Reform of graduate medical education has been raised as a potential agenda item for the 114th Congress.

In an open letter released Dec. 6, 2014, eight members of the House Energy and Commerce Committee’s Health Subcommittee requested input on the structure, financing, and governance of graduate medical education. In order to frame and organize the responses, the members posed seven specific questions. Over a period of several weeks, through a process incorporating input from more than 250 Fellows in leadership positions, the ACS Health Policy and Advocacy Group, faculty of the University of North Carolina’s Cecil G. Sheps Center for Health Services Research, Chapel Hill, and ACS staff of both the Chicago and Washington offices, a letter on behalf of ACS was drafted and submitted on Jan. 15, 2015. The submitted response not only provided answers to the seven questions but also included a set of principles that ACS advocates should guide reform efforts. Those principles are as follows:

1. Education and training are essential mechanisms in the process by which new medical discovery and excellence in new therapy are achieved. In order to foster and preserve the innovation for which our country’s medical system is noted, graduate medical education (GME) should continue to be supported as a public good.

2. Surgical GME has unique needs linked to the skills training required for an additional set of technical competencies. Accordingly, in order to acquire and achieve mastery of those skills, it is imperative that those unique training needs be recognized.

3. Reforms should focus on creating a system that produces the optimal workforce of physicians to meet our country’s medical needs. The population of the United States deserves consistent service across the board.

4. Given that the practice of medicine is dynamic and therefore what we need today is not necessarily what we will need in 10 years, the system should be nimble enough to adjust rapidly to the changing medical landscape. Methodologies to project workforce needs will need to be developed and continually refined as data becomes available. This methodology should be used to distribute funding in a way that meets workforce needs, not vested political or financial interests.

5. There must be accountability and transparency built into the system, not only to certify that funds are being spent appropriately to support the training of physicians, but also to ensure quality and the readiness of the physicians emerging from training. A combined governance system with articulated goals and measured outcomes is needed.

6. Programs that produce high-quality graduates in an efficient manner and consistent with workforce needs should be rewarded through financial incentives or higher levels of support. Similarly, funds should be set aside to support innovation in GME, which will incentivize higher quality training.

It is our intent that these principles be used to inform decisions on any proposal affecting how surgeons and other physicians are trained and how such training is financed. The Energy and Commerce Committee is currently reviewing the responses received from ACS and other stakeholders and is expected to use the information received to compose draft reform legislation in the late spring or early summer.

As of yet, neither of the other two committees with jurisdiction over GME reform, (House Ways and Means or Senate Finance), have expressed interest in the topic in the new 114th Congress just underway. However, it is entirely possible such could change if hearings held by the Energy and Commerce Committee generate such interest or if there are broader conversations about Medicare financing in general.

In addition to plans for ACS Division of Advocacy and Health Policy (DAHP) staff to visit and personally present the ACS perspective on GME reform to each member office of the Energy and Commerce Committee, the DAHP is also in the early stages of planning a summit in the Washington office to further explore the topic. The goal would be the development and proposal of innovative solutions designed to improve the way our physician workforce is trained based on our principles listed above.

The topic of GME has long been one of the top priorities for the College and accordingly, this office. Fellows can be assured that the staff of the DAHP recognize such and are diligently directing their efforts into assuring that the surgeon’s perspective is well represented as discussions and deliberations on GME reform get underway on Capitol Hill.

Until next month ...

Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy, for the Division of Advocacy and Health Policy, in the ACS offices in Washington, D.C.

Reform of graduate medical education has been raised as a potential agenda item for the 114th Congress.

In an open letter released Dec. 6, 2014, eight members of the House Energy and Commerce Committee’s Health Subcommittee requested input on the structure, financing, and governance of graduate medical education. In order to frame and organize the responses, the members posed seven specific questions. Over a period of several weeks, through a process incorporating input from more than 250 Fellows in leadership positions, the ACS Health Policy and Advocacy Group, faculty of the University of North Carolina’s Cecil G. Sheps Center for Health Services Research, Chapel Hill, and ACS staff of both the Chicago and Washington offices, a letter on behalf of ACS was drafted and submitted on Jan. 15, 2015. The submitted response not only provided answers to the seven questions but also included a set of principles that ACS advocates should guide reform efforts. Those principles are as follows:

1. Education and training are essential mechanisms in the process by which new medical discovery and excellence in new therapy are achieved. In order to foster and preserve the innovation for which our country’s medical system is noted, graduate medical education (GME) should continue to be supported as a public good.

2. Surgical GME has unique needs linked to the skills training required for an additional set of technical competencies. Accordingly, in order to acquire and achieve mastery of those skills, it is imperative that those unique training needs be recognized.

3. Reforms should focus on creating a system that produces the optimal workforce of physicians to meet our country’s medical needs. The population of the United States deserves consistent service across the board.

4. Given that the practice of medicine is dynamic and therefore what we need today is not necessarily what we will need in 10 years, the system should be nimble enough to adjust rapidly to the changing medical landscape. Methodologies to project workforce needs will need to be developed and continually refined as data becomes available. This methodology should be used to distribute funding in a way that meets workforce needs, not vested political or financial interests.

5. There must be accountability and transparency built into the system, not only to certify that funds are being spent appropriately to support the training of physicians, but also to ensure quality and the readiness of the physicians emerging from training. A combined governance system with articulated goals and measured outcomes is needed.

6. Programs that produce high-quality graduates in an efficient manner and consistent with workforce needs should be rewarded through financial incentives or higher levels of support. Similarly, funds should be set aside to support innovation in GME, which will incentivize higher quality training.

It is our intent that these principles be used to inform decisions on any proposal affecting how surgeons and other physicians are trained and how such training is financed. The Energy and Commerce Committee is currently reviewing the responses received from ACS and other stakeholders and is expected to use the information received to compose draft reform legislation in the late spring or early summer.

As of yet, neither of the other two committees with jurisdiction over GME reform, (House Ways and Means or Senate Finance), have expressed interest in the topic in the new 114th Congress just underway. However, it is entirely possible such could change if hearings held by the Energy and Commerce Committee generate such interest or if there are broader conversations about Medicare financing in general.

In addition to plans for ACS Division of Advocacy and Health Policy (DAHP) staff to visit and personally present the ACS perspective on GME reform to each member office of the Energy and Commerce Committee, the DAHP is also in the early stages of planning a summit in the Washington office to further explore the topic. The goal would be the development and proposal of innovative solutions designed to improve the way our physician workforce is trained based on our principles listed above.

The topic of GME has long been one of the top priorities for the College and accordingly, this office. Fellows can be assured that the staff of the DAHP recognize such and are diligently directing their efforts into assuring that the surgeon’s perspective is well represented as discussions and deliberations on GME reform get underway on Capitol Hill.

Until next month ...

Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy, for the Division of Advocacy and Health Policy, in the ACS offices in Washington, D.C.

Reform of graduate medical education has been raised as a potential agenda item for the 114th Congress.

In an open letter released Dec. 6, 2014, eight members of the House Energy and Commerce Committee’s Health Subcommittee requested input on the structure, financing, and governance of graduate medical education. In order to frame and organize the responses, the members posed seven specific questions. Over a period of several weeks, through a process incorporating input from more than 250 Fellows in leadership positions, the ACS Health Policy and Advocacy Group, faculty of the University of North Carolina’s Cecil G. Sheps Center for Health Services Research, Chapel Hill, and ACS staff of both the Chicago and Washington offices, a letter on behalf of ACS was drafted and submitted on Jan. 15, 2015. The submitted response not only provided answers to the seven questions but also included a set of principles that ACS advocates should guide reform efforts. Those principles are as follows:

1. Education and training are essential mechanisms in the process by which new medical discovery and excellence in new therapy are achieved. In order to foster and preserve the innovation for which our country’s medical system is noted, graduate medical education (GME) should continue to be supported as a public good.

2. Surgical GME has unique needs linked to the skills training required for an additional set of technical competencies. Accordingly, in order to acquire and achieve mastery of those skills, it is imperative that those unique training needs be recognized.

3. Reforms should focus on creating a system that produces the optimal workforce of physicians to meet our country’s medical needs. The population of the United States deserves consistent service across the board.

4. Given that the practice of medicine is dynamic and therefore what we need today is not necessarily what we will need in 10 years, the system should be nimble enough to adjust rapidly to the changing medical landscape. Methodologies to project workforce needs will need to be developed and continually refined as data becomes available. This methodology should be used to distribute funding in a way that meets workforce needs, not vested political or financial interests.

5. There must be accountability and transparency built into the system, not only to certify that funds are being spent appropriately to support the training of physicians, but also to ensure quality and the readiness of the physicians emerging from training. A combined governance system with articulated goals and measured outcomes is needed.

6. Programs that produce high-quality graduates in an efficient manner and consistent with workforce needs should be rewarded through financial incentives or higher levels of support. Similarly, funds should be set aside to support innovation in GME, which will incentivize higher quality training.

It is our intent that these principles be used to inform decisions on any proposal affecting how surgeons and other physicians are trained and how such training is financed. The Energy and Commerce Committee is currently reviewing the responses received from ACS and other stakeholders and is expected to use the information received to compose draft reform legislation in the late spring or early summer.

As of yet, neither of the other two committees with jurisdiction over GME reform, (House Ways and Means or Senate Finance), have expressed interest in the topic in the new 114th Congress just underway. However, it is entirely possible such could change if hearings held by the Energy and Commerce Committee generate such interest or if there are broader conversations about Medicare financing in general.

In addition to plans for ACS Division of Advocacy and Health Policy (DAHP) staff to visit and personally present the ACS perspective on GME reform to each member office of the Energy and Commerce Committee, the DAHP is also in the early stages of planning a summit in the Washington office to further explore the topic. The goal would be the development and proposal of innovative solutions designed to improve the way our physician workforce is trained based on our principles listed above.

The topic of GME has long been one of the top priorities for the College and accordingly, this office. Fellows can be assured that the staff of the DAHP recognize such and are diligently directing their efforts into assuring that the surgeon’s perspective is well represented as discussions and deliberations on GME reform get underway on Capitol Hill.

Until next month ...

Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy, for the Division of Advocacy and Health Policy, in the ACS offices in Washington, D.C.

We are currently embroiled in a health care crisis, characterized by the need for malpractice reform, pressures of the 80-hour work week regulations on resident education, and a decreasing interest in pursuing a career in surgery. As we face these difficult problems, we should reflect upon one of the aspects that makes surgery a great profession – namely, devotion to our patients and our craft. As we look forward to the future, I would like to share my personal reminiscences of a rural surgeon from the 20th century who affected my personal development and growth as a general and trauma surgeon.

My father, William J. Baker, M.D., was the first surgeon I ever knew. His effects on me (both as a parent and as a mentor) have been profound and long lasting. Born in Cambridge, Mass., Bill Baker attended Cambridge Latin, Harvard College (BS, 1936), Tufts University (MS in psychology, 1937), and Harvard Medical School (MD, 1941). He then worked as an intern at the Massachusetts General Hospital, where he met Jean “Pinky” Houghton who was working as a scrub nurse for Dr. Robert Linton. Pinky and Bill were married in Hawaii just before he joined the Navy in 1942. He was assigned to a Marine infantry assault division in the Philippines, where he was honored with a Purple Heart and the Silver Star.

>After the war, Dr. Baker returned to Boston where he trained under Dr. Richard Warren at the West Roxbury VA. In 1950 he and Pinky moved to the small town of Laconia in central New Hampshire; he was the first board-certified general surgeon in the State of New Hampshire outside of Dartmouth (which is, after all, almost in Vermont). He performed the first thoracic operation at the Laconia Hospital and brought a high standard of surgical care to the Lakes Region. At the end of his career, he served as Chief of Surgery at the Brockton VA from 1981 to 1985, allowing him to go back to his roots as a Visiting Attending at the West Roxbury VA.

Although Bill Baker did not pursue a career in academic surgery, he made major contributions to surgical care in New Hampshire. He was a charter member of the Northeast Medical Association (NEMA), founded in 1957, which was devoted to improving the care of injured skiers. I remember attending the second meeting at Stowe, Vt., in 1958 (at the age of 10). We both enjoyed our participation in the National Ski Patrol Association, and we were both very proud when I was able to join him as a member of the NEMA in 1984. As a strong advocate for prevention in the area of trauma, Bill Baker spearheaded efforts that led to legislation for the mandatory use of seatbelts and motorcycle helmets in New Hampshire. In the field of breast cancer, he developed an informal but well-organized group of breast cancer survivors (whom he lovingly called his “bosom buddies”). These ladies connected to women who had recently undergone mastectomy for breast cancer. This initiative preceded the Reach to Recovery program that was later sponsored by the American Cancer Society.

As a parent, Bill Baker taught me many things. As a rural surgeon, he evinced a dedication to excellent patient care, a legacy of life-long learning, and a strong commitment to community service and the prevention of injury. He served as President of the New Hampshire Chapter of the American College of Surgeons and was an active member of the New England Surgical Society. As a father, he was a great role model, who taught me the satisfaction that a career in rural general surgery could provide. As the quintessential rural surgeon, Bill Baker made multiple contributions to his community and his adopted state of New Hampshire. His death at the age of 78 was mourned by his family, friends, and the many patients whose lives he had affected as a surgeon, combined with his special mixture of a personal touch and compassion.

Dr. William Baker practiced general surgery from 1950 to 1985, in what some have called “the golden age of medicine.” What insights can be learned from his story for today’s rural surgeon? Rural surgeons today still work in hospitals with fewer resources and lateral support systems than are typically available in larger, urban hospitals. Although these conditions create problems, they mean that the rural surgeon can enjoy closer relationships with patients, nursing staff, colleagues in other specialties, and administrators. And rural surgeons can become influential community leaders and strong advocates for change and improvements in systems of care. The impact of activism is all the greater in rural communities because of the unique role of rural surgeons in the community.

Taking an active role in regional societies is key for rural surgeons. Participation in these societies helps individual surgeons develop networks of like-minded colleagues. Meetings help to “recharge batteries,” both intellectually and emotionally. Knowing that other surgeons are facing similar problems enhances solidarity, leads to creative solutions to issues, and develops bonds of friendship and support. Participation in the state chapter of the ACS can provide resources and leadership opportunities, particularly involvement in the Committee on Rural Surgery. Individuals such as Dr. Phil Caropreso and Dr. Tyler Hughes have been powerful spokespersons for rural surgery with the ACS leadership and their activism has produced results. The Listserve and the ACS Communities that they have developed provide rural surgeons with unprecedented networking and communication channels, the potential of which is only beginning to be understood.

Finally, consider partnering with a regional surgical program so that you can participate in the Transition to Practice program. This could be an opportunity to mentor and welcome energetic young surgeons to rural practice. Although this program is in its early stages, some trainees have decided to remain in those communities and partner with their senior mentor.

As a number of rural surgeons age, they will need to be replaced by dedicated young surgeons. Having interviewed resident applicants for 30 years, I have observed that today’s applicants have a strong commitment to service. Rural surgery can be a challenging career, but the rewards are substantial. One can elevate the standard of care in smaller communities, and the joy of caring for patients and improving their lives with surgical procedures is unparalleled. Living in a small community allows the rural surgeon to maintain a good standard of living and a positive work-life balance, allowing quality time with one’s family. As the son of a rural surgeon, I can personally attest to these advantages.

Dr. Christopher Baker has practiced as a general and trauma surgeon in a number of academic medical centers. He is currently chair of surgery at Carilion Clinic, and professor of surgery at the newly formed Virginia Tech Carilion School in Roanoke, Va. He is proud of the fact that the majority of Carilion’s surgery residents go directly into practice, often in rural settings.

We are currently embroiled in a health care crisis, characterized by the need for malpractice reform, pressures of the 80-hour work week regulations on resident education, and a decreasing interest in pursuing a career in surgery. As we face these difficult problems, we should reflect upon one of the aspects that makes surgery a great profession – namely, devotion to our patients and our craft. As we look forward to the future, I would like to share my personal reminiscences of a rural surgeon from the 20th century who affected my personal development and growth as a general and trauma surgeon.

My father, William J. Baker, M.D., was the first surgeon I ever knew. His effects on me (both as a parent and as a mentor) have been profound and long lasting. Born in Cambridge, Mass., Bill Baker attended Cambridge Latin, Harvard College (BS, 1936), Tufts University (MS in psychology, 1937), and Harvard Medical School (MD, 1941). He then worked as an intern at the Massachusetts General Hospital, where he met Jean “Pinky” Houghton who was working as a scrub nurse for Dr. Robert Linton. Pinky and Bill were married in Hawaii just before he joined the Navy in 1942. He was assigned to a Marine infantry assault division in the Philippines, where he was honored with a Purple Heart and the Silver Star.

>After the war, Dr. Baker returned to Boston where he trained under Dr. Richard Warren at the West Roxbury VA. In 1950 he and Pinky moved to the small town of Laconia in central New Hampshire; he was the first board-certified general surgeon in the State of New Hampshire outside of Dartmouth (which is, after all, almost in Vermont). He performed the first thoracic operation at the Laconia Hospital and brought a high standard of surgical care to the Lakes Region. At the end of his career, he served as Chief of Surgery at the Brockton VA from 1981 to 1985, allowing him to go back to his roots as a Visiting Attending at the West Roxbury VA.

Although Bill Baker did not pursue a career in academic surgery, he made major contributions to surgical care in New Hampshire. He was a charter member of the Northeast Medical Association (NEMA), founded in 1957, which was devoted to improving the care of injured skiers. I remember attending the second meeting at Stowe, Vt., in 1958 (at the age of 10). We both enjoyed our participation in the National Ski Patrol Association, and we were both very proud when I was able to join him as a member of the NEMA in 1984. As a strong advocate for prevention in the area of trauma, Bill Baker spearheaded efforts that led to legislation for the mandatory use of seatbelts and motorcycle helmets in New Hampshire. In the field of breast cancer, he developed an informal but well-organized group of breast cancer survivors (whom he lovingly called his “bosom buddies”). These ladies connected to women who had recently undergone mastectomy for breast cancer. This initiative preceded the Reach to Recovery program that was later sponsored by the American Cancer Society.

As a parent, Bill Baker taught me many things. As a rural surgeon, he evinced a dedication to excellent patient care, a legacy of life-long learning, and a strong commitment to community service and the prevention of injury. He served as President of the New Hampshire Chapter of the American College of Surgeons and was an active member of the New England Surgical Society. As a father, he was a great role model, who taught me the satisfaction that a career in rural general surgery could provide. As the quintessential rural surgeon, Bill Baker made multiple contributions to his community and his adopted state of New Hampshire. His death at the age of 78 was mourned by his family, friends, and the many patients whose lives he had affected as a surgeon, combined with his special mixture of a personal touch and compassion.

Dr. William Baker practiced general surgery from 1950 to 1985, in what some have called “the golden age of medicine.” What insights can be learned from his story for today’s rural surgeon? Rural surgeons today still work in hospitals with fewer resources and lateral support systems than are typically available in larger, urban hospitals. Although these conditions create problems, they mean that the rural surgeon can enjoy closer relationships with patients, nursing staff, colleagues in other specialties, and administrators. And rural surgeons can become influential community leaders and strong advocates for change and improvements in systems of care. The impact of activism is all the greater in rural communities because of the unique role of rural surgeons in the community.

Taking an active role in regional societies is key for rural surgeons. Participation in these societies helps individual surgeons develop networks of like-minded colleagues. Meetings help to “recharge batteries,” both intellectually and emotionally. Knowing that other surgeons are facing similar problems enhances solidarity, leads to creative solutions to issues, and develops bonds of friendship and support. Participation in the state chapter of the ACS can provide resources and leadership opportunities, particularly involvement in the Committee on Rural Surgery. Individuals such as Dr. Phil Caropreso and Dr. Tyler Hughes have been powerful spokespersons for rural surgery with the ACS leadership and their activism has produced results. The Listserve and the ACS Communities that they have developed provide rural surgeons with unprecedented networking and communication channels, the potential of which is only beginning to be understood.

Finally, consider partnering with a regional surgical program so that you can participate in the Transition to Practice program. This could be an opportunity to mentor and welcome energetic young surgeons to rural practice. Although this program is in its early stages, some trainees have decided to remain in those communities and partner with their senior mentor.

As a number of rural surgeons age, they will need to be replaced by dedicated young surgeons. Having interviewed resident applicants for 30 years, I have observed that today’s applicants have a strong commitment to service. Rural surgery can be a challenging career, but the rewards are substantial. One can elevate the standard of care in smaller communities, and the joy of caring for patients and improving their lives with surgical procedures is unparalleled. Living in a small community allows the rural surgeon to maintain a good standard of living and a positive work-life balance, allowing quality time with one’s family. As the son of a rural surgeon, I can personally attest to these advantages.

Dr. Christopher Baker has practiced as a general and trauma surgeon in a number of academic medical centers. He is currently chair of surgery at Carilion Clinic, and professor of surgery at the newly formed Virginia Tech Carilion School in Roanoke, Va. He is proud of the fact that the majority of Carilion’s surgery residents go directly into practice, often in rural settings.

We are currently embroiled in a health care crisis, characterized by the need for malpractice reform, pressures of the 80-hour work week regulations on resident education, and a decreasing interest in pursuing a career in surgery. As we face these difficult problems, we should reflect upon one of the aspects that makes surgery a great profession – namely, devotion to our patients and our craft. As we look forward to the future, I would like to share my personal reminiscences of a rural surgeon from the 20th century who affected my personal development and growth as a general and trauma surgeon.

My father, William J. Baker, M.D., was the first surgeon I ever knew. His effects on me (both as a parent and as a mentor) have been profound and long lasting. Born in Cambridge, Mass., Bill Baker attended Cambridge Latin, Harvard College (BS, 1936), Tufts University (MS in psychology, 1937), and Harvard Medical School (MD, 1941). He then worked as an intern at the Massachusetts General Hospital, where he met Jean “Pinky” Houghton who was working as a scrub nurse for Dr. Robert Linton. Pinky and Bill were married in Hawaii just before he joined the Navy in 1942. He was assigned to a Marine infantry assault division in the Philippines, where he was honored with a Purple Heart and the Silver Star.

>After the war, Dr. Baker returned to Boston where he trained under Dr. Richard Warren at the West Roxbury VA. In 1950 he and Pinky moved to the small town of Laconia in central New Hampshire; he was the first board-certified general surgeon in the State of New Hampshire outside of Dartmouth (which is, after all, almost in Vermont). He performed the first thoracic operation at the Laconia Hospital and brought a high standard of surgical care to the Lakes Region. At the end of his career, he served as Chief of Surgery at the Brockton VA from 1981 to 1985, allowing him to go back to his roots as a Visiting Attending at the West Roxbury VA.

Although Bill Baker did not pursue a career in academic surgery, he made major contributions to surgical care in New Hampshire. He was a charter member of the Northeast Medical Association (NEMA), founded in 1957, which was devoted to improving the care of injured skiers. I remember attending the second meeting at Stowe, Vt., in 1958 (at the age of 10). We both enjoyed our participation in the National Ski Patrol Association, and we were both very proud when I was able to join him as a member of the NEMA in 1984. As a strong advocate for prevention in the area of trauma, Bill Baker spearheaded efforts that led to legislation for the mandatory use of seatbelts and motorcycle helmets in New Hampshire. In the field of breast cancer, he developed an informal but well-organized group of breast cancer survivors (whom he lovingly called his “bosom buddies”). These ladies connected to women who had recently undergone mastectomy for breast cancer. This initiative preceded the Reach to Recovery program that was later sponsored by the American Cancer Society.

As a parent, Bill Baker taught me many things. As a rural surgeon, he evinced a dedication to excellent patient care, a legacy of life-long learning, and a strong commitment to community service and the prevention of injury. He served as President of the New Hampshire Chapter of the American College of Surgeons and was an active member of the New England Surgical Society. As a father, he was a great role model, who taught me the satisfaction that a career in rural general surgery could provide. As the quintessential rural surgeon, Bill Baker made multiple contributions to his community and his adopted state of New Hampshire. His death at the age of 78 was mourned by his family, friends, and the many patients whose lives he had affected as a surgeon, combined with his special mixture of a personal touch and compassion.

Dr. William Baker practiced general surgery from 1950 to 1985, in what some have called “the golden age of medicine.” What insights can be learned from his story for today’s rural surgeon? Rural surgeons today still work in hospitals with fewer resources and lateral support systems than are typically available in larger, urban hospitals. Although these conditions create problems, they mean that the rural surgeon can enjoy closer relationships with patients, nursing staff, colleagues in other specialties, and administrators. And rural surgeons can become influential community leaders and strong advocates for change and improvements in systems of care. The impact of activism is all the greater in rural communities because of the unique role of rural surgeons in the community.

Taking an active role in regional societies is key for rural surgeons. Participation in these societies helps individual surgeons develop networks of like-minded colleagues. Meetings help to “recharge batteries,” both intellectually and emotionally. Knowing that other surgeons are facing similar problems enhances solidarity, leads to creative solutions to issues, and develops bonds of friendship and support. Participation in the state chapter of the ACS can provide resources and leadership opportunities, particularly involvement in the Committee on Rural Surgery. Individuals such as Dr. Phil Caropreso and Dr. Tyler Hughes have been powerful spokespersons for rural surgery with the ACS leadership and their activism has produced results. The Listserve and the ACS Communities that they have developed provide rural surgeons with unprecedented networking and communication channels, the potential of which is only beginning to be understood.

Finally, consider partnering with a regional surgical program so that you can participate in the Transition to Practice program. This could be an opportunity to mentor and welcome energetic young surgeons to rural practice. Although this program is in its early stages, some trainees have decided to remain in those communities and partner with their senior mentor.

As a number of rural surgeons age, they will need to be replaced by dedicated young surgeons. Having interviewed resident applicants for 30 years, I have observed that today’s applicants have a strong commitment to service. Rural surgery can be a challenging career, but the rewards are substantial. One can elevate the standard of care in smaller communities, and the joy of caring for patients and improving their lives with surgical procedures is unparalleled. Living in a small community allows the rural surgeon to maintain a good standard of living and a positive work-life balance, allowing quality time with one’s family. As the son of a rural surgeon, I can personally attest to these advantages.

Dr. Christopher Baker has practiced as a general and trauma surgeon in a number of academic medical centers. He is currently chair of surgery at Carilion Clinic, and professor of surgery at the newly formed Virginia Tech Carilion School in Roanoke, Va. He is proud of the fact that the majority of Carilion’s surgery residents go directly into practice, often in rural settings.

When I was a resident, one of the surgery faculty who often performed big, high-risk operations liked to say, “If the patient can tolerate a haircut, he can tolerate an operation.” By this, he meant that there were not patients who were too sick for surgery if the operation was indicated. However, over the last 2 decades, I have seen a handful of patients for whom the risks of the operation far outweigh the potential benefits and for whom I have said I am not offering surgery as an option.

Recently, I had a chance to discuss troubling ethics cases with group of thoughtful surgical residents. They raised concerns over the common scenario of being consulted in the middle of the night on the critically ill patient in the intensive care unit for whom the risks of surgery are extremely high. These residents asked the question of whether it is ever acceptable for surgeons to simply refuse to take such patients to the operating room if the alternative to surgery is virtually certain death. The overriding concern among the residents was whether saying “no” to a request for operative intervention in a critically ill patient can ever be justified since the surgeon is essentially “playing God” by not offering the possibility of intervention.

There is no question that there can be very sick patients who have a poor prognosis and the decision is appropriately made to recommend surgery even though the risks are very high. I also believe that there are patients for whom the risks of surgery are so high, and the prospects for a good outcome are so low, that surgery should not be recommended. However, it is important to distinguish two different scenarios. In one scenario, the surgical consultant decides that surgery is an option, but then tries to convince the surrogate decision makers (usually the patient’s family) to decline surgery because of the very high risks. In the second scenario, the surgeon decides that the risks to the patient are so high that it would be wrong to even take the patient to the operating room.

In both scenarios, the patient does not get an operation and in the vast majority of such cases, the patient will die in a short period of time. The question remains whether it is better to give families a choice or not. I believe that posing the question in this manner is misleading and presents a false dichotomy.

Although the distinctions can be subtle, it is critical for the surgeon to decide whether each patient has a high enough chance for survival that the operation is medically justifiable. If the answer is “yes,” then the next question will be one for the surrogate decision makers to decide whether to consent to the surgery or not. Based on the importance of respecting the autonomous choices of patients or their surrogates, it is important that surgeons respect the choice not to have an operation even if one is being recommended. If the answer to the question of whether the operation is medically justifiable is “no,” to offer surgery to family and then try to convince them to decline it by overstating the risks is misleading. Although such a strategy would give the family a sense of control over the situation, it would also give the false impression that surgery is truly an option. To act this way would allow the surgeon the ability to avoid “playing God” since the family is “making the decision”. However, I believe that taking that decision away from families when there is not really a reasonable choice for surgery is a better way to eliminate their potential guilt. Not only is it ethically acceptable to decline to offer an operation to an extremely high-risk patient, I would argue that such behavior is actually the ethical responsibility of the surgeon. We should take on the burden of saying “no” when surgery should NOT be performed. Forcing such a decision on families in the name of respecting autonomy is to shirk our responsibility and something that we must avoid doing whenever possible.

Dr. Angelos is an ACS Fellow; the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

When I was a resident, one of the surgery faculty who often performed big, high-risk operations liked to say, “If the patient can tolerate a haircut, he can tolerate an operation.” By this, he meant that there were not patients who were too sick for surgery if the operation was indicated. However, over the last 2 decades, I have seen a handful of patients for whom the risks of the operation far outweigh the potential benefits and for whom I have said I am not offering surgery as an option.

Recently, I had a chance to discuss troubling ethics cases with group of thoughtful surgical residents. They raised concerns over the common scenario of being consulted in the middle of the night on the critically ill patient in the intensive care unit for whom the risks of surgery are extremely high. These residents asked the question of whether it is ever acceptable for surgeons to simply refuse to take such patients to the operating room if the alternative to surgery is virtually certain death. The overriding concern among the residents was whether saying “no” to a request for operative intervention in a critically ill patient can ever be justified since the surgeon is essentially “playing God” by not offering the possibility of intervention.

There is no question that there can be very sick patients who have a poor prognosis and the decision is appropriately made to recommend surgery even though the risks are very high. I also believe that there are patients for whom the risks of surgery are so high, and the prospects for a good outcome are so low, that surgery should not be recommended. However, it is important to distinguish two different scenarios. In one scenario, the surgical consultant decides that surgery is an option, but then tries to convince the surrogate decision makers (usually the patient’s family) to decline surgery because of the very high risks. In the second scenario, the surgeon decides that the risks to the patient are so high that it would be wrong to even take the patient to the operating room.

In both scenarios, the patient does not get an operation and in the vast majority of such cases, the patient will die in a short period of time. The question remains whether it is better to give families a choice or not. I believe that posing the question in this manner is misleading and presents a false dichotomy.

Although the distinctions can be subtle, it is critical for the surgeon to decide whether each patient has a high enough chance for survival that the operation is medically justifiable. If the answer is “yes,” then the next question will be one for the surrogate decision makers to decide whether to consent to the surgery or not. Based on the importance of respecting the autonomous choices of patients or their surrogates, it is important that surgeons respect the choice not to have an operation even if one is being recommended. If the answer to the question of whether the operation is medically justifiable is “no,” to offer surgery to family and then try to convince them to decline it by overstating the risks is misleading. Although such a strategy would give the family a sense of control over the situation, it would also give the false impression that surgery is truly an option. To act this way would allow the surgeon the ability to avoid “playing God” since the family is “making the decision”. However, I believe that taking that decision away from families when there is not really a reasonable choice for surgery is a better way to eliminate their potential guilt. Not only is it ethically acceptable to decline to offer an operation to an extremely high-risk patient, I would argue that such behavior is actually the ethical responsibility of the surgeon. We should take on the burden of saying “no” when surgery should NOT be performed. Forcing such a decision on families in the name of respecting autonomy is to shirk our responsibility and something that we must avoid doing whenever possible.

Dr. Angelos is an ACS Fellow; the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

When I was a resident, one of the surgery faculty who often performed big, high-risk operations liked to say, “If the patient can tolerate a haircut, he can tolerate an operation.” By this, he meant that there were not patients who were too sick for surgery if the operation was indicated. However, over the last 2 decades, I have seen a handful of patients for whom the risks of the operation far outweigh the potential benefits and for whom I have said I am not offering surgery as an option.

Recently, I had a chance to discuss troubling ethics cases with group of thoughtful surgical residents. They raised concerns over the common scenario of being consulted in the middle of the night on the critically ill patient in the intensive care unit for whom the risks of surgery are extremely high. These residents asked the question of whether it is ever acceptable for surgeons to simply refuse to take such patients to the operating room if the alternative to surgery is virtually certain death. The overriding concern among the residents was whether saying “no” to a request for operative intervention in a critically ill patient can ever be justified since the surgeon is essentially “playing God” by not offering the possibility of intervention.

There is no question that there can be very sick patients who have a poor prognosis and the decision is appropriately made to recommend surgery even though the risks are very high. I also believe that there are patients for whom the risks of surgery are so high, and the prospects for a good outcome are so low, that surgery should not be recommended. However, it is important to distinguish two different scenarios. In one scenario, the surgical consultant decides that surgery is an option, but then tries to convince the surrogate decision makers (usually the patient’s family) to decline surgery because of the very high risks. In the second scenario, the surgeon decides that the risks to the patient are so high that it would be wrong to even take the patient to the operating room.

In both scenarios, the patient does not get an operation and in the vast majority of such cases, the patient will die in a short period of time. The question remains whether it is better to give families a choice or not. I believe that posing the question in this manner is misleading and presents a false dichotomy.

Although the distinctions can be subtle, it is critical for the surgeon to decide whether each patient has a high enough chance for survival that the operation is medically justifiable. If the answer is “yes,” then the next question will be one for the surrogate decision makers to decide whether to consent to the surgery or not. Based on the importance of respecting the autonomous choices of patients or their surrogates, it is important that surgeons respect the choice not to have an operation even if one is being recommended. If the answer to the question of whether the operation is medically justifiable is “no,” to offer surgery to family and then try to convince them to decline it by overstating the risks is misleading. Although such a strategy would give the family a sense of control over the situation, it would also give the false impression that surgery is truly an option. To act this way would allow the surgeon the ability to avoid “playing God” since the family is “making the decision”. However, I believe that taking that decision away from families when there is not really a reasonable choice for surgery is a better way to eliminate their potential guilt. Not only is it ethically acceptable to decline to offer an operation to an extremely high-risk patient, I would argue that such behavior is actually the ethical responsibility of the surgeon. We should take on the burden of saying “no” when surgery should NOT be performed. Forcing such a decision on families in the name of respecting autonomy is to shirk our responsibility and something that we must avoid doing whenever possible.

Dr. Angelos is an ACS Fellow; the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

As a significant cause of cancer-related mortality, head and neck cancer presents an important therapeutic challenge that has proven relatively resistant to attempts to improve patient outcomes over the past several decades. In recent years, molecular profiling of head and neck cancers has provided greater insight into their significant genetic heterogeneity, creating potential opportunities for novel therapies. Here, we discuss the most promising advances.

Limited progress in HNSCC treatment
Cancers of the nasal cavity, sinuses, mouth, lips, salivary glands, throat, and larynx, collectively called head and neck cancers, are the sixth leading cause of cancer-related death worldwide. The majority of head and neck cancer arises in the epithelial cells that line the mucosal surfaces of the head and neck and is known as squamous cell carcinoma (HNSCC). If caught in the early stages, HNSCC has a high cure rate with single-modality treatment with either surgery or radiation therapy (RT).¹ However, a substantial proportion of patients present with advanced disease that requires multimodality therapy and has significantly poorer outcomes. Locally advanced HNSCC is typically treated with various combinations of surgery, RT, and chemotherapy and survival rates for all patients at 5 years are 40%- 60%, compared with 70%-90% for patients with early-stage disease.^1,3 Up to half of locally advanced tumors relapse within the first 2 years after treatment. For patients with recurrent/metastatic disease, various chemotherapeutic regimens are available but median survival is typically less than a year.^3-5  

Click on the PDF icon at the top of this introduction to read the full article.

As a significant cause of cancer-related mortality, head and neck cancer presents an important therapeutic challenge that has proven relatively resistant to attempts to improve patient outcomes over the past several decades. In recent years, molecular profiling of head and neck cancers has provided greater insight into their significant genetic heterogeneity, creating potential opportunities for novel therapies. Here, we discuss the most promising advances.

Limited progress in HNSCC treatment
Cancers of the nasal cavity, sinuses, mouth, lips, salivary glands, throat, and larynx, collectively called head and neck cancers, are the sixth leading cause of cancer-related death worldwide. The majority of head and neck cancer arises in the epithelial cells that line the mucosal surfaces of the head and neck and is known as squamous cell carcinoma (HNSCC). If caught in the early stages, HNSCC has a high cure rate with single-modality treatment with either surgery or radiation therapy (RT).¹ However, a substantial proportion of patients present with advanced disease that requires multimodality therapy and has significantly poorer outcomes. Locally advanced HNSCC is typically treated with various combinations of surgery, RT, and chemotherapy and survival rates for all patients at 5 years are 40%- 60%, compared with 70%-90% for patients with early-stage disease.^1,3 Up to half of locally advanced tumors relapse within the first 2 years after treatment. For patients with recurrent/metastatic disease, various chemotherapeutic regimens are available but median survival is typically less than a year.^3-5  

Click on the PDF icon at the top of this introduction to read the full article.

As a significant cause of cancer-related mortality, head and neck cancer presents an important therapeutic challenge that has proven relatively resistant to attempts to improve patient outcomes over the past several decades. In recent years, molecular profiling of head and neck cancers has provided greater insight into their significant genetic heterogeneity, creating potential opportunities for novel therapies. Here, we discuss the most promising advances.

Limited progress in HNSCC treatment
Cancers of the nasal cavity, sinuses, mouth, lips, salivary glands, throat, and larynx, collectively called head and neck cancers, are the sixth leading cause of cancer-related death worldwide. The majority of head and neck cancer arises in the epithelial cells that line the mucosal surfaces of the head and neck and is known as squamous cell carcinoma (HNSCC). If caught in the early stages, HNSCC has a high cure rate with single-modality treatment with either surgery or radiation therapy (RT).¹ However, a substantial proportion of patients present with advanced disease that requires multimodality therapy and has significantly poorer outcomes. Locally advanced HNSCC is typically treated with various combinations of surgery, RT, and chemotherapy and survival rates for all patients at 5 years are 40%- 60%, compared with 70%-90% for patients with early-stage disease.^1,3 Up to half of locally advanced tumors relapse within the first 2 years after treatment. For patients with recurrent/metastatic disease, various chemotherapeutic regimens are available but median survival is typically less than a year.^3-5  

Click on the PDF icon at the top of this introduction to read the full article.

NASHVILLE, TENN. – A 1 million–patient analysis of the Get With the Guidelines database found striking improvements in outcomes after ischemic stroke.

Despite the proven benefits of new-generation clot-retrieval devices, however, only about 2% of such stroke patients undergo endovascular therapy.

In a video interview at the International Stroke Conference, Dr. Bijoy Menon of the department of clinical neurosciences at the University of Calgary (Alta.), who presented the findings at the conference, discussed this apparent clinical paradox.

Dr. Menon’s study echoes findings of the landmark Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) trial, which found dramatically improved stroke outcomes after endovascular therapy.

But the benefits of such treatment should never outweigh the need for thoroughly screening patients and carefully considering their recovery prospects, Dr. Michael Hill, professor of neurology at the University of Calgary and primary investigator on the ESCAPE study, cautioned in another video interview at the meeting.

[email protected]

On Twitter @alz_gal

NASHVILLE, TENN. – A 1 million–patient analysis of the Get With the Guidelines database found striking improvements in outcomes after ischemic stroke.

Despite the proven benefits of new-generation clot-retrieval devices, however, only about 2% of such stroke patients undergo endovascular therapy.

In a video interview at the International Stroke Conference, Dr. Bijoy Menon of the department of clinical neurosciences at the University of Calgary (Alta.), who presented the findings at the conference, discussed this apparent clinical paradox.

Dr. Menon’s study echoes findings of the landmark Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) trial, which found dramatically improved stroke outcomes after endovascular therapy.

But the benefits of such treatment should never outweigh the need for thoroughly screening patients and carefully considering their recovery prospects, Dr. Michael Hill, professor of neurology at the University of Calgary and primary investigator on the ESCAPE study, cautioned in another video interview at the meeting.

[email protected]

On Twitter @alz_gal

NASHVILLE, TENN. – A 1 million–patient analysis of the Get With the Guidelines database found striking improvements in outcomes after ischemic stroke.

Despite the proven benefits of new-generation clot-retrieval devices, however, only about 2% of such stroke patients undergo endovascular therapy.

In a video interview at the International Stroke Conference, Dr. Bijoy Menon of the department of clinical neurosciences at the University of Calgary (Alta.), who presented the findings at the conference, discussed this apparent clinical paradox.

Dr. Menon’s study echoes findings of the landmark Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) trial, which found dramatically improved stroke outcomes after endovascular therapy.

But the benefits of such treatment should never outweigh the need for thoroughly screening patients and carefully considering their recovery prospects, Dr. Michael Hill, professor of neurology at the University of Calgary and primary investigator on the ESCAPE study, cautioned in another video interview at the meeting.

[email protected]

On Twitter @alz_gal

LAKE BUENA VISTA, FLA. – Trauma patients on contact isolation were nearly six times more likely to develop venous thromboembolism (VTE) as those who were not isolated, based on an analysis of 4,317 patients.

VTE occurred in 17.5% (44/251) of patients on contact isolation and 3.5% (141/4,066) of patients who were not isolated (P < .0001). Injury Severity Score (ISS), age, male gender, and obesity also were significantly associated with the risk of VTE.

The relationship between VTE risk and contact isolation remained significant after adjusting for gender, age, ISS, and comorbidities (odds ratio, 3.28; P < .0001), Dr. Robert Ferguson reported at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

Odds ratios also were significantly elevated for obesity (OR, 2.35; P < .006), male gender (OR, 2.1; P < .0001), ISS (OR, 1.08; P < .0001), and age (OR, 1.02; P < .0001). The presence of diabetes, dementia/Alzheimer’s, history of cerebrovascular accident, psychiatric disease, cirrhosis, cancer, or alcohol abuse was not statistically significant.

The increased risk for VTE in trauma patients on contact isolation “is likely multifactorial in nature and is related but not limited to decreased ambulation, noncompliance with prophylaxis, and restricted access by staff,” said Dr. Ferguson, a third-year resident at the Virginia Tech, Roanoke.

The risk:benefit ratio of contact isolation in the trauma population needs to be reevaluated, the researchers concluded. “We encourage hospital committees to alter protocols and supplement strategies such as staff education, dedicated ambulation areas and/or isolation wards, and eliminate contact isolation following routine methicillin-resistant Staphylococcus aureus surveillance screening.”

Dr. Ferguson and his coauthors reported having no financial disclosures.

[email protected]

LAKE BUENA VISTA, FLA. – Trauma patients on contact isolation were nearly six times more likely to develop venous thromboembolism (VTE) as those who were not isolated, based on an analysis of 4,317 patients.

VTE occurred in 17.5% (44/251) of patients on contact isolation and 3.5% (141/4,066) of patients who were not isolated (P < .0001). Injury Severity Score (ISS), age, male gender, and obesity also were significantly associated with the risk of VTE.

The relationship between VTE risk and contact isolation remained significant after adjusting for gender, age, ISS, and comorbidities (odds ratio, 3.28; P < .0001), Dr. Robert Ferguson reported at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

Odds ratios also were significantly elevated for obesity (OR, 2.35; P < .006), male gender (OR, 2.1; P < .0001), ISS (OR, 1.08; P < .0001), and age (OR, 1.02; P < .0001). The presence of diabetes, dementia/Alzheimer’s, history of cerebrovascular accident, psychiatric disease, cirrhosis, cancer, or alcohol abuse was not statistically significant.

The increased risk for VTE in trauma patients on contact isolation “is likely multifactorial in nature and is related but not limited to decreased ambulation, noncompliance with prophylaxis, and restricted access by staff,” said Dr. Ferguson, a third-year resident at the Virginia Tech, Roanoke.

The risk:benefit ratio of contact isolation in the trauma population needs to be reevaluated, the researchers concluded. “We encourage hospital committees to alter protocols and supplement strategies such as staff education, dedicated ambulation areas and/or isolation wards, and eliminate contact isolation following routine methicillin-resistant Staphylococcus aureus surveillance screening.”

Dr. Ferguson and his coauthors reported having no financial disclosures.

[email protected]

LAKE BUENA VISTA, FLA. – Trauma patients on contact isolation were nearly six times more likely to develop venous thromboembolism (VTE) as those who were not isolated, based on an analysis of 4,317 patients.

VTE occurred in 17.5% (44/251) of patients on contact isolation and 3.5% (141/4,066) of patients who were not isolated (P < .0001). Injury Severity Score (ISS), age, male gender, and obesity also were significantly associated with the risk of VTE.

The relationship between VTE risk and contact isolation remained significant after adjusting for gender, age, ISS, and comorbidities (odds ratio, 3.28; P < .0001), Dr. Robert Ferguson reported at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

Odds ratios also were significantly elevated for obesity (OR, 2.35; P < .006), male gender (OR, 2.1; P < .0001), ISS (OR, 1.08; P < .0001), and age (OR, 1.02; P < .0001). The presence of diabetes, dementia/Alzheimer’s, history of cerebrovascular accident, psychiatric disease, cirrhosis, cancer, or alcohol abuse was not statistically significant.

The increased risk for VTE in trauma patients on contact isolation “is likely multifactorial in nature and is related but not limited to decreased ambulation, noncompliance with prophylaxis, and restricted access by staff,” said Dr. Ferguson, a third-year resident at the Virginia Tech, Roanoke.

The risk:benefit ratio of contact isolation in the trauma population needs to be reevaluated, the researchers concluded. “We encourage hospital committees to alter protocols and supplement strategies such as staff education, dedicated ambulation areas and/or isolation wards, and eliminate contact isolation following routine methicillin-resistant Staphylococcus aureus surveillance screening.”

Dr. Ferguson and his coauthors reported having no financial disclosures.

[email protected]

Diagnosing and treating illnesses are the bread and butter of hospitalist medicine. Has your bread become stale?

I used to be envious of older physicians who ‘grandfathered in’ and became exempt from the requirement to recertify every 10 years for the American Board of Internal Medicine. Preparing for the boards is extremely time consuming and, at times, incredibly stressful, but it’s what we have to do to prove that our medical knowledge is up to date, right?

Who hasn’t heard of at least one nightmare outcome after a physician treated a patient with out-of-date standards, probably the same ones he learned in medical school a long, long time ago? We may snicker at this scenario, but could we be guilty too? Could we be so set in our ways, so self-confident that we refuse to grow?

I was watching a hospital medicine CME DVD a few months ago and was shocked, as well as embarrassed, to learn that the way I was performing part of my neurological exam was antiquated. There was a new “gold standard” that I had never learned before. After all, I had been doing the exact same thing for years; too many years, it seems. I mistakenly assumed that all the physical examination skills I had learned in medical school were set in stone. But as in all aspects of medicine, even best practices for performing a basic examination have evolved over the years.

Then there is the old habit of ordering multiple blood tests on hospitalized patients every day. That’s just how many of us were trained during residency, but in real life it’s not always necessary. Sure, if there’s a reason to be concerned about specific parameters they should be followed closely, but most inpatients don’t really need chemistries and a CBC each and every day; if they weren’t already anemic, we could make them anemic with excessive blood draws. And how much of that knee-jerk reflex to order daily “routine labs” is really just defensive medicine anyway?

I recently started teaching residents and was a little apprehensive in the very beginning. After all, 2 decades later, I still remember the good (and bad) attendings, and to this very day I incorporate parts of what the good ones taught me into patient encounters. Now I would be the one who could leave a lasting, hopefully positive impression in brilliant young minds. I have found teaching residents to be motivating and eye-opening. I get to see what’s new on their burgeoning, technologically advanced horizons; and I am learning from them, too. It’s invigorating to grow in the field I love so much, to expand my mind and, sometimes, humbly acknowledge I need to switch gears and proceed in a different direction; I suspect many others would benefit from this revelation as well.

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

Diagnosing and treating illnesses are the bread and butter of hospitalist medicine. Has your bread become stale?

I used to be envious of older physicians who ‘grandfathered in’ and became exempt from the requirement to recertify every 10 years for the American Board of Internal Medicine. Preparing for the boards is extremely time consuming and, at times, incredibly stressful, but it’s what we have to do to prove that our medical knowledge is up to date, right?

Who hasn’t heard of at least one nightmare outcome after a physician treated a patient with out-of-date standards, probably the same ones he learned in medical school a long, long time ago? We may snicker at this scenario, but could we be guilty too? Could we be so set in our ways, so self-confident that we refuse to grow?

I was watching a hospital medicine CME DVD a few months ago and was shocked, as well as embarrassed, to learn that the way I was performing part of my neurological exam was antiquated. There was a new “gold standard” that I had never learned before. After all, I had been doing the exact same thing for years; too many years, it seems. I mistakenly assumed that all the physical examination skills I had learned in medical school were set in stone. But as in all aspects of medicine, even best practices for performing a basic examination have evolved over the years.

Then there is the old habit of ordering multiple blood tests on hospitalized patients every day. That’s just how many of us were trained during residency, but in real life it’s not always necessary. Sure, if there’s a reason to be concerned about specific parameters they should be followed closely, but most inpatients don’t really need chemistries and a CBC each and every day; if they weren’t already anemic, we could make them anemic with excessive blood draws. And how much of that knee-jerk reflex to order daily “routine labs” is really just defensive medicine anyway?

I recently started teaching residents and was a little apprehensive in the very beginning. After all, 2 decades later, I still remember the good (and bad) attendings, and to this very day I incorporate parts of what the good ones taught me into patient encounters. Now I would be the one who could leave a lasting, hopefully positive impression in brilliant young minds. I have found teaching residents to be motivating and eye-opening. I get to see what’s new on their burgeoning, technologically advanced horizons; and I am learning from them, too. It’s invigorating to grow in the field I love so much, to expand my mind and, sometimes, humbly acknowledge I need to switch gears and proceed in a different direction; I suspect many others would benefit from this revelation as well.

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

Diagnosing and treating illnesses are the bread and butter of hospitalist medicine. Has your bread become stale?

I used to be envious of older physicians who ‘grandfathered in’ and became exempt from the requirement to recertify every 10 years for the American Board of Internal Medicine. Preparing for the boards is extremely time consuming and, at times, incredibly stressful, but it’s what we have to do to prove that our medical knowledge is up to date, right?

Who hasn’t heard of at least one nightmare outcome after a physician treated a patient with out-of-date standards, probably the same ones he learned in medical school a long, long time ago? We may snicker at this scenario, but could we be guilty too? Could we be so set in our ways, so self-confident that we refuse to grow?

I was watching a hospital medicine CME DVD a few months ago and was shocked, as well as embarrassed, to learn that the way I was performing part of my neurological exam was antiquated. There was a new “gold standard” that I had never learned before. After all, I had been doing the exact same thing for years; too many years, it seems. I mistakenly assumed that all the physical examination skills I had learned in medical school were set in stone. But as in all aspects of medicine, even best practices for performing a basic examination have evolved over the years.

Then there is the old habit of ordering multiple blood tests on hospitalized patients every day. That’s just how many of us were trained during residency, but in real life it’s not always necessary. Sure, if there’s a reason to be concerned about specific parameters they should be followed closely, but most inpatients don’t really need chemistries and a CBC each and every day; if they weren’t already anemic, we could make them anemic with excessive blood draws. And how much of that knee-jerk reflex to order daily “routine labs” is really just defensive medicine anyway?

I recently started teaching residents and was a little apprehensive in the very beginning. After all, 2 decades later, I still remember the good (and bad) attendings, and to this very day I incorporate parts of what the good ones taught me into patient encounters. Now I would be the one who could leave a lasting, hopefully positive impression in brilliant young minds. I have found teaching residents to be motivating and eye-opening. I get to see what’s new on their burgeoning, technologically advanced horizons; and I am learning from them, too. It’s invigorating to grow in the field I love so much, to expand my mind and, sometimes, humbly acknowledge I need to switch gears and proceed in a different direction; I suspect many others would benefit from this revelation as well.

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

Umbilical cord blood donation

Photo courtesy of NHS

SAN DIEGO—A product that promotes CD34 expansion has solved the problem of poor engraftment associated with umbilical cord blood transplant (UCBT), according to a speaker at the 2015 BMT Tandem Meetings.

John Wagner, MD, of the University of Minnesota in Minneapolis, supported this statement with early results from trials of HSC835, cord

blood units in which CD34 cells were expanded using the aryl hydrocarbon

receptor antagonist StemRegenin 1.

Dr Wagner and his colleagues conducted phase 1 and 2 trials of HSC835, which were supported by Novartis, the company developing the product.

Dr Wagner presented results of these trials at the BMT Tandem Meetings as abstract 29.*

The phase 1 trial included 18 patients who received double UCBT after myeloablative conditioning. They received an unmanipulated cord blood unit and an HSC835 unit.

In the phase 2 trial, 3 patients received a single HSC835 unit after myeloablative conditioning, and 3 received an HSC835 unit after non-myeloablative conditioning.

Manufacturing HSC835 took 15 days. Following expansion, the median CD34 cell dose increased 346-fold, and the median total nucleated cell (TNC) dose increased 848-fold.

Twenty-eight HSC835 products were produced, but 4 of them were not infused. Two products were contaminated, 1 was not infused due to patient relapse, and 1 product failed to expand. Dr Wagner noted that the failed unit started out at 50% viability, whereas the other units started at about 90% viability.

Phase 1

Eighteen patients were treated in the phase 1 trial. Eleven had acute lymphoblastic leukemia, 5 had acute myeloid leukemia, and 2 had myelodysplastic syndromes. The median age was 28 (range, 12 to 53).

The median TNC dose was 2.5 x 10⁷/kg for the unmanipulated cord blood unit and 5.1 x 10⁷/kg for the HSC835 unit. The median CD34 count was 0.4 x 10⁶/kg and 17.4 x 10⁶/kg, respectively. And the median CD3 count was 8.5 x 10⁶/kg and 2.5 x 10⁶/kg, respectively.

Most units were a 5/6 HLA match—50% for the unmanipulated unit and 67% for the HSC835 unit. Forty-four percent and 22% of the units, respectively, were 4/6 matches. And 6% and 11%, respectively, were 6/6 matches.

Neutrophil recovery was 100%, and the median time to recovery was 14.5 days.

Dr Wagner compared this to results in 121 matched historical controls who received UCBT with 2 unmanipulated units. Of those patients, 86% achieved neutrophil engraftment, and the median time to engraftment was 25 days (P<0.001).

In the current study, 6 patients had complete chimerism with HSC835, 6 had complete chimerism with the unmanipulated unit, and 6 had dual chimerism. In the dual-chimerism patients, both units were present, but all the T cells were derived from the unmanipulated unit.

“When we look at those patients who had engraftment of HSC835, whether it be this dual chimerism or complete chimerism, you see there is a very rapid recovery of 10.5 days, as compared to the historical control [recovery time] of 25 days,” Dr Wagner said. “And those that engrafted with the unmanipulated unit fall right where you’d expect them; that is, with the historical controls [23 days].”

Dr Wagner noted that the CD34 dose correlated with the pace of neutrophil recovery in patients who engrafted with the HSC835 unit, and patients with dual chimerism had the fastest neutrophil recovery.

Furthermore, the HSC835 unit predominated more than expected (P=0.05), winning out over the cord blood unit with a higher CD3 dose a disproportionate amount of time. The unit with a higher CD3 dose typically predominates two-thirds of the time in double UCBT.

“[These results] gave us enough information to say that [HSC835] could be a stand-alone product,” Dr Wagner said.

Phase 2

For phase 2, the researchers used a single HSC835 unit. They chose the lesser of 2 cord blood units (keeping the better unit as a backup), expanded it, and infused the resulting HSC835 unit into 3 patients who received myeloablative conditioning and 3 patients who did not.

In patients who received myeloablative conditioning, chimerism was complete at days 8, 12, and 14. Among the patients who received non-myeloablative conditioning, 1 had mixed chimerism at day 6. The other 2 had complete chimerism at days 5 and 7.

“So in conclusion, we believe that HSC835 is safe and effective in speeding neutrophil recovery after cord blood transplant,” Dr Wagner said. “These are very promising early results that compel us now to explore the single expanded product.”

Dr Wagner added that other considerations for HSC835 are that it may reduce the unit selection threshold, improve HLA match, enable re-cryopreservation (for transplant delays, backup, or multiple dosing), and perhaps allow for reduced-intensity conditioning with “mega-dose” grafts.

*Information in the abstract differs from that presented at the meeting.

Umbilical cord blood donation

Photo courtesy of NHS

SAN DIEGO—A product that promotes CD34 expansion has solved the problem of poor engraftment associated with umbilical cord blood transplant (UCBT), according to a speaker at the 2015 BMT Tandem Meetings.

John Wagner, MD, of the University of Minnesota in Minneapolis, supported this statement with early results from trials of HSC835, cord

blood units in which CD34 cells were expanded using the aryl hydrocarbon

receptor antagonist StemRegenin 1.

Dr Wagner and his colleagues conducted phase 1 and 2 trials of HSC835, which were supported by Novartis, the company developing the product.

Dr Wagner presented results of these trials at the BMT Tandem Meetings as abstract 29.*

The phase 1 trial included 18 patients who received double UCBT after myeloablative conditioning. They received an unmanipulated cord blood unit and an HSC835 unit.

In the phase 2 trial, 3 patients received a single HSC835 unit after myeloablative conditioning, and 3 received an HSC835 unit after non-myeloablative conditioning.

Manufacturing HSC835 took 15 days. Following expansion, the median CD34 cell dose increased 346-fold, and the median total nucleated cell (TNC) dose increased 848-fold.

Twenty-eight HSC835 products were produced, but 4 of them were not infused. Two products were contaminated, 1 was not infused due to patient relapse, and 1 product failed to expand. Dr Wagner noted that the failed unit started out at 50% viability, whereas the other units started at about 90% viability.

Phase 1

Eighteen patients were treated in the phase 1 trial. Eleven had acute lymphoblastic leukemia, 5 had acute myeloid leukemia, and 2 had myelodysplastic syndromes. The median age was 28 (range, 12 to 53).

The median TNC dose was 2.5 x 10⁷/kg for the unmanipulated cord blood unit and 5.1 x 10⁷/kg for the HSC835 unit. The median CD34 count was 0.4 x 10⁶/kg and 17.4 x 10⁶/kg, respectively. And the median CD3 count was 8.5 x 10⁶/kg and 2.5 x 10⁶/kg, respectively.

Most units were a 5/6 HLA match—50% for the unmanipulated unit and 67% for the HSC835 unit. Forty-four percent and 22% of the units, respectively, were 4/6 matches. And 6% and 11%, respectively, were 6/6 matches.

Neutrophil recovery was 100%, and the median time to recovery was 14.5 days.

Dr Wagner compared this to results in 121 matched historical controls who received UCBT with 2 unmanipulated units. Of those patients, 86% achieved neutrophil engraftment, and the median time to engraftment was 25 days (P<0.001).

In the current study, 6 patients had complete chimerism with HSC835, 6 had complete chimerism with the unmanipulated unit, and 6 had dual chimerism. In the dual-chimerism patients, both units were present, but all the T cells were derived from the unmanipulated unit.

“When we look at those patients who had engraftment of HSC835, whether it be this dual chimerism or complete chimerism, you see there is a very rapid recovery of 10.5 days, as compared to the historical control [recovery time] of 25 days,” Dr Wagner said. “And those that engrafted with the unmanipulated unit fall right where you’d expect them; that is, with the historical controls [23 days].”

Dr Wagner noted that the CD34 dose correlated with the pace of neutrophil recovery in patients who engrafted with the HSC835 unit, and patients with dual chimerism had the fastest neutrophil recovery.

Furthermore, the HSC835 unit predominated more than expected (P=0.05), winning out over the cord blood unit with a higher CD3 dose a disproportionate amount of time. The unit with a higher CD3 dose typically predominates two-thirds of the time in double UCBT.

“[These results] gave us enough information to say that [HSC835] could be a stand-alone product,” Dr Wagner said.

Phase 2

For phase 2, the researchers used a single HSC835 unit. They chose the lesser of 2 cord blood units (keeping the better unit as a backup), expanded it, and infused the resulting HSC835 unit into 3 patients who received myeloablative conditioning and 3 patients who did not.

In patients who received myeloablative conditioning, chimerism was complete at days 8, 12, and 14. Among the patients who received non-myeloablative conditioning, 1 had mixed chimerism at day 6. The other 2 had complete chimerism at days 5 and 7.

“So in conclusion, we believe that HSC835 is safe and effective in speeding neutrophil recovery after cord blood transplant,” Dr Wagner said. “These are very promising early results that compel us now to explore the single expanded product.”

Dr Wagner added that other considerations for HSC835 are that it may reduce the unit selection threshold, improve HLA match, enable re-cryopreservation (for transplant delays, backup, or multiple dosing), and perhaps allow for reduced-intensity conditioning with “mega-dose” grafts.

*Information in the abstract differs from that presented at the meeting.

Umbilical cord blood donation

Photo courtesy of NHS

SAN DIEGO—A product that promotes CD34 expansion has solved the problem of poor engraftment associated with umbilical cord blood transplant (UCBT), according to a speaker at the 2015 BMT Tandem Meetings.

John Wagner, MD, of the University of Minnesota in Minneapolis, supported this statement with early results from trials of HSC835, cord

blood units in which CD34 cells were expanded using the aryl hydrocarbon

receptor antagonist StemRegenin 1.

Dr Wagner and his colleagues conducted phase 1 and 2 trials of HSC835, which were supported by Novartis, the company developing the product.

Dr Wagner presented results of these trials at the BMT Tandem Meetings as abstract 29.*

The phase 1 trial included 18 patients who received double UCBT after myeloablative conditioning. They received an unmanipulated cord blood unit and an HSC835 unit.

In the phase 2 trial, 3 patients received a single HSC835 unit after myeloablative conditioning, and 3 received an HSC835 unit after non-myeloablative conditioning.

Manufacturing HSC835 took 15 days. Following expansion, the median CD34 cell dose increased 346-fold, and the median total nucleated cell (TNC) dose increased 848-fold.

Twenty-eight HSC835 products were produced, but 4 of them were not infused. Two products were contaminated, 1 was not infused due to patient relapse, and 1 product failed to expand. Dr Wagner noted that the failed unit started out at 50% viability, whereas the other units started at about 90% viability.

Phase 1

Eighteen patients were treated in the phase 1 trial. Eleven had acute lymphoblastic leukemia, 5 had acute myeloid leukemia, and 2 had myelodysplastic syndromes. The median age was 28 (range, 12 to 53).

The median TNC dose was 2.5 x 10⁷/kg for the unmanipulated cord blood unit and 5.1 x 10⁷/kg for the HSC835 unit. The median CD34 count was 0.4 x 10⁶/kg and 17.4 x 10⁶/kg, respectively. And the median CD3 count was 8.5 x 10⁶/kg and 2.5 x 10⁶/kg, respectively.

Most units were a 5/6 HLA match—50% for the unmanipulated unit and 67% for the HSC835 unit. Forty-four percent and 22% of the units, respectively, were 4/6 matches. And 6% and 11%, respectively, were 6/6 matches.

Neutrophil recovery was 100%, and the median time to recovery was 14.5 days.

Dr Wagner compared this to results in 121 matched historical controls who received UCBT with 2 unmanipulated units. Of those patients, 86% achieved neutrophil engraftment, and the median time to engraftment was 25 days (P<0.001).

In the current study, 6 patients had complete chimerism with HSC835, 6 had complete chimerism with the unmanipulated unit, and 6 had dual chimerism. In the dual-chimerism patients, both units were present, but all the T cells were derived from the unmanipulated unit.

“When we look at those patients who had engraftment of HSC835, whether it be this dual chimerism or complete chimerism, you see there is a very rapid recovery of 10.5 days, as compared to the historical control [recovery time] of 25 days,” Dr Wagner said. “And those that engrafted with the unmanipulated unit fall right where you’d expect them; that is, with the historical controls [23 days].”

Dr Wagner noted that the CD34 dose correlated with the pace of neutrophil recovery in patients who engrafted with the HSC835 unit, and patients with dual chimerism had the fastest neutrophil recovery.

Furthermore, the HSC835 unit predominated more than expected (P=0.05), winning out over the cord blood unit with a higher CD3 dose a disproportionate amount of time. The unit with a higher CD3 dose typically predominates two-thirds of the time in double UCBT.

“[These results] gave us enough information to say that [HSC835] could be a stand-alone product,” Dr Wagner said.

Phase 2

For phase 2, the researchers used a single HSC835 unit. They chose the lesser of 2 cord blood units (keeping the better unit as a backup), expanded it, and infused the resulting HSC835 unit into 3 patients who received myeloablative conditioning and 3 patients who did not.

In patients who received myeloablative conditioning, chimerism was complete at days 8, 12, and 14. Among the patients who received non-myeloablative conditioning, 1 had mixed chimerism at day 6. The other 2 had complete chimerism at days 5 and 7.

“So in conclusion, we believe that HSC835 is safe and effective in speeding neutrophil recovery after cord blood transplant,” Dr Wagner said. “These are very promising early results that compel us now to explore the single expanded product.”

Dr Wagner added that other considerations for HSC835 are that it may reduce the unit selection threshold, improve HLA match, enable re-cryopreservation (for transplant delays, backup, or multiple dosing), and perhaps allow for reduced-intensity conditioning with “mega-dose” grafts.

*Information in the abstract differs from that presented at the meeting.

Mesenchymal stem cells

SAN DIEGO—Infusions of expanded mesenchymal stem cells (MSCs) can treat severe, steroid-resistant, acute graft-vs-host disease (aGVHD) in pediatric patients, according to a study presented at the 2015 BMT Tandem Meetings.

The MSC product, known as remestemcel-L, induced responses in all grades of aGVHD and all organ systems.

Response at day 28 was associated with improved survival at day 100, and clinically significant toxicities were minimal, according to investigators.

“The enrolled patients represent a very challenging population with severe graft-vs-host disease that was non-responsive to treatments, including steroids and, for many of these children, multiple immunosuppressive agents, so we believe these results are very promising,” said Joanne Kurtzberg, MD, of Duke University Medical Center in Durham, North Carolina.

Dr Kurtzberg and her colleagues reported the results in a poster presentation (abstract 492*). Three investigators involved in this research are employed by Mesoblast, Inc., the company developing remestemcel-L.

The study included 160 patients who had a median age of 10 years (range, 0.3 to 17.5 years). Eighty-four percent of patients had received an unrelated donor transplant, and 46% received a mismatched transplant.

At baseline, 19% of patients had grade B aGVHD, 28% had grade C, and 53% had grade D. Eighty-nine percent of patients had gastrointestinal involvement, 50% had skin involvement, and 29% had liver involvement. Forty-one percent of patients had 2 organs involved, and 15% had 3.

The median duration of aGVHD before study enrollment was 28 days (range, 1 to 237), and patients had failed a median of 3 immunosuppressive agents.

Treatment and outcomes

Patients received 8 bi-weekly, intravenous infusions of 2 × 10⁶ MSCs/kg for 4 weeks. They could receive additional weekly infusions if deemed eligible at day 28.

The patients received a median of 11 infusions (range, 1-20) and were exposed to the treatment for a median of 43.5 days.

Fifty-three percent of patients had at least 1 serious adverse event. Eight patients (5%) had serious events that investigators thought might be treatment-related. These included neutropenia, infusion-related reaction, pulmonary hemorrhage, respiratory distress, tachycardia, respiratory failure, and hypertension.

Three events (6%) that were considered possibly treatment-related (pulmonary hemorrhage, respiratory distress, and respiratory failure) ultimately resulted in death. Fifty-four patients (34%) died in all.

At day 28, the overall response rate (ORR) was 64%. The ORR was 74% for grade B aGVHD, 66% for grade C, and 59% for grade D. The ORR was 62% for gastrointestinal, 77% for skin, and 53% for liver aGVHD.

Response correlated with a significant improvement in survival at day 100. Eighty-one percent of patients who responded at day 28 were still alive at day 100, compared to 21% of non-responders (P<0.0001).

The investigators said this study provides support for remestemcel-L to treat aGVHD in children. A single-arm, phase 3 trial of pediatric patients with aGVHD is underway.

*Information in the abstract differs from that presented at the meeting.

Mesenchymal stem cells

SAN DIEGO—Infusions of expanded mesenchymal stem cells (MSCs) can treat severe, steroid-resistant, acute graft-vs-host disease (aGVHD) in pediatric patients, according to a study presented at the 2015 BMT Tandem Meetings.

The MSC product, known as remestemcel-L, induced responses in all grades of aGVHD and all organ systems.

Response at day 28 was associated with improved survival at day 100, and clinically significant toxicities were minimal, according to investigators.

“The enrolled patients represent a very challenging population with severe graft-vs-host disease that was non-responsive to treatments, including steroids and, for many of these children, multiple immunosuppressive agents, so we believe these results are very promising,” said Joanne Kurtzberg, MD, of Duke University Medical Center in Durham, North Carolina.

Dr Kurtzberg and her colleagues reported the results in a poster presentation (abstract 492*). Three investigators involved in this research are employed by Mesoblast, Inc., the company developing remestemcel-L.

The study included 160 patients who had a median age of 10 years (range, 0.3 to 17.5 years). Eighty-four percent of patients had received an unrelated donor transplant, and 46% received a mismatched transplant.

At baseline, 19% of patients had grade B aGVHD, 28% had grade C, and 53% had grade D. Eighty-nine percent of patients had gastrointestinal involvement, 50% had skin involvement, and 29% had liver involvement. Forty-one percent of patients had 2 organs involved, and 15% had 3.

The median duration of aGVHD before study enrollment was 28 days (range, 1 to 237), and patients had failed a median of 3 immunosuppressive agents.

Treatment and outcomes

Patients received 8 bi-weekly, intravenous infusions of 2 × 10⁶ MSCs/kg for 4 weeks. They could receive additional weekly infusions if deemed eligible at day 28.

The patients received a median of 11 infusions (range, 1-20) and were exposed to the treatment for a median of 43.5 days.

Fifty-three percent of patients had at least 1 serious adverse event. Eight patients (5%) had serious events that investigators thought might be treatment-related. These included neutropenia, infusion-related reaction, pulmonary hemorrhage, respiratory distress, tachycardia, respiratory failure, and hypertension.

Three events (6%) that were considered possibly treatment-related (pulmonary hemorrhage, respiratory distress, and respiratory failure) ultimately resulted in death. Fifty-four patients (34%) died in all.

At day 28, the overall response rate (ORR) was 64%. The ORR was 74% for grade B aGVHD, 66% for grade C, and 59% for grade D. The ORR was 62% for gastrointestinal, 77% for skin, and 53% for liver aGVHD.

Response correlated with a significant improvement in survival at day 100. Eighty-one percent of patients who responded at day 28 were still alive at day 100, compared to 21% of non-responders (P<0.0001).

The investigators said this study provides support for remestemcel-L to treat aGVHD in children. A single-arm, phase 3 trial of pediatric patients with aGVHD is underway.

*Information in the abstract differs from that presented at the meeting.

Mesenchymal stem cells

SAN DIEGO—Infusions of expanded mesenchymal stem cells (MSCs) can treat severe, steroid-resistant, acute graft-vs-host disease (aGVHD) in pediatric patients, according to a study presented at the 2015 BMT Tandem Meetings.

The MSC product, known as remestemcel-L, induced responses in all grades of aGVHD and all organ systems.

Response at day 28 was associated with improved survival at day 100, and clinically significant toxicities were minimal, according to investigators.

“The enrolled patients represent a very challenging population with severe graft-vs-host disease that was non-responsive to treatments, including steroids and, for many of these children, multiple immunosuppressive agents, so we believe these results are very promising,” said Joanne Kurtzberg, MD, of Duke University Medical Center in Durham, North Carolina.

Dr Kurtzberg and her colleagues reported the results in a poster presentation (abstract 492*). Three investigators involved in this research are employed by Mesoblast, Inc., the company developing remestemcel-L.

The study included 160 patients who had a median age of 10 years (range, 0.3 to 17.5 years). Eighty-four percent of patients had received an unrelated donor transplant, and 46% received a mismatched transplant.

At baseline, 19% of patients had grade B aGVHD, 28% had grade C, and 53% had grade D. Eighty-nine percent of patients had gastrointestinal involvement, 50% had skin involvement, and 29% had liver involvement. Forty-one percent of patients had 2 organs involved, and 15% had 3.

The median duration of aGVHD before study enrollment was 28 days (range, 1 to 237), and patients had failed a median of 3 immunosuppressive agents.

Treatment and outcomes

Patients received 8 bi-weekly, intravenous infusions of 2 × 10⁶ MSCs/kg for 4 weeks. They could receive additional weekly infusions if deemed eligible at day 28.

The patients received a median of 11 infusions (range, 1-20) and were exposed to the treatment for a median of 43.5 days.

Fifty-three percent of patients had at least 1 serious adverse event. Eight patients (5%) had serious events that investigators thought might be treatment-related. These included neutropenia, infusion-related reaction, pulmonary hemorrhage, respiratory distress, tachycardia, respiratory failure, and hypertension.

Three events (6%) that were considered possibly treatment-related (pulmonary hemorrhage, respiratory distress, and respiratory failure) ultimately resulted in death. Fifty-four patients (34%) died in all.

At day 28, the overall response rate (ORR) was 64%. The ORR was 74% for grade B aGVHD, 66% for grade C, and 59% for grade D. The ORR was 62% for gastrointestinal, 77% for skin, and 53% for liver aGVHD.

Response correlated with a significant improvement in survival at day 100. Eighty-one percent of patients who responded at day 28 were still alive at day 100, compared to 21% of non-responders (P<0.0001).

The investigators said this study provides support for remestemcel-L to treat aGVHD in children. A single-arm, phase 3 trial of pediatric patients with aGVHD is underway.

*Information in the abstract differs from that presented at the meeting.

Thrombus

Image by Andre E.X. Brown

The factor Xa inhibitor fondaparinux may confer a lower risk of death and bleeding after heart attack than low-molecular-weight heparin (LMWH).

In a large study, patients who received fondaparinux after non-ST-segment elevation myocardial infarction (NSTEMI) had a lower risk of major bleeding and death, both in the hospital and after discharge, compared to patients who received LMWH.

However, both arms had similar rates of subsequent heart attack or stroke.

Karolina Szummer, MD, PhD, of the Karolinska Institutet in Stockholm, Sweden, and her colleagues disclosed these results in JAMA.

The researchers analyzed data from a Swedish registry that included 40,616 patients with NSTEMI. The patients received in-hospital treatment with fondaparinux (n=14,791; 36.4%) or LMWH (25,825; 63.6%) between September 2006 and June 2010, with follow-up through December 2010.

Patients in the fondaparinux arm were, on average, 2 years younger (72 years vs 74 years) than patients in the LMWH arm. Fondaparinux-treated patients also had fewer previous heart attacks (28.2% vs 32.2%), and fewer had been diagnosed with congestive heart failure (14.5% vs 18.7%), but more had undergone percutaneous coronary intervention (46.4% vs 38.9%).

The rate of prior bleeding events and previous hemorrhagic stroke was similar between the arms. Prior bleeding was reported in 6.1% of patients in both arms, and hemorrhagic stroke was reported in 1.4% of patients in the fondaparinux arm and 1.3% in the LMWH arm.

Following treatment, the absolute rate of severe in-hospital bleeding events was lower in the fondaparinux arm than in the LMWH arm—1.1% vs 1.8% (odds ratio [OR]=0.54).

The rate of severe bleeding while in the hospital or causing readmission was lower in the fondaparinux arm, both at 30 days—1.4% vs 2.1% (OR=0.56)—and at 180 days—1.9% vs 2.8% (OR=0.60).

In-hospital mortality was lower in the fondaparinux arm than the LMWH arm—2.7% and 4.0%, respectively (OR=0.75). The same pattern was observed for mortality at 30 days (OR=0.82) and 180 days (OR=0.76).

However, the rate of recurrent heart attack was similar in both arms. At 30 days, it was 9.0% in the fondaparinux arm and 9.5% in the LMWH arm (OR=0.94). And at 180 days, rates were 14.2% and 15.8%, respectively (OR=0.97).

Likewise, the rate of stroke did not differ significantly between the arms. At 30 days, it was 0.5% in the fondaparinux arm and 0.6% in the LMWH arm (OR=1.11). And at 180 days, rates were 1.7% and 2.0%, respectively (OR=0.98).

The results were similar in patients with varying degrees of kidney function and in the subset of patients who had undergone early percutaneous coronary intervention.

The researchers said these results provide an estimate of the treatment effect in a selected patient population. However, the effects may differ in clinical practice and should therefore be investigated in observational cohorts and in continuous registries.

Thrombus

Image by Andre E.X. Brown

The factor Xa inhibitor fondaparinux may confer a lower risk of death and bleeding after heart attack than low-molecular-weight heparin (LMWH).

In a large study, patients who received fondaparinux after non-ST-segment elevation myocardial infarction (NSTEMI) had a lower risk of major bleeding and death, both in the hospital and after discharge, compared to patients who received LMWH.

However, both arms had similar rates of subsequent heart attack or stroke.

Karolina Szummer, MD, PhD, of the Karolinska Institutet in Stockholm, Sweden, and her colleagues disclosed these results in JAMA.

The researchers analyzed data from a Swedish registry that included 40,616 patients with NSTEMI. The patients received in-hospital treatment with fondaparinux (n=14,791; 36.4%) or LMWH (25,825; 63.6%) between September 2006 and June 2010, with follow-up through December 2010.

Patients in the fondaparinux arm were, on average, 2 years younger (72 years vs 74 years) than patients in the LMWH arm. Fondaparinux-treated patients also had fewer previous heart attacks (28.2% vs 32.2%), and fewer had been diagnosed with congestive heart failure (14.5% vs 18.7%), but more had undergone percutaneous coronary intervention (46.4% vs 38.9%).

The rate of prior bleeding events and previous hemorrhagic stroke was similar between the arms. Prior bleeding was reported in 6.1% of patients in both arms, and hemorrhagic stroke was reported in 1.4% of patients in the fondaparinux arm and 1.3% in the LMWH arm.

Following treatment, the absolute rate of severe in-hospital bleeding events was lower in the fondaparinux arm than in the LMWH arm—1.1% vs 1.8% (odds ratio [OR]=0.54).

The rate of severe bleeding while in the hospital or causing readmission was lower in the fondaparinux arm, both at 30 days—1.4% vs 2.1% (OR=0.56)—and at 180 days—1.9% vs 2.8% (OR=0.60).

In-hospital mortality was lower in the fondaparinux arm than the LMWH arm—2.7% and 4.0%, respectively (OR=0.75). The same pattern was observed for mortality at 30 days (OR=0.82) and 180 days (OR=0.76).

However, the rate of recurrent heart attack was similar in both arms. At 30 days, it was 9.0% in the fondaparinux arm and 9.5% in the LMWH arm (OR=0.94). And at 180 days, rates were 14.2% and 15.8%, respectively (OR=0.97).

Likewise, the rate of stroke did not differ significantly between the arms. At 30 days, it was 0.5% in the fondaparinux arm and 0.6% in the LMWH arm (OR=1.11). And at 180 days, rates were 1.7% and 2.0%, respectively (OR=0.98).

The results were similar in patients with varying degrees of kidney function and in the subset of patients who had undergone early percutaneous coronary intervention.

The researchers said these results provide an estimate of the treatment effect in a selected patient population. However, the effects may differ in clinical practice and should therefore be investigated in observational cohorts and in continuous registries.

Thrombus

Image by Andre E.X. Brown

The factor Xa inhibitor fondaparinux may confer a lower risk of death and bleeding after heart attack than low-molecular-weight heparin (LMWH).

In a large study, patients who received fondaparinux after non-ST-segment elevation myocardial infarction (NSTEMI) had a lower risk of major bleeding and death, both in the hospital and after discharge, compared to patients who received LMWH.

However, both arms had similar rates of subsequent heart attack or stroke.

Karolina Szummer, MD, PhD, of the Karolinska Institutet in Stockholm, Sweden, and her colleagues disclosed these results in JAMA.

The researchers analyzed data from a Swedish registry that included 40,616 patients with NSTEMI. The patients received in-hospital treatment with fondaparinux (n=14,791; 36.4%) or LMWH (25,825; 63.6%) between September 2006 and June 2010, with follow-up through December 2010.

Patients in the fondaparinux arm were, on average, 2 years younger (72 years vs 74 years) than patients in the LMWH arm. Fondaparinux-treated patients also had fewer previous heart attacks (28.2% vs 32.2%), and fewer had been diagnosed with congestive heart failure (14.5% vs 18.7%), but more had undergone percutaneous coronary intervention (46.4% vs 38.9%).

The rate of prior bleeding events and previous hemorrhagic stroke was similar between the arms. Prior bleeding was reported in 6.1% of patients in both arms, and hemorrhagic stroke was reported in 1.4% of patients in the fondaparinux arm and 1.3% in the LMWH arm.

Following treatment, the absolute rate of severe in-hospital bleeding events was lower in the fondaparinux arm than in the LMWH arm—1.1% vs 1.8% (odds ratio [OR]=0.54).

The rate of severe bleeding while in the hospital or causing readmission was lower in the fondaparinux arm, both at 30 days—1.4% vs 2.1% (OR=0.56)—and at 180 days—1.9% vs 2.8% (OR=0.60).

In-hospital mortality was lower in the fondaparinux arm than the LMWH arm—2.7% and 4.0%, respectively (OR=0.75). The same pattern was observed for mortality at 30 days (OR=0.82) and 180 days (OR=0.76).

However, the rate of recurrent heart attack was similar in both arms. At 30 days, it was 9.0% in the fondaparinux arm and 9.5% in the LMWH arm (OR=0.94). And at 180 days, rates were 14.2% and 15.8%, respectively (OR=0.97).

Likewise, the rate of stroke did not differ significantly between the arms. At 30 days, it was 0.5% in the fondaparinux arm and 0.6% in the LMWH arm (OR=1.11). And at 180 days, rates were 1.7% and 2.0%, respectively (OR=0.98).

The results were similar in patients with varying degrees of kidney function and in the subset of patients who had undergone early percutaneous coronary intervention.

The researchers said these results provide an estimate of the treatment effect in a selected patient population. However, the effects may differ in clinical practice and should therefore be investigated in observational cohorts and in continuous registries.