective, single-center cohort study.

Setting: ED at an academic tertiary-care center.

Synopsis: Two hundred sixty-one patients in the ED in 2005-2006 presenting with severe sepsis or septic shock were enrolled in the hospital’s early goal-directed therapy (EGDT) algorithm, either at triage or later during their ED stay. Labs showed 56.7% of patients were culture-positive, with the most common sources being respiratory (30.6%), genitourinary (22.8%), and gastrointestinal (19.7%).

All patients received antibiotics and were stratified in one-hour intervals by the following categories: time from triage to antibiotics; time from qualification for EGDT to antibiotics; time from triage to appropriate antibiotics; and time from qualification for EGDT to appropriate antibiotics.

Total in-hospital mortality was 31% (35.1% for culture-positive patients vs. 25.7% for culture-negative patients, P=0.11). A significant decrease in mortality was only found when appropriate antibiotics were administered within one hour of triage, or within one hour of qualification for EGDT (OR=0.30; 95% CI, 0.11-0.83; P=0.02, and OR=0.50; 95% CI, 0.27-0.92; P=0.03, respectively).

Study limitations included the single-center site and small sample size.

Bottom line: In patients with severe sepsis and septic shock, initiating appropriate antimicrobial therapy within one hour of triage or entry into goal-directed therapy significantly reduces mortality.

Citation: Gaieski DF, Mikkelsen ME, Band RA, et al. Impact of time to antibiotics on survival in patients with severe sepsis or septic shock in whom early goal-directed therapy was initiated in the emergency department. Crit Care Med. 2010;38(4):1045-1053.

Treatment with Higher Levels of Positive End-Expiratory Pressure Has Limited Affect on Hospital Survival

Clinical question: Is treatment with higher versus lower levels of positive end-expiratory pressure (PEEP) associated with improved hospital survival?

Background: In the management of patients with acute lung injury or acute respiratory distress syndrome (ARDS), a fundamental goal is to protect the lungs from ventilation-induced injury, but the optimal PEEP level has not been established.

Study design: Systematic review and meta-analysis.

Setting: N/A.

Synopsis: Three randomized-controlled trials eligible for this review included 2,299 critically ill adults with acute lung injury, as defined by the American-European Consensus Conference. The meta-analysis compared higher and lower PEEP levels with a mean difference of at least 3 cm H2O, incorporated a target tidal volume of less than 8 mL/kg of predicted body weight in both ventilation strategies, and provided patient follow-up until death or for at least 20 days.

This review demonstrated no statistically significant difference in hospital mortality between the groups. However, in patients with ARDS, higher levels of PEEP were associated with a relative reduction in mortality of 10%. This is supported by a recent cohort study in patients with acute lung injury or ARDS, which showed that the effect of PEEP on lung recruitment was associated with the proportion of potentially recruitable lung, as determined by computed tomography.

Since patients with ARDS have more pulmonary edema than those with acute lung injury without ARDS, the former have greater recruitability, and thus might benefit more from higher levels of PEEP.

Bottom line: Higher levels of PEEP might be associated with lower hospital mortality in patients with ARDS, but such a benefit is unlikely in patients with less severe lung injuries, and could actually be harmful.

Citation: Briel M, Meade M, Mercat A, et al. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010;303(9):865-873. TH

PEDIATRIC HM LITERATURE

By Mark Shen, MD

High-Performing State Healthcare Systems Have Higher Children’s Hospital Readmission Rates

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

Clinical question: What is the relationship between a hospital’s readmission rate and performance of the surrounding healthcare system?

Background: Hospital readmission rates might be influenced by factors related to the specific patient and hospital care, as well as such external factors as the performance of the surrounding healthcare system. Traditionally, readmission rates are thought to most accurately reflect the quality of hospital care; however, the relative contributions of patient, hospital, and external factors to hospital readmission rates have not been delineated.

Study design: Multilevel cohort study.

Setting: Thirty-nine children’s hospitals in 24 states.

Synopsis: The Pediatric Health Information System (PHIS) administrative database was sampled for the 2005 calendar year to review discharges from 39 participating children’s hospitals. Patients 2 to 18 years were included, and out of a total of 198,422 patients, 32,196 were readmitted within 365 days of discharge.

The Commonwealth Fund’s 2008 State Variations in Child Health System Performance ranking was used to define the state-level health system performance. Higher readmission rates correlated with higher-ranked state child health systems after adjustment for patient-level characteristics.

This surprising result calls into question the often-assumed link between hospital readmission rates and poor systems of care. However, despite the strength of its large sample size, this study’s macro-level view of the healthcare system might be too crude to truly define the external factors that play a role in readmission. State-level healthcare rankings might not accurately reflect the healthcare ecosystem surrounding each children’s hospital, and children’s hospitals do not care for the majority of children in the U.S.

Bottom line: Children’s hospital readmissions correlate with higher state child health system performance.

Citation: Feudtner C, Pati S, Goodman DM, et al. State-level child health system performance and the likelihood of readmission to children’s hospitals. J Pediatr. 2010;157(1):98-102.

In This Edition

Literature at a Glance

A guide to this month’s studies

• Antibiotics after drainage of uncomplicated skin abscesses
• Clopidogrel vs. combined aspirin-dipyridamole for acute ischemic stroke
• BNP-guided therapy in chronic heart failure outpatients
• Cognitive decline and dementia after hospitalization
• Clopidogrel delays up risks for DES implantation patients
• Clinical score identifies prolonged length of stay
• Time to therapy reduces mortality in sepsis patients
• PEEP associated with lower mortality for ARDS patients

Antibiotics Might Be Unnecessary after Drainage of Uncomplicated Skin Abscesses

Clinical question: Does trimethoprim/sulfamethoxazole (TMP/SMX) treatment after drainage of a skin abscess reduce treatment failure at seven days or development of new lesions at 30 days?

Background: Community ac-quired methicillin-resistant Staphylococcus aureus (MRSA) skin abscesses are increasing in frequency. The benefit of antibiotic treatment after incision and drainage is not clear, as there is a high cure rate without antibiotics.

Study design: Multicenter, double-blinded, randomized, placebo-controlled trial.

Setting: Four military EDs treating civilians and military patients.

Synopsis: The study enrolled a convenience sample of 220 patients, each of whom presented to EDs with uncomplicated skin abscesses from November 2007 to June 2009. Abscesses were drained in the ED, then patients were randomized to either placebo or to TMP/SMX (two DS tablets twice daily) for seven days. Re-evaluation for wound checks occurred at two days and seven days.

Treatment failure at seven days, defined as worsening infection, new lesions, or absence of clinical improvement, occurred in 26% of placebo patients and 17% of patients in the treatment arm, a nonsignificant difference (P=0.12). Fewer patients in the treatment arm had new lesions at 30 days (28% vs. 9%, P=0.02). MRSA was cultured from 53% of patients overall; all samples were sensitive to TMP/SMX.

The study was limited by the fact that only 69% of patients were evaluated at 30 days.

Bottom line: TMP/SMX treatment of uncomplicated skin abscess after drainage in EDs does not decrease treatment failure at seven days, but might decrease the development of new lesions.

Citation: Schmitz GR, Bruner D, Pitotti R, et al. Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection [published online ahead of print March 29, 2010]. Ann Emerg Med. doi:10.1016/j.annemerg med.2010.03.002.

Clopidogrel and Combined Aspirin-Dipyridamole Have Similar Safety and Efficacy Profiles for Acute Ischemic Stroke

Clinical question: What is the efficacy and safety of combined aspirin and extended-release dipyridamole (Asp/ER-DP) compared to clopidogrel in patients with acute ischemic stroke?

Background: Long-term antiplatelet therapy is effective at reducing recurrence after ischemic stroke. However, the relative safety and efficacy of Asp/ER-DP or clopidogrel is not known in patients with acute ischemic stroke.

Study design: Randomized, controlled trial.

Setting: A multicenter trial involving 695 sites in 35 countries.

Synopsis: This post-hoc subgroup analysis of the PRoFESS (Prevention Regimen for Effectively Avoiding Second Strokes) trial assessed the relative safety and efficacy of Asp/ER-DP versus clopidogrel administered within 72 hours of stroke onset in 1,360 patients. The primary endpoint was functional outcome at 30 days.

Secondary outcomes included symptomatic hemorrhagic transformation of the infarct, cerebral edema, recurrent stroke, myocardial infarction (MI), composite vascular events (combination of nonfatal stroke, nonfatal MI, and vascular death), death, cognition, bleeding, and serious adverse events studied at seven, 30, and 90 days.

Combined death or dependency did not differ between treatment groups. Nonsignificant trends to reduced recurrence and vascular events were present with Asp/ER-DP. Rates of death, major bleeding, and serious adverse events did not differ between treatment groups.

Bottom line: Either clopidogrel or combined aspirin and extended-release dipyridamole can be used to treat acute ischemic stroke, with similar outcomes and safety profiles.

Citation: Bath PM, Cotton D, Martin RH, et al. Effect of combined aspirin and extended-release dipyridamole versus clopidogrel on functional outcome and recurrence in acute, mild ischemic stroke: PRoFESS subgroup analysis. Stroke. 2010;41(4):732-738.

BNP-Guided Therapy Reduces All-Cause Mortality in Outpatients with Chronic Heart Failure

Clinical question: Is there a clinical benefit in using B-type natriuretic peptide (BNP) to guide adjustment of proven medications in chronic heart failure?

Background: BNP is secreted by the heart in response to increased volume. It has been shown to be useful in the diagnosis of decompensated heart failure, and it can be decreased by treatment with proven heart failure medications. It is unclear if this effect provides clinical benefit on mortality and hospitalization.

Study design: Meta-analysis of prospective randomized controlled trials.

Setting: Eight studies involving 1,726 patients, published internationally from 2005-2009.

Synopsis: Study sizes ranged from 41 to 499 patients, with three- to 24-month follow-up. Patients had New York Heart Association (NYHA) class II or greater heart failure, with ejection fractions <50%.

All-cause mortality was significantly lower in BNP-guided therapy compared with clinical-guided therapy (RR=0.76; 95% CI, 0.63-0.91; P=0.003), specifically in patients younger than 75 years old (RR=0.52; 95% CI, 0.33-0.82; P=0.005).

A proposed mechanism for this result was a statistically significant increase in adjustment of most heart failure medications for BNP-guided therapy compared with clinical-guided therapy (75% vs. 58%, P<0.001 in diuretics; 49.6% vs. 30.9%, P<0.001 in ACE inhibitors or Angiotensin II receptor blockers (ARBs); and 51.1% vs. 41.6%, P=0.02 in beta-blockers) and a higher percentage reaching target doses in the BNP-guided therapy group. However, there was no significant decrease in all-cause hospitalization or survival free of hospitalization.

The study limitations include: Hospitalization for heart failure was not meta-analyzed, the pooled data were weighted toward one study, and BNP-guided titration parameters varied across studies.

Bottom line: BNP-guided therapy reduces all-cause mortality in chronic heart failure patients younger than 75 years old, but not all-cause hospitalization or survival free of hospitalization.

Citation: Porapakkham P, Porapakkham P, Zimmet H, Billah B, Krum H. B-type natriuretic peptide-guided heart failure therapy: A meta-analysis. Arch Intern Med. 2010;170(6):507-514.

Hospitalization Is Associated with Cognitive Decline and Subsequent Risk for Dementia in the Elderly

Clinical question: Is critical illness in patients 65 and older associated with long-term cognitive impairment, and does it affect the incidence of dementia?

Background: There is literature suggesting that survivors of critical illness suffer long-term cognitive impairment, but premorbid measures of cognitive function have not been researched. No studies have evaluated the risk of incident dementia among this patient population.

Study design: Prospective cohort study.

Setting: Group Health Cooperative in Seattle.

Synopsis: This study analyzed data from 2,929 community-dwelling adults older than 65 without baseline dementia. From 1994 to 2007, the individuals were screened with the Cognitive Abilities Screening Instrument (CASI) at follow-up visits every two years. CASI scores lower than 86 (out of 100) led to an examination for dementia; the diagnosis of dementia was an outcome measure. Scores were adjusted for baseline cognitive scores, age, and other risk factors.

For patients following acute-care hospitalization, adjusted CASI scores were 1.01 points lower on average than for those not hospitalized. For patients following critical-illness hospitalization, scores were 2.14 points lower. The dementia rate was 14.6 cases per 1,000 person-years among patients not hospitalized, and 33.6 among those admitted for noncritical illness.

As suspected, hospitalization might be a marker for cognitive decline in the elderly after adjusting for premorbid CASI scores and comorbid illness. Some factors in acute illness—and moreso in critical illness—might be causally related to cognitive decline.

Bottom line: In elderly patients without dementia at baseline, hospitalization for acute care and critical illness increases the likelihood of cognitive decline compared with patients who were not hospitalized. Only noncritical-illness hospitalization was not associated with the development of dementia.

Citation: Ehlenbach WJ, Hough CL, Crane PK, et al. Association between acute care and critical illness hospitalization and cognitive function in older adults. JAMA. 2010;303(8): 763-770.

Increased Risk of Death and Myocardial Infarction in Patients Who Delay Filling Clopidogrel Prescription after Drug-Eluting Stent Implantation

Clinical question: Is there an increased risk of death or myocardial infarction (MI) in patients with recent drug-eluting stent (DES) implantation who delayed filling their clopidogrel prescription compared with those who filled their prescription on the day of hospital discharge?

Background: Filling an initial prescription of clopidogrel on the day of discharge is important after DES implantation, as prior studies suggest that lack of thienopyridine therapy is a risk factor for early stent thrombosis.

Study design: Retrospective cohort study.

Setting: Three large, integrated healthcare systems.

Synopsis: The cohort included 7,042 patients discharged after DES implantation. Filling of a clopidogrel prescription was based on pharmacy dispensing data. Primary analysis divided patients based on whether they filled the prescription on the day of discharge or any time after discharge. Secondary analysis further characterized delays as >1 day, >3 days, or >5 days after discharge.

One in 6 patients delayed filling the initial prescription. Patients with any degree of delay had significantly higher death and MI rates during follow-up (14.2% vs. 7.9%, P<0.001), as well as an increased risk of death/MI (hazard ratio 1.53; 95% CI, 1.25-1.87). Factors associated with a delay in filling clopidogrel included older age, prior MI, diabetes, renal dysfunction, prior revascularization, cardiogenic shock, in-hospital bleeding, and use of clopidogrel upon admission.

The study was limited in that data were based on pharmacy records, and that patients might have received medication at discharge or outside the healthcare system.

Bottom line: The delay in filling a clopidogrel prescription is associated with an increased risk of death and MI in patients with recent DES implantation.

Citation: Ho PM, Tsai TT, Maddox TM, et al. Delays in filling clopidogrel prescription after hospital discharge and adverse outcomes after drug-eluting stent implantation: implications for transitions of care. Circ Cardiovasc Qual Outcomes. 2010;3(3):261-266.

Predicting Length of Stay after Stroke

Clinical question: Does a clinical score accurately predict prolonged length of stay after stroke?

Background: Stroke is a costly health problem, and length of stay is the most prominent factor contributing to the high costs. The factors leading to prolonged length of stay are varied, and there are no established tools to predict length of stay.

Study design: Prospective cohort study.

Setting: All 28 Israeli hospitals that admit stroke patients.

Synopsis: All patients admitted to Israeli hospitals during established two-month periods in 2004 (1,700 patients) and 2007 (1,648 patients) were included in the National Acute Stroke Israeli Survey (NASIS), and served as the derivation and validation cohort for development of a Prolonged Length of Stay (PLOS) score.

Using the 2004 data, investigators identified stroke severity using the National Institutes of Health Stroke Scale (NIHSS), history of congestive heart failure (CHF), history of atrial fibrillation, decreased level of consciousness on presentation, and intracerebral hemorrhage (as opposed to ischemic stroke) as predictors of prolonged length of stay. Four of these factors were expressed as dichotomous variables, whereas the stroke severity by NIHSS class was incorporated as a range; all were incorporated into a PLOS score.

Higher PLOS score correlated with longer length of stay. In the derivation cohort, 22% of patients with a PLOS score of 0 had a prolonged length of stay, whereas 85% of patients with PLOS scores of 6 or 7 had a prolonged length of stay. In the validation cohort, the corresponding figures were 19% and 72%.

Bottom line: Use of a simple score can predict risk of prolonged length of stay after stroke.

Citation: Koton S, Bornstein NM, Tsabari R, Tanne D, NASIS Investigators. Derivation and validation of the prolonged length of stay score in acute stroke patients. Neurology. 2010;74(19);1511-1516.

Earlier Administration of Appropriate Antimicrobials Decreases Mortality in Patients with Severe Sepsis and Septic Shock

Clinical question: Is the timing of antimicrobial administration an important determinant of survival in patients diagnosed with severe sepsis and septic shock?

Background: Severe sepsis and septic shock are associated with a 25% to 50% mortality rate. Early goal-directed therapy has been shown to increase survival in these patients. Antimicrobial treatment is a mainstay of this therapy, but the most effective timing of this treatment remains unclear.

Study design: Retrospective, single-center cohort study.

Setting: ED at an academic tertiary-care center.

Synopsis: Two hundred sixty-one patients in the ED in 2005-2006 presenting with severe sepsis or septic shock were enrolled in the hospital’s early goal-directed therapy (EGDT) algorithm, either at triage or later during their ED stay. Labs showed 56.7% of patients were culture-positive, with the most common sources being respiratory (30.6%), genitourinary (22.8%), and gastrointestinal (19.7%).

All patients received antibiotics and were stratified in one-hour intervals by the following categories: time from triage to antibiotics; time from qualification for EGDT to antibiotics; time from triage to appropriate antibiotics; and time from qualification for EGDT to appropriate antibiotics.

Total in-hospital mortality was 31% (35.1% for culture-positive patients vs. 25.7% for culture-negative patients, P=0.11). A significant decrease in mortality was only found when appropriate antibiotics were administered within one hour of triage, or within one hour of qualification for EGDT (OR=0.30; 95% CI, 0.11-0.83; P=0.02, and OR=0.50; 95% CI, 0.27-0.92; P=0.03, respectively).

Study limitations included the single-center site and small sample size.

Bottom line: In patients with severe sepsis and septic shock, initiating appropriate antimicrobial therapy within one hour of triage or entry into goal-directed therapy significantly reduces mortality.

Citation: Gaieski DF, Mikkelsen ME, Band RA, et al. Impact of time to antibiotics on survival in patients with severe sepsis or septic shock in whom early goal-directed therapy was initiated in the emergency department. Crit Care Med. 2010;38(4):1045-1053.

Treatment with Higher Levels of Positive End-Expiratory Pressure Has Limited Affect on Hospital Survival

Clinical question: Is treatment with higher versus lower levels of positive end-expiratory pressure (PEEP) associated with improved hospital survival?

Background: In the management of patients with acute lung injury or acute respiratory distress syndrome (ARDS), a fundamental goal is to protect the lungs from ventilation-induced injury, but the optimal PEEP level has not been established.

Study design: Systematic review and meta-analysis.

Setting: N/A.

Synopsis: Three randomized-controlled trials eligible for this review included 2,299 critically ill adults with acute lung injury, as defined by the American-European Consensus Conference. The meta-analysis compared higher and lower PEEP levels with a mean difference of at least 3 cm H2O, incorporated a target tidal volume of less than 8 mL/kg of predicted body weight in both ventilation strategies, and provided patient follow-up until death or for at least 20 days.

This review demonstrated no statistically significant difference in hospital mortality between the groups. However, in patients with ARDS, higher levels of PEEP were associated with a relative reduction in mortality of 10%. This is supported by a recent cohort study in patients with acute lung injury or ARDS, which showed that the effect of PEEP on lung recruitment was associated with the proportion of potentially recruitable lung, as determined by computed tomography.

Since patients with ARDS have more pulmonary edema than those with acute lung injury without ARDS, the former have greater recruitability, and thus might benefit more from higher levels of PEEP.

Bottom line: Higher levels of PEEP might be associated with lower hospital mortality in patients with ARDS, but such a benefit is unlikely in patients with less severe lung injuries, and could actually be harmful.

Citation: Briel M, Meade M, Mercat A, et al. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010;303(9):865-873. TH

PEDIATRIC HM LITERATURE

By Mark Shen, MD

High-Performing State Healthcare Systems Have Higher Children’s Hospital Readmission Rates

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

Clinical question: What is the relationship between a hospital’s readmission rate and performance of the surrounding healthcare system?

Background: Hospital readmission rates might be influenced by factors related to the specific patient and hospital care, as well as such external factors as the performance of the surrounding healthcare system. Traditionally, readmission rates are thought to most accurately reflect the quality of hospital care; however, the relative contributions of patient, hospital, and external factors to hospital readmission rates have not been delineated.

Study design: Multilevel cohort study.

Setting: Thirty-nine children’s hospitals in 24 states.

Synopsis: The Pediatric Health Information System (PHIS) administrative database was sampled for the 2005 calendar year to review discharges from 39 participating children’s hospitals. Patients 2 to 18 years were included, and out of a total of 198,422 patients, 32,196 were readmitted within 365 days of discharge.

The Commonwealth Fund’s 2008 State Variations in Child Health System Performance ranking was used to define the state-level health system performance. Higher readmission rates correlated with higher-ranked state child health systems after adjustment for patient-level characteristics.

This surprising result calls into question the often-assumed link between hospital readmission rates and poor systems of care. However, despite the strength of its large sample size, this study’s macro-level view of the healthcare system might be too crude to truly define the external factors that play a role in readmission. State-level healthcare rankings might not accurately reflect the healthcare ecosystem surrounding each children’s hospital, and children’s hospitals do not care for the majority of children in the U.S.

Bottom line: Children’s hospital readmissions correlate with higher state child health system performance.

Citation: Feudtner C, Pati S, Goodman DM, et al. State-level child health system performance and the likelihood of readmission to children’s hospitals. J Pediatr. 2010;157(1):98-102.

In This Edition

Literature at a Glance

A guide to this month’s studies

• Antibiotics after drainage of uncomplicated skin abscesses
• Clopidogrel vs. combined aspirin-dipyridamole for acute ischemic stroke
• BNP-guided therapy in chronic heart failure outpatients
• Cognitive decline and dementia after hospitalization
• Clopidogrel delays up risks for DES implantation patients
• Clinical score identifies prolonged length of stay
• Time to therapy reduces mortality in sepsis patients
• PEEP associated with lower mortality for ARDS patients

Antibiotics Might Be Unnecessary after Drainage of Uncomplicated Skin Abscesses

Clinical question: Does trimethoprim/sulfamethoxazole (TMP/SMX) treatment after drainage of a skin abscess reduce treatment failure at seven days or development of new lesions at 30 days?

Background: Community ac-quired methicillin-resistant Staphylococcus aureus (MRSA) skin abscesses are increasing in frequency. The benefit of antibiotic treatment after incision and drainage is not clear, as there is a high cure rate without antibiotics.

Study design: Multicenter, double-blinded, randomized, placebo-controlled trial.

Setting: Four military EDs treating civilians and military patients.

Synopsis: The study enrolled a convenience sample of 220 patients, each of whom presented to EDs with uncomplicated skin abscesses from November 2007 to June 2009. Abscesses were drained in the ED, then patients were randomized to either placebo or to TMP/SMX (two DS tablets twice daily) for seven days. Re-evaluation for wound checks occurred at two days and seven days.

Treatment failure at seven days, defined as worsening infection, new lesions, or absence of clinical improvement, occurred in 26% of placebo patients and 17% of patients in the treatment arm, a nonsignificant difference (P=0.12). Fewer patients in the treatment arm had new lesions at 30 days (28% vs. 9%, P=0.02). MRSA was cultured from 53% of patients overall; all samples were sensitive to TMP/SMX.

The study was limited by the fact that only 69% of patients were evaluated at 30 days.

Bottom line: TMP/SMX treatment of uncomplicated skin abscess after drainage in EDs does not decrease treatment failure at seven days, but might decrease the development of new lesions.

Citation: Schmitz GR, Bruner D, Pitotti R, et al. Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection [published online ahead of print March 29, 2010]. Ann Emerg Med. doi:10.1016/j.annemerg med.2010.03.002.

Clopidogrel and Combined Aspirin-Dipyridamole Have Similar Safety and Efficacy Profiles for Acute Ischemic Stroke

Clinical question: What is the efficacy and safety of combined aspirin and extended-release dipyridamole (Asp/ER-DP) compared to clopidogrel in patients with acute ischemic stroke?

Background: Long-term antiplatelet therapy is effective at reducing recurrence after ischemic stroke. However, the relative safety and efficacy of Asp/ER-DP or clopidogrel is not known in patients with acute ischemic stroke.

Study design: Randomized, controlled trial.

Setting: A multicenter trial involving 695 sites in 35 countries.

Synopsis: This post-hoc subgroup analysis of the PRoFESS (Prevention Regimen for Effectively Avoiding Second Strokes) trial assessed the relative safety and efficacy of Asp/ER-DP versus clopidogrel administered within 72 hours of stroke onset in 1,360 patients. The primary endpoint was functional outcome at 30 days.

Secondary outcomes included symptomatic hemorrhagic transformation of the infarct, cerebral edema, recurrent stroke, myocardial infarction (MI), composite vascular events (combination of nonfatal stroke, nonfatal MI, and vascular death), death, cognition, bleeding, and serious adverse events studied at seven, 30, and 90 days.

Combined death or dependency did not differ between treatment groups. Nonsignificant trends to reduced recurrence and vascular events were present with Asp/ER-DP. Rates of death, major bleeding, and serious adverse events did not differ between treatment groups.

Bottom line: Either clopidogrel or combined aspirin and extended-release dipyridamole can be used to treat acute ischemic stroke, with similar outcomes and safety profiles.

Citation: Bath PM, Cotton D, Martin RH, et al. Effect of combined aspirin and extended-release dipyridamole versus clopidogrel on functional outcome and recurrence in acute, mild ischemic stroke: PRoFESS subgroup analysis. Stroke. 2010;41(4):732-738.

BNP-Guided Therapy Reduces All-Cause Mortality in Outpatients with Chronic Heart Failure

Clinical question: Is there a clinical benefit in using B-type natriuretic peptide (BNP) to guide adjustment of proven medications in chronic heart failure?

Background: BNP is secreted by the heart in response to increased volume. It has been shown to be useful in the diagnosis of decompensated heart failure, and it can be decreased by treatment with proven heart failure medications. It is unclear if this effect provides clinical benefit on mortality and hospitalization.

Study design: Meta-analysis of prospective randomized controlled trials.

Setting: Eight studies involving 1,726 patients, published internationally from 2005-2009.

Synopsis: Study sizes ranged from 41 to 499 patients, with three- to 24-month follow-up. Patients had New York Heart Association (NYHA) class II or greater heart failure, with ejection fractions <50%.

All-cause mortality was significantly lower in BNP-guided therapy compared with clinical-guided therapy (RR=0.76; 95% CI, 0.63-0.91; P=0.003), specifically in patients younger than 75 years old (RR=0.52; 95% CI, 0.33-0.82; P=0.005).

A proposed mechanism for this result was a statistically significant increase in adjustment of most heart failure medications for BNP-guided therapy compared with clinical-guided therapy (75% vs. 58%, P<0.001 in diuretics; 49.6% vs. 30.9%, P<0.001 in ACE inhibitors or Angiotensin II receptor blockers (ARBs); and 51.1% vs. 41.6%, P=0.02 in beta-blockers) and a higher percentage reaching target doses in the BNP-guided therapy group. However, there was no significant decrease in all-cause hospitalization or survival free of hospitalization.

The study limitations include: Hospitalization for heart failure was not meta-analyzed, the pooled data were weighted toward one study, and BNP-guided titration parameters varied across studies.

Bottom line: BNP-guided therapy reduces all-cause mortality in chronic heart failure patients younger than 75 years old, but not all-cause hospitalization or survival free of hospitalization.

Citation: Porapakkham P, Porapakkham P, Zimmet H, Billah B, Krum H. B-type natriuretic peptide-guided heart failure therapy: A meta-analysis. Arch Intern Med. 2010;170(6):507-514.

Hospitalization Is Associated with Cognitive Decline and Subsequent Risk for Dementia in the Elderly

Clinical question: Is critical illness in patients 65 and older associated with long-term cognitive impairment, and does it affect the incidence of dementia?

Background: There is literature suggesting that survivors of critical illness suffer long-term cognitive impairment, but premorbid measures of cognitive function have not been researched. No studies have evaluated the risk of incident dementia among this patient population.

Study design: Prospective cohort study.

Setting: Group Health Cooperative in Seattle.

Synopsis: This study analyzed data from 2,929 community-dwelling adults older than 65 without baseline dementia. From 1994 to 2007, the individuals were screened with the Cognitive Abilities Screening Instrument (CASI) at follow-up visits every two years. CASI scores lower than 86 (out of 100) led to an examination for dementia; the diagnosis of dementia was an outcome measure. Scores were adjusted for baseline cognitive scores, age, and other risk factors.

For patients following acute-care hospitalization, adjusted CASI scores were 1.01 points lower on average than for those not hospitalized. For patients following critical-illness hospitalization, scores were 2.14 points lower. The dementia rate was 14.6 cases per 1,000 person-years among patients not hospitalized, and 33.6 among those admitted for noncritical illness.

As suspected, hospitalization might be a marker for cognitive decline in the elderly after adjusting for premorbid CASI scores and comorbid illness. Some factors in acute illness—and moreso in critical illness—might be causally related to cognitive decline.

Bottom line: In elderly patients without dementia at baseline, hospitalization for acute care and critical illness increases the likelihood of cognitive decline compared with patients who were not hospitalized. Only noncritical-illness hospitalization was not associated with the development of dementia.

Citation: Ehlenbach WJ, Hough CL, Crane PK, et al. Association between acute care and critical illness hospitalization and cognitive function in older adults. JAMA. 2010;303(8): 763-770.

Increased Risk of Death and Myocardial Infarction in Patients Who Delay Filling Clopidogrel Prescription after Drug-Eluting Stent Implantation

Clinical question: Is there an increased risk of death or myocardial infarction (MI) in patients with recent drug-eluting stent (DES) implantation who delayed filling their clopidogrel prescription compared with those who filled their prescription on the day of hospital discharge?

Background: Filling an initial prescription of clopidogrel on the day of discharge is important after DES implantation, as prior studies suggest that lack of thienopyridine therapy is a risk factor for early stent thrombosis.

Study design: Retrospective cohort study.

Setting: Three large, integrated healthcare systems.

Synopsis: The cohort included 7,042 patients discharged after DES implantation. Filling of a clopidogrel prescription was based on pharmacy dispensing data. Primary analysis divided patients based on whether they filled the prescription on the day of discharge or any time after discharge. Secondary analysis further characterized delays as >1 day, >3 days, or >5 days after discharge.

One in 6 patients delayed filling the initial prescription. Patients with any degree of delay had significantly higher death and MI rates during follow-up (14.2% vs. 7.9%, P<0.001), as well as an increased risk of death/MI (hazard ratio 1.53; 95% CI, 1.25-1.87). Factors associated with a delay in filling clopidogrel included older age, prior MI, diabetes, renal dysfunction, prior revascularization, cardiogenic shock, in-hospital bleeding, and use of clopidogrel upon admission.

The study was limited in that data were based on pharmacy records, and that patients might have received medication at discharge or outside the healthcare system.

Bottom line: The delay in filling a clopidogrel prescription is associated with an increased risk of death and MI in patients with recent DES implantation.

Citation: Ho PM, Tsai TT, Maddox TM, et al. Delays in filling clopidogrel prescription after hospital discharge and adverse outcomes after drug-eluting stent implantation: implications for transitions of care. Circ Cardiovasc Qual Outcomes. 2010;3(3):261-266.

Predicting Length of Stay after Stroke

Clinical question: Does a clinical score accurately predict prolonged length of stay after stroke?

Background: Stroke is a costly health problem, and length of stay is the most prominent factor contributing to the high costs. The factors leading to prolonged length of stay are varied, and there are no established tools to predict length of stay.

Study design: Prospective cohort study.

Setting: All 28 Israeli hospitals that admit stroke patients.

Synopsis: All patients admitted to Israeli hospitals during established two-month periods in 2004 (1,700 patients) and 2007 (1,648 patients) were included in the National Acute Stroke Israeli Survey (NASIS), and served as the derivation and validation cohort for development of a Prolonged Length of Stay (PLOS) score.

Using the 2004 data, investigators identified stroke severity using the National Institutes of Health Stroke Scale (NIHSS), history of congestive heart failure (CHF), history of atrial fibrillation, decreased level of consciousness on presentation, and intracerebral hemorrhage (as opposed to ischemic stroke) as predictors of prolonged length of stay. Four of these factors were expressed as dichotomous variables, whereas the stroke severity by NIHSS class was incorporated as a range; all were incorporated into a PLOS score.

Higher PLOS score correlated with longer length of stay. In the derivation cohort, 22% of patients with a PLOS score of 0 had a prolonged length of stay, whereas 85% of patients with PLOS scores of 6 or 7 had a prolonged length of stay. In the validation cohort, the corresponding figures were 19% and 72%.

Bottom line: Use of a simple score can predict risk of prolonged length of stay after stroke.

Citation: Koton S, Bornstein NM, Tsabari R, Tanne D, NASIS Investigators. Derivation and validation of the prolonged length of stay score in acute stroke patients. Neurology. 2010;74(19);1511-1516.

Earlier Administration of Appropriate Antimicrobials Decreases Mortality in Patients with Severe Sepsis and Septic Shock

Clinical question: Is the timing of antimicrobial administration an important determinant of survival in patients diagnosed with severe sepsis and septic shock?

Background: Severe sepsis and septic shock are associated with a 25% to 50% mortality rate. Early goal-directed therapy has been shown to increase survival in these patients. Antimicrobial treatment is a mainstay of this therapy, but the most effective timing of this treatment remains unclear.

Study design: Retrospective, single-center cohort study.

Setting: ED at an academic tertiary-care center.

Synopsis: Two hundred sixty-one patients in the ED in 2005-2006 presenting with severe sepsis or septic shock were enrolled in the hospital’s early goal-directed therapy (EGDT) algorithm, either at triage or later during their ED stay. Labs showed 56.7% of patients were culture-positive, with the most common sources being respiratory (30.6%), genitourinary (22.8%), and gastrointestinal (19.7%).

All patients received antibiotics and were stratified in one-hour intervals by the following categories: time from triage to antibiotics; time from qualification for EGDT to antibiotics; time from triage to appropriate antibiotics; and time from qualification for EGDT to appropriate antibiotics.

Total in-hospital mortality was 31% (35.1% for culture-positive patients vs. 25.7% for culture-negative patients, P=0.11). A significant decrease in mortality was only found when appropriate antibiotics were administered within one hour of triage, or within one hour of qualification for EGDT (OR=0.30; 95% CI, 0.11-0.83; P=0.02, and OR=0.50; 95% CI, 0.27-0.92; P=0.03, respectively).

Study limitations included the single-center site and small sample size.

Bottom line: In patients with severe sepsis and septic shock, initiating appropriate antimicrobial therapy within one hour of triage or entry into goal-directed therapy significantly reduces mortality.

Citation: Gaieski DF, Mikkelsen ME, Band RA, et al. Impact of time to antibiotics on survival in patients with severe sepsis or septic shock in whom early goal-directed therapy was initiated in the emergency department. Crit Care Med. 2010;38(4):1045-1053.

Treatment with Higher Levels of Positive End-Expiratory Pressure Has Limited Affect on Hospital Survival

Clinical question: Is treatment with higher versus lower levels of positive end-expiratory pressure (PEEP) associated with improved hospital survival?

Background: In the management of patients with acute lung injury or acute respiratory distress syndrome (ARDS), a fundamental goal is to protect the lungs from ventilation-induced injury, but the optimal PEEP level has not been established.

Study design: Systematic review and meta-analysis.

Setting: N/A.

Synopsis: Three randomized-controlled trials eligible for this review included 2,299 critically ill adults with acute lung injury, as defined by the American-European Consensus Conference. The meta-analysis compared higher and lower PEEP levels with a mean difference of at least 3 cm H2O, incorporated a target tidal volume of less than 8 mL/kg of predicted body weight in both ventilation strategies, and provided patient follow-up until death or for at least 20 days.

This review demonstrated no statistically significant difference in hospital mortality between the groups. However, in patients with ARDS, higher levels of PEEP were associated with a relative reduction in mortality of 10%. This is supported by a recent cohort study in patients with acute lung injury or ARDS, which showed that the effect of PEEP on lung recruitment was associated with the proportion of potentially recruitable lung, as determined by computed tomography.

Since patients with ARDS have more pulmonary edema than those with acute lung injury without ARDS, the former have greater recruitability, and thus might benefit more from higher levels of PEEP.

Bottom line: Higher levels of PEEP might be associated with lower hospital mortality in patients with ARDS, but such a benefit is unlikely in patients with less severe lung injuries, and could actually be harmful.

Citation: Briel M, Meade M, Mercat A, et al. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010;303(9):865-873. TH

PEDIATRIC HM LITERATURE

By Mark Shen, MD

High-Performing State Healthcare Systems Have Higher Children’s Hospital Readmission Rates

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

Clinical question: What is the relationship between a hospital’s readmission rate and performance of the surrounding healthcare system?

Background: Hospital readmission rates might be influenced by factors related to the specific patient and hospital care, as well as such external factors as the performance of the surrounding healthcare system. Traditionally, readmission rates are thought to most accurately reflect the quality of hospital care; however, the relative contributions of patient, hospital, and external factors to hospital readmission rates have not been delineated.

Study design: Multilevel cohort study.

Setting: Thirty-nine children’s hospitals in 24 states.

Synopsis: The Pediatric Health Information System (PHIS) administrative database was sampled for the 2005 calendar year to review discharges from 39 participating children’s hospitals. Patients 2 to 18 years were included, and out of a total of 198,422 patients, 32,196 were readmitted within 365 days of discharge.

The Commonwealth Fund’s 2008 State Variations in Child Health System Performance ranking was used to define the state-level health system performance. Higher readmission rates correlated with higher-ranked state child health systems after adjustment for patient-level characteristics.

This surprising result calls into question the often-assumed link between hospital readmission rates and poor systems of care. However, despite the strength of its large sample size, this study’s macro-level view of the healthcare system might be too crude to truly define the external factors that play a role in readmission. State-level healthcare rankings might not accurately reflect the healthcare ecosystem surrounding each children’s hospital, and children’s hospitals do not care for the majority of children in the U.S.

Bottom line: Children’s hospital readmissions correlate with higher state child health system performance.

Citation: Feudtner C, Pati S, Goodman DM, et al. State-level child health system performance and the likelihood of readmission to children’s hospitals. J Pediatr. 2010;157(1):98-102.

Case

A 66-year-old woman with metastatic, non-small-cell carcinoma of the lung, chronic obstructive pulmonary disease (COPD), and hypertension presents with progressive shortness of breath and back pain. Her vital signs are normal, with the exception of tachypnea and an oxygen saturation of 84% on room air. A CT scan shows marked progression of her disease and new metastases to her spine. You begin a discussion about advance directives and code status. During the exchange, the patient asks for guidance regarding resuscitation. How can you best answer her questions about the likelihood of surviving an in-hospital arrest?

Background

Discussion regarding resuscitation status is a challenge for most hospitalists. The absence of an established relationship, limited time, patient emotion, and difficulty applying general scientific data to a single patient coalesce into a complex interaction. Further complicating matters, patients frequently have unrealistic expectations and overestimate their chance of survival.

Experience has shown that many patients pursue what physicians consider inappropriately aggressive resuscitation measures. Before you have an informed discussion about cardiopulmonary resuscitation (CPR) outcomes, patients tend to overestimate their likelihood of survival.¹ In 2009, Kaldjian and colleagues found that patients’ initial mean prediction of post-arrest survival was 60.4%, compared with the actual mean of approximately 17%.2,3 Furthermore, nearly half of the patients who initially expressed a desire to receive CPR in the event of cardiac arrest opted to change their code status after they were informed of the actual survival estimates.^1,2

Patient autonomy and the law, as defined by the 1990 Patient Self-Determination Act, require that physicians share responsibility with patients in making prospective resuscitation decisions.⁴ Shared decision-making necessitates a basic discussion on admission within the context of the patient’s prognosis and previously expressed wishes. It might simply include an acknowledgment of a previously completed advance directive. A more complex discussion might require in-depth conversation to address patient performance status, prognosis of acute and chronic illnesses, and education about the typical resuscitation procedures. After listening to the patient’s perspective, the admitting physician can provide input and an interpretation of available data regarding the patient’s likelihood of surviving an in-hospital arrest.

Review of the Data

In the past 40 years, the overall survival rates for cardiac arrest have changed little. Despite numerous advances made in the delivery of medical care, on average, only 17% of all adult arrest patients survive to hospital discharge.³ A variety of factors influence this overall survival rate, both pre-arrest and intra-arrest. Clinical experience allows most physicians to sense what probability a patient has for survival and quality of life following a cardiac arrest. However, anecdotal evidence alone does not provide a patient and their family with the information necessary to make an informed decision regarding code status.

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Numerous studies have investigated the patient factors that might influence how likely one is to survive a cardiac arrest. Researchers have paid particular attention to such factors as age, race, presence or absence of a cancer diagnosis, and associated comorbidities. Not surprisingly, older age has been shown to be significantly associated with a lower likelihood of survival to discharge following cardiac arrest.^5,6

Ehlenbach and colleagues examined medical data from 433,985 Medicare patients 65 and older who underwent in-hospital CPR.⁵ Both older age and prior residence in a skilled nursing facility were found to be associated with poorer survival rates.⁵ Although neither study was able to define an upper-age cutoff for certain peri-arrest mortality, age affects overall survival likelihood in an inverse fashion, with those 85 and older having only a 6% chance of surviving to hospital discharge (see Figure 1, p. 18).^1,5,6

The degree of comorbid illness can be used to help predict mortality following cardiac arrest. Review of data from the National Registry of Cardiopulmonary Resuscitation (NRCPR) identified particular comorbidities that portend poor post-arrest prognosis.⁶ In general, the more pre-existing comorbidities a patient has, the less likely they are to survive.⁶ The presence of hepatic insufficiency, acute stroke, immunodeficiency, renal failure, or dialysis were associated with lower survival rates (see Figure 2, right).^6,7

Poor performance status on admission, defined as severe disability, coma, or vegetative state, was predictive of worse outcomes.⁶ Understandably, patients with hypotension and those who required vasopressors or mechanical ventilation also tended to have lower post-arrest survival rates.⁶

The presence of a cancer diagnosis is another prognostic factor of interest when considering the chances of surviving an arrest. Classically, CPR was thought to be a futile intervention in this patient population. Specific characteristics within this subset of patients have been shown to influence prognosis, and multiple studies have confirmed that cancer patients generally do worse after an arrest with an overall survival rate of only 6.2%.⁸ Survival rates tend to be lower in patients with metastatic disease, hematologic malignancies, a history of stem cell transplant, those who arrest within an ICU, and inpatients whose cardiac arrest was anticipated.^8,9

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In fact, cancer patients whose hospital course followed a path of gradual deterioration showed a 0% survival rate.⁹ In patients with metastatic disease, poor performance status prior to arrest appeared to account for their particularly poor survival odds (this supports the intuitive, rule-of-thumb that sicker cancer patients have worse outcomes).⁸

Growing evidence suggests the probability of post-arrest survival is not equal between racial groups. Specifically, black or nonwhite race is associated with higher utilization of CPR and lower survival rates (see Figure 3, right).¹⁰ Among Medicare patients, Ehlenbach and colleagues found that black and nonwhite patients were much more likely to undergo CPR, presumably as a result of being less likely to opt for DNR status.^5,10 Although this could account for the differences seen in survival rates among these populations, these findings also raise concerns about the possibility of racial disparities in medical care. A subsequent cohort study also suggested that blacks and nonwhites were less likely to survive following cardiac arrest.¹⁰ However, adjusted analysis revealed that these differences were strongly associated with the medical center at which these patients received care. Therefore, although being nonwhite does portend worse outcomes following an arrest, the increased risk is likely attributed to the fact that many of these patients receive care at hospitals that have poorer overall CPR performance measures.^5,10

Survival is not the only outcome measure patients need to take into account when deciding whether to undergo CPR. Quality of life following resuscitation also warrants consideration. Interestingly, research has shown that neurologic outcomes among the majority of cardiac arrest survivors are generally good.³

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Approximately 86% of survivors with intact pre-arrest cerebral performance maintain it on discharge, and only a minority of survivors are eventually declared brain-dead.³ Still, there are certain peri-arrest factors that pose risk for poorer neurologic and functional outcomes. For arrest from a shockable rhythm, time to defibrillation is a key determinant.¹¹ In patients for whom time to defibrillation is greater than two minutes, there is significantly higher risk of permanent disability following cardiac arrest.¹¹

In the event of coma following resuscitation, particular clinical findings can be used to accurately predict poor outcome.¹² The absence of pupillary reflexes, corneal reflexes, or absent or extensor motor responses three days after arrest are poor prognostic indicators.¹² As a general rule, if a patient does not awaken within three days, neurologic and functional impairment can be expected.¹² For those patients who do survive to hospital discharge, more than 50% ultimately will be able to be discharged home.³

However, nearly a quarter will need to be newly placed in a rehabilitation or skilled nursing facility.³

Back to the Case

The patient was admitted with hypoxia secondary to both progressive lung malignancy and COPD exacerbation. She had no advanced directives, so the admitting hospitalist, in collaboration with her oncologist, had a detailed discussion regarding her understanding of her disease progression, prognosis, and goals for her remaining time. Her questions regarding survivability of cardiac arrest were answered directly with an estimate of 5% to 10%, based on her age, comorbidities, and the presence of advanced malignancy.

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After hearing this information, the patient responded, “I still want everything done.” The hospitalist acknowledged her feelings of wanting to fight on, but asked her to think about what “everything” meant to her. After taking some additional time to reflect with friends and family, the patient was clear that she wanted to continue disease-focused therapies, but did not want to be resuscitated in the event of cardiac or pulmonary arrest.

Eventually, her hypoxia improved with antibiotics, steroids, and bronchodilators. She was discharged home with follow-up in the oncology clinic for additional chemotherapy and palliative radiation.

Bottom Line

For hospitalized adults, the average survival rate to discharge after cardiac arrest is about 17%. Many factors lower a patient’s chance of survival, including advanced age, performance status, malignancy, and presence of multiple comorbidities. TH

Dr. Neagle and Dr. Wachsberg are hospitalists and instructors in the division of hospital medicine at Northwestern University Medical Center in Chicago.

References

1. Murphy DJ, Burrows D, Santali S, et al. The influence of the probability of survival on patients’ preferences regarding cardiopulmonary resuscitation. N Engl J Med. 1994;330(8):545-549.
2. Kaldjian LC, Erekson ZD, Haberle TH, et al. Code status discussions and goals of care among hospitalised adults. J Med Ethics. 2009;35(6):338-342.
3. Peberdy MA, Kaye W, Ornato JP, et al. Cardiopulmonary resuscitation of adults in the hospital: a report of 14720 cardiac arrests from the National Registry of Cardiopulmonary Resuscitation. Resuscitation. 2003;58(3):297-308.
4. La Puma J, Orentlicher D, Moss RJ. Advance directives on admission. Clinical implications and analysis of the Patient Self-Determination Act of 1990. JAMA. 1991;266(3):402-405.
5. Ehlenbach WJ, Barnato AE, Curtis JR, et al. Epidemiologic study of in-hospital cardiopulmonary resuscitation in the elderly. N Engl J Med. 2009;361(1):22-31.
6. Larkin GL, Copes WS, Nathanson BH, Kaye W. Pre-resuscitation factors associated with mortality in 49,130 cases of in-hospital cardiac arrest: a report from the National Registry for Cardiopulmonary Resuscitation. Resuscitation. 2010;81(3):302-311.
7. de Vos R, Koster RW, De Haan RJ, Oosting H, van der Wouw PA, Lampe-Schoenmaeckers AJ. In-hospital cardiopulmonary resuscitation: prearrest morbidity and outcome. Arch Intern Med. 1999;159(8):845-850.
8. Reisfield GM, Wallace SK, Munsell MF, Webb FJ, Alvarez ER, Wilson GR. Survival in cancer patients undergoing in-hospital cardiopulmonary resuscitation: a meta-analysis. Resuscitation. 2006;71(2):152-160.
9. Ewer MS, Kish SK, Martin CG, Price KJ, Feeley TW. Characteristics of cardiac arrest in cancer patients as a predictor of survival after cardiopulmonary resuscitation. Cancer. 2001;92(7):1905-1912.
10. Chan PS, Nichol G, Krumholz HM, et al. Racial differences in survival after in-hospital cardiac arrest. JAMA. 2009;302(11):1195-1201.
11. Chan PS, Krumholz HM, Nichol G, Nallamothu BK. Delayed time to defibrillation after in-hospital cardiac arrest. N Engl J Med. 2008;358(1):9-17.
12. Wijdicks EF, Hijdra A, Young GB, Bassetti CL, Wiebe S. Practice parameter: prediction of outcome in comatose survivors after cardiopulmonary resuscitation (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2006;67(2):203-210.

Case

A 66-year-old woman with metastatic, non-small-cell carcinoma of the lung, chronic obstructive pulmonary disease (COPD), and hypertension presents with progressive shortness of breath and back pain. Her vital signs are normal, with the exception of tachypnea and an oxygen saturation of 84% on room air. A CT scan shows marked progression of her disease and new metastases to her spine. You begin a discussion about advance directives and code status. During the exchange, the patient asks for guidance regarding resuscitation. How can you best answer her questions about the likelihood of surviving an in-hospital arrest?

Background

Discussion regarding resuscitation status is a challenge for most hospitalists. The absence of an established relationship, limited time, patient emotion, and difficulty applying general scientific data to a single patient coalesce into a complex interaction. Further complicating matters, patients frequently have unrealistic expectations and overestimate their chance of survival.

Experience has shown that many patients pursue what physicians consider inappropriately aggressive resuscitation measures. Before you have an informed discussion about cardiopulmonary resuscitation (CPR) outcomes, patients tend to overestimate their likelihood of survival.¹ In 2009, Kaldjian and colleagues found that patients’ initial mean prediction of post-arrest survival was 60.4%, compared with the actual mean of approximately 17%.2,3 Furthermore, nearly half of the patients who initially expressed a desire to receive CPR in the event of cardiac arrest opted to change their code status after they were informed of the actual survival estimates.^1,2

Patient autonomy and the law, as defined by the 1990 Patient Self-Determination Act, require that physicians share responsibility with patients in making prospective resuscitation decisions.⁴ Shared decision-making necessitates a basic discussion on admission within the context of the patient’s prognosis and previously expressed wishes. It might simply include an acknowledgment of a previously completed advance directive. A more complex discussion might require in-depth conversation to address patient performance status, prognosis of acute and chronic illnesses, and education about the typical resuscitation procedures. After listening to the patient’s perspective, the admitting physician can provide input and an interpretation of available data regarding the patient’s likelihood of surviving an in-hospital arrest.

Review of the Data

In the past 40 years, the overall survival rates for cardiac arrest have changed little. Despite numerous advances made in the delivery of medical care, on average, only 17% of all adult arrest patients survive to hospital discharge.³ A variety of factors influence this overall survival rate, both pre-arrest and intra-arrest. Clinical experience allows most physicians to sense what probability a patient has for survival and quality of life following a cardiac arrest. However, anecdotal evidence alone does not provide a patient and their family with the information necessary to make an informed decision regarding code status.

click for large version

Numerous studies have investigated the patient factors that might influence how likely one is to survive a cardiac arrest. Researchers have paid particular attention to such factors as age, race, presence or absence of a cancer diagnosis, and associated comorbidities. Not surprisingly, older age has been shown to be significantly associated with a lower likelihood of survival to discharge following cardiac arrest.^5,6

Ehlenbach and colleagues examined medical data from 433,985 Medicare patients 65 and older who underwent in-hospital CPR.⁵ Both older age and prior residence in a skilled nursing facility were found to be associated with poorer survival rates.⁵ Although neither study was able to define an upper-age cutoff for certain peri-arrest mortality, age affects overall survival likelihood in an inverse fashion, with those 85 and older having only a 6% chance of surviving to hospital discharge (see Figure 1, p. 18).^1,5,6

The degree of comorbid illness can be used to help predict mortality following cardiac arrest. Review of data from the National Registry of Cardiopulmonary Resuscitation (NRCPR) identified particular comorbidities that portend poor post-arrest prognosis.⁶ In general, the more pre-existing comorbidities a patient has, the less likely they are to survive.⁶ The presence of hepatic insufficiency, acute stroke, immunodeficiency, renal failure, or dialysis were associated with lower survival rates (see Figure 2, right).^6,7

Poor performance status on admission, defined as severe disability, coma, or vegetative state, was predictive of worse outcomes.⁶ Understandably, patients with hypotension and those who required vasopressors or mechanical ventilation also tended to have lower post-arrest survival rates.⁶

The presence of a cancer diagnosis is another prognostic factor of interest when considering the chances of surviving an arrest. Classically, CPR was thought to be a futile intervention in this patient population. Specific characteristics within this subset of patients have been shown to influence prognosis, and multiple studies have confirmed that cancer patients generally do worse after an arrest with an overall survival rate of only 6.2%.⁸ Survival rates tend to be lower in patients with metastatic disease, hematologic malignancies, a history of stem cell transplant, those who arrest within an ICU, and inpatients whose cardiac arrest was anticipated.^8,9

click for large version

In fact, cancer patients whose hospital course followed a path of gradual deterioration showed a 0% survival rate.⁹ In patients with metastatic disease, poor performance status prior to arrest appeared to account for their particularly poor survival odds (this supports the intuitive, rule-of-thumb that sicker cancer patients have worse outcomes).⁸

Growing evidence suggests the probability of post-arrest survival is not equal between racial groups. Specifically, black or nonwhite race is associated with higher utilization of CPR and lower survival rates (see Figure 3, right).¹⁰ Among Medicare patients, Ehlenbach and colleagues found that black and nonwhite patients were much more likely to undergo CPR, presumably as a result of being less likely to opt for DNR status.^5,10 Although this could account for the differences seen in survival rates among these populations, these findings also raise concerns about the possibility of racial disparities in medical care. A subsequent cohort study also suggested that blacks and nonwhites were less likely to survive following cardiac arrest.¹⁰ However, adjusted analysis revealed that these differences were strongly associated with the medical center at which these patients received care. Therefore, although being nonwhite does portend worse outcomes following an arrest, the increased risk is likely attributed to the fact that many of these patients receive care at hospitals that have poorer overall CPR performance measures.^5,10

Survival is not the only outcome measure patients need to take into account when deciding whether to undergo CPR. Quality of life following resuscitation also warrants consideration. Interestingly, research has shown that neurologic outcomes among the majority of cardiac arrest survivors are generally good.³

click for large version

Approximately 86% of survivors with intact pre-arrest cerebral performance maintain it on discharge, and only a minority of survivors are eventually declared brain-dead.³ Still, there are certain peri-arrest factors that pose risk for poorer neurologic and functional outcomes. For arrest from a shockable rhythm, time to defibrillation is a key determinant.¹¹ In patients for whom time to defibrillation is greater than two minutes, there is significantly higher risk of permanent disability following cardiac arrest.¹¹

In the event of coma following resuscitation, particular clinical findings can be used to accurately predict poor outcome.¹² The absence of pupillary reflexes, corneal reflexes, or absent or extensor motor responses three days after arrest are poor prognostic indicators.¹² As a general rule, if a patient does not awaken within three days, neurologic and functional impairment can be expected.¹² For those patients who do survive to hospital discharge, more than 50% ultimately will be able to be discharged home.³

However, nearly a quarter will need to be newly placed in a rehabilitation or skilled nursing facility.³

Back to the Case

The patient was admitted with hypoxia secondary to both progressive lung malignancy and COPD exacerbation. She had no advanced directives, so the admitting hospitalist, in collaboration with her oncologist, had a detailed discussion regarding her understanding of her disease progression, prognosis, and goals for her remaining time. Her questions regarding survivability of cardiac arrest were answered directly with an estimate of 5% to 10%, based on her age, comorbidities, and the presence of advanced malignancy.

click for large version

After hearing this information, the patient responded, “I still want everything done.” The hospitalist acknowledged her feelings of wanting to fight on, but asked her to think about what “everything” meant to her. After taking some additional time to reflect with friends and family, the patient was clear that she wanted to continue disease-focused therapies, but did not want to be resuscitated in the event of cardiac or pulmonary arrest.

Eventually, her hypoxia improved with antibiotics, steroids, and bronchodilators. She was discharged home with follow-up in the oncology clinic for additional chemotherapy and palliative radiation.

Bottom Line

For hospitalized adults, the average survival rate to discharge after cardiac arrest is about 17%. Many factors lower a patient’s chance of survival, including advanced age, performance status, malignancy, and presence of multiple comorbidities. TH

Dr. Neagle and Dr. Wachsberg are hospitalists and instructors in the division of hospital medicine at Northwestern University Medical Center in Chicago.

References

1. Murphy DJ, Burrows D, Santali S, et al. The influence of the probability of survival on patients’ preferences regarding cardiopulmonary resuscitation. N Engl J Med. 1994;330(8):545-549.
2. Kaldjian LC, Erekson ZD, Haberle TH, et al. Code status discussions and goals of care among hospitalised adults. J Med Ethics. 2009;35(6):338-342.
3. Peberdy MA, Kaye W, Ornato JP, et al. Cardiopulmonary resuscitation of adults in the hospital: a report of 14720 cardiac arrests from the National Registry of Cardiopulmonary Resuscitation. Resuscitation. 2003;58(3):297-308.
4. La Puma J, Orentlicher D, Moss RJ. Advance directives on admission. Clinical implications and analysis of the Patient Self-Determination Act of 1990. JAMA. 1991;266(3):402-405.
5. Ehlenbach WJ, Barnato AE, Curtis JR, et al. Epidemiologic study of in-hospital cardiopulmonary resuscitation in the elderly. N Engl J Med. 2009;361(1):22-31.
6. Larkin GL, Copes WS, Nathanson BH, Kaye W. Pre-resuscitation factors associated with mortality in 49,130 cases of in-hospital cardiac arrest: a report from the National Registry for Cardiopulmonary Resuscitation. Resuscitation. 2010;81(3):302-311.
7. de Vos R, Koster RW, De Haan RJ, Oosting H, van der Wouw PA, Lampe-Schoenmaeckers AJ. In-hospital cardiopulmonary resuscitation: prearrest morbidity and outcome. Arch Intern Med. 1999;159(8):845-850.
8. Reisfield GM, Wallace SK, Munsell MF, Webb FJ, Alvarez ER, Wilson GR. Survival in cancer patients undergoing in-hospital cardiopulmonary resuscitation: a meta-analysis. Resuscitation. 2006;71(2):152-160.
9. Ewer MS, Kish SK, Martin CG, Price KJ, Feeley TW. Characteristics of cardiac arrest in cancer patients as a predictor of survival after cardiopulmonary resuscitation. Cancer. 2001;92(7):1905-1912.
10. Chan PS, Nichol G, Krumholz HM, et al. Racial differences in survival after in-hospital cardiac arrest. JAMA. 2009;302(11):1195-1201.
11. Chan PS, Krumholz HM, Nichol G, Nallamothu BK. Delayed time to defibrillation after in-hospital cardiac arrest. N Engl J Med. 2008;358(1):9-17.
12. Wijdicks EF, Hijdra A, Young GB, Bassetti CL, Wiebe S. Practice parameter: prediction of outcome in comatose survivors after cardiopulmonary resuscitation (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2006;67(2):203-210.

Case

A 66-year-old woman with metastatic, non-small-cell carcinoma of the lung, chronic obstructive pulmonary disease (COPD), and hypertension presents with progressive shortness of breath and back pain. Her vital signs are normal, with the exception of tachypnea and an oxygen saturation of 84% on room air. A CT scan shows marked progression of her disease and new metastases to her spine. You begin a discussion about advance directives and code status. During the exchange, the patient asks for guidance regarding resuscitation. How can you best answer her questions about the likelihood of surviving an in-hospital arrest?

Background

Discussion regarding resuscitation status is a challenge for most hospitalists. The absence of an established relationship, limited time, patient emotion, and difficulty applying general scientific data to a single patient coalesce into a complex interaction. Further complicating matters, patients frequently have unrealistic expectations and overestimate their chance of survival.

Experience has shown that many patients pursue what physicians consider inappropriately aggressive resuscitation measures. Before you have an informed discussion about cardiopulmonary resuscitation (CPR) outcomes, patients tend to overestimate their likelihood of survival.¹ In 2009, Kaldjian and colleagues found that patients’ initial mean prediction of post-arrest survival was 60.4%, compared with the actual mean of approximately 17%.2,3 Furthermore, nearly half of the patients who initially expressed a desire to receive CPR in the event of cardiac arrest opted to change their code status after they were informed of the actual survival estimates.^1,2

Patient autonomy and the law, as defined by the 1990 Patient Self-Determination Act, require that physicians share responsibility with patients in making prospective resuscitation decisions.⁴ Shared decision-making necessitates a basic discussion on admission within the context of the patient’s prognosis and previously expressed wishes. It might simply include an acknowledgment of a previously completed advance directive. A more complex discussion might require in-depth conversation to address patient performance status, prognosis of acute and chronic illnesses, and education about the typical resuscitation procedures. After listening to the patient’s perspective, the admitting physician can provide input and an interpretation of available data regarding the patient’s likelihood of surviving an in-hospital arrest.

Review of the Data

In the past 40 years, the overall survival rates for cardiac arrest have changed little. Despite numerous advances made in the delivery of medical care, on average, only 17% of all adult arrest patients survive to hospital discharge.³ A variety of factors influence this overall survival rate, both pre-arrest and intra-arrest. Clinical experience allows most physicians to sense what probability a patient has for survival and quality of life following a cardiac arrest. However, anecdotal evidence alone does not provide a patient and their family with the information necessary to make an informed decision regarding code status.

click for large version

Numerous studies have investigated the patient factors that might influence how likely one is to survive a cardiac arrest. Researchers have paid particular attention to such factors as age, race, presence or absence of a cancer diagnosis, and associated comorbidities. Not surprisingly, older age has been shown to be significantly associated with a lower likelihood of survival to discharge following cardiac arrest.^5,6

Ehlenbach and colleagues examined medical data from 433,985 Medicare patients 65 and older who underwent in-hospital CPR.⁵ Both older age and prior residence in a skilled nursing facility were found to be associated with poorer survival rates.⁵ Although neither study was able to define an upper-age cutoff for certain peri-arrest mortality, age affects overall survival likelihood in an inverse fashion, with those 85 and older having only a 6% chance of surviving to hospital discharge (see Figure 1, p. 18).^1,5,6

The degree of comorbid illness can be used to help predict mortality following cardiac arrest. Review of data from the National Registry of Cardiopulmonary Resuscitation (NRCPR) identified particular comorbidities that portend poor post-arrest prognosis.⁶ In general, the more pre-existing comorbidities a patient has, the less likely they are to survive.⁶ The presence of hepatic insufficiency, acute stroke, immunodeficiency, renal failure, or dialysis were associated with lower survival rates (see Figure 2, right).^6,7

Poor performance status on admission, defined as severe disability, coma, or vegetative state, was predictive of worse outcomes.⁶ Understandably, patients with hypotension and those who required vasopressors or mechanical ventilation also tended to have lower post-arrest survival rates.⁶

The presence of a cancer diagnosis is another prognostic factor of interest when considering the chances of surviving an arrest. Classically, CPR was thought to be a futile intervention in this patient population. Specific characteristics within this subset of patients have been shown to influence prognosis, and multiple studies have confirmed that cancer patients generally do worse after an arrest with an overall survival rate of only 6.2%.⁸ Survival rates tend to be lower in patients with metastatic disease, hematologic malignancies, a history of stem cell transplant, those who arrest within an ICU, and inpatients whose cardiac arrest was anticipated.^8,9

click for large version

In fact, cancer patients whose hospital course followed a path of gradual deterioration showed a 0% survival rate.⁹ In patients with metastatic disease, poor performance status prior to arrest appeared to account for their particularly poor survival odds (this supports the intuitive, rule-of-thumb that sicker cancer patients have worse outcomes).⁸

Growing evidence suggests the probability of post-arrest survival is not equal between racial groups. Specifically, black or nonwhite race is associated with higher utilization of CPR and lower survival rates (see Figure 3, right).¹⁰ Among Medicare patients, Ehlenbach and colleagues found that black and nonwhite patients were much more likely to undergo CPR, presumably as a result of being less likely to opt for DNR status.^5,10 Although this could account for the differences seen in survival rates among these populations, these findings also raise concerns about the possibility of racial disparities in medical care. A subsequent cohort study also suggested that blacks and nonwhites were less likely to survive following cardiac arrest.¹⁰ However, adjusted analysis revealed that these differences were strongly associated with the medical center at which these patients received care. Therefore, although being nonwhite does portend worse outcomes following an arrest, the increased risk is likely attributed to the fact that many of these patients receive care at hospitals that have poorer overall CPR performance measures.^5,10

Survival is not the only outcome measure patients need to take into account when deciding whether to undergo CPR. Quality of life following resuscitation also warrants consideration. Interestingly, research has shown that neurologic outcomes among the majority of cardiac arrest survivors are generally good.³

click for large version

Approximately 86% of survivors with intact pre-arrest cerebral performance maintain it on discharge, and only a minority of survivors are eventually declared brain-dead.³ Still, there are certain peri-arrest factors that pose risk for poorer neurologic and functional outcomes. For arrest from a shockable rhythm, time to defibrillation is a key determinant.¹¹ In patients for whom time to defibrillation is greater than two minutes, there is significantly higher risk of permanent disability following cardiac arrest.¹¹

In the event of coma following resuscitation, particular clinical findings can be used to accurately predict poor outcome.¹² The absence of pupillary reflexes, corneal reflexes, or absent or extensor motor responses three days after arrest are poor prognostic indicators.¹² As a general rule, if a patient does not awaken within three days, neurologic and functional impairment can be expected.¹² For those patients who do survive to hospital discharge, more than 50% ultimately will be able to be discharged home.³

However, nearly a quarter will need to be newly placed in a rehabilitation or skilled nursing facility.³

Back to the Case

The patient was admitted with hypoxia secondary to both progressive lung malignancy and COPD exacerbation. She had no advanced directives, so the admitting hospitalist, in collaboration with her oncologist, had a detailed discussion regarding her understanding of her disease progression, prognosis, and goals for her remaining time. Her questions regarding survivability of cardiac arrest were answered directly with an estimate of 5% to 10%, based on her age, comorbidities, and the presence of advanced malignancy.

click for large version

After hearing this information, the patient responded, “I still want everything done.” The hospitalist acknowledged her feelings of wanting to fight on, but asked her to think about what “everything” meant to her. After taking some additional time to reflect with friends and family, the patient was clear that she wanted to continue disease-focused therapies, but did not want to be resuscitated in the event of cardiac or pulmonary arrest.

Eventually, her hypoxia improved with antibiotics, steroids, and bronchodilators. She was discharged home with follow-up in the oncology clinic for additional chemotherapy and palliative radiation.

Bottom Line

For hospitalized adults, the average survival rate to discharge after cardiac arrest is about 17%. Many factors lower a patient’s chance of survival, including advanced age, performance status, malignancy, and presence of multiple comorbidities. TH

Dr. Neagle and Dr. Wachsberg are hospitalists and instructors in the division of hospital medicine at Northwestern University Medical Center in Chicago.

References

1. Murphy DJ, Burrows D, Santali S, et al. The influence of the probability of survival on patients’ preferences regarding cardiopulmonary resuscitation. N Engl J Med. 1994;330(8):545-549.
2. Kaldjian LC, Erekson ZD, Haberle TH, et al. Code status discussions and goals of care among hospitalised adults. J Med Ethics. 2009;35(6):338-342.
3. Peberdy MA, Kaye W, Ornato JP, et al. Cardiopulmonary resuscitation of adults in the hospital: a report of 14720 cardiac arrests from the National Registry of Cardiopulmonary Resuscitation. Resuscitation. 2003;58(3):297-308.
4. La Puma J, Orentlicher D, Moss RJ. Advance directives on admission. Clinical implications and analysis of the Patient Self-Determination Act of 1990. JAMA. 1991;266(3):402-405.
5. Ehlenbach WJ, Barnato AE, Curtis JR, et al. Epidemiologic study of in-hospital cardiopulmonary resuscitation in the elderly. N Engl J Med. 2009;361(1):22-31.
6. Larkin GL, Copes WS, Nathanson BH, Kaye W. Pre-resuscitation factors associated with mortality in 49,130 cases of in-hospital cardiac arrest: a report from the National Registry for Cardiopulmonary Resuscitation. Resuscitation. 2010;81(3):302-311.
7. de Vos R, Koster RW, De Haan RJ, Oosting H, van der Wouw PA, Lampe-Schoenmaeckers AJ. In-hospital cardiopulmonary resuscitation: prearrest morbidity and outcome. Arch Intern Med. 1999;159(8):845-850.
8. Reisfield GM, Wallace SK, Munsell MF, Webb FJ, Alvarez ER, Wilson GR. Survival in cancer patients undergoing in-hospital cardiopulmonary resuscitation: a meta-analysis. Resuscitation. 2006;71(2):152-160.
9. Ewer MS, Kish SK, Martin CG, Price KJ, Feeley TW. Characteristics of cardiac arrest in cancer patients as a predictor of survival after cardiopulmonary resuscitation. Cancer. 2001;92(7):1905-1912.
10. Chan PS, Nichol G, Krumholz HM, et al. Racial differences in survival after in-hospital cardiac arrest. JAMA. 2009;302(11):1195-1201.
11. Chan PS, Krumholz HM, Nichol G, Nallamothu BK. Delayed time to defibrillation after in-hospital cardiac arrest. N Engl J Med. 2008;358(1):9-17.
12. Wijdicks EF, Hijdra A, Young GB, Bassetti CL, Wiebe S. Practice parameter: prediction of outcome in comatose survivors after cardiopulmonary resuscitation (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2006;67(2):203-210.

The mark of any great society is balance—balance between the production realized today and the preservation of “production capacity” to ensure the same or greater production in the future. HM is not exempt from this fundamental tenet. What we do now in the way of advancing quality, efficiency, and patient safety will matter little if our contributions are not sustained by the generation that follows us.

It is tempting to think that the issue of how we train residents is germane only to universities, but the reality is that it affects us all. There are 126 “university” medical school programs, but there are 384 residency programs, most of which are within community-based hospitals. The result is that most hospitalists encounter resident physicians in some capacity, and all hospitalists will encounter the results of residency training when they welcome a new recruit to their ranks.

The education and socialization of our residents will define the character of the hospitalists of the future. But the “residency” in which most of us trained does not exist anymore: The duty-hours changes and additional training requirements have dramatically changed the landscape of residency training in the past 10 years, and another series of sea changes is underway. As with all things HM, we again have a choice: Be reactive, wait for the dust to clear, and then lament the results, or be proactive and see this change for what it is—an opportunity to improve healthcare quality now, and in the future.

The ACGME

HM felt the impact of the first wave of duty-hours restrictions beginning in 2003, as many training programs opted to employ hospitalists to provide the coverage that could no longer be maintained by residents working under tighter admission caps and duty-hour restrictions. In doing so, hospitalists have provided a valuable service in preserving the integrity of training environments and fidelity to the Accreditation Council for Graduate Medical Education (ACGME) regulations (more than 85% of training programs have hospitalists working in their systems). But the model of hospitalists working solely as “resident-extenders” is not sustainable.

First, hospitalists who work solely on nonteaching services are at great risk of burning out, especially if the distribution of patients has been manipulated such that the more interesting patients are funneled away from the hospitalist’s service to the teaching service. Second, there is a risk in perception: In models in which the hospitalist is solely the “overflow cap coverage” or the night-float physician (i.e., the resident-extender), residents come to see hospitalists as the “PGY-4, 5, 6 …” physicians—that is, the physician who becomes a resident for life. The result is a serious pipeline issue for us, as the most talented resident physicians are unlikely to forego subspecialty training for a career in HM if hospitalists are perceived as perpetual residents.

The solution is simple: The hospitalist’s role in training environments has to be more than merely solving admission cap or duty-hour issues. It is fine for hospitalists to operate nonteaching services, but the hospitalist also has to be a part of the fulfillment that comes with overseeing teaching services. Further, residents have to see the hospitalist career for what it actually is: Academic or not, HM is much more than merely clinical service. HM is about the value-added services of system interventions to improve quality and patient safety; it is about developing a career as a systems architect. Getting the best and brightest residents to choose HM as a career is contingent upon residents seeing hospitalists in the training environment who are happy and fulfilled in the execution of this career goal.

The hospitalist’s plight was helped substantially on June 23, when ACGME released for comment the revised Common Program Requirements (www.acgme.org). The duty-hours changes are unlikely to substantially alter hospitalists’ lives; the only significant change was a limitation on intern shift durations to fewer than 16 hours in a row (upper-level residents still operate under the 24+6 hour rule, with increased flexibility to stay longer by volition). But the interesting part of the new requirements is an augmented focus on teaching residents transitions-of-care skills, improving direct supervision of residents, and constructing educational systems that minimize handoffs.

There is no specialty that is as suited as HM for fulfilling these unique (and, as of yet, unmet) requirements. Transitions, quality, being present on the hospital wards … this is what we do. And requiring instruction in transitions and quality is an unprecedented leverage point for HM to advance the quality of future physicians. How great it would be to attend HM20 and realize that the attendees had already learned the “Quality 101” lessons (i.e., those we are currently teaching at our annual meeting) as part of their residency? Freed from the need to do basic quality sessions, the content of the annual meeting could escalate to even higher-level principles that would result in substantial and sustainable quality improvement (QI).

MedPAC and GME Funding

Simultaneous with the ACGME changes are changes at the Medicare Payment Advisory Committee (MedPAC), the advisory organization responsible for recommending changes in the distribution of Centers for Medicare and Medicaid Services (CMS) funds to support graduate medical education. CMS is the primary funding agent for residency training. Each hospital receives direct medical expenditures to cover a resident’s salary and benefits. Each hospital has a pre-set per-resident allotment, or PRA. This number varies by hospital, but the average is $100,000 per resident. CMS reimburses the hospital a percentage of this number based upon the percentage of hospital days occupied by Medicare patients (e.g., 35% Medicare days=$35,000 per resident).

The hospital also receives indirect medical expenditures, or IME. IME is not a distinct payment to the hospital, but rather an “inflator” of the clinical-care payments the hospital receives from CMS. IME is paid to the hospital under the presumption that a typical training facility incurs greater cost due to higher patient severity, a higher indigent care percentage, and has higher resource utilization due to residents’ excessive testing, etc. The final presumption is that support is needed for the educational infrastructure (i.e., supervision and teaching).

IME is not inconsequential to a hospital; depending upon the payor mix, a 200-bed hospital might have from $4 million to $8 million in annual IME payments. CMS’ total IME payments to hospitals is more than $6 billion a year. Each hospital’s IME revenue can be found at www.graham-center.org/online/graham/home/tools-resources/data-tables/dt001-gme-2007.html.

The game-changing event occurred in April, when MedPAC announced its intent to reassess the mechanisms of IME funding, with a vision of IME funding eventually being linked to a hospital’s training programs’ ability to demonstrate substantial improvement in quality and patient safety. And here is the leverage point that is a unique opportunity for hospitalists in the training environment. For many hospitalists, especially if employed directly by the hospital, there is little financial incentive to engaging on a teaching service. The ACGME caps limit the service size, and this in turn limits the possible RVUs. Up until now, asking the hospital to compensate for teaching time (i.e., EVUs) was a pipe dream. But the linking of IME funding to quality outcomes (and quality instruction to residents) could change all of that.

If you put the two together: ACGME calling for instruction in quality and transitions, plus MedPAC calling for payments linked to resident outcomes in quality and patient safety, you have one inescapable conclusion—the residency of the future will hinge upon having supervisors with the necessary expertise to ensure that residents participate in, and understand the principles of, patient safety and quality as a part of the residency curriculum. And the people who can ensure that goal are likely to be in a position to warrant compensation for doing so.

Who is better to do this than the hospitalist?

SHM’s Proactive Strategy

This is the opportune time for HM to advance its stature as a profession and to ensure its future via a pipeline of residents adequately training in quality and patient safety. But it is not enough to merely wish for this to happen. There are real barriers that have kept hospitalists from being more intimately involved in physician training, the first of which is age.

HM is a young specialty (the average hospitalist is 37; the average HM leader is 41), and its youth makes it hard to compete with older subspecialists/generalists who have more experience in education. But deficits in experience can be compensated by additional training.

The Academic Hospitalist Academy (AHA)—cosponsored by SHM, the Society of General Internal Medicine (SGIM), and the Association of Chiefs and Leaders of General Internal Medicine (ACLGIM)—is the key to the strategy of catching up quickly. The academy will convene this month outside of Atlanta, and it is very important that each training facility think about sending one of its hospitalists to receive the advanced training in education necessary to compensate for not having years of experience in medical education. Academy details are available at http://academichospitalist.org.

SHM’s initiatives on this front do not stop with the academy. Over the past three months, Kevin O’Leary, MD, and his Quality Improvement Education Committee have been furiously building a “Quality and Patient Safety” curriculum, with a target audience of new hospitalists and resident physicians. The vision is to create a Web-based, interactive curriculum that teaches resident physicians the basics of quality and patient safety, design projects with their colleagues (under the supervision of their hospitalist mentor), and track their data to see real-time results.

Unlike other curricula on the market, the SHM Quality Curriculum for residents will be dynamic, requiring participating institutions commit to SHM’s modus operandi of mentored implementation by sponsoring a hospitalist to receive the training necessary to put the curriculum in motion. To this end, SHM has collaborated with the Alliance for Internal Medicine (AIM) in co-sponsoring the Quality Academy, with a focus on how to teach quality and patient safety. Jen Meyers, MD, FHM, and Jeff Glasheen, MD, SFHM, will be leading the team responsible for the development of this Quality Training Course, which should emerge in the fall of 2011.

As this project proceeds, Paul Grant, MD, chair of the Early Career Hospitalist Committee, and Cheryl O’Malley, MD, chair of the Pipeline Committee, will provide counsel. Both of these groups will continue efforts to improve the process by which residents transition from residency to HM practice, and supporting young physicians with distance mentoring.

The SHM vision of our production capacity is simple: Bring in the best and brightest hospitalists who are interested in teaching quality and patient safety, train them in the fundamentals of medical education, provide them with an “off the net” curriculum for how to teach quality, then return them to their respective training environments to coach residents on the principles of quality.

Training programs that invest in this vision will reap the rewards of fidelity to the new ACGME requirements. Hospitals that support such a vision will receive assurances, should MedPAC’s recommendation come to fruition, that DME and IME funding is secure. Hospitalists investing in this vision will find a fulfilling career in quality education.

And all of us will find assurances that, for as good as things are right now for HM, the future will be even better. TH

Dr. Wiese is president of SHM.

The mark of any great society is balance—balance between the production realized today and the preservation of “production capacity” to ensure the same or greater production in the future. HM is not exempt from this fundamental tenet. What we do now in the way of advancing quality, efficiency, and patient safety will matter little if our contributions are not sustained by the generation that follows us.

It is tempting to think that the issue of how we train residents is germane only to universities, but the reality is that it affects us all. There are 126 “university” medical school programs, but there are 384 residency programs, most of which are within community-based hospitals. The result is that most hospitalists encounter resident physicians in some capacity, and all hospitalists will encounter the results of residency training when they welcome a new recruit to their ranks.

The education and socialization of our residents will define the character of the hospitalists of the future. But the “residency” in which most of us trained does not exist anymore: The duty-hours changes and additional training requirements have dramatically changed the landscape of residency training in the past 10 years, and another series of sea changes is underway. As with all things HM, we again have a choice: Be reactive, wait for the dust to clear, and then lament the results, or be proactive and see this change for what it is—an opportunity to improve healthcare quality now, and in the future.

The ACGME

HM felt the impact of the first wave of duty-hours restrictions beginning in 2003, as many training programs opted to employ hospitalists to provide the coverage that could no longer be maintained by residents working under tighter admission caps and duty-hour restrictions. In doing so, hospitalists have provided a valuable service in preserving the integrity of training environments and fidelity to the Accreditation Council for Graduate Medical Education (ACGME) regulations (more than 85% of training programs have hospitalists working in their systems). But the model of hospitalists working solely as “resident-extenders” is not sustainable.

First, hospitalists who work solely on nonteaching services are at great risk of burning out, especially if the distribution of patients has been manipulated such that the more interesting patients are funneled away from the hospitalist’s service to the teaching service. Second, there is a risk in perception: In models in which the hospitalist is solely the “overflow cap coverage” or the night-float physician (i.e., the resident-extender), residents come to see hospitalists as the “PGY-4, 5, 6 …” physicians—that is, the physician who becomes a resident for life. The result is a serious pipeline issue for us, as the most talented resident physicians are unlikely to forego subspecialty training for a career in HM if hospitalists are perceived as perpetual residents.

The solution is simple: The hospitalist’s role in training environments has to be more than merely solving admission cap or duty-hour issues. It is fine for hospitalists to operate nonteaching services, but the hospitalist also has to be a part of the fulfillment that comes with overseeing teaching services. Further, residents have to see the hospitalist career for what it actually is: Academic or not, HM is much more than merely clinical service. HM is about the value-added services of system interventions to improve quality and patient safety; it is about developing a career as a systems architect. Getting the best and brightest residents to choose HM as a career is contingent upon residents seeing hospitalists in the training environment who are happy and fulfilled in the execution of this career goal.

The hospitalist’s plight was helped substantially on June 23, when ACGME released for comment the revised Common Program Requirements (www.acgme.org). The duty-hours changes are unlikely to substantially alter hospitalists’ lives; the only significant change was a limitation on intern shift durations to fewer than 16 hours in a row (upper-level residents still operate under the 24+6 hour rule, with increased flexibility to stay longer by volition). But the interesting part of the new requirements is an augmented focus on teaching residents transitions-of-care skills, improving direct supervision of residents, and constructing educational systems that minimize handoffs.

There is no specialty that is as suited as HM for fulfilling these unique (and, as of yet, unmet) requirements. Transitions, quality, being present on the hospital wards … this is what we do. And requiring instruction in transitions and quality is an unprecedented leverage point for HM to advance the quality of future physicians. How great it would be to attend HM20 and realize that the attendees had already learned the “Quality 101” lessons (i.e., those we are currently teaching at our annual meeting) as part of their residency? Freed from the need to do basic quality sessions, the content of the annual meeting could escalate to even higher-level principles that would result in substantial and sustainable quality improvement (QI).

MedPAC and GME Funding

Simultaneous with the ACGME changes are changes at the Medicare Payment Advisory Committee (MedPAC), the advisory organization responsible for recommending changes in the distribution of Centers for Medicare and Medicaid Services (CMS) funds to support graduate medical education. CMS is the primary funding agent for residency training. Each hospital receives direct medical expenditures to cover a resident’s salary and benefits. Each hospital has a pre-set per-resident allotment, or PRA. This number varies by hospital, but the average is $100,000 per resident. CMS reimburses the hospital a percentage of this number based upon the percentage of hospital days occupied by Medicare patients (e.g., 35% Medicare days=$35,000 per resident).

The hospital also receives indirect medical expenditures, or IME. IME is not a distinct payment to the hospital, but rather an “inflator” of the clinical-care payments the hospital receives from CMS. IME is paid to the hospital under the presumption that a typical training facility incurs greater cost due to higher patient severity, a higher indigent care percentage, and has higher resource utilization due to residents’ excessive testing, etc. The final presumption is that support is needed for the educational infrastructure (i.e., supervision and teaching).

IME is not inconsequential to a hospital; depending upon the payor mix, a 200-bed hospital might have from $4 million to $8 million in annual IME payments. CMS’ total IME payments to hospitals is more than $6 billion a year. Each hospital’s IME revenue can be found at www.graham-center.org/online/graham/home/tools-resources/data-tables/dt001-gme-2007.html.

The game-changing event occurred in April, when MedPAC announced its intent to reassess the mechanisms of IME funding, with a vision of IME funding eventually being linked to a hospital’s training programs’ ability to demonstrate substantial improvement in quality and patient safety. And here is the leverage point that is a unique opportunity for hospitalists in the training environment. For many hospitalists, especially if employed directly by the hospital, there is little financial incentive to engaging on a teaching service. The ACGME caps limit the service size, and this in turn limits the possible RVUs. Up until now, asking the hospital to compensate for teaching time (i.e., EVUs) was a pipe dream. But the linking of IME funding to quality outcomes (and quality instruction to residents) could change all of that.

If you put the two together: ACGME calling for instruction in quality and transitions, plus MedPAC calling for payments linked to resident outcomes in quality and patient safety, you have one inescapable conclusion—the residency of the future will hinge upon having supervisors with the necessary expertise to ensure that residents participate in, and understand the principles of, patient safety and quality as a part of the residency curriculum. And the people who can ensure that goal are likely to be in a position to warrant compensation for doing so.

Who is better to do this than the hospitalist?

SHM’s Proactive Strategy

This is the opportune time for HM to advance its stature as a profession and to ensure its future via a pipeline of residents adequately training in quality and patient safety. But it is not enough to merely wish for this to happen. There are real barriers that have kept hospitalists from being more intimately involved in physician training, the first of which is age.

HM is a young specialty (the average hospitalist is 37; the average HM leader is 41), and its youth makes it hard to compete with older subspecialists/generalists who have more experience in education. But deficits in experience can be compensated by additional training.

The Academic Hospitalist Academy (AHA)—cosponsored by SHM, the Society of General Internal Medicine (SGIM), and the Association of Chiefs and Leaders of General Internal Medicine (ACLGIM)—is the key to the strategy of catching up quickly. The academy will convene this month outside of Atlanta, and it is very important that each training facility think about sending one of its hospitalists to receive the advanced training in education necessary to compensate for not having years of experience in medical education. Academy details are available at http://academichospitalist.org.

SHM’s initiatives on this front do not stop with the academy. Over the past three months, Kevin O’Leary, MD, and his Quality Improvement Education Committee have been furiously building a “Quality and Patient Safety” curriculum, with a target audience of new hospitalists and resident physicians. The vision is to create a Web-based, interactive curriculum that teaches resident physicians the basics of quality and patient safety, design projects with their colleagues (under the supervision of their hospitalist mentor), and track their data to see real-time results.

Unlike other curricula on the market, the SHM Quality Curriculum for residents will be dynamic, requiring participating institutions commit to SHM’s modus operandi of mentored implementation by sponsoring a hospitalist to receive the training necessary to put the curriculum in motion. To this end, SHM has collaborated with the Alliance for Internal Medicine (AIM) in co-sponsoring the Quality Academy, with a focus on how to teach quality and patient safety. Jen Meyers, MD, FHM, and Jeff Glasheen, MD, SFHM, will be leading the team responsible for the development of this Quality Training Course, which should emerge in the fall of 2011.

As this project proceeds, Paul Grant, MD, chair of the Early Career Hospitalist Committee, and Cheryl O’Malley, MD, chair of the Pipeline Committee, will provide counsel. Both of these groups will continue efforts to improve the process by which residents transition from residency to HM practice, and supporting young physicians with distance mentoring.

The SHM vision of our production capacity is simple: Bring in the best and brightest hospitalists who are interested in teaching quality and patient safety, train them in the fundamentals of medical education, provide them with an “off the net” curriculum for how to teach quality, then return them to their respective training environments to coach residents on the principles of quality.

Training programs that invest in this vision will reap the rewards of fidelity to the new ACGME requirements. Hospitals that support such a vision will receive assurances, should MedPAC’s recommendation come to fruition, that DME and IME funding is secure. Hospitalists investing in this vision will find a fulfilling career in quality education.

And all of us will find assurances that, for as good as things are right now for HM, the future will be even better. TH

Dr. Wiese is president of SHM.

The mark of any great society is balance—balance between the production realized today and the preservation of “production capacity” to ensure the same or greater production in the future. HM is not exempt from this fundamental tenet. What we do now in the way of advancing quality, efficiency, and patient safety will matter little if our contributions are not sustained by the generation that follows us.

It is tempting to think that the issue of how we train residents is germane only to universities, but the reality is that it affects us all. There are 126 “university” medical school programs, but there are 384 residency programs, most of which are within community-based hospitals. The result is that most hospitalists encounter resident physicians in some capacity, and all hospitalists will encounter the results of residency training when they welcome a new recruit to their ranks.

The education and socialization of our residents will define the character of the hospitalists of the future. But the “residency” in which most of us trained does not exist anymore: The duty-hours changes and additional training requirements have dramatically changed the landscape of residency training in the past 10 years, and another series of sea changes is underway. As with all things HM, we again have a choice: Be reactive, wait for the dust to clear, and then lament the results, or be proactive and see this change for what it is—an opportunity to improve healthcare quality now, and in the future.

The ACGME

HM felt the impact of the first wave of duty-hours restrictions beginning in 2003, as many training programs opted to employ hospitalists to provide the coverage that could no longer be maintained by residents working under tighter admission caps and duty-hour restrictions. In doing so, hospitalists have provided a valuable service in preserving the integrity of training environments and fidelity to the Accreditation Council for Graduate Medical Education (ACGME) regulations (more than 85% of training programs have hospitalists working in their systems). But the model of hospitalists working solely as “resident-extenders” is not sustainable.

First, hospitalists who work solely on nonteaching services are at great risk of burning out, especially if the distribution of patients has been manipulated such that the more interesting patients are funneled away from the hospitalist’s service to the teaching service. Second, there is a risk in perception: In models in which the hospitalist is solely the “overflow cap coverage” or the night-float physician (i.e., the resident-extender), residents come to see hospitalists as the “PGY-4, 5, 6 …” physicians—that is, the physician who becomes a resident for life. The result is a serious pipeline issue for us, as the most talented resident physicians are unlikely to forego subspecialty training for a career in HM if hospitalists are perceived as perpetual residents.

The solution is simple: The hospitalist’s role in training environments has to be more than merely solving admission cap or duty-hour issues. It is fine for hospitalists to operate nonteaching services, but the hospitalist also has to be a part of the fulfillment that comes with overseeing teaching services. Further, residents have to see the hospitalist career for what it actually is: Academic or not, HM is much more than merely clinical service. HM is about the value-added services of system interventions to improve quality and patient safety; it is about developing a career as a systems architect. Getting the best and brightest residents to choose HM as a career is contingent upon residents seeing hospitalists in the training environment who are happy and fulfilled in the execution of this career goal.

The hospitalist’s plight was helped substantially on June 23, when ACGME released for comment the revised Common Program Requirements (www.acgme.org). The duty-hours changes are unlikely to substantially alter hospitalists’ lives; the only significant change was a limitation on intern shift durations to fewer than 16 hours in a row (upper-level residents still operate under the 24+6 hour rule, with increased flexibility to stay longer by volition). But the interesting part of the new requirements is an augmented focus on teaching residents transitions-of-care skills, improving direct supervision of residents, and constructing educational systems that minimize handoffs.

There is no specialty that is as suited as HM for fulfilling these unique (and, as of yet, unmet) requirements. Transitions, quality, being present on the hospital wards … this is what we do. And requiring instruction in transitions and quality is an unprecedented leverage point for HM to advance the quality of future physicians. How great it would be to attend HM20 and realize that the attendees had already learned the “Quality 101” lessons (i.e., those we are currently teaching at our annual meeting) as part of their residency? Freed from the need to do basic quality sessions, the content of the annual meeting could escalate to even higher-level principles that would result in substantial and sustainable quality improvement (QI).

MedPAC and GME Funding

Simultaneous with the ACGME changes are changes at the Medicare Payment Advisory Committee (MedPAC), the advisory organization responsible for recommending changes in the distribution of Centers for Medicare and Medicaid Services (CMS) funds to support graduate medical education. CMS is the primary funding agent for residency training. Each hospital receives direct medical expenditures to cover a resident’s salary and benefits. Each hospital has a pre-set per-resident allotment, or PRA. This number varies by hospital, but the average is $100,000 per resident. CMS reimburses the hospital a percentage of this number based upon the percentage of hospital days occupied by Medicare patients (e.g., 35% Medicare days=$35,000 per resident).

The hospital also receives indirect medical expenditures, or IME. IME is not a distinct payment to the hospital, but rather an “inflator” of the clinical-care payments the hospital receives from CMS. IME is paid to the hospital under the presumption that a typical training facility incurs greater cost due to higher patient severity, a higher indigent care percentage, and has higher resource utilization due to residents’ excessive testing, etc. The final presumption is that support is needed for the educational infrastructure (i.e., supervision and teaching).

IME is not inconsequential to a hospital; depending upon the payor mix, a 200-bed hospital might have from $4 million to $8 million in annual IME payments. CMS’ total IME payments to hospitals is more than $6 billion a year. Each hospital’s IME revenue can be found at www.graham-center.org/online/graham/home/tools-resources/data-tables/dt001-gme-2007.html.

The game-changing event occurred in April, when MedPAC announced its intent to reassess the mechanisms of IME funding, with a vision of IME funding eventually being linked to a hospital’s training programs’ ability to demonstrate substantial improvement in quality and patient safety. And here is the leverage point that is a unique opportunity for hospitalists in the training environment. For many hospitalists, especially if employed directly by the hospital, there is little financial incentive to engaging on a teaching service. The ACGME caps limit the service size, and this in turn limits the possible RVUs. Up until now, asking the hospital to compensate for teaching time (i.e., EVUs) was a pipe dream. But the linking of IME funding to quality outcomes (and quality instruction to residents) could change all of that.

If you put the two together: ACGME calling for instruction in quality and transitions, plus MedPAC calling for payments linked to resident outcomes in quality and patient safety, you have one inescapable conclusion—the residency of the future will hinge upon having supervisors with the necessary expertise to ensure that residents participate in, and understand the principles of, patient safety and quality as a part of the residency curriculum. And the people who can ensure that goal are likely to be in a position to warrant compensation for doing so.

Who is better to do this than the hospitalist?

SHM’s Proactive Strategy

This is the opportune time for HM to advance its stature as a profession and to ensure its future via a pipeline of residents adequately training in quality and patient safety. But it is not enough to merely wish for this to happen. There are real barriers that have kept hospitalists from being more intimately involved in physician training, the first of which is age.

HM is a young specialty (the average hospitalist is 37; the average HM leader is 41), and its youth makes it hard to compete with older subspecialists/generalists who have more experience in education. But deficits in experience can be compensated by additional training.

The Academic Hospitalist Academy (AHA)—cosponsored by SHM, the Society of General Internal Medicine (SGIM), and the Association of Chiefs and Leaders of General Internal Medicine (ACLGIM)—is the key to the strategy of catching up quickly. The academy will convene this month outside of Atlanta, and it is very important that each training facility think about sending one of its hospitalists to receive the advanced training in education necessary to compensate for not having years of experience in medical education. Academy details are available at http://academichospitalist.org.

SHM’s initiatives on this front do not stop with the academy. Over the past three months, Kevin O’Leary, MD, and his Quality Improvement Education Committee have been furiously building a “Quality and Patient Safety” curriculum, with a target audience of new hospitalists and resident physicians. The vision is to create a Web-based, interactive curriculum that teaches resident physicians the basics of quality and patient safety, design projects with their colleagues (under the supervision of their hospitalist mentor), and track their data to see real-time results.

Unlike other curricula on the market, the SHM Quality Curriculum for residents will be dynamic, requiring participating institutions commit to SHM’s modus operandi of mentored implementation by sponsoring a hospitalist to receive the training necessary to put the curriculum in motion. To this end, SHM has collaborated with the Alliance for Internal Medicine (AIM) in co-sponsoring the Quality Academy, with a focus on how to teach quality and patient safety. Jen Meyers, MD, FHM, and Jeff Glasheen, MD, SFHM, will be leading the team responsible for the development of this Quality Training Course, which should emerge in the fall of 2011.

As this project proceeds, Paul Grant, MD, chair of the Early Career Hospitalist Committee, and Cheryl O’Malley, MD, chair of the Pipeline Committee, will provide counsel. Both of these groups will continue efforts to improve the process by which residents transition from residency to HM practice, and supporting young physicians with distance mentoring.

The SHM vision of our production capacity is simple: Bring in the best and brightest hospitalists who are interested in teaching quality and patient safety, train them in the fundamentals of medical education, provide them with an “off the net” curriculum for how to teach quality, then return them to their respective training environments to coach residents on the principles of quality.

Training programs that invest in this vision will reap the rewards of fidelity to the new ACGME requirements. Hospitals that support such a vision will receive assurances, should MedPAC’s recommendation come to fruition, that DME and IME funding is secure. Hospitalists investing in this vision will find a fulfilling career in quality education.

And all of us will find assurances that, for as good as things are right now for HM, the future will be even better. TH

Dr. Wiese is president of SHM.

How much has Medicare saved by not paying hospitals when patients get infections?

Hugh Black, DO

Charlotte, N.C.

Dr. Hospitalist responds: Since 2007, the Centers for Medicare and Medicaid Services (CMS) has tried to reduce the number of high-cost, hospital-acquired conditions (HACs), including infections, by encouraging providers to adhere to evidence-based guidelines. Some examples of these hospital-acquired conditions include:

• Catheter-associated urinary tract infections;
• Foreign objects retained after surgery; and
• Stage III and IV pressure ulcers.

CMS requires that acute-care hospitals, “effective with discharges occurring on or after Oct. 1, 2007, submit information on Medicare claims specifying whether diagnoses were present on admission.” Effective Oct. 1, 2008, Medicare no longer pays for charges associated with these HACs. So, if a Medicare beneficiary developed a Stage III pressure ulcer during his stay at an acute-care hospital, CMS would not pay for the incremental cost of the care associated with the “HAC.”

click for large version

The U.S. government, in the May 4, 2010, edition of the Federal Register, reviewed the impact of this program. The data are based on Medicare claims data from October 2008 to June 2009. During this period of time, there were approximately 7.17 million acute-care hospital Medicare discharges.

The total net savings during this nine-month period for all HACs was $16.4 million. Three HACs (Stage III and IV pressure ulcers, DVT/PE after orthopedic procedure, and falls and trauma) accounted for more than $15.1 million in savings. Pro-rated for a 12-month period, the total net savings for all HACs would exceed $20 million.

Falls and trauma accounted for 34% of all HACs reported (11,253), followed by vascular catheter-associated infection (16%) and catheter-associated UTIs (16%). Air embolism and mediastinitis after CABG were the least recorded HACs; both were less than .01% if the total.

The goal is that, over time, with improvement in care, there would be a decrease in the number of hospital discharges where these conditions would be present. Therefore, the net savings would be expected to decline.

Medicare has considered a number of other HACs for this program, and reviewed the numbers of these conditions over the same nine-month period (see “Medicare’s Potential New Hospital-Acquired Conditions,” above). Despite some large numbers, CMS has stated it’s not proposing to add or remove HAC categories at this time. If you are interested in reviewing the entire report, visit http://edocket.access.gpo.gov/2010/pdf/ 2010-9163.pdf. TH

How much has Medicare saved by not paying hospitals when patients get infections?

Hugh Black, DO

Charlotte, N.C.

Dr. Hospitalist responds: Since 2007, the Centers for Medicare and Medicaid Services (CMS) has tried to reduce the number of high-cost, hospital-acquired conditions (HACs), including infections, by encouraging providers to adhere to evidence-based guidelines. Some examples of these hospital-acquired conditions include:

• Catheter-associated urinary tract infections;
• Foreign objects retained after surgery; and
• Stage III and IV pressure ulcers.

CMS requires that acute-care hospitals, “effective with discharges occurring on or after Oct. 1, 2007, submit information on Medicare claims specifying whether diagnoses were present on admission.” Effective Oct. 1, 2008, Medicare no longer pays for charges associated with these HACs. So, if a Medicare beneficiary developed a Stage III pressure ulcer during his stay at an acute-care hospital, CMS would not pay for the incremental cost of the care associated with the “HAC.”

click for large version

The U.S. government, in the May 4, 2010, edition of the Federal Register, reviewed the impact of this program. The data are based on Medicare claims data from October 2008 to June 2009. During this period of time, there were approximately 7.17 million acute-care hospital Medicare discharges.

The total net savings during this nine-month period for all HACs was $16.4 million. Three HACs (Stage III and IV pressure ulcers, DVT/PE after orthopedic procedure, and falls and trauma) accounted for more than $15.1 million in savings. Pro-rated for a 12-month period, the total net savings for all HACs would exceed $20 million.

Falls and trauma accounted for 34% of all HACs reported (11,253), followed by vascular catheter-associated infection (16%) and catheter-associated UTIs (16%). Air embolism and mediastinitis after CABG were the least recorded HACs; both were less than .01% if the total.

The goal is that, over time, with improvement in care, there would be a decrease in the number of hospital discharges where these conditions would be present. Therefore, the net savings would be expected to decline.

Medicare has considered a number of other HACs for this program, and reviewed the numbers of these conditions over the same nine-month period (see “Medicare’s Potential New Hospital-Acquired Conditions,” above). Despite some large numbers, CMS has stated it’s not proposing to add or remove HAC categories at this time. If you are interested in reviewing the entire report, visit http://edocket.access.gpo.gov/2010/pdf/ 2010-9163.pdf. TH

How much has Medicare saved by not paying hospitals when patients get infections?

Hugh Black, DO

Charlotte, N.C.

Dr. Hospitalist responds: Since 2007, the Centers for Medicare and Medicaid Services (CMS) has tried to reduce the number of high-cost, hospital-acquired conditions (HACs), including infections, by encouraging providers to adhere to evidence-based guidelines. Some examples of these hospital-acquired conditions include:

• Catheter-associated urinary tract infections;
• Foreign objects retained after surgery; and
• Stage III and IV pressure ulcers.

CMS requires that acute-care hospitals, “effective with discharges occurring on or after Oct. 1, 2007, submit information on Medicare claims specifying whether diagnoses were present on admission.” Effective Oct. 1, 2008, Medicare no longer pays for charges associated with these HACs. So, if a Medicare beneficiary developed a Stage III pressure ulcer during his stay at an acute-care hospital, CMS would not pay for the incremental cost of the care associated with the “HAC.”

click for large version

The U.S. government, in the May 4, 2010, edition of the Federal Register, reviewed the impact of this program. The data are based on Medicare claims data from October 2008 to June 2009. During this period of time, there were approximately 7.17 million acute-care hospital Medicare discharges.

The total net savings during this nine-month period for all HACs was $16.4 million. Three HACs (Stage III and IV pressure ulcers, DVT/PE after orthopedic procedure, and falls and trauma) accounted for more than $15.1 million in savings. Pro-rated for a 12-month period, the total net savings for all HACs would exceed $20 million.

Falls and trauma accounted for 34% of all HACs reported (11,253), followed by vascular catheter-associated infection (16%) and catheter-associated UTIs (16%). Air embolism and mediastinitis after CABG were the least recorded HACs; both were less than .01% if the total.

The goal is that, over time, with improvement in care, there would be a decrease in the number of hospital discharges where these conditions would be present. Therefore, the net savings would be expected to decline.

Medicare has considered a number of other HACs for this program, and reviewed the numbers of these conditions over the same nine-month period (see “Medicare’s Potential New Hospital-Acquired Conditions,” above). Despite some large numbers, CMS has stated it’s not proposing to add or remove HAC categories at this time. If you are interested in reviewing the entire report, visit http://edocket.access.gpo.gov/2010/pdf/ 2010-9163.pdf. TH

In This Edition

Literature at a Glance

A guide to this month’s studies

• Risk factors for iatrogenic pneumothorax
• Residency acceptance and use of pharmaceutical industry funding
• Early cholecystectomy outcomes for gallstone pancreatitis
• Use of microbial DNA in sepsis
• Adding rifampicin to vancomycin in MRSA pneumonia
• Rate and outcomes of culture-negative severe sepsis
• Rates of surgical comanagement in U.S. hospitals
• Probiotics and rates of ventilator-associated pneumonia

Ultrasound Guidance and Operator Experience Decrease Risk of Pneumothorax Following Thoracentesis

Clinical question: How often does pneumothorax happen following thoracentesis, and what factors are associated with increased risk of this complication?

Background: Procedural complications are an important source of adverse events in the hospital. Iatrogenic pneumothorax after thoracentesis results in increased hospital length of stay, morbidity, and mortality. Large variation exists in reported pneumothorax rates, and little is known about procedure- and patient-specific factors associated with development of this complication.

Study design: Systematic review and meta-analysis.

Setting: Review of 24 MEDLINE-indexed studies from January 1966 to April 2009.

Synopsis: A total of 349 pneumothoraces were reported after 6,605 thoracenteses (overall incidence 6.0%). Chest-tube insertion was required in 34.1% of the cases. Risk for pneumothorax was significantly higher when larger needles or catheters were used compared with needles smaller than 20-gauge (odds ratio 2.5, 95% confidence interval [CI], 1.1-6.0) and after therapeutic thoracentesis compared with diagnostic procedures (OR 2.6, 95% CI, 1.8-3.8).

Procedures requiring two or more needle passes did not significantly increase pneumothorax risk (OR 2.5, 95% CI, 0.3-20.1). In contrast, pneumothorax rates were significantly lower when using ultrasound guidance (OR 0.3, 95% CI, 0.2-0.7) and with experienced operators (3.9% vs. 8.5%, P=0.04).

Examining patient risk factors, pneumothorax rates were similar regardless of effusion size and patient gender. Additionally, rates were similar among non-ICU inpatients, ICU inpatients, and outpatients. Data did show a trend toward increased risk of pneumothorax with mechanical ventilation (OR 4.0, 95% CI, 0.95-16.8), although no study directly compared rates in ICU patients with and without mechanical ventilation.

Bottom line: Ultrasound guidance is a modifiable factor that decreases the risk of post-thoracentesis pneumothorax. Pneumothorax rates are lower when performed by experienced clinicians, providing an important opportunity to reduce procedure-related complications by increasing direct trainee supervision.

Citation: Gordon CE, Feller-Kopman D, Balk EM, Smetana GW. Pneumothorax following thoracentesis: a systematic review and meta-analysis. Arch Intern Med. 2010;170(4):332-339.

Pharmaceutical Industry Support Is Common in U.S. Internal-Medicine Residency Programs

Clinical question: What are the current attitudes of program directors regarding pharmaceutical industry support of internal-medicine residency activities? What are the potential associations between program characteristics and acceptance of industry support?

Background: Increasing evidence suggests that interactions with the pharmaceutical industry influence physician attitudes and practices. Recently, the Association of American Medical Colleges (AAMC) proposed that academic medical centers prohibit the acceptance of all gifts and restrict access by pharmaceutical industry representatives.

Study design: Survey of U.S. internal-medicine residency program directors.

Setting: Web-based survey of residency program directors in 388 U.S. internal-medicine residency programs.

Synopsis: Of the 236 program directors responding to the survey, 132 (55.9%) reported accepting some kind of support from the pharmaceutical industry. Support was most commonly provided in the form of food for conferences (90.9%), educational materials (83.3%), office supplies (68.9%), and drug samples (57.6%).

When programs reported accepting pharmaceutical industry support, 67.9% cited a lack of other funding sources as the reason for acceptance. Only 22.7% of programs with a program director who thinks pharmaceutical support is unacceptable actually accepted industry support. The likelihood of accepting support was associated with location in the Southern U.S. and was inversely associated with the three-year rolling American Board of Internal Medicine (ABIM) pass rates (each 1% decrease in the pass rate was associated with a 21% increase in the odds of accepting pharmaceutical industry support).

Bottom line: While most program directors did not find pharmaceutical industry support desirable, more than half reported acceptance of such support, with most citing lack of other funding resources as the reason for acceptance.

Citation: Loertscher LL, Halvorsen AJ, Beasley BW, Holmboe ES, Kolars JC, McDonald FS. Pharmaceutical industry support and residency education: a survey of internal medicine program directors. Arch Intern Med. 2010;170(4):356-362.

Early Cholecystectomy Safely Decreases Hospital Stay in Patients with Mild Gallstone Pancreatitis

Clinical question: Can laparoscopic cholecystectomy performed within 48 hours of admission for mild gallstone pancreatitis reduce hospital length of stay without increasing perioperative complications?

Background: Although there is a clear consensus that patients who present with gallstone pancreatitis should undergo cholecystectomy to prevent recurrence, precise timing of surgery remains controversial.

Study design: Randomized prospective trial.

Setting: Harbor-UCLA Medical Center, a Los Angeles County public teaching hospital and Level I trauma center.

Synopsis: Patients were prospectively randomized to an early group and a control group. Inclusion criteria consisted of adults from the ages of 18 to 100 with mild gallstone pancreatitis and three or fewer Ranson criteria. The primary endpoint was length of hospital stay. The secondary endpoint was a composite of complications, including the need for conversion to open cholecystectomy, readmission within 30 days, bleeding requiring transfusion, bile duct injury, or wound infection.

The study was terminated after 50 patients, as there was a difference in the length of hospital stay with a predefined alpha level of 0.005. Patients in the early group were taken to the operating room at a mean of 35.1 hours after admission, compared with 77.8 hours in the control group. The overall length of hospital stay was shorter in the early group (mean 3.5 days, 95% CI, 2.7-4.3), compared with the control group (mean 5.8, 95% CI, 3.8-7.9). All cholecystectomies were completed laparoscopically, without conversion to open. No statistically significant difference existed in secondary endpoints (P=0.48, OR 1.66, 95% CI, 0.41-6.78).

Bottom line: Laparoscopic cholecystectomy performed within 48 hours of admission, irrespective of normalization of laboratory values or clinical progress, safely decreases the overall length of stay, compared with delaying laparoscopic cholecystectomy until laboratory values and clinical condition normalize.

Citation: Aboulian A, Chan T, Yaghoubian A, et al. Early cholecystectomy safely decreases hospital stay in patients with mild gallstone pancreatitis: a randomized prospective study. Ann Surg. 2010;251(4): 615-619.

Presence of Microbial DNA in Blood Correlates with Disease Severity

Clinical question: Is the presence of microbial DNA in the blood associated with disease severity in severe sepsis, and how does detection of this microbial DNA by polymerase chain reaction (PCR) compare with blood cultures (BC)?

Background: Inadequate antibiotic therapy is a strong and independent predictor of poor outcomes in sepsis. Diagnostic uncertainty regarding the causative micro-organism is compensated for by liberal use of broad-spectrum antibiotics. As a result, resistance to antibiotics is an increasing public-health problem.

Study design: Prospective multicenter controlled observational study.

Setting: Three ICUs in Germany and France.

Synopsis: From 2005 to 2007, 63 patients were enrolled in the control group and 142 patients were enrolled in the sepsis group. In control patients, blood cultures and specimens were drawn daily at a maximum of three days after admission. In the sepsis group, blood samples were obtained on the day severe sepsis was suspected. Consecutive samples for the next two days after study inclusion were taken.

Taking BC as the laboratory comparison method, the sensitivity of PCR to detect culture-positive bacteremia in sepsis was 0.80 with a specificity of 0.77. PCR detected 29 of 41 microorganisms (70.3%) found in the BC. The highest recovery rate was observed for gram-negative bacteria (78.6%), fungi (50.0%), and gram-positive bacteria (47.6%). PCR from septic patients correlated well with markers of host response (IL-6 and PCT) and disease severity (SOFA score), even when the BC remained negative.

The appropriateness of antimicrobial therapy based on culture-based methods was not recorded, so it’s impossible to conclude whether or not the PCR would have contributed to a more effective therapy.

Bottom line: Concordance between BC and PCR is moderate in septic patients. PCR-based pathogen detection correlated with disease severity even if the BC remained negative, suggesting that the presence of microbial DNA in the bloodstream is a clinically significant event.

Citation: Bloos F, Hinder F, Becker K, et al. A multicenter trial to compare blood culture with polymerase chain reaction in severe human sepsis. Intensive Care Med. 2010;36(2):241-247.

Adding Rifampicin to Vancomycin Improves Outcomes in MRSA Pneumonia

Clinical question: Does adding rifampicin to vancomycin improve outcomes in patients with hospital-acquired MRSA pneumonia?

Background: Hospital-acquired MRSA pneumonia has a mortality of more than 20%. Vancomycin penetrates the lung tissue poorly. The value of adding rifampicin, an antibiotic with broad-spectrum coverage and good tissue penetration, was investigated.

Study design: Randomized open-label trial.

Setting: Medical ICU patients at Ulsan College of Medicine, Asan Medical Center, South Korea.

Synopsis: Patients older than 18 years of age with clinical symptoms suggestive of nosocomial pneumonia were randomized to receive vancomycin alone (V) or vancomycin plus rifampicin (VR). Clinicians could add additional antibiotics for gram-negative coverage as needed.

Of the 183 patients screened, 93 met the inclusion criteria and were randomized in a 1:1 ratio. MRSA infection was microbiologically confirmed. Clinical cure rate in VR patients was significantly greater at day 14 compared with the V group (53.7% vs. 31.0%, P=0.047) based on a modified intention-to-treat model. The overall mortality at day 28 did not significantly differ between the groups (22.0% vs. 38.1%, P=0.15), although the 60-day mortality was lower in the VR group (26.8% vs. 50.0%, P=0.042). Mortality from MRSA pneumonia had a trend toward a decrease in the VR group (14.7% vs. 28.6%, P=0.18).

The trial was limited because it was a single-site study and lacked statistical power to assess certain outcomes. Additionally, treatment protocols were not compared with other antimicrobial therapies.

Bottom line: Vancomycin plus rifampicin improves MRSA pneumonia outcomes in ICU patients.

Citation: Jung YJ, Koh Y, Hong SB, et al. Effect of vancomycin plus rifampicin in the treatment of nosocomial MRSA pneumonia. Crit Care Med. 2010;38(1):175-180.

Severe Sepsis Syndromes Are Not Always Caused by Bacteremia

Clinical question: What are the common causes of clinical sepsis?

Background: When sepsis is defined by systemic inflammatory response syndrome (SIRS) criteria, the etiology is not always infectious. Rapid initiation of antimicrobial therapy for infectious SIRS is a priority, but it could result in treating a significant number of patients who are not bacteremic.

Study design: Prospective secondary analysis of a registry of patients created to evaluate an institutional standard-of-care protocol.

Setting: Urban, 850-bed, tertiary-care teaching institution in North Carolina.

Synopsis: ED cases meeting the criteria for severe sepsis underwent a secondary review that looked at the cause of the sepsis. Only 45% of patients identified as having severe sepsis were blood-culture-positive during that episode of care. The culture-positive group was more likely to have central lines, malignancies, or reside in a nursing home.

Of the subgroup of culture-negative patients, 52% had another infectious etiology, most commonly pneumonia. Other “noninfectious mimics,” including inflammatory colitis, myocardial infarction, and pulmonary embolism, were noted in 32% of patients in the subgroup, and the cause was not identified in 16% of the patients.

In-hospital mortality was higher in the culture-positive group than in the culture-negative group (25% vs. 4%, P=0.05). There was no evidence of harm in patients with culture-negative sepsis treated for a systemic infection.

Bottom line: Many patients with a clinical picture of severe sepsis will not have positive blood cultures or an infectious etiology.

Citation: Heffner AC, Horton JM, Marchick MR, Jones AE. Etiology of illness in patients with severe sepsis admitted to the hospital from the emergency department. Clin Infect Dis. 2010;50(6):814-820.

Comanagement of Surgical Inpatients by Hospitalists Is Rapidly Expanding

Clinical question: What is the prevalence and nature of comanagement of surgical patients by medicine physicians?

Background: Comanagement of surgical patients is a common clinical role for hospitalists, but the relationship is not well characterized in the literature in terms of numbers of patients or types of physicians involved in this practice.

Study design: Retrospective cohort.

Setting: Cross-section of hospitals from a Medicare database.

Synopsis: During the study period, 35.2% of patients were comanaged by a medicine physician—23.7% by a generalist and 14% by a subspecialist. Cardiothoracic surgery patients were more likely to be comanaged by a subspecialist, whereas all other patients were more likely to be comanaged by a generalist.

Although subspecialist comanagement actually declined during the study period, overall comanagement increased from 33.3% in 1996 to 40.8% in 2006. This increase is entirely attributable to the increase in comanagement by hospitalists. Most of this growth occurred with orthopedic patients.

Patient factors associated with comanagement include advanced age, emergency admissions, and increasing comorbidities. Teaching hospitals had less comanagement, while midsize, nonteaching, and for-profit hospitals had more comanagement.

Bottom line: Comanagement of surgical patients by medicine physicians is a common and growing clinical relationship. Hospitalists are responsible for increasing numbers of comanaged surgical patients.

Citation: Sharma G, Kuo YF, Freeman J, Zhang DD, Goodwin JS. Comanagement of hospitalized surgical patients by medicine physicians in the United States. Arch Intern Med. 2010;170(4):363-368.

Probiotics Might Decrease Risk of Ventilator-Associated Pneumonia

Clinical question: Does the administration of probiotics decrease the incidence of ventilator-associated pneumonia in critically ill patients?

Background: Ventilator-associated pneumonia (VAP) is a major nosocomial infection in ICUs. Probiotics are thought to decrease colonization and, therefore, infection with serious hospital-acquired pathogens.

Study design: Meta-analysis of five randomized controlled trials.

Setting: ICU patients on mechanical ventilation for at least 24 hours.

Synopsis: Five trials met the inclusion criteria of comparing probiotics to placebo in critically ill patients on mechanical ventilation and reporting the outcome of VAP. Administration of probiotics decreased the incidence of VAP (odds ratio 0.61, 95% CI, 0.41-0.91) and colonization of the respiratory tract with Pseudomonas aeruginosa (OR 0.35, 95% CI, 0.13-0.93).

Length of ICU stay was decreased in the probiotic arm, although this effect was not statistically significant in all analyses. Probiotics had no effect on such outcomes as ICU mortality, in-hospital mortality, or duration of mechanical ventilation.

Bottom line: Probiotics might be an effective strategy to reduce the risk of VAP, even if they do not appear to impact such outcomes as mortality.

Citation: Siempos II, Ntaidou TK, Falagas ME. Impact of the administration of probiotics on the incidence of ventilator-associated pneumonia: a meta-analysis of randomized controlled trials. Crit Care Med. 2010;38(3):954-962. TH

PEDIATRIC HM LITERATURE

By Mark Shen, MD

Renal Ultrasound Identifies Children with High-Grade Vesicoureteral Reflux

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

Clinical question: What is the diagnostic accuracy of specific renal ultrasound (US) criterion for detection of vesicoureteral reflux (VUR)?

Background: Based on the paradigm that undetected and untreated VUR might lead to long-term complications, voiding cystography traditionally has been recommended for all young children with a first urinary tract infection (UTI). An increasing base of evidence suggests that antibiotic prophylaxis for low-grade VUR might be unnecessary. However, less-invasive methods of screening for high-grade reflux have not yet been identified.

Study design: Secondary analysis of data from a prior prospective study.

Setting: Nephrology department of a French teaching hospital.

Synopsis: One hundred seventeen children (0-16 years) with a UTI were included and underwent renal US and voiding cystography. Patients with a known uropathy or those who had received antibiotics within the past 48 hours were excluded. A generalized linear multilevel model was used to analyze the relationship between standardized renal US criterion and VUR.

Twenty-seven percent of children had VUR and 8% had high-grade VUR (grade ≥3). Pelvic, ureteral, and urinary tract dilatation were significantly associated with high-grade VUR. Ureteral dilatation offered the best combination of standardized criterion, sensitivity (75%), and specificity (88%).

Significant limitations of this study include the use of bag urine cultures and the lack of consensus-based US criterion for ureteral and pelvic dilatation. The authors appropriately caution that these renal US criteria do not identify all children with high-grade VUR and are merely one step toward an intermediate screening strategy for high-grade VUR in order to mitigate adverse effects of universal voiding cystography. Further validation of this work in a clinically representative population will be needed.

Bottom line: Ureteral dilatation accurately identifies children with high-grade VUR.

Citation: Leroy S, Vantalon S, Larakeb A, Ducou-Le-Pointe H, Bensman A. Vesicoureteral reflux in children with urinary tract infection: comparison of diagnostic accuracy of renal US criteria. Radiology. 2010;255(3):890-898.

In This Edition

Literature at a Glance

A guide to this month’s studies

• Risk factors for iatrogenic pneumothorax
• Residency acceptance and use of pharmaceutical industry funding
• Early cholecystectomy outcomes for gallstone pancreatitis
• Use of microbial DNA in sepsis
• Adding rifampicin to vancomycin in MRSA pneumonia
• Rate and outcomes of culture-negative severe sepsis
• Rates of surgical comanagement in U.S. hospitals
• Probiotics and rates of ventilator-associated pneumonia

Ultrasound Guidance and Operator Experience Decrease Risk of Pneumothorax Following Thoracentesis

Clinical question: How often does pneumothorax happen following thoracentesis, and what factors are associated with increased risk of this complication?

Background: Procedural complications are an important source of adverse events in the hospital. Iatrogenic pneumothorax after thoracentesis results in increased hospital length of stay, morbidity, and mortality. Large variation exists in reported pneumothorax rates, and little is known about procedure- and patient-specific factors associated with development of this complication.

Study design: Systematic review and meta-analysis.

Setting: Review of 24 MEDLINE-indexed studies from January 1966 to April 2009.

Synopsis: A total of 349 pneumothoraces were reported after 6,605 thoracenteses (overall incidence 6.0%). Chest-tube insertion was required in 34.1% of the cases. Risk for pneumothorax was significantly higher when larger needles or catheters were used compared with needles smaller than 20-gauge (odds ratio 2.5, 95% confidence interval [CI], 1.1-6.0) and after therapeutic thoracentesis compared with diagnostic procedures (OR 2.6, 95% CI, 1.8-3.8).

Procedures requiring two or more needle passes did not significantly increase pneumothorax risk (OR 2.5, 95% CI, 0.3-20.1). In contrast, pneumothorax rates were significantly lower when using ultrasound guidance (OR 0.3, 95% CI, 0.2-0.7) and with experienced operators (3.9% vs. 8.5%, P=0.04).

Examining patient risk factors, pneumothorax rates were similar regardless of effusion size and patient gender. Additionally, rates were similar among non-ICU inpatients, ICU inpatients, and outpatients. Data did show a trend toward increased risk of pneumothorax with mechanical ventilation (OR 4.0, 95% CI, 0.95-16.8), although no study directly compared rates in ICU patients with and without mechanical ventilation.

Bottom line: Ultrasound guidance is a modifiable factor that decreases the risk of post-thoracentesis pneumothorax. Pneumothorax rates are lower when performed by experienced clinicians, providing an important opportunity to reduce procedure-related complications by increasing direct trainee supervision.

Citation: Gordon CE, Feller-Kopman D, Balk EM, Smetana GW. Pneumothorax following thoracentesis: a systematic review and meta-analysis. Arch Intern Med. 2010;170(4):332-339.

Pharmaceutical Industry Support Is Common in U.S. Internal-Medicine Residency Programs

Clinical question: What are the current attitudes of program directors regarding pharmaceutical industry support of internal-medicine residency activities? What are the potential associations between program characteristics and acceptance of industry support?

Background: Increasing evidence suggests that interactions with the pharmaceutical industry influence physician attitudes and practices. Recently, the Association of American Medical Colleges (AAMC) proposed that academic medical centers prohibit the acceptance of all gifts and restrict access by pharmaceutical industry representatives.

Study design: Survey of U.S. internal-medicine residency program directors.

Setting: Web-based survey of residency program directors in 388 U.S. internal-medicine residency programs.

Synopsis: Of the 236 program directors responding to the survey, 132 (55.9%) reported accepting some kind of support from the pharmaceutical industry. Support was most commonly provided in the form of food for conferences (90.9%), educational materials (83.3%), office supplies (68.9%), and drug samples (57.6%).

When programs reported accepting pharmaceutical industry support, 67.9% cited a lack of other funding sources as the reason for acceptance. Only 22.7% of programs with a program director who thinks pharmaceutical support is unacceptable actually accepted industry support. The likelihood of accepting support was associated with location in the Southern U.S. and was inversely associated with the three-year rolling American Board of Internal Medicine (ABIM) pass rates (each 1% decrease in the pass rate was associated with a 21% increase in the odds of accepting pharmaceutical industry support).

Bottom line: While most program directors did not find pharmaceutical industry support desirable, more than half reported acceptance of such support, with most citing lack of other funding resources as the reason for acceptance.

Citation: Loertscher LL, Halvorsen AJ, Beasley BW, Holmboe ES, Kolars JC, McDonald FS. Pharmaceutical industry support and residency education: a survey of internal medicine program directors. Arch Intern Med. 2010;170(4):356-362.

Early Cholecystectomy Safely Decreases Hospital Stay in Patients with Mild Gallstone Pancreatitis

Clinical question: Can laparoscopic cholecystectomy performed within 48 hours of admission for mild gallstone pancreatitis reduce hospital length of stay without increasing perioperative complications?

Background: Although there is a clear consensus that patients who present with gallstone pancreatitis should undergo cholecystectomy to prevent recurrence, precise timing of surgery remains controversial.

Study design: Randomized prospective trial.

Setting: Harbor-UCLA Medical Center, a Los Angeles County public teaching hospital and Level I trauma center.

Synopsis: Patients were prospectively randomized to an early group and a control group. Inclusion criteria consisted of adults from the ages of 18 to 100 with mild gallstone pancreatitis and three or fewer Ranson criteria. The primary endpoint was length of hospital stay. The secondary endpoint was a composite of complications, including the need for conversion to open cholecystectomy, readmission within 30 days, bleeding requiring transfusion, bile duct injury, or wound infection.

The study was terminated after 50 patients, as there was a difference in the length of hospital stay with a predefined alpha level of 0.005. Patients in the early group were taken to the operating room at a mean of 35.1 hours after admission, compared with 77.8 hours in the control group. The overall length of hospital stay was shorter in the early group (mean 3.5 days, 95% CI, 2.7-4.3), compared with the control group (mean 5.8, 95% CI, 3.8-7.9). All cholecystectomies were completed laparoscopically, without conversion to open. No statistically significant difference existed in secondary endpoints (P=0.48, OR 1.66, 95% CI, 0.41-6.78).

Bottom line: Laparoscopic cholecystectomy performed within 48 hours of admission, irrespective of normalization of laboratory values or clinical progress, safely decreases the overall length of stay, compared with delaying laparoscopic cholecystectomy until laboratory values and clinical condition normalize.

Citation: Aboulian A, Chan T, Yaghoubian A, et al. Early cholecystectomy safely decreases hospital stay in patients with mild gallstone pancreatitis: a randomized prospective study. Ann Surg. 2010;251(4): 615-619.

Presence of Microbial DNA in Blood Correlates with Disease Severity

Clinical question: Is the presence of microbial DNA in the blood associated with disease severity in severe sepsis, and how does detection of this microbial DNA by polymerase chain reaction (PCR) compare with blood cultures (BC)?

Background: Inadequate antibiotic therapy is a strong and independent predictor of poor outcomes in sepsis. Diagnostic uncertainty regarding the causative micro-organism is compensated for by liberal use of broad-spectrum antibiotics. As a result, resistance to antibiotics is an increasing public-health problem.

Study design: Prospective multicenter controlled observational study.

Setting: Three ICUs in Germany and France.

Synopsis: From 2005 to 2007, 63 patients were enrolled in the control group and 142 patients were enrolled in the sepsis group. In control patients, blood cultures and specimens were drawn daily at a maximum of three days after admission. In the sepsis group, blood samples were obtained on the day severe sepsis was suspected. Consecutive samples for the next two days after study inclusion were taken.

Taking BC as the laboratory comparison method, the sensitivity of PCR to detect culture-positive bacteremia in sepsis was 0.80 with a specificity of 0.77. PCR detected 29 of 41 microorganisms (70.3%) found in the BC. The highest recovery rate was observed for gram-negative bacteria (78.6%), fungi (50.0%), and gram-positive bacteria (47.6%). PCR from septic patients correlated well with markers of host response (IL-6 and PCT) and disease severity (SOFA score), even when the BC remained negative.

The appropriateness of antimicrobial therapy based on culture-based methods was not recorded, so it’s impossible to conclude whether or not the PCR would have contributed to a more effective therapy.

Bottom line: Concordance between BC and PCR is moderate in septic patients. PCR-based pathogen detection correlated with disease severity even if the BC remained negative, suggesting that the presence of microbial DNA in the bloodstream is a clinically significant event.

Citation: Bloos F, Hinder F, Becker K, et al. A multicenter trial to compare blood culture with polymerase chain reaction in severe human sepsis. Intensive Care Med. 2010;36(2):241-247.

Adding Rifampicin to Vancomycin Improves Outcomes in MRSA Pneumonia

Clinical question: Does adding rifampicin to vancomycin improve outcomes in patients with hospital-acquired MRSA pneumonia?

Background: Hospital-acquired MRSA pneumonia has a mortality of more than 20%. Vancomycin penetrates the lung tissue poorly. The value of adding rifampicin, an antibiotic with broad-spectrum coverage and good tissue penetration, was investigated.

Study design: Randomized open-label trial.

Setting: Medical ICU patients at Ulsan College of Medicine, Asan Medical Center, South Korea.

Synopsis: Patients older than 18 years of age with clinical symptoms suggestive of nosocomial pneumonia were randomized to receive vancomycin alone (V) or vancomycin plus rifampicin (VR). Clinicians could add additional antibiotics for gram-negative coverage as needed.

Of the 183 patients screened, 93 met the inclusion criteria and were randomized in a 1:1 ratio. MRSA infection was microbiologically confirmed. Clinical cure rate in VR patients was significantly greater at day 14 compared with the V group (53.7% vs. 31.0%, P=0.047) based on a modified intention-to-treat model. The overall mortality at day 28 did not significantly differ between the groups (22.0% vs. 38.1%, P=0.15), although the 60-day mortality was lower in the VR group (26.8% vs. 50.0%, P=0.042). Mortality from MRSA pneumonia had a trend toward a decrease in the VR group (14.7% vs. 28.6%, P=0.18).

The trial was limited because it was a single-site study and lacked statistical power to assess certain outcomes. Additionally, treatment protocols were not compared with other antimicrobial therapies.

Bottom line: Vancomycin plus rifampicin improves MRSA pneumonia outcomes in ICU patients.

Citation: Jung YJ, Koh Y, Hong SB, et al. Effect of vancomycin plus rifampicin in the treatment of nosocomial MRSA pneumonia. Crit Care Med. 2010;38(1):175-180.

Severe Sepsis Syndromes Are Not Always Caused by Bacteremia

Clinical question: What are the common causes of clinical sepsis?

Background: When sepsis is defined by systemic inflammatory response syndrome (SIRS) criteria, the etiology is not always infectious. Rapid initiation of antimicrobial therapy for infectious SIRS is a priority, but it could result in treating a significant number of patients who are not bacteremic.

Study design: Prospective secondary analysis of a registry of patients created to evaluate an institutional standard-of-care protocol.

Setting: Urban, 850-bed, tertiary-care teaching institution in North Carolina.

Synopsis: ED cases meeting the criteria for severe sepsis underwent a secondary review that looked at the cause of the sepsis. Only 45% of patients identified as having severe sepsis were blood-culture-positive during that episode of care. The culture-positive group was more likely to have central lines, malignancies, or reside in a nursing home.

Of the subgroup of culture-negative patients, 52% had another infectious etiology, most commonly pneumonia. Other “noninfectious mimics,” including inflammatory colitis, myocardial infarction, and pulmonary embolism, were noted in 32% of patients in the subgroup, and the cause was not identified in 16% of the patients.

In-hospital mortality was higher in the culture-positive group than in the culture-negative group (25% vs. 4%, P=0.05). There was no evidence of harm in patients with culture-negative sepsis treated for a systemic infection.

Bottom line: Many patients with a clinical picture of severe sepsis will not have positive blood cultures or an infectious etiology.

Citation: Heffner AC, Horton JM, Marchick MR, Jones AE. Etiology of illness in patients with severe sepsis admitted to the hospital from the emergency department. Clin Infect Dis. 2010;50(6):814-820.

Comanagement of Surgical Inpatients by Hospitalists Is Rapidly Expanding

Clinical question: What is the prevalence and nature of comanagement of surgical patients by medicine physicians?

Background: Comanagement of surgical patients is a common clinical role for hospitalists, but the relationship is not well characterized in the literature in terms of numbers of patients or types of physicians involved in this practice.

Study design: Retrospective cohort.

Setting: Cross-section of hospitals from a Medicare database.

Synopsis: During the study period, 35.2% of patients were comanaged by a medicine physician—23.7% by a generalist and 14% by a subspecialist. Cardiothoracic surgery patients were more likely to be comanaged by a subspecialist, whereas all other patients were more likely to be comanaged by a generalist.

Although subspecialist comanagement actually declined during the study period, overall comanagement increased from 33.3% in 1996 to 40.8% in 2006. This increase is entirely attributable to the increase in comanagement by hospitalists. Most of this growth occurred with orthopedic patients.

Patient factors associated with comanagement include advanced age, emergency admissions, and increasing comorbidities. Teaching hospitals had less comanagement, while midsize, nonteaching, and for-profit hospitals had more comanagement.

Bottom line: Comanagement of surgical patients by medicine physicians is a common and growing clinical relationship. Hospitalists are responsible for increasing numbers of comanaged surgical patients.

Citation: Sharma G, Kuo YF, Freeman J, Zhang DD, Goodwin JS. Comanagement of hospitalized surgical patients by medicine physicians in the United States. Arch Intern Med. 2010;170(4):363-368.

Probiotics Might Decrease Risk of Ventilator-Associated Pneumonia

Clinical question: Does the administration of probiotics decrease the incidence of ventilator-associated pneumonia in critically ill patients?

Background: Ventilator-associated pneumonia (VAP) is a major nosocomial infection in ICUs. Probiotics are thought to decrease colonization and, therefore, infection with serious hospital-acquired pathogens.

Study design: Meta-analysis of five randomized controlled trials.

Setting: ICU patients on mechanical ventilation for at least 24 hours.

Synopsis: Five trials met the inclusion criteria of comparing probiotics to placebo in critically ill patients on mechanical ventilation and reporting the outcome of VAP. Administration of probiotics decreased the incidence of VAP (odds ratio 0.61, 95% CI, 0.41-0.91) and colonization of the respiratory tract with Pseudomonas aeruginosa (OR 0.35, 95% CI, 0.13-0.93).

Length of ICU stay was decreased in the probiotic arm, although this effect was not statistically significant in all analyses. Probiotics had no effect on such outcomes as ICU mortality, in-hospital mortality, or duration of mechanical ventilation.

Bottom line: Probiotics might be an effective strategy to reduce the risk of VAP, even if they do not appear to impact such outcomes as mortality.

Citation: Siempos II, Ntaidou TK, Falagas ME. Impact of the administration of probiotics on the incidence of ventilator-associated pneumonia: a meta-analysis of randomized controlled trials. Crit Care Med. 2010;38(3):954-962. TH

PEDIATRIC HM LITERATURE

By Mark Shen, MD

Renal Ultrasound Identifies Children with High-Grade Vesicoureteral Reflux

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

Clinical question: What is the diagnostic accuracy of specific renal ultrasound (US) criterion for detection of vesicoureteral reflux (VUR)?

Background: Based on the paradigm that undetected and untreated VUR might lead to long-term complications, voiding cystography traditionally has been recommended for all young children with a first urinary tract infection (UTI). An increasing base of evidence suggests that antibiotic prophylaxis for low-grade VUR might be unnecessary. However, less-invasive methods of screening for high-grade reflux have not yet been identified.

Study design: Secondary analysis of data from a prior prospective study.

Setting: Nephrology department of a French teaching hospital.

Synopsis: One hundred seventeen children (0-16 years) with a UTI were included and underwent renal US and voiding cystography. Patients with a known uropathy or those who had received antibiotics within the past 48 hours were excluded. A generalized linear multilevel model was used to analyze the relationship between standardized renal US criterion and VUR.

Twenty-seven percent of children had VUR and 8% had high-grade VUR (grade ≥3). Pelvic, ureteral, and urinary tract dilatation were significantly associated with high-grade VUR. Ureteral dilatation offered the best combination of standardized criterion, sensitivity (75%), and specificity (88%).

Significant limitations of this study include the use of bag urine cultures and the lack of consensus-based US criterion for ureteral and pelvic dilatation. The authors appropriately caution that these renal US criteria do not identify all children with high-grade VUR and are merely one step toward an intermediate screening strategy for high-grade VUR in order to mitigate adverse effects of universal voiding cystography. Further validation of this work in a clinically representative population will be needed.

Bottom line: Ureteral dilatation accurately identifies children with high-grade VUR.

Citation: Leroy S, Vantalon S, Larakeb A, Ducou-Le-Pointe H, Bensman A. Vesicoureteral reflux in children with urinary tract infection: comparison of diagnostic accuracy of renal US criteria. Radiology. 2010;255(3):890-898.

In This Edition

Literature at a Glance

A guide to this month’s studies

• Risk factors for iatrogenic pneumothorax
• Residency acceptance and use of pharmaceutical industry funding
• Early cholecystectomy outcomes for gallstone pancreatitis
• Use of microbial DNA in sepsis
• Adding rifampicin to vancomycin in MRSA pneumonia
• Rate and outcomes of culture-negative severe sepsis
• Rates of surgical comanagement in U.S. hospitals
• Probiotics and rates of ventilator-associated pneumonia

Ultrasound Guidance and Operator Experience Decrease Risk of Pneumothorax Following Thoracentesis

Clinical question: How often does pneumothorax happen following thoracentesis, and what factors are associated with increased risk of this complication?

Background: Procedural complications are an important source of adverse events in the hospital. Iatrogenic pneumothorax after thoracentesis results in increased hospital length of stay, morbidity, and mortality. Large variation exists in reported pneumothorax rates, and little is known about procedure- and patient-specific factors associated with development of this complication.

Study design: Systematic review and meta-analysis.

Setting: Review of 24 MEDLINE-indexed studies from January 1966 to April 2009.

Synopsis: A total of 349 pneumothoraces were reported after 6,605 thoracenteses (overall incidence 6.0%). Chest-tube insertion was required in 34.1% of the cases. Risk for pneumothorax was significantly higher when larger needles or catheters were used compared with needles smaller than 20-gauge (odds ratio 2.5, 95% confidence interval [CI], 1.1-6.0) and after therapeutic thoracentesis compared with diagnostic procedures (OR 2.6, 95% CI, 1.8-3.8).

Procedures requiring two or more needle passes did not significantly increase pneumothorax risk (OR 2.5, 95% CI, 0.3-20.1). In contrast, pneumothorax rates were significantly lower when using ultrasound guidance (OR 0.3, 95% CI, 0.2-0.7) and with experienced operators (3.9% vs. 8.5%, P=0.04).

Examining patient risk factors, pneumothorax rates were similar regardless of effusion size and patient gender. Additionally, rates were similar among non-ICU inpatients, ICU inpatients, and outpatients. Data did show a trend toward increased risk of pneumothorax with mechanical ventilation (OR 4.0, 95% CI, 0.95-16.8), although no study directly compared rates in ICU patients with and without mechanical ventilation.

Bottom line: Ultrasound guidance is a modifiable factor that decreases the risk of post-thoracentesis pneumothorax. Pneumothorax rates are lower when performed by experienced clinicians, providing an important opportunity to reduce procedure-related complications by increasing direct trainee supervision.

Citation: Gordon CE, Feller-Kopman D, Balk EM, Smetana GW. Pneumothorax following thoracentesis: a systematic review and meta-analysis. Arch Intern Med. 2010;170(4):332-339.

Pharmaceutical Industry Support Is Common in U.S. Internal-Medicine Residency Programs

Clinical question: What are the current attitudes of program directors regarding pharmaceutical industry support of internal-medicine residency activities? What are the potential associations between program characteristics and acceptance of industry support?

Background: Increasing evidence suggests that interactions with the pharmaceutical industry influence physician attitudes and practices. Recently, the Association of American Medical Colleges (AAMC) proposed that academic medical centers prohibit the acceptance of all gifts and restrict access by pharmaceutical industry representatives.

Study design: Survey of U.S. internal-medicine residency program directors.

Setting: Web-based survey of residency program directors in 388 U.S. internal-medicine residency programs.

Synopsis: Of the 236 program directors responding to the survey, 132 (55.9%) reported accepting some kind of support from the pharmaceutical industry. Support was most commonly provided in the form of food for conferences (90.9%), educational materials (83.3%), office supplies (68.9%), and drug samples (57.6%).

When programs reported accepting pharmaceutical industry support, 67.9% cited a lack of other funding sources as the reason for acceptance. Only 22.7% of programs with a program director who thinks pharmaceutical support is unacceptable actually accepted industry support. The likelihood of accepting support was associated with location in the Southern U.S. and was inversely associated with the three-year rolling American Board of Internal Medicine (ABIM) pass rates (each 1% decrease in the pass rate was associated with a 21% increase in the odds of accepting pharmaceutical industry support).

Bottom line: While most program directors did not find pharmaceutical industry support desirable, more than half reported acceptance of such support, with most citing lack of other funding resources as the reason for acceptance.

Citation: Loertscher LL, Halvorsen AJ, Beasley BW, Holmboe ES, Kolars JC, McDonald FS. Pharmaceutical industry support and residency education: a survey of internal medicine program directors. Arch Intern Med. 2010;170(4):356-362.

Early Cholecystectomy Safely Decreases Hospital Stay in Patients with Mild Gallstone Pancreatitis

Clinical question: Can laparoscopic cholecystectomy performed within 48 hours of admission for mild gallstone pancreatitis reduce hospital length of stay without increasing perioperative complications?

Background: Although there is a clear consensus that patients who present with gallstone pancreatitis should undergo cholecystectomy to prevent recurrence, precise timing of surgery remains controversial.

Study design: Randomized prospective trial.

Setting: Harbor-UCLA Medical Center, a Los Angeles County public teaching hospital and Level I trauma center.

Synopsis: Patients were prospectively randomized to an early group and a control group. Inclusion criteria consisted of adults from the ages of 18 to 100 with mild gallstone pancreatitis and three or fewer Ranson criteria. The primary endpoint was length of hospital stay. The secondary endpoint was a composite of complications, including the need for conversion to open cholecystectomy, readmission within 30 days, bleeding requiring transfusion, bile duct injury, or wound infection.

The study was terminated after 50 patients, as there was a difference in the length of hospital stay with a predefined alpha level of 0.005. Patients in the early group were taken to the operating room at a mean of 35.1 hours after admission, compared with 77.8 hours in the control group. The overall length of hospital stay was shorter in the early group (mean 3.5 days, 95% CI, 2.7-4.3), compared with the control group (mean 5.8, 95% CI, 3.8-7.9). All cholecystectomies were completed laparoscopically, without conversion to open. No statistically significant difference existed in secondary endpoints (P=0.48, OR 1.66, 95% CI, 0.41-6.78).

Bottom line: Laparoscopic cholecystectomy performed within 48 hours of admission, irrespective of normalization of laboratory values or clinical progress, safely decreases the overall length of stay, compared with delaying laparoscopic cholecystectomy until laboratory values and clinical condition normalize.

Citation: Aboulian A, Chan T, Yaghoubian A, et al. Early cholecystectomy safely decreases hospital stay in patients with mild gallstone pancreatitis: a randomized prospective study. Ann Surg. 2010;251(4): 615-619.

Presence of Microbial DNA in Blood Correlates with Disease Severity

Clinical question: Is the presence of microbial DNA in the blood associated with disease severity in severe sepsis, and how does detection of this microbial DNA by polymerase chain reaction (PCR) compare with blood cultures (BC)?

Background: Inadequate antibiotic therapy is a strong and independent predictor of poor outcomes in sepsis. Diagnostic uncertainty regarding the causative micro-organism is compensated for by liberal use of broad-spectrum antibiotics. As a result, resistance to antibiotics is an increasing public-health problem.

Study design: Prospective multicenter controlled observational study.

Setting: Three ICUs in Germany and France.

Synopsis: From 2005 to 2007, 63 patients were enrolled in the control group and 142 patients were enrolled in the sepsis group. In control patients, blood cultures and specimens were drawn daily at a maximum of three days after admission. In the sepsis group, blood samples were obtained on the day severe sepsis was suspected. Consecutive samples for the next two days after study inclusion were taken.

Taking BC as the laboratory comparison method, the sensitivity of PCR to detect culture-positive bacteremia in sepsis was 0.80 with a specificity of 0.77. PCR detected 29 of 41 microorganisms (70.3%) found in the BC. The highest recovery rate was observed for gram-negative bacteria (78.6%), fungi (50.0%), and gram-positive bacteria (47.6%). PCR from septic patients correlated well with markers of host response (IL-6 and PCT) and disease severity (SOFA score), even when the BC remained negative.

The appropriateness of antimicrobial therapy based on culture-based methods was not recorded, so it’s impossible to conclude whether or not the PCR would have contributed to a more effective therapy.

Bottom line: Concordance between BC and PCR is moderate in septic patients. PCR-based pathogen detection correlated with disease severity even if the BC remained negative, suggesting that the presence of microbial DNA in the bloodstream is a clinically significant event.

Citation: Bloos F, Hinder F, Becker K, et al. A multicenter trial to compare blood culture with polymerase chain reaction in severe human sepsis. Intensive Care Med. 2010;36(2):241-247.

Adding Rifampicin to Vancomycin Improves Outcomes in MRSA Pneumonia

Clinical question: Does adding rifampicin to vancomycin improve outcomes in patients with hospital-acquired MRSA pneumonia?

Background: Hospital-acquired MRSA pneumonia has a mortality of more than 20%. Vancomycin penetrates the lung tissue poorly. The value of adding rifampicin, an antibiotic with broad-spectrum coverage and good tissue penetration, was investigated.

Study design: Randomized open-label trial.

Setting: Medical ICU patients at Ulsan College of Medicine, Asan Medical Center, South Korea.

Synopsis: Patients older than 18 years of age with clinical symptoms suggestive of nosocomial pneumonia were randomized to receive vancomycin alone (V) or vancomycin plus rifampicin (VR). Clinicians could add additional antibiotics for gram-negative coverage as needed.

Of the 183 patients screened, 93 met the inclusion criteria and were randomized in a 1:1 ratio. MRSA infection was microbiologically confirmed. Clinical cure rate in VR patients was significantly greater at day 14 compared with the V group (53.7% vs. 31.0%, P=0.047) based on a modified intention-to-treat model. The overall mortality at day 28 did not significantly differ between the groups (22.0% vs. 38.1%, P=0.15), although the 60-day mortality was lower in the VR group (26.8% vs. 50.0%, P=0.042). Mortality from MRSA pneumonia had a trend toward a decrease in the VR group (14.7% vs. 28.6%, P=0.18).

The trial was limited because it was a single-site study and lacked statistical power to assess certain outcomes. Additionally, treatment protocols were not compared with other antimicrobial therapies.

Bottom line: Vancomycin plus rifampicin improves MRSA pneumonia outcomes in ICU patients.

Citation: Jung YJ, Koh Y, Hong SB, et al. Effect of vancomycin plus rifampicin in the treatment of nosocomial MRSA pneumonia. Crit Care Med. 2010;38(1):175-180.

Severe Sepsis Syndromes Are Not Always Caused by Bacteremia

Clinical question: What are the common causes of clinical sepsis?

Background: When sepsis is defined by systemic inflammatory response syndrome (SIRS) criteria, the etiology is not always infectious. Rapid initiation of antimicrobial therapy for infectious SIRS is a priority, but it could result in treating a significant number of patients who are not bacteremic.

Study design: Prospective secondary analysis of a registry of patients created to evaluate an institutional standard-of-care protocol.

Setting: Urban, 850-bed, tertiary-care teaching institution in North Carolina.

Synopsis: ED cases meeting the criteria for severe sepsis underwent a secondary review that looked at the cause of the sepsis. Only 45% of patients identified as having severe sepsis were blood-culture-positive during that episode of care. The culture-positive group was more likely to have central lines, malignancies, or reside in a nursing home.

Of the subgroup of culture-negative patients, 52% had another infectious etiology, most commonly pneumonia. Other “noninfectious mimics,” including inflammatory colitis, myocardial infarction, and pulmonary embolism, were noted in 32% of patients in the subgroup, and the cause was not identified in 16% of the patients.

In-hospital mortality was higher in the culture-positive group than in the culture-negative group (25% vs. 4%, P=0.05). There was no evidence of harm in patients with culture-negative sepsis treated for a systemic infection.

Bottom line: Many patients with a clinical picture of severe sepsis will not have positive blood cultures or an infectious etiology.

Citation: Heffner AC, Horton JM, Marchick MR, Jones AE. Etiology of illness in patients with severe sepsis admitted to the hospital from the emergency department. Clin Infect Dis. 2010;50(6):814-820.

Comanagement of Surgical Inpatients by Hospitalists Is Rapidly Expanding

Clinical question: What is the prevalence and nature of comanagement of surgical patients by medicine physicians?

Background: Comanagement of surgical patients is a common clinical role for hospitalists, but the relationship is not well characterized in the literature in terms of numbers of patients or types of physicians involved in this practice.

Study design: Retrospective cohort.

Setting: Cross-section of hospitals from a Medicare database.

Synopsis: During the study period, 35.2% of patients were comanaged by a medicine physician—23.7% by a generalist and 14% by a subspecialist. Cardiothoracic surgery patients were more likely to be comanaged by a subspecialist, whereas all other patients were more likely to be comanaged by a generalist.

Although subspecialist comanagement actually declined during the study period, overall comanagement increased from 33.3% in 1996 to 40.8% in 2006. This increase is entirely attributable to the increase in comanagement by hospitalists. Most of this growth occurred with orthopedic patients.

Patient factors associated with comanagement include advanced age, emergency admissions, and increasing comorbidities. Teaching hospitals had less comanagement, while midsize, nonteaching, and for-profit hospitals had more comanagement.

Bottom line: Comanagement of surgical patients by medicine physicians is a common and growing clinical relationship. Hospitalists are responsible for increasing numbers of comanaged surgical patients.

Citation: Sharma G, Kuo YF, Freeman J, Zhang DD, Goodwin JS. Comanagement of hospitalized surgical patients by medicine physicians in the United States. Arch Intern Med. 2010;170(4):363-368.

Probiotics Might Decrease Risk of Ventilator-Associated Pneumonia

Clinical question: Does the administration of probiotics decrease the incidence of ventilator-associated pneumonia in critically ill patients?

Background: Ventilator-associated pneumonia (VAP) is a major nosocomial infection in ICUs. Probiotics are thought to decrease colonization and, therefore, infection with serious hospital-acquired pathogens.

Study design: Meta-analysis of five randomized controlled trials.

Setting: ICU patients on mechanical ventilation for at least 24 hours.

Synopsis: Five trials met the inclusion criteria of comparing probiotics to placebo in critically ill patients on mechanical ventilation and reporting the outcome of VAP. Administration of probiotics decreased the incidence of VAP (odds ratio 0.61, 95% CI, 0.41-0.91) and colonization of the respiratory tract with Pseudomonas aeruginosa (OR 0.35, 95% CI, 0.13-0.93).

Length of ICU stay was decreased in the probiotic arm, although this effect was not statistically significant in all analyses. Probiotics had no effect on such outcomes as ICU mortality, in-hospital mortality, or duration of mechanical ventilation.

Bottom line: Probiotics might be an effective strategy to reduce the risk of VAP, even if they do not appear to impact such outcomes as mortality.

Citation: Siempos II, Ntaidou TK, Falagas ME. Impact of the administration of probiotics on the incidence of ventilator-associated pneumonia: a meta-analysis of randomized controlled trials. Crit Care Med. 2010;38(3):954-962. TH

PEDIATRIC HM LITERATURE

By Mark Shen, MD

Renal Ultrasound Identifies Children with High-Grade Vesicoureteral Reflux

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

Clinical question: What is the diagnostic accuracy of specific renal ultrasound (US) criterion for detection of vesicoureteral reflux (VUR)?

Background: Based on the paradigm that undetected and untreated VUR might lead to long-term complications, voiding cystography traditionally has been recommended for all young children with a first urinary tract infection (UTI). An increasing base of evidence suggests that antibiotic prophylaxis for low-grade VUR might be unnecessary. However, less-invasive methods of screening for high-grade reflux have not yet been identified.

Study design: Secondary analysis of data from a prior prospective study.

Setting: Nephrology department of a French teaching hospital.

Synopsis: One hundred seventeen children (0-16 years) with a UTI were included and underwent renal US and voiding cystography. Patients with a known uropathy or those who had received antibiotics within the past 48 hours were excluded. A generalized linear multilevel model was used to analyze the relationship between standardized renal US criterion and VUR.

Twenty-seven percent of children had VUR and 8% had high-grade VUR (grade ≥3). Pelvic, ureteral, and urinary tract dilatation were significantly associated with high-grade VUR. Ureteral dilatation offered the best combination of standardized criterion, sensitivity (75%), and specificity (88%).

Significant limitations of this study include the use of bag urine cultures and the lack of consensus-based US criterion for ureteral and pelvic dilatation. The authors appropriately caution that these renal US criteria do not identify all children with high-grade VUR and are merely one step toward an intermediate screening strategy for high-grade VUR in order to mitigate adverse effects of universal voiding cystography. Further validation of this work in a clinically representative population will be needed.

Bottom line: Ureteral dilatation accurately identifies children with high-grade VUR.

Citation: Leroy S, Vantalon S, Larakeb A, Ducou-Le-Pointe H, Bensman A. Vesicoureteral reflux in children with urinary tract infection: comparison of diagnostic accuracy of renal US criteria. Radiology. 2010;255(3):890-898.

New Drugs, Indications, Dosage Forms, and Approvals

• Hydromorphone extended-release tablets (Exalgo) have been approved by the FDA as a once-daily treatment for managing moderate to severe pain in opioid-tolerant patients needing continuous opioid analgesia for an extended period of time.¹ This formulation uses the OROS osmotic delivery system to control the release rate. It is a CII controlled substance and is accompanied by a comprehensive Risk Evaluation and Mitigation Strategy (REMS) to ensure that the medication’s benefits outweigh its risks.
• IMGN910 has received orphan drug status for treating Merkel cell carcinoma, a skin cancer that usually occurs on the head or neck.² It is in early-stage clinical trials.
• Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA as a once-weekly immunoglobulin replacement therapy for patients with primary immunodeficiency.³ It’s the first 20% subcutaneous immunoglobulin to receive FDA approval. This high-concentration product is stabilized with L-proline, a naturally occurring amino acid, which allows it to be stored at room temperature (up to 25°C [77°F]). Some adverse reactions include injection site bruising, pain, cysts, eczema, irritation, headache, cough, diarrhea, and fatigue.⁴
• Velaglucerase alfa for injection (VPRIV) has been approved by the FDA to treat adults and children with the rare genetic disorder Gaucher disease.⁵ Patients with Gaucher disease have a deficiency of the glucocerebrosidase enzyme. This enzyme prevents lipids from building up in the liver, spleen, bone marrow, and nervous system, which prevents them from working properly. VPRIV, a long-term replacement therapy, is approved for Type 1 Gaucher disease, the most common form, and is an alternative to imiglucerase (Cerezyme), which is in short supply. The most common reactions seen in clinical trials were allergic reactions, headache, dizziness, abdominal and back pain, nausea, fatigue/weakness, fever, and prolonged activated partial thromboplastin time.

Pipeline

• Betrixaban is a once-daily oral anticoagulant in Phase 2 clinical studies.⁶ Compared with warfarin in the EXPLORE-Xa study, betrixaban decreased the bleeding incidence in patients with nonvalvular atrial fibrillation or atrial flutter who had at least one stroke risk factor. The major and clinically relevant nonmajor bleeding episodes occurred less frequently in betrixaban-treated patients.
• Dabigatran etexilate is an oral anticoagulant in Phase 3 clinical trials.⁷ At the recent American College of Cardiology meeting in Ingelheim, Germany, dabigatran demonstrated consistent stroke prevention in patients with atrial fibrillation. It also reduced the number of strokes in patients with atrial fibrillation, compared with warfarin therapy. Additionally, dabigatran etexilate 110 mg and 150 mg twice daily was associated with a lower rate of major bleeding compared with warfarin in atrial fibrillation patients at low risk of stroke.
• Fentanyl sublingual spray (SL Spray) is in Phase 3 clinical trials to treat breakthrough pain in cancer patients. Sublingual administration of this product showed rapid, effective pain relief within five minutes.⁸
• Ketamine intranasal (Ereska) is a nonopioid NMDA receptor antagonist analgesic, which is undergoing Phase 3 clinical trials for managing moderate to severe acute pain.⁹ Studies have shown rapid, statistically significant relief of moderate to severe acute postoperative pain following dental surgery, following a variety of major orthopedic surgical procedures, and in cancer breakthrough pain.
• Lu AA21004 and Lu AA24530 are undergoing Phase 3 clinical trials for treating major depressive disorder (MDD).¹⁰ Lu AA21004 is a 5-HT3, 5-HT7 and 5-HT1B receptor antagonist, 5HT1A receptor agonist, and 5-HT transporter inhibitor. To date, it has shown a low propensity for drug-drug interactions and is extensively metabolized in the liver. Lu AA24530 has shown activity as a multimodal enhancer with reuptake inhibition at monoamine transporters, and having 5-HT3 and 5-HT2c receptor antagonist activity.
• Lurasidone is an atypical antipsychotic with high affinity and antagonist effects at the dopamine D2, serotonin 5-HT2, and serotonin 5-HT7 receptors.¹¹ It is a partial agonist at serotonin 5HT1A receptor. The NDA was filed for this agent Dec. 30, 2009.
• Mipomersen, an apo-B synthesis inhibitor, is in Phase 3 clinical trials for treating patients with homozygous familial hypercholesterolemia (HoFM).¹² This agent is proposed to reduce LDL-C by preventing the development of atherogenic lipids. In a study published in Lancet, mipomersen reduced LDL-C levels by an average of more than 100 mg/dL in HoFM patients.¹³
• Oxycodone/niacin (Acurox), an abuse deterrent formulation for this popular opioid, has been rejected by the FDA.¹⁴ According to the FDA and its review committee, the rejection was due to the “flushing” from the niacin, which was deemed ineffective as an abuse deterrent. In addition, the FDA said the “flushing” could be overcome by food intake or administration with over-the-counter pain relievers.
• Vilanterol/fluticasone is a combination of the inhaled corticosteroid fluticasone and the long-acting beta-agonist (LABA) vilanterol.¹⁵ It is in Phase 3 clinical trials for treating asthma. TH

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

References

1. FDA approves Exaglo (hydromorphone HCl) extended-release tablets. Drugs.com website. Available at: www.drugs.com/newdrugs/fda-approves-exaglo-hydromorphone-hcl-extended-release-2033.html?printable=1. Accessed April 27, 2010.
2. ImmunoGen’s skin cancer drug gets orphan drug status. Reuters website. Available at: www.reuters.com/article/idUSSGE6270L720100308. Accessed April 27, 2010.
3. CSL Behring receives FDA approval of Hizentra, first 20 percent subcutaneous immunoglobulin therapy. Drugs.com website. Available at: www.drugs.com/newdrugs/csl-behring-receives-fda-approval-hizentra-first-20-percent-subcutaneous-immunoglobulin-therapy-2037.html. Accessed April 27, 2010.
4. Petrochko C. FDA okays 20% skin-injection immunodeficiency treatment. MedPage Today website. Available at: www.medpagetoday.com/tbprint.cfm?tbid=18858. Accessed April 27, 2010.
5. Gansz Bobo E. FDA approves therapy to treat Gaucher disease. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm202288.htm. Accessed April 27, 2010.
6. Portola Pharmaceuticals and Merck announce that Phase 2 study showed investigational factor Xa inhibitor, betrixaban, reduced incidence of bleeding compared to warfarin in patients with atrial fibrillation. Merck website. Available at: www.merck.com/newsroom/news-release-archive/research-and-development/2010_0315.html. Accessed April 27, 2010.
7. Dabigatran etexilate shows greater reductions than warfarin in stroke in patients with atrial fibrillation across all stroke risk groups. Beohringer Ingelheim website. Available at: www.boehringer-ingelheim.com/news/news_releases/press_releases/2010/15_march_2010.html. Accessed April 27, 2010.
8. INSYS Therapeutics, Inc. Announces Positive Phase III Efficacy Trial Results for Fentanyl Sublingual Spray. INSYS Therapeutics website. Available at: www.insysrx.com/news.htm. Accessed April 27, 2010.
9. Third party reexamination of Javelin Pharmaceuticals’ Phase III trial data for Ereska (intranasal ketamine) yields statistically significant primary endpoint. Javelin website. Available at: ir.javelinpharmaceuticals.com/releasedetail.cfm?ReleaseID=444353. Accessed April 27, 2010.
10. Lundbeck and Takeda finalise plans to initiate phase III pivotal clinical trials with Lu AA21004 and Lu AA24530. Takeda Pharmaceutical Company Limited website. Available at: www.takeda.com/press/article_35859.html. Accessed April 27, 2010.
11. Dainippon Sumitomo Pharma America announces FDA acceptance of lurasidone new drug application for treatment of schizophrenia. PR Newswire website. Available at: www.prnewswire.com/news-releases/dainippon-sumitomo-pharma-america-announces-fda-acceptance-of-lurasidone-new-drug-application-for-treatment-of-schizophrenia-87265597.html. Accessed April 27, 2010.
12. Mipomersen Phase 3 study in HoFH featured in The Lancet. Business Wire website. Available at: www.businesswire.com/portal/site/home/email/alert/?ndmViewId=news_view&newsLang=en&newsId=20100315005928. Accessed April 27, 2010.
13. Raal FJ, Santos RD, Blom DJ, et al. Mipomersen, an apolipoprotein B synthesis inhibitor, for lowering of LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;375(9719):998-1006.
14. US FDA panel rejects King, Acura painkiller. Reuters website. Available at: www.reuters.com/assets/print?aid=USN2223552220100422. Accessed April 27, 2010.
15. Dennis M. GlaxoSmithKline begins late-stage clinical programme for asthma drug Relovair. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=E256469FBD8F4A2F80C5DD3E844CC1E1&logRowId=356423. Accessed April 27, 2010.

New Drugs, Indications, Dosage Forms, and Approvals

• Hydromorphone extended-release tablets (Exalgo) have been approved by the FDA as a once-daily treatment for managing moderate to severe pain in opioid-tolerant patients needing continuous opioid analgesia for an extended period of time.¹ This formulation uses the OROS osmotic delivery system to control the release rate. It is a CII controlled substance and is accompanied by a comprehensive Risk Evaluation and Mitigation Strategy (REMS) to ensure that the medication’s benefits outweigh its risks.
• IMGN910 has received orphan drug status for treating Merkel cell carcinoma, a skin cancer that usually occurs on the head or neck.² It is in early-stage clinical trials.
• Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA as a once-weekly immunoglobulin replacement therapy for patients with primary immunodeficiency.³ It’s the first 20% subcutaneous immunoglobulin to receive FDA approval. This high-concentration product is stabilized with L-proline, a naturally occurring amino acid, which allows it to be stored at room temperature (up to 25°C [77°F]). Some adverse reactions include injection site bruising, pain, cysts, eczema, irritation, headache, cough, diarrhea, and fatigue.⁴
• Velaglucerase alfa for injection (VPRIV) has been approved by the FDA to treat adults and children with the rare genetic disorder Gaucher disease.⁵ Patients with Gaucher disease have a deficiency of the glucocerebrosidase enzyme. This enzyme prevents lipids from building up in the liver, spleen, bone marrow, and nervous system, which prevents them from working properly. VPRIV, a long-term replacement therapy, is approved for Type 1 Gaucher disease, the most common form, and is an alternative to imiglucerase (Cerezyme), which is in short supply. The most common reactions seen in clinical trials were allergic reactions, headache, dizziness, abdominal and back pain, nausea, fatigue/weakness, fever, and prolonged activated partial thromboplastin time.

Pipeline

• Betrixaban is a once-daily oral anticoagulant in Phase 2 clinical studies.⁶ Compared with warfarin in the EXPLORE-Xa study, betrixaban decreased the bleeding incidence in patients with nonvalvular atrial fibrillation or atrial flutter who had at least one stroke risk factor. The major and clinically relevant nonmajor bleeding episodes occurred less frequently in betrixaban-treated patients.
• Dabigatran etexilate is an oral anticoagulant in Phase 3 clinical trials.⁷ At the recent American College of Cardiology meeting in Ingelheim, Germany, dabigatran demonstrated consistent stroke prevention in patients with atrial fibrillation. It also reduced the number of strokes in patients with atrial fibrillation, compared with warfarin therapy. Additionally, dabigatran etexilate 110 mg and 150 mg twice daily was associated with a lower rate of major bleeding compared with warfarin in atrial fibrillation patients at low risk of stroke.
• Fentanyl sublingual spray (SL Spray) is in Phase 3 clinical trials to treat breakthrough pain in cancer patients. Sublingual administration of this product showed rapid, effective pain relief within five minutes.⁸
• Ketamine intranasal (Ereska) is a nonopioid NMDA receptor antagonist analgesic, which is undergoing Phase 3 clinical trials for managing moderate to severe acute pain.⁹ Studies have shown rapid, statistically significant relief of moderate to severe acute postoperative pain following dental surgery, following a variety of major orthopedic surgical procedures, and in cancer breakthrough pain.
• Lu AA21004 and Lu AA24530 are undergoing Phase 3 clinical trials for treating major depressive disorder (MDD).¹⁰ Lu AA21004 is a 5-HT3, 5-HT7 and 5-HT1B receptor antagonist, 5HT1A receptor agonist, and 5-HT transporter inhibitor. To date, it has shown a low propensity for drug-drug interactions and is extensively metabolized in the liver. Lu AA24530 has shown activity as a multimodal enhancer with reuptake inhibition at monoamine transporters, and having 5-HT3 and 5-HT2c receptor antagonist activity.
• Lurasidone is an atypical antipsychotic with high affinity and antagonist effects at the dopamine D2, serotonin 5-HT2, and serotonin 5-HT7 receptors.¹¹ It is a partial agonist at serotonin 5HT1A receptor. The NDA was filed for this agent Dec. 30, 2009.
• Mipomersen, an apo-B synthesis inhibitor, is in Phase 3 clinical trials for treating patients with homozygous familial hypercholesterolemia (HoFM).¹² This agent is proposed to reduce LDL-C by preventing the development of atherogenic lipids. In a study published in Lancet, mipomersen reduced LDL-C levels by an average of more than 100 mg/dL in HoFM patients.¹³
• Oxycodone/niacin (Acurox), an abuse deterrent formulation for this popular opioid, has been rejected by the FDA.¹⁴ According to the FDA and its review committee, the rejection was due to the “flushing” from the niacin, which was deemed ineffective as an abuse deterrent. In addition, the FDA said the “flushing” could be overcome by food intake or administration with over-the-counter pain relievers.
• Vilanterol/fluticasone is a combination of the inhaled corticosteroid fluticasone and the long-acting beta-agonist (LABA) vilanterol.¹⁵ It is in Phase 3 clinical trials for treating asthma. TH

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

References

1. FDA approves Exaglo (hydromorphone HCl) extended-release tablets. Drugs.com website. Available at: www.drugs.com/newdrugs/fda-approves-exaglo-hydromorphone-hcl-extended-release-2033.html?printable=1. Accessed April 27, 2010.
2. ImmunoGen’s skin cancer drug gets orphan drug status. Reuters website. Available at: www.reuters.com/article/idUSSGE6270L720100308. Accessed April 27, 2010.
3. CSL Behring receives FDA approval of Hizentra, first 20 percent subcutaneous immunoglobulin therapy. Drugs.com website. Available at: www.drugs.com/newdrugs/csl-behring-receives-fda-approval-hizentra-first-20-percent-subcutaneous-immunoglobulin-therapy-2037.html. Accessed April 27, 2010.
4. Petrochko C. FDA okays 20% skin-injection immunodeficiency treatment. MedPage Today website. Available at: www.medpagetoday.com/tbprint.cfm?tbid=18858. Accessed April 27, 2010.
5. Gansz Bobo E. FDA approves therapy to treat Gaucher disease. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm202288.htm. Accessed April 27, 2010.
6. Portola Pharmaceuticals and Merck announce that Phase 2 study showed investigational factor Xa inhibitor, betrixaban, reduced incidence of bleeding compared to warfarin in patients with atrial fibrillation. Merck website. Available at: www.merck.com/newsroom/news-release-archive/research-and-development/2010_0315.html. Accessed April 27, 2010.
7. Dabigatran etexilate shows greater reductions than warfarin in stroke in patients with atrial fibrillation across all stroke risk groups. Beohringer Ingelheim website. Available at: www.boehringer-ingelheim.com/news/news_releases/press_releases/2010/15_march_2010.html. Accessed April 27, 2010.
8. INSYS Therapeutics, Inc. Announces Positive Phase III Efficacy Trial Results for Fentanyl Sublingual Spray. INSYS Therapeutics website. Available at: www.insysrx.com/news.htm. Accessed April 27, 2010.
9. Third party reexamination of Javelin Pharmaceuticals’ Phase III trial data for Ereska (intranasal ketamine) yields statistically significant primary endpoint. Javelin website. Available at: ir.javelinpharmaceuticals.com/releasedetail.cfm?ReleaseID=444353. Accessed April 27, 2010.
10. Lundbeck and Takeda finalise plans to initiate phase III pivotal clinical trials with Lu AA21004 and Lu AA24530. Takeda Pharmaceutical Company Limited website. Available at: www.takeda.com/press/article_35859.html. Accessed April 27, 2010.
11. Dainippon Sumitomo Pharma America announces FDA acceptance of lurasidone new drug application for treatment of schizophrenia. PR Newswire website. Available at: www.prnewswire.com/news-releases/dainippon-sumitomo-pharma-america-announces-fda-acceptance-of-lurasidone-new-drug-application-for-treatment-of-schizophrenia-87265597.html. Accessed April 27, 2010.
12. Mipomersen Phase 3 study in HoFH featured in The Lancet. Business Wire website. Available at: www.businesswire.com/portal/site/home/email/alert/?ndmViewId=news_view&newsLang=en&newsId=20100315005928. Accessed April 27, 2010.
13. Raal FJ, Santos RD, Blom DJ, et al. Mipomersen, an apolipoprotein B synthesis inhibitor, for lowering of LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;375(9719):998-1006.
14. US FDA panel rejects King, Acura painkiller. Reuters website. Available at: www.reuters.com/assets/print?aid=USN2223552220100422. Accessed April 27, 2010.
15. Dennis M. GlaxoSmithKline begins late-stage clinical programme for asthma drug Relovair. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=E256469FBD8F4A2F80C5DD3E844CC1E1&logRowId=356423. Accessed April 27, 2010.

New Drugs, Indications, Dosage Forms, and Approvals

• Hydromorphone extended-release tablets (Exalgo) have been approved by the FDA as a once-daily treatment for managing moderate to severe pain in opioid-tolerant patients needing continuous opioid analgesia for an extended period of time.¹ This formulation uses the OROS osmotic delivery system to control the release rate. It is a CII controlled substance and is accompanied by a comprehensive Risk Evaluation and Mitigation Strategy (REMS) to ensure that the medication’s benefits outweigh its risks.
• IMGN910 has received orphan drug status for treating Merkel cell carcinoma, a skin cancer that usually occurs on the head or neck.² It is in early-stage clinical trials.
• Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA as a once-weekly immunoglobulin replacement therapy for patients with primary immunodeficiency.³ It’s the first 20% subcutaneous immunoglobulin to receive FDA approval. This high-concentration product is stabilized with L-proline, a naturally occurring amino acid, which allows it to be stored at room temperature (up to 25°C [77°F]). Some adverse reactions include injection site bruising, pain, cysts, eczema, irritation, headache, cough, diarrhea, and fatigue.⁴
• Velaglucerase alfa for injection (VPRIV) has been approved by the FDA to treat adults and children with the rare genetic disorder Gaucher disease.⁵ Patients with Gaucher disease have a deficiency of the glucocerebrosidase enzyme. This enzyme prevents lipids from building up in the liver, spleen, bone marrow, and nervous system, which prevents them from working properly. VPRIV, a long-term replacement therapy, is approved for Type 1 Gaucher disease, the most common form, and is an alternative to imiglucerase (Cerezyme), which is in short supply. The most common reactions seen in clinical trials were allergic reactions, headache, dizziness, abdominal and back pain, nausea, fatigue/weakness, fever, and prolonged activated partial thromboplastin time.

Pipeline

• Betrixaban is a once-daily oral anticoagulant in Phase 2 clinical studies.⁶ Compared with warfarin in the EXPLORE-Xa study, betrixaban decreased the bleeding incidence in patients with nonvalvular atrial fibrillation or atrial flutter who had at least one stroke risk factor. The major and clinically relevant nonmajor bleeding episodes occurred less frequently in betrixaban-treated patients.
• Dabigatran etexilate is an oral anticoagulant in Phase 3 clinical trials.⁷ At the recent American College of Cardiology meeting in Ingelheim, Germany, dabigatran demonstrated consistent stroke prevention in patients with atrial fibrillation. It also reduced the number of strokes in patients with atrial fibrillation, compared with warfarin therapy. Additionally, dabigatran etexilate 110 mg and 150 mg twice daily was associated with a lower rate of major bleeding compared with warfarin in atrial fibrillation patients at low risk of stroke.
• Fentanyl sublingual spray (SL Spray) is in Phase 3 clinical trials to treat breakthrough pain in cancer patients. Sublingual administration of this product showed rapid, effective pain relief within five minutes.⁸
• Ketamine intranasal (Ereska) is a nonopioid NMDA receptor antagonist analgesic, which is undergoing Phase 3 clinical trials for managing moderate to severe acute pain.⁹ Studies have shown rapid, statistically significant relief of moderate to severe acute postoperative pain following dental surgery, following a variety of major orthopedic surgical procedures, and in cancer breakthrough pain.
• Lu AA21004 and Lu AA24530 are undergoing Phase 3 clinical trials for treating major depressive disorder (MDD).¹⁰ Lu AA21004 is a 5-HT3, 5-HT7 and 5-HT1B receptor antagonist, 5HT1A receptor agonist, and 5-HT transporter inhibitor. To date, it has shown a low propensity for drug-drug interactions and is extensively metabolized in the liver. Lu AA24530 has shown activity as a multimodal enhancer with reuptake inhibition at monoamine transporters, and having 5-HT3 and 5-HT2c receptor antagonist activity.
• Lurasidone is an atypical antipsychotic with high affinity and antagonist effects at the dopamine D2, serotonin 5-HT2, and serotonin 5-HT7 receptors.¹¹ It is a partial agonist at serotonin 5HT1A receptor. The NDA was filed for this agent Dec. 30, 2009.
• Mipomersen, an apo-B synthesis inhibitor, is in Phase 3 clinical trials for treating patients with homozygous familial hypercholesterolemia (HoFM).¹² This agent is proposed to reduce LDL-C by preventing the development of atherogenic lipids. In a study published in Lancet, mipomersen reduced LDL-C levels by an average of more than 100 mg/dL in HoFM patients.¹³
• Oxycodone/niacin (Acurox), an abuse deterrent formulation for this popular opioid, has been rejected by the FDA.¹⁴ According to the FDA and its review committee, the rejection was due to the “flushing” from the niacin, which was deemed ineffective as an abuse deterrent. In addition, the FDA said the “flushing” could be overcome by food intake or administration with over-the-counter pain relievers.
• Vilanterol/fluticasone is a combination of the inhaled corticosteroid fluticasone and the long-acting beta-agonist (LABA) vilanterol.¹⁵ It is in Phase 3 clinical trials for treating asthma. TH

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

References

1. FDA approves Exaglo (hydromorphone HCl) extended-release tablets. Drugs.com website. Available at: www.drugs.com/newdrugs/fda-approves-exaglo-hydromorphone-hcl-extended-release-2033.html?printable=1. Accessed April 27, 2010.
2. ImmunoGen’s skin cancer drug gets orphan drug status. Reuters website. Available at: www.reuters.com/article/idUSSGE6270L720100308. Accessed April 27, 2010.
3. CSL Behring receives FDA approval of Hizentra, first 20 percent subcutaneous immunoglobulin therapy. Drugs.com website. Available at: www.drugs.com/newdrugs/csl-behring-receives-fda-approval-hizentra-first-20-percent-subcutaneous-immunoglobulin-therapy-2037.html. Accessed April 27, 2010.
4. Petrochko C. FDA okays 20% skin-injection immunodeficiency treatment. MedPage Today website. Available at: www.medpagetoday.com/tbprint.cfm?tbid=18858. Accessed April 27, 2010.
5. Gansz Bobo E. FDA approves therapy to treat Gaucher disease. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm202288.htm. Accessed April 27, 2010.
6. Portola Pharmaceuticals and Merck announce that Phase 2 study showed investigational factor Xa inhibitor, betrixaban, reduced incidence of bleeding compared to warfarin in patients with atrial fibrillation. Merck website. Available at: www.merck.com/newsroom/news-release-archive/research-and-development/2010_0315.html. Accessed April 27, 2010.
7. Dabigatran etexilate shows greater reductions than warfarin in stroke in patients with atrial fibrillation across all stroke risk groups. Beohringer Ingelheim website. Available at: www.boehringer-ingelheim.com/news/news_releases/press_releases/2010/15_march_2010.html. Accessed April 27, 2010.
8. INSYS Therapeutics, Inc. Announces Positive Phase III Efficacy Trial Results for Fentanyl Sublingual Spray. INSYS Therapeutics website. Available at: www.insysrx.com/news.htm. Accessed April 27, 2010.
9. Third party reexamination of Javelin Pharmaceuticals’ Phase III trial data for Ereska (intranasal ketamine) yields statistically significant primary endpoint. Javelin website. Available at: ir.javelinpharmaceuticals.com/releasedetail.cfm?ReleaseID=444353. Accessed April 27, 2010.
10. Lundbeck and Takeda finalise plans to initiate phase III pivotal clinical trials with Lu AA21004 and Lu AA24530. Takeda Pharmaceutical Company Limited website. Available at: www.takeda.com/press/article_35859.html. Accessed April 27, 2010.
11. Dainippon Sumitomo Pharma America announces FDA acceptance of lurasidone new drug application for treatment of schizophrenia. PR Newswire website. Available at: www.prnewswire.com/news-releases/dainippon-sumitomo-pharma-america-announces-fda-acceptance-of-lurasidone-new-drug-application-for-treatment-of-schizophrenia-87265597.html. Accessed April 27, 2010.
12. Mipomersen Phase 3 study in HoFH featured in The Lancet. Business Wire website. Available at: www.businesswire.com/portal/site/home/email/alert/?ndmViewId=news_view&newsLang=en&newsId=20100315005928. Accessed April 27, 2010.
13. Raal FJ, Santos RD, Blom DJ, et al. Mipomersen, an apolipoprotein B synthesis inhibitor, for lowering of LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;375(9719):998-1006.
14. US FDA panel rejects King, Acura painkiller. Reuters website. Available at: www.reuters.com/assets/print?aid=USN2223552220100422. Accessed April 27, 2010.
15. Dennis M. GlaxoSmithKline begins late-stage clinical programme for asthma drug Relovair. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=E256469FBD8F4A2F80C5DD3E844CC1E1&logRowId=356423. Accessed April 27, 2010.