Dr. Feldman discusses a multidisciplinary approach to cosmetic medicine and reviews the findings from his survey of physicians from different specialties. For more information, read Dr. Feldman's article in the July 2012 issue, "Academic Physicians' Attitudes Toward Implementation of Multidisciplinary Cosmetic Centers and the Challenges of Subspecialties Working Together."

Dr. Feldman discusses a multidisciplinary approach to cosmetic medicine and reviews the findings from his survey of physicians from different specialties. For more information, read Dr. Feldman's article in the July 2012 issue, "Academic Physicians' Attitudes Toward Implementation of Multidisciplinary Cosmetic Centers and the Challenges of Subspecialties Working Together."

Dr. Feldman discusses a multidisciplinary approach to cosmetic medicine and reviews the findings from his survey of physicians from different specialties. For more information, read Dr. Feldman's article in the July 2012 issue, "Academic Physicians' Attitudes Toward Implementation of Multidisciplinary Cosmetic Centers and the Challenges of Subspecialties Working Together."

This morbidity and mortality conference was like any other: First, we reviewed the case of a patient with a complication from anticoagulation and then another with an anastomotic leak. Finally, we discussed an elderly patient who had a major emergent procedure to treat complications from an underlying life-limiting condition, only to die in hospital weeks later after developing insurmountable medical, surgical, and infectious complications.

This elderly patient was a man in his mid-70s recently diagnosed with recurrent melanoma. He came to our emergency department with peritonitis and hypotension. His wife of 52 years sat beside him. She was tearful and afraid. "We want everything done," she said. Eight weeks ago, he was working full time and playing golf. But, 6 weeks ago he became confused. A CT scan revealed brain metastasis. He spent 5 of the last 6 weeks in the ICU and in a step-down unit, or a nursing home after a series of complications from his brain biopsy. Now he was back in the hospital with a bowel perforation.

Before our surgical team even saw him, he was told he needed surgery, or he would die. We discussed the surgical risks including the likelihood of a protracted ICU stay, and the high risk he would never go home. Still, he and his wife were unprepared for death and so we went to the operating room.

The following weeks were fraught with complications. His symptoms – including delirium, tumor headaches, and pain – were all difficult to manage on his cocktail of steroids, opiates, and antipsychotics. Occasionally, he would mumble something about dying but we couldn’t determine if he was lucid. His symptoms and "talk about death" were distressing for his family. All in all, our team spent almost an hour each day answering their questions and tending to their anxiety and suffering. It took a high emotional toll on our entire team, as we each worried to ourselves that we were doing more harm than good.

One organ system failed after the other. And finally, after two operations, 10 different consultants, and 3 weeks in the hospital, we stopped talking about organ systems and told the family that this man was dying. That day we consulted palliative care to help us with "goals of care." The next day, he became oliguric, and we shifted our focus to comfort. He died within hours surrounded by his loving extended family.

When we discussed this case at M&M, there were no objections to the decision to operate or how we managed his laundry list of complications. His death was deemed "nonpreventable." But, at then end of the discussion, a colleague asked, with some exasperation, "I never know when to call palliative care. How do you decide when the patient is dying?"

In retrospect, it is clear that this patient was dying when we met him in the emergency department. He was malnourished and disabled from his cancer and treatment. His bowel perforation was caused by the steroids prescribed to treat his underlying terminal disease. The best outcome we could hope for was a good quality of life in his last days, a peaceful and dignified death, and an uncomplicated bereavement for his survivors. Our emergency, life-saving surgery was, in fact, palliative. Death was near, but we just didn’t want him to die this way.

According to the American College of Surgeons code of professional conduct, surgeons play a pivotal role in facilitating the transition from curative to palliative treatment for the patients and the entire health care team. Furthermore, "effective palliation obligates sensitive discussion with patients and their families." These conversations can be particularly onerous for surgeons because we take on tremendous sense of personal responsibility for postoperative outcomes. Once we commit to operating on a patient, their death, especially if it follows complications, can be equated with personal defeat. We may benefit from consulting specialists who can help us set the stage, and smooth the transition for our patients and their families. Surgeons may also personally benefit from the support of other providers to help us cope with these emotionally difficult cases.

Palliative care is a multidisciplinary model of care to address the physical, intellectual, emotional, social, and spiritual needs of patients and families facing serious illness. The goal of palliative care is to support the best possible quality of life for patients at all stages of serious illness, through providing aggressive symptom management, psychosocial and spiritual care, and grief and bereavement counseling before and after death. Palliative care seeks to be life affirming and is based on the understanding of death as a normal life process. It can and should be delivered along with life-prolonging treatment.

In this case, palliative care should have been offered in the emergency department as soon as this patient was admitted to our service. The patient, and his family, would have benefited from a team of physicians, nurses, pharmacists, social workers, and chaplains with the time and expertise to manage distressing symptoms from his cancer, and attend to the grief and suffering that characterized his final weeks. Earlier palliative care may have also steered us away from the slog of high-burden treatments that ultimately offered him little benefit. For the surgeons, palliative care would have provided additional resources to take the best possible care of our patient who, whether or not he made it home, was near the end of his life from an advanced illness.

Dr. Zara Cooper is an ACS Fellow, and assistant professor of surgery, Harvard Medical School, and department of surgery, division of trauma, burns and critical care at Brigham and Women’s Hospital, Boston. Dr. Cooper has no disclosures relevant to this editorial.

This morbidity and mortality conference was like any other: First, we reviewed the case of a patient with a complication from anticoagulation and then another with an anastomotic leak. Finally, we discussed an elderly patient who had a major emergent procedure to treat complications from an underlying life-limiting condition, only to die in hospital weeks later after developing insurmountable medical, surgical, and infectious complications.

This elderly patient was a man in his mid-70s recently diagnosed with recurrent melanoma. He came to our emergency department with peritonitis and hypotension. His wife of 52 years sat beside him. She was tearful and afraid. "We want everything done," she said. Eight weeks ago, he was working full time and playing golf. But, 6 weeks ago he became confused. A CT scan revealed brain metastasis. He spent 5 of the last 6 weeks in the ICU and in a step-down unit, or a nursing home after a series of complications from his brain biopsy. Now he was back in the hospital with a bowel perforation.

Before our surgical team even saw him, he was told he needed surgery, or he would die. We discussed the surgical risks including the likelihood of a protracted ICU stay, and the high risk he would never go home. Still, he and his wife were unprepared for death and so we went to the operating room.

The following weeks were fraught with complications. His symptoms – including delirium, tumor headaches, and pain – were all difficult to manage on his cocktail of steroids, opiates, and antipsychotics. Occasionally, he would mumble something about dying but we couldn’t determine if he was lucid. His symptoms and "talk about death" were distressing for his family. All in all, our team spent almost an hour each day answering their questions and tending to their anxiety and suffering. It took a high emotional toll on our entire team, as we each worried to ourselves that we were doing more harm than good.

One organ system failed after the other. And finally, after two operations, 10 different consultants, and 3 weeks in the hospital, we stopped talking about organ systems and told the family that this man was dying. That day we consulted palliative care to help us with "goals of care." The next day, he became oliguric, and we shifted our focus to comfort. He died within hours surrounded by his loving extended family.

When we discussed this case at M&M, there were no objections to the decision to operate or how we managed his laundry list of complications. His death was deemed "nonpreventable." But, at then end of the discussion, a colleague asked, with some exasperation, "I never know when to call palliative care. How do you decide when the patient is dying?"

In retrospect, it is clear that this patient was dying when we met him in the emergency department. He was malnourished and disabled from his cancer and treatment. His bowel perforation was caused by the steroids prescribed to treat his underlying terminal disease. The best outcome we could hope for was a good quality of life in his last days, a peaceful and dignified death, and an uncomplicated bereavement for his survivors. Our emergency, life-saving surgery was, in fact, palliative. Death was near, but we just didn’t want him to die this way.

According to the American College of Surgeons code of professional conduct, surgeons play a pivotal role in facilitating the transition from curative to palliative treatment for the patients and the entire health care team. Furthermore, "effective palliation obligates sensitive discussion with patients and their families." These conversations can be particularly onerous for surgeons because we take on tremendous sense of personal responsibility for postoperative outcomes. Once we commit to operating on a patient, their death, especially if it follows complications, can be equated with personal defeat. We may benefit from consulting specialists who can help us set the stage, and smooth the transition for our patients and their families. Surgeons may also personally benefit from the support of other providers to help us cope with these emotionally difficult cases.

Palliative care is a multidisciplinary model of care to address the physical, intellectual, emotional, social, and spiritual needs of patients and families facing serious illness. The goal of palliative care is to support the best possible quality of life for patients at all stages of serious illness, through providing aggressive symptom management, psychosocial and spiritual care, and grief and bereavement counseling before and after death. Palliative care seeks to be life affirming and is based on the understanding of death as a normal life process. It can and should be delivered along with life-prolonging treatment.

In this case, palliative care should have been offered in the emergency department as soon as this patient was admitted to our service. The patient, and his family, would have benefited from a team of physicians, nurses, pharmacists, social workers, and chaplains with the time and expertise to manage distressing symptoms from his cancer, and attend to the grief and suffering that characterized his final weeks. Earlier palliative care may have also steered us away from the slog of high-burden treatments that ultimately offered him little benefit. For the surgeons, palliative care would have provided additional resources to take the best possible care of our patient who, whether or not he made it home, was near the end of his life from an advanced illness.

Dr. Zara Cooper is an ACS Fellow, and assistant professor of surgery, Harvard Medical School, and department of surgery, division of trauma, burns and critical care at Brigham and Women’s Hospital, Boston. Dr. Cooper has no disclosures relevant to this editorial.

This morbidity and mortality conference was like any other: First, we reviewed the case of a patient with a complication from anticoagulation and then another with an anastomotic leak. Finally, we discussed an elderly patient who had a major emergent procedure to treat complications from an underlying life-limiting condition, only to die in hospital weeks later after developing insurmountable medical, surgical, and infectious complications.

This elderly patient was a man in his mid-70s recently diagnosed with recurrent melanoma. He came to our emergency department with peritonitis and hypotension. His wife of 52 years sat beside him. She was tearful and afraid. "We want everything done," she said. Eight weeks ago, he was working full time and playing golf. But, 6 weeks ago he became confused. A CT scan revealed brain metastasis. He spent 5 of the last 6 weeks in the ICU and in a step-down unit, or a nursing home after a series of complications from his brain biopsy. Now he was back in the hospital with a bowel perforation.

Before our surgical team even saw him, he was told he needed surgery, or he would die. We discussed the surgical risks including the likelihood of a protracted ICU stay, and the high risk he would never go home. Still, he and his wife were unprepared for death and so we went to the operating room.

The following weeks were fraught with complications. His symptoms – including delirium, tumor headaches, and pain – were all difficult to manage on his cocktail of steroids, opiates, and antipsychotics. Occasionally, he would mumble something about dying but we couldn’t determine if he was lucid. His symptoms and "talk about death" were distressing for his family. All in all, our team spent almost an hour each day answering their questions and tending to their anxiety and suffering. It took a high emotional toll on our entire team, as we each worried to ourselves that we were doing more harm than good.

One organ system failed after the other. And finally, after two operations, 10 different consultants, and 3 weeks in the hospital, we stopped talking about organ systems and told the family that this man was dying. That day we consulted palliative care to help us with "goals of care." The next day, he became oliguric, and we shifted our focus to comfort. He died within hours surrounded by his loving extended family.

When we discussed this case at M&M, there were no objections to the decision to operate or how we managed his laundry list of complications. His death was deemed "nonpreventable." But, at then end of the discussion, a colleague asked, with some exasperation, "I never know when to call palliative care. How do you decide when the patient is dying?"

In retrospect, it is clear that this patient was dying when we met him in the emergency department. He was malnourished and disabled from his cancer and treatment. His bowel perforation was caused by the steroids prescribed to treat his underlying terminal disease. The best outcome we could hope for was a good quality of life in his last days, a peaceful and dignified death, and an uncomplicated bereavement for his survivors. Our emergency, life-saving surgery was, in fact, palliative. Death was near, but we just didn’t want him to die this way.

According to the American College of Surgeons code of professional conduct, surgeons play a pivotal role in facilitating the transition from curative to palliative treatment for the patients and the entire health care team. Furthermore, "effective palliation obligates sensitive discussion with patients and their families." These conversations can be particularly onerous for surgeons because we take on tremendous sense of personal responsibility for postoperative outcomes. Once we commit to operating on a patient, their death, especially if it follows complications, can be equated with personal defeat. We may benefit from consulting specialists who can help us set the stage, and smooth the transition for our patients and their families. Surgeons may also personally benefit from the support of other providers to help us cope with these emotionally difficult cases.

Palliative care is a multidisciplinary model of care to address the physical, intellectual, emotional, social, and spiritual needs of patients and families facing serious illness. The goal of palliative care is to support the best possible quality of life for patients at all stages of serious illness, through providing aggressive symptom management, psychosocial and spiritual care, and grief and bereavement counseling before and after death. Palliative care seeks to be life affirming and is based on the understanding of death as a normal life process. It can and should be delivered along with life-prolonging treatment.

In this case, palliative care should have been offered in the emergency department as soon as this patient was admitted to our service. The patient, and his family, would have benefited from a team of physicians, nurses, pharmacists, social workers, and chaplains with the time and expertise to manage distressing symptoms from his cancer, and attend to the grief and suffering that characterized his final weeks. Earlier palliative care may have also steered us away from the slog of high-burden treatments that ultimately offered him little benefit. For the surgeons, palliative care would have provided additional resources to take the best possible care of our patient who, whether or not he made it home, was near the end of his life from an advanced illness.

Dr. Zara Cooper is an ACS Fellow, and assistant professor of surgery, Harvard Medical School, and department of surgery, division of trauma, burns and critical care at Brigham and Women’s Hospital, Boston. Dr. Cooper has no disclosures relevant to this editorial.

Thrombus
Credit: Andre E.X. Brown

New research suggests dabigatran is noninferior to warfarin as extended prophylaxis for recurrent venous thromboembolism (VTE), and warfarin presents a significantly higher risk of bleeding.

These results are from the RE-MEDY study, which compared the 2 drugs as long-term prophylaxis in patients who had received at least 3 months of VTE treatment.

The data appear in an NEJM article alongside results of the RE-SONATE study, which compared dabigatran and placebo in a similar patient population.

Both of these randomized, double-blind studies were sponsored by the makers of dabigatran, Boehringer Ingelheim.

In the RE-MEDY trial, 2856 patients were randomized in a 1:1 ratio to receive dabigatran or warfarin for up to 36 months. Patients either received active dabigatran at 150 mg twice daily and a warfarin-like placebo or active warfarin and a dabigatran-like placebo. The warfarin dose was adjusted to maintain an INR of 2.0 to 3.0.

In the RE-SONATE trial, 1343 patients were randomized to receive treatment for 6 months. They were assigned in a 1:1 ratio to receive dabigatran at 150 mg twice daily or a matching placebo.

Extended follow-up to evaluate the long-term risk of VTE recurrence took place 12 months after the completion of study treatment.

In RE-MEDY, recurrent VTE occurred in 1.8% of patients in the dabigatran arm and 1.3% of patients in the warfarin arm (P=0.01 for noninferiority).

In RE-SONATE, recurrent VTE occurred in 0.4% of patients in the dabigatran arm and 5.6% of patients in the placebo arm (P<0.001 for superiority).

The rate of clinically relevant or major bleeding was lower with dabigatran than with warfarin—at 5.6% and 10.2%, respectively (P<0.001).

But the rate of clinically relevant or major bleeding was higher with dabigatran than with placebo, at 5.3% and 1.8%, respectively (P=0.001).

“[These results] suggest dabigatran is a good option to prevent deep vein thrombosis and pulmonary embolism from happening again after an initial event,” said lead study author Sam Schulman, MD, PhD, of McMaster University in Hamilton, Ontario, Canada.

“They reinforce the efficacy and favorable safety profile of dabigatran seen in the RE-COVER trials, where dabigatran showed similar efficacy and a significant reduction in clinically relevant bleeding versus warfarin in the treatment of acute venous thromboembolism.”

Thrombus
Credit: Andre E.X. Brown

New research suggests dabigatran is noninferior to warfarin as extended prophylaxis for recurrent venous thromboembolism (VTE), and warfarin presents a significantly higher risk of bleeding.

These results are from the RE-MEDY study, which compared the 2 drugs as long-term prophylaxis in patients who had received at least 3 months of VTE treatment.

The data appear in an NEJM article alongside results of the RE-SONATE study, which compared dabigatran and placebo in a similar patient population.

Both of these randomized, double-blind studies were sponsored by the makers of dabigatran, Boehringer Ingelheim.

In the RE-MEDY trial, 2856 patients were randomized in a 1:1 ratio to receive dabigatran or warfarin for up to 36 months. Patients either received active dabigatran at 150 mg twice daily and a warfarin-like placebo or active warfarin and a dabigatran-like placebo. The warfarin dose was adjusted to maintain an INR of 2.0 to 3.0.

In the RE-SONATE trial, 1343 patients were randomized to receive treatment for 6 months. They were assigned in a 1:1 ratio to receive dabigatran at 150 mg twice daily or a matching placebo.

Extended follow-up to evaluate the long-term risk of VTE recurrence took place 12 months after the completion of study treatment.

In RE-MEDY, recurrent VTE occurred in 1.8% of patients in the dabigatran arm and 1.3% of patients in the warfarin arm (P=0.01 for noninferiority).

In RE-SONATE, recurrent VTE occurred in 0.4% of patients in the dabigatran arm and 5.6% of patients in the placebo arm (P<0.001 for superiority).

The rate of clinically relevant or major bleeding was lower with dabigatran than with warfarin—at 5.6% and 10.2%, respectively (P<0.001).

But the rate of clinically relevant or major bleeding was higher with dabigatran than with placebo, at 5.3% and 1.8%, respectively (P=0.001).

“[These results] suggest dabigatran is a good option to prevent deep vein thrombosis and pulmonary embolism from happening again after an initial event,” said lead study author Sam Schulman, MD, PhD, of McMaster University in Hamilton, Ontario, Canada.

“They reinforce the efficacy and favorable safety profile of dabigatran seen in the RE-COVER trials, where dabigatran showed similar efficacy and a significant reduction in clinically relevant bleeding versus warfarin in the treatment of acute venous thromboembolism.”

Thrombus
Credit: Andre E.X. Brown

New research suggests dabigatran is noninferior to warfarin as extended prophylaxis for recurrent venous thromboembolism (VTE), and warfarin presents a significantly higher risk of bleeding.

These results are from the RE-MEDY study, which compared the 2 drugs as long-term prophylaxis in patients who had received at least 3 months of VTE treatment.

The data appear in an NEJM article alongside results of the RE-SONATE study, which compared dabigatran and placebo in a similar patient population.

Both of these randomized, double-blind studies were sponsored by the makers of dabigatran, Boehringer Ingelheim.

In the RE-MEDY trial, 2856 patients were randomized in a 1:1 ratio to receive dabigatran or warfarin for up to 36 months. Patients either received active dabigatran at 150 mg twice daily and a warfarin-like placebo or active warfarin and a dabigatran-like placebo. The warfarin dose was adjusted to maintain an INR of 2.0 to 3.0.

In the RE-SONATE trial, 1343 patients were randomized to receive treatment for 6 months. They were assigned in a 1:1 ratio to receive dabigatran at 150 mg twice daily or a matching placebo.

Extended follow-up to evaluate the long-term risk of VTE recurrence took place 12 months after the completion of study treatment.

In RE-MEDY, recurrent VTE occurred in 1.8% of patients in the dabigatran arm and 1.3% of patients in the warfarin arm (P=0.01 for noninferiority).

In RE-SONATE, recurrent VTE occurred in 0.4% of patients in the dabigatran arm and 5.6% of patients in the placebo arm (P<0.001 for superiority).

The rate of clinically relevant or major bleeding was lower with dabigatran than with warfarin—at 5.6% and 10.2%, respectively (P<0.001).

But the rate of clinically relevant or major bleeding was higher with dabigatran than with placebo, at 5.3% and 1.8%, respectively (P=0.001).

“[These results] suggest dabigatran is a good option to prevent deep vein thrombosis and pulmonary embolism from happening again after an initial event,” said lead study author Sam Schulman, MD, PhD, of McMaster University in Hamilton, Ontario, Canada.

“They reinforce the efficacy and favorable safety profile of dabigatran seen in the RE-COVER trials, where dabigatran showed similar efficacy and a significant reduction in clinically relevant bleeding versus warfarin in the treatment of acute venous thromboembolism.”

SHM has joined the American Board of Internal Medicine (ABIM) Foundation’s Choosing Wisely campaign, a multiyear effort to spark national dialogue about waste in the healthcare system and the kinds of common treatments that doctors and patients should think twice about before deciding to pursue. Ad hoc subcommittees of SHM’s Hospital Quality and Patient Safety Committee created lists of five adult and five pediatric treatments that hospitalists and their patients should question (see below). Those lists were shared alongside 15 other medical specialty societies at a Feb. 21 news conference in Washington, D.C.

SHM has joined the American Board of Internal Medicine (ABIM) Foundation’s Choosing Wisely campaign, a multiyear effort to spark national dialogue about waste in the healthcare system and the kinds of common treatments that doctors and patients should think twice about before deciding to pursue. Ad hoc subcommittees of SHM’s Hospital Quality and Patient Safety Committee created lists of five adult and five pediatric treatments that hospitalists and their patients should question (see below). Those lists were shared alongside 15 other medical specialty societies at a Feb. 21 news conference in Washington, D.C.

SHM has joined the American Board of Internal Medicine (ABIM) Foundation’s Choosing Wisely campaign, a multiyear effort to spark national dialogue about waste in the healthcare system and the kinds of common treatments that doctors and patients should think twice about before deciding to pursue. Ad hoc subcommittees of SHM’s Hospital Quality and Patient Safety Committee created lists of five adult and five pediatric treatments that hospitalists and their patients should question (see below). Those lists were shared alongside 15 other medical specialty societies at a Feb. 21 news conference in Washington, D.C.

WASHINGTON, D.C.—SHM joined hands today with 15 other U.S. medical specialty societies in the fight to eliminate wasteful medical tests, drugs, and treatments.

The 10,000-member SHM, which represents more than 40,000 hospitalists, released two lists of common tests and procedures that clinicians and patients should seriously question as part of the ABIM Foundation’s Choosing Wisely campaign. The campaign debuted in April 2012 with nine medical societies providing input on medical decisions that lack evidence, waste finite healthcare resources, or potentially harm patients.

“We acknowledge that there is waste in our system,” says Gregory Maynard, MD, MSc, SFHM, senior vice president of SHM’s Center for Healthcare Improvement and Innovation. “We also believe that if you have an engaged, empowered patient, together you will make better choices, have less waste, and probably also reduce costs.”

SHM’s Hospital Quality and Patient Safety Committee created two lists of five recommendations: one for adult hospitalists and inpatients, and one for pediatric hospitalists and patients. Examples include:

• Do not prescribe medications for stress ulcer prophylaxis to medical inpatients unless they are at high risk for gastrointestinal complications;
• Do not order continuous telemetry monitoring outside the ICU without using a protocol that governs its continuation; and
• Do not order chest radiography in children who have uncomplicated asthma or bronchiolitis.

The “avoid” lists were chosen by SHM because they potentially represent significant, needless waste of healthcare resources, according to John Bulger, DO, MBA, SFHM, chief quality officer at Geisinger Medical Center in Danville, Pa. Dr. Bulger, who chaired SHM’s Choosing Wisely committee, encourages hospitalists to stop and take a long look at the list and think about ways to improve their own practice. He encourages hospitalists to take the recommendations to their hospitals’ quality-improvement (QI) committee and start collecting baseline data, he says. “We should be able to come back a year from now and show that we’ve been able to change practice using these lists,” he says.

We acknowledge that there is waste in our system. We also believe that if you have an engaged, empowered patient, together you will make better choices, have less waste, and probably also reduce costs.

—Gregory Maynard, MD, MSc, SFHM, senior vice president of SHM’s Center for Healthcare Improvement and Innovation

HM pioneer Robert Wachter, MD, MHM, who heads the division of hospital medicine at the University of California at San Francisco, chairs the American Board of Internal Medicine, and sits on the board of the ABIM Foundation, agrees.

“I think you’ll be hearing similar kinds of drumbeats about waste from every national organization involved in healthcare,” says Dr. Wachter, author of the Wachter’s World blog. “I think hospitalists should be active and enthusiastic partners in the Choosing Wisely campaign and leaders in American healthcare’s efforts to figure out how to purge waste from the system and decrease unnecessary expense.”

Click here to listen to more of Dr. Wachter’s interview on the Choosing Wisely campaign.

A similar kind of focus on efficiency and cost-effectiveness was part of the initial motivation for developing hospital medicine, Dr. Wachter says. He compares the current national obsession about healthcare waste with the medical quality and patient safety movements of the past decade.

“It’s the right time, the right message, and the right messenger,” he says. “But now we’re a little scared about raised expectations. Delivering on them is going to be more difficult, even, than patient safety was because, ultimately, it will require curtailing some income streams. You can’t reach the final outcome of cutting costs in healthcare without someone making less money.” TH

Larry Beresford is a freelance writer in Oakland, Calif. 

WASHINGTON, D.C.—SHM joined hands today with 15 other U.S. medical specialty societies in the fight to eliminate wasteful medical tests, drugs, and treatments.

The 10,000-member SHM, which represents more than 40,000 hospitalists, released two lists of common tests and procedures that clinicians and patients should seriously question as part of the ABIM Foundation’s Choosing Wisely campaign. The campaign debuted in April 2012 with nine medical societies providing input on medical decisions that lack evidence, waste finite healthcare resources, or potentially harm patients.

“We acknowledge that there is waste in our system,” says Gregory Maynard, MD, MSc, SFHM, senior vice president of SHM’s Center for Healthcare Improvement and Innovation. “We also believe that if you have an engaged, empowered patient, together you will make better choices, have less waste, and probably also reduce costs.”

SHM’s Hospital Quality and Patient Safety Committee created two lists of five recommendations: one for adult hospitalists and inpatients, and one for pediatric hospitalists and patients. Examples include:

• Do not prescribe medications for stress ulcer prophylaxis to medical inpatients unless they are at high risk for gastrointestinal complications;
• Do not order continuous telemetry monitoring outside the ICU without using a protocol that governs its continuation; and
• Do not order chest radiography in children who have uncomplicated asthma or bronchiolitis.

The “avoid” lists were chosen by SHM because they potentially represent significant, needless waste of healthcare resources, according to John Bulger, DO, MBA, SFHM, chief quality officer at Geisinger Medical Center in Danville, Pa. Dr. Bulger, who chaired SHM’s Choosing Wisely committee, encourages hospitalists to stop and take a long look at the list and think about ways to improve their own practice. He encourages hospitalists to take the recommendations to their hospitals’ quality-improvement (QI) committee and start collecting baseline data, he says. “We should be able to come back a year from now and show that we’ve been able to change practice using these lists,” he says.

We acknowledge that there is waste in our system. We also believe that if you have an engaged, empowered patient, together you will make better choices, have less waste, and probably also reduce costs.

—Gregory Maynard, MD, MSc, SFHM, senior vice president of SHM’s Center for Healthcare Improvement and Innovation

HM pioneer Robert Wachter, MD, MHM, who heads the division of hospital medicine at the University of California at San Francisco, chairs the American Board of Internal Medicine, and sits on the board of the ABIM Foundation, agrees.

“I think you’ll be hearing similar kinds of drumbeats about waste from every national organization involved in healthcare,” says Dr. Wachter, author of the Wachter’s World blog. “I think hospitalists should be active and enthusiastic partners in the Choosing Wisely campaign and leaders in American healthcare’s efforts to figure out how to purge waste from the system and decrease unnecessary expense.”

Click here to listen to more of Dr. Wachter’s interview on the Choosing Wisely campaign.

A similar kind of focus on efficiency and cost-effectiveness was part of the initial motivation for developing hospital medicine, Dr. Wachter says. He compares the current national obsession about healthcare waste with the medical quality and patient safety movements of the past decade.

“It’s the right time, the right message, and the right messenger,” he says. “But now we’re a little scared about raised expectations. Delivering on them is going to be more difficult, even, than patient safety was because, ultimately, it will require curtailing some income streams. You can’t reach the final outcome of cutting costs in healthcare without someone making less money.” TH

Larry Beresford is a freelance writer in Oakland, Calif. 

WASHINGTON, D.C.—SHM joined hands today with 15 other U.S. medical specialty societies in the fight to eliminate wasteful medical tests, drugs, and treatments.

The 10,000-member SHM, which represents more than 40,000 hospitalists, released two lists of common tests and procedures that clinicians and patients should seriously question as part of the ABIM Foundation’s Choosing Wisely campaign. The campaign debuted in April 2012 with nine medical societies providing input on medical decisions that lack evidence, waste finite healthcare resources, or potentially harm patients.

“We acknowledge that there is waste in our system,” says Gregory Maynard, MD, MSc, SFHM, senior vice president of SHM’s Center for Healthcare Improvement and Innovation. “We also believe that if you have an engaged, empowered patient, together you will make better choices, have less waste, and probably also reduce costs.”

SHM’s Hospital Quality and Patient Safety Committee created two lists of five recommendations: one for adult hospitalists and inpatients, and one for pediatric hospitalists and patients. Examples include:

• Do not prescribe medications for stress ulcer prophylaxis to medical inpatients unless they are at high risk for gastrointestinal complications;
• Do not order continuous telemetry monitoring outside the ICU without using a protocol that governs its continuation; and
• Do not order chest radiography in children who have uncomplicated asthma or bronchiolitis.

The “avoid” lists were chosen by SHM because they potentially represent significant, needless waste of healthcare resources, according to John Bulger, DO, MBA, SFHM, chief quality officer at Geisinger Medical Center in Danville, Pa. Dr. Bulger, who chaired SHM’s Choosing Wisely committee, encourages hospitalists to stop and take a long look at the list and think about ways to improve their own practice. He encourages hospitalists to take the recommendations to their hospitals’ quality-improvement (QI) committee and start collecting baseline data, he says. “We should be able to come back a year from now and show that we’ve been able to change practice using these lists,” he says.

We acknowledge that there is waste in our system. We also believe that if you have an engaged, empowered patient, together you will make better choices, have less waste, and probably also reduce costs.

—Gregory Maynard, MD, MSc, SFHM, senior vice president of SHM’s Center for Healthcare Improvement and Innovation

HM pioneer Robert Wachter, MD, MHM, who heads the division of hospital medicine at the University of California at San Francisco, chairs the American Board of Internal Medicine, and sits on the board of the ABIM Foundation, agrees.

“I think you’ll be hearing similar kinds of drumbeats about waste from every national organization involved in healthcare,” says Dr. Wachter, author of the Wachter’s World blog. “I think hospitalists should be active and enthusiastic partners in the Choosing Wisely campaign and leaders in American healthcare’s efforts to figure out how to purge waste from the system and decrease unnecessary expense.”

Click here to listen to more of Dr. Wachter’s interview on the Choosing Wisely campaign.

A similar kind of focus on efficiency and cost-effectiveness was part of the initial motivation for developing hospital medicine, Dr. Wachter says. He compares the current national obsession about healthcare waste with the medical quality and patient safety movements of the past decade.

“It’s the right time, the right message, and the right messenger,” he says. “But now we’re a little scared about raised expectations. Delivering on them is going to be more difficult, even, than patient safety was because, ultimately, it will require curtailing some income streams. You can’t reach the final outcome of cutting costs in healthcare without someone making less money.” TH

Larry Beresford is a freelance writer in Oakland, Calif. 

The lead author of a new report that says hospitalized Medicare patients are happier in facilities using a greater number of hospitalists didn't expect that would be the case.

The study, "Hospitalist Staffing and Patient Satisfaction in the National Medicare Population," which was recently published in the Journal of Hospital Medicine, sprung from the theory that hospitals using a large number of hospitalists generally would rank lower in patient satisfaction than others. In part, the expectation was tied to the belief that patients might prefer to be seen by their primary-care physician (PCP) rather than a hospitalist.

"What we'd like people to take away is that in our study—and it's only one study—hospitals with higher levels of hospitalist care had modestly higher patient satisfaction scores, especially in the areas of discharge planning and overall satisfaction," says Lena Chen, MD, MS, clinical lecturer in the division of general medicine at the University of Michigan in Ann Arbor. "It suggests that there doesn't need to be a tradeoff between greater use of hospitalist services and patient satisfaction."

The retrospective cohort study looked at 2,843 acute-care hospitals and split them into groups ranked by the percentage of patients cared for by hospitalists. Those categorized as "nonhospitalist" hospitals had a median of 0% of general medicine patients cared for by hospitalists; a "mixed" hospital had a median of 39.5% of general medicine patients cared for by hospitalists; and a "hospitalist" hospital had a median of 76.5% cared for by hospitalists, according to the report. "Hospitalist" hospitals scored better (65.6%) on global measures of satisfaction than "mixed" (63.9%) or "nonhospitalist" (63.9%) hospitals (P<0.001), the study found. Hospitalist care was not associated with patient satisfaction in the areas of room cleanliness or communication with a physician.

Dr. Chen says she would like to see the research prompt more investigation into why hospitalist care is associated with patient satisfaction.

"We all want to have satisfied patients," she adds. "It would be important to have research that explores what the factors are that lead to greater patient satisfaction. This is a first step, but it's definitely not the end of the road."

Visit our website for more information about patient satisfaction.

The lead author of a new report that says hospitalized Medicare patients are happier in facilities using a greater number of hospitalists didn't expect that would be the case.

The study, "Hospitalist Staffing and Patient Satisfaction in the National Medicare Population," which was recently published in the Journal of Hospital Medicine, sprung from the theory that hospitals using a large number of hospitalists generally would rank lower in patient satisfaction than others. In part, the expectation was tied to the belief that patients might prefer to be seen by their primary-care physician (PCP) rather than a hospitalist.

"What we'd like people to take away is that in our study—and it's only one study—hospitals with higher levels of hospitalist care had modestly higher patient satisfaction scores, especially in the areas of discharge planning and overall satisfaction," says Lena Chen, MD, MS, clinical lecturer in the division of general medicine at the University of Michigan in Ann Arbor. "It suggests that there doesn't need to be a tradeoff between greater use of hospitalist services and patient satisfaction."

The retrospective cohort study looked at 2,843 acute-care hospitals and split them into groups ranked by the percentage of patients cared for by hospitalists. Those categorized as "nonhospitalist" hospitals had a median of 0% of general medicine patients cared for by hospitalists; a "mixed" hospital had a median of 39.5% of general medicine patients cared for by hospitalists; and a "hospitalist" hospital had a median of 76.5% cared for by hospitalists, according to the report. "Hospitalist" hospitals scored better (65.6%) on global measures of satisfaction than "mixed" (63.9%) or "nonhospitalist" (63.9%) hospitals (P<0.001), the study found. Hospitalist care was not associated with patient satisfaction in the areas of room cleanliness or communication with a physician.

Dr. Chen says she would like to see the research prompt more investigation into why hospitalist care is associated with patient satisfaction.

"We all want to have satisfied patients," she adds. "It would be important to have research that explores what the factors are that lead to greater patient satisfaction. This is a first step, but it's definitely not the end of the road."

Visit our website for more information about patient satisfaction.

The lead author of a new report that says hospitalized Medicare patients are happier in facilities using a greater number of hospitalists didn't expect that would be the case.

The study, "Hospitalist Staffing and Patient Satisfaction in the National Medicare Population," which was recently published in the Journal of Hospital Medicine, sprung from the theory that hospitals using a large number of hospitalists generally would rank lower in patient satisfaction than others. In part, the expectation was tied to the belief that patients might prefer to be seen by their primary-care physician (PCP) rather than a hospitalist.

"What we'd like people to take away is that in our study—and it's only one study—hospitals with higher levels of hospitalist care had modestly higher patient satisfaction scores, especially in the areas of discharge planning and overall satisfaction," says Lena Chen, MD, MS, clinical lecturer in the division of general medicine at the University of Michigan in Ann Arbor. "It suggests that there doesn't need to be a tradeoff between greater use of hospitalist services and patient satisfaction."

The retrospective cohort study looked at 2,843 acute-care hospitals and split them into groups ranked by the percentage of patients cared for by hospitalists. Those categorized as "nonhospitalist" hospitals had a median of 0% of general medicine patients cared for by hospitalists; a "mixed" hospital had a median of 39.5% of general medicine patients cared for by hospitalists; and a "hospitalist" hospital had a median of 76.5% cared for by hospitalists, according to the report. "Hospitalist" hospitals scored better (65.6%) on global measures of satisfaction than "mixed" (63.9%) or "nonhospitalist" (63.9%) hospitals (P<0.001), the study found. Hospitalist care was not associated with patient satisfaction in the areas of room cleanliness or communication with a physician.

Dr. Chen says she would like to see the research prompt more investigation into why hospitalist care is associated with patient satisfaction.

"We all want to have satisfied patients," she adds. "It would be important to have research that explores what the factors are that lead to greater patient satisfaction. This is a first step, but it's definitely not the end of the road."

Visit our website for more information about patient satisfaction.

The need for effective weight management medications as an adjunct to diet and exercise has escalated in the United States as obesity has reached epidemic proportions.

However, in recent years, several Food and Drug Administration–approved medications for weight loss have been plagued with safety concerns and many have been removed from the market, leaving clinicians with limited choices for treatment of overweight or obese patients.

In 2012, two new weight loss medications were approved by the FDA – the first new medications approved for this indication in over a decade (N. Engl. J. Med. 2012;367:1577-9).

As of February 2013, one of the two products, a combination product containing the anorexant phentermine and the anticonvulsant topiramate in an extended-release form, is currently available by prescription in the United States. Marketed as Qysmia, the product is intended to be used together with a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m² or greater (obese).

The medication is also indicated for adults with a BMI of 27 or greater (overweight) who also have at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol. The recommended starting daily dose contains 3.75 mg of phentermine and 23 mg of topiramate; the maximum dose contains 15 mg of phentermine and 92 mg of topiramate.

In part, due to concerns about the teratogenicity of topiramate, Qysmia has been designated a category X drug, and specific pregnancy prevention measures in the form of a Risk Evaluation and Mitigation Strategy (REMS) have been put in place. The medication can be obtained only by prescription obtained directly from a health care provider, and providers receive training on the risks of birth defects. A prescription for Qysmia can only be filled by specially certified mail order pharmacies in the United States.

Educational materials indicate that the drug should not be prescribed to women who are pregnant or who are planning on becoming pregnant. Women who are not planning pregnancy but have the potential to become pregnant should have a negative pregnancy test before starting the drug and again every month while taking the drug, and they should use an effective method or combination of methods of contraception. The manufacturer has also initiated a pregnancy surveillance system.

Given the likelihood that many women of reproductive age will use this medication, even with a REMS in place, the potential for unintentional exposure in pregnancy exists. In the inevitable event of an exposed pregnancy, what are the specific risks and their magnitude? The concern about birth defects with this medication stems from previously published data suggesting that topiramate used in monotherapy for other indications, most commonly epilepsy, is associated with an increased risk for oral clefts (cleft lip with or without cleft palate). Although numbers are still small, a few studies have suggested the risk for oral clefts, with the most recent a large pooled case-control analysis from two data sources in the United States (Am. J. Obstet. Gynecol. 2012;207:405e1-7). The pooled estimate of the risk of oral clefts was 5.36 with very wide confidence intervals (1.49-20.07), based on seven exposed children with cleft lip with or without cleft palate. To the extent that this estimate is correct, this translates to an absolute risk of about 5 in 1,000 first-trimester topiramate-exposed pregnancies, compared with a baseline risk of about 1 in 1,000 in unexposed pregnancies.

Published studies of topiramate and oral clefts have not involved sufficient numbers of exposed and affected children to allow examination of a dose threshold; however, the range of recommended doses for seizure prevention in adults treated with topiramate monotherapy (50-400 mg/day) overlaps with the dosing range of topiramate contained in Qysmia. It is important to note that based on the published reports suggesting an increased risk for oral clefts, the pregnancy category for topiramate alone was recently changed from a C to a D, while the pregnancy category for Qysmia is an X. The rationale behind the category D is likely that the benefits of topiramate might outweigh the risks in a pregnant woman with a seizure disorder for whom topiramate is the only effective medication. However, topiramate use for weight loss would typically never be indicated in pregnancy.

The second drug, lorcaserin (Belviq), is a single-ingredient serotonergic medication – a selective agonist of the 5-HT_2C receptor. Lorcaserin was approved by the FDA in 2012, but as of February 2013, it is not yet available in the United States. This medication also received a pregnancy category X designation; however, in this situation, it was presumably for the sole reason that intentional weight loss in pregnancy is not recommended. Preclinical data for lorcaserin did not suggest teratogenicity, but maternal exposure in rats late in gestation resulted in lower pup body weight that persisted into adulthood.

To the extent that these new medications are effective in reducing and maintaining BMI within a healthier range in women who are currently overweight or obese, they may lead to improvement in subsequent pregnancy outcomes. However, avoiding exposure to these medications during early pregnancy will be a challenge, even with pregnancy prevention guidance and restricted distribution programs. Postmarketing surveillance for outcomes of inadvertently exposed pregnancies will be essential.

Dr. Chambers is associate professor of pediatrics and family and preventive medicine at the University of California, San Diego. She is director of the California Teratogen Information Service and Clinical Research Program. Dr. Chambers is a past president of the Organization of Teratology Information Specialists and past president of the Teratology Society. She said she had no relevant financial disclosures. To comment, e-mail her at obnews@elsevier.com.

The need for effective weight management medications as an adjunct to diet and exercise has escalated in the United States as obesity has reached epidemic proportions.

However, in recent years, several Food and Drug Administration–approved medications for weight loss have been plagued with safety concerns and many have been removed from the market, leaving clinicians with limited choices for treatment of overweight or obese patients.

In 2012, two new weight loss medications were approved by the FDA – the first new medications approved for this indication in over a decade (N. Engl. J. Med. 2012;367:1577-9).

As of February 2013, one of the two products, a combination product containing the anorexant phentermine and the anticonvulsant topiramate in an extended-release form, is currently available by prescription in the United States. Marketed as Qysmia, the product is intended to be used together with a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m² or greater (obese).

The medication is also indicated for adults with a BMI of 27 or greater (overweight) who also have at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol. The recommended starting daily dose contains 3.75 mg of phentermine and 23 mg of topiramate; the maximum dose contains 15 mg of phentermine and 92 mg of topiramate.

In part, due to concerns about the teratogenicity of topiramate, Qysmia has been designated a category X drug, and specific pregnancy prevention measures in the form of a Risk Evaluation and Mitigation Strategy (REMS) have been put in place. The medication can be obtained only by prescription obtained directly from a health care provider, and providers receive training on the risks of birth defects. A prescription for Qysmia can only be filled by specially certified mail order pharmacies in the United States.

Educational materials indicate that the drug should not be prescribed to women who are pregnant or who are planning on becoming pregnant. Women who are not planning pregnancy but have the potential to become pregnant should have a negative pregnancy test before starting the drug and again every month while taking the drug, and they should use an effective method or combination of methods of contraception. The manufacturer has also initiated a pregnancy surveillance system.

Given the likelihood that many women of reproductive age will use this medication, even with a REMS in place, the potential for unintentional exposure in pregnancy exists. In the inevitable event of an exposed pregnancy, what are the specific risks and their magnitude? The concern about birth defects with this medication stems from previously published data suggesting that topiramate used in monotherapy for other indications, most commonly epilepsy, is associated with an increased risk for oral clefts (cleft lip with or without cleft palate). Although numbers are still small, a few studies have suggested the risk for oral clefts, with the most recent a large pooled case-control analysis from two data sources in the United States (Am. J. Obstet. Gynecol. 2012;207:405e1-7). The pooled estimate of the risk of oral clefts was 5.36 with very wide confidence intervals (1.49-20.07), based on seven exposed children with cleft lip with or without cleft palate. To the extent that this estimate is correct, this translates to an absolute risk of about 5 in 1,000 first-trimester topiramate-exposed pregnancies, compared with a baseline risk of about 1 in 1,000 in unexposed pregnancies.

Published studies of topiramate and oral clefts have not involved sufficient numbers of exposed and affected children to allow examination of a dose threshold; however, the range of recommended doses for seizure prevention in adults treated with topiramate monotherapy (50-400 mg/day) overlaps with the dosing range of topiramate contained in Qysmia. It is important to note that based on the published reports suggesting an increased risk for oral clefts, the pregnancy category for topiramate alone was recently changed from a C to a D, while the pregnancy category for Qysmia is an X. The rationale behind the category D is likely that the benefits of topiramate might outweigh the risks in a pregnant woman with a seizure disorder for whom topiramate is the only effective medication. However, topiramate use for weight loss would typically never be indicated in pregnancy.

The second drug, lorcaserin (Belviq), is a single-ingredient serotonergic medication – a selective agonist of the 5-HT_2C receptor. Lorcaserin was approved by the FDA in 2012, but as of February 2013, it is not yet available in the United States. This medication also received a pregnancy category X designation; however, in this situation, it was presumably for the sole reason that intentional weight loss in pregnancy is not recommended. Preclinical data for lorcaserin did not suggest teratogenicity, but maternal exposure in rats late in gestation resulted in lower pup body weight that persisted into adulthood.

To the extent that these new medications are effective in reducing and maintaining BMI within a healthier range in women who are currently overweight or obese, they may lead to improvement in subsequent pregnancy outcomes. However, avoiding exposure to these medications during early pregnancy will be a challenge, even with pregnancy prevention guidance and restricted distribution programs. Postmarketing surveillance for outcomes of inadvertently exposed pregnancies will be essential.

Dr. Chambers is associate professor of pediatrics and family and preventive medicine at the University of California, San Diego. She is director of the California Teratogen Information Service and Clinical Research Program. Dr. Chambers is a past president of the Organization of Teratology Information Specialists and past president of the Teratology Society. She said she had no relevant financial disclosures. To comment, e-mail her at obnews@elsevier.com.

The need for effective weight management medications as an adjunct to diet and exercise has escalated in the United States as obesity has reached epidemic proportions.

However, in recent years, several Food and Drug Administration–approved medications for weight loss have been plagued with safety concerns and many have been removed from the market, leaving clinicians with limited choices for treatment of overweight or obese patients.

In 2012, two new weight loss medications were approved by the FDA – the first new medications approved for this indication in over a decade (N. Engl. J. Med. 2012;367:1577-9).

As of February 2013, one of the two products, a combination product containing the anorexant phentermine and the anticonvulsant topiramate in an extended-release form, is currently available by prescription in the United States. Marketed as Qysmia, the product is intended to be used together with a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m² or greater (obese).

The medication is also indicated for adults with a BMI of 27 or greater (overweight) who also have at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol. The recommended starting daily dose contains 3.75 mg of phentermine and 23 mg of topiramate; the maximum dose contains 15 mg of phentermine and 92 mg of topiramate.

In part, due to concerns about the teratogenicity of topiramate, Qysmia has been designated a category X drug, and specific pregnancy prevention measures in the form of a Risk Evaluation and Mitigation Strategy (REMS) have been put in place. The medication can be obtained only by prescription obtained directly from a health care provider, and providers receive training on the risks of birth defects. A prescription for Qysmia can only be filled by specially certified mail order pharmacies in the United States.

Educational materials indicate that the drug should not be prescribed to women who are pregnant or who are planning on becoming pregnant. Women who are not planning pregnancy but have the potential to become pregnant should have a negative pregnancy test before starting the drug and again every month while taking the drug, and they should use an effective method or combination of methods of contraception. The manufacturer has also initiated a pregnancy surveillance system.

Given the likelihood that many women of reproductive age will use this medication, even with a REMS in place, the potential for unintentional exposure in pregnancy exists. In the inevitable event of an exposed pregnancy, what are the specific risks and their magnitude? The concern about birth defects with this medication stems from previously published data suggesting that topiramate used in monotherapy for other indications, most commonly epilepsy, is associated with an increased risk for oral clefts (cleft lip with or without cleft palate). Although numbers are still small, a few studies have suggested the risk for oral clefts, with the most recent a large pooled case-control analysis from two data sources in the United States (Am. J. Obstet. Gynecol. 2012;207:405e1-7). The pooled estimate of the risk of oral clefts was 5.36 with very wide confidence intervals (1.49-20.07), based on seven exposed children with cleft lip with or without cleft palate. To the extent that this estimate is correct, this translates to an absolute risk of about 5 in 1,000 first-trimester topiramate-exposed pregnancies, compared with a baseline risk of about 1 in 1,000 in unexposed pregnancies.

Published studies of topiramate and oral clefts have not involved sufficient numbers of exposed and affected children to allow examination of a dose threshold; however, the range of recommended doses for seizure prevention in adults treated with topiramate monotherapy (50-400 mg/day) overlaps with the dosing range of topiramate contained in Qysmia. It is important to note that based on the published reports suggesting an increased risk for oral clefts, the pregnancy category for topiramate alone was recently changed from a C to a D, while the pregnancy category for Qysmia is an X. The rationale behind the category D is likely that the benefits of topiramate might outweigh the risks in a pregnant woman with a seizure disorder for whom topiramate is the only effective medication. However, topiramate use for weight loss would typically never be indicated in pregnancy.

The second drug, lorcaserin (Belviq), is a single-ingredient serotonergic medication – a selective agonist of the 5-HT_2C receptor. Lorcaserin was approved by the FDA in 2012, but as of February 2013, it is not yet available in the United States. This medication also received a pregnancy category X designation; however, in this situation, it was presumably for the sole reason that intentional weight loss in pregnancy is not recommended. Preclinical data for lorcaserin did not suggest teratogenicity, but maternal exposure in rats late in gestation resulted in lower pup body weight that persisted into adulthood.

To the extent that these new medications are effective in reducing and maintaining BMI within a healthier range in women who are currently overweight or obese, they may lead to improvement in subsequent pregnancy outcomes. However, avoiding exposure to these medications during early pregnancy will be a challenge, even with pregnancy prevention guidance and restricted distribution programs. Postmarketing surveillance for outcomes of inadvertently exposed pregnancies will be essential.

Dr. Chambers is associate professor of pediatrics and family and preventive medicine at the University of California, San Diego. She is director of the California Teratogen Information Service and Clinical Research Program. Dr. Chambers is a past president of the Organization of Teratology Information Specialists and past president of the Teratology Society. She said she had no relevant financial disclosures. To comment, e-mail her at obnews@elsevier.com.

Preparing drugs for a trial

Credit: Esther Dyson

After 2 deaths among patients receiving the BCL-2 inhibitor ABT-199, the company developing the drug has suspended enrollment in 5 trials and stopped dose-escalation of the drug.

The patients died of tumor lysis syndrome, a complication that likely stems from the drug’s potency, according to Tracy Sorrentino, a spokeswoman for the company, AbbVie.

Research has suggested the risk of tumor lysis syndrome might be eliminated by altering the dose of ABT-199, Sorrentino said.

But until that is confirmed, AbbVie has stopped dose-escalation in patients receiving ABT-199 and voluntarily suspended enrollment in phase 1 trials of the drug.

The trials are testing ABT-199, both alone and in combination, as a treatment for chronic lymphocytic leukemia, non-Hodgkin lymphoma, and small lymphocytic lymphoma.

Though enrollment has stopped for these trials, dosing of active patients in ABT-199 trials will continue. In addition, a study testing ABT-199 in women with systemic lupus erythematosus is still enrolling patients.

Sorrentino said AbbVie has “every expectation” the suspended enrollment is temporary, and refining the dose of ABT-199 may eliminate the problem. In fact, the company is still planning to begin phase 3 trials of the drug later this year.

Preparing drugs for a trial

Credit: Esther Dyson

After 2 deaths among patients receiving the BCL-2 inhibitor ABT-199, the company developing the drug has suspended enrollment in 5 trials and stopped dose-escalation of the drug.

The patients died of tumor lysis syndrome, a complication that likely stems from the drug’s potency, according to Tracy Sorrentino, a spokeswoman for the company, AbbVie.

Research has suggested the risk of tumor lysis syndrome might be eliminated by altering the dose of ABT-199, Sorrentino said.

But until that is confirmed, AbbVie has stopped dose-escalation in patients receiving ABT-199 and voluntarily suspended enrollment in phase 1 trials of the drug.

The trials are testing ABT-199, both alone and in combination, as a treatment for chronic lymphocytic leukemia, non-Hodgkin lymphoma, and small lymphocytic lymphoma.

Though enrollment has stopped for these trials, dosing of active patients in ABT-199 trials will continue. In addition, a study testing ABT-199 in women with systemic lupus erythematosus is still enrolling patients.

Sorrentino said AbbVie has “every expectation” the suspended enrollment is temporary, and refining the dose of ABT-199 may eliminate the problem. In fact, the company is still planning to begin phase 3 trials of the drug later this year.

Preparing drugs for a trial

Credit: Esther Dyson

After 2 deaths among patients receiving the BCL-2 inhibitor ABT-199, the company developing the drug has suspended enrollment in 5 trials and stopped dose-escalation of the drug.

The patients died of tumor lysis syndrome, a complication that likely stems from the drug’s potency, according to Tracy Sorrentino, a spokeswoman for the company, AbbVie.

Research has suggested the risk of tumor lysis syndrome might be eliminated by altering the dose of ABT-199, Sorrentino said.

But until that is confirmed, AbbVie has stopped dose-escalation in patients receiving ABT-199 and voluntarily suspended enrollment in phase 1 trials of the drug.

The trials are testing ABT-199, both alone and in combination, as a treatment for chronic lymphocytic leukemia, non-Hodgkin lymphoma, and small lymphocytic lymphoma.

Though enrollment has stopped for these trials, dosing of active patients in ABT-199 trials will continue. In addition, a study testing ABT-199 in women with systemic lupus erythematosus is still enrolling patients.

Sorrentino said AbbVie has “every expectation” the suspended enrollment is temporary, and refining the dose of ABT-199 may eliminate the problem. In fact, the company is still planning to begin phase 3 trials of the drug later this year.

LOS ANGELES – Neonates in particular are at risk for poor outcomes from Ebstein’s malformation, showing significantly higher mortality than infants, children, and adults, according to a database study presented by Dr. Ryan R. Davies at the annual meeting of the Society of Thoracic Surgeons.

Ebstein’s malformation is a rare congenital cardiac anomaly. Surgery for Ebstein’s involves a range of procedures, and with low institutional volumes, the only available data on treatment have been limited to individual reports demonstrating highly variable approaches.

Dr. Davies of the Nemours/A.I. duPont Hospital for Children, Wilmington, Del., and his colleagues performed a retrospective study of procedures performed on patients with a primary diagnosis of Ebstein’s malformation (2002-2009) in the STS Congenital Heart Surgery Database.

A total of 595 operations on patients with Ebstein’s were included: 116 on neonates (19%), 122 on infants (21%), 264 on children (44%), and 93 on adults (16%). The authors found that average annual institutional case volumes were low (median, 1 case/year), and procedures varied according to age. Neonates had a high rate of palliative procedures: tricuspid valve (TV) closure (16%) and systemic-to-pulmonary shunts with or without TV closure (37%) and isolated TV closure (8.6%), with Ebstein’s repair or TV valvuloplasty performed in 32%.

Infants usually underwent superior cavopulmonary connections (52%).

Among older patients, procedures were mostly in three categories: TV surgery (children, 55%; adults, 69%), arrhythmia procedures (children, 9%; adults, 17%), and Fontan (children, 16%). In-hospital mortality was higher among neonatal patients (23%) than in infants (4%), children (0.8%), and adults (1.1%).

Among neonates, 36 subsequent procedures were performed during the same hospitalization in 27 patients (23%); including TV closure (11%); shunt (15%); Ebstein’s repair (17%) or TV replacement (15%); and heart transplantation (7.4%). Mortality was similar among neonates who had a second procedure and those who did not (27% vs. 23%, respectively). ECMO (extracorporeal membrane oxygenation) was used in 9% of neonates but in less than 2% of patients in other age groups.

"This study represents a broad overview of the diverse options for surgical treatment of Ebstein’s anomaly. It shows the challenges faced in caring for extremely ill neonatal patients. We have also shown that repair of Ebstein’s anomaly is performed infrequently at most centers, limiting the ability of individual series to define optimal management strategies," Dr. Davies said in an interview.

"Unfortunately, currently available databases do not contain information that may be important in defining such strategies (both surgical and nonsurgical), including anatomic and physiologic variables – whether they are neonates presenting in severe heart failure or older patients presenting for tricuspid valve repair or replacement," he added.

"We feel that in this setting, a prospective multi-institutional study would be of significant value. It should include operative and nonoperative patients, as well as precise diagnostic information and procedural details, to evaluate long-term outcomes including survival, reoperation and other reinterventions, as well as neurodevelopmental outcomes, functional health status, and quality of life," Dr. Davies concluded.

Dr. Davies and his colleagues reported having no relevant disclosures.

m.lesney@elsevier.com

LOS ANGELES – Neonates in particular are at risk for poor outcomes from Ebstein’s malformation, showing significantly higher mortality than infants, children, and adults, according to a database study presented by Dr. Ryan R. Davies at the annual meeting of the Society of Thoracic Surgeons.

Ebstein’s malformation is a rare congenital cardiac anomaly. Surgery for Ebstein’s involves a range of procedures, and with low institutional volumes, the only available data on treatment have been limited to individual reports demonstrating highly variable approaches.

Dr. Davies of the Nemours/A.I. duPont Hospital for Children, Wilmington, Del., and his colleagues performed a retrospective study of procedures performed on patients with a primary diagnosis of Ebstein’s malformation (2002-2009) in the STS Congenital Heart Surgery Database.

A total of 595 operations on patients with Ebstein’s were included: 116 on neonates (19%), 122 on infants (21%), 264 on children (44%), and 93 on adults (16%). The authors found that average annual institutional case volumes were low (median, 1 case/year), and procedures varied according to age. Neonates had a high rate of palliative procedures: tricuspid valve (TV) closure (16%) and systemic-to-pulmonary shunts with or without TV closure (37%) and isolated TV closure (8.6%), with Ebstein’s repair or TV valvuloplasty performed in 32%.

Infants usually underwent superior cavopulmonary connections (52%).

Among older patients, procedures were mostly in three categories: TV surgery (children, 55%; adults, 69%), arrhythmia procedures (children, 9%; adults, 17%), and Fontan (children, 16%). In-hospital mortality was higher among neonatal patients (23%) than in infants (4%), children (0.8%), and adults (1.1%).

Among neonates, 36 subsequent procedures were performed during the same hospitalization in 27 patients (23%); including TV closure (11%); shunt (15%); Ebstein’s repair (17%) or TV replacement (15%); and heart transplantation (7.4%). Mortality was similar among neonates who had a second procedure and those who did not (27% vs. 23%, respectively). ECMO (extracorporeal membrane oxygenation) was used in 9% of neonates but in less than 2% of patients in other age groups.

"This study represents a broad overview of the diverse options for surgical treatment of Ebstein’s anomaly. It shows the challenges faced in caring for extremely ill neonatal patients. We have also shown that repair of Ebstein’s anomaly is performed infrequently at most centers, limiting the ability of individual series to define optimal management strategies," Dr. Davies said in an interview.

"Unfortunately, currently available databases do not contain information that may be important in defining such strategies (both surgical and nonsurgical), including anatomic and physiologic variables – whether they are neonates presenting in severe heart failure or older patients presenting for tricuspid valve repair or replacement," he added.

"We feel that in this setting, a prospective multi-institutional study would be of significant value. It should include operative and nonoperative patients, as well as precise diagnostic information and procedural details, to evaluate long-term outcomes including survival, reoperation and other reinterventions, as well as neurodevelopmental outcomes, functional health status, and quality of life," Dr. Davies concluded.

Dr. Davies and his colleagues reported having no relevant disclosures.

m.lesney@elsevier.com

LOS ANGELES – Neonates in particular are at risk for poor outcomes from Ebstein’s malformation, showing significantly higher mortality than infants, children, and adults, according to a database study presented by Dr. Ryan R. Davies at the annual meeting of the Society of Thoracic Surgeons.

Ebstein’s malformation is a rare congenital cardiac anomaly. Surgery for Ebstein’s involves a range of procedures, and with low institutional volumes, the only available data on treatment have been limited to individual reports demonstrating highly variable approaches.

Dr. Davies of the Nemours/A.I. duPont Hospital for Children, Wilmington, Del., and his colleagues performed a retrospective study of procedures performed on patients with a primary diagnosis of Ebstein’s malformation (2002-2009) in the STS Congenital Heart Surgery Database.

A total of 595 operations on patients with Ebstein’s were included: 116 on neonates (19%), 122 on infants (21%), 264 on children (44%), and 93 on adults (16%). The authors found that average annual institutional case volumes were low (median, 1 case/year), and procedures varied according to age. Neonates had a high rate of palliative procedures: tricuspid valve (TV) closure (16%) and systemic-to-pulmonary shunts with or without TV closure (37%) and isolated TV closure (8.6%), with Ebstein’s repair or TV valvuloplasty performed in 32%.

Infants usually underwent superior cavopulmonary connections (52%).

Among older patients, procedures were mostly in three categories: TV surgery (children, 55%; adults, 69%), arrhythmia procedures (children, 9%; adults, 17%), and Fontan (children, 16%). In-hospital mortality was higher among neonatal patients (23%) than in infants (4%), children (0.8%), and adults (1.1%).

Among neonates, 36 subsequent procedures were performed during the same hospitalization in 27 patients (23%); including TV closure (11%); shunt (15%); Ebstein’s repair (17%) or TV replacement (15%); and heart transplantation (7.4%). Mortality was similar among neonates who had a second procedure and those who did not (27% vs. 23%, respectively). ECMO (extracorporeal membrane oxygenation) was used in 9% of neonates but in less than 2% of patients in other age groups.

"This study represents a broad overview of the diverse options for surgical treatment of Ebstein’s anomaly. It shows the challenges faced in caring for extremely ill neonatal patients. We have also shown that repair of Ebstein’s anomaly is performed infrequently at most centers, limiting the ability of individual series to define optimal management strategies," Dr. Davies said in an interview.

"Unfortunately, currently available databases do not contain information that may be important in defining such strategies (both surgical and nonsurgical), including anatomic and physiologic variables – whether they are neonates presenting in severe heart failure or older patients presenting for tricuspid valve repair or replacement," he added.

"We feel that in this setting, a prospective multi-institutional study would be of significant value. It should include operative and nonoperative patients, as well as precise diagnostic information and procedural details, to evaluate long-term outcomes including survival, reoperation and other reinterventions, as well as neurodevelopmental outcomes, functional health status, and quality of life," Dr. Davies concluded.

Dr. Davies and his colleagues reported having no relevant disclosures.

m.lesney@elsevier.com