SILVER SPRING, MD. – A Food and Drug Administration advisory committee voted 7-4 on March 21 to recommend accelerated approval of Marqibo, a liposomal-encapsulated version of vincristine, for adult patients with relapsed or refractory Philadelphia-negative acute lymphoblastic leukemia.

Under accelerated approval regulations, a drug can only be approved if it is superior to what is currently available and eventually is proven superior by a confirmatory trial, said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Office of New Drugs.

That sets a high bar for Marqibo, which according to its maker, Talon Therapeutics, is vincristine sulfate "encapsulated in the aqueous core of proprietary, sphingomyelin-based liposomes."

The encapsulated form offers "prolonged plasma circulation, enhanced target tissue delivery, and increased tissue concentration," along with extended release of vincristine, according to Talon. But the advisory panel’s pharmacology experts said the company had not offered enough evidence to support those theoretical advantages.

The panel – the Oncologic Drugs Advisory Committee (ODAC) – was less than enthusiastic in urging approval of Marqibo. Even some of those who voted in favor said they had done so somewhat unwillingly.

Dr. Wyndham H. Wilson, ODAC chairperson and chief of the lymphoma therapeutics section at the National Cancer Institute, said, "I was more voting against the lack of other things than voting for the efficacy of this agent." Dr. Wilson said that although the drug did appear to induce remissions in some patients, there were open questions about toxicity. "I am not at all convinced it is going to be that much more active than vincristine," he added.

"This was a difficult decision," said Dr. Antoinette J. Wozniak, a panelist from the Karmanos Cancer Institute at Wayne State University, Detroit.

Panelist Dr. Mikkael Sekeres of the Cleveland Clinic Taussig Cancer Institute was more sanguine. "I felt that this drug was able to convert patients who were in a palliative setting into a potentially curative setting," he said.

But Dr. Sekeres and other panelists said they hoped the agency would subsequently remove approval if Marqibo did not pan out in a planned phase III confirmatory study.

Some were openly skeptical that the phase III trial – TTX404 – would prove anything. Talon reached an agreement with the FDA in August 2011 on the conduct of that study, said Dr. Steven R. Deitcher, Talon’s president, CEO, and chief medical officer. The randomized two-arm study has a planned enrollment of 348 newly diagnosed patients, which he said will likely take 48 months. The trial is a superiority study with overall survival as the primary end point, and will compare standard vincristine with Marqibo in a five-course regimen known as the Larson regimen.

So far, not a single patient has been enrolled, but Dr. Deitcher said that three trial sites are open, and an additional 14 sites are "ready to be activated."

If the FDA follows its panel’s advice, Marqibo would be approved this spring for a very small patient population with Philadelphia chromosome (Ph)-negative acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more treatment lines of antileukemia therapy. Talon estimated that out of some 1,400 adult patients with Ph-negative ALL, only about 458 a year would be eligible for Marqibo.

Talon, however, has its sights set on bigger markets. Dr. Deitcher said the company is currently enrolling or already beginning trials in newly diagnosed Ph-negative ALL; as a front-line therapy for aggressive non-Hodgkin’s lymphoma (NHL); in child and adolescent cancers; and in newly diagnosed Ph-positive ALL.

It is not Marqibo’s first time before ODAC. The committee unanimously voted against accelerated approval of the agent for aggressive NHL in 2004. That application had been submitted by Inex Pharmaceuticals, which later sold its rights to Talon.

In seeking approval this time, Talon submitted data from a pivotal, single-arm, 68-patient phase II trial. The median age was 31 years, and 48% of the patients had a prior hematopoietic stem cell transplant. Fifty-one percent had failed three or more prior lines of treatment. The median bone marrow blast percentage was 84%. All had previous vincristine exposure, which made it not surprising that 80% had neuropathy at baseline.

The FDA allowed the company to use a surrogate end point, complete response (CR) plus CRi (defined as a CR with incomplete blood count recovery, as determined by the principal investigator). Talon determined that the response rate was 17% (11 responders) of the 65 patients who underwent treatment. The FDA reviewers, however, said that the response rate was 15%, or 10 of the 65 patients.

Talon posited that patients who went on to bone marrow transplant after treatment should be counted as responders, but the agency noted that of the 12 patients who had transplants, only 5 were actually responders.

The agency’s reviewers also raised questions about Marqibo’s safety, which was judged on an 83-patient database. A third of patients (27 of 83) had a grade 3 or greater adverse event. Twenty percent (17) missed a dose, and 22% (18) had a dose reduction. Twenty-three percent of patients died on study.

Talon said that adverse events and patient deaths were in line with what would be expected for the ALL population, especially one with so much prior vincristine exposure.

By law, the FDA must act on Talon’s accelerated approval application by May 13.

SILVER SPRING, MD. – A Food and Drug Administration advisory committee voted 7-4 on March 21 to recommend accelerated approval of Marqibo, a liposomal-encapsulated version of vincristine, for adult patients with relapsed or refractory Philadelphia-negative acute lymphoblastic leukemia.

Under accelerated approval regulations, a drug can only be approved if it is superior to what is currently available and eventually is proven superior by a confirmatory trial, said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Office of New Drugs.

That sets a high bar for Marqibo, which according to its maker, Talon Therapeutics, is vincristine sulfate "encapsulated in the aqueous core of proprietary, sphingomyelin-based liposomes."

The encapsulated form offers "prolonged plasma circulation, enhanced target tissue delivery, and increased tissue concentration," along with extended release of vincristine, according to Talon. But the advisory panel’s pharmacology experts said the company had not offered enough evidence to support those theoretical advantages.

The panel – the Oncologic Drugs Advisory Committee (ODAC) – was less than enthusiastic in urging approval of Marqibo. Even some of those who voted in favor said they had done so somewhat unwillingly.

Dr. Wyndham H. Wilson, ODAC chairperson and chief of the lymphoma therapeutics section at the National Cancer Institute, said, "I was more voting against the lack of other things than voting for the efficacy of this agent." Dr. Wilson said that although the drug did appear to induce remissions in some patients, there were open questions about toxicity. "I am not at all convinced it is going to be that much more active than vincristine," he added.

"This was a difficult decision," said Dr. Antoinette J. Wozniak, a panelist from the Karmanos Cancer Institute at Wayne State University, Detroit.

Panelist Dr. Mikkael Sekeres of the Cleveland Clinic Taussig Cancer Institute was more sanguine. "I felt that this drug was able to convert patients who were in a palliative setting into a potentially curative setting," he said.

But Dr. Sekeres and other panelists said they hoped the agency would subsequently remove approval if Marqibo did not pan out in a planned phase III confirmatory study.

Some were openly skeptical that the phase III trial – TTX404 – would prove anything. Talon reached an agreement with the FDA in August 2011 on the conduct of that study, said Dr. Steven R. Deitcher, Talon’s president, CEO, and chief medical officer. The randomized two-arm study has a planned enrollment of 348 newly diagnosed patients, which he said will likely take 48 months. The trial is a superiority study with overall survival as the primary end point, and will compare standard vincristine with Marqibo in a five-course regimen known as the Larson regimen.

So far, not a single patient has been enrolled, but Dr. Deitcher said that three trial sites are open, and an additional 14 sites are "ready to be activated."

If the FDA follows its panel’s advice, Marqibo would be approved this spring for a very small patient population with Philadelphia chromosome (Ph)-negative acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more treatment lines of antileukemia therapy. Talon estimated that out of some 1,400 adult patients with Ph-negative ALL, only about 458 a year would be eligible for Marqibo.

Talon, however, has its sights set on bigger markets. Dr. Deitcher said the company is currently enrolling or already beginning trials in newly diagnosed Ph-negative ALL; as a front-line therapy for aggressive non-Hodgkin’s lymphoma (NHL); in child and adolescent cancers; and in newly diagnosed Ph-positive ALL.

It is not Marqibo’s first time before ODAC. The committee unanimously voted against accelerated approval of the agent for aggressive NHL in 2004. That application had been submitted by Inex Pharmaceuticals, which later sold its rights to Talon.

In seeking approval this time, Talon submitted data from a pivotal, single-arm, 68-patient phase II trial. The median age was 31 years, and 48% of the patients had a prior hematopoietic stem cell transplant. Fifty-one percent had failed three or more prior lines of treatment. The median bone marrow blast percentage was 84%. All had previous vincristine exposure, which made it not surprising that 80% had neuropathy at baseline.

The FDA allowed the company to use a surrogate end point, complete response (CR) plus CRi (defined as a CR with incomplete blood count recovery, as determined by the principal investigator). Talon determined that the response rate was 17% (11 responders) of the 65 patients who underwent treatment. The FDA reviewers, however, said that the response rate was 15%, or 10 of the 65 patients.

Talon posited that patients who went on to bone marrow transplant after treatment should be counted as responders, but the agency noted that of the 12 patients who had transplants, only 5 were actually responders.

The agency’s reviewers also raised questions about Marqibo’s safety, which was judged on an 83-patient database. A third of patients (27 of 83) had a grade 3 or greater adverse event. Twenty percent (17) missed a dose, and 22% (18) had a dose reduction. Twenty-three percent of patients died on study.

Talon said that adverse events and patient deaths were in line with what would be expected for the ALL population, especially one with so much prior vincristine exposure.

By law, the FDA must act on Talon’s accelerated approval application by May 13.

SILVER SPRING, MD. – A Food and Drug Administration advisory committee voted 7-4 on March 21 to recommend accelerated approval of Marqibo, a liposomal-encapsulated version of vincristine, for adult patients with relapsed or refractory Philadelphia-negative acute lymphoblastic leukemia.

Under accelerated approval regulations, a drug can only be approved if it is superior to what is currently available and eventually is proven superior by a confirmatory trial, said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Office of New Drugs.

That sets a high bar for Marqibo, which according to its maker, Talon Therapeutics, is vincristine sulfate "encapsulated in the aqueous core of proprietary, sphingomyelin-based liposomes."

The encapsulated form offers "prolonged plasma circulation, enhanced target tissue delivery, and increased tissue concentration," along with extended release of vincristine, according to Talon. But the advisory panel’s pharmacology experts said the company had not offered enough evidence to support those theoretical advantages.

The panel – the Oncologic Drugs Advisory Committee (ODAC) – was less than enthusiastic in urging approval of Marqibo. Even some of those who voted in favor said they had done so somewhat unwillingly.

Dr. Wyndham H. Wilson, ODAC chairperson and chief of the lymphoma therapeutics section at the National Cancer Institute, said, "I was more voting against the lack of other things than voting for the efficacy of this agent." Dr. Wilson said that although the drug did appear to induce remissions in some patients, there were open questions about toxicity. "I am not at all convinced it is going to be that much more active than vincristine," he added.

"This was a difficult decision," said Dr. Antoinette J. Wozniak, a panelist from the Karmanos Cancer Institute at Wayne State University, Detroit.

Panelist Dr. Mikkael Sekeres of the Cleveland Clinic Taussig Cancer Institute was more sanguine. "I felt that this drug was able to convert patients who were in a palliative setting into a potentially curative setting," he said.

But Dr. Sekeres and other panelists said they hoped the agency would subsequently remove approval if Marqibo did not pan out in a planned phase III confirmatory study.

Some were openly skeptical that the phase III trial – TTX404 – would prove anything. Talon reached an agreement with the FDA in August 2011 on the conduct of that study, said Dr. Steven R. Deitcher, Talon’s president, CEO, and chief medical officer. The randomized two-arm study has a planned enrollment of 348 newly diagnosed patients, which he said will likely take 48 months. The trial is a superiority study with overall survival as the primary end point, and will compare standard vincristine with Marqibo in a five-course regimen known as the Larson regimen.

So far, not a single patient has been enrolled, but Dr. Deitcher said that three trial sites are open, and an additional 14 sites are "ready to be activated."

If the FDA follows its panel’s advice, Marqibo would be approved this spring for a very small patient population with Philadelphia chromosome (Ph)-negative acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more treatment lines of antileukemia therapy. Talon estimated that out of some 1,400 adult patients with Ph-negative ALL, only about 458 a year would be eligible for Marqibo.

Talon, however, has its sights set on bigger markets. Dr. Deitcher said the company is currently enrolling or already beginning trials in newly diagnosed Ph-negative ALL; as a front-line therapy for aggressive non-Hodgkin’s lymphoma (NHL); in child and adolescent cancers; and in newly diagnosed Ph-positive ALL.

It is not Marqibo’s first time before ODAC. The committee unanimously voted against accelerated approval of the agent for aggressive NHL in 2004. That application had been submitted by Inex Pharmaceuticals, which later sold its rights to Talon.

In seeking approval this time, Talon submitted data from a pivotal, single-arm, 68-patient phase II trial. The median age was 31 years, and 48% of the patients had a prior hematopoietic stem cell transplant. Fifty-one percent had failed three or more prior lines of treatment. The median bone marrow blast percentage was 84%. All had previous vincristine exposure, which made it not surprising that 80% had neuropathy at baseline.

The FDA allowed the company to use a surrogate end point, complete response (CR) plus CRi (defined as a CR with incomplete blood count recovery, as determined by the principal investigator). Talon determined that the response rate was 17% (11 responders) of the 65 patients who underwent treatment. The FDA reviewers, however, said that the response rate was 15%, or 10 of the 65 patients.

Talon posited that patients who went on to bone marrow transplant after treatment should be counted as responders, but the agency noted that of the 12 patients who had transplants, only 5 were actually responders.

The agency’s reviewers also raised questions about Marqibo’s safety, which was judged on an 83-patient database. A third of patients (27 of 83) had a grade 3 or greater adverse event. Twenty percent (17) missed a dose, and 22% (18) had a dose reduction. Twenty-three percent of patients died on study.

Talon said that adverse events and patient deaths were in line with what would be expected for the ALL population, especially one with so much prior vincristine exposure.

By law, the FDA must act on Talon’s accelerated approval application by May 13.

My last few columns have covered various techniques for assuring that you are paid for what you do. However, despite your best efforts, there will always be a few deadbeats whom you will need to pursue. For the record, I’m speaking not about patients who fall on hard times and are unable to pay, but those who are able to pay and do not.

The worst kinds of deadbeats are the ones who rob you twice; they accept payments from insurance companies and then spend the money themselves. Such crooks must be pursued aggressively, with all the means at your disposal; but to reiterate the point I’ve tried to drive home recently, the best cure is prevention.

You already know that you should collect as many fees as possible at the time of service. For cosmetic procedures you should require a substantial deposit in advance, with the balance due at the time of service. When that is impossible, maximize the chances you will be paid by making sure all available payment mechanisms are in place.

In the last several columns (click here to access them), I described my credit-card-on-file system; patients who fail to pay their credit card bill are the credit card company’s problem, not yours. In cases in which you suspect fees might exceed credit card limits, you can arrange a realistic payment schedule in advance and have the patient fill out a credit application. You can find forms for this online at allbusiness.com, lawdog.com, and other sites.

In some cases, it may be worth the trouble to run a background check. There are easy and affordable ways to do this. Dunn & Bradstreet, for example, will furnish a report containing payment records and details of any lawsuits, liens, and other legal actions for as little as $30. The more financial information you have on file, the more leverage you have if a patient later balks at paying the balance.

Photo turner890/iStockphoto.com

For cosmetic work, always take before and after photos and have all patients sign a written consent giving permission for the procedure, assuming full financial responsibility, and acknowledging that no guarantees have been given or implied. This defuses the common deadbeat tactics of professing ignorance of personal financial obligation and/or dissatisfaction with results.

Despite all your precautions, a deadbeat will inevitably slip through on occasion; but even then, you have options for extracting payment. Collection agencies are the traditional first line of attack for most medical practices. Ideally, your agency should specialize in handling medical accounts, so it will know exactly how much pressure to exert to avoid charges of harassment. Delinquent accounts should be submitted earlier rather than later to maximize the chances of success; my manager never allows an account to age more than 90 days, and if circumstances dictate, she refers them sooner than that.

When collection agencies fail, think about small claims court. You’ll need to learn the rules for filing in your state, but most charge a nominal fee and place a limit of $5,000 or so on claims. No attorneys are involved. If your paperwork is in order, the court will nearly always rule in your favor, but it will not provide the means for actual collection. In other words, you’ll still have to persuade the deadbeat to pay up. However, in many states, a court order will give you the authority to attach a lien to property or garnish wages, which often provides enough leverage to force payment.

What about those double deadbeats who steal the insurance checks? First, check your third-party contract; sometimes, the insurance company or HMO will be compelled to pay you directly and then will go after the patient itself to get back its money. (They won’t volunteer this service, however – you’ll have to ask for it.)

If that’s not an option, consider reporting the misdirected payment to the Internal Revenue Service as income to the patient, by submitting a 1099-Miscellaneous Income form. Be sure to notify the deadbeat that you will be doing this. Sometimes, the threat of such action will convince the crook to pay up; but if not, at least you’ll have the satisfaction of knowing he or she will have to pay taxes on the money.

Dr. Eastern practices dermatology and dermatologic surgery in Bellevue, N.J. 

My last few columns have covered various techniques for assuring that you are paid for what you do. However, despite your best efforts, there will always be a few deadbeats whom you will need to pursue. For the record, I’m speaking not about patients who fall on hard times and are unable to pay, but those who are able to pay and do not.

The worst kinds of deadbeats are the ones who rob you twice; they accept payments from insurance companies and then spend the money themselves. Such crooks must be pursued aggressively, with all the means at your disposal; but to reiterate the point I’ve tried to drive home recently, the best cure is prevention.

You already know that you should collect as many fees as possible at the time of service. For cosmetic procedures you should require a substantial deposit in advance, with the balance due at the time of service. When that is impossible, maximize the chances you will be paid by making sure all available payment mechanisms are in place.

In the last several columns (click here to access them), I described my credit-card-on-file system; patients who fail to pay their credit card bill are the credit card company’s problem, not yours. In cases in which you suspect fees might exceed credit card limits, you can arrange a realistic payment schedule in advance and have the patient fill out a credit application. You can find forms for this online at allbusiness.com, lawdog.com, and other sites.

In some cases, it may be worth the trouble to run a background check. There are easy and affordable ways to do this. Dunn & Bradstreet, for example, will furnish a report containing payment records and details of any lawsuits, liens, and other legal actions for as little as $30. The more financial information you have on file, the more leverage you have if a patient later balks at paying the balance.

Photo turner890/iStockphoto.com

For cosmetic work, always take before and after photos and have all patients sign a written consent giving permission for the procedure, assuming full financial responsibility, and acknowledging that no guarantees have been given or implied. This defuses the common deadbeat tactics of professing ignorance of personal financial obligation and/or dissatisfaction with results.

Despite all your precautions, a deadbeat will inevitably slip through on occasion; but even then, you have options for extracting payment. Collection agencies are the traditional first line of attack for most medical practices. Ideally, your agency should specialize in handling medical accounts, so it will know exactly how much pressure to exert to avoid charges of harassment. Delinquent accounts should be submitted earlier rather than later to maximize the chances of success; my manager never allows an account to age more than 90 days, and if circumstances dictate, she refers them sooner than that.

When collection agencies fail, think about small claims court. You’ll need to learn the rules for filing in your state, but most charge a nominal fee and place a limit of $5,000 or so on claims. No attorneys are involved. If your paperwork is in order, the court will nearly always rule in your favor, but it will not provide the means for actual collection. In other words, you’ll still have to persuade the deadbeat to pay up. However, in many states, a court order will give you the authority to attach a lien to property or garnish wages, which often provides enough leverage to force payment.

What about those double deadbeats who steal the insurance checks? First, check your third-party contract; sometimes, the insurance company or HMO will be compelled to pay you directly and then will go after the patient itself to get back its money. (They won’t volunteer this service, however – you’ll have to ask for it.)

If that’s not an option, consider reporting the misdirected payment to the Internal Revenue Service as income to the patient, by submitting a 1099-Miscellaneous Income form. Be sure to notify the deadbeat that you will be doing this. Sometimes, the threat of such action will convince the crook to pay up; but if not, at least you’ll have the satisfaction of knowing he or she will have to pay taxes on the money.

Dr. Eastern practices dermatology and dermatologic surgery in Bellevue, N.J. 

My last few columns have covered various techniques for assuring that you are paid for what you do. However, despite your best efforts, there will always be a few deadbeats whom you will need to pursue. For the record, I’m speaking not about patients who fall on hard times and are unable to pay, but those who are able to pay and do not.

The worst kinds of deadbeats are the ones who rob you twice; they accept payments from insurance companies and then spend the money themselves. Such crooks must be pursued aggressively, with all the means at your disposal; but to reiterate the point I’ve tried to drive home recently, the best cure is prevention.

You already know that you should collect as many fees as possible at the time of service. For cosmetic procedures you should require a substantial deposit in advance, with the balance due at the time of service. When that is impossible, maximize the chances you will be paid by making sure all available payment mechanisms are in place.

In the last several columns (click here to access them), I described my credit-card-on-file system; patients who fail to pay their credit card bill are the credit card company’s problem, not yours. In cases in which you suspect fees might exceed credit card limits, you can arrange a realistic payment schedule in advance and have the patient fill out a credit application. You can find forms for this online at allbusiness.com, lawdog.com, and other sites.

In some cases, it may be worth the trouble to run a background check. There are easy and affordable ways to do this. Dunn & Bradstreet, for example, will furnish a report containing payment records and details of any lawsuits, liens, and other legal actions for as little as $30. The more financial information you have on file, the more leverage you have if a patient later balks at paying the balance.

Photo turner890/iStockphoto.com

For cosmetic work, always take before and after photos and have all patients sign a written consent giving permission for the procedure, assuming full financial responsibility, and acknowledging that no guarantees have been given or implied. This defuses the common deadbeat tactics of professing ignorance of personal financial obligation and/or dissatisfaction with results.

Despite all your precautions, a deadbeat will inevitably slip through on occasion; but even then, you have options for extracting payment. Collection agencies are the traditional first line of attack for most medical practices. Ideally, your agency should specialize in handling medical accounts, so it will know exactly how much pressure to exert to avoid charges of harassment. Delinquent accounts should be submitted earlier rather than later to maximize the chances of success; my manager never allows an account to age more than 90 days, and if circumstances dictate, she refers them sooner than that.

When collection agencies fail, think about small claims court. You’ll need to learn the rules for filing in your state, but most charge a nominal fee and place a limit of $5,000 or so on claims. No attorneys are involved. If your paperwork is in order, the court will nearly always rule in your favor, but it will not provide the means for actual collection. In other words, you’ll still have to persuade the deadbeat to pay up. However, in many states, a court order will give you the authority to attach a lien to property or garnish wages, which often provides enough leverage to force payment.

What about those double deadbeats who steal the insurance checks? First, check your third-party contract; sometimes, the insurance company or HMO will be compelled to pay you directly and then will go after the patient itself to get back its money. (They won’t volunteer this service, however – you’ll have to ask for it.)

If that’s not an option, consider reporting the misdirected payment to the Internal Revenue Service as income to the patient, by submitting a 1099-Miscellaneous Income form. Be sure to notify the deadbeat that you will be doing this. Sometimes, the threat of such action will convince the crook to pay up; but if not, at least you’ll have the satisfaction of knowing he or she will have to pay taxes on the money.

Dr. Eastern practices dermatology and dermatologic surgery in Bellevue, N.J. 

A new report shows that not all physicians agree on how forthcoming they should be with patients, but this should not be viewed by the public as evidence that most doctors lie, according to a senior clinical ethicist.

Evan DeRenzo, PhD, of the Center for Ethics at Washington Hospital Center in Washington, D.C., says the report, "Survey Shows that at Least Some Physicians are not Always Open or Honest With Patients," published last month in Health Affairs, is useful for sparking discussion of professional ethics, but adds that medicine is an art, and communication with patients is a subjective topic.

Physicians should ask themselves, "How much information is the right amount of information for this particular patient to grasp the most important parts of the panoply of information?" she says.

Dr. DeRenzo says that fraud or abuse is both illegal and unethical but, in most situations, what and how to communicate with patients or colleagues is "not black and white." The Health Affairs report surveyed 1,891 physicians nationwide and found that about one-third of doctors don’t “completely agree” that they should “disclose all significant medical errors to affected patients.” More than 35% of respondents did not completely agree they should disclose to patients financial relationships with pharmaceutical companies or medical device firms, and 11% reported that they had told patients something false.

Dr. DeRenzo believes that a stronger focus on training physicians to communicate with patients and colleagues would help instill a sense of how best to ethically handle discussions. She adds that the construct on how to best communicate is not dependent on specialties, but on common sense.

"I don't see any difference whether [the communication is] hospital to community, surgery to medicine," she says. "I don't see any difference at all because you're talking about how do we communicate with patients, what are the optimal ways to convey and exchange information, and how ought physicians—hospitalist, surgeon, community doctor, it doesn’t matter—act in the best interest of their patient."

A new report shows that not all physicians agree on how forthcoming they should be with patients, but this should not be viewed by the public as evidence that most doctors lie, according to a senior clinical ethicist.

Evan DeRenzo, PhD, of the Center for Ethics at Washington Hospital Center in Washington, D.C., says the report, "Survey Shows that at Least Some Physicians are not Always Open or Honest With Patients," published last month in Health Affairs, is useful for sparking discussion of professional ethics, but adds that medicine is an art, and communication with patients is a subjective topic.

Physicians should ask themselves, "How much information is the right amount of information for this particular patient to grasp the most important parts of the panoply of information?" she says.

Dr. DeRenzo says that fraud or abuse is both illegal and unethical but, in most situations, what and how to communicate with patients or colleagues is "not black and white." The Health Affairs report surveyed 1,891 physicians nationwide and found that about one-third of doctors don’t “completely agree” that they should “disclose all significant medical errors to affected patients.” More than 35% of respondents did not completely agree they should disclose to patients financial relationships with pharmaceutical companies or medical device firms, and 11% reported that they had told patients something false.

Dr. DeRenzo believes that a stronger focus on training physicians to communicate with patients and colleagues would help instill a sense of how best to ethically handle discussions. She adds that the construct on how to best communicate is not dependent on specialties, but on common sense.

"I don't see any difference whether [the communication is] hospital to community, surgery to medicine," she says. "I don't see any difference at all because you're talking about how do we communicate with patients, what are the optimal ways to convey and exchange information, and how ought physicians—hospitalist, surgeon, community doctor, it doesn’t matter—act in the best interest of their patient."

A new report shows that not all physicians agree on how forthcoming they should be with patients, but this should not be viewed by the public as evidence that most doctors lie, according to a senior clinical ethicist.

Evan DeRenzo, PhD, of the Center for Ethics at Washington Hospital Center in Washington, D.C., says the report, "Survey Shows that at Least Some Physicians are not Always Open or Honest With Patients," published last month in Health Affairs, is useful for sparking discussion of professional ethics, but adds that medicine is an art, and communication with patients is a subjective topic.

Physicians should ask themselves, "How much information is the right amount of information for this particular patient to grasp the most important parts of the panoply of information?" she says.

Dr. DeRenzo says that fraud or abuse is both illegal and unethical but, in most situations, what and how to communicate with patients or colleagues is "not black and white." The Health Affairs report surveyed 1,891 physicians nationwide and found that about one-third of doctors don’t “completely agree” that they should “disclose all significant medical errors to affected patients.” More than 35% of respondents did not completely agree they should disclose to patients financial relationships with pharmaceutical companies or medical device firms, and 11% reported that they had told patients something false.

Dr. DeRenzo believes that a stronger focus on training physicians to communicate with patients and colleagues would help instill a sense of how best to ethically handle discussions. She adds that the construct on how to best communicate is not dependent on specialties, but on common sense.

"I don't see any difference whether [the communication is] hospital to community, surgery to medicine," she says. "I don't see any difference at all because you're talking about how do we communicate with patients, what are the optimal ways to convey and exchange information, and how ought physicians—hospitalist, surgeon, community doctor, it doesn’t matter—act in the best interest of their patient."

A recent article in Academic Medicine examines medical students' and residents' experiences learning the practice of defensive medicine, which the authors define as deviation from sound medical practice due to a perceived threat of malpractice liability. The authors found that while defensive medicine may not be written into the curriculum, it is still being taught.

"We hope this study sheds light on the fact that defensive medicine practices are frequently recommended by faculty as part of the informal curriculum," says Kevin O'Leary, MD, MS, associate chief of hospital medicine at Northwestern University Feinberg School of Medicine in Chicago and lead author of the study. Better, he says, for medical training to reframe the discussion on the risk for preventable adverse events or injuries to patients and the provision of safer patient care, which is not only more ethical but also more likely to reduce malpractice exposure.

A cross-section of 126 fourth-year medical students and 76 third-year residents at Northwestern were asked how often their attendings explicitly recommended taking liability concerns into account when making medical decisions. Forty-one percent of med students and 53% of residents responded that this occurred sometimes or often. Ninety-two percent of medical students and 96% of residents reported encountering the provision of additional services of little clinical value. Withholding necessary procedures out of malpractice concerns was less common.

One student surveyed said, "All the time in the outpatient setting, [my] attending reminds us that we're in a service industry dealing with litigious people and that sometimes you have to do the extra scan or prescribe the antibiotics that are unnecessary to keep people from suing you."

A recent article in Academic Medicine examines medical students' and residents' experiences learning the practice of defensive medicine, which the authors define as deviation from sound medical practice due to a perceived threat of malpractice liability. The authors found that while defensive medicine may not be written into the curriculum, it is still being taught.

"We hope this study sheds light on the fact that defensive medicine practices are frequently recommended by faculty as part of the informal curriculum," says Kevin O'Leary, MD, MS, associate chief of hospital medicine at Northwestern University Feinberg School of Medicine in Chicago and lead author of the study. Better, he says, for medical training to reframe the discussion on the risk for preventable adverse events or injuries to patients and the provision of safer patient care, which is not only more ethical but also more likely to reduce malpractice exposure.

A cross-section of 126 fourth-year medical students and 76 third-year residents at Northwestern were asked how often their attendings explicitly recommended taking liability concerns into account when making medical decisions. Forty-one percent of med students and 53% of residents responded that this occurred sometimes or often. Ninety-two percent of medical students and 96% of residents reported encountering the provision of additional services of little clinical value. Withholding necessary procedures out of malpractice concerns was less common.

One student surveyed said, "All the time in the outpatient setting, [my] attending reminds us that we're in a service industry dealing with litigious people and that sometimes you have to do the extra scan or prescribe the antibiotics that are unnecessary to keep people from suing you."

A recent article in Academic Medicine examines medical students' and residents' experiences learning the practice of defensive medicine, which the authors define as deviation from sound medical practice due to a perceived threat of malpractice liability. The authors found that while defensive medicine may not be written into the curriculum, it is still being taught.

"We hope this study sheds light on the fact that defensive medicine practices are frequently recommended by faculty as part of the informal curriculum," says Kevin O'Leary, MD, MS, associate chief of hospital medicine at Northwestern University Feinberg School of Medicine in Chicago and lead author of the study. Better, he says, for medical training to reframe the discussion on the risk for preventable adverse events or injuries to patients and the provision of safer patient care, which is not only more ethical but also more likely to reduce malpractice exposure.

A cross-section of 126 fourth-year medical students and 76 third-year residents at Northwestern were asked how often their attendings explicitly recommended taking liability concerns into account when making medical decisions. Forty-one percent of med students and 53% of residents responded that this occurred sometimes or often. Ninety-two percent of medical students and 96% of residents reported encountering the provision of additional services of little clinical value. Withholding necessary procedures out of malpractice concerns was less common.

One student surveyed said, "All the time in the outpatient setting, [my] attending reminds us that we're in a service industry dealing with litigious people and that sometimes you have to do the extra scan or prescribe the antibiotics that are unnecessary to keep people from suing you."

Women with both hypothyroidism and inflammatory arthritis have a nearly fourfold greater risk of developing heart disease, compared with controls.

The finding adds to "sparse" data on the long-hypothesized association between hypothyroidism and inflammatory arthritis, and also "emphasizes the need for cardiovascular risk management in this case," wrote Dr. Hennie G. Raterman and colleagues in Annals of the Rheumatic Diseases, published online March 14.

©STAN ROHRER/ISTOCKPHOTO.COM

Dr. Raterman of the department of rheumatology at the VU University Medical Center in Amsterdam and colleagues looked at more than 175,000 patients from the Netherlands Information Network of General Practice, retrieved from the electronic medical records of a representative sample of 69 general practices with 360,000 registered patients in 2006 (Ann. Rheum. Dis. 2012 [doi: 10.1136/annrheumdis-2011-200836]).

Patients younger than 30 years of age were excluded, given that cardiovascular disease is uncommon in this population. Morbidity data were derived from diagnostic coding, with codes for myocardial infarction, transient ischemic attack, and stroke/cerebrovascular accident indicating cardiovascular disease.

Overall, 1,518 (0.9%) of patients had inflammatory arthritis (including 973 females).

"In both male and female patients with inflammatory arthritis, hypothyroidism prevalence rates were significantly higher than in controls: 2.4% vs. 0.8% in male patients and 6.5% vs. 3.9% in female patients," wrote the authors, with an overall prevalence of hypothyroidism among inflammatory arthritis patients of 5.01% (vs. an overall 2.39 in controls, with P less than .0005).

The authors then calculated the prevalence of cardiovascular disease in this cohort. The analysis was restricted to female patients, however, "as there were too few men with both hypothyroidism and inflammatory arthritis to yield meaningful estimates."

They found that, after adjustment for age, hypertension, diabetes, and hypercholesterolemia, women with hypothyroidism plus inflammatory arthritis had an odds ratio of 3.72 for heart disease, compared with controls (95% confidence interval, 1.74-7.95).

That compared with an odds ratio of 1.48 for inflammatory arthritis alone (95% CI, 1.10-2.00) and 1.19 for patients with only hypothyroid (95% CI, 0.99-1.43).

According to Dr. Raterman, hypothyroidism acts on the cardiovascular system in several ways: by increasing oxidative stress and deteriorating endothelial function; and by decreasing nitric oxide production while increasing platelet activity, stimulating atherogenesis.

Additionally, "it is noteworthy that functional polymorphisms of protein tyrosine phosphatase N22 – a susceptibility factor for several autoimmune diseases such as hypothyroidism, inflammatory arthritis, and diabetes – accelerate atherosclerosis," wrote Dr. Raterman and his associates.

The authors cautioned that their study included several important limitations.

For one, "several CVD risk factors, such as lifestyle factors, family history of CVD, socioeconomic status, and ethnic background, were unavailable and could not be adjusted for in this study," they wrote.

Moreover, "we cannot exclude that part of our observed findings may be explained by an increased frequency of testing for thyroid disorders, as we and others previously described an increased prevalence of hypothyroidism in secondary care patients with RA."

Finally, they pointed out that the coding system used to identify inflammatory arthritis was unable to distinguish between different types, including rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.

"This association needs further elaboration in prospective studies."

The authors stated that they had no competing interests and no outside funding to disclose.

The investigators stated that they had no competing interests in relation to this study and received no outside funding.

Women with both hypothyroidism and inflammatory arthritis have a nearly fourfold greater risk of developing heart disease, compared with controls.

The finding adds to "sparse" data on the long-hypothesized association between hypothyroidism and inflammatory arthritis, and also "emphasizes the need for cardiovascular risk management in this case," wrote Dr. Hennie G. Raterman and colleagues in Annals of the Rheumatic Diseases, published online March 14.

©STAN ROHRER/ISTOCKPHOTO.COM

Dr. Raterman of the department of rheumatology at the VU University Medical Center in Amsterdam and colleagues looked at more than 175,000 patients from the Netherlands Information Network of General Practice, retrieved from the electronic medical records of a representative sample of 69 general practices with 360,000 registered patients in 2006 (Ann. Rheum. Dis. 2012 [doi: 10.1136/annrheumdis-2011-200836]).

Patients younger than 30 years of age were excluded, given that cardiovascular disease is uncommon in this population. Morbidity data were derived from diagnostic coding, with codes for myocardial infarction, transient ischemic attack, and stroke/cerebrovascular accident indicating cardiovascular disease.

Overall, 1,518 (0.9%) of patients had inflammatory arthritis (including 973 females).

"In both male and female patients with inflammatory arthritis, hypothyroidism prevalence rates were significantly higher than in controls: 2.4% vs. 0.8% in male patients and 6.5% vs. 3.9% in female patients," wrote the authors, with an overall prevalence of hypothyroidism among inflammatory arthritis patients of 5.01% (vs. an overall 2.39 in controls, with P less than .0005).

The authors then calculated the prevalence of cardiovascular disease in this cohort. The analysis was restricted to female patients, however, "as there were too few men with both hypothyroidism and inflammatory arthritis to yield meaningful estimates."

They found that, after adjustment for age, hypertension, diabetes, and hypercholesterolemia, women with hypothyroidism plus inflammatory arthritis had an odds ratio of 3.72 for heart disease, compared with controls (95% confidence interval, 1.74-7.95).

That compared with an odds ratio of 1.48 for inflammatory arthritis alone (95% CI, 1.10-2.00) and 1.19 for patients with only hypothyroid (95% CI, 0.99-1.43).

According to Dr. Raterman, hypothyroidism acts on the cardiovascular system in several ways: by increasing oxidative stress and deteriorating endothelial function; and by decreasing nitric oxide production while increasing platelet activity, stimulating atherogenesis.

Additionally, "it is noteworthy that functional polymorphisms of protein tyrosine phosphatase N22 – a susceptibility factor for several autoimmune diseases such as hypothyroidism, inflammatory arthritis, and diabetes – accelerate atherosclerosis," wrote Dr. Raterman and his associates.

The authors cautioned that their study included several important limitations.

For one, "several CVD risk factors, such as lifestyle factors, family history of CVD, socioeconomic status, and ethnic background, were unavailable and could not be adjusted for in this study," they wrote.

Moreover, "we cannot exclude that part of our observed findings may be explained by an increased frequency of testing for thyroid disorders, as we and others previously described an increased prevalence of hypothyroidism in secondary care patients with RA."

Finally, they pointed out that the coding system used to identify inflammatory arthritis was unable to distinguish between different types, including rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.

"This association needs further elaboration in prospective studies."

The authors stated that they had no competing interests and no outside funding to disclose.

The investigators stated that they had no competing interests in relation to this study and received no outside funding.

Women with both hypothyroidism and inflammatory arthritis have a nearly fourfold greater risk of developing heart disease, compared with controls.

The finding adds to "sparse" data on the long-hypothesized association between hypothyroidism and inflammatory arthritis, and also "emphasizes the need for cardiovascular risk management in this case," wrote Dr. Hennie G. Raterman and colleagues in Annals of the Rheumatic Diseases, published online March 14.

©STAN ROHRER/ISTOCKPHOTO.COM

Dr. Raterman of the department of rheumatology at the VU University Medical Center in Amsterdam and colleagues looked at more than 175,000 patients from the Netherlands Information Network of General Practice, retrieved from the electronic medical records of a representative sample of 69 general practices with 360,000 registered patients in 2006 (Ann. Rheum. Dis. 2012 [doi: 10.1136/annrheumdis-2011-200836]).

Patients younger than 30 years of age were excluded, given that cardiovascular disease is uncommon in this population. Morbidity data were derived from diagnostic coding, with codes for myocardial infarction, transient ischemic attack, and stroke/cerebrovascular accident indicating cardiovascular disease.

Overall, 1,518 (0.9%) of patients had inflammatory arthritis (including 973 females).

"In both male and female patients with inflammatory arthritis, hypothyroidism prevalence rates were significantly higher than in controls: 2.4% vs. 0.8% in male patients and 6.5% vs. 3.9% in female patients," wrote the authors, with an overall prevalence of hypothyroidism among inflammatory arthritis patients of 5.01% (vs. an overall 2.39 in controls, with P less than .0005).

The authors then calculated the prevalence of cardiovascular disease in this cohort. The analysis was restricted to female patients, however, "as there were too few men with both hypothyroidism and inflammatory arthritis to yield meaningful estimates."

They found that, after adjustment for age, hypertension, diabetes, and hypercholesterolemia, women with hypothyroidism plus inflammatory arthritis had an odds ratio of 3.72 for heart disease, compared with controls (95% confidence interval, 1.74-7.95).

That compared with an odds ratio of 1.48 for inflammatory arthritis alone (95% CI, 1.10-2.00) and 1.19 for patients with only hypothyroid (95% CI, 0.99-1.43).

According to Dr. Raterman, hypothyroidism acts on the cardiovascular system in several ways: by increasing oxidative stress and deteriorating endothelial function; and by decreasing nitric oxide production while increasing platelet activity, stimulating atherogenesis.

Additionally, "it is noteworthy that functional polymorphisms of protein tyrosine phosphatase N22 – a susceptibility factor for several autoimmune diseases such as hypothyroidism, inflammatory arthritis, and diabetes – accelerate atherosclerosis," wrote Dr. Raterman and his associates.

The authors cautioned that their study included several important limitations.

For one, "several CVD risk factors, such as lifestyle factors, family history of CVD, socioeconomic status, and ethnic background, were unavailable and could not be adjusted for in this study," they wrote.

Moreover, "we cannot exclude that part of our observed findings may be explained by an increased frequency of testing for thyroid disorders, as we and others previously described an increased prevalence of hypothyroidism in secondary care patients with RA."

Finally, they pointed out that the coding system used to identify inflammatory arthritis was unable to distinguish between different types, including rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.

"This association needs further elaboration in prospective studies."

The authors stated that they had no competing interests and no outside funding to disclose.

The investigators stated that they had no competing interests in relation to this study and received no outside funding.

Hospitalist Jordan Messler, MD, SFHM, has experienced SHM’s mentored-implementation program as both mentee and mentor. So when he heard that the mentored-implementation model was named the winner of the 2011 John M. Eisenberg Innovation in Patient Safety and Quality at the National Level Award, he knew it was well-earned.

Hospitalists and SHM should be very proud that NQF and The Joint Commission chose to bestow this award onto SHM. But at the end of the day, we at SHM also recognize that this is an award. We’re going to celebrate in San Diego with everybody, but once the [annual] meeting is over, we’re going to roll up our sleeves. There’s a heck of a lot more work to get done.

—Joseph Ming-Wah Li, MD, SFHM, SHM president

“The biggest aspect of these programs has been the collegiality and the learning from others,” says Dr. Messler, medical director at Morton Plant Hospital in Clearwater, Fla. “That’s really the core of this. We’ve all felt that we’re out on an island and we’re all building these projects from the ground up. We all probably at one point in a meeting say, ‘Someone else must have solved this.’ ... These mentored-implementation programs say, ‘Yes, of course other folks have solved this.’” 

SHM is the first professional society to earn the award, bestowed by the National Quality Forum (NQF) and The Joint Commission. The model has helped propel SHM’s Glycemic Control Mentored Implementation (GCMI) Program, Project BOOST (Better Outcomes for Older Adults through Safe Transitions), and the VTE Prevention Collaborative.

Mentors have been put in place in more than 300 hospitals in the U.S. and Canada, according to an announcement.

“There are significant congratulations [due] to the profession and all the people at the society who have done all the work on this,” says SHM president Joseph Ming-Wah Li, MD, SFHM. “Part of what we’ve been saying all along is that quality is important. In terms of teaching quality—it’s a real team effort.”

NQF president and chief executive Janet Corrigan, PhD, MBA, says that one of the hallmarks of SHM’s program is its ability to be applied to different quality initiatives. Corrigan adds that while a professional society had never previously won the national award, SHM’s execution in creating, implementing, and providing follow-up resources helped differentiate the construct.

“We want to shed light on the kinds of things that are working and encourage others to emulate them, to build on them, and to reinvent them in new and even better ways,” Corrigan says. “It is a whole process of quality improvement.”

Dr. Li says the honor is a milestone for SHM, but the society must not rest on its laurels because it “hit a home run.” Instead, the society should use the momentum of the award to push for and apply for more QI programs. The more successful programs the society and its members launch and successfully implement, the more HM as a field will be considered a leader in quality improvement, he adds.

“We’re an absolute infant compared to many other medical organizations and other medical societies,” Dr. Li says. “Hospitalists and SHM should be very proud that NQF and The Joint Commission chose to bestow this award onto SHM. But at the end of the day, we at SHM also recognize that this is an award.

"We’re going to celebrate in San Diego with everybody, but once the [annual] meeting is over, we’re going to roll up our sleeves. There’s a heck of a lot more work to get done.”

 Richard Quinn is a freelance writer based in New Jersey. 

Hospitalist Jordan Messler, MD, SFHM, has experienced SHM’s mentored-implementation program as both mentee and mentor. So when he heard that the mentored-implementation model was named the winner of the 2011 John M. Eisenberg Innovation in Patient Safety and Quality at the National Level Award, he knew it was well-earned.

Hospitalists and SHM should be very proud that NQF and The Joint Commission chose to bestow this award onto SHM. But at the end of the day, we at SHM also recognize that this is an award. We’re going to celebrate in San Diego with everybody, but once the [annual] meeting is over, we’re going to roll up our sleeves. There’s a heck of a lot more work to get done.

—Joseph Ming-Wah Li, MD, SFHM, SHM president

“The biggest aspect of these programs has been the collegiality and the learning from others,” says Dr. Messler, medical director at Morton Plant Hospital in Clearwater, Fla. “That’s really the core of this. We’ve all felt that we’re out on an island and we’re all building these projects from the ground up. We all probably at one point in a meeting say, ‘Someone else must have solved this.’ ... These mentored-implementation programs say, ‘Yes, of course other folks have solved this.’” 

SHM is the first professional society to earn the award, bestowed by the National Quality Forum (NQF) and The Joint Commission. The model has helped propel SHM’s Glycemic Control Mentored Implementation (GCMI) Program, Project BOOST (Better Outcomes for Older Adults through Safe Transitions), and the VTE Prevention Collaborative.

Mentors have been put in place in more than 300 hospitals in the U.S. and Canada, according to an announcement.

“There are significant congratulations [due] to the profession and all the people at the society who have done all the work on this,” says SHM president Joseph Ming-Wah Li, MD, SFHM. “Part of what we’ve been saying all along is that quality is important. In terms of teaching quality—it’s a real team effort.”

NQF president and chief executive Janet Corrigan, PhD, MBA, says that one of the hallmarks of SHM’s program is its ability to be applied to different quality initiatives. Corrigan adds that while a professional society had never previously won the national award, SHM’s execution in creating, implementing, and providing follow-up resources helped differentiate the construct.

“We want to shed light on the kinds of things that are working and encourage others to emulate them, to build on them, and to reinvent them in new and even better ways,” Corrigan says. “It is a whole process of quality improvement.”

Dr. Li says the honor is a milestone for SHM, but the society must not rest on its laurels because it “hit a home run.” Instead, the society should use the momentum of the award to push for and apply for more QI programs. The more successful programs the society and its members launch and successfully implement, the more HM as a field will be considered a leader in quality improvement, he adds.

“We’re an absolute infant compared to many other medical organizations and other medical societies,” Dr. Li says. “Hospitalists and SHM should be very proud that NQF and The Joint Commission chose to bestow this award onto SHM. But at the end of the day, we at SHM also recognize that this is an award.

"We’re going to celebrate in San Diego with everybody, but once the [annual] meeting is over, we’re going to roll up our sleeves. There’s a heck of a lot more work to get done.”

 Richard Quinn is a freelance writer based in New Jersey. 

Hospitalist Jordan Messler, MD, SFHM, has experienced SHM’s mentored-implementation program as both mentee and mentor. So when he heard that the mentored-implementation model was named the winner of the 2011 John M. Eisenberg Innovation in Patient Safety and Quality at the National Level Award, he knew it was well-earned.

Hospitalists and SHM should be very proud that NQF and The Joint Commission chose to bestow this award onto SHM. But at the end of the day, we at SHM also recognize that this is an award. We’re going to celebrate in San Diego with everybody, but once the [annual] meeting is over, we’re going to roll up our sleeves. There’s a heck of a lot more work to get done.

—Joseph Ming-Wah Li, MD, SFHM, SHM president

“The biggest aspect of these programs has been the collegiality and the learning from others,” says Dr. Messler, medical director at Morton Plant Hospital in Clearwater, Fla. “That’s really the core of this. We’ve all felt that we’re out on an island and we’re all building these projects from the ground up. We all probably at one point in a meeting say, ‘Someone else must have solved this.’ ... These mentored-implementation programs say, ‘Yes, of course other folks have solved this.’” 

SHM is the first professional society to earn the award, bestowed by the National Quality Forum (NQF) and The Joint Commission. The model has helped propel SHM’s Glycemic Control Mentored Implementation (GCMI) Program, Project BOOST (Better Outcomes for Older Adults through Safe Transitions), and the VTE Prevention Collaborative.

Mentors have been put in place in more than 300 hospitals in the U.S. and Canada, according to an announcement.

“There are significant congratulations [due] to the profession and all the people at the society who have done all the work on this,” says SHM president Joseph Ming-Wah Li, MD, SFHM. “Part of what we’ve been saying all along is that quality is important. In terms of teaching quality—it’s a real team effort.”

NQF president and chief executive Janet Corrigan, PhD, MBA, says that one of the hallmarks of SHM’s program is its ability to be applied to different quality initiatives. Corrigan adds that while a professional society had never previously won the national award, SHM’s execution in creating, implementing, and providing follow-up resources helped differentiate the construct.

“We want to shed light on the kinds of things that are working and encourage others to emulate them, to build on them, and to reinvent them in new and even better ways,” Corrigan says. “It is a whole process of quality improvement.”

Dr. Li says the honor is a milestone for SHM, but the society must not rest on its laurels because it “hit a home run.” Instead, the society should use the momentum of the award to push for and apply for more QI programs. The more successful programs the society and its members launch and successfully implement, the more HM as a field will be considered a leader in quality improvement, he adds.

“We’re an absolute infant compared to many other medical organizations and other medical societies,” Dr. Li says. “Hospitalists and SHM should be very proud that NQF and The Joint Commission chose to bestow this award onto SHM. But at the end of the day, we at SHM also recognize that this is an award.

"We’re going to celebrate in San Diego with everybody, but once the [annual] meeting is over, we’re going to roll up our sleeves. There’s a heck of a lot more work to get done.”

 Richard Quinn is a freelance writer based in New Jersey. 

More detailed genetic profiling of patients with acute myeloid leukemia and of those with precursor myelodysplastic syndromes is likely to improve prognostic and therapeutic decision making, according to two separate studies published online March 14 in the New England Journal of Medicine.

In one study, investigators found that the presence of DNMT3A and NPM1 mutations and MLL translocations predicted an improved outcome when patients received high-dose daunorubicin instead of the standard dose in induction chemotherapy for acute myeloid leukemia (AML).

The results suggest that "mutational profiling can be used to determine which patients will benefit from dose-intensive induction therapy," wrote Jay P. Patel of the human oncology and pathogenesis program at Memorial Sloan-Kettering Cancer Center, New York, and his associates.

In the other study, researchers reported that "nearly all" of the bone marrow cells were clonally derived in paired samples of skin and bone marrow from seven patients with myelodysplastic syndromes (MDS) and secondary AML. Founding clones and daughter subclones in all seven paired samples had recurrent gene mutations, including at least one mutation in a coding gene.

"Although clonality is not sufficient to define malignant transformation, it is a cardinal manifestation of most human cancers, and our findings suggest that the myelodysplastic syndromes and secondary AML are both highly clonal hematologic cancers," said Dr. Matthew J. Walter of the departments of internal medicine and genetics at the Siteman Cancer Center, Washington University, St. Louis, and his associates.

Mutational Analysis of Trial Results

In the first study, researchers performed a more-extensive mutational analysis than is typically done to better discriminate among patients with different prognoses.

"Previous studies have suggested that mutational analysis of [the genes] CEBPA, NPM1, and FLT3-ITD can be used to stratify risk among patients with intermediate-risk AML," wrote Mr. Patel and his colleagues.

"We hypothesized that integrated mutational analysis of all known molecular alterations occurring in more than 5% of patients with AML would allow us to identify novel molecular markers of outcome ... and to identify molecularly defined subgroups of patients who would benefit from dose-intensified induction therapy."

For DNA extraction and profiling, the investigators used diagnostic samples of bone marrow and peripheral blood from 398 patients who were participating in the phase III ECOG (Eastern Cooperative Oncology Group) E1900 clinical trial in which two doses of induction therapy were tested. They found that 97.3% of the study subjects had mutations in 18 genes, and performed extensive mutational analysis of these 18 candidate genes.

The results led them to identify three distinct risk groups. Patients with favorable genetic profiles had a 3-year overall survival of 64% and had not yet reached a median survival; those with intermediate-risk genetic profiles had a 3-year survival of 42% and a median survival of 25 months; and those with unfavorable genetic profiles had a 3-year overall survival of 12% and a median survival of 10 months.

These findings were then validated in a separate group of 104 patients from the same clinical trial. The value of the genetic risk profiles was confirmed, with the favorable, intermediate, and unfavorable profiles accurately predicting patient outcomes independently of patient age, white cell count, induction dose, transplantation status, and type of postremission therapy, Mr. Patel and his colleagues said (N. Engl. J. Med. 2012 March 14 [doi:10.1056/NEJMoa1112304]).

Moreover, the 3-year overall survival rate in patients with a mutation in the DNMT3A or NPM1 genes or a MLL translocation was 44% with high-dose chemotherapy vs. 25% with the standard dose. In patients with other genotypes, it was 35% with the high-dose regimen and 39% with the standard dose.

"These data indicate that more detailed genetic analysis may lead to improved risk stratification and identification of patients who can benefit from more intensive induction chemotherapy. The challenge is to provide genetic information in a timely and affordable way and show that this information could prospectively influence treatment decisions," they noted.

Founding MDS Clones Persist in AML

In the second study, Dr. Walter and his associates used bone marrow biopsy specimens from seven patients who progressed from MDS to AML to define changes in the proportion of clonal cells and the genetic architecture that took place during that progression.

Several genes have already been identified that show recurrent mutations during this process, "but our understanding of the total number and clonal distribution of mutations in this disease is limited," they noted.

For each subject, DNA sequences were obtained from samples of normal skin, bone marrow obtained during the MDS stage, and bone marrow obtained during the secondary AML stage, to analyze mutations. In all seven samples, the founding clones (containing 182-660 mutations) persisted in the secondary samples, while acquiring at least one new mutation predicting translational consequences.

"We have found that the proportion of neoplastic bone marrow cells is indistinguishable [between] myelodysplastic-syndrome and secondary-AML samples, suggesting that the myelodysplastic syndromes are as clonal as secondary AML," Dr. Walter and his colleagues said (N. Engl. J. Med. 2012 March 14 [doi:10.1056/NEJMoa1106968]).

There are three major clinical implications, according to the authors.

First, MDS is currently distinguished from secondary AML based on hand counting of bone marrow myeloblasts – a method prone to inaccuracy but nonetheless relied upon to drive major treatment decisions. "Ultimately, identifying the patterns of pathogenic mutations and their clonality in bone marrow samples ... should lead to greater diagnostic certainty and improved prognostic algorithms," the investigators said.

Second, the dominant AML clone was derived from a founding MDS clone in every case, suggesting that "therapies targeted to these early mutations might be the most effective strategy for eliminating disease-propagating cells and improving the rate of response to traditional chemotherapy."

Third, it is possible that progression from MDS to AML "is driven not only by the presence of recurrent mutations ... but also by the clone ([that is], founding vs. daughter) in which they arise." Combining genotyping of samples with analysis of the clonal architecture "may yield more informative biomarkers and a better understanding of the pathogenesis of the myelodysplastic syndrome," Dr. Walter and his associates said.

Dr. Patel’s study was supported by the National Cancer Institute Physical Sciences Oncology Center, Gabrielle’s Angel Fund, the Starr Cancer Consortium, the Peter Solomon Fund, the American Society of Hematology, the Leukemia and Lymphoma Society, the Fund for Scientific Research Flanders, Burroughs Wellcome, the Sackler Center for Biomedical and Research Sciences, and the Howard Hughes Medical Institute. One of Dr. Patel’s associates reported ties to Agios, Incyte, and Novartis. Dr. Walter’s study was supported by the National Institutes of Health, the Howard Hughes Medical Institute, and the National Center for Research Resources. He and his associates reported no financial conflicts of interest.

More detailed genetic profiling of patients with acute myeloid leukemia and of those with precursor myelodysplastic syndromes is likely to improve prognostic and therapeutic decision making, according to two separate studies published online March 14 in the New England Journal of Medicine.

In one study, investigators found that the presence of DNMT3A and NPM1 mutations and MLL translocations predicted an improved outcome when patients received high-dose daunorubicin instead of the standard dose in induction chemotherapy for acute myeloid leukemia (AML).

The results suggest that "mutational profiling can be used to determine which patients will benefit from dose-intensive induction therapy," wrote Jay P. Patel of the human oncology and pathogenesis program at Memorial Sloan-Kettering Cancer Center, New York, and his associates.

In the other study, researchers reported that "nearly all" of the bone marrow cells were clonally derived in paired samples of skin and bone marrow from seven patients with myelodysplastic syndromes (MDS) and secondary AML. Founding clones and daughter subclones in all seven paired samples had recurrent gene mutations, including at least one mutation in a coding gene.

"Although clonality is not sufficient to define malignant transformation, it is a cardinal manifestation of most human cancers, and our findings suggest that the myelodysplastic syndromes and secondary AML are both highly clonal hematologic cancers," said Dr. Matthew J. Walter of the departments of internal medicine and genetics at the Siteman Cancer Center, Washington University, St. Louis, and his associates.

Mutational Analysis of Trial Results

In the first study, researchers performed a more-extensive mutational analysis than is typically done to better discriminate among patients with different prognoses.

"Previous studies have suggested that mutational analysis of [the genes] CEBPA, NPM1, and FLT3-ITD can be used to stratify risk among patients with intermediate-risk AML," wrote Mr. Patel and his colleagues.

"We hypothesized that integrated mutational analysis of all known molecular alterations occurring in more than 5% of patients with AML would allow us to identify novel molecular markers of outcome ... and to identify molecularly defined subgroups of patients who would benefit from dose-intensified induction therapy."

For DNA extraction and profiling, the investigators used diagnostic samples of bone marrow and peripheral blood from 398 patients who were participating in the phase III ECOG (Eastern Cooperative Oncology Group) E1900 clinical trial in which two doses of induction therapy were tested. They found that 97.3% of the study subjects had mutations in 18 genes, and performed extensive mutational analysis of these 18 candidate genes.

The results led them to identify three distinct risk groups. Patients with favorable genetic profiles had a 3-year overall survival of 64% and had not yet reached a median survival; those with intermediate-risk genetic profiles had a 3-year survival of 42% and a median survival of 25 months; and those with unfavorable genetic profiles had a 3-year overall survival of 12% and a median survival of 10 months.

These findings were then validated in a separate group of 104 patients from the same clinical trial. The value of the genetic risk profiles was confirmed, with the favorable, intermediate, and unfavorable profiles accurately predicting patient outcomes independently of patient age, white cell count, induction dose, transplantation status, and type of postremission therapy, Mr. Patel and his colleagues said (N. Engl. J. Med. 2012 March 14 [doi:10.1056/NEJMoa1112304]).

Moreover, the 3-year overall survival rate in patients with a mutation in the DNMT3A or NPM1 genes or a MLL translocation was 44% with high-dose chemotherapy vs. 25% with the standard dose. In patients with other genotypes, it was 35% with the high-dose regimen and 39% with the standard dose.

"These data indicate that more detailed genetic analysis may lead to improved risk stratification and identification of patients who can benefit from more intensive induction chemotherapy. The challenge is to provide genetic information in a timely and affordable way and show that this information could prospectively influence treatment decisions," they noted.

Founding MDS Clones Persist in AML

In the second study, Dr. Walter and his associates used bone marrow biopsy specimens from seven patients who progressed from MDS to AML to define changes in the proportion of clonal cells and the genetic architecture that took place during that progression.

Several genes have already been identified that show recurrent mutations during this process, "but our understanding of the total number and clonal distribution of mutations in this disease is limited," they noted.

For each subject, DNA sequences were obtained from samples of normal skin, bone marrow obtained during the MDS stage, and bone marrow obtained during the secondary AML stage, to analyze mutations. In all seven samples, the founding clones (containing 182-660 mutations) persisted in the secondary samples, while acquiring at least one new mutation predicting translational consequences.

"We have found that the proportion of neoplastic bone marrow cells is indistinguishable [between] myelodysplastic-syndrome and secondary-AML samples, suggesting that the myelodysplastic syndromes are as clonal as secondary AML," Dr. Walter and his colleagues said (N. Engl. J. Med. 2012 March 14 [doi:10.1056/NEJMoa1106968]).

There are three major clinical implications, according to the authors.

First, MDS is currently distinguished from secondary AML based on hand counting of bone marrow myeloblasts – a method prone to inaccuracy but nonetheless relied upon to drive major treatment decisions. "Ultimately, identifying the patterns of pathogenic mutations and their clonality in bone marrow samples ... should lead to greater diagnostic certainty and improved prognostic algorithms," the investigators said.

Second, the dominant AML clone was derived from a founding MDS clone in every case, suggesting that "therapies targeted to these early mutations might be the most effective strategy for eliminating disease-propagating cells and improving the rate of response to traditional chemotherapy."

Third, it is possible that progression from MDS to AML "is driven not only by the presence of recurrent mutations ... but also by the clone ([that is], founding vs. daughter) in which they arise." Combining genotyping of samples with analysis of the clonal architecture "may yield more informative biomarkers and a better understanding of the pathogenesis of the myelodysplastic syndrome," Dr. Walter and his associates said.

Dr. Patel’s study was supported by the National Cancer Institute Physical Sciences Oncology Center, Gabrielle’s Angel Fund, the Starr Cancer Consortium, the Peter Solomon Fund, the American Society of Hematology, the Leukemia and Lymphoma Society, the Fund for Scientific Research Flanders, Burroughs Wellcome, the Sackler Center for Biomedical and Research Sciences, and the Howard Hughes Medical Institute. One of Dr. Patel’s associates reported ties to Agios, Incyte, and Novartis. Dr. Walter’s study was supported by the National Institutes of Health, the Howard Hughes Medical Institute, and the National Center for Research Resources. He and his associates reported no financial conflicts of interest.

More detailed genetic profiling of patients with acute myeloid leukemia and of those with precursor myelodysplastic syndromes is likely to improve prognostic and therapeutic decision making, according to two separate studies published online March 14 in the New England Journal of Medicine.

In one study, investigators found that the presence of DNMT3A and NPM1 mutations and MLL translocations predicted an improved outcome when patients received high-dose daunorubicin instead of the standard dose in induction chemotherapy for acute myeloid leukemia (AML).

The results suggest that "mutational profiling can be used to determine which patients will benefit from dose-intensive induction therapy," wrote Jay P. Patel of the human oncology and pathogenesis program at Memorial Sloan-Kettering Cancer Center, New York, and his associates.

In the other study, researchers reported that "nearly all" of the bone marrow cells were clonally derived in paired samples of skin and bone marrow from seven patients with myelodysplastic syndromes (MDS) and secondary AML. Founding clones and daughter subclones in all seven paired samples had recurrent gene mutations, including at least one mutation in a coding gene.

"Although clonality is not sufficient to define malignant transformation, it is a cardinal manifestation of most human cancers, and our findings suggest that the myelodysplastic syndromes and secondary AML are both highly clonal hematologic cancers," said Dr. Matthew J. Walter of the departments of internal medicine and genetics at the Siteman Cancer Center, Washington University, St. Louis, and his associates.

Mutational Analysis of Trial Results

In the first study, researchers performed a more-extensive mutational analysis than is typically done to better discriminate among patients with different prognoses.

"Previous studies have suggested that mutational analysis of [the genes] CEBPA, NPM1, and FLT3-ITD can be used to stratify risk among patients with intermediate-risk AML," wrote Mr. Patel and his colleagues.

"We hypothesized that integrated mutational analysis of all known molecular alterations occurring in more than 5% of patients with AML would allow us to identify novel molecular markers of outcome ... and to identify molecularly defined subgroups of patients who would benefit from dose-intensified induction therapy."

For DNA extraction and profiling, the investigators used diagnostic samples of bone marrow and peripheral blood from 398 patients who were participating in the phase III ECOG (Eastern Cooperative Oncology Group) E1900 clinical trial in which two doses of induction therapy were tested. They found that 97.3% of the study subjects had mutations in 18 genes, and performed extensive mutational analysis of these 18 candidate genes.

The results led them to identify three distinct risk groups. Patients with favorable genetic profiles had a 3-year overall survival of 64% and had not yet reached a median survival; those with intermediate-risk genetic profiles had a 3-year survival of 42% and a median survival of 25 months; and those with unfavorable genetic profiles had a 3-year overall survival of 12% and a median survival of 10 months.

These findings were then validated in a separate group of 104 patients from the same clinical trial. The value of the genetic risk profiles was confirmed, with the favorable, intermediate, and unfavorable profiles accurately predicting patient outcomes independently of patient age, white cell count, induction dose, transplantation status, and type of postremission therapy, Mr. Patel and his colleagues said (N. Engl. J. Med. 2012 March 14 [doi:10.1056/NEJMoa1112304]).

Moreover, the 3-year overall survival rate in patients with a mutation in the DNMT3A or NPM1 genes or a MLL translocation was 44% with high-dose chemotherapy vs. 25% with the standard dose. In patients with other genotypes, it was 35% with the high-dose regimen and 39% with the standard dose.

"These data indicate that more detailed genetic analysis may lead to improved risk stratification and identification of patients who can benefit from more intensive induction chemotherapy. The challenge is to provide genetic information in a timely and affordable way and show that this information could prospectively influence treatment decisions," they noted.

Founding MDS Clones Persist in AML

In the second study, Dr. Walter and his associates used bone marrow biopsy specimens from seven patients who progressed from MDS to AML to define changes in the proportion of clonal cells and the genetic architecture that took place during that progression.

Several genes have already been identified that show recurrent mutations during this process, "but our understanding of the total number and clonal distribution of mutations in this disease is limited," they noted.

For each subject, DNA sequences were obtained from samples of normal skin, bone marrow obtained during the MDS stage, and bone marrow obtained during the secondary AML stage, to analyze mutations. In all seven samples, the founding clones (containing 182-660 mutations) persisted in the secondary samples, while acquiring at least one new mutation predicting translational consequences.

"We have found that the proportion of neoplastic bone marrow cells is indistinguishable [between] myelodysplastic-syndrome and secondary-AML samples, suggesting that the myelodysplastic syndromes are as clonal as secondary AML," Dr. Walter and his colleagues said (N. Engl. J. Med. 2012 March 14 [doi:10.1056/NEJMoa1106968]).

There are three major clinical implications, according to the authors.

First, MDS is currently distinguished from secondary AML based on hand counting of bone marrow myeloblasts – a method prone to inaccuracy but nonetheless relied upon to drive major treatment decisions. "Ultimately, identifying the patterns of pathogenic mutations and their clonality in bone marrow samples ... should lead to greater diagnostic certainty and improved prognostic algorithms," the investigators said.

Second, the dominant AML clone was derived from a founding MDS clone in every case, suggesting that "therapies targeted to these early mutations might be the most effective strategy for eliminating disease-propagating cells and improving the rate of response to traditional chemotherapy."

Third, it is possible that progression from MDS to AML "is driven not only by the presence of recurrent mutations ... but also by the clone ([that is], founding vs. daughter) in which they arise." Combining genotyping of samples with analysis of the clonal architecture "may yield more informative biomarkers and a better understanding of the pathogenesis of the myelodysplastic syndrome," Dr. Walter and his associates said.

Dr. Patel’s study was supported by the National Cancer Institute Physical Sciences Oncology Center, Gabrielle’s Angel Fund, the Starr Cancer Consortium, the Peter Solomon Fund, the American Society of Hematology, the Leukemia and Lymphoma Society, the Fund for Scientific Research Flanders, Burroughs Wellcome, the Sackler Center for Biomedical and Research Sciences, and the Howard Hughes Medical Institute. One of Dr. Patel’s associates reported ties to Agios, Incyte, and Novartis. Dr. Walter’s study was supported by the National Institutes of Health, the Howard Hughes Medical Institute, and the National Center for Research Resources. He and his associates reported no financial conflicts of interest.

SHM has been tapped for the 2011 John M. Eisenberg Innovation in Patient Safety and Quality at the National Level award for its mentored-implementation model.

The award, given by the National Quality Forum and the Joint Commission marks the first time a professional society has been given the honor, according to an NQF spokeswoman.

The model links mentors with constituent hospitals to help push quality improvement models tied to transitional care, glycemic control, and VTE prevention. Mentors have been put in place in more than 300 hospitals in the U.S. and Canada, according to the award announcement.

“There are significant congratulations [due] to the profession and all the people at the society who have done all the work on this,” says SHM President Joseph Ming-Wah Li, MD, SFHM. “Part of what we’ve been saying all along is that quality is important. In terms of teaching quality—it’s a real team effort."

SHM has been tapped for the 2011 John M. Eisenberg Innovation in Patient Safety and Quality at the National Level award for its mentored-implementation model.

The award, given by the National Quality Forum and the Joint Commission marks the first time a professional society has been given the honor, according to an NQF spokeswoman.

The model links mentors with constituent hospitals to help push quality improvement models tied to transitional care, glycemic control, and VTE prevention. Mentors have been put in place in more than 300 hospitals in the U.S. and Canada, according to the award announcement.

“There are significant congratulations [due] to the profession and all the people at the society who have done all the work on this,” says SHM President Joseph Ming-Wah Li, MD, SFHM. “Part of what we’ve been saying all along is that quality is important. In terms of teaching quality—it’s a real team effort."

SHM has been tapped for the 2011 John M. Eisenberg Innovation in Patient Safety and Quality at the National Level award for its mentored-implementation model.

The award, given by the National Quality Forum and the Joint Commission marks the first time a professional society has been given the honor, according to an NQF spokeswoman.

The model links mentors with constituent hospitals to help push quality improvement models tied to transitional care, glycemic control, and VTE prevention. Mentors have been put in place in more than 300 hospitals in the U.S. and Canada, according to the award announcement.

“There are significant congratulations [due] to the profession and all the people at the society who have done all the work on this,” says SHM President Joseph Ming-Wah Li, MD, SFHM. “Part of what we’ve been saying all along is that quality is important. In terms of teaching quality—it’s a real team effort."

Hospitalists should view a new American College of Physicians (ACP) list of three dozen commonly overused clinical tests that offer lower value as an opportunity to review their use of screening and diagnostic tools, according to one of the list's authors.

Jeff Wiese, MD, SFHM, professor of medicine and residency program director at Tulane University Health Sciences Center in New Orleans, coauthored research published in January in the Annals of Internal Medicine that he says represents clinical situations in which tests have historically been administered but, upon further review, do not reflect "high-value care."

"Nobody is trying to waste money," says Dr. Wiese, a former president of SHM who adds that physicians over time might learn that tests that once offered higher value may no longer do so. "Only by critically reviewing our habits are we able to make the necessary adjustments to ensure we are delivering high-value, cost-conscious care."

ACP convened an ad hoc workgroup of internal-medicine specialists to review lower-value tests; the list that the team came up with includes:

• Repeat screening ultrasonography for abdominal aortic aneurysm following a negative study; 
• Screening for prostate cancer in men older than 75 or with a life expectancy of less than 10 years; and
• Performing serologic testing for suspected early Lyme disease.

Dr. Wiese emphasizes that decisions regarding "cost-conscious care" must be interpreted in the context of the specific patient in front of them.

"There is no decision rule that applies to all patients," he says. "The tests addressed in the article are examples of tests that do not routinely offer high value, but this is not to say that there are not specific circumstances when they might be useful."

Hospitalists should view a new American College of Physicians (ACP) list of three dozen commonly overused clinical tests that offer lower value as an opportunity to review their use of screening and diagnostic tools, according to one of the list's authors.

Jeff Wiese, MD, SFHM, professor of medicine and residency program director at Tulane University Health Sciences Center in New Orleans, coauthored research published in January in the Annals of Internal Medicine that he says represents clinical situations in which tests have historically been administered but, upon further review, do not reflect "high-value care."

"Nobody is trying to waste money," says Dr. Wiese, a former president of SHM who adds that physicians over time might learn that tests that once offered higher value may no longer do so. "Only by critically reviewing our habits are we able to make the necessary adjustments to ensure we are delivering high-value, cost-conscious care."

ACP convened an ad hoc workgroup of internal-medicine specialists to review lower-value tests; the list that the team came up with includes:

• Repeat screening ultrasonography for abdominal aortic aneurysm following a negative study; 
• Screening for prostate cancer in men older than 75 or with a life expectancy of less than 10 years; and
• Performing serologic testing for suspected early Lyme disease.

Dr. Wiese emphasizes that decisions regarding "cost-conscious care" must be interpreted in the context of the specific patient in front of them.

"There is no decision rule that applies to all patients," he says. "The tests addressed in the article are examples of tests that do not routinely offer high value, but this is not to say that there are not specific circumstances when they might be useful."

Hospitalists should view a new American College of Physicians (ACP) list of three dozen commonly overused clinical tests that offer lower value as an opportunity to review their use of screening and diagnostic tools, according to one of the list's authors.

Jeff Wiese, MD, SFHM, professor of medicine and residency program director at Tulane University Health Sciences Center in New Orleans, coauthored research published in January in the Annals of Internal Medicine that he says represents clinical situations in which tests have historically been administered but, upon further review, do not reflect "high-value care."

"Nobody is trying to waste money," says Dr. Wiese, a former president of SHM who adds that physicians over time might learn that tests that once offered higher value may no longer do so. "Only by critically reviewing our habits are we able to make the necessary adjustments to ensure we are delivering high-value, cost-conscious care."

ACP convened an ad hoc workgroup of internal-medicine specialists to review lower-value tests; the list that the team came up with includes:

• Repeat screening ultrasonography for abdominal aortic aneurysm following a negative study; 
• Screening for prostate cancer in men older than 75 or with a life expectancy of less than 10 years; and
• Performing serologic testing for suspected early Lyme disease.

Dr. Wiese emphasizes that decisions regarding "cost-conscious care" must be interpreted in the context of the specific patient in front of them.

"There is no decision rule that applies to all patients," he says. "The tests addressed in the article are examples of tests that do not routinely offer high value, but this is not to say that there are not specific circumstances when they might be useful."

Clinical question: What is the current level of continuity of care, and what factors affect continuity of care in the hospital setting? Has this changed with increasing use of hospitalists and limits on residency duty hours?

Background: Outpatient continuity of care leads to lower costs, better quality of life, and less emergency room use. Recent changes in residency hours have increased hand-offs and decreased inpatient continuity, but to what extent is unknown.

Study design: Retrospective cohort of 5% of Medicare claims data (530,000 patients in all) from 1996 to 2006, including patients admitted for COPD, congestive heart failure, or pneumonia who were cared for by a general internist or family practitioner.

Setting: Nationwide in the U.S.

Synopsis: The authors defined patients as having a primary-care physician (PCP) if they had three billed visits with the PCP in the last year, hospitalists as those who derived at least 90% of their Medicare claims from inpatient billing, and other generalists as those who met criteria as a generalist but did not fit these categories. Inpatient continuity of care decreased to 59% of patients seeing a single physician in the hospital in 2006 from 71% in 1996, with an accompanying decrease in the length of stay of one full day. There were large variations by geographic region, population size, and hospital characteristics. Patients cared for by hospitalists had slightly better continuity of care than those cared for by nonhospitalist generalists, and those who were cared for by both hospitalists and nonhospitalist generalists had the worst continuity of care. Having a PCP was associated with increased discontinuity of care as an inpatient, perhaps because of individual members of a practice rounding on all of the practice’s inpatients.

Bottom line: Patients were 5% less likely per year between 1996 and 2006 to have a single physician be their primary caregiver in the hospital, but the rise of the hospitalist movement does not seem to be the cause.

Citation: Fletcher KE, Sharma G, Zhang D, Kuo YF, Goodwin JS. Trends in inpatient continuity of care for a cohort of Medicare patients 1996-2006. J Hosp Med. 2011;6:441-447.

For more physician reviews of HM-relevant literature, visit our website.

Clinical question: What is the current level of continuity of care, and what factors affect continuity of care in the hospital setting? Has this changed with increasing use of hospitalists and limits on residency duty hours?

Background: Outpatient continuity of care leads to lower costs, better quality of life, and less emergency room use. Recent changes in residency hours have increased hand-offs and decreased inpatient continuity, but to what extent is unknown.

Study design: Retrospective cohort of 5% of Medicare claims data (530,000 patients in all) from 1996 to 2006, including patients admitted for COPD, congestive heart failure, or pneumonia who were cared for by a general internist or family practitioner.

Setting: Nationwide in the U.S.

Synopsis: The authors defined patients as having a primary-care physician (PCP) if they had three billed visits with the PCP in the last year, hospitalists as those who derived at least 90% of their Medicare claims from inpatient billing, and other generalists as those who met criteria as a generalist but did not fit these categories. Inpatient continuity of care decreased to 59% of patients seeing a single physician in the hospital in 2006 from 71% in 1996, with an accompanying decrease in the length of stay of one full day. There were large variations by geographic region, population size, and hospital characteristics. Patients cared for by hospitalists had slightly better continuity of care than those cared for by nonhospitalist generalists, and those who were cared for by both hospitalists and nonhospitalist generalists had the worst continuity of care. Having a PCP was associated with increased discontinuity of care as an inpatient, perhaps because of individual members of a practice rounding on all of the practice’s inpatients.

Bottom line: Patients were 5% less likely per year between 1996 and 2006 to have a single physician be their primary caregiver in the hospital, but the rise of the hospitalist movement does not seem to be the cause.

Citation: Fletcher KE, Sharma G, Zhang D, Kuo YF, Goodwin JS. Trends in inpatient continuity of care for a cohort of Medicare patients 1996-2006. J Hosp Med. 2011;6:441-447.

For more physician reviews of HM-relevant literature, visit our website.

Clinical question: What is the current level of continuity of care, and what factors affect continuity of care in the hospital setting? Has this changed with increasing use of hospitalists and limits on residency duty hours?

Background: Outpatient continuity of care leads to lower costs, better quality of life, and less emergency room use. Recent changes in residency hours have increased hand-offs and decreased inpatient continuity, but to what extent is unknown.

Study design: Retrospective cohort of 5% of Medicare claims data (530,000 patients in all) from 1996 to 2006, including patients admitted for COPD, congestive heart failure, or pneumonia who were cared for by a general internist or family practitioner.

Setting: Nationwide in the U.S.

Synopsis: The authors defined patients as having a primary-care physician (PCP) if they had three billed visits with the PCP in the last year, hospitalists as those who derived at least 90% of their Medicare claims from inpatient billing, and other generalists as those who met criteria as a generalist but did not fit these categories. Inpatient continuity of care decreased to 59% of patients seeing a single physician in the hospital in 2006 from 71% in 1996, with an accompanying decrease in the length of stay of one full day. There were large variations by geographic region, population size, and hospital characteristics. Patients cared for by hospitalists had slightly better continuity of care than those cared for by nonhospitalist generalists, and those who were cared for by both hospitalists and nonhospitalist generalists had the worst continuity of care. Having a PCP was associated with increased discontinuity of care as an inpatient, perhaps because of individual members of a practice rounding on all of the practice’s inpatients.

Bottom line: Patients were 5% less likely per year between 1996 and 2006 to have a single physician be their primary caregiver in the hospital, but the rise of the hospitalist movement does not seem to be the cause.

Citation: Fletcher KE, Sharma G, Zhang D, Kuo YF, Goodwin JS. Trends in inpatient continuity of care for a cohort of Medicare patients 1996-2006. J Hosp Med. 2011;6:441-447.

For more physician reviews of HM-relevant literature, visit our website.