Commentary

BOSTON – This year’s F. Stanley Crawford Critical Issues Forum, titled "Appropriate Use of Vascular Surgery Procedures: Do We Have a Problem?," was a response to the question of whether vascular surgeons are performing too many procedures and if enough evidence exists to support the ones that are being done, according to Dr. Peter F. Lawrence, incoming president of the SVS. Dr. Lawrence, who organized this year’s session, discussed how the issue of overuse and appropriateness has become a common theme in the media, in public policy discussions, and among medical societies.

"In Vascular Specialist, our newspaper, both Drs. Frank Veith and Russell Samson have written editorials about the overuse of vascular procedures. Dr. Veith titled his topic ‘The Blacksnake Phenomenon’ and pointed out that not everything that we find and identify needs to be treated."

Martin J. Allred

Dr. Lawrence chose and introduced five speakers charged with addressing the problem.

Dr. Robert M. Zwolak addressed the currently available data on vascular surgery procedures, focusing in particular on the Medicare procedural data derived from the Centers for Medicare & Medicaid Services. He pointed out several instances where the number of vascular procedures performed decreased tremendously over time, independent of reimbursement, including a remarkable 47% decrease in major amputations from 1996 to 2013. Open lower extremity bypass decreased, by 57%, to such a low level that it called into question the ability of the specialty to maintain excellence in performing the procedure. On the flip side, there was also a tremendous increase in certain procedures, including vein treatments, which grew more than 6,000% when reimbursement became available.

Dr. Michael D. Dake addressed the critical issue of optimizing multispecialty involvement in vascular procedures. In particular, he advocated a cooperative vs. adversarial approach. This included working together for common credentialing, institutional harmonization, and development of "care teams" for vascular diseases, such as already exist for transcatheter aortic valve replacement. He said SVS should take responsibility for promoting a "Big Tent approach" and become the overarching society dealing with all things vascular, including involvement in common credentialing and guidelines development.

Dr. Timothy Ferris discussed the various types of influence that hospital and physician practice organizations could have that impact appropriateness. In particular, he outlined a computer program that his own institution, Massachusetts General Hospital, Boston, developed that allows physicians to recognize and comply with guideline criteria generated through multispecialty consensus at the hospital. Within a few years, they found a tremendous increase in the number of procedures deemed appropriate. This information enabled them to influence insurance providers to waive the necessity of preauthorization, which often requires up to 30 people to fill out the paperwork.

Dr. Peter Gloviczki addressed the issue of practice guidelines as criteria for determining appropriateness. He reiterated their importance, but maintained that they were highly variable in their evidentiary basis, and that the quality of individual guidelines should always be considered so as to avoid a "herd mentality."

Dr. Samson topped off the forum with a discussion of the ethical issues related to frequency of procedures. He pointed out that personal integrity is critical and that the greatest potential risk of unethical behavior exists in outpatient centers. "The only time an intervention occurs is when a major complication sends a patient to a hospital or a negligent action results in a malpractice suit. As long as our government and insurers fail to determine what and where and who should be doing these procedures, I believe we will have unscrupulous doctors let loose on their unsuspecting prey." He said one of the ways to prevent this was to require that only board-certified and appropriately trained physicians be allowed to perform procedures.

[email protected]

BOSTON – This year’s F. Stanley Crawford Critical Issues Forum, titled "Appropriate Use of Vascular Surgery Procedures: Do We Have a Problem?," was a response to the question of whether vascular surgeons are performing too many procedures and if enough evidence exists to support the ones that are being done, according to Dr. Peter F. Lawrence, incoming president of the SVS. Dr. Lawrence, who organized this year’s session, discussed how the issue of overuse and appropriateness has become a common theme in the media, in public policy discussions, and among medical societies.

"In Vascular Specialist, our newspaper, both Drs. Frank Veith and Russell Samson have written editorials about the overuse of vascular procedures. Dr. Veith titled his topic ‘The Blacksnake Phenomenon’ and pointed out that not everything that we find and identify needs to be treated."

Martin J. Allred

Dr. Lawrence chose and introduced five speakers charged with addressing the problem.

Dr. Robert M. Zwolak addressed the currently available data on vascular surgery procedures, focusing in particular on the Medicare procedural data derived from the Centers for Medicare & Medicaid Services. He pointed out several instances where the number of vascular procedures performed decreased tremendously over time, independent of reimbursement, including a remarkable 47% decrease in major amputations from 1996 to 2013. Open lower extremity bypass decreased, by 57%, to such a low level that it called into question the ability of the specialty to maintain excellence in performing the procedure. On the flip side, there was also a tremendous increase in certain procedures, including vein treatments, which grew more than 6,000% when reimbursement became available.

Dr. Michael D. Dake addressed the critical issue of optimizing multispecialty involvement in vascular procedures. In particular, he advocated a cooperative vs. adversarial approach. This included working together for common credentialing, institutional harmonization, and development of "care teams" for vascular diseases, such as already exist for transcatheter aortic valve replacement. He said SVS should take responsibility for promoting a "Big Tent approach" and become the overarching society dealing with all things vascular, including involvement in common credentialing and guidelines development.

Dr. Timothy Ferris discussed the various types of influence that hospital and physician practice organizations could have that impact appropriateness. In particular, he outlined a computer program that his own institution, Massachusetts General Hospital, Boston, developed that allows physicians to recognize and comply with guideline criteria generated through multispecialty consensus at the hospital. Within a few years, they found a tremendous increase in the number of procedures deemed appropriate. This information enabled them to influence insurance providers to waive the necessity of preauthorization, which often requires up to 30 people to fill out the paperwork.

Dr. Peter Gloviczki addressed the issue of practice guidelines as criteria for determining appropriateness. He reiterated their importance, but maintained that they were highly variable in their evidentiary basis, and that the quality of individual guidelines should always be considered so as to avoid a "herd mentality."

Dr. Samson topped off the forum with a discussion of the ethical issues related to frequency of procedures. He pointed out that personal integrity is critical and that the greatest potential risk of unethical behavior exists in outpatient centers. "The only time an intervention occurs is when a major complication sends a patient to a hospital or a negligent action results in a malpractice suit. As long as our government and insurers fail to determine what and where and who should be doing these procedures, I believe we will have unscrupulous doctors let loose on their unsuspecting prey." He said one of the ways to prevent this was to require that only board-certified and appropriately trained physicians be allowed to perform procedures.

[email protected]

BOSTON – This year’s F. Stanley Crawford Critical Issues Forum, titled "Appropriate Use of Vascular Surgery Procedures: Do We Have a Problem?," was a response to the question of whether vascular surgeons are performing too many procedures and if enough evidence exists to support the ones that are being done, according to Dr. Peter F. Lawrence, incoming president of the SVS. Dr. Lawrence, who organized this year’s session, discussed how the issue of overuse and appropriateness has become a common theme in the media, in public policy discussions, and among medical societies.

"In Vascular Specialist, our newspaper, both Drs. Frank Veith and Russell Samson have written editorials about the overuse of vascular procedures. Dr. Veith titled his topic ‘The Blacksnake Phenomenon’ and pointed out that not everything that we find and identify needs to be treated."

Martin J. Allred

Dr. Lawrence chose and introduced five speakers charged with addressing the problem.

Dr. Robert M. Zwolak addressed the currently available data on vascular surgery procedures, focusing in particular on the Medicare procedural data derived from the Centers for Medicare & Medicaid Services. He pointed out several instances where the number of vascular procedures performed decreased tremendously over time, independent of reimbursement, including a remarkable 47% decrease in major amputations from 1996 to 2013. Open lower extremity bypass decreased, by 57%, to such a low level that it called into question the ability of the specialty to maintain excellence in performing the procedure. On the flip side, there was also a tremendous increase in certain procedures, including vein treatments, which grew more than 6,000% when reimbursement became available.

Dr. Michael D. Dake addressed the critical issue of optimizing multispecialty involvement in vascular procedures. In particular, he advocated a cooperative vs. adversarial approach. This included working together for common credentialing, institutional harmonization, and development of "care teams" for vascular diseases, such as already exist for transcatheter aortic valve replacement. He said SVS should take responsibility for promoting a "Big Tent approach" and become the overarching society dealing with all things vascular, including involvement in common credentialing and guidelines development.

Dr. Timothy Ferris discussed the various types of influence that hospital and physician practice organizations could have that impact appropriateness. In particular, he outlined a computer program that his own institution, Massachusetts General Hospital, Boston, developed that allows physicians to recognize and comply with guideline criteria generated through multispecialty consensus at the hospital. Within a few years, they found a tremendous increase in the number of procedures deemed appropriate. This information enabled them to influence insurance providers to waive the necessity of preauthorization, which often requires up to 30 people to fill out the paperwork.

Dr. Peter Gloviczki addressed the issue of practice guidelines as criteria for determining appropriateness. He reiterated their importance, but maintained that they were highly variable in their evidentiary basis, and that the quality of individual guidelines should always be considered so as to avoid a "herd mentality."

Dr. Samson topped off the forum with a discussion of the ethical issues related to frequency of procedures. He pointed out that personal integrity is critical and that the greatest potential risk of unethical behavior exists in outpatient centers. "The only time an intervention occurs is when a major complication sends a patient to a hospital or a negligent action results in a malpractice suit. As long as our government and insurers fail to determine what and where and who should be doing these procedures, I believe we will have unscrupulous doctors let loose on their unsuspecting prey." He said one of the ways to prevent this was to require that only board-certified and appropriately trained physicians be allowed to perform procedures.

[email protected]

Excessive wait times at VA hospitals have become front-page news. It is a complaint that I am very familiar with as a physician who has worked in the emergency department (ED) for a long time. And although the problems uncovered at the Phoenix VA Health Care System (where I currently work) and other health care centers involve bringing new patients into the system, not the hours spent waiting in the ED, our experience trying to reduce wait times may provide useful lessons as the VA seeks to reduce the backlog and see all its patients in a reasonable amount of time.

Overcrowding and long wait times are hardly unique to VA EDs, these are problems faced at most large hospitals. Today, the increasing use of the ED is driven by patient demand, changing benefits (insurance/entitlements), and shifting expectations. Many patients in the ED for nonemergent care do not have regular primary care providers. Others may be turning to the ED because of difficulty getting appointments to see a primary care provider. Some patients simply use the ED for convenience (it is open 24 hours a day after all) and because there are no copayments.

Emergency department providers have made many attempts to address wait times and overcrowding; however, these problems are complex, caused by rapidly shifting bottlenecks, making simple solutions challenging and difficult to resolve. Seemingly rational interventions aimed at reducing the wait times are frequently unsuccessful, a result of a rapidly changing and dynamic environment—you are only as fast as delays allow.

IDENTIFYING BOTTLENECKS

Capacity issues can cause bottlenecks in the ED and lead to overcrowding. The capacity of ED resources can vary widely over time. For example, radiology capacity at night depends on the radiology technician on call and how far the technician lives from the hospital (if there is no 24/7 in hospital coverage). Often, external issues can cause problems, such as if the clinics at the institution are closed (for federal holidays at the VA, for example); there is a primary care staff shortage (a nationwide problem); scheduling issues; or the clinic staff are in mandatory meetings. In these instances patients may directly or indirectly get diverted to the ED, slowing its flow.

Similarly, responsiveness or availability of specialists to offer consults can contribute to the time spent in the ED. In addition, the delay in getting patients into a hospital bed after being admitted can sometimes take many hours, tying up the already limited bed availability.

Physician and nursing capacity is even more complicated, because the volume of patients at any one time is unpredictable. Emergency department physicians have a variety of backgrounds and different skill sets; some can process patients more efficiently than can others. And the chemistry among the various staff working on a given shift can also shape capacity. Good team chemistry helps an ED work efficiently.

The demand placed on ED resources also varies, based on the patient mix over time. There are days where seemingly everyone needs a CT scan, which creates a bottleneck. There are other days when it is a trauma day when the X-rays and radiology techs rapidly get backed up. Then there are times when the CT scanner or MRI is down, or other technology issues create delays. All ED processes are interconnected. Unless you increase capacity for those days, the flow will be decreased and waste increased. Contributing further to the ED congestion is the recent trend in the health policy community and at the VA to shrink the ED resources while at the same time trying to improve patient satisfaction scores.

Many communities, like Phoenix, have seen significant shifts in veteran populations as aging veterans choose to move to retirement communities in the south and west. Even the seasonal fluctuations as aging veterans spend the winter months in warmer communities can impact the ED. Combining these trends with recently expanded eligibility standards in the VA system creates an imbalance in the flow of patients and strains the capacity at many facilities like ours. Without adjusting the capacity of the ED (and other departments) to handle more patients, setting new benchmarks to reduce veterans’ wait times is not workable.

Some EDs have experimented with streamlining processes using “lean” business management. Sources of waste and inefficiency are identified and alternate processes developed. The Phoenix VA ED has tried some of these techniques with some success. For example, we have decreased the wait times and fewer patients leave without being seen, while at the same time the patient volume has increased. We now have front-end initiation of a workup based on the presenting complaints. Thorough workups in the ED can be useful, especially if they prevent a costly hospitalization. However, these workups add to the demands placed on the ED’s precious commodity—the bed. 

Flexible Service Environment

The ED is a complex service environment with shifting bottlenecks. To reduce wait times, EDs need flexibility in hiring and shifting responsibilities, but unfortunately federal policies are not easily adaptable for addressing such shifting demands. It routinely takes 4 or more months to hire a new physician or a nurse once a job is offered, to say nothing of the time to recruit them in the first place. If a staff member leaves, typically the position is not filled for months. The VA credentialing and hiring process needs to be thorough but significantly streamlined with the salaries reflective of equal pay for equal work. Currently, this is not the case.

To be able to confront the crowding and long wait times in the ED, the VA needs to address the root causes of crowding. First and foremost, it means expanding access to nonemergent clinics, specialists, and primary care providers. Opening clinics after hours, weekends, and on holidays would be an easy first step with significant cost saving, compared with expansion. Second, the ED needs more resources, such as more beds and additional staff, including specialists (for example, a psychiatric team in the ED). Finally, the VA needs to facilitate the movement from the ED into a hospital for patients who are admitted.

Most important, ED teams must become more nimble and flexible. Lean business practices can help keep the overall process efficient by focusing on eliminating waste or non–value-added elements. A leaner, more flexible ED can not only reduce wait times but also give veterans more value, which is exactly what they deserve.

I have worked side-by-side with the men and women who bring the VA to life, putting in long hours, with diligent attention to the highest standards and a commitment to the mission. We have saved and changed the lives of many of the patients we serve; although it is not always easy for veterans to separate issues of access to care from those of the quality of that care. Though it can be a challenge to work in a VA ED, especially now, it can also be very fulfilling. 

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Excessive wait times at VA hospitals have become front-page news. It is a complaint that I am very familiar with as a physician who has worked in the emergency department (ED) for a long time. And although the problems uncovered at the Phoenix VA Health Care System (where I currently work) and other health care centers involve bringing new patients into the system, not the hours spent waiting in the ED, our experience trying to reduce wait times may provide useful lessons as the VA seeks to reduce the backlog and see all its patients in a reasonable amount of time.

Overcrowding and long wait times are hardly unique to VA EDs, these are problems faced at most large hospitals. Today, the increasing use of the ED is driven by patient demand, changing benefits (insurance/entitlements), and shifting expectations. Many patients in the ED for nonemergent care do not have regular primary care providers. Others may be turning to the ED because of difficulty getting appointments to see a primary care provider. Some patients simply use the ED for convenience (it is open 24 hours a day after all) and because there are no copayments.

Emergency department providers have made many attempts to address wait times and overcrowding; however, these problems are complex, caused by rapidly shifting bottlenecks, making simple solutions challenging and difficult to resolve. Seemingly rational interventions aimed at reducing the wait times are frequently unsuccessful, a result of a rapidly changing and dynamic environment—you are only as fast as delays allow.

IDENTIFYING BOTTLENECKS

Capacity issues can cause bottlenecks in the ED and lead to overcrowding. The capacity of ED resources can vary widely over time. For example, radiology capacity at night depends on the radiology technician on call and how far the technician lives from the hospital (if there is no 24/7 in hospital coverage). Often, external issues can cause problems, such as if the clinics at the institution are closed (for federal holidays at the VA, for example); there is a primary care staff shortage (a nationwide problem); scheduling issues; or the clinic staff are in mandatory meetings. In these instances patients may directly or indirectly get diverted to the ED, slowing its flow.

Similarly, responsiveness or availability of specialists to offer consults can contribute to the time spent in the ED. In addition, the delay in getting patients into a hospital bed after being admitted can sometimes take many hours, tying up the already limited bed availability.

Physician and nursing capacity is even more complicated, because the volume of patients at any one time is unpredictable. Emergency department physicians have a variety of backgrounds and different skill sets; some can process patients more efficiently than can others. And the chemistry among the various staff working on a given shift can also shape capacity. Good team chemistry helps an ED work efficiently.

The demand placed on ED resources also varies, based on the patient mix over time. There are days where seemingly everyone needs a CT scan, which creates a bottleneck. There are other days when it is a trauma day when the X-rays and radiology techs rapidly get backed up. Then there are times when the CT scanner or MRI is down, or other technology issues create delays. All ED processes are interconnected. Unless you increase capacity for those days, the flow will be decreased and waste increased. Contributing further to the ED congestion is the recent trend in the health policy community and at the VA to shrink the ED resources while at the same time trying to improve patient satisfaction scores.

Many communities, like Phoenix, have seen significant shifts in veteran populations as aging veterans choose to move to retirement communities in the south and west. Even the seasonal fluctuations as aging veterans spend the winter months in warmer communities can impact the ED. Combining these trends with recently expanded eligibility standards in the VA system creates an imbalance in the flow of patients and strains the capacity at many facilities like ours. Without adjusting the capacity of the ED (and other departments) to handle more patients, setting new benchmarks to reduce veterans’ wait times is not workable.

Some EDs have experimented with streamlining processes using “lean” business management. Sources of waste and inefficiency are identified and alternate processes developed. The Phoenix VA ED has tried some of these techniques with some success. For example, we have decreased the wait times and fewer patients leave without being seen, while at the same time the patient volume has increased. We now have front-end initiation of a workup based on the presenting complaints. Thorough workups in the ED can be useful, especially if they prevent a costly hospitalization. However, these workups add to the demands placed on the ED’s precious commodity—the bed. 

Flexible Service Environment

The ED is a complex service environment with shifting bottlenecks. To reduce wait times, EDs need flexibility in hiring and shifting responsibilities, but unfortunately federal policies are not easily adaptable for addressing such shifting demands. It routinely takes 4 or more months to hire a new physician or a nurse once a job is offered, to say nothing of the time to recruit them in the first place. If a staff member leaves, typically the position is not filled for months. The VA credentialing and hiring process needs to be thorough but significantly streamlined with the salaries reflective of equal pay for equal work. Currently, this is not the case.

To be able to confront the crowding and long wait times in the ED, the VA needs to address the root causes of crowding. First and foremost, it means expanding access to nonemergent clinics, specialists, and primary care providers. Opening clinics after hours, weekends, and on holidays would be an easy first step with significant cost saving, compared with expansion. Second, the ED needs more resources, such as more beds and additional staff, including specialists (for example, a psychiatric team in the ED). Finally, the VA needs to facilitate the movement from the ED into a hospital for patients who are admitted.

Most important, ED teams must become more nimble and flexible. Lean business practices can help keep the overall process efficient by focusing on eliminating waste or non–value-added elements. A leaner, more flexible ED can not only reduce wait times but also give veterans more value, which is exactly what they deserve.

I have worked side-by-side with the men and women who bring the VA to life, putting in long hours, with diligent attention to the highest standards and a commitment to the mission. We have saved and changed the lives of many of the patients we serve; although it is not always easy for veterans to separate issues of access to care from those of the quality of that care. Though it can be a challenge to work in a VA ED, especially now, it can also be very fulfilling. 

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Excessive wait times at VA hospitals have become front-page news. It is a complaint that I am very familiar with as a physician who has worked in the emergency department (ED) for a long time. And although the problems uncovered at the Phoenix VA Health Care System (where I currently work) and other health care centers involve bringing new patients into the system, not the hours spent waiting in the ED, our experience trying to reduce wait times may provide useful lessons as the VA seeks to reduce the backlog and see all its patients in a reasonable amount of time.

Overcrowding and long wait times are hardly unique to VA EDs, these are problems faced at most large hospitals. Today, the increasing use of the ED is driven by patient demand, changing benefits (insurance/entitlements), and shifting expectations. Many patients in the ED for nonemergent care do not have regular primary care providers. Others may be turning to the ED because of difficulty getting appointments to see a primary care provider. Some patients simply use the ED for convenience (it is open 24 hours a day after all) and because there are no copayments.

Emergency department providers have made many attempts to address wait times and overcrowding; however, these problems are complex, caused by rapidly shifting bottlenecks, making simple solutions challenging and difficult to resolve. Seemingly rational interventions aimed at reducing the wait times are frequently unsuccessful, a result of a rapidly changing and dynamic environment—you are only as fast as delays allow.

IDENTIFYING BOTTLENECKS

Capacity issues can cause bottlenecks in the ED and lead to overcrowding. The capacity of ED resources can vary widely over time. For example, radiology capacity at night depends on the radiology technician on call and how far the technician lives from the hospital (if there is no 24/7 in hospital coverage). Often, external issues can cause problems, such as if the clinics at the institution are closed (for federal holidays at the VA, for example); there is a primary care staff shortage (a nationwide problem); scheduling issues; or the clinic staff are in mandatory meetings. In these instances patients may directly or indirectly get diverted to the ED, slowing its flow.

Similarly, responsiveness or availability of specialists to offer consults can contribute to the time spent in the ED. In addition, the delay in getting patients into a hospital bed after being admitted can sometimes take many hours, tying up the already limited bed availability.

Physician and nursing capacity is even more complicated, because the volume of patients at any one time is unpredictable. Emergency department physicians have a variety of backgrounds and different skill sets; some can process patients more efficiently than can others. And the chemistry among the various staff working on a given shift can also shape capacity. Good team chemistry helps an ED work efficiently.

The demand placed on ED resources also varies, based on the patient mix over time. There are days where seemingly everyone needs a CT scan, which creates a bottleneck. There are other days when it is a trauma day when the X-rays and radiology techs rapidly get backed up. Then there are times when the CT scanner or MRI is down, or other technology issues create delays. All ED processes are interconnected. Unless you increase capacity for those days, the flow will be decreased and waste increased. Contributing further to the ED congestion is the recent trend in the health policy community and at the VA to shrink the ED resources while at the same time trying to improve patient satisfaction scores.

Many communities, like Phoenix, have seen significant shifts in veteran populations as aging veterans choose to move to retirement communities in the south and west. Even the seasonal fluctuations as aging veterans spend the winter months in warmer communities can impact the ED. Combining these trends with recently expanded eligibility standards in the VA system creates an imbalance in the flow of patients and strains the capacity at many facilities like ours. Without adjusting the capacity of the ED (and other departments) to handle more patients, setting new benchmarks to reduce veterans’ wait times is not workable.

Some EDs have experimented with streamlining processes using “lean” business management. Sources of waste and inefficiency are identified and alternate processes developed. The Phoenix VA ED has tried some of these techniques with some success. For example, we have decreased the wait times and fewer patients leave without being seen, while at the same time the patient volume has increased. We now have front-end initiation of a workup based on the presenting complaints. Thorough workups in the ED can be useful, especially if they prevent a costly hospitalization. However, these workups add to the demands placed on the ED’s precious commodity—the bed. 

Flexible Service Environment

The ED is a complex service environment with shifting bottlenecks. To reduce wait times, EDs need flexibility in hiring and shifting responsibilities, but unfortunately federal policies are not easily adaptable for addressing such shifting demands. It routinely takes 4 or more months to hire a new physician or a nurse once a job is offered, to say nothing of the time to recruit them in the first place. If a staff member leaves, typically the position is not filled for months. The VA credentialing and hiring process needs to be thorough but significantly streamlined with the salaries reflective of equal pay for equal work. Currently, this is not the case.

To be able to confront the crowding and long wait times in the ED, the VA needs to address the root causes of crowding. First and foremost, it means expanding access to nonemergent clinics, specialists, and primary care providers. Opening clinics after hours, weekends, and on holidays would be an easy first step with significant cost saving, compared with expansion. Second, the ED needs more resources, such as more beds and additional staff, including specialists (for example, a psychiatric team in the ED). Finally, the VA needs to facilitate the movement from the ED into a hospital for patients who are admitted.

Most important, ED teams must become more nimble and flexible. Lean business practices can help keep the overall process efficient by focusing on eliminating waste or non–value-added elements. A leaner, more flexible ED can not only reduce wait times but also give veterans more value, which is exactly what they deserve.

I have worked side-by-side with the men and women who bring the VA to life, putting in long hours, with diligent attention to the highest standards and a commitment to the mission. We have saved and changed the lives of many of the patients we serve; although it is not always easy for veterans to separate issues of access to care from those of the quality of that care. Though it can be a challenge to work in a VA ED, especially now, it can also be very fulfilling. 

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Excessive wait times at VA hospitals have become front-page news. It is a complaint that I am very familiar with as a physician who has worked in the emergency department (ED) for a long time. And although the problems uncovered at the Phoenix VA Health Care System (where I currently work) and other health care centers involve bringing new patients into the system, not the hours spent waiting in the ED, our experience trying to reduce wait times may provide useful lessons as the VA seeks to reduce the backlog and see all its patients in a reasonable amount of time.

Overcrowding and long wait times are hardly unique to VA EDs, these are problems faced at most large hospitals. Today, the increasing use of the ED is driven by patient demand, changing benefits (insurance/entitlements), and shifting expectations. Many patients in the ED for nonemergent care do not have regular primary care providers. Others may be turning to the ED because of difficulty getting appointments to see a primary care provider. Some patients simply use the ED for convenience (it is open 24 hours a day after all) and because there are no copayments.

Emergency department providers have made many attempts to address wait times and overcrowding; however, these problems are complex, caused by rapidly shifting bottlenecks, making simple solutions challenging and difficult to resolve. Seemingly rational interventions aimed at reducing the wait times are frequently unsuccessful, a result of a rapidly changing and dynamic environment—you are only as fast as delays allow.

IDENTIFYING BOTTLENECKS

Capacity issues can cause bottlenecks in the ED and lead to overcrowding. The capacity of ED resources can vary widely over time. For example, radiology capacity at night depends on the radiology technician on call and how far the technician lives from the hospital (if there is no 24/7 in hospital coverage). Often, external issues can cause problems, such as if the clinics at the institution are closed (for federal holidays at the VA, for example); there is a primary care staff shortage (a nationwide problem); scheduling issues; or the clinic staff are in mandatory meetings. In these instances patients may directly or indirectly get diverted to the ED, slowing its flow.

Similarly, responsiveness or availability of specialists to offer consults can contribute to the time spent in the ED. In addition, the delay in getting patients into a hospital bed after being admitted can sometimes take many hours, tying up the already limited bed availability.

Physician and nursing capacity is even more complicated, because the volume of patients at any one time is unpredictable. Emergency department physicians have a variety of backgrounds and different skill sets; some can process patients more efficiently than can others. And the chemistry among the various staff working on a given shift can also shape capacity. Good team chemistry helps an ED work efficiently.

The demand placed on ED resources also varies, based on the patient mix over time. There are days where seemingly everyone needs a CT scan, which creates a bottleneck. There are other days when it is a trauma day when the X-rays and radiology techs rapidly get backed up. Then there are times when the CT scanner or MRI is down, or other technology issues create delays. All ED processes are interconnected. Unless you increase capacity for those days, the flow will be decreased and waste increased. Contributing further to the ED congestion is the recent trend in the health policy community and at the VA to shrink the ED resources while at the same time trying to improve patient satisfaction scores.

Many communities, like Phoenix, have seen significant shifts in veteran populations as aging veterans choose to move to retirement communities in the south and west. Even the seasonal fluctuations as aging veterans spend the winter months in warmer communities can impact the ED. Combining these trends with recently expanded eligibility standards in the VA system creates an imbalance in the flow of patients and strains the capacity at many facilities like ours. Without adjusting the capacity of the ED (and other departments) to handle more patients, setting new benchmarks to reduce veterans’ wait times is not workable.

Some EDs have experimented with streamlining processes using “lean” business management. Sources of waste and inefficiency are identified and alternate processes developed. The Phoenix VA ED has tried some of these techniques with some success. For example, we have decreased the wait times and fewer patients leave without being seen, while at the same time the patient volume has increased. We now have front-end initiation of a workup based on the presenting complaints. Thorough workups in the ED can be useful, especially if they prevent a costly hospitalization. However, these workups add to the demands placed on the ED’s precious commodity—the bed. 

Flexible Service Environment

The ED is a complex service environment with shifting bottlenecks. To reduce wait times, EDs need flexibility in hiring and shifting responsibilities, but unfortunately federal policies are not easily adaptable for addressing such shifting demands. It routinely takes 4 or more months to hire a new physician or a nurse once a job is offered, to say nothing of the time to recruit them in the first place. If a staff member leaves, typically the position is not filled for months. The VA credentialing and hiring process needs to be thorough but significantly streamlined with the salaries reflective of equal pay for equal work. Currently, this is not the case.

To be able to confront the crowding and long wait times in the ED, the VA needs to address the root causes of crowding. First and foremost, it means expanding access to nonemergent clinics, specialists, and primary care providers. Opening clinics after hours, weekends, and on holidays would be an easy first step with significant cost saving, compared with expansion. Second, the ED needs more resources, such as more beds and additional staff, including specialists (for example, a psychiatric team in the ED). Finally, the VA needs to facilitate the movement from the ED into a hospital for patients who are admitted.

Most important, ED teams must become more nimble and flexible. Lean business practices can help keep the overall process efficient by focusing on eliminating waste or non–value-added elements. A leaner, more flexible ED can not only reduce wait times but also give veterans more value, which is exactly what they deserve.

I have worked side-by-side with the men and women who bring the VA to life, putting in long hours, with diligent attention to the highest standards and a commitment to the mission. We have saved and changed the lives of many of the patients we serve; although it is not always easy for veterans to separate issues of access to care from those of the quality of that care. Though it can be a challenge to work in a VA ED, especially now, it can also be very fulfilling. 

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Excessive wait times at VA hospitals have become front-page news. It is a complaint that I am very familiar with as a physician who has worked in the emergency department (ED) for a long time. And although the problems uncovered at the Phoenix VA Health Care System (where I currently work) and other health care centers involve bringing new patients into the system, not the hours spent waiting in the ED, our experience trying to reduce wait times may provide useful lessons as the VA seeks to reduce the backlog and see all its patients in a reasonable amount of time.

Overcrowding and long wait times are hardly unique to VA EDs, these are problems faced at most large hospitals. Today, the increasing use of the ED is driven by patient demand, changing benefits (insurance/entitlements), and shifting expectations. Many patients in the ED for nonemergent care do not have regular primary care providers. Others may be turning to the ED because of difficulty getting appointments to see a primary care provider. Some patients simply use the ED for convenience (it is open 24 hours a day after all) and because there are no copayments.

Emergency department providers have made many attempts to address wait times and overcrowding; however, these problems are complex, caused by rapidly shifting bottlenecks, making simple solutions challenging and difficult to resolve. Seemingly rational interventions aimed at reducing the wait times are frequently unsuccessful, a result of a rapidly changing and dynamic environment—you are only as fast as delays allow.

IDENTIFYING BOTTLENECKS

Capacity issues can cause bottlenecks in the ED and lead to overcrowding. The capacity of ED resources can vary widely over time. For example, radiology capacity at night depends on the radiology technician on call and how far the technician lives from the hospital (if there is no 24/7 in hospital coverage). Often, external issues can cause problems, such as if the clinics at the institution are closed (for federal holidays at the VA, for example); there is a primary care staff shortage (a nationwide problem); scheduling issues; or the clinic staff are in mandatory meetings. In these instances patients may directly or indirectly get diverted to the ED, slowing its flow.

Similarly, responsiveness or availability of specialists to offer consults can contribute to the time spent in the ED. In addition, the delay in getting patients into a hospital bed after being admitted can sometimes take many hours, tying up the already limited bed availability.

Physician and nursing capacity is even more complicated, because the volume of patients at any one time is unpredictable. Emergency department physicians have a variety of backgrounds and different skill sets; some can process patients more efficiently than can others. And the chemistry among the various staff working on a given shift can also shape capacity. Good team chemistry helps an ED work efficiently.

The demand placed on ED resources also varies, based on the patient mix over time. There are days where seemingly everyone needs a CT scan, which creates a bottleneck. There are other days when it is a trauma day when the X-rays and radiology techs rapidly get backed up. Then there are times when the CT scanner or MRI is down, or other technology issues create delays. All ED processes are interconnected. Unless you increase capacity for those days, the flow will be decreased and waste increased. Contributing further to the ED congestion is the recent trend in the health policy community and at the VA to shrink the ED resources while at the same time trying to improve patient satisfaction scores.

Many communities, like Phoenix, have seen significant shifts in veteran populations as aging veterans choose to move to retirement communities in the south and west. Even the seasonal fluctuations as aging veterans spend the winter months in warmer communities can impact the ED. Combining these trends with recently expanded eligibility standards in the VA system creates an imbalance in the flow of patients and strains the capacity at many facilities like ours. Without adjusting the capacity of the ED (and other departments) to handle more patients, setting new benchmarks to reduce veterans’ wait times is not workable.

Some EDs have experimented with streamlining processes using “lean” business management. Sources of waste and inefficiency are identified and alternate processes developed. The Phoenix VA ED has tried some of these techniques with some success. For example, we have decreased the wait times and fewer patients leave without being seen, while at the same time the patient volume has increased. We now have front-end initiation of a workup based on the presenting complaints. Thorough workups in the ED can be useful, especially if they prevent a costly hospitalization. However, these workups add to the demands placed on the ED’s precious commodity—the bed. 

Flexible Service Environment

The ED is a complex service environment with shifting bottlenecks. To reduce wait times, EDs need flexibility in hiring and shifting responsibilities, but unfortunately federal policies are not easily adaptable for addressing such shifting demands. It routinely takes 4 or more months to hire a new physician or a nurse once a job is offered, to say nothing of the time to recruit them in the first place. If a staff member leaves, typically the position is not filled for months. The VA credentialing and hiring process needs to be thorough but significantly streamlined with the salaries reflective of equal pay for equal work. Currently, this is not the case.

To be able to confront the crowding and long wait times in the ED, the VA needs to address the root causes of crowding. First and foremost, it means expanding access to nonemergent clinics, specialists, and primary care providers. Opening clinics after hours, weekends, and on holidays would be an easy first step with significant cost saving, compared with expansion. Second, the ED needs more resources, such as more beds and additional staff, including specialists (for example, a psychiatric team in the ED). Finally, the VA needs to facilitate the movement from the ED into a hospital for patients who are admitted.

Most important, ED teams must become more nimble and flexible. Lean business practices can help keep the overall process efficient by focusing on eliminating waste or non–value-added elements. A leaner, more flexible ED can not only reduce wait times but also give veterans more value, which is exactly what they deserve.

I have worked side-by-side with the men and women who bring the VA to life, putting in long hours, with diligent attention to the highest standards and a commitment to the mission. We have saved and changed the lives of many of the patients we serve; although it is not always easy for veterans to separate issues of access to care from those of the quality of that care. Though it can be a challenge to work in a VA ED, especially now, it can also be very fulfilling. 

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Excessive wait times at VA hospitals have become front-page news. It is a complaint that I am very familiar with as a physician who has worked in the emergency department (ED) for a long time. And although the problems uncovered at the Phoenix VA Health Care System (where I currently work) and other health care centers involve bringing new patients into the system, not the hours spent waiting in the ED, our experience trying to reduce wait times may provide useful lessons as the VA seeks to reduce the backlog and see all its patients in a reasonable amount of time.

Overcrowding and long wait times are hardly unique to VA EDs, these are problems faced at most large hospitals. Today, the increasing use of the ED is driven by patient demand, changing benefits (insurance/entitlements), and shifting expectations. Many patients in the ED for nonemergent care do not have regular primary care providers. Others may be turning to the ED because of difficulty getting appointments to see a primary care provider. Some patients simply use the ED for convenience (it is open 24 hours a day after all) and because there are no copayments.

Emergency department providers have made many attempts to address wait times and overcrowding; however, these problems are complex, caused by rapidly shifting bottlenecks, making simple solutions challenging and difficult to resolve. Seemingly rational interventions aimed at reducing the wait times are frequently unsuccessful, a result of a rapidly changing and dynamic environment—you are only as fast as delays allow.

IDENTIFYING BOTTLENECKS

Capacity issues can cause bottlenecks in the ED and lead to overcrowding. The capacity of ED resources can vary widely over time. For example, radiology capacity at night depends on the radiology technician on call and how far the technician lives from the hospital (if there is no 24/7 in hospital coverage). Often, external issues can cause problems, such as if the clinics at the institution are closed (for federal holidays at the VA, for example); there is a primary care staff shortage (a nationwide problem); scheduling issues; or the clinic staff are in mandatory meetings. In these instances patients may directly or indirectly get diverted to the ED, slowing its flow.

Similarly, responsiveness or availability of specialists to offer consults can contribute to the time spent in the ED. In addition, the delay in getting patients into a hospital bed after being admitted can sometimes take many hours, tying up the already limited bed availability.

Physician and nursing capacity is even more complicated, because the volume of patients at any one time is unpredictable. Emergency department physicians have a variety of backgrounds and different skill sets; some can process patients more efficiently than can others. And the chemistry among the various staff working on a given shift can also shape capacity. Good team chemistry helps an ED work efficiently.

The demand placed on ED resources also varies, based on the patient mix over time. There are days where seemingly everyone needs a CT scan, which creates a bottleneck. There are other days when it is a trauma day when the X-rays and radiology techs rapidly get backed up. Then there are times when the CT scanner or MRI is down, or other technology issues create delays. All ED processes are interconnected. Unless you increase capacity for those days, the flow will be decreased and waste increased. Contributing further to the ED congestion is the recent trend in the health policy community and at the VA to shrink the ED resources while at the same time trying to improve patient satisfaction scores.

Many communities, like Phoenix, have seen significant shifts in veteran populations as aging veterans choose to move to retirement communities in the south and west. Even the seasonal fluctuations as aging veterans spend the winter months in warmer communities can impact the ED. Combining these trends with recently expanded eligibility standards in the VA system creates an imbalance in the flow of patients and strains the capacity at many facilities like ours. Without adjusting the capacity of the ED (and other departments) to handle more patients, setting new benchmarks to reduce veterans’ wait times is not workable.

Some EDs have experimented with streamlining processes using “lean” business management. Sources of waste and inefficiency are identified and alternate processes developed. The Phoenix VA ED has tried some of these techniques with some success. For example, we have decreased the wait times and fewer patients leave without being seen, while at the same time the patient volume has increased. We now have front-end initiation of a workup based on the presenting complaints. Thorough workups in the ED can be useful, especially if they prevent a costly hospitalization. However, these workups add to the demands placed on the ED’s precious commodity—the bed. 

Flexible Service Environment

The ED is a complex service environment with shifting bottlenecks. To reduce wait times, EDs need flexibility in hiring and shifting responsibilities, but unfortunately federal policies are not easily adaptable for addressing such shifting demands. It routinely takes 4 or more months to hire a new physician or a nurse once a job is offered, to say nothing of the time to recruit them in the first place. If a staff member leaves, typically the position is not filled for months. The VA credentialing and hiring process needs to be thorough but significantly streamlined with the salaries reflective of equal pay for equal work. Currently, this is not the case.

To be able to confront the crowding and long wait times in the ED, the VA needs to address the root causes of crowding. First and foremost, it means expanding access to nonemergent clinics, specialists, and primary care providers. Opening clinics after hours, weekends, and on holidays would be an easy first step with significant cost saving, compared with expansion. Second, the ED needs more resources, such as more beds and additional staff, including specialists (for example, a psychiatric team in the ED). Finally, the VA needs to facilitate the movement from the ED into a hospital for patients who are admitted.

Most important, ED teams must become more nimble and flexible. Lean business practices can help keep the overall process efficient by focusing on eliminating waste or non–value-added elements. A leaner, more flexible ED can not only reduce wait times but also give veterans more value, which is exactly what they deserve.

I have worked side-by-side with the men and women who bring the VA to life, putting in long hours, with diligent attention to the highest standards and a commitment to the mission. We have saved and changed the lives of many of the patients we serve; although it is not always easy for veterans to separate issues of access to care from those of the quality of that care. Though it can be a challenge to work in a VA ED, especially now, it can also be very fulfilling. 

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Continuous positive airway pressure (CPAP) has long been considered the gold standard treatment for OSA. Recently, a variety of new treatment approaches have become available for mild and moderate OSA, including nasal resistance valves, nerve stimulators, and negative pressure devices. Nonetheless, CPAP remains unmatched in efficacy, as well as the frequency and severity of side effects associated with treatment. The main drawback of CPAP is the required use of a mask interface and pressurized air during sleep, which is uncomfortable for some patients.

This article will highlight recent work investigating issues associated with equipment choice for practitioners treating OSA patients with CPAP and discuss how proper equipment choices and educational programs can reduce common complaints associated with CPAP use.

Mask choice

Finding a suitable mask interface is one of the most critical aspects of achieving adequate treatment compliance. The four general styles to choose from are oronasal (full-mask), standard nasal (over the nose), nasal pillows (in the nose), and the rarely-used oral.

Most clinicians choose an initial mask after CPAP titration based on a combination of patient feedback and air leakage rates but may change the mask style after home implementation in order to improve patient tolerance. Unfortunately, many clinicians are unaware that CPAP levels may need to be adjusted after changing masks. Two studies have shown that oronasal masks require significantly more pressure to ensure adequate OSA treatment during CPAP titration compared with standard nasal and nasal pillows masks (Ebben et al. Sleep Med. 2012;13[6]:645; Borel et al. PLoS ONE. 2013;8[5]:e64382).

In a separate study in which nasal masks were replaced with oronasal masks, the apnea-hypopnea index (AHI) increased to greater than 10 events per hour in half of patients who had been previously titrated to less than five per hour with the nasal mask (Ebben et al. Sleep Med. 2014;15[6]:619). Caution should be used when making a mask change to ensure that adequate disease control is maintained.

Humidification

In the past few years, humidification has been routinely added to most CPAP machines in order to improve comfort. The benefit appears to come from a reduction in dryness related to regular CPAP use (Ruhle et al. Sleep Breath. 2011;15[3]:479). Some patients report that humidification is particularly helpful in the winter months, when indoor humidity is low. Heated humidification has been found to produce significantly more humidity and causes less insensible water loss from the respiratory tract compared with unheated units (Randerath et al. Eur J Respir. 2002;20[1]:183). Unfortunately, the humidifier significantly increases the size and weight of the treatment machine, though it can be removed for travel if desired. In addition, the humidifier requires additional maintenance; if not cleaned regularly, there is a risk of bacterial colonization of the humidification chamber (Chin et al. J Clin Sleep Med. 2013; 9[8]:747).

In some instances, patients may complain of excess water condensation in the hose, particularly in the presence of a cool sleeping environment. Some CPAP manufacturers now offer heated hoses, which can significantly reduce this condensation. A second option is to add an insulating hose cover to help maintain a higher internal temperature. Generally, these covers are a good choice if the cost of a heated hose is not covered by a patient’s insurance.

Pressure relief

A common complaint often heard from patients using CPAP is that the pressure feels too high, particularly when exhaling. In response, some equipment makers have developed pressure relief systems that allow an adjustable pressure drop during exhalation with standard CPAP units. These systems work by transiently reducing pressure during exhalation by a set amount, according to their proprietary algorithm (Dolan et al. Sleep and Breath. 2009;13:73). However, not all patients find this pressure relief effective at making CPAP easier to use. When tested empirically, pressure relief has not been consistently shown to improve CPAP compliance (Dolan et al. Sleep Breath. 2009;13[1]:73).

Compliance data monitoring

Many patients benefit from discussing and reviewing treatment efficacy at their follow-up visits. Most modern CPAP equipment allows for such data monitoring, that may include duration and specific times of machine use, leak rate, snoring periods, and residual respiratory events, subdivided into hypopneas and apneas. In some cases, the software can distinguish between central ("clear airway") and obstructive events using forced oscillation techniques to measure upper airway resistance. This information allows the clinician to adjust settings and ensure that treatment is optimized and used as prescribed.

Clinicians should familiarize themselves with the different reporting systems that provide these data, and train their office staff on using software to capture information for all CPAP users. Notably, the algorithms used to capture residual respiratory events are not completely accurate; identification of such events is based only on measures of flow.

While it is probably acceptable to take extreme values at face value, whether low or very high, the imprecision of the methodology makes it more difficult to reliably use middling values in a clinical setting. (Schwab et al. Am J Respir Crit Care Med. 2013;188[5]:613). If a patient remains symptomatic despite no evidence of residual respiratory events from the adherence data download, a retitration study should still be considered.

Educational programs

Adherence to CPAP has been shown to increase when providers engage patients in educational programs to enhance compliance and understanding of the potential health-care consequences of untreated OSA (Lai et al. Chest. 2014 May 8. doi: 10.1378/ chest.13-2228. [Epub ahead of print]).

Early education and continuous support provide reinforcement of the need for adherence to therapy, as well as an opportunity to personalize the treatment and adjust settings and equipment as needed for each individual patient. Although specific guidelines for the best timing of the educational intervention are still lacking, evidence suggests that long-term compliance with CPAP might be determined as early as 2 weeks after therapy is initiated (Aloia et al. J Clin Sleep Med. 2005;1[4]:346). Therefore, educational programs should be readily available for prospective and new CPAP users in order to enhance their understanding of OSA and knowledge about CPAP treatment and to provide them with a venue for reviewing and managing compliance-related issues. Such programs can be run by dedicated sleep technologists, respiratory therapists, or nurses in clinics where physician availability is more limited.

Summary

CPAP remains the most effective treatment for OSA, though adherence is a struggle for many patients. Identifying the best mask for a given patient, determining whether humidification or an expiratory pressure drop should be added and making early and frequent contact after prescription can all assist in improving long-term CPAP use. Regular review of adherence data with the patient is also important, modifying the therapy as necessary to optimize comfort, understanding that such changes may necessitate a subsequent pressure adjustment to maintain disease control.

Implementing a comprehensive approach to managing patients using CPAP therapy can impact compliance by reducing treatment-related complaints and improving comfort.

Dr. Ebben is Assistant Professor of Psychology in Clinical Neurology, Department of Neurology; and Dr. Krieger is Associate Clinical Professor, Departments of Medicine, Neurology, and Genetic Medicine; Weill Cornell Medical College of Cornell University, New York, New York.

Continuous positive airway pressure (CPAP) has long been considered the gold standard treatment for OSA. Recently, a variety of new treatment approaches have become available for mild and moderate OSA, including nasal resistance valves, nerve stimulators, and negative pressure devices. Nonetheless, CPAP remains unmatched in efficacy, as well as the frequency and severity of side effects associated with treatment. The main drawback of CPAP is the required use of a mask interface and pressurized air during sleep, which is uncomfortable for some patients.

This article will highlight recent work investigating issues associated with equipment choice for practitioners treating OSA patients with CPAP and discuss how proper equipment choices and educational programs can reduce common complaints associated with CPAP use.

Mask choice

Finding a suitable mask interface is one of the most critical aspects of achieving adequate treatment compliance. The four general styles to choose from are oronasal (full-mask), standard nasal (over the nose), nasal pillows (in the nose), and the rarely-used oral.

Most clinicians choose an initial mask after CPAP titration based on a combination of patient feedback and air leakage rates but may change the mask style after home implementation in order to improve patient tolerance. Unfortunately, many clinicians are unaware that CPAP levels may need to be adjusted after changing masks. Two studies have shown that oronasal masks require significantly more pressure to ensure adequate OSA treatment during CPAP titration compared with standard nasal and nasal pillows masks (Ebben et al. Sleep Med. 2012;13[6]:645; Borel et al. PLoS ONE. 2013;8[5]:e64382).

In a separate study in which nasal masks were replaced with oronasal masks, the apnea-hypopnea index (AHI) increased to greater than 10 events per hour in half of patients who had been previously titrated to less than five per hour with the nasal mask (Ebben et al. Sleep Med. 2014;15[6]:619). Caution should be used when making a mask change to ensure that adequate disease control is maintained.

Humidification

In the past few years, humidification has been routinely added to most CPAP machines in order to improve comfort. The benefit appears to come from a reduction in dryness related to regular CPAP use (Ruhle et al. Sleep Breath. 2011;15[3]:479). Some patients report that humidification is particularly helpful in the winter months, when indoor humidity is low. Heated humidification has been found to produce significantly more humidity and causes less insensible water loss from the respiratory tract compared with unheated units (Randerath et al. Eur J Respir. 2002;20[1]:183). Unfortunately, the humidifier significantly increases the size and weight of the treatment machine, though it can be removed for travel if desired. In addition, the humidifier requires additional maintenance; if not cleaned regularly, there is a risk of bacterial colonization of the humidification chamber (Chin et al. J Clin Sleep Med. 2013; 9[8]:747).

In some instances, patients may complain of excess water condensation in the hose, particularly in the presence of a cool sleeping environment. Some CPAP manufacturers now offer heated hoses, which can significantly reduce this condensation. A second option is to add an insulating hose cover to help maintain a higher internal temperature. Generally, these covers are a good choice if the cost of a heated hose is not covered by a patient’s insurance.

Pressure relief

A common complaint often heard from patients using CPAP is that the pressure feels too high, particularly when exhaling. In response, some equipment makers have developed pressure relief systems that allow an adjustable pressure drop during exhalation with standard CPAP units. These systems work by transiently reducing pressure during exhalation by a set amount, according to their proprietary algorithm (Dolan et al. Sleep and Breath. 2009;13:73). However, not all patients find this pressure relief effective at making CPAP easier to use. When tested empirically, pressure relief has not been consistently shown to improve CPAP compliance (Dolan et al. Sleep Breath. 2009;13[1]:73).

Compliance data monitoring

Many patients benefit from discussing and reviewing treatment efficacy at their follow-up visits. Most modern CPAP equipment allows for such data monitoring, that may include duration and specific times of machine use, leak rate, snoring periods, and residual respiratory events, subdivided into hypopneas and apneas. In some cases, the software can distinguish between central ("clear airway") and obstructive events using forced oscillation techniques to measure upper airway resistance. This information allows the clinician to adjust settings and ensure that treatment is optimized and used as prescribed.

Clinicians should familiarize themselves with the different reporting systems that provide these data, and train their office staff on using software to capture information for all CPAP users. Notably, the algorithms used to capture residual respiratory events are not completely accurate; identification of such events is based only on measures of flow.

While it is probably acceptable to take extreme values at face value, whether low or very high, the imprecision of the methodology makes it more difficult to reliably use middling values in a clinical setting. (Schwab et al. Am J Respir Crit Care Med. 2013;188[5]:613). If a patient remains symptomatic despite no evidence of residual respiratory events from the adherence data download, a retitration study should still be considered.

Educational programs

Adherence to CPAP has been shown to increase when providers engage patients in educational programs to enhance compliance and understanding of the potential health-care consequences of untreated OSA (Lai et al. Chest. 2014 May 8. doi: 10.1378/ chest.13-2228. [Epub ahead of print]).

Early education and continuous support provide reinforcement of the need for adherence to therapy, as well as an opportunity to personalize the treatment and adjust settings and equipment as needed for each individual patient. Although specific guidelines for the best timing of the educational intervention are still lacking, evidence suggests that long-term compliance with CPAP might be determined as early as 2 weeks after therapy is initiated (Aloia et al. J Clin Sleep Med. 2005;1[4]:346). Therefore, educational programs should be readily available for prospective and new CPAP users in order to enhance their understanding of OSA and knowledge about CPAP treatment and to provide them with a venue for reviewing and managing compliance-related issues. Such programs can be run by dedicated sleep technologists, respiratory therapists, or nurses in clinics where physician availability is more limited.

Summary

CPAP remains the most effective treatment for OSA, though adherence is a struggle for many patients. Identifying the best mask for a given patient, determining whether humidification or an expiratory pressure drop should be added and making early and frequent contact after prescription can all assist in improving long-term CPAP use. Regular review of adherence data with the patient is also important, modifying the therapy as necessary to optimize comfort, understanding that such changes may necessitate a subsequent pressure adjustment to maintain disease control.

Implementing a comprehensive approach to managing patients using CPAP therapy can impact compliance by reducing treatment-related complaints and improving comfort.

Dr. Ebben is Assistant Professor of Psychology in Clinical Neurology, Department of Neurology; and Dr. Krieger is Associate Clinical Professor, Departments of Medicine, Neurology, and Genetic Medicine; Weill Cornell Medical College of Cornell University, New York, New York.

Continuous positive airway pressure (CPAP) has long been considered the gold standard treatment for OSA. Recently, a variety of new treatment approaches have become available for mild and moderate OSA, including nasal resistance valves, nerve stimulators, and negative pressure devices. Nonetheless, CPAP remains unmatched in efficacy, as well as the frequency and severity of side effects associated with treatment. The main drawback of CPAP is the required use of a mask interface and pressurized air during sleep, which is uncomfortable for some patients.

This article will highlight recent work investigating issues associated with equipment choice for practitioners treating OSA patients with CPAP and discuss how proper equipment choices and educational programs can reduce common complaints associated with CPAP use.

Mask choice

Finding a suitable mask interface is one of the most critical aspects of achieving adequate treatment compliance. The four general styles to choose from are oronasal (full-mask), standard nasal (over the nose), nasal pillows (in the nose), and the rarely-used oral.

Most clinicians choose an initial mask after CPAP titration based on a combination of patient feedback and air leakage rates but may change the mask style after home implementation in order to improve patient tolerance. Unfortunately, many clinicians are unaware that CPAP levels may need to be adjusted after changing masks. Two studies have shown that oronasal masks require significantly more pressure to ensure adequate OSA treatment during CPAP titration compared with standard nasal and nasal pillows masks (Ebben et al. Sleep Med. 2012;13[6]:645; Borel et al. PLoS ONE. 2013;8[5]:e64382).

In a separate study in which nasal masks were replaced with oronasal masks, the apnea-hypopnea index (AHI) increased to greater than 10 events per hour in half of patients who had been previously titrated to less than five per hour with the nasal mask (Ebben et al. Sleep Med. 2014;15[6]:619). Caution should be used when making a mask change to ensure that adequate disease control is maintained.

Humidification

In the past few years, humidification has been routinely added to most CPAP machines in order to improve comfort. The benefit appears to come from a reduction in dryness related to regular CPAP use (Ruhle et al. Sleep Breath. 2011;15[3]:479). Some patients report that humidification is particularly helpful in the winter months, when indoor humidity is low. Heated humidification has been found to produce significantly more humidity and causes less insensible water loss from the respiratory tract compared with unheated units (Randerath et al. Eur J Respir. 2002;20[1]:183). Unfortunately, the humidifier significantly increases the size and weight of the treatment machine, though it can be removed for travel if desired. In addition, the humidifier requires additional maintenance; if not cleaned regularly, there is a risk of bacterial colonization of the humidification chamber (Chin et al. J Clin Sleep Med. 2013; 9[8]:747).

In some instances, patients may complain of excess water condensation in the hose, particularly in the presence of a cool sleeping environment. Some CPAP manufacturers now offer heated hoses, which can significantly reduce this condensation. A second option is to add an insulating hose cover to help maintain a higher internal temperature. Generally, these covers are a good choice if the cost of a heated hose is not covered by a patient’s insurance.

Pressure relief

A common complaint often heard from patients using CPAP is that the pressure feels too high, particularly when exhaling. In response, some equipment makers have developed pressure relief systems that allow an adjustable pressure drop during exhalation with standard CPAP units. These systems work by transiently reducing pressure during exhalation by a set amount, according to their proprietary algorithm (Dolan et al. Sleep and Breath. 2009;13:73). However, not all patients find this pressure relief effective at making CPAP easier to use. When tested empirically, pressure relief has not been consistently shown to improve CPAP compliance (Dolan et al. Sleep Breath. 2009;13[1]:73).

Compliance data monitoring

Many patients benefit from discussing and reviewing treatment efficacy at their follow-up visits. Most modern CPAP equipment allows for such data monitoring, that may include duration and specific times of machine use, leak rate, snoring periods, and residual respiratory events, subdivided into hypopneas and apneas. In some cases, the software can distinguish between central ("clear airway") and obstructive events using forced oscillation techniques to measure upper airway resistance. This information allows the clinician to adjust settings and ensure that treatment is optimized and used as prescribed.

Clinicians should familiarize themselves with the different reporting systems that provide these data, and train their office staff on using software to capture information for all CPAP users. Notably, the algorithms used to capture residual respiratory events are not completely accurate; identification of such events is based only on measures of flow.

While it is probably acceptable to take extreme values at face value, whether low or very high, the imprecision of the methodology makes it more difficult to reliably use middling values in a clinical setting. (Schwab et al. Am J Respir Crit Care Med. 2013;188[5]:613). If a patient remains symptomatic despite no evidence of residual respiratory events from the adherence data download, a retitration study should still be considered.

Educational programs

Adherence to CPAP has been shown to increase when providers engage patients in educational programs to enhance compliance and understanding of the potential health-care consequences of untreated OSA (Lai et al. Chest. 2014 May 8. doi: 10.1378/ chest.13-2228. [Epub ahead of print]).

Early education and continuous support provide reinforcement of the need for adherence to therapy, as well as an opportunity to personalize the treatment and adjust settings and equipment as needed for each individual patient. Although specific guidelines for the best timing of the educational intervention are still lacking, evidence suggests that long-term compliance with CPAP might be determined as early as 2 weeks after therapy is initiated (Aloia et al. J Clin Sleep Med. 2005;1[4]:346). Therefore, educational programs should be readily available for prospective and new CPAP users in order to enhance their understanding of OSA and knowledge about CPAP treatment and to provide them with a venue for reviewing and managing compliance-related issues. Such programs can be run by dedicated sleep technologists, respiratory therapists, or nurses in clinics where physician availability is more limited.

Summary

CPAP remains the most effective treatment for OSA, though adherence is a struggle for many patients. Identifying the best mask for a given patient, determining whether humidification or an expiratory pressure drop should be added and making early and frequent contact after prescription can all assist in improving long-term CPAP use. Regular review of adherence data with the patient is also important, modifying the therapy as necessary to optimize comfort, understanding that such changes may necessitate a subsequent pressure adjustment to maintain disease control.

Implementing a comprehensive approach to managing patients using CPAP therapy can impact compliance by reducing treatment-related complaints and improving comfort.

Dr. Ebben is Assistant Professor of Psychology in Clinical Neurology, Department of Neurology; and Dr. Krieger is Associate Clinical Professor, Departments of Medicine, Neurology, and Genetic Medicine; Weill Cornell Medical College of Cornell University, New York, New York.

The biggest news in ethics recently is the Veterans Affairs scandal, in which secret wait lists were allegedly kept to obscure the long delays for appointments. I seem to have a different perspective than the president, who said:

"How do we make sure that there is no slippage between somebody making a phone call and them getting an appointment scheduled. And let’s have a realistic time for how soon they’re going to get an appointment. Those are things that don’t require rocket science. It requires execution; it requires discipline; it requires focus."¹

Execution, discipline, focus. I think the word the president was looking for was honesty.

Meanwhile, a VA whistleblower who told CNN about the problems at the Phoenix facility said Friday he was saddened by [Gen. Eric] Shinseki’s resignation under such circumstances.

"The VA administrators got way too focused on having good numbers, and they forgot the most important mandate, the reason we all work at the VA – to take care of veterans, to save their lives and give them good medical care," Dr. Sam Foote said.

"The next secretary’s biggest challenge will be to get that refocused and make sure the number one job is taking care of veterans – not worrying about their bureaucratic careers," Dr. Foote added.²

This analysis of being "too focused" echoes the analysis 4 months ago of a scandal involving cheating on proficiency tests at missile bases in Montana. In that situation, people were similarly focused on meeting numbers and lost track of the big picture.

"Leadership’s focus on perfection led commanders to micromanage their people," said [Lt. Gen. Stephen Wilson, the commander of the Air Force’s Global Strike Command,] pointing to pressure to get 100% scores on monthly proficiency exams when only 90% was necessary to pass. ... Leaders lost sight of the fact that execution in the field is more important than what happens in the classroom."³

"This is absolutely unacceptable behavior and it is completely contrary to our core values in the Air Force, and as everybody here knows, the No. 1 core value for us is integrity," Air Force Secretary Deborah Lee James told reporters.⁴

I’ll accept integrity as equivalent to honesty.

As in the VA scandal, the missile scandal initially seemed isolated, but on further investigation was determined to be widespread, with up to 20% of the 190-member force implicated at one point. Equally concerning to leadership was the fact that many more people were aware cheating was going on, but did not act on it. I’ve often seen the term teamwork used to justify that behavior or lack thereof.

Are the delays at the VA hospitals unique? Not in my experience. Just last month while making an appointment to see a sub-subspecialist, I was told they were scheduling 5 months out. I called back to my primary care physician, who made a call, and I was soon contacted with an appointment for about a week later. Did I get any preferential consideration as a professional courtesy because I’m a physician? I don’t know. Very possibly. Did I benefit from knowing the system and anticipating that if I called my doctor, an earlier appointment would be arranged? Absolutely. I’ve made those calls myself advocating for my own patients when I hear about a delay that seems too long. It is part of being a patient advocate.

This is a fairly (that may be a poor choice of adjective) common practice when access is limited, but it can become a significant source of injustice. I’m aware of one health care system with long delays in scheduling subspecialty appointments after hospitalizations, up to 4-5 months. However, they do a great job, when called by a member of their panel of frequently referring primary doctors, at fitting people in early. The impact is that patients who have a personal physician (which correlates with good insurance) routinely jump the queue and get seen promptly. Patients who don’t have an advocate, or who go to one of the low-income clinics, may not get care or get frustrated and look elsewhere. This arrangement allows the system to claim it sees Medicaid patients while actually seeing only a limited fraction. Despicably evil, but effective. Is there discriminatory intent? Unknown and hard to prove. Disparate impact? Absolutely. Public outrage? Nope. Public ignorance, apathy, and a good public relations department seem to avert scandal.

Focusing on the numbers, pay for performance, Press Ganey scores, getting the top box checkmark – do these take focus away from providing the best clinical therapies? One would hope professionalism would keep pediatricians focused on the noble pursuit of providing health care for children. But leadership and an occasional emphasis on honesty couldn’t hurt.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis.

References

1. http://www.whitehouse.gov/the-press-office/2014/05/30/statement-president

2. http://www.cnn.com/2014/05/30/politics/va-hospitals-shinseki/index.html

3. http://www.cnn.com/2014/03/27/us/air-force-cheating-investigation

4. http://www.cnn.com/2014/01/15/politics/air-force-nuclear-scandal

The biggest news in ethics recently is the Veterans Affairs scandal, in which secret wait lists were allegedly kept to obscure the long delays for appointments. I seem to have a different perspective than the president, who said:

"How do we make sure that there is no slippage between somebody making a phone call and them getting an appointment scheduled. And let’s have a realistic time for how soon they’re going to get an appointment. Those are things that don’t require rocket science. It requires execution; it requires discipline; it requires focus."¹

Execution, discipline, focus. I think the word the president was looking for was honesty.

Meanwhile, a VA whistleblower who told CNN about the problems at the Phoenix facility said Friday he was saddened by [Gen. Eric] Shinseki’s resignation under such circumstances.

"The VA administrators got way too focused on having good numbers, and they forgot the most important mandate, the reason we all work at the VA – to take care of veterans, to save their lives and give them good medical care," Dr. Sam Foote said.

"The next secretary’s biggest challenge will be to get that refocused and make sure the number one job is taking care of veterans – not worrying about their bureaucratic careers," Dr. Foote added.²

This analysis of being "too focused" echoes the analysis 4 months ago of a scandal involving cheating on proficiency tests at missile bases in Montana. In that situation, people were similarly focused on meeting numbers and lost track of the big picture.

"Leadership’s focus on perfection led commanders to micromanage their people," said [Lt. Gen. Stephen Wilson, the commander of the Air Force’s Global Strike Command,] pointing to pressure to get 100% scores on monthly proficiency exams when only 90% was necessary to pass. ... Leaders lost sight of the fact that execution in the field is more important than what happens in the classroom."³

"This is absolutely unacceptable behavior and it is completely contrary to our core values in the Air Force, and as everybody here knows, the No. 1 core value for us is integrity," Air Force Secretary Deborah Lee James told reporters.⁴

I’ll accept integrity as equivalent to honesty.

As in the VA scandal, the missile scandal initially seemed isolated, but on further investigation was determined to be widespread, with up to 20% of the 190-member force implicated at one point. Equally concerning to leadership was the fact that many more people were aware cheating was going on, but did not act on it. I’ve often seen the term teamwork used to justify that behavior or lack thereof.

Are the delays at the VA hospitals unique? Not in my experience. Just last month while making an appointment to see a sub-subspecialist, I was told they were scheduling 5 months out. I called back to my primary care physician, who made a call, and I was soon contacted with an appointment for about a week later. Did I get any preferential consideration as a professional courtesy because I’m a physician? I don’t know. Very possibly. Did I benefit from knowing the system and anticipating that if I called my doctor, an earlier appointment would be arranged? Absolutely. I’ve made those calls myself advocating for my own patients when I hear about a delay that seems too long. It is part of being a patient advocate.

This is a fairly (that may be a poor choice of adjective) common practice when access is limited, but it can become a significant source of injustice. I’m aware of one health care system with long delays in scheduling subspecialty appointments after hospitalizations, up to 4-5 months. However, they do a great job, when called by a member of their panel of frequently referring primary doctors, at fitting people in early. The impact is that patients who have a personal physician (which correlates with good insurance) routinely jump the queue and get seen promptly. Patients who don’t have an advocate, or who go to one of the low-income clinics, may not get care or get frustrated and look elsewhere. This arrangement allows the system to claim it sees Medicaid patients while actually seeing only a limited fraction. Despicably evil, but effective. Is there discriminatory intent? Unknown and hard to prove. Disparate impact? Absolutely. Public outrage? Nope. Public ignorance, apathy, and a good public relations department seem to avert scandal.

Focusing on the numbers, pay for performance, Press Ganey scores, getting the top box checkmark – do these take focus away from providing the best clinical therapies? One would hope professionalism would keep pediatricians focused on the noble pursuit of providing health care for children. But leadership and an occasional emphasis on honesty couldn’t hurt.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis.

References

1. http://www.whitehouse.gov/the-press-office/2014/05/30/statement-president

2. http://www.cnn.com/2014/05/30/politics/va-hospitals-shinseki/index.html

3. http://www.cnn.com/2014/03/27/us/air-force-cheating-investigation

4. http://www.cnn.com/2014/01/15/politics/air-force-nuclear-scandal

The biggest news in ethics recently is the Veterans Affairs scandal, in which secret wait lists were allegedly kept to obscure the long delays for appointments. I seem to have a different perspective than the president, who said:

"How do we make sure that there is no slippage between somebody making a phone call and them getting an appointment scheduled. And let’s have a realistic time for how soon they’re going to get an appointment. Those are things that don’t require rocket science. It requires execution; it requires discipline; it requires focus."¹

Execution, discipline, focus. I think the word the president was looking for was honesty.

Meanwhile, a VA whistleblower who told CNN about the problems at the Phoenix facility said Friday he was saddened by [Gen. Eric] Shinseki’s resignation under such circumstances.

"The VA administrators got way too focused on having good numbers, and they forgot the most important mandate, the reason we all work at the VA – to take care of veterans, to save their lives and give them good medical care," Dr. Sam Foote said.

"The next secretary’s biggest challenge will be to get that refocused and make sure the number one job is taking care of veterans – not worrying about their bureaucratic careers," Dr. Foote added.²

This analysis of being "too focused" echoes the analysis 4 months ago of a scandal involving cheating on proficiency tests at missile bases in Montana. In that situation, people were similarly focused on meeting numbers and lost track of the big picture.

"Leadership’s focus on perfection led commanders to micromanage their people," said [Lt. Gen. Stephen Wilson, the commander of the Air Force’s Global Strike Command,] pointing to pressure to get 100% scores on monthly proficiency exams when only 90% was necessary to pass. ... Leaders lost sight of the fact that execution in the field is more important than what happens in the classroom."³

"This is absolutely unacceptable behavior and it is completely contrary to our core values in the Air Force, and as everybody here knows, the No. 1 core value for us is integrity," Air Force Secretary Deborah Lee James told reporters.⁴

I’ll accept integrity as equivalent to honesty.

As in the VA scandal, the missile scandal initially seemed isolated, but on further investigation was determined to be widespread, with up to 20% of the 190-member force implicated at one point. Equally concerning to leadership was the fact that many more people were aware cheating was going on, but did not act on it. I’ve often seen the term teamwork used to justify that behavior or lack thereof.

Are the delays at the VA hospitals unique? Not in my experience. Just last month while making an appointment to see a sub-subspecialist, I was told they were scheduling 5 months out. I called back to my primary care physician, who made a call, and I was soon contacted with an appointment for about a week later. Did I get any preferential consideration as a professional courtesy because I’m a physician? I don’t know. Very possibly. Did I benefit from knowing the system and anticipating that if I called my doctor, an earlier appointment would be arranged? Absolutely. I’ve made those calls myself advocating for my own patients when I hear about a delay that seems too long. It is part of being a patient advocate.

This is a fairly (that may be a poor choice of adjective) common practice when access is limited, but it can become a significant source of injustice. I’m aware of one health care system with long delays in scheduling subspecialty appointments after hospitalizations, up to 4-5 months. However, they do a great job, when called by a member of their panel of frequently referring primary doctors, at fitting people in early. The impact is that patients who have a personal physician (which correlates with good insurance) routinely jump the queue and get seen promptly. Patients who don’t have an advocate, or who go to one of the low-income clinics, may not get care or get frustrated and look elsewhere. This arrangement allows the system to claim it sees Medicaid patients while actually seeing only a limited fraction. Despicably evil, but effective. Is there discriminatory intent? Unknown and hard to prove. Disparate impact? Absolutely. Public outrage? Nope. Public ignorance, apathy, and a good public relations department seem to avert scandal.

Focusing on the numbers, pay for performance, Press Ganey scores, getting the top box checkmark – do these take focus away from providing the best clinical therapies? One would hope professionalism would keep pediatricians focused on the noble pursuit of providing health care for children. But leadership and an occasional emphasis on honesty couldn’t hurt.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis.

References

1. http://www.whitehouse.gov/the-press-office/2014/05/30/statement-president

2. http://www.cnn.com/2014/05/30/politics/va-hospitals-shinseki/index.html

3. http://www.cnn.com/2014/03/27/us/air-force-cheating-investigation

4. http://www.cnn.com/2014/01/15/politics/air-force-nuclear-scandal

The American Academy of Neurology’s position paper on the evaluation and management of sports-related concussion states a belief in the ethical obligation of the treating physician to make sure an athlete is ready to return to play following a concussion and that he or she is educated and protected from what could be a serious neurological injury.

As a practicing sports neurologist for the past 30 years, I agree with the stance that the AAN has taken, and I have found in my own practice that while the injured player and coaches are often anxious for the injured player to get back on the field, it is imperative for the player sit out until he or she has been given the okay by a qualified physician.

In my work with athletes from different sports and of all ages – as an adviser for Pop Warner football up through working on the NFL Players Association Mackey-White Traumatic Brain Injury Committee – the care of the patient has always been and will always be my greatest concern. Contact and collision sports, like football, hockey, and boxing, will never be completely safe, but that doesn’t lessen our responsibility as physicians to shield players from unnecessary injury and to ensure they are well enough to continue the sport.

If a player returns to the game before he is ready, he raises the likelihood of sustaining a second concussion, which is most likely to occur within 10 days of the initial concussion. He also increases his risk of "second-impact syndrome." While this is rare, its effects can be disastrous: traumatic injury and even death has occurred. A concussion is not just a "bump on the head," and everyone involved in a player’s care should take that seriously.

The AAN statement also supports the inclusion of concussion evaluation and training for neurology residency programs. Education on this particular issue is paramount in the fight to keep athletes safe. Making sure that all neurologists have the proper tools and are kept abreast of any changes to concussion management guidelines and testing will continue to ensure players’ safety.

Education for athletes, coaches, athletic trainers, parents, and the community in general also is critical. Once they know and understand the signs and symptoms – and the impact – of a concussion, the easier it will be for everyone to be on board with keeping an athlete out of play until she has been cleared by her doctor. It’s also important to have a better understanding of the scope of the problem and its impact. To that end, the AAN’s idea to create a mandatory national concussion registry is definitely a step in the right direction and could be an integral way to gain a better understanding of the issue at hand.

No matter whether a player has dedicated his life to the sport or if he is in his first Pop Warner season, it will always be tough to tell him that he has to sit out for one or more games. (And, for the younger set, that is often difficult for parents to hear.) But it is the ethical obligation of a physician to make sure a player has no visible signs or symptoms and is cognitively ready to return to play. That, combined with education and knowledge on the subject, as the AAN recommends, will help neurologists and other physicians throughout the country keep players safe and limit the number of concussions and their impact on today’s athletes.

Dr. Jordan is the director of the brain injury program and the memory evaluation treatment service at Burke Rehabilitation Hospital in White Plains, N.Y. He also serves as the assistant medical director there. He currently serves as the chief medical officer of the New York State Athletic Commission, as a team physician for USA Boxing, and as a member of the NFL Players Association Mackey-White Traumatic Brain Injury Committee and the NFL Neuro-Cognitive Disability Committee.

The American Academy of Neurology’s position paper on the evaluation and management of sports-related concussion states a belief in the ethical obligation of the treating physician to make sure an athlete is ready to return to play following a concussion and that he or she is educated and protected from what could be a serious neurological injury.

As a practicing sports neurologist for the past 30 years, I agree with the stance that the AAN has taken, and I have found in my own practice that while the injured player and coaches are often anxious for the injured player to get back on the field, it is imperative for the player sit out until he or she has been given the okay by a qualified physician.

In my work with athletes from different sports and of all ages – as an adviser for Pop Warner football up through working on the NFL Players Association Mackey-White Traumatic Brain Injury Committee – the care of the patient has always been and will always be my greatest concern. Contact and collision sports, like football, hockey, and boxing, will never be completely safe, but that doesn’t lessen our responsibility as physicians to shield players from unnecessary injury and to ensure they are well enough to continue the sport.

If a player returns to the game before he is ready, he raises the likelihood of sustaining a second concussion, which is most likely to occur within 10 days of the initial concussion. He also increases his risk of "second-impact syndrome." While this is rare, its effects can be disastrous: traumatic injury and even death has occurred. A concussion is not just a "bump on the head," and everyone involved in a player’s care should take that seriously.

The AAN statement also supports the inclusion of concussion evaluation and training for neurology residency programs. Education on this particular issue is paramount in the fight to keep athletes safe. Making sure that all neurologists have the proper tools and are kept abreast of any changes to concussion management guidelines and testing will continue to ensure players’ safety.

Education for athletes, coaches, athletic trainers, parents, and the community in general also is critical. Once they know and understand the signs and symptoms – and the impact – of a concussion, the easier it will be for everyone to be on board with keeping an athlete out of play until she has been cleared by her doctor. It’s also important to have a better understanding of the scope of the problem and its impact. To that end, the AAN’s idea to create a mandatory national concussion registry is definitely a step in the right direction and could be an integral way to gain a better understanding of the issue at hand.

No matter whether a player has dedicated his life to the sport or if he is in his first Pop Warner season, it will always be tough to tell him that he has to sit out for one or more games. (And, for the younger set, that is often difficult for parents to hear.) But it is the ethical obligation of a physician to make sure a player has no visible signs or symptoms and is cognitively ready to return to play. That, combined with education and knowledge on the subject, as the AAN recommends, will help neurologists and other physicians throughout the country keep players safe and limit the number of concussions and their impact on today’s athletes.

Dr. Jordan is the director of the brain injury program and the memory evaluation treatment service at Burke Rehabilitation Hospital in White Plains, N.Y. He also serves as the assistant medical director there. He currently serves as the chief medical officer of the New York State Athletic Commission, as a team physician for USA Boxing, and as a member of the NFL Players Association Mackey-White Traumatic Brain Injury Committee and the NFL Neuro-Cognitive Disability Committee.

The American Academy of Neurology’s position paper on the evaluation and management of sports-related concussion states a belief in the ethical obligation of the treating physician to make sure an athlete is ready to return to play following a concussion and that he or she is educated and protected from what could be a serious neurological injury.

As a practicing sports neurologist for the past 30 years, I agree with the stance that the AAN has taken, and I have found in my own practice that while the injured player and coaches are often anxious for the injured player to get back on the field, it is imperative for the player sit out until he or she has been given the okay by a qualified physician.

In my work with athletes from different sports and of all ages – as an adviser for Pop Warner football up through working on the NFL Players Association Mackey-White Traumatic Brain Injury Committee – the care of the patient has always been and will always be my greatest concern. Contact and collision sports, like football, hockey, and boxing, will never be completely safe, but that doesn’t lessen our responsibility as physicians to shield players from unnecessary injury and to ensure they are well enough to continue the sport.

If a player returns to the game before he is ready, he raises the likelihood of sustaining a second concussion, which is most likely to occur within 10 days of the initial concussion. He also increases his risk of "second-impact syndrome." While this is rare, its effects can be disastrous: traumatic injury and even death has occurred. A concussion is not just a "bump on the head," and everyone involved in a player’s care should take that seriously.

The AAN statement also supports the inclusion of concussion evaluation and training for neurology residency programs. Education on this particular issue is paramount in the fight to keep athletes safe. Making sure that all neurologists have the proper tools and are kept abreast of any changes to concussion management guidelines and testing will continue to ensure players’ safety.

Education for athletes, coaches, athletic trainers, parents, and the community in general also is critical. Once they know and understand the signs and symptoms – and the impact – of a concussion, the easier it will be for everyone to be on board with keeping an athlete out of play until she has been cleared by her doctor. It’s also important to have a better understanding of the scope of the problem and its impact. To that end, the AAN’s idea to create a mandatory national concussion registry is definitely a step in the right direction and could be an integral way to gain a better understanding of the issue at hand.

No matter whether a player has dedicated his life to the sport or if he is in his first Pop Warner season, it will always be tough to tell him that he has to sit out for one or more games. (And, for the younger set, that is often difficult for parents to hear.) But it is the ethical obligation of a physician to make sure a player has no visible signs or symptoms and is cognitively ready to return to play. That, combined with education and knowledge on the subject, as the AAN recommends, will help neurologists and other physicians throughout the country keep players safe and limit the number of concussions and their impact on today’s athletes.

Dr. Jordan is the director of the brain injury program and the memory evaluation treatment service at Burke Rehabilitation Hospital in White Plains, N.Y. He also serves as the assistant medical director there. He currently serves as the chief medical officer of the New York State Athletic Commission, as a team physician for USA Boxing, and as a member of the NFL Players Association Mackey-White Traumatic Brain Injury Committee and the NFL Neuro-Cognitive Disability Committee.

Dr. Sarah Hawley and her coinvestigators are to be applauded for generating insightful data regarding factors and concerns that motivate a woman to undergo contralateral prophylactic mastectomy in the setting of unilateral breast cancer (JAMA Surgery 2014 May 21 [doi:10.1001/jamasurg.2013.5689]).

Hawley et al. found that fear of recurrence was one of the strongest factors leading women to choose contralateral prophylactic mastectomy (CPM). This finding clearly demonstrates that we need to do a better job of explaining and defining the significance of (i) breast cancer local recurrence; (ii) breast cancer distant recurrence; and (iii) the development of a new/second primary breast cancer. Since cross-metastasis of a primary breast cancer to the contralateral breast is an extremely rare event, and since distant metastasis from the initial primary breast cancer tends to determine survival rates, CPM by definition will influence the incidence of only the third pattern. Furthermore, since the risk of experiencing a new contralateral malignancy is less than 1% per year for the general population of breast cancer patients, only a minority of these women will actually become bilateral breast cancer patients. Fear of recurrence is therefore a totally inappropriate reason for patients to pursue CPM, and the reasonableness of CPM to reduce the risk of a contralateral new primary breast cancer is debatable.

It can be reasonably stated that prophylactic surgery by definition is never a medically indicated necessity. Furthermore, despite the fact that a personal history of breast cancer is indeed a risk factor for developing a second primary cancer in the contralateral breast, numerous studies have demonstrated equivalent survival rates for women with unilateral breast cancer, compared with those diagnosed with bilateral/metachronous breast cancer (Cancer 2001;91:1845-53; Am. J. Clin. Oncol. 1997;20:541-5). Survival tends to be driven by the stage and effectiveness of treatment for the first cancer. By virtue of its earlier presentation, it is likely that the initially diagnosed cancer has established itself as the faster-growing malignancy with a lead time advantage in establishing distant organ micrometastatic disease; furthermore, patients with a unilateral breast cancer diagnosis are generally undergoing diligent surveillance and a contralateral malignancy is more often detected at an early stage.

Messages to our patients

It is essential for those of us who manage breast cancer to clearly emphasize several messages to our newly diagnosed breast cancer patients: First, although unilateral breast cancer increases the likelihood of developing a second primary tumor, it is certainly not inevitable, and in fact, the majority of patients are not destined to develop contralateral disease. Second, reducing the risk of being diagnosed with a contralateral breast cancer does not mitigate the mortality risk associated with the first cancer. And, finally, prophylactic mastectomy is the most aggressive and effective strategy for reducing the incidence of primary breast cancer (by approximately 90%), but it does not confer complete protection, as microscopic foci of breast tissue may be left behind in the mastectomy skin flaps, along the pectoralis, or in the axilla.

The messages above are critical: Our patients must understand that the priority is to address the known cancer. In this regard, appropriately selected patients should be encouraged to strongly consider breast-conserving surgery whenever feasible, as this low-morbidity treatment is equivalent to mastectomy from the perspective of overall survival. The question of CPM is most relevant for those patients that are ineligible for breast conservation or patients unwilling to undergo lumpectomy and breast radiation.

If a mastectomy for the cancerous breast is planned, we must then address the questions that routinely arise regarding bilateral surgery. In our efforts to clarify the reality of what CPM can and cannot achieve, we must also avoid being too dogmatic and paternalistic with our patients. There are clearly specific scenarios, as delineated in Dr. Hawley’s work, where the risk of a second primary breast cancer is likely to be considered excessive by most women, and where the decision to pursue CPM may be easier. Examples of such cases would be women known to harbor BRCA mutations or women with suspected hereditary susceptibility based on a strong family history of breast and/or ovarian cancer. The risk of a new contralateral breast cancer can be in the range of 4%-5% per year in cases of hereditary disease, compared with the general population of women with sporadic breast cancer, where the risk ranges from 0.25% to 1% per year.

Conveying an understanding of risk

Patients must understand that the risk to the contralateral breast is predominantly expressed in the future – the likelihood of having a clinically occult, incidentally detected cancer identified in the contralateral mastectomy specimen is only 6%, as demonstrated most recently by King et al. (Ann. Surg. 2011;254:2-7), and with ductal carcinoma in situ accounting for the high majority of these lesions.

Defining the threshold for the amount of risk that an individual woman finds to be acceptable, however, can be a very difficult and personal decision. Even after a patient comes to understand that CPM is unlikely to provide a survival advantage, she may continue to request bilateral surgery purely for the risk-reducing benefits, and out of a desire to minimize her chances of having to repeat the breast cancer diagnosis and treatment experience. In some cases this choice will be influenced by reconstruction factors. A woman may be motivated to pursue bilateral surgery if she has an adequate volume of abdominal tissue because of the fact that the autogenous TRAM (transverse rectus abdominis myocutaneous) flap can be harvested only once. In other cases the decision is influenced by body habitus, for example, a woman with large pendulous breasts who is not interested in breast reconstruction may decide that she is more comfortable with a symmetrically flat chest wall in order to avoid chest wall imbalance and the inconvenience of finding/wearing a prosthesis that matches the remaining breast.

As breast cancer surgeons we should openly discuss these issues with our patients and present viable alternatives when feasible, such as reduction mammoplasty for the large-breasted patient. Ultimately, however, the patient must decide the surgical approach that provides her with the optimal sense of treatment satisfaction, quality of life, and comfort.

Discussion strategies

In my own practice I have found two discussion strategies to be particularly useful in guiding patients through the decision about CPM.

The first approach is relevant for women who are lumpectomy candidates, but who express a "reflex" interest in bilateral mastectomy while they are still in the emotional fog of processing the new cancer diagnosis. For these women it is obviously important to stress the survival equivalence of mastectomy and breast-conserving surgery, and this is also a great opportunity to educate patients about the potential axillary surgery advantages of breast conservation. The American College of Surgeons Oncology Group Z11 trial (JAMA 2011;305:69-75) has provided strong evidence supporting the safety of avoiding an axillary lymph node dissection (ALND) in women with sentinel lymph node (SLN) metastatic disease if the primary breast cancer is managed by lumpectomy and breast radiation.

At this point in time, we do not have comparably strong data to justify avoiding the ALND in the setting of mastectomy patients with SLN metastatic disease. The mastectomy patient with SLN metastasis is usually committed to undergo the completion axillary lymph node dissection specifically so that definitive decisions can be made regarding the need for postmastectomy radiation, and many of these patients become ineligible for immediate reconstruction because of this possible radiation. I therefore accentuate the advantage of at least initiating treatment with lumpectomy and sentinel lymph node biopsy. The patient preserves all of her surgical options with the benefit of having more staging information. If she is found to have SLN metastatic disease then she is in a better position to avoid the ALND with lumpectomy and radiation, and the option of future mastectomy and immediate reconstruction would still be available to her in the future (after completing all of her cancer treatment and healing from her radiation); if the SLN is negative, she can either continue with the breast-conservation treatment plan or she can pursue mastectomy (with or without immediate breast reconstruction, since prophylactic mamillary radiation therapy is not likely to be indicated for node-negative disease).

The second approach is relevant to the patient requiring mastectomy but for whom delayed reconstruction is planned because of medical issues or anticipated postmastectomy radiation. I encourage these patients to at least consider deferring the decision for the CPM until they return for the delayed reconstruction of the cancerous mastectomy, because at that time they can undergo the prophylactic mastectomy with the cosmetic advantages of immediate reconstruction.

Cost considerations

From the public health and population-based breast cancer burden perspectives as well as for individual patients, there are additional issues to be factored into the CPM discussion. It is a basic reality that cost is relevant when it comes to sorting out the net benefit of particular medical interventions, especially those that are prophylactic. Interestingly, a cost analysis study by Zendejas et al. (J. Clin. Oncol. 2011;29:2993-3000) from the Mayo Clinic demonstrated that CPM is actually cost effective, compared with surveillance for patients diagnosed when they are younger than 70 years of age.

The Women’s Health and Cancer Rights Act was implemented in 1999, mandating insurance coverage for breast reconstruction after mastectomy performed for cancer. This legislation promoted more widespread acceptance (and reimbursement) for contralateral mastectomy/reconstruction, but patients should nonetheless be proactive about confirming that their individual policy will indeed cover the expenses of prophylactic surgery. Furthermore, we must continue to monitor outcomes in women who choose to undergo CPM, as advances in breast cancer therapies may influence the survival benefits of this surgical approach. Indeed, selected retrospective studies have recently demonstrated that patients undergoing CPM have an improved survival, compared with those focusing on unilateral breast cancer surgery (Ann. Surg. Oncol. 2010;17:2702-9; J. Natl. Cancer Inst. 2010;102:401-9; J. Clin. Oncol. 2005;23:4275-86; Am. J. Surg. 2000;180:439-45). These results suggest a survival advantage associated with avoidance of a contralateral breast cancer, in contrast to the historical data alluded to above, regarding survival equivalence for patients with unilateral compared to metachronous bilateral breast cancer. As adjuvant systemic therapies for breast cancer continue to improve in effectiveness and ability to completely eliminate distant organ micrometastases, it is likely that we will continue to increase the pool of women who are essentially "cured" of the first cancer. This in turn could potentially increase the longevity threat of a second/metachronous cancer though a renewed metastatic risk. Nonetheless, data on possible survival advantages of CPM have not yet matured to the point where it can be recommended as a medically "indicated" procedure.

Our breast cancer patients face an abundance of very legitimate fears related to the morbidity and mortality risks of the actual cancer as well as the adverse effects and toxicities of treatment for that cancer. Fortunately, we can assure them that for the majority of cases these treatments will be effective and their longevity will be protected. It is therefore understandable that the desire to avoid repeating this particular life experience may be strong. We have an obligation to explain the advantages and disadvantages, as well as the alternatives to CPM, with sensitivity and patience. We must also strive to make sure that our patients do not make premature decisions without understanding the consequences. Last, but certainly not least, we are ethically bound to offer only those treatments that we feel are medically reasonable and safe as well as oncologically sound. But we must also remember that the decision to pursue treatment and the choice between the options that we offer are ultimately rights that belong to the patient.

Dr. Newman in an ACS Fellow, professor of surgery, and director of the Breast Care Center and Multidisciplinary Breast Fellowship Program, University of Michigan Comprehensive Cancer Center, Ann Arbor.

Dr. Sarah Hawley and her coinvestigators are to be applauded for generating insightful data regarding factors and concerns that motivate a woman to undergo contralateral prophylactic mastectomy in the setting of unilateral breast cancer (JAMA Surgery 2014 May 21 [doi:10.1001/jamasurg.2013.5689]).

Hawley et al. found that fear of recurrence was one of the strongest factors leading women to choose contralateral prophylactic mastectomy (CPM). This finding clearly demonstrates that we need to do a better job of explaining and defining the significance of (i) breast cancer local recurrence; (ii) breast cancer distant recurrence; and (iii) the development of a new/second primary breast cancer. Since cross-metastasis of a primary breast cancer to the contralateral breast is an extremely rare event, and since distant metastasis from the initial primary breast cancer tends to determine survival rates, CPM by definition will influence the incidence of only the third pattern. Furthermore, since the risk of experiencing a new contralateral malignancy is less than 1% per year for the general population of breast cancer patients, only a minority of these women will actually become bilateral breast cancer patients. Fear of recurrence is therefore a totally inappropriate reason for patients to pursue CPM, and the reasonableness of CPM to reduce the risk of a contralateral new primary breast cancer is debatable.

It can be reasonably stated that prophylactic surgery by definition is never a medically indicated necessity. Furthermore, despite the fact that a personal history of breast cancer is indeed a risk factor for developing a second primary cancer in the contralateral breast, numerous studies have demonstrated equivalent survival rates for women with unilateral breast cancer, compared with those diagnosed with bilateral/metachronous breast cancer (Cancer 2001;91:1845-53; Am. J. Clin. Oncol. 1997;20:541-5). Survival tends to be driven by the stage and effectiveness of treatment for the first cancer. By virtue of its earlier presentation, it is likely that the initially diagnosed cancer has established itself as the faster-growing malignancy with a lead time advantage in establishing distant organ micrometastatic disease; furthermore, patients with a unilateral breast cancer diagnosis are generally undergoing diligent surveillance and a contralateral malignancy is more often detected at an early stage.

Messages to our patients

It is essential for those of us who manage breast cancer to clearly emphasize several messages to our newly diagnosed breast cancer patients: First, although unilateral breast cancer increases the likelihood of developing a second primary tumor, it is certainly not inevitable, and in fact, the majority of patients are not destined to develop contralateral disease. Second, reducing the risk of being diagnosed with a contralateral breast cancer does not mitigate the mortality risk associated with the first cancer. And, finally, prophylactic mastectomy is the most aggressive and effective strategy for reducing the incidence of primary breast cancer (by approximately 90%), but it does not confer complete protection, as microscopic foci of breast tissue may be left behind in the mastectomy skin flaps, along the pectoralis, or in the axilla.

The messages above are critical: Our patients must understand that the priority is to address the known cancer. In this regard, appropriately selected patients should be encouraged to strongly consider breast-conserving surgery whenever feasible, as this low-morbidity treatment is equivalent to mastectomy from the perspective of overall survival. The question of CPM is most relevant for those patients that are ineligible for breast conservation or patients unwilling to undergo lumpectomy and breast radiation.

If a mastectomy for the cancerous breast is planned, we must then address the questions that routinely arise regarding bilateral surgery. In our efforts to clarify the reality of what CPM can and cannot achieve, we must also avoid being too dogmatic and paternalistic with our patients. There are clearly specific scenarios, as delineated in Dr. Hawley’s work, where the risk of a second primary breast cancer is likely to be considered excessive by most women, and where the decision to pursue CPM may be easier. Examples of such cases would be women known to harbor BRCA mutations or women with suspected hereditary susceptibility based on a strong family history of breast and/or ovarian cancer. The risk of a new contralateral breast cancer can be in the range of 4%-5% per year in cases of hereditary disease, compared with the general population of women with sporadic breast cancer, where the risk ranges from 0.25% to 1% per year.

Conveying an understanding of risk

Patients must understand that the risk to the contralateral breast is predominantly expressed in the future – the likelihood of having a clinically occult, incidentally detected cancer identified in the contralateral mastectomy specimen is only 6%, as demonstrated most recently by King et al. (Ann. Surg. 2011;254:2-7), and with ductal carcinoma in situ accounting for the high majority of these lesions.

Defining the threshold for the amount of risk that an individual woman finds to be acceptable, however, can be a very difficult and personal decision. Even after a patient comes to understand that CPM is unlikely to provide a survival advantage, she may continue to request bilateral surgery purely for the risk-reducing benefits, and out of a desire to minimize her chances of having to repeat the breast cancer diagnosis and treatment experience. In some cases this choice will be influenced by reconstruction factors. A woman may be motivated to pursue bilateral surgery if she has an adequate volume of abdominal tissue because of the fact that the autogenous TRAM (transverse rectus abdominis myocutaneous) flap can be harvested only once. In other cases the decision is influenced by body habitus, for example, a woman with large pendulous breasts who is not interested in breast reconstruction may decide that she is more comfortable with a symmetrically flat chest wall in order to avoid chest wall imbalance and the inconvenience of finding/wearing a prosthesis that matches the remaining breast.

As breast cancer surgeons we should openly discuss these issues with our patients and present viable alternatives when feasible, such as reduction mammoplasty for the large-breasted patient. Ultimately, however, the patient must decide the surgical approach that provides her with the optimal sense of treatment satisfaction, quality of life, and comfort.

Discussion strategies

In my own practice I have found two discussion strategies to be particularly useful in guiding patients through the decision about CPM.

The first approach is relevant for women who are lumpectomy candidates, but who express a "reflex" interest in bilateral mastectomy while they are still in the emotional fog of processing the new cancer diagnosis. For these women it is obviously important to stress the survival equivalence of mastectomy and breast-conserving surgery, and this is also a great opportunity to educate patients about the potential axillary surgery advantages of breast conservation. The American College of Surgeons Oncology Group Z11 trial (JAMA 2011;305:69-75) has provided strong evidence supporting the safety of avoiding an axillary lymph node dissection (ALND) in women with sentinel lymph node (SLN) metastatic disease if the primary breast cancer is managed by lumpectomy and breast radiation.

At this point in time, we do not have comparably strong data to justify avoiding the ALND in the setting of mastectomy patients with SLN metastatic disease. The mastectomy patient with SLN metastasis is usually committed to undergo the completion axillary lymph node dissection specifically so that definitive decisions can be made regarding the need for postmastectomy radiation, and many of these patients become ineligible for immediate reconstruction because of this possible radiation. I therefore accentuate the advantage of at least initiating treatment with lumpectomy and sentinel lymph node biopsy. The patient preserves all of her surgical options with the benefit of having more staging information. If she is found to have SLN metastatic disease then she is in a better position to avoid the ALND with lumpectomy and radiation, and the option of future mastectomy and immediate reconstruction would still be available to her in the future (after completing all of her cancer treatment and healing from her radiation); if the SLN is negative, she can either continue with the breast-conservation treatment plan or she can pursue mastectomy (with or without immediate breast reconstruction, since prophylactic mamillary radiation therapy is not likely to be indicated for node-negative disease).

The second approach is relevant to the patient requiring mastectomy but for whom delayed reconstruction is planned because of medical issues or anticipated postmastectomy radiation. I encourage these patients to at least consider deferring the decision for the CPM until they return for the delayed reconstruction of the cancerous mastectomy, because at that time they can undergo the prophylactic mastectomy with the cosmetic advantages of immediate reconstruction.

Cost considerations

From the public health and population-based breast cancer burden perspectives as well as for individual patients, there are additional issues to be factored into the CPM discussion. It is a basic reality that cost is relevant when it comes to sorting out the net benefit of particular medical interventions, especially those that are prophylactic. Interestingly, a cost analysis study by Zendejas et al. (J. Clin. Oncol. 2011;29:2993-3000) from the Mayo Clinic demonstrated that CPM is actually cost effective, compared with surveillance for patients diagnosed when they are younger than 70 years of age.

The Women’s Health and Cancer Rights Act was implemented in 1999, mandating insurance coverage for breast reconstruction after mastectomy performed for cancer. This legislation promoted more widespread acceptance (and reimbursement) for contralateral mastectomy/reconstruction, but patients should nonetheless be proactive about confirming that their individual policy will indeed cover the expenses of prophylactic surgery. Furthermore, we must continue to monitor outcomes in women who choose to undergo CPM, as advances in breast cancer therapies may influence the survival benefits of this surgical approach. Indeed, selected retrospective studies have recently demonstrated that patients undergoing CPM have an improved survival, compared with those focusing on unilateral breast cancer surgery (Ann. Surg. Oncol. 2010;17:2702-9; J. Natl. Cancer Inst. 2010;102:401-9; J. Clin. Oncol. 2005;23:4275-86; Am. J. Surg. 2000;180:439-45). These results suggest a survival advantage associated with avoidance of a contralateral breast cancer, in contrast to the historical data alluded to above, regarding survival equivalence for patients with unilateral compared to metachronous bilateral breast cancer. As adjuvant systemic therapies for breast cancer continue to improve in effectiveness and ability to completely eliminate distant organ micrometastases, it is likely that we will continue to increase the pool of women who are essentially "cured" of the first cancer. This in turn could potentially increase the longevity threat of a second/metachronous cancer though a renewed metastatic risk. Nonetheless, data on possible survival advantages of CPM have not yet matured to the point where it can be recommended as a medically "indicated" procedure.

Our breast cancer patients face an abundance of very legitimate fears related to the morbidity and mortality risks of the actual cancer as well as the adverse effects and toxicities of treatment for that cancer. Fortunately, we can assure them that for the majority of cases these treatments will be effective and their longevity will be protected. It is therefore understandable that the desire to avoid repeating this particular life experience may be strong. We have an obligation to explain the advantages and disadvantages, as well as the alternatives to CPM, with sensitivity and patience. We must also strive to make sure that our patients do not make premature decisions without understanding the consequences. Last, but certainly not least, we are ethically bound to offer only those treatments that we feel are medically reasonable and safe as well as oncologically sound. But we must also remember that the decision to pursue treatment and the choice between the options that we offer are ultimately rights that belong to the patient.

Dr. Newman in an ACS Fellow, professor of surgery, and director of the Breast Care Center and Multidisciplinary Breast Fellowship Program, University of Michigan Comprehensive Cancer Center, Ann Arbor.

Dr. Sarah Hawley and her coinvestigators are to be applauded for generating insightful data regarding factors and concerns that motivate a woman to undergo contralateral prophylactic mastectomy in the setting of unilateral breast cancer (JAMA Surgery 2014 May 21 [doi:10.1001/jamasurg.2013.5689]).

Hawley et al. found that fear of recurrence was one of the strongest factors leading women to choose contralateral prophylactic mastectomy (CPM). This finding clearly demonstrates that we need to do a better job of explaining and defining the significance of (i) breast cancer local recurrence; (ii) breast cancer distant recurrence; and (iii) the development of a new/second primary breast cancer. Since cross-metastasis of a primary breast cancer to the contralateral breast is an extremely rare event, and since distant metastasis from the initial primary breast cancer tends to determine survival rates, CPM by definition will influence the incidence of only the third pattern. Furthermore, since the risk of experiencing a new contralateral malignancy is less than 1% per year for the general population of breast cancer patients, only a minority of these women will actually become bilateral breast cancer patients. Fear of recurrence is therefore a totally inappropriate reason for patients to pursue CPM, and the reasonableness of CPM to reduce the risk of a contralateral new primary breast cancer is debatable.

It can be reasonably stated that prophylactic surgery by definition is never a medically indicated necessity. Furthermore, despite the fact that a personal history of breast cancer is indeed a risk factor for developing a second primary cancer in the contralateral breast, numerous studies have demonstrated equivalent survival rates for women with unilateral breast cancer, compared with those diagnosed with bilateral/metachronous breast cancer (Cancer 2001;91:1845-53; Am. J. Clin. Oncol. 1997;20:541-5). Survival tends to be driven by the stage and effectiveness of treatment for the first cancer. By virtue of its earlier presentation, it is likely that the initially diagnosed cancer has established itself as the faster-growing malignancy with a lead time advantage in establishing distant organ micrometastatic disease; furthermore, patients with a unilateral breast cancer diagnosis are generally undergoing diligent surveillance and a contralateral malignancy is more often detected at an early stage.

Messages to our patients

It is essential for those of us who manage breast cancer to clearly emphasize several messages to our newly diagnosed breast cancer patients: First, although unilateral breast cancer increases the likelihood of developing a second primary tumor, it is certainly not inevitable, and in fact, the majority of patients are not destined to develop contralateral disease. Second, reducing the risk of being diagnosed with a contralateral breast cancer does not mitigate the mortality risk associated with the first cancer. And, finally, prophylactic mastectomy is the most aggressive and effective strategy for reducing the incidence of primary breast cancer (by approximately 90%), but it does not confer complete protection, as microscopic foci of breast tissue may be left behind in the mastectomy skin flaps, along the pectoralis, or in the axilla.

The messages above are critical: Our patients must understand that the priority is to address the known cancer. In this regard, appropriately selected patients should be encouraged to strongly consider breast-conserving surgery whenever feasible, as this low-morbidity treatment is equivalent to mastectomy from the perspective of overall survival. The question of CPM is most relevant for those patients that are ineligible for breast conservation or patients unwilling to undergo lumpectomy and breast radiation.

If a mastectomy for the cancerous breast is planned, we must then address the questions that routinely arise regarding bilateral surgery. In our efforts to clarify the reality of what CPM can and cannot achieve, we must also avoid being too dogmatic and paternalistic with our patients. There are clearly specific scenarios, as delineated in Dr. Hawley’s work, where the risk of a second primary breast cancer is likely to be considered excessive by most women, and where the decision to pursue CPM may be easier. Examples of such cases would be women known to harbor BRCA mutations or women with suspected hereditary susceptibility based on a strong family history of breast and/or ovarian cancer. The risk of a new contralateral breast cancer can be in the range of 4%-5% per year in cases of hereditary disease, compared with the general population of women with sporadic breast cancer, where the risk ranges from 0.25% to 1% per year.

Conveying an understanding of risk

Patients must understand that the risk to the contralateral breast is predominantly expressed in the future – the likelihood of having a clinically occult, incidentally detected cancer identified in the contralateral mastectomy specimen is only 6%, as demonstrated most recently by King et al. (Ann. Surg. 2011;254:2-7), and with ductal carcinoma in situ accounting for the high majority of these lesions.

Defining the threshold for the amount of risk that an individual woman finds to be acceptable, however, can be a very difficult and personal decision. Even after a patient comes to understand that CPM is unlikely to provide a survival advantage, she may continue to request bilateral surgery purely for the risk-reducing benefits, and out of a desire to minimize her chances of having to repeat the breast cancer diagnosis and treatment experience. In some cases this choice will be influenced by reconstruction factors. A woman may be motivated to pursue bilateral surgery if she has an adequate volume of abdominal tissue because of the fact that the autogenous TRAM (transverse rectus abdominis myocutaneous) flap can be harvested only once. In other cases the decision is influenced by body habitus, for example, a woman with large pendulous breasts who is not interested in breast reconstruction may decide that she is more comfortable with a symmetrically flat chest wall in order to avoid chest wall imbalance and the inconvenience of finding/wearing a prosthesis that matches the remaining breast.

As breast cancer surgeons we should openly discuss these issues with our patients and present viable alternatives when feasible, such as reduction mammoplasty for the large-breasted patient. Ultimately, however, the patient must decide the surgical approach that provides her with the optimal sense of treatment satisfaction, quality of life, and comfort.

Discussion strategies

In my own practice I have found two discussion strategies to be particularly useful in guiding patients through the decision about CPM.

The first approach is relevant for women who are lumpectomy candidates, but who express a "reflex" interest in bilateral mastectomy while they are still in the emotional fog of processing the new cancer diagnosis. For these women it is obviously important to stress the survival equivalence of mastectomy and breast-conserving surgery, and this is also a great opportunity to educate patients about the potential axillary surgery advantages of breast conservation. The American College of Surgeons Oncology Group Z11 trial (JAMA 2011;305:69-75) has provided strong evidence supporting the safety of avoiding an axillary lymph node dissection (ALND) in women with sentinel lymph node (SLN) metastatic disease if the primary breast cancer is managed by lumpectomy and breast radiation.

At this point in time, we do not have comparably strong data to justify avoiding the ALND in the setting of mastectomy patients with SLN metastatic disease. The mastectomy patient with SLN metastasis is usually committed to undergo the completion axillary lymph node dissection specifically so that definitive decisions can be made regarding the need for postmastectomy radiation, and many of these patients become ineligible for immediate reconstruction because of this possible radiation. I therefore accentuate the advantage of at least initiating treatment with lumpectomy and sentinel lymph node biopsy. The patient preserves all of her surgical options with the benefit of having more staging information. If she is found to have SLN metastatic disease then she is in a better position to avoid the ALND with lumpectomy and radiation, and the option of future mastectomy and immediate reconstruction would still be available to her in the future (after completing all of her cancer treatment and healing from her radiation); if the SLN is negative, she can either continue with the breast-conservation treatment plan or she can pursue mastectomy (with or without immediate breast reconstruction, since prophylactic mamillary radiation therapy is not likely to be indicated for node-negative disease).

The second approach is relevant to the patient requiring mastectomy but for whom delayed reconstruction is planned because of medical issues or anticipated postmastectomy radiation. I encourage these patients to at least consider deferring the decision for the CPM until they return for the delayed reconstruction of the cancerous mastectomy, because at that time they can undergo the prophylactic mastectomy with the cosmetic advantages of immediate reconstruction.

Cost considerations

From the public health and population-based breast cancer burden perspectives as well as for individual patients, there are additional issues to be factored into the CPM discussion. It is a basic reality that cost is relevant when it comes to sorting out the net benefit of particular medical interventions, especially those that are prophylactic. Interestingly, a cost analysis study by Zendejas et al. (J. Clin. Oncol. 2011;29:2993-3000) from the Mayo Clinic demonstrated that CPM is actually cost effective, compared with surveillance for patients diagnosed when they are younger than 70 years of age.

The Women’s Health and Cancer Rights Act was implemented in 1999, mandating insurance coverage for breast reconstruction after mastectomy performed for cancer. This legislation promoted more widespread acceptance (and reimbursement) for contralateral mastectomy/reconstruction, but patients should nonetheless be proactive about confirming that their individual policy will indeed cover the expenses of prophylactic surgery. Furthermore, we must continue to monitor outcomes in women who choose to undergo CPM, as advances in breast cancer therapies may influence the survival benefits of this surgical approach. Indeed, selected retrospective studies have recently demonstrated that patients undergoing CPM have an improved survival, compared with those focusing on unilateral breast cancer surgery (Ann. Surg. Oncol. 2010;17:2702-9; J. Natl. Cancer Inst. 2010;102:401-9; J. Clin. Oncol. 2005;23:4275-86; Am. J. Surg. 2000;180:439-45). These results suggest a survival advantage associated with avoidance of a contralateral breast cancer, in contrast to the historical data alluded to above, regarding survival equivalence for patients with unilateral compared to metachronous bilateral breast cancer. As adjuvant systemic therapies for breast cancer continue to improve in effectiveness and ability to completely eliminate distant organ micrometastases, it is likely that we will continue to increase the pool of women who are essentially "cured" of the first cancer. This in turn could potentially increase the longevity threat of a second/metachronous cancer though a renewed metastatic risk. Nonetheless, data on possible survival advantages of CPM have not yet matured to the point where it can be recommended as a medically "indicated" procedure.

Our breast cancer patients face an abundance of very legitimate fears related to the morbidity and mortality risks of the actual cancer as well as the adverse effects and toxicities of treatment for that cancer. Fortunately, we can assure them that for the majority of cases these treatments will be effective and their longevity will be protected. It is therefore understandable that the desire to avoid repeating this particular life experience may be strong. We have an obligation to explain the advantages and disadvantages, as well as the alternatives to CPM, with sensitivity and patience. We must also strive to make sure that our patients do not make premature decisions without understanding the consequences. Last, but certainly not least, we are ethically bound to offer only those treatments that we feel are medically reasonable and safe as well as oncologically sound. But we must also remember that the decision to pursue treatment and the choice between the options that we offer are ultimately rights that belong to the patient.

Dr. Newman in an ACS Fellow, professor of surgery, and director of the Breast Care Center and Multidisciplinary Breast Fellowship Program, University of Michigan Comprehensive Cancer Center, Ann Arbor.