According to a survey released last fall by the Health Forum, a subsidiary of the American Hospital Association, and the Samueli Institute of Alexandria, Va., complementary and alternative medicine (CAM) services in responding hospitals increased to 42% in 2010 from 37% in 2007.

The fourth Complementary and Alternative Medicine Survey of Hospitals is a follow-up report to the 2007 survey, which The Hospitalist featured in January 2010.

Twelve percent of 5,858 hospitals answered a 42-question instrument in 2010, according to Sita Ananth, MHA, director of knowledge services at the Samueli Institute and study report author. The results, Ananth says, showed that the hospitals most likely to offer CAM were urban and tended to be either medium-size (50-299 beds) or large (500+ beds) institutions.

What’s driving the increase? She believes that hospitals are simply responding to patients’ desire to have “the best that both conventional and alternative medicine can offer.”

[Hospitals undertaking complementary services should] start small and not have high expectations of breaking even for several years.

—Sita Ananth, MHA, director of knowledge services at the Samueli Institute and study report author

Sixty-five percent of hospitals responding to the survey offer CAM therapies for pain management. That figure is echoed in a 2008 National Health Statistics report (PDF) published by the Centers for Disease Control and Prevention. Back pain, neck pain, and joint pain were the three top reasons for using CAM, according to the CDC report.

“Adjacent” Treatment

Hospitalist Sanjay Reddy, MD, assistant clinical professor of medicine in the Department of Medicine at the University of California at San Francisco (UCSF), says acupuncture can be a valuable adjunct when treating patients for pain, chemotherapy-induced nausea, and insomnia. He is a trained acupuncturist and has studied complementary therapies extensively. He also is interested in exploring ways to incorporate acupuncture into the UCSF’s Osher Center for Integrative Medicine program.

David H. Gorski, MD, PhD, FACS, associate professor of surgery and director of the Breast Cancer Multidisciplinary Team at the Barbara Ann Karmanos Cancer Institute at Wayne State University School of Medicine in Detroit, strenuously objects to the incorporation of alternative therapies (often under the moniker of “integrative medicine”) in the hospital setting.

“If you accept the premise that medicine should be based in sound science and evidence, then we have an obligation not to be offering treatments that are not based in science,” he asserts. Dr. Gorski, who also blogs on such topics, finds that many of those who endorse integrative medicine have become “true believers,” and that some are mixing pseudo-science with science.

In an August 2011 post regarding the College of Physicians and Surgeons of Ontario’s draft policy on alternative treatments, Dr. Gorski wrote: “Competent adults have every right to seek out non-science-based medicine if that is what they desire. However, informed consent mandates that physicians who encounter such patients provide an honest professional assessment of such treatments based on science.”

Dr. Reddy notes that with appropriate disclosure, offering a modality such as acupuncture can be appropriate. For example, in the setting of pain relief, acupuncture offers a less sedative approach. He explains that Chinese diagnostics and treatment approaches are slightly different, so it’s difficult to study them in the context of randomized trials. (Click here to listen to more of Dr. Reddy’s discussion of appropriate indications for acupuncture.)

In the Health Forum/Samueli Institute survey, 57% of hospitals reported that their programs were not yet breaking even and only 16% said they'd be breaking even in three years (see Figure 1). In light of these results, Ananth says, hospitals undertaking complementary services should “start small and not have high expectations of breaking even for several years.”

Gretchen Henkel is a freelance writer in California. 

According to a survey released last fall by the Health Forum, a subsidiary of the American Hospital Association, and the Samueli Institute of Alexandria, Va., complementary and alternative medicine (CAM) services in responding hospitals increased to 42% in 2010 from 37% in 2007.

The fourth Complementary and Alternative Medicine Survey of Hospitals is a follow-up report to the 2007 survey, which The Hospitalist featured in January 2010.

Twelve percent of 5,858 hospitals answered a 42-question instrument in 2010, according to Sita Ananth, MHA, director of knowledge services at the Samueli Institute and study report author. The results, Ananth says, showed that the hospitals most likely to offer CAM were urban and tended to be either medium-size (50-299 beds) or large (500+ beds) institutions.

What’s driving the increase? She believes that hospitals are simply responding to patients’ desire to have “the best that both conventional and alternative medicine can offer.”

[Hospitals undertaking complementary services should] start small and not have high expectations of breaking even for several years.

—Sita Ananth, MHA, director of knowledge services at the Samueli Institute and study report author

Sixty-five percent of hospitals responding to the survey offer CAM therapies for pain management. That figure is echoed in a 2008 National Health Statistics report (PDF) published by the Centers for Disease Control and Prevention. Back pain, neck pain, and joint pain were the three top reasons for using CAM, according to the CDC report.

“Adjacent” Treatment

Hospitalist Sanjay Reddy, MD, assistant clinical professor of medicine in the Department of Medicine at the University of California at San Francisco (UCSF), says acupuncture can be a valuable adjunct when treating patients for pain, chemotherapy-induced nausea, and insomnia. He is a trained acupuncturist and has studied complementary therapies extensively. He also is interested in exploring ways to incorporate acupuncture into the UCSF’s Osher Center for Integrative Medicine program.

David H. Gorski, MD, PhD, FACS, associate professor of surgery and director of the Breast Cancer Multidisciplinary Team at the Barbara Ann Karmanos Cancer Institute at Wayne State University School of Medicine in Detroit, strenuously objects to the incorporation of alternative therapies (often under the moniker of “integrative medicine”) in the hospital setting.

“If you accept the premise that medicine should be based in sound science and evidence, then we have an obligation not to be offering treatments that are not based in science,” he asserts. Dr. Gorski, who also blogs on such topics, finds that many of those who endorse integrative medicine have become “true believers,” and that some are mixing pseudo-science with science.

In an August 2011 post regarding the College of Physicians and Surgeons of Ontario’s draft policy on alternative treatments, Dr. Gorski wrote: “Competent adults have every right to seek out non-science-based medicine if that is what they desire. However, informed consent mandates that physicians who encounter such patients provide an honest professional assessment of such treatments based on science.”

Dr. Reddy notes that with appropriate disclosure, offering a modality such as acupuncture can be appropriate. For example, in the setting of pain relief, acupuncture offers a less sedative approach. He explains that Chinese diagnostics and treatment approaches are slightly different, so it’s difficult to study them in the context of randomized trials. (Click here to listen to more of Dr. Reddy’s discussion of appropriate indications for acupuncture.)

In the Health Forum/Samueli Institute survey, 57% of hospitals reported that their programs were not yet breaking even and only 16% said they'd be breaking even in three years (see Figure 1). In light of these results, Ananth says, hospitals undertaking complementary services should “start small and not have high expectations of breaking even for several years.”

Gretchen Henkel is a freelance writer in California. 

According to a survey released last fall by the Health Forum, a subsidiary of the American Hospital Association, and the Samueli Institute of Alexandria, Va., complementary and alternative medicine (CAM) services in responding hospitals increased to 42% in 2010 from 37% in 2007.

The fourth Complementary and Alternative Medicine Survey of Hospitals is a follow-up report to the 2007 survey, which The Hospitalist featured in January 2010.

Twelve percent of 5,858 hospitals answered a 42-question instrument in 2010, according to Sita Ananth, MHA, director of knowledge services at the Samueli Institute and study report author. The results, Ananth says, showed that the hospitals most likely to offer CAM were urban and tended to be either medium-size (50-299 beds) or large (500+ beds) institutions.

What’s driving the increase? She believes that hospitals are simply responding to patients’ desire to have “the best that both conventional and alternative medicine can offer.”

[Hospitals undertaking complementary services should] start small and not have high expectations of breaking even for several years.

—Sita Ananth, MHA, director of knowledge services at the Samueli Institute and study report author

Sixty-five percent of hospitals responding to the survey offer CAM therapies for pain management. That figure is echoed in a 2008 National Health Statistics report (PDF) published by the Centers for Disease Control and Prevention. Back pain, neck pain, and joint pain were the three top reasons for using CAM, according to the CDC report.

“Adjacent” Treatment

Hospitalist Sanjay Reddy, MD, assistant clinical professor of medicine in the Department of Medicine at the University of California at San Francisco (UCSF), says acupuncture can be a valuable adjunct when treating patients for pain, chemotherapy-induced nausea, and insomnia. He is a trained acupuncturist and has studied complementary therapies extensively. He also is interested in exploring ways to incorporate acupuncture into the UCSF’s Osher Center for Integrative Medicine program.

David H. Gorski, MD, PhD, FACS, associate professor of surgery and director of the Breast Cancer Multidisciplinary Team at the Barbara Ann Karmanos Cancer Institute at Wayne State University School of Medicine in Detroit, strenuously objects to the incorporation of alternative therapies (often under the moniker of “integrative medicine”) in the hospital setting.

“If you accept the premise that medicine should be based in sound science and evidence, then we have an obligation not to be offering treatments that are not based in science,” he asserts. Dr. Gorski, who also blogs on such topics, finds that many of those who endorse integrative medicine have become “true believers,” and that some are mixing pseudo-science with science.

In an August 2011 post regarding the College of Physicians and Surgeons of Ontario’s draft policy on alternative treatments, Dr. Gorski wrote: “Competent adults have every right to seek out non-science-based medicine if that is what they desire. However, informed consent mandates that physicians who encounter such patients provide an honest professional assessment of such treatments based on science.”

Dr. Reddy notes that with appropriate disclosure, offering a modality such as acupuncture can be appropriate. For example, in the setting of pain relief, acupuncture offers a less sedative approach. He explains that Chinese diagnostics and treatment approaches are slightly different, so it’s difficult to study them in the context of randomized trials. (Click here to listen to more of Dr. Reddy’s discussion of appropriate indications for acupuncture.)

In the Health Forum/Samueli Institute survey, 57% of hospitals reported that their programs were not yet breaking even and only 16% said they'd be breaking even in three years (see Figure 1). In light of these results, Ananth says, hospitals undertaking complementary services should “start small and not have high expectations of breaking even for several years.”

Gretchen Henkel is a freelance writer in California. 

SILVER SPRING, MD. – The leukemia drug decitabine didn’t show robust-enough results to convince the majority of an advisory panel to support its approval by the U.S. Food and Drug Administration as a new treatment for elderly patients with acute myeloid leukemia.

Ten members of the independent Oncologic Drugs Advisory Committee (ODAC) voted no, three voted yes, and one member abstained on a question related to the proposed indication. They were asked whether decitabine (Dacogen) demonstrated a favorable risk-benefit profile for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients 65 years and older who are not candidates for induction chemotherapy.

Those who voted no said they didn't find the results of a key study convincing and were not comfortable drawing any solid conclusions. The yea-sayers said they looked beyond the fact that the study didn’t meet its end point and instead erred on the side of adding another treatment choice for doctors and their patients.

The FDA considers the panel’s recommendations, but doesn’t necessarily follow them.

Drugmaker Eisai sought the drug’s approval by filing an application to the FDA in May 2011, with the goal of meeting the "unmet medical need" of older adults with AML who are not candidates for induction therapy.

Although the company’s trials didn’t reach a statistically significant result, its officials made the argument that aggregate clinical data from a randomized trial and a single-arm study showed that the drug was well tolerated, had good efficacy and safety profiles, and would provide a clinically meaningful benefit to older patients with AML who are not candidates for induction chemotherapy.

But FDA officials made the case that the "primary end point of overall survival was not met and any further analyses are expiatory and inflate the false-positive rate." They also pointed out that they defined efficacy as a statistically significant survival rate or a rigorous analysis that shows noninferiority.

AML is mainly a disease of the elderly, with an onset at the median age of 69 years. Because of poorer outcomes among this age group, one-third of patients don’t receive chemotherapy.

Decitabine, a hypomethylating agent, was FDA approved in 2006 for the treatment of myelodysplastic syndromes.

A 2009 randomized, open-label, multinational phase III trial, conducted by Eisai, enrolled 485 patients, with a median age of 73. Patients were randomized to decitabine (242) or treatment of choice (low-dose cytarabine or supportive care) (243), with the primary end point of overall survival, prespecified as a 25% reduction in mortality risk.

Patients in the decitabine arm had a median overall survival of 7.7 months, compared with 5 months in the treatment of choice group, (hazard ratio, 0.85; P = .11). A 2010 post hoc analysis showed the median overall survival was unchanged, but the difference became statistically significant (HR, 0.82; P = .037).

FDA officials argued that, "given the final analysis results, post hoc analysis results could be due to chance," adding that the false-positive rate is greater than 5%.

Eisai also conducted a phase II supportive study, which was a single-arm trial that enrolled 55 patients with a median age of 60 years or older. The efficacy and safety results were similar to those of the randomized trial. The safety profile of decitabine was comparable to that in the label for myelodysplastic syndrome, Eisai officials reported.

"Elderly patients [with AML] are desperate for new treatments," said Dr. Mikkael Sekeres, an ODAC member from the department of hematologic oncology and blood disorders at the Cleveland Clinic Taussig Cancer Institute who voted no. "Unfortunately this drug didn’t do the job."

Dr. Wyndham Wilson, ODAC chair and chief of the lymphoma therapeutics section at the National Institutes of Health, voted yes and said he looked at the totality of the data and thought that they favored its approval.

"I see it as a rare setting, where we really have no good drugs. I couldn’t get stuck on that the primary end point wasn’t met. I feel that I wanted to err on the side of choice," he said. "For me the data was sufficiently robust to approve the drug and have the choice available for physicians and patients."

Dr. Ralph Freedman of the University of Texas M.D. Anderson Cancer Center in Houston – the only ODAC member who abstained from voting – said it was his first time doing so, and he expressed his ambivalence on the risks and benefits of the drug based on the study’s results.

Meanwhile, the issue at hand highlights the fact that the standard of care for treating older adults with AML is not clearly defined, said Dr. Sekeres. Their treatment options currently range from induction chemotherapy to aggressive supportive care, with low-dose cytarabine therapy as a middle-of-the-road therapy.

There are currently four FDA-approved first-line drugs for AML. The last drug was idarubicin, approved in 1990.

Another issue highlighted during the discussions was the available treatments for the growing aging population. The medical community is entering somewhat of an uncharted territory and such trials are important, said Dr. William Kevin Kelly, a voting member of ODAC and professor of medical oncology and urology at Thomas Jefferson University, Philadelphia who voted no.

Panelists were cleared of potential conflicts before voting on decitabine.

SILVER SPRING, MD. – The leukemia drug decitabine didn’t show robust-enough results to convince the majority of an advisory panel to support its approval by the U.S. Food and Drug Administration as a new treatment for elderly patients with acute myeloid leukemia.

Ten members of the independent Oncologic Drugs Advisory Committee (ODAC) voted no, three voted yes, and one member abstained on a question related to the proposed indication. They were asked whether decitabine (Dacogen) demonstrated a favorable risk-benefit profile for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients 65 years and older who are not candidates for induction chemotherapy.

Those who voted no said they didn't find the results of a key study convincing and were not comfortable drawing any solid conclusions. The yea-sayers said they looked beyond the fact that the study didn’t meet its end point and instead erred on the side of adding another treatment choice for doctors and their patients.

The FDA considers the panel’s recommendations, but doesn’t necessarily follow them.

Drugmaker Eisai sought the drug’s approval by filing an application to the FDA in May 2011, with the goal of meeting the "unmet medical need" of older adults with AML who are not candidates for induction therapy.

Although the company’s trials didn’t reach a statistically significant result, its officials made the argument that aggregate clinical data from a randomized trial and a single-arm study showed that the drug was well tolerated, had good efficacy and safety profiles, and would provide a clinically meaningful benefit to older patients with AML who are not candidates for induction chemotherapy.

But FDA officials made the case that the "primary end point of overall survival was not met and any further analyses are expiatory and inflate the false-positive rate." They also pointed out that they defined efficacy as a statistically significant survival rate or a rigorous analysis that shows noninferiority.

AML is mainly a disease of the elderly, with an onset at the median age of 69 years. Because of poorer outcomes among this age group, one-third of patients don’t receive chemotherapy.

Decitabine, a hypomethylating agent, was FDA approved in 2006 for the treatment of myelodysplastic syndromes.

A 2009 randomized, open-label, multinational phase III trial, conducted by Eisai, enrolled 485 patients, with a median age of 73. Patients were randomized to decitabine (242) or treatment of choice (low-dose cytarabine or supportive care) (243), with the primary end point of overall survival, prespecified as a 25% reduction in mortality risk.

Patients in the decitabine arm had a median overall survival of 7.7 months, compared with 5 months in the treatment of choice group, (hazard ratio, 0.85; P = .11). A 2010 post hoc analysis showed the median overall survival was unchanged, but the difference became statistically significant (HR, 0.82; P = .037).

FDA officials argued that, "given the final analysis results, post hoc analysis results could be due to chance," adding that the false-positive rate is greater than 5%.

Eisai also conducted a phase II supportive study, which was a single-arm trial that enrolled 55 patients with a median age of 60 years or older. The efficacy and safety results were similar to those of the randomized trial. The safety profile of decitabine was comparable to that in the label for myelodysplastic syndrome, Eisai officials reported.

"Elderly patients [with AML] are desperate for new treatments," said Dr. Mikkael Sekeres, an ODAC member from the department of hematologic oncology and blood disorders at the Cleveland Clinic Taussig Cancer Institute who voted no. "Unfortunately this drug didn’t do the job."

Dr. Wyndham Wilson, ODAC chair and chief of the lymphoma therapeutics section at the National Institutes of Health, voted yes and said he looked at the totality of the data and thought that they favored its approval.

"I see it as a rare setting, where we really have no good drugs. I couldn’t get stuck on that the primary end point wasn’t met. I feel that I wanted to err on the side of choice," he said. "For me the data was sufficiently robust to approve the drug and have the choice available for physicians and patients."

Dr. Ralph Freedman of the University of Texas M.D. Anderson Cancer Center in Houston – the only ODAC member who abstained from voting – said it was his first time doing so, and he expressed his ambivalence on the risks and benefits of the drug based on the study’s results.

Meanwhile, the issue at hand highlights the fact that the standard of care for treating older adults with AML is not clearly defined, said Dr. Sekeres. Their treatment options currently range from induction chemotherapy to aggressive supportive care, with low-dose cytarabine therapy as a middle-of-the-road therapy.

There are currently four FDA-approved first-line drugs for AML. The last drug was idarubicin, approved in 1990.

Another issue highlighted during the discussions was the available treatments for the growing aging population. The medical community is entering somewhat of an uncharted territory and such trials are important, said Dr. William Kevin Kelly, a voting member of ODAC and professor of medical oncology and urology at Thomas Jefferson University, Philadelphia who voted no.

Panelists were cleared of potential conflicts before voting on decitabine.

SILVER SPRING, MD. – The leukemia drug decitabine didn’t show robust-enough results to convince the majority of an advisory panel to support its approval by the U.S. Food and Drug Administration as a new treatment for elderly patients with acute myeloid leukemia.

Ten members of the independent Oncologic Drugs Advisory Committee (ODAC) voted no, three voted yes, and one member abstained on a question related to the proposed indication. They were asked whether decitabine (Dacogen) demonstrated a favorable risk-benefit profile for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients 65 years and older who are not candidates for induction chemotherapy.

Those who voted no said they didn't find the results of a key study convincing and were not comfortable drawing any solid conclusions. The yea-sayers said they looked beyond the fact that the study didn’t meet its end point and instead erred on the side of adding another treatment choice for doctors and their patients.

The FDA considers the panel’s recommendations, but doesn’t necessarily follow them.

Drugmaker Eisai sought the drug’s approval by filing an application to the FDA in May 2011, with the goal of meeting the "unmet medical need" of older adults with AML who are not candidates for induction therapy.

Although the company’s trials didn’t reach a statistically significant result, its officials made the argument that aggregate clinical data from a randomized trial and a single-arm study showed that the drug was well tolerated, had good efficacy and safety profiles, and would provide a clinically meaningful benefit to older patients with AML who are not candidates for induction chemotherapy.

But FDA officials made the case that the "primary end point of overall survival was not met and any further analyses are expiatory and inflate the false-positive rate." They also pointed out that they defined efficacy as a statistically significant survival rate or a rigorous analysis that shows noninferiority.

AML is mainly a disease of the elderly, with an onset at the median age of 69 years. Because of poorer outcomes among this age group, one-third of patients don’t receive chemotherapy.

Decitabine, a hypomethylating agent, was FDA approved in 2006 for the treatment of myelodysplastic syndromes.

A 2009 randomized, open-label, multinational phase III trial, conducted by Eisai, enrolled 485 patients, with a median age of 73. Patients were randomized to decitabine (242) or treatment of choice (low-dose cytarabine or supportive care) (243), with the primary end point of overall survival, prespecified as a 25% reduction in mortality risk.

Patients in the decitabine arm had a median overall survival of 7.7 months, compared with 5 months in the treatment of choice group, (hazard ratio, 0.85; P = .11). A 2010 post hoc analysis showed the median overall survival was unchanged, but the difference became statistically significant (HR, 0.82; P = .037).

FDA officials argued that, "given the final analysis results, post hoc analysis results could be due to chance," adding that the false-positive rate is greater than 5%.

Eisai also conducted a phase II supportive study, which was a single-arm trial that enrolled 55 patients with a median age of 60 years or older. The efficacy and safety results were similar to those of the randomized trial. The safety profile of decitabine was comparable to that in the label for myelodysplastic syndrome, Eisai officials reported.

"Elderly patients [with AML] are desperate for new treatments," said Dr. Mikkael Sekeres, an ODAC member from the department of hematologic oncology and blood disorders at the Cleveland Clinic Taussig Cancer Institute who voted no. "Unfortunately this drug didn’t do the job."

Dr. Wyndham Wilson, ODAC chair and chief of the lymphoma therapeutics section at the National Institutes of Health, voted yes and said he looked at the totality of the data and thought that they favored its approval.

"I see it as a rare setting, where we really have no good drugs. I couldn’t get stuck on that the primary end point wasn’t met. I feel that I wanted to err on the side of choice," he said. "For me the data was sufficiently robust to approve the drug and have the choice available for physicians and patients."

Dr. Ralph Freedman of the University of Texas M.D. Anderson Cancer Center in Houston – the only ODAC member who abstained from voting – said it was his first time doing so, and he expressed his ambivalence on the risks and benefits of the drug based on the study’s results.

Meanwhile, the issue at hand highlights the fact that the standard of care for treating older adults with AML is not clearly defined, said Dr. Sekeres. Their treatment options currently range from induction chemotherapy to aggressive supportive care, with low-dose cytarabine therapy as a middle-of-the-road therapy.

There are currently four FDA-approved first-line drugs for AML. The last drug was idarubicin, approved in 1990.

Another issue highlighted during the discussions was the available treatments for the growing aging population. The medical community is entering somewhat of an uncharted territory and such trials are important, said Dr. William Kevin Kelly, a voting member of ODAC and professor of medical oncology and urology at Thomas Jefferson University, Philadelphia who voted no.

Panelists were cleared of potential conflicts before voting on decitabine.

A pair of new studies suggest that dabigatran etexilate (Pradaxa), the first new oral anticoagulant approved in 56 years, increases the risk of myocardial infarction (MI) and acute coronary syndrome (ACS) in patients. But the author of one of the reports says the drug's benefits may be worth the risks.

"Yes, there's an increase, but that tends to be the headline," says Ken Uchino, MD, FAHA, program director of the Vascular Neurology Fellowship at the Cleveland Clinic's Cerebrovascular Center. "We have to think about the benefits and the risk balance. So far, it is favorable."

Dr. Uchino and a colleague's meta-analysis, "Dabigatran Association with Higher Risk of Acute Coronary Events," was published last month on the Archives of Internal Medicine's website. The report found dabigatran, which was approved last year, was significantly associated with a higher risk of MI or ACS when measured against multiple control groups.

A separate study, "Myocardial Ischemic Events in Patients with Atrial Fibrillation Treated with Dabigatran or Warfarin in the RE-LY Trial," published on Circulation's website, reported a nonsignificant increase in MI with dabigatran compared with warfarin, but other myocardial ischemic events were not increased.

Both reports come as the FDA evaluates post-marketing reports of serious bleeds in patients taking the drug.

Dr. Uchino believes that, taken together, the two studies are important, but more research would need to be completed to sway public opinion on whether dabigatran and other new anticoagulation therapies can unseat warfarin as the go-to treatment.

"Warfarin is such a cumbersome medication, we have all been waiting for a new medication," he adds. "So there are clear advantages to dabigatran and other newer anticoagulants. ... Our study puts us at a caution, but we should continue to gather data and continue to assess risk and benefits."

A pair of new studies suggest that dabigatran etexilate (Pradaxa), the first new oral anticoagulant approved in 56 years, increases the risk of myocardial infarction (MI) and acute coronary syndrome (ACS) in patients. But the author of one of the reports says the drug's benefits may be worth the risks.

"Yes, there's an increase, but that tends to be the headline," says Ken Uchino, MD, FAHA, program director of the Vascular Neurology Fellowship at the Cleveland Clinic's Cerebrovascular Center. "We have to think about the benefits and the risk balance. So far, it is favorable."

Dr. Uchino and a colleague's meta-analysis, "Dabigatran Association with Higher Risk of Acute Coronary Events," was published last month on the Archives of Internal Medicine's website. The report found dabigatran, which was approved last year, was significantly associated with a higher risk of MI or ACS when measured against multiple control groups.

A separate study, "Myocardial Ischemic Events in Patients with Atrial Fibrillation Treated with Dabigatran or Warfarin in the RE-LY Trial," published on Circulation's website, reported a nonsignificant increase in MI with dabigatran compared with warfarin, but other myocardial ischemic events were not increased.

Both reports come as the FDA evaluates post-marketing reports of serious bleeds in patients taking the drug.

Dr. Uchino believes that, taken together, the two studies are important, but more research would need to be completed to sway public opinion on whether dabigatran and other new anticoagulation therapies can unseat warfarin as the go-to treatment.

"Warfarin is such a cumbersome medication, we have all been waiting for a new medication," he adds. "So there are clear advantages to dabigatran and other newer anticoagulants. ... Our study puts us at a caution, but we should continue to gather data and continue to assess risk and benefits."

A pair of new studies suggest that dabigatran etexilate (Pradaxa), the first new oral anticoagulant approved in 56 years, increases the risk of myocardial infarction (MI) and acute coronary syndrome (ACS) in patients. But the author of one of the reports says the drug's benefits may be worth the risks.

"Yes, there's an increase, but that tends to be the headline," says Ken Uchino, MD, FAHA, program director of the Vascular Neurology Fellowship at the Cleveland Clinic's Cerebrovascular Center. "We have to think about the benefits and the risk balance. So far, it is favorable."

Dr. Uchino and a colleague's meta-analysis, "Dabigatran Association with Higher Risk of Acute Coronary Events," was published last month on the Archives of Internal Medicine's website. The report found dabigatran, which was approved last year, was significantly associated with a higher risk of MI or ACS when measured against multiple control groups.

A separate study, "Myocardial Ischemic Events in Patients with Atrial Fibrillation Treated with Dabigatran or Warfarin in the RE-LY Trial," published on Circulation's website, reported a nonsignificant increase in MI with dabigatran compared with warfarin, but other myocardial ischemic events were not increased.

Both reports come as the FDA evaluates post-marketing reports of serious bleeds in patients taking the drug.

Dr. Uchino believes that, taken together, the two studies are important, but more research would need to be completed to sway public opinion on whether dabigatran and other new anticoagulation therapies can unseat warfarin as the go-to treatment.

"Warfarin is such a cumbersome medication, we have all been waiting for a new medication," he adds. "So there are clear advantages to dabigatran and other newer anticoagulants. ... Our study puts us at a caution, but we should continue to gather data and continue to assess risk and benefits."

Clinical question: What is the relationship between well-being and demographic factors, educational debt, and medical knowledge in internal-medicine residents?

Background: Physician distress during training is common and can negatively impact patient care. There has never been a study of internal-medicine residents nationally that examined the patterns of distress across demographic factors or the association of these factors with medical knowledge.

Study design: Cross-sectional study.

Setting: U.S. internal-medicine residency programs.

Synopsis: Of the 21,208 U.S. internal-medicine residents who completed the 2008 in-training examination, 77.3% had both survey and demographic data available for analysis. Nearly 15% of these 16,394 residents rated quality of life “as bad as it can be” or “somewhat bad,” and 32.9% felt somewhat or very dissatisfied with work-life balance.

Overall burnout, high levels of weekly emotional exhaustion, and weekly depersonalization were reported by 51.5%, 45.8%, and 28.9% of residents, respectively. Symptoms of emotional exhaustion decreased as training increased, while depersonalization increased after the first postgraduate year. Residents reporting quality of life “as bad as it can be,” emotional exhaustion, or debt greater than $200,000 had mean exam scores 2.7, 4.2, and 5 points, respectively, lower than others surveyed.

Although unlikely given the study design, nonresponse bias could affect these results. Not all demographic variables or domains of well-being were studied, and self-reported educational debt could have been misclassified. Nonetheless, findings suggest that distress remains among residents despite the changes made to duty-hour regulations in 2003.

Bottom line: Suboptimal quality of life and burnout were common among internal-medicine residents nationally; symptoms of burnout were associated with higher debt and lower exam scores.

Citation: West CP, Shanafelt TD, Kolars JC. Quality of life, burnout, educational debt, and medical knowledge among internal medicine residents. JAMA. 2011;306:952-960.

Visit our website for more physician reviews of HM-related research.

Clinical question: What is the relationship between well-being and demographic factors, educational debt, and medical knowledge in internal-medicine residents?

Background: Physician distress during training is common and can negatively impact patient care. There has never been a study of internal-medicine residents nationally that examined the patterns of distress across demographic factors or the association of these factors with medical knowledge.

Study design: Cross-sectional study.

Setting: U.S. internal-medicine residency programs.

Synopsis: Of the 21,208 U.S. internal-medicine residents who completed the 2008 in-training examination, 77.3% had both survey and demographic data available for analysis. Nearly 15% of these 16,394 residents rated quality of life “as bad as it can be” or “somewhat bad,” and 32.9% felt somewhat or very dissatisfied with work-life balance.

Overall burnout, high levels of weekly emotional exhaustion, and weekly depersonalization were reported by 51.5%, 45.8%, and 28.9% of residents, respectively. Symptoms of emotional exhaustion decreased as training increased, while depersonalization increased after the first postgraduate year. Residents reporting quality of life “as bad as it can be,” emotional exhaustion, or debt greater than $200,000 had mean exam scores 2.7, 4.2, and 5 points, respectively, lower than others surveyed.

Although unlikely given the study design, nonresponse bias could affect these results. Not all demographic variables or domains of well-being were studied, and self-reported educational debt could have been misclassified. Nonetheless, findings suggest that distress remains among residents despite the changes made to duty-hour regulations in 2003.

Bottom line: Suboptimal quality of life and burnout were common among internal-medicine residents nationally; symptoms of burnout were associated with higher debt and lower exam scores.

Citation: West CP, Shanafelt TD, Kolars JC. Quality of life, burnout, educational debt, and medical knowledge among internal medicine residents. JAMA. 2011;306:952-960.

Visit our website for more physician reviews of HM-related research.

Clinical question: What is the relationship between well-being and demographic factors, educational debt, and medical knowledge in internal-medicine residents?

Background: Physician distress during training is common and can negatively impact patient care. There has never been a study of internal-medicine residents nationally that examined the patterns of distress across demographic factors or the association of these factors with medical knowledge.

Study design: Cross-sectional study.

Setting: U.S. internal-medicine residency programs.

Synopsis: Of the 21,208 U.S. internal-medicine residents who completed the 2008 in-training examination, 77.3% had both survey and demographic data available for analysis. Nearly 15% of these 16,394 residents rated quality of life “as bad as it can be” or “somewhat bad,” and 32.9% felt somewhat or very dissatisfied with work-life balance.

Overall burnout, high levels of weekly emotional exhaustion, and weekly depersonalization were reported by 51.5%, 45.8%, and 28.9% of residents, respectively. Symptoms of emotional exhaustion decreased as training increased, while depersonalization increased after the first postgraduate year. Residents reporting quality of life “as bad as it can be,” emotional exhaustion, or debt greater than $200,000 had mean exam scores 2.7, 4.2, and 5 points, respectively, lower than others surveyed.

Although unlikely given the study design, nonresponse bias could affect these results. Not all demographic variables or domains of well-being were studied, and self-reported educational debt could have been misclassified. Nonetheless, findings suggest that distress remains among residents despite the changes made to duty-hour regulations in 2003.

Bottom line: Suboptimal quality of life and burnout were common among internal-medicine residents nationally; symptoms of burnout were associated with higher debt and lower exam scores.

Citation: West CP, Shanafelt TD, Kolars JC. Quality of life, burnout, educational debt, and medical knowledge among internal medicine residents. JAMA. 2011;306:952-960.

Visit our website for more physician reviews of HM-related research.

Welcome to the EHR Report Podcast!

In this edition of the EHR Report Podcast, Dr. Neil Skolnik and Dr. Chris Notte take a look at how handheld devices such as smartphones, tablets, and PDAs can fit into an EHR system.

To download this podcast, click here.

To listen via this Web page, click on the player below:

Welcome to the EHR Report Podcast!

In this edition of the EHR Report Podcast, Dr. Neil Skolnik and Dr. Chris Notte take a look at how handheld devices such as smartphones, tablets, and PDAs can fit into an EHR system.

To download this podcast, click here.

To listen via this Web page, click on the player below:

Welcome to the EHR Report Podcast!

In this edition of the EHR Report Podcast, Dr. Neil Skolnik and Dr. Chris Notte take a look at how handheld devices such as smartphones, tablets, and PDAs can fit into an EHR system.

To download this podcast, click here.

To listen via this Web page, click on the player below:

Team Hospitalist is the only reader-involvement program of its kind in hospital medicine. The 12-member advisory panel provides invaluable information about the current state of hospital medicine, including the daily issues facing hospitalists, group leaders, and their patients. Team members offer ideas for articles, assist writers with contacts and expert sources, and participate in monthly conference calls to discuss new ideas.

The team will seat new members for tw0-year terms at HM12 in San Diego, April 1-4. Team members must be an SHM member in good standing and be able to attend SHM's annual meetings. To apply, email the editors your CV and a letter of interest no later than Feb. 15, 2012.

Team Hospitalist is the only reader-involvement program of its kind in hospital medicine. The 12-member advisory panel provides invaluable information about the current state of hospital medicine, including the daily issues facing hospitalists, group leaders, and their patients. Team members offer ideas for articles, assist writers with contacts and expert sources, and participate in monthly conference calls to discuss new ideas.

The team will seat new members for tw0-year terms at HM12 in San Diego, April 1-4. Team members must be an SHM member in good standing and be able to attend SHM's annual meetings. To apply, email the editors your CV and a letter of interest no later than Feb. 15, 2012.

Team Hospitalist is the only reader-involvement program of its kind in hospital medicine. The 12-member advisory panel provides invaluable information about the current state of hospital medicine, including the daily issues facing hospitalists, group leaders, and their patients. Team members offer ideas for articles, assist writers with contacts and expert sources, and participate in monthly conference calls to discuss new ideas.

The team will seat new members for tw0-year terms at HM12 in San Diego, April 1-4. Team members must be an SHM member in good standing and be able to attend SHM's annual meetings. To apply, email the editors your CV and a letter of interest no later than Feb. 15, 2012.

Every day in the life of an internist and pediatrician, clinical questions arise. For HM practitioners, treating patients with chronic illnesses who are also on the cusp of adulthood presents a new set of challenges.

That’s when physicians trained in both internal medicine and pediatrics (med-peds) can lend their expertise. Once a physician successfully completes a four-year combined med-peds residency program, he or she may take the board certification exams in both internal medicine and pediatrics. Med-peds programs are now accredited by the Accreditation Council for Graduate Medical Education (ACGME) as a combined program instead of separate accreditation in internal medicine and pediatrics.

“The best solution would be to have more med-peds specialists as hospitalists,” says Moises Auron, MD, an assistant professor of medicine and pediatrics at Cleveland Clinic. They “can facilitate the transition by identifying these patients and providing an increased sensibility to the pediatric provider to ‘let the patient go’ and to open new insights to the adult providers to welcome those patients,” he says.

Broad-Based Training

A med-peds physician can care for people of all ages—from newborns to geriatric patients. He or she is prepared for the demands of private practice, academic medicine, hospitalist programs, and fellowships, according to the National Med-Peds Residents’ Association.

While med-peds residency offers exceptional training for primary care, it also leaves open the option of pursuing a subspecialty in either internal medicine or pediatrics, or both. Subspecialties include cardiology, infectious disease, pulmonary/critical care, women’s health, and sports medicine.

Med-peds celebrated its 40th anniversary as a formal training option in 2007. There are currently about 1,400 med-peds residents in training and about 6,300 med-peds physicians in practice, according to the American Academy of Pediatrics’ section on med-peds.

This broad-based training helps ensure smoother transitions of care. “It’s incumbent upon adult physicians to make the pediatric physicians aware of what services they offer, and also for the pediatricians to reach out with specific patients and refer them to adult physicians,” says W. Benjamin Rothwell, MD, associate program director of the med-peds residency at Tulane University School of Medicine in New Orleans.

Susan Kreimer is a freelance medical writer based in New York.

Every day in the life of an internist and pediatrician, clinical questions arise. For HM practitioners, treating patients with chronic illnesses who are also on the cusp of adulthood presents a new set of challenges.

That’s when physicians trained in both internal medicine and pediatrics (med-peds) can lend their expertise. Once a physician successfully completes a four-year combined med-peds residency program, he or she may take the board certification exams in both internal medicine and pediatrics. Med-peds programs are now accredited by the Accreditation Council for Graduate Medical Education (ACGME) as a combined program instead of separate accreditation in internal medicine and pediatrics.

“The best solution would be to have more med-peds specialists as hospitalists,” says Moises Auron, MD, an assistant professor of medicine and pediatrics at Cleveland Clinic. They “can facilitate the transition by identifying these patients and providing an increased sensibility to the pediatric provider to ‘let the patient go’ and to open new insights to the adult providers to welcome those patients,” he says.

Broad-Based Training

A med-peds physician can care for people of all ages—from newborns to geriatric patients. He or she is prepared for the demands of private practice, academic medicine, hospitalist programs, and fellowships, according to the National Med-Peds Residents’ Association.

While med-peds residency offers exceptional training for primary care, it also leaves open the option of pursuing a subspecialty in either internal medicine or pediatrics, or both. Subspecialties include cardiology, infectious disease, pulmonary/critical care, women’s health, and sports medicine.

Med-peds celebrated its 40th anniversary as a formal training option in 2007. There are currently about 1,400 med-peds residents in training and about 6,300 med-peds physicians in practice, according to the American Academy of Pediatrics’ section on med-peds.

This broad-based training helps ensure smoother transitions of care. “It’s incumbent upon adult physicians to make the pediatric physicians aware of what services they offer, and also for the pediatricians to reach out with specific patients and refer them to adult physicians,” says W. Benjamin Rothwell, MD, associate program director of the med-peds residency at Tulane University School of Medicine in New Orleans.

Susan Kreimer is a freelance medical writer based in New York.

Every day in the life of an internist and pediatrician, clinical questions arise. For HM practitioners, treating patients with chronic illnesses who are also on the cusp of adulthood presents a new set of challenges.

That’s when physicians trained in both internal medicine and pediatrics (med-peds) can lend their expertise. Once a physician successfully completes a four-year combined med-peds residency program, he or she may take the board certification exams in both internal medicine and pediatrics. Med-peds programs are now accredited by the Accreditation Council for Graduate Medical Education (ACGME) as a combined program instead of separate accreditation in internal medicine and pediatrics.

“The best solution would be to have more med-peds specialists as hospitalists,” says Moises Auron, MD, an assistant professor of medicine and pediatrics at Cleveland Clinic. They “can facilitate the transition by identifying these patients and providing an increased sensibility to the pediatric provider to ‘let the patient go’ and to open new insights to the adult providers to welcome those patients,” he says.

Broad-Based Training

A med-peds physician can care for people of all ages—from newborns to geriatric patients. He or she is prepared for the demands of private practice, academic medicine, hospitalist programs, and fellowships, according to the National Med-Peds Residents’ Association.

While med-peds residency offers exceptional training for primary care, it also leaves open the option of pursuing a subspecialty in either internal medicine or pediatrics, or both. Subspecialties include cardiology, infectious disease, pulmonary/critical care, women’s health, and sports medicine.

Med-peds celebrated its 40th anniversary as a formal training option in 2007. There are currently about 1,400 med-peds residents in training and about 6,300 med-peds physicians in practice, according to the American Academy of Pediatrics’ section on med-peds.

This broad-based training helps ensure smoother transitions of care. “It’s incumbent upon adult physicians to make the pediatric physicians aware of what services they offer, and also for the pediatricians to reach out with specific patients and refer them to adult physicians,” says W. Benjamin Rothwell, MD, associate program director of the med-peds residency at Tulane University School of Medicine in New Orleans.

Susan Kreimer is a freelance medical writer based in New York.

As hospitalists have learned, sometimes a workload problem is related to how that work is apportioned. The trick is to devise a solution that’s good for patients, doctors, and the hospital.

Adam Singer, MD, CEO of North Hollywood, Calif.-based IPC: The Hospitalist Company, has long advocated changing from a shift-based model to a more full-time model that expands the number of days worked per month. Although the concept has faced resistance from many rank-and-file hospitalists, Dr. Singer argues that the latter model means that more staff will be available to care for patients on any given day, leading to a lower and more manageable average census. Dr. Singer concedes that switching to a full-time model can be a “painful process,” but it’s one that has led to improved patient outcomes, higher revenues, and more sustainable workloads.

John Nelson, MD, MHM, FACP, medical director of the hospitalist practice at Overlake Hospital Medical Center in Bellevue, Wash., agrees that titrating the same annual workload over more shifts is desirable. “If you work a small number of days in a year, then every day you work, you’re going to get smacked,” says Dr. Nelson, co-founder of SHM and longtime practice management columnist for The Hospitalist. “It’s going to be hard. And that’s just not smart. It’s not a good idea.”

Dr. Nelson worries that a straightforward, Monday-to-Friday model with periodic weekend responsibilities, though, can be disruptive to doctor-patient continuity. Another strategy, he says, is to take each doctor’s workload preferences into account when devising a practice’s schedule, with compensation distributed accordingly. At one practice in the Pacific Northwest, for example, the hospitalists all decided they wanted to work about half as much as they were. Their pay dropped accordingly, Dr. Nelson says, providing the necessary funds for hiring new doctors to pick up the slack.

Bryn Nelson is a freelance medical journalist in Seattle.

As hospitalists have learned, sometimes a workload problem is related to how that work is apportioned. The trick is to devise a solution that’s good for patients, doctors, and the hospital.

Adam Singer, MD, CEO of North Hollywood, Calif.-based IPC: The Hospitalist Company, has long advocated changing from a shift-based model to a more full-time model that expands the number of days worked per month. Although the concept has faced resistance from many rank-and-file hospitalists, Dr. Singer argues that the latter model means that more staff will be available to care for patients on any given day, leading to a lower and more manageable average census. Dr. Singer concedes that switching to a full-time model can be a “painful process,” but it’s one that has led to improved patient outcomes, higher revenues, and more sustainable workloads.

John Nelson, MD, MHM, FACP, medical director of the hospitalist practice at Overlake Hospital Medical Center in Bellevue, Wash., agrees that titrating the same annual workload over more shifts is desirable. “If you work a small number of days in a year, then every day you work, you’re going to get smacked,” says Dr. Nelson, co-founder of SHM and longtime practice management columnist for The Hospitalist. “It’s going to be hard. And that’s just not smart. It’s not a good idea.”

Dr. Nelson worries that a straightforward, Monday-to-Friday model with periodic weekend responsibilities, though, can be disruptive to doctor-patient continuity. Another strategy, he says, is to take each doctor’s workload preferences into account when devising a practice’s schedule, with compensation distributed accordingly. At one practice in the Pacific Northwest, for example, the hospitalists all decided they wanted to work about half as much as they were. Their pay dropped accordingly, Dr. Nelson says, providing the necessary funds for hiring new doctors to pick up the slack.

Bryn Nelson is a freelance medical journalist in Seattle.

As hospitalists have learned, sometimes a workload problem is related to how that work is apportioned. The trick is to devise a solution that’s good for patients, doctors, and the hospital.

Adam Singer, MD, CEO of North Hollywood, Calif.-based IPC: The Hospitalist Company, has long advocated changing from a shift-based model to a more full-time model that expands the number of days worked per month. Although the concept has faced resistance from many rank-and-file hospitalists, Dr. Singer argues that the latter model means that more staff will be available to care for patients on any given day, leading to a lower and more manageable average census. Dr. Singer concedes that switching to a full-time model can be a “painful process,” but it’s one that has led to improved patient outcomes, higher revenues, and more sustainable workloads.

John Nelson, MD, MHM, FACP, medical director of the hospitalist practice at Overlake Hospital Medical Center in Bellevue, Wash., agrees that titrating the same annual workload over more shifts is desirable. “If you work a small number of days in a year, then every day you work, you’re going to get smacked,” says Dr. Nelson, co-founder of SHM and longtime practice management columnist for The Hospitalist. “It’s going to be hard. And that’s just not smart. It’s not a good idea.”

Dr. Nelson worries that a straightforward, Monday-to-Friday model with periodic weekend responsibilities, though, can be disruptive to doctor-patient continuity. Another strategy, he says, is to take each doctor’s workload preferences into account when devising a practice’s schedule, with compensation distributed accordingly. At one practice in the Pacific Northwest, for example, the hospitalists all decided they wanted to work about half as much as they were. Their pay dropped accordingly, Dr. Nelson says, providing the necessary funds for hiring new doctors to pick up the slack.

Bryn Nelson is a freelance medical journalist in Seattle.

Click here to listen to Drs. Knight and Litvak

Click here to listen to Drs. Knight and Litvak

Click here to listen to Drs. Knight and Litvak