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Patient safety and tort reform
Question: Developments in medical tort reform include:
A. Continued constitutional challenges to caps on damages.
B. An emphasis on patient safety.
C. Hillary Clinton’s Senate bill.
D. Linking medical tort reform to error reduction.
E. All of the above.
Answer: E. Recent years have witnessed a stabilizing environment for medical liability, although insurance premiums continue to vary greatly by specialty and geographic location.
Recent statistics from the American Medical Association show that 2014 ob.gyn. insurance rates range from less than $50,000 in some areas of California to a high of $215,000 in Nassau and Suffolk counties in New York. The highest average expense in 2013, around a quarter of a million dollars, was for those claims that resulted in plaintiff verdicts, while defendant verdicts were substantially lower and averaged $140,000.
As in the past, most claims were dropped, dismissed, or withdrawn. About one-quarter of claims were settled, with only 2% decided by an alternative dispute resolution. Less than 8% were decided by trial verdict, with the vast majority won by the defendant.
The plaintiff bar continues to mount constitutional challenges to caps on damages. The California Supreme Court had previously ruled that reforms under California’s historic Medical Injury Compensation Reform Act (MICRA)1, which limits noneconomic recovery to $250,000, are constitutional, because they are rationally related to the legitimate legislative goal of reducing medical costs.
However, the statute has again come under challenge, only to be reaffirmed by a California state appeals court. In November 2014, California voters rejected Proposition 46, which sought to increase the cap from $250,000 to $1.1 million.
Texas, another pro-reform state, sides with California, and Mississippi also ruled that its damage cap is constitutional. However, Florida and Oklahoma recently joined jurisdictions such as Georgia, Illinois, and Missouri in ruling that damage caps are unconstitutional.
Asserting that the current health care liability system has been an inefficient and sometimes ineffective mechanism for initiating or resolving claims of medical error, medical negligence, or malpractice, then-U.S. senators Hillary Clinton (D-N.Y.) and Barack Obama (D-Ill.) in 2005 jointly sponsored legislation (S. 1784) to establish a National Medical Error Disclosure and Compensation Program (National MEDiC Act). Although the bill was killed in Senate committee, its key provisions were subsequently published in the New England Journal of Medicine (2006;354:2205-8).
The senators noted that the liability system has failed to the extent that only one medical malpractice claim is filed for every eight medical injuries, that it takes 4-8 years to resolve a claim, and that “solutions to the patient safety, litigation, and medical liability insurance problems have been elusive.”
Accordingly, the bill’s purpose was to promote the confidential disclosure to patients of medical errors in an effort to improve patient-safety systems. At the time of disclosure, there would be negotiations for compensation and proposals to prevent a recurrence of the problem that led to the patient’s injury. However, the patient would retain the right to counsel during negotiations, as well as access to the courts if no agreement were reached. The bill was entirely silent on traditional tort reform measures.
Nearly 4 decades earlier, a no-fault proposal by Professor Jeffrey O’Connell made some of these points, but with sharper focus and specificity, especially regarding damages.2
In marked contrast to the Clinton-Obama bill, his proposal gave the medical provider the exclusive option to tender payment, which would completely foreclose future tort action by the victim. Compensation benefits included net economic loss such as 100% of lost wages, replacement service loss, medical treatment expenses, and reasonable attorney’s fees. But noneconomic losses, such as pain and suffering, were not reimbursable, and payment was net of any benefits from collateral sources.
This proposal elegantly combined efficiency and fairness, and would have ameliorated the financial and emotional toll that comes with litigating injuries arising out of health care. Legislation in the House of Representatives, the Alternative Medical Liability Act (H.R. 5400), incorporated many of these features, and came before the 98th U.S. Congress in 1984. It, too, died in committee.
There may be something to the current trend toward pairing tort reform with error reduction. Thoughtful observers point to “disclosure and offer” programs such as the one at the Lexington (Ky.) Veterans Affairs Medical Center, which boasts average settlements of approximately $15,000 per claim – compared with more than $98,000 at other VA institutions. Its policy has also decreased the average duration of cases, previously 2-4 years, to 2-4 months, as well as reduced costs for legal defense.
Likewise, the program at the University of Michigan Health System has reduced both the frequency and severity of claims, duration of cases, and litigation costs. Aware of these developments, some private insurers, such as the COPIC Insurance Company in Colorado, are adopting a similar approach.
In its updated 2014 tort reform position paper, the American College of Physicians continues to endorse caps on noneconomic and punitive damages, as well as other tort reform measures.
However, it now acknowledges that “improving patient safety and preventing errors must be at the fore of the medical liability reform discussion.” The ACP correctly asserts that “emphasizing patient safety, promoting a culture of quality improvement and coordinated care, and training physicians in best practices to avoid errors and reduce risk will prevent harm and reduce the waste associated with defensive medicine.”
This hybrid approach combining traditional tort reforms with a renewed attention to patient safety through medical error reduction may yet yield additional practical benefits.
Here, the experience in anesthesiology bears recounting: Its dramatic progress in risk management has cut patient death rate from 1 in 5,000 to 1 in 200,000 to 300,000 in the space of 20 years, and this has been associated with a concurrent 37% fall in insurance premiums.
References
1. Medical Injury Compensation Reform Act of 1975, Cal. Civ. Proc. Code § 3333.2 (West 1982).
2. O’Connell, J. No-Fault Insurance for Injuries Arising from Medical Treatment: A Proposal for Elective Coverage. Emory L. J. 1975;24:21.
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. Currently, he directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].
Question: Developments in medical tort reform include:
A. Continued constitutional challenges to caps on damages.
B. An emphasis on patient safety.
C. Hillary Clinton’s Senate bill.
D. Linking medical tort reform to error reduction.
E. All of the above.
Answer: E. Recent years have witnessed a stabilizing environment for medical liability, although insurance premiums continue to vary greatly by specialty and geographic location.
Recent statistics from the American Medical Association show that 2014 ob.gyn. insurance rates range from less than $50,000 in some areas of California to a high of $215,000 in Nassau and Suffolk counties in New York. The highest average expense in 2013, around a quarter of a million dollars, was for those claims that resulted in plaintiff verdicts, while defendant verdicts were substantially lower and averaged $140,000.
As in the past, most claims were dropped, dismissed, or withdrawn. About one-quarter of claims were settled, with only 2% decided by an alternative dispute resolution. Less than 8% were decided by trial verdict, with the vast majority won by the defendant.
The plaintiff bar continues to mount constitutional challenges to caps on damages. The California Supreme Court had previously ruled that reforms under California’s historic Medical Injury Compensation Reform Act (MICRA)1, which limits noneconomic recovery to $250,000, are constitutional, because they are rationally related to the legitimate legislative goal of reducing medical costs.
However, the statute has again come under challenge, only to be reaffirmed by a California state appeals court. In November 2014, California voters rejected Proposition 46, which sought to increase the cap from $250,000 to $1.1 million.
Texas, another pro-reform state, sides with California, and Mississippi also ruled that its damage cap is constitutional. However, Florida and Oklahoma recently joined jurisdictions such as Georgia, Illinois, and Missouri in ruling that damage caps are unconstitutional.
Asserting that the current health care liability system has been an inefficient and sometimes ineffective mechanism for initiating or resolving claims of medical error, medical negligence, or malpractice, then-U.S. senators Hillary Clinton (D-N.Y.) and Barack Obama (D-Ill.) in 2005 jointly sponsored legislation (S. 1784) to establish a National Medical Error Disclosure and Compensation Program (National MEDiC Act). Although the bill was killed in Senate committee, its key provisions were subsequently published in the New England Journal of Medicine (2006;354:2205-8).
The senators noted that the liability system has failed to the extent that only one medical malpractice claim is filed for every eight medical injuries, that it takes 4-8 years to resolve a claim, and that “solutions to the patient safety, litigation, and medical liability insurance problems have been elusive.”
Accordingly, the bill’s purpose was to promote the confidential disclosure to patients of medical errors in an effort to improve patient-safety systems. At the time of disclosure, there would be negotiations for compensation and proposals to prevent a recurrence of the problem that led to the patient’s injury. However, the patient would retain the right to counsel during negotiations, as well as access to the courts if no agreement were reached. The bill was entirely silent on traditional tort reform measures.
Nearly 4 decades earlier, a no-fault proposal by Professor Jeffrey O’Connell made some of these points, but with sharper focus and specificity, especially regarding damages.2
In marked contrast to the Clinton-Obama bill, his proposal gave the medical provider the exclusive option to tender payment, which would completely foreclose future tort action by the victim. Compensation benefits included net economic loss such as 100% of lost wages, replacement service loss, medical treatment expenses, and reasonable attorney’s fees. But noneconomic losses, such as pain and suffering, were not reimbursable, and payment was net of any benefits from collateral sources.
This proposal elegantly combined efficiency and fairness, and would have ameliorated the financial and emotional toll that comes with litigating injuries arising out of health care. Legislation in the House of Representatives, the Alternative Medical Liability Act (H.R. 5400), incorporated many of these features, and came before the 98th U.S. Congress in 1984. It, too, died in committee.
There may be something to the current trend toward pairing tort reform with error reduction. Thoughtful observers point to “disclosure and offer” programs such as the one at the Lexington (Ky.) Veterans Affairs Medical Center, which boasts average settlements of approximately $15,000 per claim – compared with more than $98,000 at other VA institutions. Its policy has also decreased the average duration of cases, previously 2-4 years, to 2-4 months, as well as reduced costs for legal defense.
Likewise, the program at the University of Michigan Health System has reduced both the frequency and severity of claims, duration of cases, and litigation costs. Aware of these developments, some private insurers, such as the COPIC Insurance Company in Colorado, are adopting a similar approach.
In its updated 2014 tort reform position paper, the American College of Physicians continues to endorse caps on noneconomic and punitive damages, as well as other tort reform measures.
However, it now acknowledges that “improving patient safety and preventing errors must be at the fore of the medical liability reform discussion.” The ACP correctly asserts that “emphasizing patient safety, promoting a culture of quality improvement and coordinated care, and training physicians in best practices to avoid errors and reduce risk will prevent harm and reduce the waste associated with defensive medicine.”
This hybrid approach combining traditional tort reforms with a renewed attention to patient safety through medical error reduction may yet yield additional practical benefits.
Here, the experience in anesthesiology bears recounting: Its dramatic progress in risk management has cut patient death rate from 1 in 5,000 to 1 in 200,000 to 300,000 in the space of 20 years, and this has been associated with a concurrent 37% fall in insurance premiums.
References
1. Medical Injury Compensation Reform Act of 1975, Cal. Civ. Proc. Code § 3333.2 (West 1982).
2. O’Connell, J. No-Fault Insurance for Injuries Arising from Medical Treatment: A Proposal for Elective Coverage. Emory L. J. 1975;24:21.
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. Currently, he directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].
Question: Developments in medical tort reform include:
A. Continued constitutional challenges to caps on damages.
B. An emphasis on patient safety.
C. Hillary Clinton’s Senate bill.
D. Linking medical tort reform to error reduction.
E. All of the above.
Answer: E. Recent years have witnessed a stabilizing environment for medical liability, although insurance premiums continue to vary greatly by specialty and geographic location.
Recent statistics from the American Medical Association show that 2014 ob.gyn. insurance rates range from less than $50,000 in some areas of California to a high of $215,000 in Nassau and Suffolk counties in New York. The highest average expense in 2013, around a quarter of a million dollars, was for those claims that resulted in plaintiff verdicts, while defendant verdicts were substantially lower and averaged $140,000.
As in the past, most claims were dropped, dismissed, or withdrawn. About one-quarter of claims were settled, with only 2% decided by an alternative dispute resolution. Less than 8% were decided by trial verdict, with the vast majority won by the defendant.
The plaintiff bar continues to mount constitutional challenges to caps on damages. The California Supreme Court had previously ruled that reforms under California’s historic Medical Injury Compensation Reform Act (MICRA)1, which limits noneconomic recovery to $250,000, are constitutional, because they are rationally related to the legitimate legislative goal of reducing medical costs.
However, the statute has again come under challenge, only to be reaffirmed by a California state appeals court. In November 2014, California voters rejected Proposition 46, which sought to increase the cap from $250,000 to $1.1 million.
Texas, another pro-reform state, sides with California, and Mississippi also ruled that its damage cap is constitutional. However, Florida and Oklahoma recently joined jurisdictions such as Georgia, Illinois, and Missouri in ruling that damage caps are unconstitutional.
Asserting that the current health care liability system has been an inefficient and sometimes ineffective mechanism for initiating or resolving claims of medical error, medical negligence, or malpractice, then-U.S. senators Hillary Clinton (D-N.Y.) and Barack Obama (D-Ill.) in 2005 jointly sponsored legislation (S. 1784) to establish a National Medical Error Disclosure and Compensation Program (National MEDiC Act). Although the bill was killed in Senate committee, its key provisions were subsequently published in the New England Journal of Medicine (2006;354:2205-8).
The senators noted that the liability system has failed to the extent that only one medical malpractice claim is filed for every eight medical injuries, that it takes 4-8 years to resolve a claim, and that “solutions to the patient safety, litigation, and medical liability insurance problems have been elusive.”
Accordingly, the bill’s purpose was to promote the confidential disclosure to patients of medical errors in an effort to improve patient-safety systems. At the time of disclosure, there would be negotiations for compensation and proposals to prevent a recurrence of the problem that led to the patient’s injury. However, the patient would retain the right to counsel during negotiations, as well as access to the courts if no agreement were reached. The bill was entirely silent on traditional tort reform measures.
Nearly 4 decades earlier, a no-fault proposal by Professor Jeffrey O’Connell made some of these points, but with sharper focus and specificity, especially regarding damages.2
In marked contrast to the Clinton-Obama bill, his proposal gave the medical provider the exclusive option to tender payment, which would completely foreclose future tort action by the victim. Compensation benefits included net economic loss such as 100% of lost wages, replacement service loss, medical treatment expenses, and reasonable attorney’s fees. But noneconomic losses, such as pain and suffering, were not reimbursable, and payment was net of any benefits from collateral sources.
This proposal elegantly combined efficiency and fairness, and would have ameliorated the financial and emotional toll that comes with litigating injuries arising out of health care. Legislation in the House of Representatives, the Alternative Medical Liability Act (H.R. 5400), incorporated many of these features, and came before the 98th U.S. Congress in 1984. It, too, died in committee.
There may be something to the current trend toward pairing tort reform with error reduction. Thoughtful observers point to “disclosure and offer” programs such as the one at the Lexington (Ky.) Veterans Affairs Medical Center, which boasts average settlements of approximately $15,000 per claim – compared with more than $98,000 at other VA institutions. Its policy has also decreased the average duration of cases, previously 2-4 years, to 2-4 months, as well as reduced costs for legal defense.
Likewise, the program at the University of Michigan Health System has reduced both the frequency and severity of claims, duration of cases, and litigation costs. Aware of these developments, some private insurers, such as the COPIC Insurance Company in Colorado, are adopting a similar approach.
In its updated 2014 tort reform position paper, the American College of Physicians continues to endorse caps on noneconomic and punitive damages, as well as other tort reform measures.
However, it now acknowledges that “improving patient safety and preventing errors must be at the fore of the medical liability reform discussion.” The ACP correctly asserts that “emphasizing patient safety, promoting a culture of quality improvement and coordinated care, and training physicians in best practices to avoid errors and reduce risk will prevent harm and reduce the waste associated with defensive medicine.”
This hybrid approach combining traditional tort reforms with a renewed attention to patient safety through medical error reduction may yet yield additional practical benefits.
Here, the experience in anesthesiology bears recounting: Its dramatic progress in risk management has cut patient death rate from 1 in 5,000 to 1 in 200,000 to 300,000 in the space of 20 years, and this has been associated with a concurrent 37% fall in insurance premiums.
References
1. Medical Injury Compensation Reform Act of 1975, Cal. Civ. Proc. Code § 3333.2 (West 1982).
2. O’Connell, J. No-Fault Insurance for Injuries Arising from Medical Treatment: A Proposal for Elective Coverage. Emory L. J. 1975;24:21.
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. Currently, he directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].
Going for the Gold
As we enter 2015 and approach the golden (50th) anniversary of both the NP and PA professions, dating back to Dr. Loretta Ford1 at the University of Colorado and Dr. Eugene Stead2 at Duke University (circa 1965), it is important to reflect on not only where we have been but also where we want our professions to go in the next half-century.
Since I am a PA, some may suggest that it is dangerous and ambitious for me to speak/project for both professions. They may also note that the professions are distinct and my suggestions and reflections do not apply to NPs. Well, I guess I am willing to take that risk. As a colleague, friend, and co-Editor-in-Chief of Marie-Eileen Onieal, I have found that we agree much more often on issues (both political and practical) than we disagree.
NPs and PAs have worked diligently over the past half-century to develop our individual professions, in terms of reimbursement, prescribing privileges, state licensure, commissioning in the uniformed services, and expansion of scope of practice. Studies continue to show that we provide quality health care with similar outcomes as physicians, thus making us cost-effective members of the health care team.3-7
So, here we are in 2015. While it is difficult to get accurate data, Table 1 shows the number of clinicians reported in the most recent US Health Workforce Chartbook.8 As we well know, our professions have grown exponentially from our humble beginnings in the mid-1960s. (The first class of PAs comprised four students, if you recall.)
At the risk of sounding like a fossil (Oh never mind—I am a fossil!), let me be presumptuous and share with you six areas in which I think both professions can “do more” through the second half-century of our existence. In my opinion, we should focus on:
1. Diversity. As presented in Table 2, the majority of PAs and NPs are (non-Hispanic) white. Our efforts, should you agree with me, must start at the educational program level, through recruitment and retention of students from unrepresented and underrepresented groups. Another focal point should be the recruitment and retention of faculty and staff in these programs who reflect the diversity of our nation.
When I consider the origins of my profession, the key point is opportunity. Dr. Stead and other pioneers sought to fill a serious need for health care providers while also creating opportunities for military medics who were highly skilled but who did not meet requirements for many jobs within the medical community. Now it is time for us to ensure that other groups have similar opportunities to advance themselves and also fill gaps in the health care system.
Continue for more areas to focus on >>
2. Workforce planning and policy. This requires better data collection and an improved information infrastructure. In a 2014 editorial, Rod Hooker suggested that this is the golden age for PAs (about whom he was writing, although the same holds true for NPs) because US health care reform has identified our contributions to society and new policies place us upfront and center stage in producing labor solutions.9
It is time for our professions to do a better job in studying and reporting the important contributions we make in health care delivery. We need to have a place at the table—be it within a facility or at the state or federal level—whenever policy, utilization, and roles are discussed. Even if we as employees are subordinate to management in a particular setting, we should have a voice in how we are utilized in the workplace; we should ensure that those who make decisions—if we are not them—have the fullest picture of who we are and what we can do. It is not enough to use anecdotal evidence; we need to have data readily at hand that unequivocally support our assertions of value to patient care.
Hooker went so far as to call for the creation of a “physician assistant institute” to assist in the development and dissemination of reliable information about the profession. I think this is an idea whose time has come, but who will step up to the plate? If you are an NP, you may say, “What about us?” I would suggest this issue pertains to both of our professions—and in fact, this is an area in which I would encourage a collaborative effort. What a concept!
3. Ethics. In the past decade, there has been a renewed focus on maintaining an ethical culture in health care. As clinicians, we practice in an environment that affects the lives of everyone. Our patients and their family members expect high-quality care, patient safety, and use of the latest and most appropriate technology.
In the middle of this climate, we find a health care system that is probably the most entrepreneurial, corporatized, and profit-driven health system in the world. Most of our practice settings (outside the federal government) are for-profit entities. It is easy in this environment to fall victim to conflicts of interest and to acquire an economically oriented practice attitude.
If our first priority is the best possible health care for our patients, then integrity and ethical behavior naturally follow. Professionalism at its very heart places the patient’s interests ahead of our own. We must keep this in mind as we navigate the ever-changing health system.
Next page: Key area number four >>
4. Humanitarianism. I would encourage us to be actively engaged in promoting human welfare and social reforms with no prejudice on grounds of gender, sexual orientation, or religious or ethnic differences. Our goal should be to save lives, relieve suffering, and maintain human dignity.
How do we do this? Many of us have at some point in our careers volunteered our professional services at free clinics or other venues that provide health care to those who otherwise have difficulty accessing it. Some of us take that spirit a step further, traveling abroad on medical missions or responding to natural disasters or civil disturbances.
While using our medical and nursing skills for the good of society is ideal, we can also represent ourselves and our professions well by being good members of the community—not just the “medical” community. Perhaps we provide food and shelter to the homeless in our area or mentor young people.
Anything we do to help not only benefits us and the recipient; it also shows the community that our concept of “care” extends beyond the confines of the clinic or emergency department or operating theater in which we work. We have a very special calling, and I’m always pleased when our professional journals highlight the efforts of our colleagues to “help out”; their stories should inspire us all.
5. Appreciation. As NPs and PAs, we provide health care (whether from a medical or nursing standpoint), a revered calling since the days of Hippocrates. This privilege allows us to enter into a bond with our patients and assist them in a personal and fundamental way. It is no small thing to be involved in curing illness and promoting well-being. We should always remember that our role carries responsibility as well as provides rewards.
Despite the greater availability of diagnostic technologies and advancements in therapeutic abilities, we continue to see increasing disparities in the delivery of health care. Our professions must work diligently to find ways to address the issues of quality, accessibility, and cost of health care in the US. What kind of “stewards” will we be? That is our heritage!
Continue for the last area PAs and NPs need to grow in >>
6. Action. At the risk of sounding like a cheerleader, being part of the NP or PA profession is something special; it always has been and always will be. Our professions have grown impressively in numbers, utilization, and stature. We need to cultivate and support our professions and their representative organizations (ie, AANP and AAPA).
In the early decades of each profession, individuals with a great deal of passion and dedication created, advanced, and led these organizations on both state and national levels—and even an international level. You know who they are! Without them, we would not have made the strides that we have as professionals—the attainment of licensure, authority, and reimbursement.
Now that we are being truly recognized for our role in the health care team and our contributions to patient care, some of us may become complacent with regard to our professional organizations. But there will always be legislative and regulatory gains to make, and strong representation (and “strength in numbers”) is the best way to achieve our professional goals. Please, let’s continue to support our organizations not only via membership (which provides funding for initiatives) but also by participating in whatever ways we can to further our professions.
If we are going to fully cement our place in America’s health care system, NPs and PAs must strive to keep up the national dialogue about our patients, their needs, and how our contributions address those needs. I hope you agree. Please share your thoughts with me at PAEditor@frontline medcom.com.
REFERENCES
1. Ridgway S. Loretta Ford, founded nurse practitioner movement. Working Nurse. www.workingnurse.com/articles/loretta-ford-founded-nurse-practitioner-movement. Accessed January 16, 2015.
2. Physician Assistant History Society. Eugene A. Stead Jr, MD. http://pahx.org/stead-jr-eugene. Accessed January 16, 2015.
3. Kartha A, Restuccia J, Burgess J, et al. Nurse practitioner and physician assistant scope of practice in 118 acute care hospitals. J Hosp Med. 2014:9(10); 615-620.
4. Naylor MD, Kurtzman ET. The role of nurse practitioners in reinventing primary care. Health Affairs. 2010;29(5):893-899.
5. Horrocks S, Anderson E, Salisbury C. Systematic review of whether nurse practitioners working in primary care can provide equivalent care to doctors. BMJ. 2002;324:819-823.
6. Halter M, Drennan V, Chattopadhyay K, et al. The contribution of physician assistants in primary care: a systematic review. BMC Health Services Research. 2013;13:223-236.
7. Hooker RS, Everett CM. The contributions of physician assistants in primary care systems. Health Social Care Commun. 2012;20(1):20-31.
8. US Department of Health and Human Services, Health Resources and Services Administration, National Center for Health Workforce Analysis. The US Health Workforce Chartbook. Part 1: Clinicians. Rockville, MD; 2013.
9. Hooker R. A physician assistant institute [editorial]. J Phys Assist Ed. 2014;25(3):5-6.
As we enter 2015 and approach the golden (50th) anniversary of both the NP and PA professions, dating back to Dr. Loretta Ford1 at the University of Colorado and Dr. Eugene Stead2 at Duke University (circa 1965), it is important to reflect on not only where we have been but also where we want our professions to go in the next half-century.
Since I am a PA, some may suggest that it is dangerous and ambitious for me to speak/project for both professions. They may also note that the professions are distinct and my suggestions and reflections do not apply to NPs. Well, I guess I am willing to take that risk. As a colleague, friend, and co-Editor-in-Chief of Marie-Eileen Onieal, I have found that we agree much more often on issues (both political and practical) than we disagree.
NPs and PAs have worked diligently over the past half-century to develop our individual professions, in terms of reimbursement, prescribing privileges, state licensure, commissioning in the uniformed services, and expansion of scope of practice. Studies continue to show that we provide quality health care with similar outcomes as physicians, thus making us cost-effective members of the health care team.3-7
So, here we are in 2015. While it is difficult to get accurate data, Table 1 shows the number of clinicians reported in the most recent US Health Workforce Chartbook.8 As we well know, our professions have grown exponentially from our humble beginnings in the mid-1960s. (The first class of PAs comprised four students, if you recall.)
At the risk of sounding like a fossil (Oh never mind—I am a fossil!), let me be presumptuous and share with you six areas in which I think both professions can “do more” through the second half-century of our existence. In my opinion, we should focus on:
1. Diversity. As presented in Table 2, the majority of PAs and NPs are (non-Hispanic) white. Our efforts, should you agree with me, must start at the educational program level, through recruitment and retention of students from unrepresented and underrepresented groups. Another focal point should be the recruitment and retention of faculty and staff in these programs who reflect the diversity of our nation.
When I consider the origins of my profession, the key point is opportunity. Dr. Stead and other pioneers sought to fill a serious need for health care providers while also creating opportunities for military medics who were highly skilled but who did not meet requirements for many jobs within the medical community. Now it is time for us to ensure that other groups have similar opportunities to advance themselves and also fill gaps in the health care system.
Continue for more areas to focus on >>
2. Workforce planning and policy. This requires better data collection and an improved information infrastructure. In a 2014 editorial, Rod Hooker suggested that this is the golden age for PAs (about whom he was writing, although the same holds true for NPs) because US health care reform has identified our contributions to society and new policies place us upfront and center stage in producing labor solutions.9
It is time for our professions to do a better job in studying and reporting the important contributions we make in health care delivery. We need to have a place at the table—be it within a facility or at the state or federal level—whenever policy, utilization, and roles are discussed. Even if we as employees are subordinate to management in a particular setting, we should have a voice in how we are utilized in the workplace; we should ensure that those who make decisions—if we are not them—have the fullest picture of who we are and what we can do. It is not enough to use anecdotal evidence; we need to have data readily at hand that unequivocally support our assertions of value to patient care.
Hooker went so far as to call for the creation of a “physician assistant institute” to assist in the development and dissemination of reliable information about the profession. I think this is an idea whose time has come, but who will step up to the plate? If you are an NP, you may say, “What about us?” I would suggest this issue pertains to both of our professions—and in fact, this is an area in which I would encourage a collaborative effort. What a concept!
3. Ethics. In the past decade, there has been a renewed focus on maintaining an ethical culture in health care. As clinicians, we practice in an environment that affects the lives of everyone. Our patients and their family members expect high-quality care, patient safety, and use of the latest and most appropriate technology.
In the middle of this climate, we find a health care system that is probably the most entrepreneurial, corporatized, and profit-driven health system in the world. Most of our practice settings (outside the federal government) are for-profit entities. It is easy in this environment to fall victim to conflicts of interest and to acquire an economically oriented practice attitude.
If our first priority is the best possible health care for our patients, then integrity and ethical behavior naturally follow. Professionalism at its very heart places the patient’s interests ahead of our own. We must keep this in mind as we navigate the ever-changing health system.
Next page: Key area number four >>
4. Humanitarianism. I would encourage us to be actively engaged in promoting human welfare and social reforms with no prejudice on grounds of gender, sexual orientation, or religious or ethnic differences. Our goal should be to save lives, relieve suffering, and maintain human dignity.
How do we do this? Many of us have at some point in our careers volunteered our professional services at free clinics or other venues that provide health care to those who otherwise have difficulty accessing it. Some of us take that spirit a step further, traveling abroad on medical missions or responding to natural disasters or civil disturbances.
While using our medical and nursing skills for the good of society is ideal, we can also represent ourselves and our professions well by being good members of the community—not just the “medical” community. Perhaps we provide food and shelter to the homeless in our area or mentor young people.
Anything we do to help not only benefits us and the recipient; it also shows the community that our concept of “care” extends beyond the confines of the clinic or emergency department or operating theater in which we work. We have a very special calling, and I’m always pleased when our professional journals highlight the efforts of our colleagues to “help out”; their stories should inspire us all.
5. Appreciation. As NPs and PAs, we provide health care (whether from a medical or nursing standpoint), a revered calling since the days of Hippocrates. This privilege allows us to enter into a bond with our patients and assist them in a personal and fundamental way. It is no small thing to be involved in curing illness and promoting well-being. We should always remember that our role carries responsibility as well as provides rewards.
Despite the greater availability of diagnostic technologies and advancements in therapeutic abilities, we continue to see increasing disparities in the delivery of health care. Our professions must work diligently to find ways to address the issues of quality, accessibility, and cost of health care in the US. What kind of “stewards” will we be? That is our heritage!
Continue for the last area PAs and NPs need to grow in >>
6. Action. At the risk of sounding like a cheerleader, being part of the NP or PA profession is something special; it always has been and always will be. Our professions have grown impressively in numbers, utilization, and stature. We need to cultivate and support our professions and their representative organizations (ie, AANP and AAPA).
In the early decades of each profession, individuals with a great deal of passion and dedication created, advanced, and led these organizations on both state and national levels—and even an international level. You know who they are! Without them, we would not have made the strides that we have as professionals—the attainment of licensure, authority, and reimbursement.
Now that we are being truly recognized for our role in the health care team and our contributions to patient care, some of us may become complacent with regard to our professional organizations. But there will always be legislative and regulatory gains to make, and strong representation (and “strength in numbers”) is the best way to achieve our professional goals. Please, let’s continue to support our organizations not only via membership (which provides funding for initiatives) but also by participating in whatever ways we can to further our professions.
If we are going to fully cement our place in America’s health care system, NPs and PAs must strive to keep up the national dialogue about our patients, their needs, and how our contributions address those needs. I hope you agree. Please share your thoughts with me at PAEditor@frontline medcom.com.
REFERENCES
1. Ridgway S. Loretta Ford, founded nurse practitioner movement. Working Nurse. www.workingnurse.com/articles/loretta-ford-founded-nurse-practitioner-movement. Accessed January 16, 2015.
2. Physician Assistant History Society. Eugene A. Stead Jr, MD. http://pahx.org/stead-jr-eugene. Accessed January 16, 2015.
3. Kartha A, Restuccia J, Burgess J, et al. Nurse practitioner and physician assistant scope of practice in 118 acute care hospitals. J Hosp Med. 2014:9(10); 615-620.
4. Naylor MD, Kurtzman ET. The role of nurse practitioners in reinventing primary care. Health Affairs. 2010;29(5):893-899.
5. Horrocks S, Anderson E, Salisbury C. Systematic review of whether nurse practitioners working in primary care can provide equivalent care to doctors. BMJ. 2002;324:819-823.
6. Halter M, Drennan V, Chattopadhyay K, et al. The contribution of physician assistants in primary care: a systematic review. BMC Health Services Research. 2013;13:223-236.
7. Hooker RS, Everett CM. The contributions of physician assistants in primary care systems. Health Social Care Commun. 2012;20(1):20-31.
8. US Department of Health and Human Services, Health Resources and Services Administration, National Center for Health Workforce Analysis. The US Health Workforce Chartbook. Part 1: Clinicians. Rockville, MD; 2013.
9. Hooker R. A physician assistant institute [editorial]. J Phys Assist Ed. 2014;25(3):5-6.
As we enter 2015 and approach the golden (50th) anniversary of both the NP and PA professions, dating back to Dr. Loretta Ford1 at the University of Colorado and Dr. Eugene Stead2 at Duke University (circa 1965), it is important to reflect on not only where we have been but also where we want our professions to go in the next half-century.
Since I am a PA, some may suggest that it is dangerous and ambitious for me to speak/project for both professions. They may also note that the professions are distinct and my suggestions and reflections do not apply to NPs. Well, I guess I am willing to take that risk. As a colleague, friend, and co-Editor-in-Chief of Marie-Eileen Onieal, I have found that we agree much more often on issues (both political and practical) than we disagree.
NPs and PAs have worked diligently over the past half-century to develop our individual professions, in terms of reimbursement, prescribing privileges, state licensure, commissioning in the uniformed services, and expansion of scope of practice. Studies continue to show that we provide quality health care with similar outcomes as physicians, thus making us cost-effective members of the health care team.3-7
So, here we are in 2015. While it is difficult to get accurate data, Table 1 shows the number of clinicians reported in the most recent US Health Workforce Chartbook.8 As we well know, our professions have grown exponentially from our humble beginnings in the mid-1960s. (The first class of PAs comprised four students, if you recall.)
At the risk of sounding like a fossil (Oh never mind—I am a fossil!), let me be presumptuous and share with you six areas in which I think both professions can “do more” through the second half-century of our existence. In my opinion, we should focus on:
1. Diversity. As presented in Table 2, the majority of PAs and NPs are (non-Hispanic) white. Our efforts, should you agree with me, must start at the educational program level, through recruitment and retention of students from unrepresented and underrepresented groups. Another focal point should be the recruitment and retention of faculty and staff in these programs who reflect the diversity of our nation.
When I consider the origins of my profession, the key point is opportunity. Dr. Stead and other pioneers sought to fill a serious need for health care providers while also creating opportunities for military medics who were highly skilled but who did not meet requirements for many jobs within the medical community. Now it is time for us to ensure that other groups have similar opportunities to advance themselves and also fill gaps in the health care system.
Continue for more areas to focus on >>
2. Workforce planning and policy. This requires better data collection and an improved information infrastructure. In a 2014 editorial, Rod Hooker suggested that this is the golden age for PAs (about whom he was writing, although the same holds true for NPs) because US health care reform has identified our contributions to society and new policies place us upfront and center stage in producing labor solutions.9
It is time for our professions to do a better job in studying and reporting the important contributions we make in health care delivery. We need to have a place at the table—be it within a facility or at the state or federal level—whenever policy, utilization, and roles are discussed. Even if we as employees are subordinate to management in a particular setting, we should have a voice in how we are utilized in the workplace; we should ensure that those who make decisions—if we are not them—have the fullest picture of who we are and what we can do. It is not enough to use anecdotal evidence; we need to have data readily at hand that unequivocally support our assertions of value to patient care.
Hooker went so far as to call for the creation of a “physician assistant institute” to assist in the development and dissemination of reliable information about the profession. I think this is an idea whose time has come, but who will step up to the plate? If you are an NP, you may say, “What about us?” I would suggest this issue pertains to both of our professions—and in fact, this is an area in which I would encourage a collaborative effort. What a concept!
3. Ethics. In the past decade, there has been a renewed focus on maintaining an ethical culture in health care. As clinicians, we practice in an environment that affects the lives of everyone. Our patients and their family members expect high-quality care, patient safety, and use of the latest and most appropriate technology.
In the middle of this climate, we find a health care system that is probably the most entrepreneurial, corporatized, and profit-driven health system in the world. Most of our practice settings (outside the federal government) are for-profit entities. It is easy in this environment to fall victim to conflicts of interest and to acquire an economically oriented practice attitude.
If our first priority is the best possible health care for our patients, then integrity and ethical behavior naturally follow. Professionalism at its very heart places the patient’s interests ahead of our own. We must keep this in mind as we navigate the ever-changing health system.
Next page: Key area number four >>
4. Humanitarianism. I would encourage us to be actively engaged in promoting human welfare and social reforms with no prejudice on grounds of gender, sexual orientation, or religious or ethnic differences. Our goal should be to save lives, relieve suffering, and maintain human dignity.
How do we do this? Many of us have at some point in our careers volunteered our professional services at free clinics or other venues that provide health care to those who otherwise have difficulty accessing it. Some of us take that spirit a step further, traveling abroad on medical missions or responding to natural disasters or civil disturbances.
While using our medical and nursing skills for the good of society is ideal, we can also represent ourselves and our professions well by being good members of the community—not just the “medical” community. Perhaps we provide food and shelter to the homeless in our area or mentor young people.
Anything we do to help not only benefits us and the recipient; it also shows the community that our concept of “care” extends beyond the confines of the clinic or emergency department or operating theater in which we work. We have a very special calling, and I’m always pleased when our professional journals highlight the efforts of our colleagues to “help out”; their stories should inspire us all.
5. Appreciation. As NPs and PAs, we provide health care (whether from a medical or nursing standpoint), a revered calling since the days of Hippocrates. This privilege allows us to enter into a bond with our patients and assist them in a personal and fundamental way. It is no small thing to be involved in curing illness and promoting well-being. We should always remember that our role carries responsibility as well as provides rewards.
Despite the greater availability of diagnostic technologies and advancements in therapeutic abilities, we continue to see increasing disparities in the delivery of health care. Our professions must work diligently to find ways to address the issues of quality, accessibility, and cost of health care in the US. What kind of “stewards” will we be? That is our heritage!
Continue for the last area PAs and NPs need to grow in >>
6. Action. At the risk of sounding like a cheerleader, being part of the NP or PA profession is something special; it always has been and always will be. Our professions have grown impressively in numbers, utilization, and stature. We need to cultivate and support our professions and their representative organizations (ie, AANP and AAPA).
In the early decades of each profession, individuals with a great deal of passion and dedication created, advanced, and led these organizations on both state and national levels—and even an international level. You know who they are! Without them, we would not have made the strides that we have as professionals—the attainment of licensure, authority, and reimbursement.
Now that we are being truly recognized for our role in the health care team and our contributions to patient care, some of us may become complacent with regard to our professional organizations. But there will always be legislative and regulatory gains to make, and strong representation (and “strength in numbers”) is the best way to achieve our professional goals. Please, let’s continue to support our organizations not only via membership (which provides funding for initiatives) but also by participating in whatever ways we can to further our professions.
If we are going to fully cement our place in America’s health care system, NPs and PAs must strive to keep up the national dialogue about our patients, their needs, and how our contributions address those needs. I hope you agree. Please share your thoughts with me at PAEditor@frontline medcom.com.
REFERENCES
1. Ridgway S. Loretta Ford, founded nurse practitioner movement. Working Nurse. www.workingnurse.com/articles/loretta-ford-founded-nurse-practitioner-movement. Accessed January 16, 2015.
2. Physician Assistant History Society. Eugene A. Stead Jr, MD. http://pahx.org/stead-jr-eugene. Accessed January 16, 2015.
3. Kartha A, Restuccia J, Burgess J, et al. Nurse practitioner and physician assistant scope of practice in 118 acute care hospitals. J Hosp Med. 2014:9(10); 615-620.
4. Naylor MD, Kurtzman ET. The role of nurse practitioners in reinventing primary care. Health Affairs. 2010;29(5):893-899.
5. Horrocks S, Anderson E, Salisbury C. Systematic review of whether nurse practitioners working in primary care can provide equivalent care to doctors. BMJ. 2002;324:819-823.
6. Halter M, Drennan V, Chattopadhyay K, et al. The contribution of physician assistants in primary care: a systematic review. BMC Health Services Research. 2013;13:223-236.
7. Hooker RS, Everett CM. The contributions of physician assistants in primary care systems. Health Social Care Commun. 2012;20(1):20-31.
8. US Department of Health and Human Services, Health Resources and Services Administration, National Center for Health Workforce Analysis. The US Health Workforce Chartbook. Part 1: Clinicians. Rockville, MD; 2013.
9. Hooker R. A physician assistant institute [editorial]. J Phys Assist Ed. 2014;25(3):5-6.
Mother knew better
Like most pediatricians, I often think about parenting. It’s hard to ignore when your days and some nights are surrounded by it in a variety of forms ... the good the bad, and the ugly. Recently, I was trying to recall my own parents’ (mostly my Mom’s) style of parenting and discovered that I was having trouble remembering many of the specifics of how my sister and I were raised.
The haziness of that recollection could simply reflect my aging memory, but I prefer to interpret it as a sign that our parents consciously avoided being heavy handed in their approach. Granted, my sister and I have grown up to be reasonably agreeable adults and were relatively unadventurous children. But, we were far from angelic.
My mother was a quiet person. In fact, I have trouble recalling much about the sound of her voice. She was not one to debate or argue. Although my parents had their disagreements, my mother would refuse to argue, which infuriated my father. Instead she would state her position once and wait for the issue to play out. The result usually vindicated her softly stated position.
But, my mother wasn’t perfect, and it is those few parenting missteps that I remember ... most of them fondly. For example, when she first heard me swear (I don’t even remember the word), she said that I was to have my mouth washed out with soap. I assume she had heard this advice from my grandmother. However, she wasn’t quite clear on the technique. The result was a lot of fumbling around with a large bar of soap and a very small mouth. It certainly wasn’t a deterrent in large part, because I sensed she was giggling during the ordeal.
I don’t recall being spanked, but my mother was not adverse to physical deterrent. After years of reminding me to sit up straight at the dinner table, she took to nonchalantly – and without a word – poking me between the shoulder blades with a fork as she passed behind me while serving supper. No more idle threats, just a sharp reminder. Of course, it was no more effective than the soap, and I am still a sloucher.
My mother occasionally made attempts at anticipatory guidance with mixed results. One cold December morning as I was heading off to school, she took me aside and cautioned, “Now Willy, don’t ever stick your tongue on a cold pipe.” I’m not sure what prompted this warning because it was decades before this foolishness made it to the silver screen in Jean Shepherd’s “A Christmas Story.” Up to that point, putting my tongue on a cold pipe was an activity that had never crossed my little mind. But now she had planted the seed and for many winters I couldn’t pass a parking meter without the little devil on my shoulder whispering in my ear, “Go try it.”
The only parenting misstep for which I still hold a grudge is one in which my mother ignored her ample storehouse of good sense and floated with the mainstream of bad parental advice. Those of you born prior to 1965 probably share my painful memories of having to sit on the edge of the pond or lake until it had been exactly an hour since you had last eaten – eaten anything! A thoughtlessly nibbled cookie could result in a stomach cramp that could send you to the bottom, never to take another breath of air. It is unclear which medical genius came up with this idea, but I hope he is rotting in hell, doubled over with unremitting abdominal cramps. A rough calculation reveals that between the ages of 7 and 14 years, I wasted nearly 1,000 child-hours sitting on the edge of the town pool, impatiently waiting for peanut butter sandwiches to digest. I know my mother knew that the whole stomach cramp thing was bogus. But, she wasn’t strong enough to swim against the terrible tide of old wives’ tales.
Despite these trivial errors when I was a young child, my mother did her best parenting when I reached adolescence. Pleasantville, N.Y., was a small town of 5,000, and my mother seemed to know two-thirds of them by their first name. Or, at least I thought she did. Her web of contacts covered the town like a blanket. I was convinced that, like Santa Claus, she knew when I was sleeping, she knew when I was awake, she knew if I’d been bad or good. You get the picture. It was only many years later that I realized I had been buffaloed. Her omniscience had been a masterful act ... but it had worked.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “Coping with a Picky Eater.” E-mail him at [email protected].
Like most pediatricians, I often think about parenting. It’s hard to ignore when your days and some nights are surrounded by it in a variety of forms ... the good the bad, and the ugly. Recently, I was trying to recall my own parents’ (mostly my Mom’s) style of parenting and discovered that I was having trouble remembering many of the specifics of how my sister and I were raised.
The haziness of that recollection could simply reflect my aging memory, but I prefer to interpret it as a sign that our parents consciously avoided being heavy handed in their approach. Granted, my sister and I have grown up to be reasonably agreeable adults and were relatively unadventurous children. But, we were far from angelic.
My mother was a quiet person. In fact, I have trouble recalling much about the sound of her voice. She was not one to debate or argue. Although my parents had their disagreements, my mother would refuse to argue, which infuriated my father. Instead she would state her position once and wait for the issue to play out. The result usually vindicated her softly stated position.
But, my mother wasn’t perfect, and it is those few parenting missteps that I remember ... most of them fondly. For example, when she first heard me swear (I don’t even remember the word), she said that I was to have my mouth washed out with soap. I assume she had heard this advice from my grandmother. However, she wasn’t quite clear on the technique. The result was a lot of fumbling around with a large bar of soap and a very small mouth. It certainly wasn’t a deterrent in large part, because I sensed she was giggling during the ordeal.
I don’t recall being spanked, but my mother was not adverse to physical deterrent. After years of reminding me to sit up straight at the dinner table, she took to nonchalantly – and without a word – poking me between the shoulder blades with a fork as she passed behind me while serving supper. No more idle threats, just a sharp reminder. Of course, it was no more effective than the soap, and I am still a sloucher.
My mother occasionally made attempts at anticipatory guidance with mixed results. One cold December morning as I was heading off to school, she took me aside and cautioned, “Now Willy, don’t ever stick your tongue on a cold pipe.” I’m not sure what prompted this warning because it was decades before this foolishness made it to the silver screen in Jean Shepherd’s “A Christmas Story.” Up to that point, putting my tongue on a cold pipe was an activity that had never crossed my little mind. But now she had planted the seed and for many winters I couldn’t pass a parking meter without the little devil on my shoulder whispering in my ear, “Go try it.”
The only parenting misstep for which I still hold a grudge is one in which my mother ignored her ample storehouse of good sense and floated with the mainstream of bad parental advice. Those of you born prior to 1965 probably share my painful memories of having to sit on the edge of the pond or lake until it had been exactly an hour since you had last eaten – eaten anything! A thoughtlessly nibbled cookie could result in a stomach cramp that could send you to the bottom, never to take another breath of air. It is unclear which medical genius came up with this idea, but I hope he is rotting in hell, doubled over with unremitting abdominal cramps. A rough calculation reveals that between the ages of 7 and 14 years, I wasted nearly 1,000 child-hours sitting on the edge of the town pool, impatiently waiting for peanut butter sandwiches to digest. I know my mother knew that the whole stomach cramp thing was bogus. But, she wasn’t strong enough to swim against the terrible tide of old wives’ tales.
Despite these trivial errors when I was a young child, my mother did her best parenting when I reached adolescence. Pleasantville, N.Y., was a small town of 5,000, and my mother seemed to know two-thirds of them by their first name. Or, at least I thought she did. Her web of contacts covered the town like a blanket. I was convinced that, like Santa Claus, she knew when I was sleeping, she knew when I was awake, she knew if I’d been bad or good. You get the picture. It was only many years later that I realized I had been buffaloed. Her omniscience had been a masterful act ... but it had worked.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “Coping with a Picky Eater.” E-mail him at [email protected].
Like most pediatricians, I often think about parenting. It’s hard to ignore when your days and some nights are surrounded by it in a variety of forms ... the good the bad, and the ugly. Recently, I was trying to recall my own parents’ (mostly my Mom’s) style of parenting and discovered that I was having trouble remembering many of the specifics of how my sister and I were raised.
The haziness of that recollection could simply reflect my aging memory, but I prefer to interpret it as a sign that our parents consciously avoided being heavy handed in their approach. Granted, my sister and I have grown up to be reasonably agreeable adults and were relatively unadventurous children. But, we were far from angelic.
My mother was a quiet person. In fact, I have trouble recalling much about the sound of her voice. She was not one to debate or argue. Although my parents had their disagreements, my mother would refuse to argue, which infuriated my father. Instead she would state her position once and wait for the issue to play out. The result usually vindicated her softly stated position.
But, my mother wasn’t perfect, and it is those few parenting missteps that I remember ... most of them fondly. For example, when she first heard me swear (I don’t even remember the word), she said that I was to have my mouth washed out with soap. I assume she had heard this advice from my grandmother. However, she wasn’t quite clear on the technique. The result was a lot of fumbling around with a large bar of soap and a very small mouth. It certainly wasn’t a deterrent in large part, because I sensed she was giggling during the ordeal.
I don’t recall being spanked, but my mother was not adverse to physical deterrent. After years of reminding me to sit up straight at the dinner table, she took to nonchalantly – and without a word – poking me between the shoulder blades with a fork as she passed behind me while serving supper. No more idle threats, just a sharp reminder. Of course, it was no more effective than the soap, and I am still a sloucher.
My mother occasionally made attempts at anticipatory guidance with mixed results. One cold December morning as I was heading off to school, she took me aside and cautioned, “Now Willy, don’t ever stick your tongue on a cold pipe.” I’m not sure what prompted this warning because it was decades before this foolishness made it to the silver screen in Jean Shepherd’s “A Christmas Story.” Up to that point, putting my tongue on a cold pipe was an activity that had never crossed my little mind. But now she had planted the seed and for many winters I couldn’t pass a parking meter without the little devil on my shoulder whispering in my ear, “Go try it.”
The only parenting misstep for which I still hold a grudge is one in which my mother ignored her ample storehouse of good sense and floated with the mainstream of bad parental advice. Those of you born prior to 1965 probably share my painful memories of having to sit on the edge of the pond or lake until it had been exactly an hour since you had last eaten – eaten anything! A thoughtlessly nibbled cookie could result in a stomach cramp that could send you to the bottom, never to take another breath of air. It is unclear which medical genius came up with this idea, but I hope he is rotting in hell, doubled over with unremitting abdominal cramps. A rough calculation reveals that between the ages of 7 and 14 years, I wasted nearly 1,000 child-hours sitting on the edge of the town pool, impatiently waiting for peanut butter sandwiches to digest. I know my mother knew that the whole stomach cramp thing was bogus. But, she wasn’t strong enough to swim against the terrible tide of old wives’ tales.
Despite these trivial errors when I was a young child, my mother did her best parenting when I reached adolescence. Pleasantville, N.Y., was a small town of 5,000, and my mother seemed to know two-thirds of them by their first name. Or, at least I thought she did. Her web of contacts covered the town like a blanket. I was convinced that, like Santa Claus, she knew when I was sleeping, she knew when I was awake, she knew if I’d been bad or good. You get the picture. It was only many years later that I realized I had been buffaloed. Her omniscience had been a masterful act ... but it had worked.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “Coping with a Picky Eater.” E-mail him at [email protected].
TLR - Target lesion recurrence
In November I attended the VEITHsymposium in New York. Almost 600 experts from around the world gave lectures on every aspect of vascular surgery. Given 5 minutes per talk, the presenters had to carefully select data they believed would bolster their viewpoint. So will someone please explain to me why some speakers still feel obliged to include target lesion revascularization (TLR) in their presentations? Furthermore, it’s not just in talks but also in peer-reviewed journals that we seem to be bombarded with this useless and often deceiving piece of information. I know that many feel the same way about TLR. However, for those not yet convinced, let me outline why I think TLR should rather stand for “The Least Relevant.”
The concept of TLR materialized during the early days of coronary balloon angioplasty and stenting. In the coronary arteries it is difficult to determine the restenosis rate of a treated lesion without repeating another coronary arteriogram. Accordingly, researchers resorted to TLR as an alternative method of evaluating whether a new treatment worked. However, in the peripheral circulation we have other methods of evaluating the lesion such as duplex scanning, CTA and MRA. This allows us minimally invasive and noninvasive means to evaluate the fate of the lesion itself. Thus, we are able to evaluate TLR as target lesion recurrence rather than target lesion revascularization.
Subsequently, companies and researchers have developed new devices such as balloons, stents, atherectomy devices, and drug-eluting variations that directly target peripheral vascular lesions. Despite the availability of noninvasive techniques to evaluate the target lesion itself, they use TLR data to convince physicians and purchasing entities to buy and use their device. The implication is that avoidance of another procedure to achieve the desired clinical endpoint proves that the new instrument works. However, as I have mentioned in previous editorials, semantics can have negative consequences. Here the problem arises when we attempt to define “works.” The inventor of a device that opens a narrowed or blocked artery wants to make sure that the device indeed does just that. In that case it would be appropriate to claim that it “works.”
If the lesion remains open and does not re-narrow we may conclude the device not only works but is also “effective.” The manufacturer and the FDA will want to make sure that it also does no harm and is “safe.” All are hopeful that it will improve the patient’s condition and have “clinical utility.” Certainly, success can be defined in many ways and clinical benefit must reign supreme. Accordingly, a device that is effective, safe and has clinical utility may be considered “successful” and, if cost effective, worth using. However, we are all aware that some procedures can improve a patient’s condition through a placebo effect. Therefore, it is incorrect for researchers to suggest that low TLR rates equate with clinical success. The most reliable judge of the efficacy of the procedure will be what happens to the targeted lesion and not what happens to the patient. It is more salient that we are assured that the device provides persistent improvement in luminal diameter at the site of the treated lesion.
It may help to further define the problem with TLR if we use a hypothetical example of a new medicated stent inserted to open a single SFA lesion responsible for toe gangrene. If that stent keeps the stenotic lesion widely patent, it should be considered effective even if the patient ultimately requires an above-knee amputation. On the other hand if the stent occludes in the recovery room, yet the toe subsequently heals without any further intervention, that stent did not work. In the latter scenario the patient will not have had a revascularization and so will not be included with the patients requiring TLR. Thus the stent would appear to have had more clinical utility or to have been more”successful” than it really was. Similarly, TLR will not be negatively impacted when, as in some circumstances of stent occlusion, a patient decides to live with discomfort rather than consent to another procedure. Furthermore, investigators of that stent may have a perverse incentive after occlusion to minimize TLR by not performing another procedure. On the other hand a bypass of an artery with an open and functional stent would negatively impact TLR statistics for that type of stent. This may occur if the stented lesion was not the only cause of distal ischemia.What concerns me most about TLR, even more than its limited relevance, is that this statistic is used to support data that otherwise would not stand up to scrutiny. It is often included in trials where numbers are small or where Industry bias is obvious. Accordingly, I am hopeful that researchers seriously consider describing TLR as target lesion recurrence rates omitting target lesion revascularization from their presentations and manuscripts. If they insist on using this irrelevant statistic then they should provide information as to why the revascularization was performed.
Was it for lesion recurrence or failure to improve the indicated condition? If the lesion recurred but TLR was not performed, was that because recovery had been achieved despite restenosis of the target lesion? Was it because the patient was not offered further treatment? Perhaps the patient succumbed before TLR could have been provided?
I may be accused of being overly cynical, but it may have been because the patient had decided that the better part of valor would be to run away and join a witness protection program rather than take part in that clinical trial.
In November I attended the VEITHsymposium in New York. Almost 600 experts from around the world gave lectures on every aspect of vascular surgery. Given 5 minutes per talk, the presenters had to carefully select data they believed would bolster their viewpoint. So will someone please explain to me why some speakers still feel obliged to include target lesion revascularization (TLR) in their presentations? Furthermore, it’s not just in talks but also in peer-reviewed journals that we seem to be bombarded with this useless and often deceiving piece of information. I know that many feel the same way about TLR. However, for those not yet convinced, let me outline why I think TLR should rather stand for “The Least Relevant.”
The concept of TLR materialized during the early days of coronary balloon angioplasty and stenting. In the coronary arteries it is difficult to determine the restenosis rate of a treated lesion without repeating another coronary arteriogram. Accordingly, researchers resorted to TLR as an alternative method of evaluating whether a new treatment worked. However, in the peripheral circulation we have other methods of evaluating the lesion such as duplex scanning, CTA and MRA. This allows us minimally invasive and noninvasive means to evaluate the fate of the lesion itself. Thus, we are able to evaluate TLR as target lesion recurrence rather than target lesion revascularization.
Subsequently, companies and researchers have developed new devices such as balloons, stents, atherectomy devices, and drug-eluting variations that directly target peripheral vascular lesions. Despite the availability of noninvasive techniques to evaluate the target lesion itself, they use TLR data to convince physicians and purchasing entities to buy and use their device. The implication is that avoidance of another procedure to achieve the desired clinical endpoint proves that the new instrument works. However, as I have mentioned in previous editorials, semantics can have negative consequences. Here the problem arises when we attempt to define “works.” The inventor of a device that opens a narrowed or blocked artery wants to make sure that the device indeed does just that. In that case it would be appropriate to claim that it “works.”
If the lesion remains open and does not re-narrow we may conclude the device not only works but is also “effective.” The manufacturer and the FDA will want to make sure that it also does no harm and is “safe.” All are hopeful that it will improve the patient’s condition and have “clinical utility.” Certainly, success can be defined in many ways and clinical benefit must reign supreme. Accordingly, a device that is effective, safe and has clinical utility may be considered “successful” and, if cost effective, worth using. However, we are all aware that some procedures can improve a patient’s condition through a placebo effect. Therefore, it is incorrect for researchers to suggest that low TLR rates equate with clinical success. The most reliable judge of the efficacy of the procedure will be what happens to the targeted lesion and not what happens to the patient. It is more salient that we are assured that the device provides persistent improvement in luminal diameter at the site of the treated lesion.
It may help to further define the problem with TLR if we use a hypothetical example of a new medicated stent inserted to open a single SFA lesion responsible for toe gangrene. If that stent keeps the stenotic lesion widely patent, it should be considered effective even if the patient ultimately requires an above-knee amputation. On the other hand if the stent occludes in the recovery room, yet the toe subsequently heals without any further intervention, that stent did not work. In the latter scenario the patient will not have had a revascularization and so will not be included with the patients requiring TLR. Thus the stent would appear to have had more clinical utility or to have been more”successful” than it really was. Similarly, TLR will not be negatively impacted when, as in some circumstances of stent occlusion, a patient decides to live with discomfort rather than consent to another procedure. Furthermore, investigators of that stent may have a perverse incentive after occlusion to minimize TLR by not performing another procedure. On the other hand a bypass of an artery with an open and functional stent would negatively impact TLR statistics for that type of stent. This may occur if the stented lesion was not the only cause of distal ischemia.What concerns me most about TLR, even more than its limited relevance, is that this statistic is used to support data that otherwise would not stand up to scrutiny. It is often included in trials where numbers are small or where Industry bias is obvious. Accordingly, I am hopeful that researchers seriously consider describing TLR as target lesion recurrence rates omitting target lesion revascularization from their presentations and manuscripts. If they insist on using this irrelevant statistic then they should provide information as to why the revascularization was performed.
Was it for lesion recurrence or failure to improve the indicated condition? If the lesion recurred but TLR was not performed, was that because recovery had been achieved despite restenosis of the target lesion? Was it because the patient was not offered further treatment? Perhaps the patient succumbed before TLR could have been provided?
I may be accused of being overly cynical, but it may have been because the patient had decided that the better part of valor would be to run away and join a witness protection program rather than take part in that clinical trial.
In November I attended the VEITHsymposium in New York. Almost 600 experts from around the world gave lectures on every aspect of vascular surgery. Given 5 minutes per talk, the presenters had to carefully select data they believed would bolster their viewpoint. So will someone please explain to me why some speakers still feel obliged to include target lesion revascularization (TLR) in their presentations? Furthermore, it’s not just in talks but also in peer-reviewed journals that we seem to be bombarded with this useless and often deceiving piece of information. I know that many feel the same way about TLR. However, for those not yet convinced, let me outline why I think TLR should rather stand for “The Least Relevant.”
The concept of TLR materialized during the early days of coronary balloon angioplasty and stenting. In the coronary arteries it is difficult to determine the restenosis rate of a treated lesion without repeating another coronary arteriogram. Accordingly, researchers resorted to TLR as an alternative method of evaluating whether a new treatment worked. However, in the peripheral circulation we have other methods of evaluating the lesion such as duplex scanning, CTA and MRA. This allows us minimally invasive and noninvasive means to evaluate the fate of the lesion itself. Thus, we are able to evaluate TLR as target lesion recurrence rather than target lesion revascularization.
Subsequently, companies and researchers have developed new devices such as balloons, stents, atherectomy devices, and drug-eluting variations that directly target peripheral vascular lesions. Despite the availability of noninvasive techniques to evaluate the target lesion itself, they use TLR data to convince physicians and purchasing entities to buy and use their device. The implication is that avoidance of another procedure to achieve the desired clinical endpoint proves that the new instrument works. However, as I have mentioned in previous editorials, semantics can have negative consequences. Here the problem arises when we attempt to define “works.” The inventor of a device that opens a narrowed or blocked artery wants to make sure that the device indeed does just that. In that case it would be appropriate to claim that it “works.”
If the lesion remains open and does not re-narrow we may conclude the device not only works but is also “effective.” The manufacturer and the FDA will want to make sure that it also does no harm and is “safe.” All are hopeful that it will improve the patient’s condition and have “clinical utility.” Certainly, success can be defined in many ways and clinical benefit must reign supreme. Accordingly, a device that is effective, safe and has clinical utility may be considered “successful” and, if cost effective, worth using. However, we are all aware that some procedures can improve a patient’s condition through a placebo effect. Therefore, it is incorrect for researchers to suggest that low TLR rates equate with clinical success. The most reliable judge of the efficacy of the procedure will be what happens to the targeted lesion and not what happens to the patient. It is more salient that we are assured that the device provides persistent improvement in luminal diameter at the site of the treated lesion.
It may help to further define the problem with TLR if we use a hypothetical example of a new medicated stent inserted to open a single SFA lesion responsible for toe gangrene. If that stent keeps the stenotic lesion widely patent, it should be considered effective even if the patient ultimately requires an above-knee amputation. On the other hand if the stent occludes in the recovery room, yet the toe subsequently heals without any further intervention, that stent did not work. In the latter scenario the patient will not have had a revascularization and so will not be included with the patients requiring TLR. Thus the stent would appear to have had more clinical utility or to have been more”successful” than it really was. Similarly, TLR will not be negatively impacted when, as in some circumstances of stent occlusion, a patient decides to live with discomfort rather than consent to another procedure. Furthermore, investigators of that stent may have a perverse incentive after occlusion to minimize TLR by not performing another procedure. On the other hand a bypass of an artery with an open and functional stent would negatively impact TLR statistics for that type of stent. This may occur if the stented lesion was not the only cause of distal ischemia.What concerns me most about TLR, even more than its limited relevance, is that this statistic is used to support data that otherwise would not stand up to scrutiny. It is often included in trials where numbers are small or where Industry bias is obvious. Accordingly, I am hopeful that researchers seriously consider describing TLR as target lesion recurrence rates omitting target lesion revascularization from their presentations and manuscripts. If they insist on using this irrelevant statistic then they should provide information as to why the revascularization was performed.
Was it for lesion recurrence or failure to improve the indicated condition? If the lesion recurred but TLR was not performed, was that because recovery had been achieved despite restenosis of the target lesion? Was it because the patient was not offered further treatment? Perhaps the patient succumbed before TLR could have been provided?
I may be accused of being overly cynical, but it may have been because the patient had decided that the better part of valor would be to run away and join a witness protection program rather than take part in that clinical trial.
From the Washington Office
Shortly after passage of the $1.1 trillion “Cromnibus,” the House and Senate concluded their legislative business for the 113th Congress and adjourned. Many issues of importance to surgeons and our patients remain unresolved and are expected to be high on the legislative agenda of the 114th Congress in the first quarter of 2015.
Returning as Members of Congress in January will be two physicians whose campaigns were assisted by the active participation of SurgeonsPAC. They are Dr. Ami Bera, an emergency physician from the 7th District of California (Sacramento area) and Dr. Dan Benishek, a general surgeon and fellow of the American College of Surgeons from the 1st District of Michigan (Upper Peninsula). Both Dr. Bera and Dr. Benishek have served as champions for the cause of the legislative agenda supported by the College.
One of the ways by which SurgeonsPAC participated in the re-election campaign of both Members is known as an independent expenditure (IE). The Code of Federal Regulations defines and independent expenditure as an expenditure for a communication that expressly advocates for “the election or defeat of a clearly identified candidate that is not made in cooperation, consultation, or concert with, or at the request or suggestion of, a candidate, a candidate’s authorized committee, or their agents, or a political party committee or its agents.” [11 CFR 100.16(a)]
In August, the Board of Directors of SurgeonsPAC unanimously voted to direct staff of the Division of Advocacy and Health Policy to develop recommendations for independent expenditures for a bipartisan slate of candidates who had a record of being supportive of the College’s legislative agenda and whose election was enough at risk that an independent expenditure by the College would potentially be of significant benefit for their race. In October, the PAC Board considered those recommendations and voted to support the expenditure of $100,000 each for IEs for Dr. Bera, a Democrat, and Dr. Benishek, a Republican. Both have been champions on issues such as repeal and replacement of the Sustainable Growth Rate (SGR), medical liability reform, and repeal of the 96-hour rule.
For Dr. Bera, the SurgeonsPAC dollars were utilized for a radio and direct mail campaign that was part of a larger effort in which other physician political action committees participated similarly. For Dr. Benishek, a television ad was produced and run through local cable providers.
On election night, Dr. Benishek was declared the winner, receiving 52.1% of the vote compared with his opponent’s 45.3%. As one of four fellows of the American College of Surgeons in Congress, we look forward to continuing to work with “Dr. Dan” and his excellent staff in his upcoming third term.
Dr. Bera’s race was much closer, as he actually trailed his opponent when election night closed with 49.8% of the vote. Subsequently, with the counting and inclusion of the mail-in ballots specifically targeted by the physician community’s IE effort, Dr. Bera overtook his opponent’s slim margin. Two weeks later, on 19 Nov. 2014, the Associated Press called the election for Dr. Bera, whose 1,400-vote lead at that time was felt to be substantial enough to preclude his opponent making up the difference with the remaining 4,300 provisional ballots that had yet to be counted. Dr. Bera’s CA-7 district race proved to be the most expensive in the nation with an estimated $19.6 million in total expenditures. Despite representing only 0.51% of that total, SurgeonsPAC’s contribution, in the collective with that of other physician organizations, no doubt played a significant role in returning a physician to Congress to continue to champion our causes.
In my opinion, these examples of careful candidate selection and subsequent support of Drs. Benishek and Bera exemplify the importance of a strong political action committee. The ultimate goal of SurgeonsPAC is the election to Congress and retention in Congress of those who support our policy positions and legislative agenda. Though SurgeonsPAC is one of nine physician PACs that can be accurately labeled as “million dollar” (per election cycle) PACs, our relative size and, thus, the number of candidates like Drs. Bera and Benishek we could support would be much greater if the Fellow participation rate more closely resembled that of our colleagues in other physician organizations. However, year after year, only 3%-4% of Fellows contribute, as compared with participation rates of 10%-25% in those physician PACs larger than SurgeonsPAC.
Recently, all Fellows received an e-mail from Dr. Andrew Warshaw, founding SurgeonsPAC Board Chairman and current President of the ACS, urging Fellows to make a $25 donation to SurgeonsPAC. Those wishing to learn more about the critical role SurgeonsPAC plays in our advocacy efforts can log on to www.surgeonspac.org.
Until next month...
Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy for the Division of Advocacy and Health Policy in the ACS offices in Washington, DC.
Shortly after passage of the $1.1 trillion “Cromnibus,” the House and Senate concluded their legislative business for the 113th Congress and adjourned. Many issues of importance to surgeons and our patients remain unresolved and are expected to be high on the legislative agenda of the 114th Congress in the first quarter of 2015.
Returning as Members of Congress in January will be two physicians whose campaigns were assisted by the active participation of SurgeonsPAC. They are Dr. Ami Bera, an emergency physician from the 7th District of California (Sacramento area) and Dr. Dan Benishek, a general surgeon and fellow of the American College of Surgeons from the 1st District of Michigan (Upper Peninsula). Both Dr. Bera and Dr. Benishek have served as champions for the cause of the legislative agenda supported by the College.
One of the ways by which SurgeonsPAC participated in the re-election campaign of both Members is known as an independent expenditure (IE). The Code of Federal Regulations defines and independent expenditure as an expenditure for a communication that expressly advocates for “the election or defeat of a clearly identified candidate that is not made in cooperation, consultation, or concert with, or at the request or suggestion of, a candidate, a candidate’s authorized committee, or their agents, or a political party committee or its agents.” [11 CFR 100.16(a)]
In August, the Board of Directors of SurgeonsPAC unanimously voted to direct staff of the Division of Advocacy and Health Policy to develop recommendations for independent expenditures for a bipartisan slate of candidates who had a record of being supportive of the College’s legislative agenda and whose election was enough at risk that an independent expenditure by the College would potentially be of significant benefit for their race. In October, the PAC Board considered those recommendations and voted to support the expenditure of $100,000 each for IEs for Dr. Bera, a Democrat, and Dr. Benishek, a Republican. Both have been champions on issues such as repeal and replacement of the Sustainable Growth Rate (SGR), medical liability reform, and repeal of the 96-hour rule.
For Dr. Bera, the SurgeonsPAC dollars were utilized for a radio and direct mail campaign that was part of a larger effort in which other physician political action committees participated similarly. For Dr. Benishek, a television ad was produced and run through local cable providers.
On election night, Dr. Benishek was declared the winner, receiving 52.1% of the vote compared with his opponent’s 45.3%. As one of four fellows of the American College of Surgeons in Congress, we look forward to continuing to work with “Dr. Dan” and his excellent staff in his upcoming third term.
Dr. Bera’s race was much closer, as he actually trailed his opponent when election night closed with 49.8% of the vote. Subsequently, with the counting and inclusion of the mail-in ballots specifically targeted by the physician community’s IE effort, Dr. Bera overtook his opponent’s slim margin. Two weeks later, on 19 Nov. 2014, the Associated Press called the election for Dr. Bera, whose 1,400-vote lead at that time was felt to be substantial enough to preclude his opponent making up the difference with the remaining 4,300 provisional ballots that had yet to be counted. Dr. Bera’s CA-7 district race proved to be the most expensive in the nation with an estimated $19.6 million in total expenditures. Despite representing only 0.51% of that total, SurgeonsPAC’s contribution, in the collective with that of other physician organizations, no doubt played a significant role in returning a physician to Congress to continue to champion our causes.
In my opinion, these examples of careful candidate selection and subsequent support of Drs. Benishek and Bera exemplify the importance of a strong political action committee. The ultimate goal of SurgeonsPAC is the election to Congress and retention in Congress of those who support our policy positions and legislative agenda. Though SurgeonsPAC is one of nine physician PACs that can be accurately labeled as “million dollar” (per election cycle) PACs, our relative size and, thus, the number of candidates like Drs. Bera and Benishek we could support would be much greater if the Fellow participation rate more closely resembled that of our colleagues in other physician organizations. However, year after year, only 3%-4% of Fellows contribute, as compared with participation rates of 10%-25% in those physician PACs larger than SurgeonsPAC.
Recently, all Fellows received an e-mail from Dr. Andrew Warshaw, founding SurgeonsPAC Board Chairman and current President of the ACS, urging Fellows to make a $25 donation to SurgeonsPAC. Those wishing to learn more about the critical role SurgeonsPAC plays in our advocacy efforts can log on to www.surgeonspac.org.
Until next month...
Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy for the Division of Advocacy and Health Policy in the ACS offices in Washington, DC.
Shortly after passage of the $1.1 trillion “Cromnibus,” the House and Senate concluded their legislative business for the 113th Congress and adjourned. Many issues of importance to surgeons and our patients remain unresolved and are expected to be high on the legislative agenda of the 114th Congress in the first quarter of 2015.
Returning as Members of Congress in January will be two physicians whose campaigns were assisted by the active participation of SurgeonsPAC. They are Dr. Ami Bera, an emergency physician from the 7th District of California (Sacramento area) and Dr. Dan Benishek, a general surgeon and fellow of the American College of Surgeons from the 1st District of Michigan (Upper Peninsula). Both Dr. Bera and Dr. Benishek have served as champions for the cause of the legislative agenda supported by the College.
One of the ways by which SurgeonsPAC participated in the re-election campaign of both Members is known as an independent expenditure (IE). The Code of Federal Regulations defines and independent expenditure as an expenditure for a communication that expressly advocates for “the election or defeat of a clearly identified candidate that is not made in cooperation, consultation, or concert with, or at the request or suggestion of, a candidate, a candidate’s authorized committee, or their agents, or a political party committee or its agents.” [11 CFR 100.16(a)]
In August, the Board of Directors of SurgeonsPAC unanimously voted to direct staff of the Division of Advocacy and Health Policy to develop recommendations for independent expenditures for a bipartisan slate of candidates who had a record of being supportive of the College’s legislative agenda and whose election was enough at risk that an independent expenditure by the College would potentially be of significant benefit for their race. In October, the PAC Board considered those recommendations and voted to support the expenditure of $100,000 each for IEs for Dr. Bera, a Democrat, and Dr. Benishek, a Republican. Both have been champions on issues such as repeal and replacement of the Sustainable Growth Rate (SGR), medical liability reform, and repeal of the 96-hour rule.
For Dr. Bera, the SurgeonsPAC dollars were utilized for a radio and direct mail campaign that was part of a larger effort in which other physician political action committees participated similarly. For Dr. Benishek, a television ad was produced and run through local cable providers.
On election night, Dr. Benishek was declared the winner, receiving 52.1% of the vote compared with his opponent’s 45.3%. As one of four fellows of the American College of Surgeons in Congress, we look forward to continuing to work with “Dr. Dan” and his excellent staff in his upcoming third term.
Dr. Bera’s race was much closer, as he actually trailed his opponent when election night closed with 49.8% of the vote. Subsequently, with the counting and inclusion of the mail-in ballots specifically targeted by the physician community’s IE effort, Dr. Bera overtook his opponent’s slim margin. Two weeks later, on 19 Nov. 2014, the Associated Press called the election for Dr. Bera, whose 1,400-vote lead at that time was felt to be substantial enough to preclude his opponent making up the difference with the remaining 4,300 provisional ballots that had yet to be counted. Dr. Bera’s CA-7 district race proved to be the most expensive in the nation with an estimated $19.6 million in total expenditures. Despite representing only 0.51% of that total, SurgeonsPAC’s contribution, in the collective with that of other physician organizations, no doubt played a significant role in returning a physician to Congress to continue to champion our causes.
In my opinion, these examples of careful candidate selection and subsequent support of Drs. Benishek and Bera exemplify the importance of a strong political action committee. The ultimate goal of SurgeonsPAC is the election to Congress and retention in Congress of those who support our policy positions and legislative agenda. Though SurgeonsPAC is one of nine physician PACs that can be accurately labeled as “million dollar” (per election cycle) PACs, our relative size and, thus, the number of candidates like Drs. Bera and Benishek we could support would be much greater if the Fellow participation rate more closely resembled that of our colleagues in other physician organizations. However, year after year, only 3%-4% of Fellows contribute, as compared with participation rates of 10%-25% in those physician PACs larger than SurgeonsPAC.
Recently, all Fellows received an e-mail from Dr. Andrew Warshaw, founding SurgeonsPAC Board Chairman and current President of the ACS, urging Fellows to make a $25 donation to SurgeonsPAC. Those wishing to learn more about the critical role SurgeonsPAC plays in our advocacy efforts can log on to www.surgeonspac.org.
Until next month...
Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy for the Division of Advocacy and Health Policy in the ACS offices in Washington, DC.
Rural cancer care – if you build it (and measure it!), they will come
Rural surgeons who provide cancer care face a particular set of challenges. Rural patients tend to be older, sicker, less educated and economically disadvantaged. Rural areas have a higher prevalence of chronic diseases including heart disease and cancer. Rural patients present with more advanced cancers than their urban counterparts. Specific rural regions (i.e., Appalachia) have documented higher cancer incidences and mortality rates.
In addition, there are several barriers to providing cancer care for rural populations. These include poor access to health care services and specialists; geographic barriers preventing access to providers, services, and technology; minimal transportation options for either cancer screening or treatment; limited knowledge of cancer and low participation in screening and other healthy practices; prohibitive costs of screening and cancer treatment; and, in some cases, suboptimal care provided to cancer patients (J. Am. Coll. Surg. 2014;219:814-8; Gosschalk, A. and Carozza, S., “Cancer in rural areas: A literature review,” Rural Healthy People 2010, Vol. 2 [College Station: The Texas A&M University System Health Science Center, 2003]).
Several examples of suboptimal care for rural cancer patients have appeared in professional journals and meetings and in the lay press. Examples of rural cancer care inadequacies include lower use of needle biopsy and sentinel lymph node biopsy techniques for breast cancer patients (Am. J. Surg. 2014;208:382-90; Am. J. Surg. 2013;206:674-81; ACS Surgery News, “Use of minimally invasive biopsy lags in Texas,” February 2013, p. 15); significantly lower rates of radiation treatment in breast lumpectomy patients (USA Today, Nov. 18, 2012); lower rates of adequate lymph node dissection, appropriate chemotherapy, and higher death rates in colon cancer patients (Chow, C.J., ACS Clinical Congress Presentation 2012); higher mastectomy rates and later-stage cancers in breast cancer patients (Jethwa, K., AACR Annual Conference Presentation 2013); higher likelihood of discharge to a skilled nursing facility instead of home in colon cancer patients; and the list goes on and on. These articles all come from academic centers through database studies. It is rare indeed to see data collected and published by the rural centers and providers actually caring for rural cancer patients.
My personal bias is that rural surgeons provide very competent, compassionate, high quality care that allows the cancer patient to remain close to their homes and support systems. This opinion has been reinforced by my involvement with the ACS Advisory Council on Rural Surgery, the rural listserve /ACS Rural Community and through my interaction with surgeons across the country at ACS Chapter meetings and at the Congress.
A study done by Finlayson (Med. Care 1999;37:204-9) documented that nearly 100% of rural patients preferred to receive their care locally, especially if the quality of care was the same as the larger distant hospital. In fact, nearly half of the patients polled would choose to remain local even if the mortality rate at the local hospital was double that of a hospital requiring the patient to travel for care. More recent papers however suggest that patients may be bypassing their local hospitals for care because of concerns about the quality of care provided locally (J. Rural Health 1999;10:70-9; J. Rural Health 2007;23:17-24).
A 2013 ASCO presentation documented that General Surgeons perform a majority of cancer surgeries in the United States (Stizenberg, K.; SSO 66th Annual Cancer Symposium; Abstract 75, March 8, 2013). Only 303 (< 8%) counties in the United States even have a surgical oncologist. A 2014 ASCO presentation estimated a 43% increase in inpatient oncology procedures and a 25% increase in outpatient procedures between 2002 and 2020. By 2025 the total demand for oncology care will rise by 43% (ASCO, “The state of cancer care 2014,” J. Oncol. Prac. 2014;10:119-42). Another study (ACS Surgery News, “Surgeon supply to drop 18% by 2028,” January 2013, p. 1) has estimated that, with predicted future surgeon shortages, general surgeons will be called upon to perform 25% of cases now done by other surgical specialists. General surgeons, both rural and urban, are clearly providing the bulk of cancer care to patients and this trend is on the rise in coming years.
Rural surgeons have certain barriers that prevent them from measuring, documenting, and publicizing the specifics of the care provided to their patients. These surgeons often are in single or small group practices and manage their own businesses. They have no office or hospital staff dedicated to quality endeavors. Financial and time constraints prevent them from being champions of quality care in their communities. Additionally, small numbers of specific cases can result in high statistical complication and mortality rates even if these events happen infrequently. This inability to collect data and assess the quality of care provided can lead to patient outmigration and even “tiering” by third-party payers that forces patients away from their hometown hospitals and providers using financial disincentives.
Rural surgeons can and must now take the lead in collecting, assessing, and reporting data about the care they provide for their communities. This process can be in the form of standardized programs like ACS Rural National Surgical Quality Improvement Program (NSQIP), Surgical Care Improvement Project (SCIP), or Commission on Cancer (CoC) accreditation involvement. Smaller institutions with a single surgeon may not have the financial and staff resources to formally participate but each surgeon can assess what makes up the majority of his or her caseload, whether that is endoscopy or breast or colon cases, and find national benchmarks that can easily be measured. Every endoscopy department can collect data on cecal intubation rates, withdrawal times, adequacy of preps, adenoma detection rates, and appropriate follow-up intervals. Individual surgeons can pick and chose specific benchmarks from NSQIP, Commission on Cancer, National Accreditation Program for Breast Centers (NAPBC), or ACS Committee on Trauma standards documents and use these to evaluate the care they provide. Easy examples might include number of lymph nodes harvested at colon cancer surgery, percentage of breast cancer patients diagnosed with needle biopsy, and percentage treated with conservative surgery and appropriate postop radiation and or chemotherapy, or the percentage of melanoma patients treated per National Comprehensive Cancer Network guidelines. Other ways for institutions to document quality might be to partner with their tertiary referral center for CoC accreditation or just to participate in cancer conferences by videoconferencing. The Commission on Cancer has designated CoC Liason Program Chairs in each state that are available to aid in setting up these types of programs.
It is time for rural surgeons to partner with their hospitals and communities to carry out needs assessments and think of ways to fill those needs. An example might be to work with primary care providers to develop aggressive colon, breast, or lung cancer screening programs in communities with high numbers of late-stage cases. Transparency of the data collected and the care provided in the form of “Quality Reports to the Community” can improve local referral patterns, improve the financial viability of the local hospital, and prove to the community that quality care is being rendered. Pooling the data from a large base of rural surgeons could serve to disprove the academic community notion that rural patients receive suboptimal cancer care.
Dr. Sarap is a practicing general surgeon in Cambridge, Ohio. He is a member of the Advisory Council on Rural Surgery and has been appointed the Commission on Cancer Liaison Program Chair for Ohio.
Rural surgeons who provide cancer care face a particular set of challenges. Rural patients tend to be older, sicker, less educated and economically disadvantaged. Rural areas have a higher prevalence of chronic diseases including heart disease and cancer. Rural patients present with more advanced cancers than their urban counterparts. Specific rural regions (i.e., Appalachia) have documented higher cancer incidences and mortality rates.
In addition, there are several barriers to providing cancer care for rural populations. These include poor access to health care services and specialists; geographic barriers preventing access to providers, services, and technology; minimal transportation options for either cancer screening or treatment; limited knowledge of cancer and low participation in screening and other healthy practices; prohibitive costs of screening and cancer treatment; and, in some cases, suboptimal care provided to cancer patients (J. Am. Coll. Surg. 2014;219:814-8; Gosschalk, A. and Carozza, S., “Cancer in rural areas: A literature review,” Rural Healthy People 2010, Vol. 2 [College Station: The Texas A&M University System Health Science Center, 2003]).
Several examples of suboptimal care for rural cancer patients have appeared in professional journals and meetings and in the lay press. Examples of rural cancer care inadequacies include lower use of needle biopsy and sentinel lymph node biopsy techniques for breast cancer patients (Am. J. Surg. 2014;208:382-90; Am. J. Surg. 2013;206:674-81; ACS Surgery News, “Use of minimally invasive biopsy lags in Texas,” February 2013, p. 15); significantly lower rates of radiation treatment in breast lumpectomy patients (USA Today, Nov. 18, 2012); lower rates of adequate lymph node dissection, appropriate chemotherapy, and higher death rates in colon cancer patients (Chow, C.J., ACS Clinical Congress Presentation 2012); higher mastectomy rates and later-stage cancers in breast cancer patients (Jethwa, K., AACR Annual Conference Presentation 2013); higher likelihood of discharge to a skilled nursing facility instead of home in colon cancer patients; and the list goes on and on. These articles all come from academic centers through database studies. It is rare indeed to see data collected and published by the rural centers and providers actually caring for rural cancer patients.
My personal bias is that rural surgeons provide very competent, compassionate, high quality care that allows the cancer patient to remain close to their homes and support systems. This opinion has been reinforced by my involvement with the ACS Advisory Council on Rural Surgery, the rural listserve /ACS Rural Community and through my interaction with surgeons across the country at ACS Chapter meetings and at the Congress.
A study done by Finlayson (Med. Care 1999;37:204-9) documented that nearly 100% of rural patients preferred to receive their care locally, especially if the quality of care was the same as the larger distant hospital. In fact, nearly half of the patients polled would choose to remain local even if the mortality rate at the local hospital was double that of a hospital requiring the patient to travel for care. More recent papers however suggest that patients may be bypassing their local hospitals for care because of concerns about the quality of care provided locally (J. Rural Health 1999;10:70-9; J. Rural Health 2007;23:17-24).
A 2013 ASCO presentation documented that General Surgeons perform a majority of cancer surgeries in the United States (Stizenberg, K.; SSO 66th Annual Cancer Symposium; Abstract 75, March 8, 2013). Only 303 (< 8%) counties in the United States even have a surgical oncologist. A 2014 ASCO presentation estimated a 43% increase in inpatient oncology procedures and a 25% increase in outpatient procedures between 2002 and 2020. By 2025 the total demand for oncology care will rise by 43% (ASCO, “The state of cancer care 2014,” J. Oncol. Prac. 2014;10:119-42). Another study (ACS Surgery News, “Surgeon supply to drop 18% by 2028,” January 2013, p. 1) has estimated that, with predicted future surgeon shortages, general surgeons will be called upon to perform 25% of cases now done by other surgical specialists. General surgeons, both rural and urban, are clearly providing the bulk of cancer care to patients and this trend is on the rise in coming years.
Rural surgeons have certain barriers that prevent them from measuring, documenting, and publicizing the specifics of the care provided to their patients. These surgeons often are in single or small group practices and manage their own businesses. They have no office or hospital staff dedicated to quality endeavors. Financial and time constraints prevent them from being champions of quality care in their communities. Additionally, small numbers of specific cases can result in high statistical complication and mortality rates even if these events happen infrequently. This inability to collect data and assess the quality of care provided can lead to patient outmigration and even “tiering” by third-party payers that forces patients away from their hometown hospitals and providers using financial disincentives.
Rural surgeons can and must now take the lead in collecting, assessing, and reporting data about the care they provide for their communities. This process can be in the form of standardized programs like ACS Rural National Surgical Quality Improvement Program (NSQIP), Surgical Care Improvement Project (SCIP), or Commission on Cancer (CoC) accreditation involvement. Smaller institutions with a single surgeon may not have the financial and staff resources to formally participate but each surgeon can assess what makes up the majority of his or her caseload, whether that is endoscopy or breast or colon cases, and find national benchmarks that can easily be measured. Every endoscopy department can collect data on cecal intubation rates, withdrawal times, adequacy of preps, adenoma detection rates, and appropriate follow-up intervals. Individual surgeons can pick and chose specific benchmarks from NSQIP, Commission on Cancer, National Accreditation Program for Breast Centers (NAPBC), or ACS Committee on Trauma standards documents and use these to evaluate the care they provide. Easy examples might include number of lymph nodes harvested at colon cancer surgery, percentage of breast cancer patients diagnosed with needle biopsy, and percentage treated with conservative surgery and appropriate postop radiation and or chemotherapy, or the percentage of melanoma patients treated per National Comprehensive Cancer Network guidelines. Other ways for institutions to document quality might be to partner with their tertiary referral center for CoC accreditation or just to participate in cancer conferences by videoconferencing. The Commission on Cancer has designated CoC Liason Program Chairs in each state that are available to aid in setting up these types of programs.
It is time for rural surgeons to partner with their hospitals and communities to carry out needs assessments and think of ways to fill those needs. An example might be to work with primary care providers to develop aggressive colon, breast, or lung cancer screening programs in communities with high numbers of late-stage cases. Transparency of the data collected and the care provided in the form of “Quality Reports to the Community” can improve local referral patterns, improve the financial viability of the local hospital, and prove to the community that quality care is being rendered. Pooling the data from a large base of rural surgeons could serve to disprove the academic community notion that rural patients receive suboptimal cancer care.
Dr. Sarap is a practicing general surgeon in Cambridge, Ohio. He is a member of the Advisory Council on Rural Surgery and has been appointed the Commission on Cancer Liaison Program Chair for Ohio.
Rural surgeons who provide cancer care face a particular set of challenges. Rural patients tend to be older, sicker, less educated and economically disadvantaged. Rural areas have a higher prevalence of chronic diseases including heart disease and cancer. Rural patients present with more advanced cancers than their urban counterparts. Specific rural regions (i.e., Appalachia) have documented higher cancer incidences and mortality rates.
In addition, there are several barriers to providing cancer care for rural populations. These include poor access to health care services and specialists; geographic barriers preventing access to providers, services, and technology; minimal transportation options for either cancer screening or treatment; limited knowledge of cancer and low participation in screening and other healthy practices; prohibitive costs of screening and cancer treatment; and, in some cases, suboptimal care provided to cancer patients (J. Am. Coll. Surg. 2014;219:814-8; Gosschalk, A. and Carozza, S., “Cancer in rural areas: A literature review,” Rural Healthy People 2010, Vol. 2 [College Station: The Texas A&M University System Health Science Center, 2003]).
Several examples of suboptimal care for rural cancer patients have appeared in professional journals and meetings and in the lay press. Examples of rural cancer care inadequacies include lower use of needle biopsy and sentinel lymph node biopsy techniques for breast cancer patients (Am. J. Surg. 2014;208:382-90; Am. J. Surg. 2013;206:674-81; ACS Surgery News, “Use of minimally invasive biopsy lags in Texas,” February 2013, p. 15); significantly lower rates of radiation treatment in breast lumpectomy patients (USA Today, Nov. 18, 2012); lower rates of adequate lymph node dissection, appropriate chemotherapy, and higher death rates in colon cancer patients (Chow, C.J., ACS Clinical Congress Presentation 2012); higher mastectomy rates and later-stage cancers in breast cancer patients (Jethwa, K., AACR Annual Conference Presentation 2013); higher likelihood of discharge to a skilled nursing facility instead of home in colon cancer patients; and the list goes on and on. These articles all come from academic centers through database studies. It is rare indeed to see data collected and published by the rural centers and providers actually caring for rural cancer patients.
My personal bias is that rural surgeons provide very competent, compassionate, high quality care that allows the cancer patient to remain close to their homes and support systems. This opinion has been reinforced by my involvement with the ACS Advisory Council on Rural Surgery, the rural listserve /ACS Rural Community and through my interaction with surgeons across the country at ACS Chapter meetings and at the Congress.
A study done by Finlayson (Med. Care 1999;37:204-9) documented that nearly 100% of rural patients preferred to receive their care locally, especially if the quality of care was the same as the larger distant hospital. In fact, nearly half of the patients polled would choose to remain local even if the mortality rate at the local hospital was double that of a hospital requiring the patient to travel for care. More recent papers however suggest that patients may be bypassing their local hospitals for care because of concerns about the quality of care provided locally (J. Rural Health 1999;10:70-9; J. Rural Health 2007;23:17-24).
A 2013 ASCO presentation documented that General Surgeons perform a majority of cancer surgeries in the United States (Stizenberg, K.; SSO 66th Annual Cancer Symposium; Abstract 75, March 8, 2013). Only 303 (< 8%) counties in the United States even have a surgical oncologist. A 2014 ASCO presentation estimated a 43% increase in inpatient oncology procedures and a 25% increase in outpatient procedures between 2002 and 2020. By 2025 the total demand for oncology care will rise by 43% (ASCO, “The state of cancer care 2014,” J. Oncol. Prac. 2014;10:119-42). Another study (ACS Surgery News, “Surgeon supply to drop 18% by 2028,” January 2013, p. 1) has estimated that, with predicted future surgeon shortages, general surgeons will be called upon to perform 25% of cases now done by other surgical specialists. General surgeons, both rural and urban, are clearly providing the bulk of cancer care to patients and this trend is on the rise in coming years.
Rural surgeons have certain barriers that prevent them from measuring, documenting, and publicizing the specifics of the care provided to their patients. These surgeons often are in single or small group practices and manage their own businesses. They have no office or hospital staff dedicated to quality endeavors. Financial and time constraints prevent them from being champions of quality care in their communities. Additionally, small numbers of specific cases can result in high statistical complication and mortality rates even if these events happen infrequently. This inability to collect data and assess the quality of care provided can lead to patient outmigration and even “tiering” by third-party payers that forces patients away from their hometown hospitals and providers using financial disincentives.
Rural surgeons can and must now take the lead in collecting, assessing, and reporting data about the care they provide for their communities. This process can be in the form of standardized programs like ACS Rural National Surgical Quality Improvement Program (NSQIP), Surgical Care Improvement Project (SCIP), or Commission on Cancer (CoC) accreditation involvement. Smaller institutions with a single surgeon may not have the financial and staff resources to formally participate but each surgeon can assess what makes up the majority of his or her caseload, whether that is endoscopy or breast or colon cases, and find national benchmarks that can easily be measured. Every endoscopy department can collect data on cecal intubation rates, withdrawal times, adequacy of preps, adenoma detection rates, and appropriate follow-up intervals. Individual surgeons can pick and chose specific benchmarks from NSQIP, Commission on Cancer, National Accreditation Program for Breast Centers (NAPBC), or ACS Committee on Trauma standards documents and use these to evaluate the care they provide. Easy examples might include number of lymph nodes harvested at colon cancer surgery, percentage of breast cancer patients diagnosed with needle biopsy, and percentage treated with conservative surgery and appropriate postop radiation and or chemotherapy, or the percentage of melanoma patients treated per National Comprehensive Cancer Network guidelines. Other ways for institutions to document quality might be to partner with their tertiary referral center for CoC accreditation or just to participate in cancer conferences by videoconferencing. The Commission on Cancer has designated CoC Liason Program Chairs in each state that are available to aid in setting up these types of programs.
It is time for rural surgeons to partner with their hospitals and communities to carry out needs assessments and think of ways to fill those needs. An example might be to work with primary care providers to develop aggressive colon, breast, or lung cancer screening programs in communities with high numbers of late-stage cases. Transparency of the data collected and the care provided in the form of “Quality Reports to the Community” can improve local referral patterns, improve the financial viability of the local hospital, and prove to the community that quality care is being rendered. Pooling the data from a large base of rural surgeons could serve to disprove the academic community notion that rural patients receive suboptimal cancer care.
Dr. Sarap is a practicing general surgeon in Cambridge, Ohio. He is a member of the Advisory Council on Rural Surgery and has been appointed the Commission on Cancer Liaison Program Chair for Ohio.
'The Talk'
The surgery chief resident texted me: “Patient in ED with peritonitis. Incarcerated hernia.”
I came to the ED; should be easy I thought. See the patient, have a short conversation since the chief resident would have done all the preop. Of course, things are rarely that simple.
First, she was a Jehovah’s Witness on warfarin with an INR of 4. More significantly, she had end-stage COPD. I reviewed her CT scan and labs and went to see her and could tell without any conversation she needed an operation. I needed more information, but not about her belly pain or when it started or whether she had peritonitis on exam. I needed to know how far she could walk, how much oxygen was she on at home, how much was she sleeping, how much weight had she lost, and could she leave the house.
It took 30 minutes to determine her functional status, whether she would survive the postoperative ICU care, whether she would come off the ventilator, and would she want a tracheostomy. It took another 15 minutes to discuss blood product use. Her husband was present, and I left them to decide what they wanted within the context of her goals for her life. She accepted some blood products, underwent surgery, and did well. She came off the ventilator quickly postop and returned home from the hospital. Although she did well, we had a plan for the ventilator and her goals of care defined should she have done poorly.
He was 72, had stage IV lung cancer, and was too weak for chemotherapy. Now he had free air and peritonitis. The referring institution called me and said he was too much for their surgeons. I suggested perhaps they needed to have “the talk” prior to transport. They were unwilling to do so and sent him by helicopter because he was hypotensive. He clearly needed an operation by all surgical standards. But I wanted to wait for his family and talk with them before taking him to the OR; he was in no condition for any component of informed consent.
The family arrived 30 minutes later. His wife, the daughters who had been helping to take care of him, and two more relatives that had just arrived in town. His wife was clear: The man was sleeping all the time, losing weight, barely eating a couple of bites, unsteady on his feet, and confused when he was awake. I discussed options: The surgeon part of me wanted to “fix the hole,” the ICU doc in me knew he would die in the ICU on a ventilator, and the palliative medicine part of me knew hospice was his best option. I told the family he needed surgery but would likely not leave the hospital alive. I recommended hospice.
The wife was thoughtful and looked at her daughters and said, “We need to send him to hospice.” The wife and daughters were the easiest family I have spoken with in a long time. She was clear about whet he wanted and how much he had declined in the past few months. We were able to get him to inpatient hospice from the ED.
Surgery has changed, at least in my practice. Oh, what would I give for a healthy 17-year-old with appendicitis who gets better within hours of the operating room and my conversation with the family that takes 10 seconds. Instead, I take care of the very old and the very sick and the very chronically ill. My conversations are not “you need surgery;” that is done by the chief resident. My conversations are “tell me your functional status and what do you want if/when things go poorly.” Much more complicated and much less fun. The surgeon wants to fix the hole. I can fix the hole. But have I really helped the patient and his or her family? Although it takes me longer and involves more of my emotions and skills, it really is better for the patients and their families to have “the talk.”
Next time you see a patient who is chronically ill, please have the conversation about functional status and goals of care, before you operate. Or transfer. Perhaps then we can save the patient a helicopter ride to hospice.
Dr. Toevs is a trauma critical care surgeon at Allegheny General Hospital in Pittsburgh. She has a master’s degree in bioethics and board certification in hospice and palliative medicine.
The surgery chief resident texted me: “Patient in ED with peritonitis. Incarcerated hernia.”
I came to the ED; should be easy I thought. See the patient, have a short conversation since the chief resident would have done all the preop. Of course, things are rarely that simple.
First, she was a Jehovah’s Witness on warfarin with an INR of 4. More significantly, she had end-stage COPD. I reviewed her CT scan and labs and went to see her and could tell without any conversation she needed an operation. I needed more information, but not about her belly pain or when it started or whether she had peritonitis on exam. I needed to know how far she could walk, how much oxygen was she on at home, how much was she sleeping, how much weight had she lost, and could she leave the house.
It took 30 minutes to determine her functional status, whether she would survive the postoperative ICU care, whether she would come off the ventilator, and would she want a tracheostomy. It took another 15 minutes to discuss blood product use. Her husband was present, and I left them to decide what they wanted within the context of her goals for her life. She accepted some blood products, underwent surgery, and did well. She came off the ventilator quickly postop and returned home from the hospital. Although she did well, we had a plan for the ventilator and her goals of care defined should she have done poorly.
He was 72, had stage IV lung cancer, and was too weak for chemotherapy. Now he had free air and peritonitis. The referring institution called me and said he was too much for their surgeons. I suggested perhaps they needed to have “the talk” prior to transport. They were unwilling to do so and sent him by helicopter because he was hypotensive. He clearly needed an operation by all surgical standards. But I wanted to wait for his family and talk with them before taking him to the OR; he was in no condition for any component of informed consent.
The family arrived 30 minutes later. His wife, the daughters who had been helping to take care of him, and two more relatives that had just arrived in town. His wife was clear: The man was sleeping all the time, losing weight, barely eating a couple of bites, unsteady on his feet, and confused when he was awake. I discussed options: The surgeon part of me wanted to “fix the hole,” the ICU doc in me knew he would die in the ICU on a ventilator, and the palliative medicine part of me knew hospice was his best option. I told the family he needed surgery but would likely not leave the hospital alive. I recommended hospice.
The wife was thoughtful and looked at her daughters and said, “We need to send him to hospice.” The wife and daughters were the easiest family I have spoken with in a long time. She was clear about whet he wanted and how much he had declined in the past few months. We were able to get him to inpatient hospice from the ED.
Surgery has changed, at least in my practice. Oh, what would I give for a healthy 17-year-old with appendicitis who gets better within hours of the operating room and my conversation with the family that takes 10 seconds. Instead, I take care of the very old and the very sick and the very chronically ill. My conversations are not “you need surgery;” that is done by the chief resident. My conversations are “tell me your functional status and what do you want if/when things go poorly.” Much more complicated and much less fun. The surgeon wants to fix the hole. I can fix the hole. But have I really helped the patient and his or her family? Although it takes me longer and involves more of my emotions and skills, it really is better for the patients and their families to have “the talk.”
Next time you see a patient who is chronically ill, please have the conversation about functional status and goals of care, before you operate. Or transfer. Perhaps then we can save the patient a helicopter ride to hospice.
Dr. Toevs is a trauma critical care surgeon at Allegheny General Hospital in Pittsburgh. She has a master’s degree in bioethics and board certification in hospice and palliative medicine.
The surgery chief resident texted me: “Patient in ED with peritonitis. Incarcerated hernia.”
I came to the ED; should be easy I thought. See the patient, have a short conversation since the chief resident would have done all the preop. Of course, things are rarely that simple.
First, she was a Jehovah’s Witness on warfarin with an INR of 4. More significantly, she had end-stage COPD. I reviewed her CT scan and labs and went to see her and could tell without any conversation she needed an operation. I needed more information, but not about her belly pain or when it started or whether she had peritonitis on exam. I needed to know how far she could walk, how much oxygen was she on at home, how much was she sleeping, how much weight had she lost, and could she leave the house.
It took 30 minutes to determine her functional status, whether she would survive the postoperative ICU care, whether she would come off the ventilator, and would she want a tracheostomy. It took another 15 minutes to discuss blood product use. Her husband was present, and I left them to decide what they wanted within the context of her goals for her life. She accepted some blood products, underwent surgery, and did well. She came off the ventilator quickly postop and returned home from the hospital. Although she did well, we had a plan for the ventilator and her goals of care defined should she have done poorly.
He was 72, had stage IV lung cancer, and was too weak for chemotherapy. Now he had free air and peritonitis. The referring institution called me and said he was too much for their surgeons. I suggested perhaps they needed to have “the talk” prior to transport. They were unwilling to do so and sent him by helicopter because he was hypotensive. He clearly needed an operation by all surgical standards. But I wanted to wait for his family and talk with them before taking him to the OR; he was in no condition for any component of informed consent.
The family arrived 30 minutes later. His wife, the daughters who had been helping to take care of him, and two more relatives that had just arrived in town. His wife was clear: The man was sleeping all the time, losing weight, barely eating a couple of bites, unsteady on his feet, and confused when he was awake. I discussed options: The surgeon part of me wanted to “fix the hole,” the ICU doc in me knew he would die in the ICU on a ventilator, and the palliative medicine part of me knew hospice was his best option. I told the family he needed surgery but would likely not leave the hospital alive. I recommended hospice.
The wife was thoughtful and looked at her daughters and said, “We need to send him to hospice.” The wife and daughters were the easiest family I have spoken with in a long time. She was clear about whet he wanted and how much he had declined in the past few months. We were able to get him to inpatient hospice from the ED.
Surgery has changed, at least in my practice. Oh, what would I give for a healthy 17-year-old with appendicitis who gets better within hours of the operating room and my conversation with the family that takes 10 seconds. Instead, I take care of the very old and the very sick and the very chronically ill. My conversations are not “you need surgery;” that is done by the chief resident. My conversations are “tell me your functional status and what do you want if/when things go poorly.” Much more complicated and much less fun. The surgeon wants to fix the hole. I can fix the hole. But have I really helped the patient and his or her family? Although it takes me longer and involves more of my emotions and skills, it really is better for the patients and their families to have “the talk.”
Next time you see a patient who is chronically ill, please have the conversation about functional status and goals of care, before you operate. Or transfer. Perhaps then we can save the patient a helicopter ride to hospice.
Dr. Toevs is a trauma critical care surgeon at Allegheny General Hospital in Pittsburgh. She has a master’s degree in bioethics and board certification in hospice and palliative medicine.
An oversight
After reading the Child Psychiatry Consult column “Aggression and angry outbursts” by Dr. Robert R. Althoff in the September 2014 issue of Pediatric News, I was disappointed that the differential diagnosis did not include an autism spectrum disorder such as DSM-IV Asperger syndrome.
The complex of symptoms described almost perfectly reflects the history of a child with autism. Typical autism spectrum disorder (ASD) issues of needing to direct the play, playing by their rules, and being adamant that things must be the way they see it are noted in the patient’s history. Aggression and outbursts also are typical of a patient with ASD.
Even though autistic behavior is typically predictable, parents are not always alert to the triggers. Most meltdowns are over transitions and denials. Parents of patients with autism often complain that they “walk on eggshells.”
Edward B. Aull, M.D.
Behavioral Pediatrics
St. Vincent Carmel Hospital
Carmel, Ind.
Dr. Althoff responds: I’d like to thank Dr. Aull for pointing out an oversight in my article. Certainly, children on the autistic spectrum can exhibit aggression, although it is not part of the diagnostic criteria for DSM-5 ASD, which include deficits in social interaction and communication, and restricted, repetitive patterns of behavior, interests, or activities. I was not intending for the case to give the impression that this child had difficulty with social communication and restricted interests, but the diagnosis of ASD should be considered on the differential. Similar to the situation in obsessive compulsive disorder or other anxiety disorders, when either the need for social communication becomes exceptionally high or the restricted behavior or interests are challenged, these children can become aggressive, although most do not. Interestingly enough, children with DSM-IV Asperger syndrome and high-functioning autism have co-occurring disorders up to 74% of the time, with the highest percentages in the disorders on the differential that I listed in the original article: behavior disorders, anxiety disorders, and mood disorders (J. Autism Dev. Disord. 2010;40:1080-93). Given these findings, one might consider that, while the diagnosis of an ASD should be considered in the differential, the aggressive behavior may not be associated with the autism symptoms, per se, but rather may be co-occurring symptoms.
After reading the Child Psychiatry Consult column “Aggression and angry outbursts” by Dr. Robert R. Althoff in the September 2014 issue of Pediatric News, I was disappointed that the differential diagnosis did not include an autism spectrum disorder such as DSM-IV Asperger syndrome.
The complex of symptoms described almost perfectly reflects the history of a child with autism. Typical autism spectrum disorder (ASD) issues of needing to direct the play, playing by their rules, and being adamant that things must be the way they see it are noted in the patient’s history. Aggression and outbursts also are typical of a patient with ASD.
Even though autistic behavior is typically predictable, parents are not always alert to the triggers. Most meltdowns are over transitions and denials. Parents of patients with autism often complain that they “walk on eggshells.”
Edward B. Aull, M.D.
Behavioral Pediatrics
St. Vincent Carmel Hospital
Carmel, Ind.
Dr. Althoff responds: I’d like to thank Dr. Aull for pointing out an oversight in my article. Certainly, children on the autistic spectrum can exhibit aggression, although it is not part of the diagnostic criteria for DSM-5 ASD, which include deficits in social interaction and communication, and restricted, repetitive patterns of behavior, interests, or activities. I was not intending for the case to give the impression that this child had difficulty with social communication and restricted interests, but the diagnosis of ASD should be considered on the differential. Similar to the situation in obsessive compulsive disorder or other anxiety disorders, when either the need for social communication becomes exceptionally high or the restricted behavior or interests are challenged, these children can become aggressive, although most do not. Interestingly enough, children with DSM-IV Asperger syndrome and high-functioning autism have co-occurring disorders up to 74% of the time, with the highest percentages in the disorders on the differential that I listed in the original article: behavior disorders, anxiety disorders, and mood disorders (J. Autism Dev. Disord. 2010;40:1080-93). Given these findings, one might consider that, while the diagnosis of an ASD should be considered in the differential, the aggressive behavior may not be associated with the autism symptoms, per se, but rather may be co-occurring symptoms.
After reading the Child Psychiatry Consult column “Aggression and angry outbursts” by Dr. Robert R. Althoff in the September 2014 issue of Pediatric News, I was disappointed that the differential diagnosis did not include an autism spectrum disorder such as DSM-IV Asperger syndrome.
The complex of symptoms described almost perfectly reflects the history of a child with autism. Typical autism spectrum disorder (ASD) issues of needing to direct the play, playing by their rules, and being adamant that things must be the way they see it are noted in the patient’s history. Aggression and outbursts also are typical of a patient with ASD.
Even though autistic behavior is typically predictable, parents are not always alert to the triggers. Most meltdowns are over transitions and denials. Parents of patients with autism often complain that they “walk on eggshells.”
Edward B. Aull, M.D.
Behavioral Pediatrics
St. Vincent Carmel Hospital
Carmel, Ind.
Dr. Althoff responds: I’d like to thank Dr. Aull for pointing out an oversight in my article. Certainly, children on the autistic spectrum can exhibit aggression, although it is not part of the diagnostic criteria for DSM-5 ASD, which include deficits in social interaction and communication, and restricted, repetitive patterns of behavior, interests, or activities. I was not intending for the case to give the impression that this child had difficulty with social communication and restricted interests, but the diagnosis of ASD should be considered on the differential. Similar to the situation in obsessive compulsive disorder or other anxiety disorders, when either the need for social communication becomes exceptionally high or the restricted behavior or interests are challenged, these children can become aggressive, although most do not. Interestingly enough, children with DSM-IV Asperger syndrome and high-functioning autism have co-occurring disorders up to 74% of the time, with the highest percentages in the disorders on the differential that I listed in the original article: behavior disorders, anxiety disorders, and mood disorders (J. Autism Dev. Disord. 2010;40:1080-93). Given these findings, one might consider that, while the diagnosis of an ASD should be considered in the differential, the aggressive behavior may not be associated with the autism symptoms, per se, but rather may be co-occurring symptoms.
Pertussis persists
The Centers for Disease Control and Prevention suggests that recurring pertussis outbreaks may be the “new normal.” Such outbreaks show that some of what we “know” about pertussis is still correct, but some things are evolving. So in this new year, what do we need to know about patient vulnerability post vaccine as well as the clinical course, diagnosis, and treatment of this stubborn persisting disease?
Vulnerability after acellular pertussis vaccine
The recent large 2014 California outbreak surpassed the record numbers for the previously highest incidence year, 2010 (MMWR 2014;63:1129-32). This is scary because more cases had been reported in California in 2010 than in any prior year since the 1940s. The overall 2014 California pertussis rate (26/100,000 population) was approximately 10 times the national average for the first 9 years of this century, Are there clues as to who is most vulnerable and why?
No age group was spared, but certain age groups did appear more vulnerable. Infants had a startling 174.6/100,000 incidence (six times the rate for the overall population). It is not surprising to any clinician that infants less than 1 year of age were hardest hit. Infants have the most evident symptoms with pertussis. Infants also have 5-7 months of their first year in which they are incompletely immunized. Therefore, many are not expected to be protected until about 7-9 months of age. This vulnerability could be partly remedied if all pregnant women got Tdap boosters as recommended during pregnancy.
Of note, 15-year-olds had an incidence similar to that of infants (137.8/100,000). Ethnically, non-Hispanic whites had the highest incidence among adolescents (166.2/100,000), compared with Hispanics (64.2/100,000), Asian/Pacific Islanders (43.9/100,000), and non-Hispanic blacks (23.7/100,000). Disturbingly, 87% of cases among 15-year-olds had received a prior Tdap booster dose (median time since booster Tdap = 3 years, range = 0-7 years). Previous data from the 2010 outbreak suggested that immunity to pertussis wanes 3-4 years after receipt of the last acellular pertussis (aP)–containing vaccine. This is likely part of the explanation in 2014 as well. However, waning immunity after the booster does not explain why non-Hispanic whites had two to six times the incidence of other ethnicities. Non-Hispanic whites are thought to be the demographic with the most vaccine refusal and vaccine delay in California, so this may partially explain excess cases. Racial differences in access to care or genetic differences in disease susceptibility also may play a role.
Why is this biphasic increase in incidence in California a microcosm of the new epidemiology of pertussis in the United States? A kinder, gentler DTaP vaccine replaced the whole-cell DTP in the late 1990s. This occurred in response to the public’s concern about potential central nervous system adverse effects associated with the whole-cell DTP vaccine. Immunogenicity studies seemed to show equivalent immune responses in infants and toddlers receiving DTaP, compared with those who received DTP. It has only been in the last 5 years that we now know that the new DTaP and Tdap are not working as well as we had hoped.
The two aspects to the lesser protection provided by aP vaccines are pertactin-deficient pertussis strains and quicker waning of aP vaccine–induced immunity. Antibody to pertactin appears to be important in protection against clinical pertussis. New circulating clinical strains of pertussis may not have pertactin (N. Engl. J. Med. 2013;368:583-4). The strains used in our current DTaP and Tdap were designed to protect against pertactin-containing strains and were tested for this. This means that a proportion of the antibodies induced by vaccine strains are not useful against pertactin-deficient strains. The aP vaccine still induces antibody to the pertussis toxin and other pertussis components in the vaccines, so they will likely still reduce the severity of disease. But the vaccines are not likely to prevent infections from pertactin-deficient strains. This is similar to the partial vaccine mismatch that we are seeing with the current seasonal H3N2 influenza vaccine strain.
The second aspect is that protection appears to wane approximately 3-5 years after the last dose of aP-containing vaccine. This contrasts sharply with expectations in the past of 7-10 years of protection from whole cell pertussis–containing vaccines. The less reactive aP vaccine produces fewer adverse effects by not producing as much inflammation as DPT. The problem is that part of the reason the DPT has such good protective responses is the amount of inflammation it produces. So with less aP vaccine–induced inflammation comes less robust antibody and T-cell responses.
Nevertheless, the current acellular pertussis vaccines remain the most effective available tools to reduce pertussis disease (Cochrane Database Syst. Rev. 2014;9:CD001478]). But until we have new versions of pertussis vaccines that address these two issues, we clinicians need to remain vigilant for signs and symptoms of pertussis.
Clinical course
Remember that a whoop is rarely seen in young children and often also not seen when older patients present. The many outbreaks over the last 10 years have confirmed that paroxysmal cough with/without apnea in an infant/toddler should raise our index of suspicion. Likewise, older children, adolescents, and adults with persistent cough beyond 2 weeks are potential pertussis cases. Once the diagnosis is made, treatment is not expected to have a major impact on the clinical course, in part because the diagnosis is usually delayed (more than 10 days into symptoms). This delay allows more injury to the respiratory mucosa and cilia so that healing can require 6-12 weeks after bacterial replication ceases. This prolonged healing process is what is mostly responsible for the syndrome known as the “100-day cough.” So the clinical course of pertussis has not changed in the last 10 years. However, there have been changes in the commonly used diagnostic approach.
Pertussis diagnosis and contagion
During the last 5 years, polymerase chain reaction (PCR) testing has become the preferred technology to detect pertussis. This is due to the sensitivity and quick turnaround time of the assay. The gold standard for pertussis diagnosis remains culture, but it is expensive, cumbersome, and slow (up to a week to provide results). An ongoing debate arose about how long PCR testing remains positive after the onset of symptoms or treatment. This was not the problem when culture was the diagnostic tool of choice. Data from the 1970s and 1980s indicated that cultures were rarely positive after the third week of symptoms even without treatment. Furthermore, macrolides eliminated both contagion and positive culture results of infected patients after 5 days of treatment.
So now that we use PCR most often for diagnosis, what is the outer limit of positivity? A recent prospective cohort study from Salt Lake City suggests that PCR may detect pertussis DNA way beyond 3 weeks after symptom onset (J. Ped. Infect. Dis. 2014;3:347-9). Among patients hospitalized with laboratory-confirmed Bordetella pertussis infection, half had persistently positive pertussis PCR testing more than 50 days after symptom onset, despite antibiotic treatment and clinical improvement. The median (range) for the last day for a positive test after symptom onset was 58 days (4-172 days).
This raises the question as to whether there are viable pertussis organisms in the respiratory tract beyond the traditional 3 weeks defined by culture data. It is likely that DNA persists in the thick mucus of the respiratory tract way beyond viability of the last pertussis organisms. Put another way, PCR likely detects bacterial corpses or components way beyond the time that the patient is contagious. Unfortunately, current PCR data do not tell us how long patients remain contagious with the current strains of pertussis as infecting agents. Some institutions appear to be extending the isolation time for patients treated for pertussis beyond the traditional 5 days post initiation of effective treatment. Until more data are available, we are somewhat in the dark. But I would take comfort in the fact that it is unlikely the “new” data will be much different from those derived from the traditional studies that use culture to define infectivity. The American Academy of Pediatrics Committee on Infectious Diseases Red Book appears to agree.
For hospitalized pertussis patients, the AAP Committee on Infectious Diseases Red Book recommends standard and droplet precautions for 5 days after starting effective therapy, or 3 weeks after cough onset if appropriate antimicrobial therapy has not been given.
In addition, the CDC states: “PCR has optimal sensitivity during the first 3 weeks of cough when bacterial DNA is still present in the nasopharynx. After the fourth week of cough, the amount of bacterial DNA rapidly diminishes, which increases the risk of obtaining falsely negative results.” Later in the same document, the CDC says: “PCR testing following antibiotic therapy also can result in falsely negative findings. The exact duration of positivity following antibiotic use is not well understood, but PCR testing after 5 days of antibiotic use is unlikely to be of benefit and is generally not recommended.”
So what do we know? Not all PCR assays use the same primers, so some variance from the usual experience of up to 4 weeks of positive PCR results may be due to differences in the assays. But this raises concern that the PCR that you order may be positive at times when the patient is no longer contagious.
Pertussis treatment
If strains of pertussis have changed their pertactin antigen, are they changing their antibiotic susceptibility patterns? While there have been reports of macrolide resistance in a few pertussis strains, these still remain rare. The most recent comprehensive review of treatment efficacy was a Cochrane review performed in 2005 and published in 2007 (Cochrane Database Syst. Rev. 2007;3:CD004404). They evaluated 10 trials from 1969 to 2004 in which microbiologic eradication was defined by negative results from repeat pertussis culture. While meta-analysis of microbiologic eradication was not possible because of differences in antibiotic use, the investigators did conclude that antibiotic treatment “is effective in eliminating B. pertussis from patients with the disease to render them noninfectious, but does not alter the subsequent clinical course of the illness.”
Further, they state that “the best regimens for microbiologic clearance, with fewer side effects,” are 3 days of azithromycin (a single 10-mg/kg dose on 3 consecutive days) or 7 days of clarithromycin (7.5-mg/kg dose twice daily).
Another effective regimen is 14 days of erythromycin ethylsuccinate (60 mg/kg per day in 3 divided doses) .
CDC treatment recommendations include azithromycin or erythromycin, with trimethoprim-sulfamethoxazole as a possibility for macrolide-intolerant patients, although there are less data and success rates may not be as high.
Conclusion
So what do we know now about pertussis?
• Outbreaks are ongoing and likely will continue until newer more effective vaccines are produced, including those that circumvent the problem of pertactin-deficient strains.
• Pertussis is likely contagious up to 5 days on effective therapy, and for as long as 3 weeks if effective therapy has not been administered.
• PCR is a sensitive test that may remain positive for many weeks beyond contagion.
• Treatment with macrolides appears to be the most effective way to eradicate replicating pertussis pathogens.
• Treatment is not likely to have a major impact on the clinical course of disease because most of the damage to the respiratory tract is done prior to diagnosis and treatment. Treatment does reduce infectivity and subsequent cases.
• Current aP vaccines currently are our best preventative tools – including use in pregnant women to protect young infants.
As clinicians, our best course is to continue to immunize with the current vaccines, and remain vigilant for symptoms and signs of pertussis infection of patients so that early diagnosis and treatment can prevent further spread.
Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics, Kansas City, Mo. Children’s Mercy Hospitals receives funds from GlaxoSmithKline for Dr. Harrison being principal investigator on a multicenter research study of a hexavalent pertussis-containing infant vaccine. E-mail Dr. Harrison at [email protected].
The Centers for Disease Control and Prevention suggests that recurring pertussis outbreaks may be the “new normal.” Such outbreaks show that some of what we “know” about pertussis is still correct, but some things are evolving. So in this new year, what do we need to know about patient vulnerability post vaccine as well as the clinical course, diagnosis, and treatment of this stubborn persisting disease?
Vulnerability after acellular pertussis vaccine
The recent large 2014 California outbreak surpassed the record numbers for the previously highest incidence year, 2010 (MMWR 2014;63:1129-32). This is scary because more cases had been reported in California in 2010 than in any prior year since the 1940s. The overall 2014 California pertussis rate (26/100,000 population) was approximately 10 times the national average for the first 9 years of this century, Are there clues as to who is most vulnerable and why?
No age group was spared, but certain age groups did appear more vulnerable. Infants had a startling 174.6/100,000 incidence (six times the rate for the overall population). It is not surprising to any clinician that infants less than 1 year of age were hardest hit. Infants have the most evident symptoms with pertussis. Infants also have 5-7 months of their first year in which they are incompletely immunized. Therefore, many are not expected to be protected until about 7-9 months of age. This vulnerability could be partly remedied if all pregnant women got Tdap boosters as recommended during pregnancy.
Of note, 15-year-olds had an incidence similar to that of infants (137.8/100,000). Ethnically, non-Hispanic whites had the highest incidence among adolescents (166.2/100,000), compared with Hispanics (64.2/100,000), Asian/Pacific Islanders (43.9/100,000), and non-Hispanic blacks (23.7/100,000). Disturbingly, 87% of cases among 15-year-olds had received a prior Tdap booster dose (median time since booster Tdap = 3 years, range = 0-7 years). Previous data from the 2010 outbreak suggested that immunity to pertussis wanes 3-4 years after receipt of the last acellular pertussis (aP)–containing vaccine. This is likely part of the explanation in 2014 as well. However, waning immunity after the booster does not explain why non-Hispanic whites had two to six times the incidence of other ethnicities. Non-Hispanic whites are thought to be the demographic with the most vaccine refusal and vaccine delay in California, so this may partially explain excess cases. Racial differences in access to care or genetic differences in disease susceptibility also may play a role.
Why is this biphasic increase in incidence in California a microcosm of the new epidemiology of pertussis in the United States? A kinder, gentler DTaP vaccine replaced the whole-cell DTP in the late 1990s. This occurred in response to the public’s concern about potential central nervous system adverse effects associated with the whole-cell DTP vaccine. Immunogenicity studies seemed to show equivalent immune responses in infants and toddlers receiving DTaP, compared with those who received DTP. It has only been in the last 5 years that we now know that the new DTaP and Tdap are not working as well as we had hoped.
The two aspects to the lesser protection provided by aP vaccines are pertactin-deficient pertussis strains and quicker waning of aP vaccine–induced immunity. Antibody to pertactin appears to be important in protection against clinical pertussis. New circulating clinical strains of pertussis may not have pertactin (N. Engl. J. Med. 2013;368:583-4). The strains used in our current DTaP and Tdap were designed to protect against pertactin-containing strains and were tested for this. This means that a proportion of the antibodies induced by vaccine strains are not useful against pertactin-deficient strains. The aP vaccine still induces antibody to the pertussis toxin and other pertussis components in the vaccines, so they will likely still reduce the severity of disease. But the vaccines are not likely to prevent infections from pertactin-deficient strains. This is similar to the partial vaccine mismatch that we are seeing with the current seasonal H3N2 influenza vaccine strain.
The second aspect is that protection appears to wane approximately 3-5 years after the last dose of aP-containing vaccine. This contrasts sharply with expectations in the past of 7-10 years of protection from whole cell pertussis–containing vaccines. The less reactive aP vaccine produces fewer adverse effects by not producing as much inflammation as DPT. The problem is that part of the reason the DPT has such good protective responses is the amount of inflammation it produces. So with less aP vaccine–induced inflammation comes less robust antibody and T-cell responses.
Nevertheless, the current acellular pertussis vaccines remain the most effective available tools to reduce pertussis disease (Cochrane Database Syst. Rev. 2014;9:CD001478]). But until we have new versions of pertussis vaccines that address these two issues, we clinicians need to remain vigilant for signs and symptoms of pertussis.
Clinical course
Remember that a whoop is rarely seen in young children and often also not seen when older patients present. The many outbreaks over the last 10 years have confirmed that paroxysmal cough with/without apnea in an infant/toddler should raise our index of suspicion. Likewise, older children, adolescents, and adults with persistent cough beyond 2 weeks are potential pertussis cases. Once the diagnosis is made, treatment is not expected to have a major impact on the clinical course, in part because the diagnosis is usually delayed (more than 10 days into symptoms). This delay allows more injury to the respiratory mucosa and cilia so that healing can require 6-12 weeks after bacterial replication ceases. This prolonged healing process is what is mostly responsible for the syndrome known as the “100-day cough.” So the clinical course of pertussis has not changed in the last 10 years. However, there have been changes in the commonly used diagnostic approach.
Pertussis diagnosis and contagion
During the last 5 years, polymerase chain reaction (PCR) testing has become the preferred technology to detect pertussis. This is due to the sensitivity and quick turnaround time of the assay. The gold standard for pertussis diagnosis remains culture, but it is expensive, cumbersome, and slow (up to a week to provide results). An ongoing debate arose about how long PCR testing remains positive after the onset of symptoms or treatment. This was not the problem when culture was the diagnostic tool of choice. Data from the 1970s and 1980s indicated that cultures were rarely positive after the third week of symptoms even without treatment. Furthermore, macrolides eliminated both contagion and positive culture results of infected patients after 5 days of treatment.
So now that we use PCR most often for diagnosis, what is the outer limit of positivity? A recent prospective cohort study from Salt Lake City suggests that PCR may detect pertussis DNA way beyond 3 weeks after symptom onset (J. Ped. Infect. Dis. 2014;3:347-9). Among patients hospitalized with laboratory-confirmed Bordetella pertussis infection, half had persistently positive pertussis PCR testing more than 50 days after symptom onset, despite antibiotic treatment and clinical improvement. The median (range) for the last day for a positive test after symptom onset was 58 days (4-172 days).
This raises the question as to whether there are viable pertussis organisms in the respiratory tract beyond the traditional 3 weeks defined by culture data. It is likely that DNA persists in the thick mucus of the respiratory tract way beyond viability of the last pertussis organisms. Put another way, PCR likely detects bacterial corpses or components way beyond the time that the patient is contagious. Unfortunately, current PCR data do not tell us how long patients remain contagious with the current strains of pertussis as infecting agents. Some institutions appear to be extending the isolation time for patients treated for pertussis beyond the traditional 5 days post initiation of effective treatment. Until more data are available, we are somewhat in the dark. But I would take comfort in the fact that it is unlikely the “new” data will be much different from those derived from the traditional studies that use culture to define infectivity. The American Academy of Pediatrics Committee on Infectious Diseases Red Book appears to agree.
For hospitalized pertussis patients, the AAP Committee on Infectious Diseases Red Book recommends standard and droplet precautions for 5 days after starting effective therapy, or 3 weeks after cough onset if appropriate antimicrobial therapy has not been given.
In addition, the CDC states: “PCR has optimal sensitivity during the first 3 weeks of cough when bacterial DNA is still present in the nasopharynx. After the fourth week of cough, the amount of bacterial DNA rapidly diminishes, which increases the risk of obtaining falsely negative results.” Later in the same document, the CDC says: “PCR testing following antibiotic therapy also can result in falsely negative findings. The exact duration of positivity following antibiotic use is not well understood, but PCR testing after 5 days of antibiotic use is unlikely to be of benefit and is generally not recommended.”
So what do we know? Not all PCR assays use the same primers, so some variance from the usual experience of up to 4 weeks of positive PCR results may be due to differences in the assays. But this raises concern that the PCR that you order may be positive at times when the patient is no longer contagious.
Pertussis treatment
If strains of pertussis have changed their pertactin antigen, are they changing their antibiotic susceptibility patterns? While there have been reports of macrolide resistance in a few pertussis strains, these still remain rare. The most recent comprehensive review of treatment efficacy was a Cochrane review performed in 2005 and published in 2007 (Cochrane Database Syst. Rev. 2007;3:CD004404). They evaluated 10 trials from 1969 to 2004 in which microbiologic eradication was defined by negative results from repeat pertussis culture. While meta-analysis of microbiologic eradication was not possible because of differences in antibiotic use, the investigators did conclude that antibiotic treatment “is effective in eliminating B. pertussis from patients with the disease to render them noninfectious, but does not alter the subsequent clinical course of the illness.”
Further, they state that “the best regimens for microbiologic clearance, with fewer side effects,” are 3 days of azithromycin (a single 10-mg/kg dose on 3 consecutive days) or 7 days of clarithromycin (7.5-mg/kg dose twice daily).
Another effective regimen is 14 days of erythromycin ethylsuccinate (60 mg/kg per day in 3 divided doses) .
CDC treatment recommendations include azithromycin or erythromycin, with trimethoprim-sulfamethoxazole as a possibility for macrolide-intolerant patients, although there are less data and success rates may not be as high.
Conclusion
So what do we know now about pertussis?
• Outbreaks are ongoing and likely will continue until newer more effective vaccines are produced, including those that circumvent the problem of pertactin-deficient strains.
• Pertussis is likely contagious up to 5 days on effective therapy, and for as long as 3 weeks if effective therapy has not been administered.
• PCR is a sensitive test that may remain positive for many weeks beyond contagion.
• Treatment with macrolides appears to be the most effective way to eradicate replicating pertussis pathogens.
• Treatment is not likely to have a major impact on the clinical course of disease because most of the damage to the respiratory tract is done prior to diagnosis and treatment. Treatment does reduce infectivity and subsequent cases.
• Current aP vaccines currently are our best preventative tools – including use in pregnant women to protect young infants.
As clinicians, our best course is to continue to immunize with the current vaccines, and remain vigilant for symptoms and signs of pertussis infection of patients so that early diagnosis and treatment can prevent further spread.
Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics, Kansas City, Mo. Children’s Mercy Hospitals receives funds from GlaxoSmithKline for Dr. Harrison being principal investigator on a multicenter research study of a hexavalent pertussis-containing infant vaccine. E-mail Dr. Harrison at [email protected].
The Centers for Disease Control and Prevention suggests that recurring pertussis outbreaks may be the “new normal.” Such outbreaks show that some of what we “know” about pertussis is still correct, but some things are evolving. So in this new year, what do we need to know about patient vulnerability post vaccine as well as the clinical course, diagnosis, and treatment of this stubborn persisting disease?
Vulnerability after acellular pertussis vaccine
The recent large 2014 California outbreak surpassed the record numbers for the previously highest incidence year, 2010 (MMWR 2014;63:1129-32). This is scary because more cases had been reported in California in 2010 than in any prior year since the 1940s. The overall 2014 California pertussis rate (26/100,000 population) was approximately 10 times the national average for the first 9 years of this century, Are there clues as to who is most vulnerable and why?
No age group was spared, but certain age groups did appear more vulnerable. Infants had a startling 174.6/100,000 incidence (six times the rate for the overall population). It is not surprising to any clinician that infants less than 1 year of age were hardest hit. Infants have the most evident symptoms with pertussis. Infants also have 5-7 months of their first year in which they are incompletely immunized. Therefore, many are not expected to be protected until about 7-9 months of age. This vulnerability could be partly remedied if all pregnant women got Tdap boosters as recommended during pregnancy.
Of note, 15-year-olds had an incidence similar to that of infants (137.8/100,000). Ethnically, non-Hispanic whites had the highest incidence among adolescents (166.2/100,000), compared with Hispanics (64.2/100,000), Asian/Pacific Islanders (43.9/100,000), and non-Hispanic blacks (23.7/100,000). Disturbingly, 87% of cases among 15-year-olds had received a prior Tdap booster dose (median time since booster Tdap = 3 years, range = 0-7 years). Previous data from the 2010 outbreak suggested that immunity to pertussis wanes 3-4 years after receipt of the last acellular pertussis (aP)–containing vaccine. This is likely part of the explanation in 2014 as well. However, waning immunity after the booster does not explain why non-Hispanic whites had two to six times the incidence of other ethnicities. Non-Hispanic whites are thought to be the demographic with the most vaccine refusal and vaccine delay in California, so this may partially explain excess cases. Racial differences in access to care or genetic differences in disease susceptibility also may play a role.
Why is this biphasic increase in incidence in California a microcosm of the new epidemiology of pertussis in the United States? A kinder, gentler DTaP vaccine replaced the whole-cell DTP in the late 1990s. This occurred in response to the public’s concern about potential central nervous system adverse effects associated with the whole-cell DTP vaccine. Immunogenicity studies seemed to show equivalent immune responses in infants and toddlers receiving DTaP, compared with those who received DTP. It has only been in the last 5 years that we now know that the new DTaP and Tdap are not working as well as we had hoped.
The two aspects to the lesser protection provided by aP vaccines are pertactin-deficient pertussis strains and quicker waning of aP vaccine–induced immunity. Antibody to pertactin appears to be important in protection against clinical pertussis. New circulating clinical strains of pertussis may not have pertactin (N. Engl. J. Med. 2013;368:583-4). The strains used in our current DTaP and Tdap were designed to protect against pertactin-containing strains and were tested for this. This means that a proportion of the antibodies induced by vaccine strains are not useful against pertactin-deficient strains. The aP vaccine still induces antibody to the pertussis toxin and other pertussis components in the vaccines, so they will likely still reduce the severity of disease. But the vaccines are not likely to prevent infections from pertactin-deficient strains. This is similar to the partial vaccine mismatch that we are seeing with the current seasonal H3N2 influenza vaccine strain.
The second aspect is that protection appears to wane approximately 3-5 years after the last dose of aP-containing vaccine. This contrasts sharply with expectations in the past of 7-10 years of protection from whole cell pertussis–containing vaccines. The less reactive aP vaccine produces fewer adverse effects by not producing as much inflammation as DPT. The problem is that part of the reason the DPT has such good protective responses is the amount of inflammation it produces. So with less aP vaccine–induced inflammation comes less robust antibody and T-cell responses.
Nevertheless, the current acellular pertussis vaccines remain the most effective available tools to reduce pertussis disease (Cochrane Database Syst. Rev. 2014;9:CD001478]). But until we have new versions of pertussis vaccines that address these two issues, we clinicians need to remain vigilant for signs and symptoms of pertussis.
Clinical course
Remember that a whoop is rarely seen in young children and often also not seen when older patients present. The many outbreaks over the last 10 years have confirmed that paroxysmal cough with/without apnea in an infant/toddler should raise our index of suspicion. Likewise, older children, adolescents, and adults with persistent cough beyond 2 weeks are potential pertussis cases. Once the diagnosis is made, treatment is not expected to have a major impact on the clinical course, in part because the diagnosis is usually delayed (more than 10 days into symptoms). This delay allows more injury to the respiratory mucosa and cilia so that healing can require 6-12 weeks after bacterial replication ceases. This prolonged healing process is what is mostly responsible for the syndrome known as the “100-day cough.” So the clinical course of pertussis has not changed in the last 10 years. However, there have been changes in the commonly used diagnostic approach.
Pertussis diagnosis and contagion
During the last 5 years, polymerase chain reaction (PCR) testing has become the preferred technology to detect pertussis. This is due to the sensitivity and quick turnaround time of the assay. The gold standard for pertussis diagnosis remains culture, but it is expensive, cumbersome, and slow (up to a week to provide results). An ongoing debate arose about how long PCR testing remains positive after the onset of symptoms or treatment. This was not the problem when culture was the diagnostic tool of choice. Data from the 1970s and 1980s indicated that cultures were rarely positive after the third week of symptoms even without treatment. Furthermore, macrolides eliminated both contagion and positive culture results of infected patients after 5 days of treatment.
So now that we use PCR most often for diagnosis, what is the outer limit of positivity? A recent prospective cohort study from Salt Lake City suggests that PCR may detect pertussis DNA way beyond 3 weeks after symptom onset (J. Ped. Infect. Dis. 2014;3:347-9). Among patients hospitalized with laboratory-confirmed Bordetella pertussis infection, half had persistently positive pertussis PCR testing more than 50 days after symptom onset, despite antibiotic treatment and clinical improvement. The median (range) for the last day for a positive test after symptom onset was 58 days (4-172 days).
This raises the question as to whether there are viable pertussis organisms in the respiratory tract beyond the traditional 3 weeks defined by culture data. It is likely that DNA persists in the thick mucus of the respiratory tract way beyond viability of the last pertussis organisms. Put another way, PCR likely detects bacterial corpses or components way beyond the time that the patient is contagious. Unfortunately, current PCR data do not tell us how long patients remain contagious with the current strains of pertussis as infecting agents. Some institutions appear to be extending the isolation time for patients treated for pertussis beyond the traditional 5 days post initiation of effective treatment. Until more data are available, we are somewhat in the dark. But I would take comfort in the fact that it is unlikely the “new” data will be much different from those derived from the traditional studies that use culture to define infectivity. The American Academy of Pediatrics Committee on Infectious Diseases Red Book appears to agree.
For hospitalized pertussis patients, the AAP Committee on Infectious Diseases Red Book recommends standard and droplet precautions for 5 days after starting effective therapy, or 3 weeks after cough onset if appropriate antimicrobial therapy has not been given.
In addition, the CDC states: “PCR has optimal sensitivity during the first 3 weeks of cough when bacterial DNA is still present in the nasopharynx. After the fourth week of cough, the amount of bacterial DNA rapidly diminishes, which increases the risk of obtaining falsely negative results.” Later in the same document, the CDC says: “PCR testing following antibiotic therapy also can result in falsely negative findings. The exact duration of positivity following antibiotic use is not well understood, but PCR testing after 5 days of antibiotic use is unlikely to be of benefit and is generally not recommended.”
So what do we know? Not all PCR assays use the same primers, so some variance from the usual experience of up to 4 weeks of positive PCR results may be due to differences in the assays. But this raises concern that the PCR that you order may be positive at times when the patient is no longer contagious.
Pertussis treatment
If strains of pertussis have changed their pertactin antigen, are they changing their antibiotic susceptibility patterns? While there have been reports of macrolide resistance in a few pertussis strains, these still remain rare. The most recent comprehensive review of treatment efficacy was a Cochrane review performed in 2005 and published in 2007 (Cochrane Database Syst. Rev. 2007;3:CD004404). They evaluated 10 trials from 1969 to 2004 in which microbiologic eradication was defined by negative results from repeat pertussis culture. While meta-analysis of microbiologic eradication was not possible because of differences in antibiotic use, the investigators did conclude that antibiotic treatment “is effective in eliminating B. pertussis from patients with the disease to render them noninfectious, but does not alter the subsequent clinical course of the illness.”
Further, they state that “the best regimens for microbiologic clearance, with fewer side effects,” are 3 days of azithromycin (a single 10-mg/kg dose on 3 consecutive days) or 7 days of clarithromycin (7.5-mg/kg dose twice daily).
Another effective regimen is 14 days of erythromycin ethylsuccinate (60 mg/kg per day in 3 divided doses) .
CDC treatment recommendations include azithromycin or erythromycin, with trimethoprim-sulfamethoxazole as a possibility for macrolide-intolerant patients, although there are less data and success rates may not be as high.
Conclusion
So what do we know now about pertussis?
• Outbreaks are ongoing and likely will continue until newer more effective vaccines are produced, including those that circumvent the problem of pertactin-deficient strains.
• Pertussis is likely contagious up to 5 days on effective therapy, and for as long as 3 weeks if effective therapy has not been administered.
• PCR is a sensitive test that may remain positive for many weeks beyond contagion.
• Treatment with macrolides appears to be the most effective way to eradicate replicating pertussis pathogens.
• Treatment is not likely to have a major impact on the clinical course of disease because most of the damage to the respiratory tract is done prior to diagnosis and treatment. Treatment does reduce infectivity and subsequent cases.
• Current aP vaccines currently are our best preventative tools – including use in pregnant women to protect young infants.
As clinicians, our best course is to continue to immunize with the current vaccines, and remain vigilant for symptoms and signs of pertussis infection of patients so that early diagnosis and treatment can prevent further spread.
Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics, Kansas City, Mo. Children’s Mercy Hospitals receives funds from GlaxoSmithKline for Dr. Harrison being principal investigator on a multicenter research study of a hexavalent pertussis-containing infant vaccine. E-mail Dr. Harrison at [email protected].
Prevention of Venous Thromboembolism After Total Joint Arthroplasty: Aspirin Is Enough for Most Patients
The orthopedic community continues to be concerned about venous thromboembolism (VTE) after orthopedic procedures. There is currently no consensus on the optimal strategy for prevention of VTE after knee and hip arthroplasty. In North America, the American Association of Orthopaedic Surgeons (AAOS) and the American College of Chest Physicians (ACCP) have both been involved in putting forth guidelines that are intended to minimize this complication after orthopedic procedures.1-2
Both of these guidelines have evaluated the available literature, whenever present, to reach their recommendations. Although the AAOS guidelines do not mention aspirin specifically, they do endorse any form of anticoagulation as acceptable after total hip and knee arthroplasty. The ACCP, on the other hand, gives their highest endorsement (1B) to aspirin as an effective prophylactic agent for prevention of VTE after total joint arthroplasty (TJA).1 In the analysis, surgeon choice of VTE prophylaxis should be based on a balance between safety and efficacy of a particular anticoagulant, with risk stratification used to identify patients at standard risk (the vast majority) or high risk of VTE or bleeding.
Recent studies have helped to dispel the age-old misconception that aspirin is an effective modality for prevention of clots in the high-pressure (arterial) system but not in the low-pressure (venous) system. The ASPIRE study evaluated 822 patients and detected that the incidence of VTE was 4.8% in patients who received aspirin versus 6.5% in patients who did not receive aspirin.3 Although the difference in the incidence of VTE in the given sample size did not reach statistical significance, the difference did reach statistical significance when other major vascular issues were taken into account.3 Another study (WARFASA), evaluating 402 patients with prior VTE, detected 42% reduction in the incidence of recurrent VTE in patients that received aspirin, confirming the fact that aspirin does indeed act on the venous low-pressure system.4
The prevailing evidence over the last decade supports the notion that aspirin is an effective agent for prevention of VTE with a lower risk of imparting many of the harms that other aggressive anticoagulant agents are likely to cause, such as wound drainage, bleeding, increased incidence of readmission, reoperation, periprosthetic infection, and even mortality.5-7
With the increasing scrutiny and penalties imposed on surgeons and health care systems by the regulatory bodies in the United States for a variety of “quality metric” considerations related to readmission and reoperation, including VTE prevention and its complications, the notion of using anticoagulant agents that are not only effective but also less harmful is gaining momentum and greater endorsement. Visiting the US Food and Drug Administration website reveals that among all drugs in the medical community, aggressive anticoagulants are associated with the highest number of adverse effects, including mortality.8
The medical community also needs to recognize that there have been immense changes in the practice of orthopedics, particularly in the realm of knee and hip arthroplasty. The majority of patients undergoing TJA receive regional anesthesia, using expeditious surgical techniques, and are mobilized immediately in the postoperative period—all of these elements have contributed to a declining incidence of VTE after TJA. Furthermore, patients are often discharged from the hospital within a day or two, making compliance with outpatient anticoagulant therapy more of a challenge. Thus, the historical protocols related to TJA—when patients stayed in bed for days before beginning a delayed and limited physical therapy program and a lengthy hospital stay—are behind us. These major changes in surgical and anesthesia techniques as well as accelerated postoperative protocols highlight the fact that any literature from the far past needs to be examined with caution as it may not be applicable to modern-day surgical patients.
Moving forward, while we strongly endorse risk stratification for VTE prophylaxis, in our opinion aspirin will become the mainstay of prevention of VTE for the majority of patients after TJA. The challenge that lies ahead is to determine which patients are at increased risk of VTE and in need of more aggressive anticoagulants. There has been a recent development on this front that aims to provide some guidance for selection of high-risk patients.9 It appears that over 90% of patients undergoing TJA can safely receive aspirin as an anticoagulation prophylaxis, while a validated risk profile can be used to detect those at higher risk for VTE and in need of more aggressive agents.9
Thanks to the diligent work of the ACCP and AAOS workgroups and many other scholars in the field, the science of VTE prophylaxis after TJA has truly evolved. The adaptation of the recent ACCP guidelines by the Surgical Care Improvement Project (SCIP), which accepts aspirin as an effective anticoagulation modality, is yet another step in the direction of optimizing outcomes for our patients, by preventing the feared VTE while also limiting untoward bleeding complications that can occur with administration of aggressive anticoagulants.10
1. Falck-Ytter Y, Francis CW, Johanson NA, et al; American College of Chest Physicians. Prevention of VTE in Orthopedic Surgery Patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 Suppl):e278S-325S.
2. Sharrock NE, Gonzalez Della Valle A, Go G, Lyman S, Salvati EA. Potent anticoagulants are associated with a higher all-cause mortality rate after hip and knee arthroplasty. Clin Orthop. 2008;466(3):714-721.
3. Brighton TA, Eikelboom JW, Mann K, et al; ASPIRE Investigators. Low-dose aspirin for preventing recurrent venous thromboembolism. N Engl J Med. 2012;367(21):1979-1987.
4. Becattini C, Agnelli G, Schenone A, et al; WARFASA Investigators. Aspirin for preventing the recurrence of venous thromboembolism. N Engl J Med. 2012;366(21):1959-1967.
5. Parvizi J, Ghanem E, Joshi A, Sharkey PF, Hozack WJ, Rothman RH. Does “excessive” anticoagulation predispose to periprosthetic infection? J Arthroplasty. 2007;22(6 Suppl 2):24-28.
6. Sachs RA, Smith JH, Kuney M, Paxton L. Does anticoagulation do more harm than good? A comparison of patients treated without prophylaxis and patients treated with low-dose warfarin after total knee arthroplasty. J Arthroplasty. 2003;18(4):389-395.
7. Lotke PA, Lonner JH. The benefit of aspirin chemoprophylaxis for thromboembolism after total knee arthroplasty. Clin Orthop. 2006;452:175-180.
8. Medical Product Safety Information. US Food and Drug Administration website. http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm. Updated December 11, 2014. Accessed December 29, 2014.
9. Parvizi J, Huang R, Raphael IJ, Arnold WV, Rothman RH. Symptomatic pulmonary embolus after joint arthroplasty: stratification of risk factors. Clin Orthop. 2014;472(3):903-912.
10. Mont MA, Hozack WJ, Callaghan JJ, Krebs V, Parvizi J, Mason JB. Venous thromboemboli following total joint arthroplasty: SCIP measures move us closer to an agreement. J Arthroplasty. 2014;29(4):651-652.
The orthopedic community continues to be concerned about venous thromboembolism (VTE) after orthopedic procedures. There is currently no consensus on the optimal strategy for prevention of VTE after knee and hip arthroplasty. In North America, the American Association of Orthopaedic Surgeons (AAOS) and the American College of Chest Physicians (ACCP) have both been involved in putting forth guidelines that are intended to minimize this complication after orthopedic procedures.1-2
Both of these guidelines have evaluated the available literature, whenever present, to reach their recommendations. Although the AAOS guidelines do not mention aspirin specifically, they do endorse any form of anticoagulation as acceptable after total hip and knee arthroplasty. The ACCP, on the other hand, gives their highest endorsement (1B) to aspirin as an effective prophylactic agent for prevention of VTE after total joint arthroplasty (TJA).1 In the analysis, surgeon choice of VTE prophylaxis should be based on a balance between safety and efficacy of a particular anticoagulant, with risk stratification used to identify patients at standard risk (the vast majority) or high risk of VTE or bleeding.
Recent studies have helped to dispel the age-old misconception that aspirin is an effective modality for prevention of clots in the high-pressure (arterial) system but not in the low-pressure (venous) system. The ASPIRE study evaluated 822 patients and detected that the incidence of VTE was 4.8% in patients who received aspirin versus 6.5% in patients who did not receive aspirin.3 Although the difference in the incidence of VTE in the given sample size did not reach statistical significance, the difference did reach statistical significance when other major vascular issues were taken into account.3 Another study (WARFASA), evaluating 402 patients with prior VTE, detected 42% reduction in the incidence of recurrent VTE in patients that received aspirin, confirming the fact that aspirin does indeed act on the venous low-pressure system.4
The prevailing evidence over the last decade supports the notion that aspirin is an effective agent for prevention of VTE with a lower risk of imparting many of the harms that other aggressive anticoagulant agents are likely to cause, such as wound drainage, bleeding, increased incidence of readmission, reoperation, periprosthetic infection, and even mortality.5-7
With the increasing scrutiny and penalties imposed on surgeons and health care systems by the regulatory bodies in the United States for a variety of “quality metric” considerations related to readmission and reoperation, including VTE prevention and its complications, the notion of using anticoagulant agents that are not only effective but also less harmful is gaining momentum and greater endorsement. Visiting the US Food and Drug Administration website reveals that among all drugs in the medical community, aggressive anticoagulants are associated with the highest number of adverse effects, including mortality.8
The medical community also needs to recognize that there have been immense changes in the practice of orthopedics, particularly in the realm of knee and hip arthroplasty. The majority of patients undergoing TJA receive regional anesthesia, using expeditious surgical techniques, and are mobilized immediately in the postoperative period—all of these elements have contributed to a declining incidence of VTE after TJA. Furthermore, patients are often discharged from the hospital within a day or two, making compliance with outpatient anticoagulant therapy more of a challenge. Thus, the historical protocols related to TJA—when patients stayed in bed for days before beginning a delayed and limited physical therapy program and a lengthy hospital stay—are behind us. These major changes in surgical and anesthesia techniques as well as accelerated postoperative protocols highlight the fact that any literature from the far past needs to be examined with caution as it may not be applicable to modern-day surgical patients.
Moving forward, while we strongly endorse risk stratification for VTE prophylaxis, in our opinion aspirin will become the mainstay of prevention of VTE for the majority of patients after TJA. The challenge that lies ahead is to determine which patients are at increased risk of VTE and in need of more aggressive anticoagulants. There has been a recent development on this front that aims to provide some guidance for selection of high-risk patients.9 It appears that over 90% of patients undergoing TJA can safely receive aspirin as an anticoagulation prophylaxis, while a validated risk profile can be used to detect those at higher risk for VTE and in need of more aggressive agents.9
Thanks to the diligent work of the ACCP and AAOS workgroups and many other scholars in the field, the science of VTE prophylaxis after TJA has truly evolved. The adaptation of the recent ACCP guidelines by the Surgical Care Improvement Project (SCIP), which accepts aspirin as an effective anticoagulation modality, is yet another step in the direction of optimizing outcomes for our patients, by preventing the feared VTE while also limiting untoward bleeding complications that can occur with administration of aggressive anticoagulants.10
The orthopedic community continues to be concerned about venous thromboembolism (VTE) after orthopedic procedures. There is currently no consensus on the optimal strategy for prevention of VTE after knee and hip arthroplasty. In North America, the American Association of Orthopaedic Surgeons (AAOS) and the American College of Chest Physicians (ACCP) have both been involved in putting forth guidelines that are intended to minimize this complication after orthopedic procedures.1-2
Both of these guidelines have evaluated the available literature, whenever present, to reach their recommendations. Although the AAOS guidelines do not mention aspirin specifically, they do endorse any form of anticoagulation as acceptable after total hip and knee arthroplasty. The ACCP, on the other hand, gives their highest endorsement (1B) to aspirin as an effective prophylactic agent for prevention of VTE after total joint arthroplasty (TJA).1 In the analysis, surgeon choice of VTE prophylaxis should be based on a balance between safety and efficacy of a particular anticoagulant, with risk stratification used to identify patients at standard risk (the vast majority) or high risk of VTE or bleeding.
Recent studies have helped to dispel the age-old misconception that aspirin is an effective modality for prevention of clots in the high-pressure (arterial) system but not in the low-pressure (venous) system. The ASPIRE study evaluated 822 patients and detected that the incidence of VTE was 4.8% in patients who received aspirin versus 6.5% in patients who did not receive aspirin.3 Although the difference in the incidence of VTE in the given sample size did not reach statistical significance, the difference did reach statistical significance when other major vascular issues were taken into account.3 Another study (WARFASA), evaluating 402 patients with prior VTE, detected 42% reduction in the incidence of recurrent VTE in patients that received aspirin, confirming the fact that aspirin does indeed act on the venous low-pressure system.4
The prevailing evidence over the last decade supports the notion that aspirin is an effective agent for prevention of VTE with a lower risk of imparting many of the harms that other aggressive anticoagulant agents are likely to cause, such as wound drainage, bleeding, increased incidence of readmission, reoperation, periprosthetic infection, and even mortality.5-7
With the increasing scrutiny and penalties imposed on surgeons and health care systems by the regulatory bodies in the United States for a variety of “quality metric” considerations related to readmission and reoperation, including VTE prevention and its complications, the notion of using anticoagulant agents that are not only effective but also less harmful is gaining momentum and greater endorsement. Visiting the US Food and Drug Administration website reveals that among all drugs in the medical community, aggressive anticoagulants are associated with the highest number of adverse effects, including mortality.8
The medical community also needs to recognize that there have been immense changes in the practice of orthopedics, particularly in the realm of knee and hip arthroplasty. The majority of patients undergoing TJA receive regional anesthesia, using expeditious surgical techniques, and are mobilized immediately in the postoperative period—all of these elements have contributed to a declining incidence of VTE after TJA. Furthermore, patients are often discharged from the hospital within a day or two, making compliance with outpatient anticoagulant therapy more of a challenge. Thus, the historical protocols related to TJA—when patients stayed in bed for days before beginning a delayed and limited physical therapy program and a lengthy hospital stay—are behind us. These major changes in surgical and anesthesia techniques as well as accelerated postoperative protocols highlight the fact that any literature from the far past needs to be examined with caution as it may not be applicable to modern-day surgical patients.
Moving forward, while we strongly endorse risk stratification for VTE prophylaxis, in our opinion aspirin will become the mainstay of prevention of VTE for the majority of patients after TJA. The challenge that lies ahead is to determine which patients are at increased risk of VTE and in need of more aggressive anticoagulants. There has been a recent development on this front that aims to provide some guidance for selection of high-risk patients.9 It appears that over 90% of patients undergoing TJA can safely receive aspirin as an anticoagulation prophylaxis, while a validated risk profile can be used to detect those at higher risk for VTE and in need of more aggressive agents.9
Thanks to the diligent work of the ACCP and AAOS workgroups and many other scholars in the field, the science of VTE prophylaxis after TJA has truly evolved. The adaptation of the recent ACCP guidelines by the Surgical Care Improvement Project (SCIP), which accepts aspirin as an effective anticoagulation modality, is yet another step in the direction of optimizing outcomes for our patients, by preventing the feared VTE while also limiting untoward bleeding complications that can occur with administration of aggressive anticoagulants.10
1. Falck-Ytter Y, Francis CW, Johanson NA, et al; American College of Chest Physicians. Prevention of VTE in Orthopedic Surgery Patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 Suppl):e278S-325S.
2. Sharrock NE, Gonzalez Della Valle A, Go G, Lyman S, Salvati EA. Potent anticoagulants are associated with a higher all-cause mortality rate after hip and knee arthroplasty. Clin Orthop. 2008;466(3):714-721.
3. Brighton TA, Eikelboom JW, Mann K, et al; ASPIRE Investigators. Low-dose aspirin for preventing recurrent venous thromboembolism. N Engl J Med. 2012;367(21):1979-1987.
4. Becattini C, Agnelli G, Schenone A, et al; WARFASA Investigators. Aspirin for preventing the recurrence of venous thromboembolism. N Engl J Med. 2012;366(21):1959-1967.
5. Parvizi J, Ghanem E, Joshi A, Sharkey PF, Hozack WJ, Rothman RH. Does “excessive” anticoagulation predispose to periprosthetic infection? J Arthroplasty. 2007;22(6 Suppl 2):24-28.
6. Sachs RA, Smith JH, Kuney M, Paxton L. Does anticoagulation do more harm than good? A comparison of patients treated without prophylaxis and patients treated with low-dose warfarin after total knee arthroplasty. J Arthroplasty. 2003;18(4):389-395.
7. Lotke PA, Lonner JH. The benefit of aspirin chemoprophylaxis for thromboembolism after total knee arthroplasty. Clin Orthop. 2006;452:175-180.
8. Medical Product Safety Information. US Food and Drug Administration website. http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm. Updated December 11, 2014. Accessed December 29, 2014.
9. Parvizi J, Huang R, Raphael IJ, Arnold WV, Rothman RH. Symptomatic pulmonary embolus after joint arthroplasty: stratification of risk factors. Clin Orthop. 2014;472(3):903-912.
10. Mont MA, Hozack WJ, Callaghan JJ, Krebs V, Parvizi J, Mason JB. Venous thromboemboli following total joint arthroplasty: SCIP measures move us closer to an agreement. J Arthroplasty. 2014;29(4):651-652.
1. Falck-Ytter Y, Francis CW, Johanson NA, et al; American College of Chest Physicians. Prevention of VTE in Orthopedic Surgery Patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 Suppl):e278S-325S.
2. Sharrock NE, Gonzalez Della Valle A, Go G, Lyman S, Salvati EA. Potent anticoagulants are associated with a higher all-cause mortality rate after hip and knee arthroplasty. Clin Orthop. 2008;466(3):714-721.
3. Brighton TA, Eikelboom JW, Mann K, et al; ASPIRE Investigators. Low-dose aspirin for preventing recurrent venous thromboembolism. N Engl J Med. 2012;367(21):1979-1987.
4. Becattini C, Agnelli G, Schenone A, et al; WARFASA Investigators. Aspirin for preventing the recurrence of venous thromboembolism. N Engl J Med. 2012;366(21):1959-1967.
5. Parvizi J, Ghanem E, Joshi A, Sharkey PF, Hozack WJ, Rothman RH. Does “excessive” anticoagulation predispose to periprosthetic infection? J Arthroplasty. 2007;22(6 Suppl 2):24-28.
6. Sachs RA, Smith JH, Kuney M, Paxton L. Does anticoagulation do more harm than good? A comparison of patients treated without prophylaxis and patients treated with low-dose warfarin after total knee arthroplasty. J Arthroplasty. 2003;18(4):389-395.
7. Lotke PA, Lonner JH. The benefit of aspirin chemoprophylaxis for thromboembolism after total knee arthroplasty. Clin Orthop. 2006;452:175-180.
8. Medical Product Safety Information. US Food and Drug Administration website. http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm. Updated December 11, 2014. Accessed December 29, 2014.
9. Parvizi J, Huang R, Raphael IJ, Arnold WV, Rothman RH. Symptomatic pulmonary embolus after joint arthroplasty: stratification of risk factors. Clin Orthop. 2014;472(3):903-912.
10. Mont MA, Hozack WJ, Callaghan JJ, Krebs V, Parvizi J, Mason JB. Venous thromboemboli following total joint arthroplasty: SCIP measures move us closer to an agreement. J Arthroplasty. 2014;29(4):651-652.
