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Hospital employment or physician-led ACO?
Primary care physicians around the country are facing the largest decision of their lives: Do I stay independent and maybe form an accountable care organization with other independent physicians, or do I become an employee of a hospital or health system?
As accountable care is taking hold, new data may alter historic thinking on this "bet-the-practice" question.
Tired of being overworked, undersatisfied, and overwhelmed with growing regulatory requirements, many primary care physicians have sought the security and strength of hospital employment. They say the pressures to invest in technology, billing, coding, and continued reimbursement pressures are just too great.
Yet, the majority of these physicians miss their days of self-employed autonomy, are on average less productive, and worry that the clocks on their compensation guarantees are ticking down.
Most of the moves by your colleagues, and perhaps you, to hospital employment have been defensive. It was just no longer feasible to stay afloat in the current fee-for-service system. You cannot work any harder, faster, or cheaper. You can no longer spend satisfactory time with your patients.
On the other hand, some of you may have joined a hospital or health system to be proactive and gain a solid platform to prepare for the new value-based payment era.
You may have envisioned being integrated with a critical mass of like-minded physicians and facilities, aided by advanced population management tools and a strong balance sheet, and all linked together on the hospital’s health information technology platform. You read that primary care should be in a leadership position and financially incentivized in any accountable care organization – including a hospital’s. Independent physicians could theoretically form ACOs, too, but lack the up-front capital, know-how, and any spare intellectual bandwidth to do so.
So, from a strategic perspective, becoming employed with other physicians by a health system seemed the way to go.
The pace has quickened of health care’s movement away from fee for service or "pay for volume" to payment for better outcomes at lower overall costs, or "pay for value." The factors that applied to the decision to become employed in the fee-for-service era may be yielding to those in the accountable care era sooner than anticipated.
Independent physician-led ACOs appear to be adapting better than hospitals to this change. Although much better prepared fiscally, hospitals are conflicted, or at least hesitant, to make this switch, because much of the savings comes from avoidable admissions and readmissions. On the other hand, emerging data and experience are showing that physician-led ACOs can be very successful.
There are some very integrated and successful hospital-led ACOs or other value-delivery hospital/physician models. In fact, I believe that if the hospital is willing to right-size and truly commit to value, it can be the most successful model.
However, many physicians signed volume-only physician work relative value unit (wRVU) compensation formulas in their hospital employment agreements, with no incentive payments for value. They have not been involved as partners, much less leaders, in any ACO planning. Even though the fee-for-service days are waning and strains are showing for many hospitals that are not adapting, for many employed physicians, the pace of preparedness for the accountable care era has been disappointing.
New data show that while most of the early ACOs in the Medicare Shared Savings Program were hospital led, there are now more physician-led ACOs than any other. At the same time, early results of some modest primary care–only ACOs have been exciting. The rural primary care physician ACO previously reported on in this column, Rio Grande Valley Health Alliance in McAllen, Tex., is preliminarily looking at 90th-percentile quality results and more than $500,000 in (unofficial) savings per physician in their first year under the Medicare Shared Savings Program.
In fact, in a May 14, 2014, article in JAMA, its authors stated: "Even though most adult primary care physicians may not realize it, they each can be seen as a chief executive officer (CEO) in charge of approximately $10 million in annual revenue" (JAMA 2014;311:1855-6). They noted that primary care receives only 5% of that spending, but can control much of the average of $5,000 in annual spending of their 2,000 or so patients. The independent physician-led Palm Beach ACO is cited as an example, with $22 million in savings their first year. The authors recommend physician-led ACOs as the best way to leverage that "CEO" power.
These new success lessons are being learned and need to be shared. Primary care physicians need to understand that the risk of change is now much less than the risk of maintaining the status quo. You need transparency regarding the realities of all your choices, including hospital employment and physician ACOs.
As readers of this column know, I heartily endorse the trend recognized in the JAMA article: "[A]n increasing number of primary care physicians see physician-led ACOs as a powerful opportunity to retain their autonomy and make a positive difference for their patient – as well as their practices’ bottom lines."
Mr. Bobbitt is a senior partner and head of the Health Law Group at the Smith Anderson law firm in Raleigh, N.C. He has many years’ experience assisting physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact the author at [email protected] or 919-821-6612.
Primary care physicians around the country are facing the largest decision of their lives: Do I stay independent and maybe form an accountable care organization with other independent physicians, or do I become an employee of a hospital or health system?
As accountable care is taking hold, new data may alter historic thinking on this "bet-the-practice" question.
Tired of being overworked, undersatisfied, and overwhelmed with growing regulatory requirements, many primary care physicians have sought the security and strength of hospital employment. They say the pressures to invest in technology, billing, coding, and continued reimbursement pressures are just too great.
Yet, the majority of these physicians miss their days of self-employed autonomy, are on average less productive, and worry that the clocks on their compensation guarantees are ticking down.
Most of the moves by your colleagues, and perhaps you, to hospital employment have been defensive. It was just no longer feasible to stay afloat in the current fee-for-service system. You cannot work any harder, faster, or cheaper. You can no longer spend satisfactory time with your patients.
On the other hand, some of you may have joined a hospital or health system to be proactive and gain a solid platform to prepare for the new value-based payment era.
You may have envisioned being integrated with a critical mass of like-minded physicians and facilities, aided by advanced population management tools and a strong balance sheet, and all linked together on the hospital’s health information technology platform. You read that primary care should be in a leadership position and financially incentivized in any accountable care organization – including a hospital’s. Independent physicians could theoretically form ACOs, too, but lack the up-front capital, know-how, and any spare intellectual bandwidth to do so.
So, from a strategic perspective, becoming employed with other physicians by a health system seemed the way to go.
The pace has quickened of health care’s movement away from fee for service or "pay for volume" to payment for better outcomes at lower overall costs, or "pay for value." The factors that applied to the decision to become employed in the fee-for-service era may be yielding to those in the accountable care era sooner than anticipated.
Independent physician-led ACOs appear to be adapting better than hospitals to this change. Although much better prepared fiscally, hospitals are conflicted, or at least hesitant, to make this switch, because much of the savings comes from avoidable admissions and readmissions. On the other hand, emerging data and experience are showing that physician-led ACOs can be very successful.
There are some very integrated and successful hospital-led ACOs or other value-delivery hospital/physician models. In fact, I believe that if the hospital is willing to right-size and truly commit to value, it can be the most successful model.
However, many physicians signed volume-only physician work relative value unit (wRVU) compensation formulas in their hospital employment agreements, with no incentive payments for value. They have not been involved as partners, much less leaders, in any ACO planning. Even though the fee-for-service days are waning and strains are showing for many hospitals that are not adapting, for many employed physicians, the pace of preparedness for the accountable care era has been disappointing.
New data show that while most of the early ACOs in the Medicare Shared Savings Program were hospital led, there are now more physician-led ACOs than any other. At the same time, early results of some modest primary care–only ACOs have been exciting. The rural primary care physician ACO previously reported on in this column, Rio Grande Valley Health Alliance in McAllen, Tex., is preliminarily looking at 90th-percentile quality results and more than $500,000 in (unofficial) savings per physician in their first year under the Medicare Shared Savings Program.
In fact, in a May 14, 2014, article in JAMA, its authors stated: "Even though most adult primary care physicians may not realize it, they each can be seen as a chief executive officer (CEO) in charge of approximately $10 million in annual revenue" (JAMA 2014;311:1855-6). They noted that primary care receives only 5% of that spending, but can control much of the average of $5,000 in annual spending of their 2,000 or so patients. The independent physician-led Palm Beach ACO is cited as an example, with $22 million in savings their first year. The authors recommend physician-led ACOs as the best way to leverage that "CEO" power.
These new success lessons are being learned and need to be shared. Primary care physicians need to understand that the risk of change is now much less than the risk of maintaining the status quo. You need transparency regarding the realities of all your choices, including hospital employment and physician ACOs.
As readers of this column know, I heartily endorse the trend recognized in the JAMA article: "[A]n increasing number of primary care physicians see physician-led ACOs as a powerful opportunity to retain their autonomy and make a positive difference for their patient – as well as their practices’ bottom lines."
Mr. Bobbitt is a senior partner and head of the Health Law Group at the Smith Anderson law firm in Raleigh, N.C. He has many years’ experience assisting physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact the author at [email protected] or 919-821-6612.
Primary care physicians around the country are facing the largest decision of their lives: Do I stay independent and maybe form an accountable care organization with other independent physicians, or do I become an employee of a hospital or health system?
As accountable care is taking hold, new data may alter historic thinking on this "bet-the-practice" question.
Tired of being overworked, undersatisfied, and overwhelmed with growing regulatory requirements, many primary care physicians have sought the security and strength of hospital employment. They say the pressures to invest in technology, billing, coding, and continued reimbursement pressures are just too great.
Yet, the majority of these physicians miss their days of self-employed autonomy, are on average less productive, and worry that the clocks on their compensation guarantees are ticking down.
Most of the moves by your colleagues, and perhaps you, to hospital employment have been defensive. It was just no longer feasible to stay afloat in the current fee-for-service system. You cannot work any harder, faster, or cheaper. You can no longer spend satisfactory time with your patients.
On the other hand, some of you may have joined a hospital or health system to be proactive and gain a solid platform to prepare for the new value-based payment era.
You may have envisioned being integrated with a critical mass of like-minded physicians and facilities, aided by advanced population management tools and a strong balance sheet, and all linked together on the hospital’s health information technology platform. You read that primary care should be in a leadership position and financially incentivized in any accountable care organization – including a hospital’s. Independent physicians could theoretically form ACOs, too, but lack the up-front capital, know-how, and any spare intellectual bandwidth to do so.
So, from a strategic perspective, becoming employed with other physicians by a health system seemed the way to go.
The pace has quickened of health care’s movement away from fee for service or "pay for volume" to payment for better outcomes at lower overall costs, or "pay for value." The factors that applied to the decision to become employed in the fee-for-service era may be yielding to those in the accountable care era sooner than anticipated.
Independent physician-led ACOs appear to be adapting better than hospitals to this change. Although much better prepared fiscally, hospitals are conflicted, or at least hesitant, to make this switch, because much of the savings comes from avoidable admissions and readmissions. On the other hand, emerging data and experience are showing that physician-led ACOs can be very successful.
There are some very integrated and successful hospital-led ACOs or other value-delivery hospital/physician models. In fact, I believe that if the hospital is willing to right-size and truly commit to value, it can be the most successful model.
However, many physicians signed volume-only physician work relative value unit (wRVU) compensation formulas in their hospital employment agreements, with no incentive payments for value. They have not been involved as partners, much less leaders, in any ACO planning. Even though the fee-for-service days are waning and strains are showing for many hospitals that are not adapting, for many employed physicians, the pace of preparedness for the accountable care era has been disappointing.
New data show that while most of the early ACOs in the Medicare Shared Savings Program were hospital led, there are now more physician-led ACOs than any other. At the same time, early results of some modest primary care–only ACOs have been exciting. The rural primary care physician ACO previously reported on in this column, Rio Grande Valley Health Alliance in McAllen, Tex., is preliminarily looking at 90th-percentile quality results and more than $500,000 in (unofficial) savings per physician in their first year under the Medicare Shared Savings Program.
In fact, in a May 14, 2014, article in JAMA, its authors stated: "Even though most adult primary care physicians may not realize it, they each can be seen as a chief executive officer (CEO) in charge of approximately $10 million in annual revenue" (JAMA 2014;311:1855-6). They noted that primary care receives only 5% of that spending, but can control much of the average of $5,000 in annual spending of their 2,000 or so patients. The independent physician-led Palm Beach ACO is cited as an example, with $22 million in savings their first year. The authors recommend physician-led ACOs as the best way to leverage that "CEO" power.
These new success lessons are being learned and need to be shared. Primary care physicians need to understand that the risk of change is now much less than the risk of maintaining the status quo. You need transparency regarding the realities of all your choices, including hospital employment and physician ACOs.
As readers of this column know, I heartily endorse the trend recognized in the JAMA article: "[A]n increasing number of primary care physicians see physician-led ACOs as a powerful opportunity to retain their autonomy and make a positive difference for their patient – as well as their practices’ bottom lines."
Mr. Bobbitt is a senior partner and head of the Health Law Group at the Smith Anderson law firm in Raleigh, N.C. He has many years’ experience assisting physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact the author at [email protected] or 919-821-6612.
Shifting our focus to HIV as a chronic disease
Last month in our practice we had a patient with a positive HIV enzyme-linked immunoassay (ELISA) test and a negative Western blot. The patient’s doctor was astute, elicited a history of a recent viral-like syndrome, and considered the possibility of recent HIV infection, which further testing confirmed as the correct diagnosis.
It has been fascinating to watch the discovery of HIV/acquired immunodeficiency syndrome (AIDS) and the evolution of diagnosis and treatment since the inception of the epidemic in 1981. In 1981, I was practicing in a small town in Michigan’s Upper Peninsula, and I did not see a patient with HIV infection in my office until 1990. In 2014, with an estimated prevalence of 1.1 million HIV cases in the United States,1 family physicians are likely to come into contact with several patients with HIV every year. Practicing on Chicago’s south side in 2008, I diagnosed 2 teenagers with HIV. It was a heartbreaking reality.
The discovery of highly active antiretroviral therapy (HAART) has transformed HIV/AIDS from an acute, infectious specialty disease to a chronic primary care disease. Although the annual incidence of HIV in the United States has dropped precipitously from its peak of 130,000 in the 1980s to about 50,000 in 2010,1 the prevalence continues to rise as more people with HIV infection are living for many years. People with HIV who receive proper care do have a shortened life span, but not by many years, and they are highly likely to show up in our offices for treatment of not only chronic illnesses that accompany HIV but also common diseases such as hypertension, diabetes, and coronary artery disease. More and more patients with HIV are being managed in primary care settings, with infectious disease specialists acting as consultants.
Universal screening for HIV is recommended and becoming the norm, and the stigma for testing appears to be decreasing. The burdensome informed consent process has been streamlined in many states, making screening seem routine to patients. Family physicians must do their part to help control the HIV epidemic by screening, properly diagnosing new cases of HIV, and providing chronic disease and preventive care. To that end, I encourage you to read “HIV screening: How we can do better,” by Editorial Board member Jeffrey T. Kirchner, DO, FAAFP, AAHIVS.
REFERENCE
1. Centers for Disease Control and Prevention (CDC). Today's HIV/AIDS epidemic. CDC Web site. Available at: http://www.cdc.gov/nchhstp/newsroom/docs/hivfactsheets/todaysepidemic-508.pdf. Accessed June 23, 2014.
Last month in our practice we had a patient with a positive HIV enzyme-linked immunoassay (ELISA) test and a negative Western blot. The patient’s doctor was astute, elicited a history of a recent viral-like syndrome, and considered the possibility of recent HIV infection, which further testing confirmed as the correct diagnosis.
It has been fascinating to watch the discovery of HIV/acquired immunodeficiency syndrome (AIDS) and the evolution of diagnosis and treatment since the inception of the epidemic in 1981. In 1981, I was practicing in a small town in Michigan’s Upper Peninsula, and I did not see a patient with HIV infection in my office until 1990. In 2014, with an estimated prevalence of 1.1 million HIV cases in the United States,1 family physicians are likely to come into contact with several patients with HIV every year. Practicing on Chicago’s south side in 2008, I diagnosed 2 teenagers with HIV. It was a heartbreaking reality.
The discovery of highly active antiretroviral therapy (HAART) has transformed HIV/AIDS from an acute, infectious specialty disease to a chronic primary care disease. Although the annual incidence of HIV in the United States has dropped precipitously from its peak of 130,000 in the 1980s to about 50,000 in 2010,1 the prevalence continues to rise as more people with HIV infection are living for many years. People with HIV who receive proper care do have a shortened life span, but not by many years, and they are highly likely to show up in our offices for treatment of not only chronic illnesses that accompany HIV but also common diseases such as hypertension, diabetes, and coronary artery disease. More and more patients with HIV are being managed in primary care settings, with infectious disease specialists acting as consultants.
Universal screening for HIV is recommended and becoming the norm, and the stigma for testing appears to be decreasing. The burdensome informed consent process has been streamlined in many states, making screening seem routine to patients. Family physicians must do their part to help control the HIV epidemic by screening, properly diagnosing new cases of HIV, and providing chronic disease and preventive care. To that end, I encourage you to read “HIV screening: How we can do better,” by Editorial Board member Jeffrey T. Kirchner, DO, FAAFP, AAHIVS.
Last month in our practice we had a patient with a positive HIV enzyme-linked immunoassay (ELISA) test and a negative Western blot. The patient’s doctor was astute, elicited a history of a recent viral-like syndrome, and considered the possibility of recent HIV infection, which further testing confirmed as the correct diagnosis.
It has been fascinating to watch the discovery of HIV/acquired immunodeficiency syndrome (AIDS) and the evolution of diagnosis and treatment since the inception of the epidemic in 1981. In 1981, I was practicing in a small town in Michigan’s Upper Peninsula, and I did not see a patient with HIV infection in my office until 1990. In 2014, with an estimated prevalence of 1.1 million HIV cases in the United States,1 family physicians are likely to come into contact with several patients with HIV every year. Practicing on Chicago’s south side in 2008, I diagnosed 2 teenagers with HIV. It was a heartbreaking reality.
The discovery of highly active antiretroviral therapy (HAART) has transformed HIV/AIDS from an acute, infectious specialty disease to a chronic primary care disease. Although the annual incidence of HIV in the United States has dropped precipitously from its peak of 130,000 in the 1980s to about 50,000 in 2010,1 the prevalence continues to rise as more people with HIV infection are living for many years. People with HIV who receive proper care do have a shortened life span, but not by many years, and they are highly likely to show up in our offices for treatment of not only chronic illnesses that accompany HIV but also common diseases such as hypertension, diabetes, and coronary artery disease. More and more patients with HIV are being managed in primary care settings, with infectious disease specialists acting as consultants.
Universal screening for HIV is recommended and becoming the norm, and the stigma for testing appears to be decreasing. The burdensome informed consent process has been streamlined in many states, making screening seem routine to patients. Family physicians must do their part to help control the HIV epidemic by screening, properly diagnosing new cases of HIV, and providing chronic disease and preventive care. To that end, I encourage you to read “HIV screening: How we can do better,” by Editorial Board member Jeffrey T. Kirchner, DO, FAAFP, AAHIVS.
REFERENCE
1. Centers for Disease Control and Prevention (CDC). Today's HIV/AIDS epidemic. CDC Web site. Available at: http://www.cdc.gov/nchhstp/newsroom/docs/hivfactsheets/todaysepidemic-508.pdf. Accessed June 23, 2014.
REFERENCE
1. Centers for Disease Control and Prevention (CDC). Today's HIV/AIDS epidemic. CDC Web site. Available at: http://www.cdc.gov/nchhstp/newsroom/docs/hivfactsheets/todaysepidemic-508.pdf. Accessed June 23, 2014.
Safety, Quality, Compassion...and Cost
Since the development of the Arbeitsgemeinschaft für Osteosynthesefragen (AO) principles,1 we in the orthopedic trauma community have evaluated and reevaluated our work with a very critical eye.2-4 The desire to maximize our ability to restore functional mobility has not grown any less strong,5 but many of us are aware that we are reaching the limit of what a new implant or technical solution can do for our patients. Over the past 20 years, this realization has turned many in the orthopedic trauma community to debate the merits of particular solutions
to the same problem,6 to give appropriate weight to the patient’s subjective experience,7 and to feverishly debate the appropriate timing of fracture care.8 Dr. Vallier and her group in Cleveland have brought this conversation into the era of meaningful use in medicine with their article in this month’s issue of The American Journal of Orthopedics, “Cost Savings Associated With a Multidisciplinary Protocol That Expedites Definitive Fracture Care.”
This type of work is extremely difficult to accomplish in any system, and exceptionally so in the United States. In order to achieve even the simplest work in this domain, a number of obstacles must be overcome. First, we must reach consensus on the simplest data points to use in building a decision tree. Dr. Vallier’s group wisely chose straightforward endpoints of resuscitation readily and
rapidly available to any surgical team.9 Second, we must organize a hospital system (a system currently set up more to create turf battles than alliances) in a way that commits interdepartmental resources to an injured patient—one that inevitably appears without warning and often at the most inconvenient of times. Furthermore, we must agree to commit those resources within a relatively brief time frame (36 hours), requiring coordinated mobilization of various teams. Simply achieving these goals is a major accomplishment. Dr. Vallier’s real leadership in this area is her ability to argue the merits of this approach in terms that every administrator can understand.
Her team’s paper presents predicted savings to both patients and society when a uniform method is applied to determine when fracture care should be administered to the multiply injured patient. It is important to understand that “savings” in this context isn’t simply dollars not spent but includes preventable harm not inflicted. Complications can no longer be considered the cost of doing business, and not just because the Center for Medicare and Medicaid Services tells us so in the latest pay-for-performance dictum. We must expand our idea of primum non nocere to
include skillfully navigating the patient’s care in a way that predicts the most likely avoidance of trouble. This type of evaluation will require us to flexibly adapt our behavior in ways that may be personally inconvenient, seem redundant, or even appear to make little difference at all given our limited perspective at the sharp end of care.
It can be very difficult to understand why we should be trying to achieve better than 95% to 98% success rates when for an individual such success could easily be considered a measure of excellence. Moving health care into the realm of the High Reliability Organization, however, will require more than the work of expert individuals; it will require teams of people who know how to work together and who understand that expertise in their role both as an individual and as a team member is essential to an outcome even though they may be far removed from the
individual patient who experiences the successful outcome.
Finally, there can be little debate that safety, quality, and compassion are the pillars of effective health care.10-12 Though we can never have enough of these 3 elements, most of us now acknowledge the need to wrestle with the tension of dealing with the fourth pillar: cost in dollars spent on the systems level. Other systems (eg, the National Health Service in Great Britain, the Canadian Orthopaedic Trauma Society) have been leading the way for some time in developing integrated systems approaches for addressing both quality and cost. This is an extremely precarious but necessary marriage of goals, as we are now firmly in an era of shrinking resources even as we rightly demand higherquality, safer, and more compassionate care. Analyzing this type of work in the unique quilt that is the US health care system is extraordinarily difficult, as is evident in Dr. Vallier’s paper. I encourage you to read Dr. Vallier’s article, but more importantly, to ask yourself where you can take the baton she and others are handing us.
References
1. Muller ME, Allgower M, Willenegger H. Technique of Internal Fixation of
Fractures. Berlin, Germany: Springer-Verlag; 1965.
2. Schatzker J, Tile M. The Rationale of Operative Fracture Care. Berlin,
Germany: Springer-Verlag; 1987.
3. Letournel E, Judet R. Fractures of the Acetabulum. Berlin, Germany:
Springer-Verlag; 1981. 4. Mast J, Jakob R, Ganz R. Planning and Reduction Technique in Fracture
Surgery. Berlin, Germany: Springer-Verlag; 1989.
5. Ganz R, Horowitz K, Leunig M. Algorithm for femoral and periacetabular
osteotomies in complex hip deformities. Clin Orthop. 2010;468(12):3168-3180.
6. Bhandari M, Devereaux PJ, Montori V, Cinà C, Tandan V, Guyatt GH;
Evidence-Based Surgery Working Group. Users’ guide to the surgical
literature: how to use a systematic literature review and meta-analysis.
Can J Surg. 2004;47(1):60-67.
7. Poolman RW, Swiontkowski MF, Fairbank JC, Schemitsch EH, Sprague
S, de Vet HC. Outcome instruments: rationale for their use. J Bone Joint
Surg Am. 2009;91(suppl 3):41-49.
8. Pape HC, Rixen D, Morley J, et al; EPOFF Study Group. Impact of
method of initial stabilization for femoral shaft fractures in patients with
multiple injuries at risk for complications (borderline patients). Ann Surg.
2007;246(3):491-501.
9. Vallier HA, Wang X, Moore TA, Wilber JH, Como JJ. Timing of orthopaedic
surgery in multiple trauma patients: development of a protocol
for early appropriate care. J Orthop Trauma. 2013;27(10):543-551.
10. Jotterand F. The Hippocratic oath and contemporary medicine: dialectic
between past ideals and present reality? J Med Philos. 2005;30(1):107-128.
11. Seeskin K. Maimonides. In: Zalta EN, Nodelman U, Allen C, et al, eds.
Stanford Encyclopedia of Philosophy. http://plato.stanford.edu/archives
/spr2014/entries/maimonides/. Published January 24, 2006. Revised
June 12, 2013. Accessed April 27, 2014.
12. Osler W. Aequanimitas. In: Aequanimitas, With Other Addresses to Medical
Students, Nurses and Practitioners of Medicine. 2nd ed. Philadelphia,
PA: P. Blakiston’s Son & Co; 1925:chap 1. Celebrating the Contributions
of William Osler. http://www.medicalarchives.jhmi.edu/osler/aequessay.
htm. Published December 9, 1999. Accessed April 27, 2014.
Since the development of the Arbeitsgemeinschaft für Osteosynthesefragen (AO) principles,1 we in the orthopedic trauma community have evaluated and reevaluated our work with a very critical eye.2-4 The desire to maximize our ability to restore functional mobility has not grown any less strong,5 but many of us are aware that we are reaching the limit of what a new implant or technical solution can do for our patients. Over the past 20 years, this realization has turned many in the orthopedic trauma community to debate the merits of particular solutions
to the same problem,6 to give appropriate weight to the patient’s subjective experience,7 and to feverishly debate the appropriate timing of fracture care.8 Dr. Vallier and her group in Cleveland have brought this conversation into the era of meaningful use in medicine with their article in this month’s issue of The American Journal of Orthopedics, “Cost Savings Associated With a Multidisciplinary Protocol That Expedites Definitive Fracture Care.”
This type of work is extremely difficult to accomplish in any system, and exceptionally so in the United States. In order to achieve even the simplest work in this domain, a number of obstacles must be overcome. First, we must reach consensus on the simplest data points to use in building a decision tree. Dr. Vallier’s group wisely chose straightforward endpoints of resuscitation readily and
rapidly available to any surgical team.9 Second, we must organize a hospital system (a system currently set up more to create turf battles than alliances) in a way that commits interdepartmental resources to an injured patient—one that inevitably appears without warning and often at the most inconvenient of times. Furthermore, we must agree to commit those resources within a relatively brief time frame (36 hours), requiring coordinated mobilization of various teams. Simply achieving these goals is a major accomplishment. Dr. Vallier’s real leadership in this area is her ability to argue the merits of this approach in terms that every administrator can understand.
Her team’s paper presents predicted savings to both patients and society when a uniform method is applied to determine when fracture care should be administered to the multiply injured patient. It is important to understand that “savings” in this context isn’t simply dollars not spent but includes preventable harm not inflicted. Complications can no longer be considered the cost of doing business, and not just because the Center for Medicare and Medicaid Services tells us so in the latest pay-for-performance dictum. We must expand our idea of primum non nocere to
include skillfully navigating the patient’s care in a way that predicts the most likely avoidance of trouble. This type of evaluation will require us to flexibly adapt our behavior in ways that may be personally inconvenient, seem redundant, or even appear to make little difference at all given our limited perspective at the sharp end of care.
It can be very difficult to understand why we should be trying to achieve better than 95% to 98% success rates when for an individual such success could easily be considered a measure of excellence. Moving health care into the realm of the High Reliability Organization, however, will require more than the work of expert individuals; it will require teams of people who know how to work together and who understand that expertise in their role both as an individual and as a team member is essential to an outcome even though they may be far removed from the
individual patient who experiences the successful outcome.
Finally, there can be little debate that safety, quality, and compassion are the pillars of effective health care.10-12 Though we can never have enough of these 3 elements, most of us now acknowledge the need to wrestle with the tension of dealing with the fourth pillar: cost in dollars spent on the systems level. Other systems (eg, the National Health Service in Great Britain, the Canadian Orthopaedic Trauma Society) have been leading the way for some time in developing integrated systems approaches for addressing both quality and cost. This is an extremely precarious but necessary marriage of goals, as we are now firmly in an era of shrinking resources even as we rightly demand higherquality, safer, and more compassionate care. Analyzing this type of work in the unique quilt that is the US health care system is extraordinarily difficult, as is evident in Dr. Vallier’s paper. I encourage you to read Dr. Vallier’s article, but more importantly, to ask yourself where you can take the baton she and others are handing us.
References
1. Muller ME, Allgower M, Willenegger H. Technique of Internal Fixation of
Fractures. Berlin, Germany: Springer-Verlag; 1965.
2. Schatzker J, Tile M. The Rationale of Operative Fracture Care. Berlin,
Germany: Springer-Verlag; 1987.
3. Letournel E, Judet R. Fractures of the Acetabulum. Berlin, Germany:
Springer-Verlag; 1981. 4. Mast J, Jakob R, Ganz R. Planning and Reduction Technique in Fracture
Surgery. Berlin, Germany: Springer-Verlag; 1989.
5. Ganz R, Horowitz K, Leunig M. Algorithm for femoral and periacetabular
osteotomies in complex hip deformities. Clin Orthop. 2010;468(12):3168-3180.
6. Bhandari M, Devereaux PJ, Montori V, Cinà C, Tandan V, Guyatt GH;
Evidence-Based Surgery Working Group. Users’ guide to the surgical
literature: how to use a systematic literature review and meta-analysis.
Can J Surg. 2004;47(1):60-67.
7. Poolman RW, Swiontkowski MF, Fairbank JC, Schemitsch EH, Sprague
S, de Vet HC. Outcome instruments: rationale for their use. J Bone Joint
Surg Am. 2009;91(suppl 3):41-49.
8. Pape HC, Rixen D, Morley J, et al; EPOFF Study Group. Impact of
method of initial stabilization for femoral shaft fractures in patients with
multiple injuries at risk for complications (borderline patients). Ann Surg.
2007;246(3):491-501.
9. Vallier HA, Wang X, Moore TA, Wilber JH, Como JJ. Timing of orthopaedic
surgery in multiple trauma patients: development of a protocol
for early appropriate care. J Orthop Trauma. 2013;27(10):543-551.
10. Jotterand F. The Hippocratic oath and contemporary medicine: dialectic
between past ideals and present reality? J Med Philos. 2005;30(1):107-128.
11. Seeskin K. Maimonides. In: Zalta EN, Nodelman U, Allen C, et al, eds.
Stanford Encyclopedia of Philosophy. http://plato.stanford.edu/archives
/spr2014/entries/maimonides/. Published January 24, 2006. Revised
June 12, 2013. Accessed April 27, 2014.
12. Osler W. Aequanimitas. In: Aequanimitas, With Other Addresses to Medical
Students, Nurses and Practitioners of Medicine. 2nd ed. Philadelphia,
PA: P. Blakiston’s Son & Co; 1925:chap 1. Celebrating the Contributions
of William Osler. http://www.medicalarchives.jhmi.edu/osler/aequessay.
htm. Published December 9, 1999. Accessed April 27, 2014.
Since the development of the Arbeitsgemeinschaft für Osteosynthesefragen (AO) principles,1 we in the orthopedic trauma community have evaluated and reevaluated our work with a very critical eye.2-4 The desire to maximize our ability to restore functional mobility has not grown any less strong,5 but many of us are aware that we are reaching the limit of what a new implant or technical solution can do for our patients. Over the past 20 years, this realization has turned many in the orthopedic trauma community to debate the merits of particular solutions
to the same problem,6 to give appropriate weight to the patient’s subjective experience,7 and to feverishly debate the appropriate timing of fracture care.8 Dr. Vallier and her group in Cleveland have brought this conversation into the era of meaningful use in medicine with their article in this month’s issue of The American Journal of Orthopedics, “Cost Savings Associated With a Multidisciplinary Protocol That Expedites Definitive Fracture Care.”
This type of work is extremely difficult to accomplish in any system, and exceptionally so in the United States. In order to achieve even the simplest work in this domain, a number of obstacles must be overcome. First, we must reach consensus on the simplest data points to use in building a decision tree. Dr. Vallier’s group wisely chose straightforward endpoints of resuscitation readily and
rapidly available to any surgical team.9 Second, we must organize a hospital system (a system currently set up more to create turf battles than alliances) in a way that commits interdepartmental resources to an injured patient—one that inevitably appears without warning and often at the most inconvenient of times. Furthermore, we must agree to commit those resources within a relatively brief time frame (36 hours), requiring coordinated mobilization of various teams. Simply achieving these goals is a major accomplishment. Dr. Vallier’s real leadership in this area is her ability to argue the merits of this approach in terms that every administrator can understand.
Her team’s paper presents predicted savings to both patients and society when a uniform method is applied to determine when fracture care should be administered to the multiply injured patient. It is important to understand that “savings” in this context isn’t simply dollars not spent but includes preventable harm not inflicted. Complications can no longer be considered the cost of doing business, and not just because the Center for Medicare and Medicaid Services tells us so in the latest pay-for-performance dictum. We must expand our idea of primum non nocere to
include skillfully navigating the patient’s care in a way that predicts the most likely avoidance of trouble. This type of evaluation will require us to flexibly adapt our behavior in ways that may be personally inconvenient, seem redundant, or even appear to make little difference at all given our limited perspective at the sharp end of care.
It can be very difficult to understand why we should be trying to achieve better than 95% to 98% success rates when for an individual such success could easily be considered a measure of excellence. Moving health care into the realm of the High Reliability Organization, however, will require more than the work of expert individuals; it will require teams of people who know how to work together and who understand that expertise in their role both as an individual and as a team member is essential to an outcome even though they may be far removed from the
individual patient who experiences the successful outcome.
Finally, there can be little debate that safety, quality, and compassion are the pillars of effective health care.10-12 Though we can never have enough of these 3 elements, most of us now acknowledge the need to wrestle with the tension of dealing with the fourth pillar: cost in dollars spent on the systems level. Other systems (eg, the National Health Service in Great Britain, the Canadian Orthopaedic Trauma Society) have been leading the way for some time in developing integrated systems approaches for addressing both quality and cost. This is an extremely precarious but necessary marriage of goals, as we are now firmly in an era of shrinking resources even as we rightly demand higherquality, safer, and more compassionate care. Analyzing this type of work in the unique quilt that is the US health care system is extraordinarily difficult, as is evident in Dr. Vallier’s paper. I encourage you to read Dr. Vallier’s article, but more importantly, to ask yourself where you can take the baton she and others are handing us.
References
1. Muller ME, Allgower M, Willenegger H. Technique of Internal Fixation of
Fractures. Berlin, Germany: Springer-Verlag; 1965.
2. Schatzker J, Tile M. The Rationale of Operative Fracture Care. Berlin,
Germany: Springer-Verlag; 1987.
3. Letournel E, Judet R. Fractures of the Acetabulum. Berlin, Germany:
Springer-Verlag; 1981. 4. Mast J, Jakob R, Ganz R. Planning and Reduction Technique in Fracture
Surgery. Berlin, Germany: Springer-Verlag; 1989.
5. Ganz R, Horowitz K, Leunig M. Algorithm for femoral and periacetabular
osteotomies in complex hip deformities. Clin Orthop. 2010;468(12):3168-3180.
6. Bhandari M, Devereaux PJ, Montori V, Cinà C, Tandan V, Guyatt GH;
Evidence-Based Surgery Working Group. Users’ guide to the surgical
literature: how to use a systematic literature review and meta-analysis.
Can J Surg. 2004;47(1):60-67.
7. Poolman RW, Swiontkowski MF, Fairbank JC, Schemitsch EH, Sprague
S, de Vet HC. Outcome instruments: rationale for their use. J Bone Joint
Surg Am. 2009;91(suppl 3):41-49.
8. Pape HC, Rixen D, Morley J, et al; EPOFF Study Group. Impact of
method of initial stabilization for femoral shaft fractures in patients with
multiple injuries at risk for complications (borderline patients). Ann Surg.
2007;246(3):491-501.
9. Vallier HA, Wang X, Moore TA, Wilber JH, Como JJ. Timing of orthopaedic
surgery in multiple trauma patients: development of a protocol
for early appropriate care. J Orthop Trauma. 2013;27(10):543-551.
10. Jotterand F. The Hippocratic oath and contemporary medicine: dialectic
between past ideals and present reality? J Med Philos. 2005;30(1):107-128.
11. Seeskin K. Maimonides. In: Zalta EN, Nodelman U, Allen C, et al, eds.
Stanford Encyclopedia of Philosophy. http://plato.stanford.edu/archives
/spr2014/entries/maimonides/. Published January 24, 2006. Revised
June 12, 2013. Accessed April 27, 2014.
12. Osler W. Aequanimitas. In: Aequanimitas, With Other Addresses to Medical
Students, Nurses and Practitioners of Medicine. 2nd ed. Philadelphia,
PA: P. Blakiston’s Son & Co; 1925:chap 1. Celebrating the Contributions
of William Osler. http://www.medicalarchives.jhmi.edu/osler/aequessay.
htm. Published December 9, 1999. Accessed April 27, 2014.
Editorial: A Night (and Week) to Remember!
Charlotte Yeh, MD, former chief of emergency medicine at Newton Wellesley Hospital and at Tufts Medical Center in Massachusetts before becoming Regional Administrator for CMS in Boston, is currently the chief medical officer for AARP Services. On a dark, rainy night in December 2011, Dr Yeh was struck by a car while crossing an intersection in Washington, DC.
After being placed on a backboard and C-collar, she was transported by ambulance to a Level I trauma center where, without identifying herself as an EP, she became another injured patient in a crowded ED.
The experiences Dr Yeh relates in the June 2014 issue of Health Affairs (http://content.healthaffairs.org/content/33/6/1094.full), which were also excerpted in the June 9, 2014 edition of the Washington Post (Go to washingtonpost.com and search for “Yeh.”), sound all too familiar, and none too comforting.
The triage nurse repeatedly asked Dr Yeh where in the car she was sitting despite her responses that she was not in a car but hit by a car—a “pedestrian struck” as they say in NYC. After triage, her pain was addressed, primary and secondary surveys were completed, and focused exams were conducted to enable safe removal of the C-collar and backboard. So far so good.
But over the next 2 days, Dr Yeh’s repeated complaints about knee and gluteal region pain went unaddressed, even as CT scans of the abdomen and pelvis, and X-rays of the chest were ordered and completed. When she returned to the ED from Radiology, Dr Yeh was “parked in a hallway” where she remained through the night after being informed by a new group of clinicians that she was going to be admitted, but “boarded” in the ED until an inpatient bed became available. After 15 hours, the day crew arrived and, recognizing that Dr Yeh was an EP, moved her from the hallway to a private ED room.
Later in the day, the trauma team informed Dr Yeh that with nothing broken, and no major injuries turning up since she arrived, she could go home—despite her excruciating pain and still unexamined knee and hip. After a physical therapy team realized that she could not stand up, the surgical resident told her “there’s no medical reason to admit you…but if you can’t walk, we’ll just have to.”
Upstairs in the first available bed (on the maternity ward!), she repeatedly requested a knee examination before an orthopedic consultant determined that Dr Yeh had a medial collateral ligament tear requiring splinting until an MRI could be obtained. Other lapses in care included a failure to identify early-on the sciatic and gluteal nerve contusions causing leg and hip numbness and tingling, and not noticing until the third hospital day that no admission history and physical exam had been performed by the admitting team. As soon as Dr Yeh was able to ambulate with assistance on day 4, she insisted on being transferred to a rehabilitation facility near her home.
Looking back at her experiences, Dr Yeh characterized the nature of her care as “uneven” and “marked by an over reliance on testing at the expense of [her] overall well-being.”
Uneven to be sure, also fragmented, episodic, sloppy, and, as she noted elsewhere, delivered with a callous attitude on the part of the trauma resident. But the picture that Dr Yeh draws is disturbing for another reason: a trauma patient in an overcrowded ED, with many different “providers” addressing specific issues, but no one coordinating all of these efforts, or looking for omissions, or caring for her as a patient. Where was the EP who should have been the captain of this ED ship ensuring the overall safety and well-being of his or her passengers? Isn’t that what an emergency physician is supposed to be doing?
Charlotte Yeh, MD, former chief of emergency medicine at Newton Wellesley Hospital and at Tufts Medical Center in Massachusetts before becoming Regional Administrator for CMS in Boston, is currently the chief medical officer for AARP Services. On a dark, rainy night in December 2011, Dr Yeh was struck by a car while crossing an intersection in Washington, DC.
After being placed on a backboard and C-collar, she was transported by ambulance to a Level I trauma center where, without identifying herself as an EP, she became another injured patient in a crowded ED.
The experiences Dr Yeh relates in the June 2014 issue of Health Affairs (http://content.healthaffairs.org/content/33/6/1094.full), which were also excerpted in the June 9, 2014 edition of the Washington Post (Go to washingtonpost.com and search for “Yeh.”), sound all too familiar, and none too comforting.
The triage nurse repeatedly asked Dr Yeh where in the car she was sitting despite her responses that she was not in a car but hit by a car—a “pedestrian struck” as they say in NYC. After triage, her pain was addressed, primary and secondary surveys were completed, and focused exams were conducted to enable safe removal of the C-collar and backboard. So far so good.
But over the next 2 days, Dr Yeh’s repeated complaints about knee and gluteal region pain went unaddressed, even as CT scans of the abdomen and pelvis, and X-rays of the chest were ordered and completed. When she returned to the ED from Radiology, Dr Yeh was “parked in a hallway” where she remained through the night after being informed by a new group of clinicians that she was going to be admitted, but “boarded” in the ED until an inpatient bed became available. After 15 hours, the day crew arrived and, recognizing that Dr Yeh was an EP, moved her from the hallway to a private ED room.
Later in the day, the trauma team informed Dr Yeh that with nothing broken, and no major injuries turning up since she arrived, she could go home—despite her excruciating pain and still unexamined knee and hip. After a physical therapy team realized that she could not stand up, the surgical resident told her “there’s no medical reason to admit you…but if you can’t walk, we’ll just have to.”
Upstairs in the first available bed (on the maternity ward!), she repeatedly requested a knee examination before an orthopedic consultant determined that Dr Yeh had a medial collateral ligament tear requiring splinting until an MRI could be obtained. Other lapses in care included a failure to identify early-on the sciatic and gluteal nerve contusions causing leg and hip numbness and tingling, and not noticing until the third hospital day that no admission history and physical exam had been performed by the admitting team. As soon as Dr Yeh was able to ambulate with assistance on day 4, she insisted on being transferred to a rehabilitation facility near her home.
Looking back at her experiences, Dr Yeh characterized the nature of her care as “uneven” and “marked by an over reliance on testing at the expense of [her] overall well-being.”
Uneven to be sure, also fragmented, episodic, sloppy, and, as she noted elsewhere, delivered with a callous attitude on the part of the trauma resident. But the picture that Dr Yeh draws is disturbing for another reason: a trauma patient in an overcrowded ED, with many different “providers” addressing specific issues, but no one coordinating all of these efforts, or looking for omissions, or caring for her as a patient. Where was the EP who should have been the captain of this ED ship ensuring the overall safety and well-being of his or her passengers? Isn’t that what an emergency physician is supposed to be doing?
Charlotte Yeh, MD, former chief of emergency medicine at Newton Wellesley Hospital and at Tufts Medical Center in Massachusetts before becoming Regional Administrator for CMS in Boston, is currently the chief medical officer for AARP Services. On a dark, rainy night in December 2011, Dr Yeh was struck by a car while crossing an intersection in Washington, DC.
After being placed on a backboard and C-collar, she was transported by ambulance to a Level I trauma center where, without identifying herself as an EP, she became another injured patient in a crowded ED.
The experiences Dr Yeh relates in the June 2014 issue of Health Affairs (http://content.healthaffairs.org/content/33/6/1094.full), which were also excerpted in the June 9, 2014 edition of the Washington Post (Go to washingtonpost.com and search for “Yeh.”), sound all too familiar, and none too comforting.
The triage nurse repeatedly asked Dr Yeh where in the car she was sitting despite her responses that she was not in a car but hit by a car—a “pedestrian struck” as they say in NYC. After triage, her pain was addressed, primary and secondary surveys were completed, and focused exams were conducted to enable safe removal of the C-collar and backboard. So far so good.
But over the next 2 days, Dr Yeh’s repeated complaints about knee and gluteal region pain went unaddressed, even as CT scans of the abdomen and pelvis, and X-rays of the chest were ordered and completed. When she returned to the ED from Radiology, Dr Yeh was “parked in a hallway” where she remained through the night after being informed by a new group of clinicians that she was going to be admitted, but “boarded” in the ED until an inpatient bed became available. After 15 hours, the day crew arrived and, recognizing that Dr Yeh was an EP, moved her from the hallway to a private ED room.
Later in the day, the trauma team informed Dr Yeh that with nothing broken, and no major injuries turning up since she arrived, she could go home—despite her excruciating pain and still unexamined knee and hip. After a physical therapy team realized that she could not stand up, the surgical resident told her “there’s no medical reason to admit you…but if you can’t walk, we’ll just have to.”
Upstairs in the first available bed (on the maternity ward!), she repeatedly requested a knee examination before an orthopedic consultant determined that Dr Yeh had a medial collateral ligament tear requiring splinting until an MRI could be obtained. Other lapses in care included a failure to identify early-on the sciatic and gluteal nerve contusions causing leg and hip numbness and tingling, and not noticing until the third hospital day that no admission history and physical exam had been performed by the admitting team. As soon as Dr Yeh was able to ambulate with assistance on day 4, she insisted on being transferred to a rehabilitation facility near her home.
Looking back at her experiences, Dr Yeh characterized the nature of her care as “uneven” and “marked by an over reliance on testing at the expense of [her] overall well-being.”
Uneven to be sure, also fragmented, episodic, sloppy, and, as she noted elsewhere, delivered with a callous attitude on the part of the trauma resident. But the picture that Dr Yeh draws is disturbing for another reason: a trauma patient in an overcrowded ED, with many different “providers” addressing specific issues, but no one coordinating all of these efforts, or looking for omissions, or caring for her as a patient. Where was the EP who should have been the captain of this ED ship ensuring the overall safety and well-being of his or her passengers? Isn’t that what an emergency physician is supposed to be doing?
Hard cases
"Hard cases," say the lawyers, "make bad law." That means something like, "Legislation works better when it’s drafted in response to average circumstances, not extreme ones."
This adage applies to our profession, too. You can learn more about how to practice and teach medicine from average cases than from rare and strange ones. Hard cases can make any of us look foolish.
Peter e-mailed me the other day. I’d seen him 6 months ago for an eczematous rash on his back. Something funny about it, though: The distribution didn’t work, and it wasn’t scaly. No response to triamcinolone. Biopsy: Nonspecific inflammation. CBC: Elevated white cells at 15,600, mostly lymphs. Hmmm.
I referred him to an academic center. They presented him at Grand Rounds, and set him up for patch testing. He avoided what they asked him to, with little success.
"The oncologist says I have lymphoma," Peter’s e-mail to the patch test clinic read, copying me. He apologetically canceled his allergy clinic follow-up. "I hope for a good prognosis, although diagnosis has been delayed for several months. I hope my example will be of value for future patients."
Peter puts his regrets gently. How valuable will his lesson be? His case teaches that strange presentations of uncommon conditions can make even good and conscientious doctors look lame.
We all congratulate ourselves on "good pick-ups," the diagnostic coups that hit the nail on the head. Fair enough, but we understandably look away when we got it right by dumb luck or got it wrong.
That subcutaneous fullness we thought was fine, but which the patient insisted be removed (and turned out to be dermatofibrosarcoma protuberans). That dark spot that looked like all the others, only the patient was nervous because he was sure it had changed (melanoma). The funny rash that ended up being measles in an unimmunized child, and when was the last time you saw measles?
Often, we never even find out about the hard cases we missed, because the people who had them got fed up with us and went elsewhere. Sometimes, they send an angry letter or – more common these days – write a bad review. "I went to another doctor who finally figured out my problem and prescribed the right treatment." Once in a while, a lawsuit.
Viewed through the "retrospectoscope," knowing how the story turned out, our initial fumblings look pretty clumsy, if not downright actionable. "Oh, come on," a critic might say, "Surely that lump was too irregular for you to pass it off as a fibroma." Or: "Why the surprise? Didn’t he tell you the mole changed?" "The kid was sick and had a funny rash, didn’t she?" says a third. "Don’t you read the papers about all the parents who won’t vaccinate their children for fear of autism?"
I’m not suggesting that these are bad questions or that we shouldn’t ask them, so we can learn what we can. What I am saying is that, even if we do, no matter how careful and thoughtful we are, we are never going to catch everything we are unprepared for – the rare, the atypical, the unexpected.
This spring, the media reported details of an outbreak that occurred 5 years ago at New Orleans Children’s Hospital of what turned out to be mucormycosis; it proved fatal for several children. Looking back, mistakes were made. Diagnostic biopsies were only done when parents demanded them. Soiled laundry was mishandled. All this at a well-respected tertiary care center staffed by clinicians no doubt as fine as specialists anywhere.
The resulting investigation will no doubt find clinical and administrative gaps and address them. Consciousness will be raised, systems streamlined, oversight tightened. This loophole will be closed. Then others will open, no doubt the way they usually do, when people are looking at something else.
I knew there was something fishy about Peter’s case, but I didn’t know what it was. The experienced and thoughtful academic physicians I sent him to didn’t figure it out, either. It is nice of Peter to be philosophical about this. I would not begrudge him a less considerate reaction.
As for us, we ought to be vigilant, thorough, and humble. Should we get full of ourselves, there’s a hard case out there just waiting to deflate us.
Dr. Rockoff practices dermatology in Brookline, Mass. He is on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. Dr. Rockoff has contributed to the Under My Skin column in Skin & Allergy News since 1997.
"Hard cases," say the lawyers, "make bad law." That means something like, "Legislation works better when it’s drafted in response to average circumstances, not extreme ones."
This adage applies to our profession, too. You can learn more about how to practice and teach medicine from average cases than from rare and strange ones. Hard cases can make any of us look foolish.
Peter e-mailed me the other day. I’d seen him 6 months ago for an eczematous rash on his back. Something funny about it, though: The distribution didn’t work, and it wasn’t scaly. No response to triamcinolone. Biopsy: Nonspecific inflammation. CBC: Elevated white cells at 15,600, mostly lymphs. Hmmm.
I referred him to an academic center. They presented him at Grand Rounds, and set him up for patch testing. He avoided what they asked him to, with little success.
"The oncologist says I have lymphoma," Peter’s e-mail to the patch test clinic read, copying me. He apologetically canceled his allergy clinic follow-up. "I hope for a good prognosis, although diagnosis has been delayed for several months. I hope my example will be of value for future patients."
Peter puts his regrets gently. How valuable will his lesson be? His case teaches that strange presentations of uncommon conditions can make even good and conscientious doctors look lame.
We all congratulate ourselves on "good pick-ups," the diagnostic coups that hit the nail on the head. Fair enough, but we understandably look away when we got it right by dumb luck or got it wrong.
That subcutaneous fullness we thought was fine, but which the patient insisted be removed (and turned out to be dermatofibrosarcoma protuberans). That dark spot that looked like all the others, only the patient was nervous because he was sure it had changed (melanoma). The funny rash that ended up being measles in an unimmunized child, and when was the last time you saw measles?
Often, we never even find out about the hard cases we missed, because the people who had them got fed up with us and went elsewhere. Sometimes, they send an angry letter or – more common these days – write a bad review. "I went to another doctor who finally figured out my problem and prescribed the right treatment." Once in a while, a lawsuit.
Viewed through the "retrospectoscope," knowing how the story turned out, our initial fumblings look pretty clumsy, if not downright actionable. "Oh, come on," a critic might say, "Surely that lump was too irregular for you to pass it off as a fibroma." Or: "Why the surprise? Didn’t he tell you the mole changed?" "The kid was sick and had a funny rash, didn’t she?" says a third. "Don’t you read the papers about all the parents who won’t vaccinate their children for fear of autism?"
I’m not suggesting that these are bad questions or that we shouldn’t ask them, so we can learn what we can. What I am saying is that, even if we do, no matter how careful and thoughtful we are, we are never going to catch everything we are unprepared for – the rare, the atypical, the unexpected.
This spring, the media reported details of an outbreak that occurred 5 years ago at New Orleans Children’s Hospital of what turned out to be mucormycosis; it proved fatal for several children. Looking back, mistakes were made. Diagnostic biopsies were only done when parents demanded them. Soiled laundry was mishandled. All this at a well-respected tertiary care center staffed by clinicians no doubt as fine as specialists anywhere.
The resulting investigation will no doubt find clinical and administrative gaps and address them. Consciousness will be raised, systems streamlined, oversight tightened. This loophole will be closed. Then others will open, no doubt the way they usually do, when people are looking at something else.
I knew there was something fishy about Peter’s case, but I didn’t know what it was. The experienced and thoughtful academic physicians I sent him to didn’t figure it out, either. It is nice of Peter to be philosophical about this. I would not begrudge him a less considerate reaction.
As for us, we ought to be vigilant, thorough, and humble. Should we get full of ourselves, there’s a hard case out there just waiting to deflate us.
Dr. Rockoff practices dermatology in Brookline, Mass. He is on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. Dr. Rockoff has contributed to the Under My Skin column in Skin & Allergy News since 1997.
"Hard cases," say the lawyers, "make bad law." That means something like, "Legislation works better when it’s drafted in response to average circumstances, not extreme ones."
This adage applies to our profession, too. You can learn more about how to practice and teach medicine from average cases than from rare and strange ones. Hard cases can make any of us look foolish.
Peter e-mailed me the other day. I’d seen him 6 months ago for an eczematous rash on his back. Something funny about it, though: The distribution didn’t work, and it wasn’t scaly. No response to triamcinolone. Biopsy: Nonspecific inflammation. CBC: Elevated white cells at 15,600, mostly lymphs. Hmmm.
I referred him to an academic center. They presented him at Grand Rounds, and set him up for patch testing. He avoided what they asked him to, with little success.
"The oncologist says I have lymphoma," Peter’s e-mail to the patch test clinic read, copying me. He apologetically canceled his allergy clinic follow-up. "I hope for a good prognosis, although diagnosis has been delayed for several months. I hope my example will be of value for future patients."
Peter puts his regrets gently. How valuable will his lesson be? His case teaches that strange presentations of uncommon conditions can make even good and conscientious doctors look lame.
We all congratulate ourselves on "good pick-ups," the diagnostic coups that hit the nail on the head. Fair enough, but we understandably look away when we got it right by dumb luck or got it wrong.
That subcutaneous fullness we thought was fine, but which the patient insisted be removed (and turned out to be dermatofibrosarcoma protuberans). That dark spot that looked like all the others, only the patient was nervous because he was sure it had changed (melanoma). The funny rash that ended up being measles in an unimmunized child, and when was the last time you saw measles?
Often, we never even find out about the hard cases we missed, because the people who had them got fed up with us and went elsewhere. Sometimes, they send an angry letter or – more common these days – write a bad review. "I went to another doctor who finally figured out my problem and prescribed the right treatment." Once in a while, a lawsuit.
Viewed through the "retrospectoscope," knowing how the story turned out, our initial fumblings look pretty clumsy, if not downright actionable. "Oh, come on," a critic might say, "Surely that lump was too irregular for you to pass it off as a fibroma." Or: "Why the surprise? Didn’t he tell you the mole changed?" "The kid was sick and had a funny rash, didn’t she?" says a third. "Don’t you read the papers about all the parents who won’t vaccinate their children for fear of autism?"
I’m not suggesting that these are bad questions or that we shouldn’t ask them, so we can learn what we can. What I am saying is that, even if we do, no matter how careful and thoughtful we are, we are never going to catch everything we are unprepared for – the rare, the atypical, the unexpected.
This spring, the media reported details of an outbreak that occurred 5 years ago at New Orleans Children’s Hospital of what turned out to be mucormycosis; it proved fatal for several children. Looking back, mistakes were made. Diagnostic biopsies were only done when parents demanded them. Soiled laundry was mishandled. All this at a well-respected tertiary care center staffed by clinicians no doubt as fine as specialists anywhere.
The resulting investigation will no doubt find clinical and administrative gaps and address them. Consciousness will be raised, systems streamlined, oversight tightened. This loophole will be closed. Then others will open, no doubt the way they usually do, when people are looking at something else.
I knew there was something fishy about Peter’s case, but I didn’t know what it was. The experienced and thoughtful academic physicians I sent him to didn’t figure it out, either. It is nice of Peter to be philosophical about this. I would not begrudge him a less considerate reaction.
As for us, we ought to be vigilant, thorough, and humble. Should we get full of ourselves, there’s a hard case out there just waiting to deflate us.
Dr. Rockoff practices dermatology in Brookline, Mass. He is on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. Dr. Rockoff has contributed to the Under My Skin column in Skin & Allergy News since 1997.
Patent foramen ovale and the risk of cryptogenic stroke
The article by Roth and Alli in this issue describes in depth more than 10 years of research that addresses the question, Should we close a patent foramen ovale (PFO) to prevent recurrent cryptogenic stroke?
There is no longer any doubt that PFO can be the pathway for thrombus from the venous circulation to go from the right atrium to the left atrium, bypassing the pulmonary capillary filtration bed, and entering the arterial side to produce a stroke, myocardial infarction, or peripheral embolus. Two questions remain: What should we do to prevent another episode? And is percutaneous closure of a PFO with the current devices preferable to medical therapy?
How much do we know about the risks and benefits of closure of PFO? I maintain that we know a great deal about interatrial shunt and paradoxical embolism as a cause of cryptogenic stroke. Prospective randomized clinical trials now give us data with which we can provide appropriate direction to our patients. Percutaneous closure is no longer an “experimental procedure,” as insurance companies claim. The experiment has been done, and the only issue is how one interprets the data from the randomized clinical trials.
The review by Roth and Alli comprehensively describes the observational studies, as well as the three randomized clinical trials done to determine whether PFO closure is preferable to medical therapy to prevent recurrent stroke in patients who have already had one cryptogenic stroke. If we understand some of the subtleties and differences between the trials, we can reach an appropriate conclusion as to what to recommend to our patients.
A review of 10 reports of transcatheter closure of PFO vs six reports of medical therapy for cryptogenic stroke showed a range of rates of recurrent stroke at 1 year—between 0% and 4.9% for transcatheter closure, and between 3.8% and 12% for medical therapy.1
These numbers are important because they were used to estimate the number of patients that would be necessary to study in a randomized clinical trial to demonstrate a benefit of PFO closure vs medical therapy. Unlike most studies of new devices, the PFO closure trials were done in an environment in which patients could get their PFO closed with other devices that were already approved by the US Food and Drug Administration (FDA) for closure of an atrial septal defect. This ability of patients to obtain PFO closure outside of the trial with an off-label device meant that the patients who agreed to be randomized tended to have lower risk for recurrence than patients studied in the observational populations. From a practical standpoint, this meant that the event rate in the patients who participated in the randomized clinical trials (1.7% per year) was lower than predicted from the observational studies.2,3
Another way of saying this is that the randomized clinical trials were underpowered to answer the question. A common way of dealing with this problem is to combine the results of different studies in a meta-analysis. This makes sense if the studies are assessing the same thing. This is not the case with the PFO closure trials. Although the topic of percutaneous PFO closure vs medical therapy was the same, the devices used were different.
In the CLOSURE trial (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale),3 the device used was the STARFlex, which is no longer produced—and for good reasons. It is not as effective as the Amplatzer or Helex devices in completely closing the right-to-left shunt produced by a PFO. In addition, the CardioSEAL or STARFlex device increases the risk of atrial fibrillation, which was seen in 6% of the treated patients.3 This was the major cause of recurrent stroke in the CLOSURE trial. The CardioSEAL STARFlex device was also more thrombogenic.
In the RESPECT trial (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment),2 which used the Amplatzer PFO closure device, there was no increased incidence of atrial fibrillation in the device group compared with the control group. Therefore, it is not appropriate to combine the results of the CLOSURE trial with the results of the RESPECT trial and PC trial,4 both of which used the Amplatzer device.
Our patients want to know what the potential risks and benefits will be if they get their PFO closed with a specific device. They don’t want to know the average risk between two different devices.
However, if you do a meta-analysis of the RESPECT and PC trials, which used the same Amplatzer PFO occluder device, and combine the number of patients studied to increase the statistical power, then the benefit of PFO closure is significant even with an intention-to-treat analysis. By combining the two studies that assessed the same device, you reach a completely different interpretation than if you do a meta-analysis including the CLOSURE trial, which showed no benefit.
The medical community should not uncritically accept meta-analysis methodology. It is a marvelous case example of how scientific methods can be inappropriately used and two diametrically opposed conclusions reached if the meta-analysis combines two different types of devices vs a meta-analysis of just the Amplatzer device.
If we combine the numbers from the RESPECT and PC trials, there were 23 strokes in 691 patients (3.3%) in the medical groups and 10 strokes in 703 patients (1.4%) who underwent PFO closure. By chi square analysis of this intention-to-treat protocol, PFO closure provides a statistically significant reduction in preventing recurrent stroke (95% confidence interval 0.20–0.89, P = .02).
From the patient’s perspective, what is important is this: If I get my PFO closed with an Amplatzer PFO occluder device, what are the risks of the procedure, and what are the potential benefits compared with medical therapy? We can now answer that question definitively. I tell my patients, “The risks of the procedure are remarkably low (about 1%) in experienced hands, and the benefit is that your risk of recurrent stroke will be reduced 73%2 compared with medical therapy.” In the RESPECT Trial, the as-treated cohort consisted of 958 patients with 21 primary end-point events (5 in the closure group and 16 in the medical-therapy group). The rate of the primary end point was 0.39 events per 100 patient-years in the closure group vs 1.45 events per 100 patient-years in the medical-therapy group (hazard ratio 0.27; 95% confidence interval 0.10–0.75; P = .007).
Not all cryptogenic strokes in people who have a PFO are caused by paradoxical embolism. PFO may be an innocent bystander. In addition, not all people who have a paradoxical embolism will have a recurrent stroke. For example, if a young woman presents with a PFO and stroke, is it possible that she can prevent another stroke just by stopping her birth-control pills and not have her PFO closed? What is the risk of recurrent stroke if she were to become pregnant? We do not know the answers to these questions.
Your patients do not want to wait to find out if they are going to have another stroke. The meta-analysis of the randomized clinical trials for paradoxical embolism demonstrates that the closure devices are safe and effective. The FDA should approve the Amplatzer PFO occluder with an indication to prevent recurrent stroke in patients with PFO and an initial cryptogenic event.
- Khairy P, O’Donnell CP, Landzberg MJ. Transcatheter closure versus medical therapy of patent foramen ovale and presumed paradoxical thromboemboli: a systematic review. Ann Intern Med 2003; 139:753–760.
- Carroll JD, Saver JL, Thaler DE, et al; RESPECT Investigators. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med 2013; 368:1092–1100.
- Furlan AJ, Reisman M, Massaro J, et al; CLOSURE Investigators. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med 2012; 366:991–999.
- Meier B, Kalesan B, Mattle HP, et al; PC Trial Investigators. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl J Med 2013; 368:1083–1091.
The article by Roth and Alli in this issue describes in depth more than 10 years of research that addresses the question, Should we close a patent foramen ovale (PFO) to prevent recurrent cryptogenic stroke?
There is no longer any doubt that PFO can be the pathway for thrombus from the venous circulation to go from the right atrium to the left atrium, bypassing the pulmonary capillary filtration bed, and entering the arterial side to produce a stroke, myocardial infarction, or peripheral embolus. Two questions remain: What should we do to prevent another episode? And is percutaneous closure of a PFO with the current devices preferable to medical therapy?
How much do we know about the risks and benefits of closure of PFO? I maintain that we know a great deal about interatrial shunt and paradoxical embolism as a cause of cryptogenic stroke. Prospective randomized clinical trials now give us data with which we can provide appropriate direction to our patients. Percutaneous closure is no longer an “experimental procedure,” as insurance companies claim. The experiment has been done, and the only issue is how one interprets the data from the randomized clinical trials.
The review by Roth and Alli comprehensively describes the observational studies, as well as the three randomized clinical trials done to determine whether PFO closure is preferable to medical therapy to prevent recurrent stroke in patients who have already had one cryptogenic stroke. If we understand some of the subtleties and differences between the trials, we can reach an appropriate conclusion as to what to recommend to our patients.
A review of 10 reports of transcatheter closure of PFO vs six reports of medical therapy for cryptogenic stroke showed a range of rates of recurrent stroke at 1 year—between 0% and 4.9% for transcatheter closure, and between 3.8% and 12% for medical therapy.1
These numbers are important because they were used to estimate the number of patients that would be necessary to study in a randomized clinical trial to demonstrate a benefit of PFO closure vs medical therapy. Unlike most studies of new devices, the PFO closure trials were done in an environment in which patients could get their PFO closed with other devices that were already approved by the US Food and Drug Administration (FDA) for closure of an atrial septal defect. This ability of patients to obtain PFO closure outside of the trial with an off-label device meant that the patients who agreed to be randomized tended to have lower risk for recurrence than patients studied in the observational populations. From a practical standpoint, this meant that the event rate in the patients who participated in the randomized clinical trials (1.7% per year) was lower than predicted from the observational studies.2,3
Another way of saying this is that the randomized clinical trials were underpowered to answer the question. A common way of dealing with this problem is to combine the results of different studies in a meta-analysis. This makes sense if the studies are assessing the same thing. This is not the case with the PFO closure trials. Although the topic of percutaneous PFO closure vs medical therapy was the same, the devices used were different.
In the CLOSURE trial (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale),3 the device used was the STARFlex, which is no longer produced—and for good reasons. It is not as effective as the Amplatzer or Helex devices in completely closing the right-to-left shunt produced by a PFO. In addition, the CardioSEAL or STARFlex device increases the risk of atrial fibrillation, which was seen in 6% of the treated patients.3 This was the major cause of recurrent stroke in the CLOSURE trial. The CardioSEAL STARFlex device was also more thrombogenic.
In the RESPECT trial (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment),2 which used the Amplatzer PFO closure device, there was no increased incidence of atrial fibrillation in the device group compared with the control group. Therefore, it is not appropriate to combine the results of the CLOSURE trial with the results of the RESPECT trial and PC trial,4 both of which used the Amplatzer device.
Our patients want to know what the potential risks and benefits will be if they get their PFO closed with a specific device. They don’t want to know the average risk between two different devices.
However, if you do a meta-analysis of the RESPECT and PC trials, which used the same Amplatzer PFO occluder device, and combine the number of patients studied to increase the statistical power, then the benefit of PFO closure is significant even with an intention-to-treat analysis. By combining the two studies that assessed the same device, you reach a completely different interpretation than if you do a meta-analysis including the CLOSURE trial, which showed no benefit.
The medical community should not uncritically accept meta-analysis methodology. It is a marvelous case example of how scientific methods can be inappropriately used and two diametrically opposed conclusions reached if the meta-analysis combines two different types of devices vs a meta-analysis of just the Amplatzer device.
If we combine the numbers from the RESPECT and PC trials, there were 23 strokes in 691 patients (3.3%) in the medical groups and 10 strokes in 703 patients (1.4%) who underwent PFO closure. By chi square analysis of this intention-to-treat protocol, PFO closure provides a statistically significant reduction in preventing recurrent stroke (95% confidence interval 0.20–0.89, P = .02).
From the patient’s perspective, what is important is this: If I get my PFO closed with an Amplatzer PFO occluder device, what are the risks of the procedure, and what are the potential benefits compared with medical therapy? We can now answer that question definitively. I tell my patients, “The risks of the procedure are remarkably low (about 1%) in experienced hands, and the benefit is that your risk of recurrent stroke will be reduced 73%2 compared with medical therapy.” In the RESPECT Trial, the as-treated cohort consisted of 958 patients with 21 primary end-point events (5 in the closure group and 16 in the medical-therapy group). The rate of the primary end point was 0.39 events per 100 patient-years in the closure group vs 1.45 events per 100 patient-years in the medical-therapy group (hazard ratio 0.27; 95% confidence interval 0.10–0.75; P = .007).
Not all cryptogenic strokes in people who have a PFO are caused by paradoxical embolism. PFO may be an innocent bystander. In addition, not all people who have a paradoxical embolism will have a recurrent stroke. For example, if a young woman presents with a PFO and stroke, is it possible that she can prevent another stroke just by stopping her birth-control pills and not have her PFO closed? What is the risk of recurrent stroke if she were to become pregnant? We do not know the answers to these questions.
Your patients do not want to wait to find out if they are going to have another stroke. The meta-analysis of the randomized clinical trials for paradoxical embolism demonstrates that the closure devices are safe and effective. The FDA should approve the Amplatzer PFO occluder with an indication to prevent recurrent stroke in patients with PFO and an initial cryptogenic event.
The article by Roth and Alli in this issue describes in depth more than 10 years of research that addresses the question, Should we close a patent foramen ovale (PFO) to prevent recurrent cryptogenic stroke?
There is no longer any doubt that PFO can be the pathway for thrombus from the venous circulation to go from the right atrium to the left atrium, bypassing the pulmonary capillary filtration bed, and entering the arterial side to produce a stroke, myocardial infarction, or peripheral embolus. Two questions remain: What should we do to prevent another episode? And is percutaneous closure of a PFO with the current devices preferable to medical therapy?
How much do we know about the risks and benefits of closure of PFO? I maintain that we know a great deal about interatrial shunt and paradoxical embolism as a cause of cryptogenic stroke. Prospective randomized clinical trials now give us data with which we can provide appropriate direction to our patients. Percutaneous closure is no longer an “experimental procedure,” as insurance companies claim. The experiment has been done, and the only issue is how one interprets the data from the randomized clinical trials.
The review by Roth and Alli comprehensively describes the observational studies, as well as the three randomized clinical trials done to determine whether PFO closure is preferable to medical therapy to prevent recurrent stroke in patients who have already had one cryptogenic stroke. If we understand some of the subtleties and differences between the trials, we can reach an appropriate conclusion as to what to recommend to our patients.
A review of 10 reports of transcatheter closure of PFO vs six reports of medical therapy for cryptogenic stroke showed a range of rates of recurrent stroke at 1 year—between 0% and 4.9% for transcatheter closure, and between 3.8% and 12% for medical therapy.1
These numbers are important because they were used to estimate the number of patients that would be necessary to study in a randomized clinical trial to demonstrate a benefit of PFO closure vs medical therapy. Unlike most studies of new devices, the PFO closure trials were done in an environment in which patients could get their PFO closed with other devices that were already approved by the US Food and Drug Administration (FDA) for closure of an atrial septal defect. This ability of patients to obtain PFO closure outside of the trial with an off-label device meant that the patients who agreed to be randomized tended to have lower risk for recurrence than patients studied in the observational populations. From a practical standpoint, this meant that the event rate in the patients who participated in the randomized clinical trials (1.7% per year) was lower than predicted from the observational studies.2,3
Another way of saying this is that the randomized clinical trials were underpowered to answer the question. A common way of dealing with this problem is to combine the results of different studies in a meta-analysis. This makes sense if the studies are assessing the same thing. This is not the case with the PFO closure trials. Although the topic of percutaneous PFO closure vs medical therapy was the same, the devices used were different.
In the CLOSURE trial (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale),3 the device used was the STARFlex, which is no longer produced—and for good reasons. It is not as effective as the Amplatzer or Helex devices in completely closing the right-to-left shunt produced by a PFO. In addition, the CardioSEAL or STARFlex device increases the risk of atrial fibrillation, which was seen in 6% of the treated patients.3 This was the major cause of recurrent stroke in the CLOSURE trial. The CardioSEAL STARFlex device was also more thrombogenic.
In the RESPECT trial (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment),2 which used the Amplatzer PFO closure device, there was no increased incidence of atrial fibrillation in the device group compared with the control group. Therefore, it is not appropriate to combine the results of the CLOSURE trial with the results of the RESPECT trial and PC trial,4 both of which used the Amplatzer device.
Our patients want to know what the potential risks and benefits will be if they get their PFO closed with a specific device. They don’t want to know the average risk between two different devices.
However, if you do a meta-analysis of the RESPECT and PC trials, which used the same Amplatzer PFO occluder device, and combine the number of patients studied to increase the statistical power, then the benefit of PFO closure is significant even with an intention-to-treat analysis. By combining the two studies that assessed the same device, you reach a completely different interpretation than if you do a meta-analysis including the CLOSURE trial, which showed no benefit.
The medical community should not uncritically accept meta-analysis methodology. It is a marvelous case example of how scientific methods can be inappropriately used and two diametrically opposed conclusions reached if the meta-analysis combines two different types of devices vs a meta-analysis of just the Amplatzer device.
If we combine the numbers from the RESPECT and PC trials, there were 23 strokes in 691 patients (3.3%) in the medical groups and 10 strokes in 703 patients (1.4%) who underwent PFO closure. By chi square analysis of this intention-to-treat protocol, PFO closure provides a statistically significant reduction in preventing recurrent stroke (95% confidence interval 0.20–0.89, P = .02).
From the patient’s perspective, what is important is this: If I get my PFO closed with an Amplatzer PFO occluder device, what are the risks of the procedure, and what are the potential benefits compared with medical therapy? We can now answer that question definitively. I tell my patients, “The risks of the procedure are remarkably low (about 1%) in experienced hands, and the benefit is that your risk of recurrent stroke will be reduced 73%2 compared with medical therapy.” In the RESPECT Trial, the as-treated cohort consisted of 958 patients with 21 primary end-point events (5 in the closure group and 16 in the medical-therapy group). The rate of the primary end point was 0.39 events per 100 patient-years in the closure group vs 1.45 events per 100 patient-years in the medical-therapy group (hazard ratio 0.27; 95% confidence interval 0.10–0.75; P = .007).
Not all cryptogenic strokes in people who have a PFO are caused by paradoxical embolism. PFO may be an innocent bystander. In addition, not all people who have a paradoxical embolism will have a recurrent stroke. For example, if a young woman presents with a PFO and stroke, is it possible that she can prevent another stroke just by stopping her birth-control pills and not have her PFO closed? What is the risk of recurrent stroke if she were to become pregnant? We do not know the answers to these questions.
Your patients do not want to wait to find out if they are going to have another stroke. The meta-analysis of the randomized clinical trials for paradoxical embolism demonstrates that the closure devices are safe and effective. The FDA should approve the Amplatzer PFO occluder with an indication to prevent recurrent stroke in patients with PFO and an initial cryptogenic event.
- Khairy P, O’Donnell CP, Landzberg MJ. Transcatheter closure versus medical therapy of patent foramen ovale and presumed paradoxical thromboemboli: a systematic review. Ann Intern Med 2003; 139:753–760.
- Carroll JD, Saver JL, Thaler DE, et al; RESPECT Investigators. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med 2013; 368:1092–1100.
- Furlan AJ, Reisman M, Massaro J, et al; CLOSURE Investigators. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med 2012; 366:991–999.
- Meier B, Kalesan B, Mattle HP, et al; PC Trial Investigators. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl J Med 2013; 368:1083–1091.
- Khairy P, O’Donnell CP, Landzberg MJ. Transcatheter closure versus medical therapy of patent foramen ovale and presumed paradoxical thromboemboli: a systematic review. Ann Intern Med 2003; 139:753–760.
- Carroll JD, Saver JL, Thaler DE, et al; RESPECT Investigators. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med 2013; 368:1092–1100.
- Furlan AJ, Reisman M, Massaro J, et al; CLOSURE Investigators. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med 2012; 366:991–999.
- Meier B, Kalesan B, Mattle HP, et al; PC Trial Investigators. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl J Med 2013; 368:1083–1091.
Changes to practice may help avoid ‘double trouble’
Large-volume thoracentesis is defined as the drainage of more than 1 L of fluid. Inherent in this procedure is the removal of a large amount of fluid from a cavity with a rigid wall, which leads to changes in pleural pressure and to expansion of the lung. Two specific complications occur, pneumothorax and reexpansion pulmonary edema. The images submitted for the Clinical Picture article by Drs. Apter and Aronowitz in this issue of the Journal highlight these complications.
Retrospective studies have found an association between the amount of fluid drained and the incidence of pneumothorax.1,2 Although technical issues may account for it (eg, needle injury to the lung that leads to postprocedural pneumothorax), the available evidence suggests that it has more to do with the drainage of larger volumes than the lung can expand to fill.3,4 That is, the patient’s lung cannot expand,5 so drainage creates a vacuum, and air enters the pleural space3 through the lung parenchyma, or perhaps from around the drainage catheter.
In a series of patients who underwent therapeutic thoracentesis,3 23 (8.7%) of 265 patients had pneumothorax. Interestingly, some patients had only symptoms, some had only excessively negative pressures (< 25 cm H2O), some had both, and some had neither. Thus, there does not seem to be a reliable sign or symptom of an unexpanding lung, but pleural manometry may help increase its detection.6 This technique, however, is rarely used in clinical practice.
Another consequence of therapeutic thoracentesis is reexpansion pulmonary edema. This rare condition occurs only after large-volume thoracentesis or evacuation of a moderate to large pneumothorax.7 The pathophysiology behind this is controversial.8 As with pneumothorax, a large case series did not find a correlation between volume removed or pleural pressures and reexpansion pulmonary edema.7 Experimental data and analysis of case series8–10 suggest that the duration of lung collapse and the speed of drainage and negative pressure applied contribute to the development of edema. Vacuum bottles are often used to speed drainage and to contain the large amount of fluid drained. These bottles have an initial negative pressure of about −723 mm Hg (personal communication with Baxter Healthcare Product information line), which may lead to rapid changes in lung volume and perhaps to higher negative pleural pressures.
Given the risks discussed above, we believe it is appropriate to avoid vacuum bottles and instead to use the syringe and one-way valve supplied in most thoracentesis kits. Further, pleural manometry to detect changes in pressure that suggest an unexpandable lung may lead to the appropriate early termination of a planned large-volume thoracentesis.3 The complications reported by Drs. Apter and Aronowitz are relatively rare and, at this point, unpredictable; therefore, generating high-quality evidence for prediction or management will be difficult. In the meantime, understanding the physiologic changes in the lung and the pleural space when draining large effusions from the chest may help avoid double trouble.
- Josephson T, Nordenskjold CA, Larsson J, Rosenberg LU, Kaijser M. Amount drained at ultrasound-guided thoracentesis and risk of pneumothorax. Acta Radiol 2009; 50:42–47.
- Gordon CE, Feller-Kopman D, Balk EM, Smetana GW. Pneumothorax following thoracentesis: a systematic review and meta-analysis. Arch Intern Med 2010; 170:332–339.
- Heidecker J, Huggins JT, Sahn SA, Doelken P. Pathophysiology of pneumothorax following ultrasound-guided thoracentesis. Chest 2006; 130:1173–1184.
- Huggins JT, Sahn SA, Heidecker J, Ravenel JG, Doelken P. Characteristics of trapped lung: pleural fluid analysis, manometry, and air-contrast chest CT. Chest 2007; 131:206–213.
- Woodring JH, Baker MD, Stark P. Pneumothorax ex vacuo. Chest 1996; 110:1102–1105.
- Feller-Kopman D. Therapeutic thoracentesis: the role of ultrasound and pleural manometry. Curr Opin Pulmon Med 2007; 13:312–318.
- Feller-Kopman D, Berkowitz D, Boiselle P, Ernst A. Large-volume thoracentesis and the risk of reexpansion pulmonary edema. Ann Thorac Surg 2007; 84:1656–1661.
- Tarver RD, Broderick LS, Conces DJ, Jr. Reexpansion pulmonary edema. J Thorac Imag 1996; 11:198–209.
- Murphy K, Tomlanovich MC. Unilateral pulmonary edema after drainage of a spontaneous pneumothorax: case report and review of the world literature. J Emerg Med 1983; 1:29–36.
- Pavlin J, Cheney FW Unilateral pulmonary edema in rabbits after reexpansion of collapsed lung. J Appl Physiol Respir Environ Exerc Physiol 1979; 46:31–35.
Large-volume thoracentesis is defined as the drainage of more than 1 L of fluid. Inherent in this procedure is the removal of a large amount of fluid from a cavity with a rigid wall, which leads to changes in pleural pressure and to expansion of the lung. Two specific complications occur, pneumothorax and reexpansion pulmonary edema. The images submitted for the Clinical Picture article by Drs. Apter and Aronowitz in this issue of the Journal highlight these complications.
Retrospective studies have found an association between the amount of fluid drained and the incidence of pneumothorax.1,2 Although technical issues may account for it (eg, needle injury to the lung that leads to postprocedural pneumothorax), the available evidence suggests that it has more to do with the drainage of larger volumes than the lung can expand to fill.3,4 That is, the patient’s lung cannot expand,5 so drainage creates a vacuum, and air enters the pleural space3 through the lung parenchyma, or perhaps from around the drainage catheter.
In a series of patients who underwent therapeutic thoracentesis,3 23 (8.7%) of 265 patients had pneumothorax. Interestingly, some patients had only symptoms, some had only excessively negative pressures (< 25 cm H2O), some had both, and some had neither. Thus, there does not seem to be a reliable sign or symptom of an unexpanding lung, but pleural manometry may help increase its detection.6 This technique, however, is rarely used in clinical practice.
Another consequence of therapeutic thoracentesis is reexpansion pulmonary edema. This rare condition occurs only after large-volume thoracentesis or evacuation of a moderate to large pneumothorax.7 The pathophysiology behind this is controversial.8 As with pneumothorax, a large case series did not find a correlation between volume removed or pleural pressures and reexpansion pulmonary edema.7 Experimental data and analysis of case series8–10 suggest that the duration of lung collapse and the speed of drainage and negative pressure applied contribute to the development of edema. Vacuum bottles are often used to speed drainage and to contain the large amount of fluid drained. These bottles have an initial negative pressure of about −723 mm Hg (personal communication with Baxter Healthcare Product information line), which may lead to rapid changes in lung volume and perhaps to higher negative pleural pressures.
Given the risks discussed above, we believe it is appropriate to avoid vacuum bottles and instead to use the syringe and one-way valve supplied in most thoracentesis kits. Further, pleural manometry to detect changes in pressure that suggest an unexpandable lung may lead to the appropriate early termination of a planned large-volume thoracentesis.3 The complications reported by Drs. Apter and Aronowitz are relatively rare and, at this point, unpredictable; therefore, generating high-quality evidence for prediction or management will be difficult. In the meantime, understanding the physiologic changes in the lung and the pleural space when draining large effusions from the chest may help avoid double trouble.
Large-volume thoracentesis is defined as the drainage of more than 1 L of fluid. Inherent in this procedure is the removal of a large amount of fluid from a cavity with a rigid wall, which leads to changes in pleural pressure and to expansion of the lung. Two specific complications occur, pneumothorax and reexpansion pulmonary edema. The images submitted for the Clinical Picture article by Drs. Apter and Aronowitz in this issue of the Journal highlight these complications.
Retrospective studies have found an association between the amount of fluid drained and the incidence of pneumothorax.1,2 Although technical issues may account for it (eg, needle injury to the lung that leads to postprocedural pneumothorax), the available evidence suggests that it has more to do with the drainage of larger volumes than the lung can expand to fill.3,4 That is, the patient’s lung cannot expand,5 so drainage creates a vacuum, and air enters the pleural space3 through the lung parenchyma, or perhaps from around the drainage catheter.
In a series of patients who underwent therapeutic thoracentesis,3 23 (8.7%) of 265 patients had pneumothorax. Interestingly, some patients had only symptoms, some had only excessively negative pressures (< 25 cm H2O), some had both, and some had neither. Thus, there does not seem to be a reliable sign or symptom of an unexpanding lung, but pleural manometry may help increase its detection.6 This technique, however, is rarely used in clinical practice.
Another consequence of therapeutic thoracentesis is reexpansion pulmonary edema. This rare condition occurs only after large-volume thoracentesis or evacuation of a moderate to large pneumothorax.7 The pathophysiology behind this is controversial.8 As with pneumothorax, a large case series did not find a correlation between volume removed or pleural pressures and reexpansion pulmonary edema.7 Experimental data and analysis of case series8–10 suggest that the duration of lung collapse and the speed of drainage and negative pressure applied contribute to the development of edema. Vacuum bottles are often used to speed drainage and to contain the large amount of fluid drained. These bottles have an initial negative pressure of about −723 mm Hg (personal communication with Baxter Healthcare Product information line), which may lead to rapid changes in lung volume and perhaps to higher negative pleural pressures.
Given the risks discussed above, we believe it is appropriate to avoid vacuum bottles and instead to use the syringe and one-way valve supplied in most thoracentesis kits. Further, pleural manometry to detect changes in pressure that suggest an unexpandable lung may lead to the appropriate early termination of a planned large-volume thoracentesis.3 The complications reported by Drs. Apter and Aronowitz are relatively rare and, at this point, unpredictable; therefore, generating high-quality evidence for prediction or management will be difficult. In the meantime, understanding the physiologic changes in the lung and the pleural space when draining large effusions from the chest may help avoid double trouble.
- Josephson T, Nordenskjold CA, Larsson J, Rosenberg LU, Kaijser M. Amount drained at ultrasound-guided thoracentesis and risk of pneumothorax. Acta Radiol 2009; 50:42–47.
- Gordon CE, Feller-Kopman D, Balk EM, Smetana GW. Pneumothorax following thoracentesis: a systematic review and meta-analysis. Arch Intern Med 2010; 170:332–339.
- Heidecker J, Huggins JT, Sahn SA, Doelken P. Pathophysiology of pneumothorax following ultrasound-guided thoracentesis. Chest 2006; 130:1173–1184.
- Huggins JT, Sahn SA, Heidecker J, Ravenel JG, Doelken P. Characteristics of trapped lung: pleural fluid analysis, manometry, and air-contrast chest CT. Chest 2007; 131:206–213.
- Woodring JH, Baker MD, Stark P. Pneumothorax ex vacuo. Chest 1996; 110:1102–1105.
- Feller-Kopman D. Therapeutic thoracentesis: the role of ultrasound and pleural manometry. Curr Opin Pulmon Med 2007; 13:312–318.
- Feller-Kopman D, Berkowitz D, Boiselle P, Ernst A. Large-volume thoracentesis and the risk of reexpansion pulmonary edema. Ann Thorac Surg 2007; 84:1656–1661.
- Tarver RD, Broderick LS, Conces DJ, Jr. Reexpansion pulmonary edema. J Thorac Imag 1996; 11:198–209.
- Murphy K, Tomlanovich MC. Unilateral pulmonary edema after drainage of a spontaneous pneumothorax: case report and review of the world literature. J Emerg Med 1983; 1:29–36.
- Pavlin J, Cheney FW Unilateral pulmonary edema in rabbits after reexpansion of collapsed lung. J Appl Physiol Respir Environ Exerc Physiol 1979; 46:31–35.
- Josephson T, Nordenskjold CA, Larsson J, Rosenberg LU, Kaijser M. Amount drained at ultrasound-guided thoracentesis and risk of pneumothorax. Acta Radiol 2009; 50:42–47.
- Gordon CE, Feller-Kopman D, Balk EM, Smetana GW. Pneumothorax following thoracentesis: a systematic review and meta-analysis. Arch Intern Med 2010; 170:332–339.
- Heidecker J, Huggins JT, Sahn SA, Doelken P. Pathophysiology of pneumothorax following ultrasound-guided thoracentesis. Chest 2006; 130:1173–1184.
- Huggins JT, Sahn SA, Heidecker J, Ravenel JG, Doelken P. Characteristics of trapped lung: pleural fluid analysis, manometry, and air-contrast chest CT. Chest 2007; 131:206–213.
- Woodring JH, Baker MD, Stark P. Pneumothorax ex vacuo. Chest 1996; 110:1102–1105.
- Feller-Kopman D. Therapeutic thoracentesis: the role of ultrasound and pleural manometry. Curr Opin Pulmon Med 2007; 13:312–318.
- Feller-Kopman D, Berkowitz D, Boiselle P, Ernst A. Large-volume thoracentesis and the risk of reexpansion pulmonary edema. Ann Thorac Surg 2007; 84:1656–1661.
- Tarver RD, Broderick LS, Conces DJ, Jr. Reexpansion pulmonary edema. J Thorac Imag 1996; 11:198–209.
- Murphy K, Tomlanovich MC. Unilateral pulmonary edema after drainage of a spontaneous pneumothorax: case report and review of the world literature. J Emerg Med 1983; 1:29–36.
- Pavlin J, Cheney FW Unilateral pulmonary edema in rabbits after reexpansion of collapsed lung. J Appl Physiol Respir Environ Exerc Physiol 1979; 46:31–35.
Stalled out
Am I the only person spooked by the way automation is taking over our public bathrooms? I appreciate some of this touch-free, infrared technology; I won’t always be nimble enough to push the flush lever with my right toe. But then I get that stall where Niagara Falls goes off every time I shift my weight. What is this, a bathroom or the Bellagio Fountains?
And darnit, people, if you're going to make the faucets automatic, can you please do the soap dispenser and paper towel roll, too? I feel like an idiot waving my hands around by the bathroom wall while the guy next to me walks up and yanks a towel off the roll. Then I smack my forehead with my wet hand, and I can't dry it without bending down under that motion-sensing ramjet thing that I should have used in the first place. The day I always feared has finally arrived: My bathroom is smarter than I am.
Playing by ear
I'm often frustrated but rarely surprised when the emergency department (ED) docs at our local hospital fail to follow basic pediatric treatment guidelines. Sore throat? Here’s some antibiotics. Runny nose? Antibiotics are good for that. Ankle sprain? Snake bite? Azithromycin for everyone! “If only,” I think, “we had a pediatric emergency department...at an academic medical center...in a more advanced country...with a public health system. ..."
But now, thanks to a new study from Sweden, my dreams are dashed. Apparently, even at an academic medical center with a pediatric ED in a country with public health care and that is capable of manufacturing affordable, sleek modern furniture that fits in the back of a station wagon and assembles in 5 minutes with a simple Allen wrench, even in freaking Sweden the ED docs overtreat acute otitis media (AOM) with antibiotics. And, according to author Jimmy Célind and his colleagues from the University of Gothenburg, they can't be stopped.
The investigators reviewed charts before and after a simple intervention to see if educating providers on evidence-based AOM guidelines would improve their compliance with those guidelines. The results? Not one outcome measure – use of drugs as opposed to nondrug management, choice of drug, drug dosage, or duration of drug treatment – improved.
The authors had several theories about why their intervention failed. The campaign consisted of one lecture and some fliers, without any ongoing monitoring and feedback. Providers were educated, but the patients were not. Patients were also in an ED, where people waited a long time to be seen and weren't keen to return in 2 days for follow-up. I have a different theory, however: They just forgot to include the Allen wrench.
The dark side of light
Here in North Carolina, a bill restricting teens' use of tanning beds appears to have stalled out in the legislature for a second year in a row, despite the success of such measures in states as diverse as Louisiana and Indiana (they both end with “ana,” but otherwise, they're diverse). I get it: Just because we keep teens from drinking, smoking, and driving, and just because tanning beds are a major cause of deadly cancer, there are also great reasons not to limit kids’ right to tan, like, um, where else can they wear those little dark eye cup things?
We've known for a while that using tanning beds increases kids' risk of developing deadly malignant melanoma, but a new study in Pediatrics adds basal cell carcinoma to the list, which is, to be fair, merely disfiguring. The study came from New Hampshire, a state which balances a paucity of intense sunlight with a rich supply of people who sunburn easily. Sunlamps, tanning beds, and tanning booths all increased the risk of cancer; kids who started tanning younger suffered more carcinoma.
None of these data are likely to impress opponents of laws limiting kids' use of tanning beds. “North Carolina shouldn't be a nanny state!”they'll shout. But when it comes to cancer, I disagree, at least when some of the people we're talking about still have an actual nanny.
My yellow stars!
Is it just me, or have sugary breakfast cereals become the latest punching bag of nutritionists and doctors? Only soft drinks and potato chips seem to draw as much blame for the obesity epidemic, although I had a slice of chocolate cake last night that I’d like to nominate for some serious scorn. Even the cereal makers didn’t see this next one coming, however. According the Environmental Working Group (EWG), this “nutritious part of a complete breakfast, fortified with vitamins and minerals” is too fortified with vitamins and minerals! Take that, you crispy flakes of morning goodness!
When it comes to vitamins and minerals, you really can have too much of a good thing, and the folks at the EWG make a compelling argument (strongly disputed by cereal manufacturers) that the levels of vitamin A, zinc, and niacin in many breakfast cereals actually pose a potential danger to kids’ health. Now, of course, I’m looking at the cereal boxes in my pantry and wondering what to do with them. I think I’ll go to a public restroom and ask the toilet.
David L. Hill, M.D., FAAP, is the author of Dad to Dad: Parenting Like a Pro (AAP Publishing, 2012). He is also vice president of Cape Fear Pediatrics in Wilmington, N.C., and adjunct assistant professor of pediatrics at the University of North Carolina at Chapel Hill. He serves as Program Director for the AAP Council on Communications and Media and as an executive committee member of the North Carolina Pediatric Society. He has recorded commentaries for NPR's All Things Considered and provided content for various print, television, and Internet outlets.
Am I the only person spooked by the way automation is taking over our public bathrooms? I appreciate some of this touch-free, infrared technology; I won’t always be nimble enough to push the flush lever with my right toe. But then I get that stall where Niagara Falls goes off every time I shift my weight. What is this, a bathroom or the Bellagio Fountains?
And darnit, people, if you're going to make the faucets automatic, can you please do the soap dispenser and paper towel roll, too? I feel like an idiot waving my hands around by the bathroom wall while the guy next to me walks up and yanks a towel off the roll. Then I smack my forehead with my wet hand, and I can't dry it without bending down under that motion-sensing ramjet thing that I should have used in the first place. The day I always feared has finally arrived: My bathroom is smarter than I am.
Playing by ear
I'm often frustrated but rarely surprised when the emergency department (ED) docs at our local hospital fail to follow basic pediatric treatment guidelines. Sore throat? Here’s some antibiotics. Runny nose? Antibiotics are good for that. Ankle sprain? Snake bite? Azithromycin for everyone! “If only,” I think, “we had a pediatric emergency department...at an academic medical center...in a more advanced country...with a public health system. ..."
But now, thanks to a new study from Sweden, my dreams are dashed. Apparently, even at an academic medical center with a pediatric ED in a country with public health care and that is capable of manufacturing affordable, sleek modern furniture that fits in the back of a station wagon and assembles in 5 minutes with a simple Allen wrench, even in freaking Sweden the ED docs overtreat acute otitis media (AOM) with antibiotics. And, according to author Jimmy Célind and his colleagues from the University of Gothenburg, they can't be stopped.
The investigators reviewed charts before and after a simple intervention to see if educating providers on evidence-based AOM guidelines would improve their compliance with those guidelines. The results? Not one outcome measure – use of drugs as opposed to nondrug management, choice of drug, drug dosage, or duration of drug treatment – improved.
The authors had several theories about why their intervention failed. The campaign consisted of one lecture and some fliers, without any ongoing monitoring and feedback. Providers were educated, but the patients were not. Patients were also in an ED, where people waited a long time to be seen and weren't keen to return in 2 days for follow-up. I have a different theory, however: They just forgot to include the Allen wrench.
The dark side of light
Here in North Carolina, a bill restricting teens' use of tanning beds appears to have stalled out in the legislature for a second year in a row, despite the success of such measures in states as diverse as Louisiana and Indiana (they both end with “ana,” but otherwise, they're diverse). I get it: Just because we keep teens from drinking, smoking, and driving, and just because tanning beds are a major cause of deadly cancer, there are also great reasons not to limit kids’ right to tan, like, um, where else can they wear those little dark eye cup things?
We've known for a while that using tanning beds increases kids' risk of developing deadly malignant melanoma, but a new study in Pediatrics adds basal cell carcinoma to the list, which is, to be fair, merely disfiguring. The study came from New Hampshire, a state which balances a paucity of intense sunlight with a rich supply of people who sunburn easily. Sunlamps, tanning beds, and tanning booths all increased the risk of cancer; kids who started tanning younger suffered more carcinoma.
None of these data are likely to impress opponents of laws limiting kids' use of tanning beds. “North Carolina shouldn't be a nanny state!”they'll shout. But when it comes to cancer, I disagree, at least when some of the people we're talking about still have an actual nanny.
My yellow stars!
Is it just me, or have sugary breakfast cereals become the latest punching bag of nutritionists and doctors? Only soft drinks and potato chips seem to draw as much blame for the obesity epidemic, although I had a slice of chocolate cake last night that I’d like to nominate for some serious scorn. Even the cereal makers didn’t see this next one coming, however. According the Environmental Working Group (EWG), this “nutritious part of a complete breakfast, fortified with vitamins and minerals” is too fortified with vitamins and minerals! Take that, you crispy flakes of morning goodness!
When it comes to vitamins and minerals, you really can have too much of a good thing, and the folks at the EWG make a compelling argument (strongly disputed by cereal manufacturers) that the levels of vitamin A, zinc, and niacin in many breakfast cereals actually pose a potential danger to kids’ health. Now, of course, I’m looking at the cereal boxes in my pantry and wondering what to do with them. I think I’ll go to a public restroom and ask the toilet.
David L. Hill, M.D., FAAP, is the author of Dad to Dad: Parenting Like a Pro (AAP Publishing, 2012). He is also vice president of Cape Fear Pediatrics in Wilmington, N.C., and adjunct assistant professor of pediatrics at the University of North Carolina at Chapel Hill. He serves as Program Director for the AAP Council on Communications and Media and as an executive committee member of the North Carolina Pediatric Society. He has recorded commentaries for NPR's All Things Considered and provided content for various print, television, and Internet outlets.
Am I the only person spooked by the way automation is taking over our public bathrooms? I appreciate some of this touch-free, infrared technology; I won’t always be nimble enough to push the flush lever with my right toe. But then I get that stall where Niagara Falls goes off every time I shift my weight. What is this, a bathroom or the Bellagio Fountains?
And darnit, people, if you're going to make the faucets automatic, can you please do the soap dispenser and paper towel roll, too? I feel like an idiot waving my hands around by the bathroom wall while the guy next to me walks up and yanks a towel off the roll. Then I smack my forehead with my wet hand, and I can't dry it without bending down under that motion-sensing ramjet thing that I should have used in the first place. The day I always feared has finally arrived: My bathroom is smarter than I am.
Playing by ear
I'm often frustrated but rarely surprised when the emergency department (ED) docs at our local hospital fail to follow basic pediatric treatment guidelines. Sore throat? Here’s some antibiotics. Runny nose? Antibiotics are good for that. Ankle sprain? Snake bite? Azithromycin for everyone! “If only,” I think, “we had a pediatric emergency department...at an academic medical center...in a more advanced country...with a public health system. ..."
But now, thanks to a new study from Sweden, my dreams are dashed. Apparently, even at an academic medical center with a pediatric ED in a country with public health care and that is capable of manufacturing affordable, sleek modern furniture that fits in the back of a station wagon and assembles in 5 minutes with a simple Allen wrench, even in freaking Sweden the ED docs overtreat acute otitis media (AOM) with antibiotics. And, according to author Jimmy Célind and his colleagues from the University of Gothenburg, they can't be stopped.
The investigators reviewed charts before and after a simple intervention to see if educating providers on evidence-based AOM guidelines would improve their compliance with those guidelines. The results? Not one outcome measure – use of drugs as opposed to nondrug management, choice of drug, drug dosage, or duration of drug treatment – improved.
The authors had several theories about why their intervention failed. The campaign consisted of one lecture and some fliers, without any ongoing monitoring and feedback. Providers were educated, but the patients were not. Patients were also in an ED, where people waited a long time to be seen and weren't keen to return in 2 days for follow-up. I have a different theory, however: They just forgot to include the Allen wrench.
The dark side of light
Here in North Carolina, a bill restricting teens' use of tanning beds appears to have stalled out in the legislature for a second year in a row, despite the success of such measures in states as diverse as Louisiana and Indiana (they both end with “ana,” but otherwise, they're diverse). I get it: Just because we keep teens from drinking, smoking, and driving, and just because tanning beds are a major cause of deadly cancer, there are also great reasons not to limit kids’ right to tan, like, um, where else can they wear those little dark eye cup things?
We've known for a while that using tanning beds increases kids' risk of developing deadly malignant melanoma, but a new study in Pediatrics adds basal cell carcinoma to the list, which is, to be fair, merely disfiguring. The study came from New Hampshire, a state which balances a paucity of intense sunlight with a rich supply of people who sunburn easily. Sunlamps, tanning beds, and tanning booths all increased the risk of cancer; kids who started tanning younger suffered more carcinoma.
None of these data are likely to impress opponents of laws limiting kids' use of tanning beds. “North Carolina shouldn't be a nanny state!”they'll shout. But when it comes to cancer, I disagree, at least when some of the people we're talking about still have an actual nanny.
My yellow stars!
Is it just me, or have sugary breakfast cereals become the latest punching bag of nutritionists and doctors? Only soft drinks and potato chips seem to draw as much blame for the obesity epidemic, although I had a slice of chocolate cake last night that I’d like to nominate for some serious scorn. Even the cereal makers didn’t see this next one coming, however. According the Environmental Working Group (EWG), this “nutritious part of a complete breakfast, fortified with vitamins and minerals” is too fortified with vitamins and minerals! Take that, you crispy flakes of morning goodness!
When it comes to vitamins and minerals, you really can have too much of a good thing, and the folks at the EWG make a compelling argument (strongly disputed by cereal manufacturers) that the levels of vitamin A, zinc, and niacin in many breakfast cereals actually pose a potential danger to kids’ health. Now, of course, I’m looking at the cereal boxes in my pantry and wondering what to do with them. I think I’ll go to a public restroom and ask the toilet.
David L. Hill, M.D., FAAP, is the author of Dad to Dad: Parenting Like a Pro (AAP Publishing, 2012). He is also vice president of Cape Fear Pediatrics in Wilmington, N.C., and adjunct assistant professor of pediatrics at the University of North Carolina at Chapel Hill. He serves as Program Director for the AAP Council on Communications and Media and as an executive committee member of the North Carolina Pediatric Society. He has recorded commentaries for NPR's All Things Considered and provided content for various print, television, and Internet outlets.
New York’s ambitious agenda seeks to end the HIV epidemic
Not every day does an elected politician turn public health hero, but that happened when New York Governor Andrew Cuomo on June 29 announced an ambitious plan to identify all New York state residents who are infected with HIV, and start them on effective treatment. The goal is that by 2020 the number of HIV patients in New York will finally start to drop, and the HIV epidemic will end, at least in New York.
The program was announced in a press release and by Mr. Cuomo before the start of the annual New York City Gay Pride March on June 29. The three-point program is dubbed Bending the Curve, an epidemiologic and public health concept of HIV that has kicked around the infectious diseases community for several years. The idea is that with today’s highly active antiretroviral therapy – with high efficacy for controlling viral load, low toxicity, and a low daily pill count – the amount of HIV circulating in infected patients can be maintained at undetectable levels, rendering the patient noninfectious.
I heard the National Institutes of Health’s Dr. Anthony Fauci, longtime leader of federally funded U.S. efforts to control HIV, present this concept at a meeting a year ago, but at the time, this great idea was just that, a concept not yet being attempted in real life.
New York’s move makes it the first U.S. jurisdiction to adopt early, aggressive treatment as a public health mandate, serving as a tryout for a highly sensible hypothesis.
Speaking to the New York Times on June 26, when word of the New York initiative first came out, Dr. Fauci commented that it would serve as a national model, and that "if you aggressively seek out people who are infected, [and] get them into voluntary testing, care, and treatment, the mathematical model shows a sharp deflection in the curve of people ultimately getting the infection. Ultimately, you can end the pandemic."
The New York program aims to do this with an aggressive program of testing and treatment paid for by the state, which has worked out a deal with a trio of drug companies to buy state-of-the-art HIV drugs at a reduced price. The program also calls for more extensive promotion of and state payment for pre-exposure prophylaxis treatment. The governor’s statement did not put a price tag on what this will cost New York, but it emphasized that substantial cost savings will result from cutting new HIV infections.
As the Times’ coverage highlighted, the program is no slam dunk. It’s a great idea that will surely encounter logistic issues. But it received praise and support from leaders of several constituency groups, a key factor that should help it succeed. For example, the statement announcing the program quoted Benjamin Bashein, acting executive director of the AIDS Community Research Initiative of America, as saying, "ACRIA applauds Governor Cuomo for his bold plan to end AIDS in New York state. We now have the knowledge and the means to dramatically reduce new infections and promote optimal health for those with HIV. Governor Cuomo’s leadership will make New York a model for ending AIDS across the country and around the globe."
On Twitter @mitchelzoler
Not every day does an elected politician turn public health hero, but that happened when New York Governor Andrew Cuomo on June 29 announced an ambitious plan to identify all New York state residents who are infected with HIV, and start them on effective treatment. The goal is that by 2020 the number of HIV patients in New York will finally start to drop, and the HIV epidemic will end, at least in New York.
The program was announced in a press release and by Mr. Cuomo before the start of the annual New York City Gay Pride March on June 29. The three-point program is dubbed Bending the Curve, an epidemiologic and public health concept of HIV that has kicked around the infectious diseases community for several years. The idea is that with today’s highly active antiretroviral therapy – with high efficacy for controlling viral load, low toxicity, and a low daily pill count – the amount of HIV circulating in infected patients can be maintained at undetectable levels, rendering the patient noninfectious.
I heard the National Institutes of Health’s Dr. Anthony Fauci, longtime leader of federally funded U.S. efforts to control HIV, present this concept at a meeting a year ago, but at the time, this great idea was just that, a concept not yet being attempted in real life.
New York’s move makes it the first U.S. jurisdiction to adopt early, aggressive treatment as a public health mandate, serving as a tryout for a highly sensible hypothesis.
Speaking to the New York Times on June 26, when word of the New York initiative first came out, Dr. Fauci commented that it would serve as a national model, and that "if you aggressively seek out people who are infected, [and] get them into voluntary testing, care, and treatment, the mathematical model shows a sharp deflection in the curve of people ultimately getting the infection. Ultimately, you can end the pandemic."
The New York program aims to do this with an aggressive program of testing and treatment paid for by the state, which has worked out a deal with a trio of drug companies to buy state-of-the-art HIV drugs at a reduced price. The program also calls for more extensive promotion of and state payment for pre-exposure prophylaxis treatment. The governor’s statement did not put a price tag on what this will cost New York, but it emphasized that substantial cost savings will result from cutting new HIV infections.
As the Times’ coverage highlighted, the program is no slam dunk. It’s a great idea that will surely encounter logistic issues. But it received praise and support from leaders of several constituency groups, a key factor that should help it succeed. For example, the statement announcing the program quoted Benjamin Bashein, acting executive director of the AIDS Community Research Initiative of America, as saying, "ACRIA applauds Governor Cuomo for his bold plan to end AIDS in New York state. We now have the knowledge and the means to dramatically reduce new infections and promote optimal health for those with HIV. Governor Cuomo’s leadership will make New York a model for ending AIDS across the country and around the globe."
On Twitter @mitchelzoler
Not every day does an elected politician turn public health hero, but that happened when New York Governor Andrew Cuomo on June 29 announced an ambitious plan to identify all New York state residents who are infected with HIV, and start them on effective treatment. The goal is that by 2020 the number of HIV patients in New York will finally start to drop, and the HIV epidemic will end, at least in New York.
The program was announced in a press release and by Mr. Cuomo before the start of the annual New York City Gay Pride March on June 29. The three-point program is dubbed Bending the Curve, an epidemiologic and public health concept of HIV that has kicked around the infectious diseases community for several years. The idea is that with today’s highly active antiretroviral therapy – with high efficacy for controlling viral load, low toxicity, and a low daily pill count – the amount of HIV circulating in infected patients can be maintained at undetectable levels, rendering the patient noninfectious.
I heard the National Institutes of Health’s Dr. Anthony Fauci, longtime leader of federally funded U.S. efforts to control HIV, present this concept at a meeting a year ago, but at the time, this great idea was just that, a concept not yet being attempted in real life.
New York’s move makes it the first U.S. jurisdiction to adopt early, aggressive treatment as a public health mandate, serving as a tryout for a highly sensible hypothesis.
Speaking to the New York Times on June 26, when word of the New York initiative first came out, Dr. Fauci commented that it would serve as a national model, and that "if you aggressively seek out people who are infected, [and] get them into voluntary testing, care, and treatment, the mathematical model shows a sharp deflection in the curve of people ultimately getting the infection. Ultimately, you can end the pandemic."
The New York program aims to do this with an aggressive program of testing and treatment paid for by the state, which has worked out a deal with a trio of drug companies to buy state-of-the-art HIV drugs at a reduced price. The program also calls for more extensive promotion of and state payment for pre-exposure prophylaxis treatment. The governor’s statement did not put a price tag on what this will cost New York, but it emphasized that substantial cost savings will result from cutting new HIV infections.
As the Times’ coverage highlighted, the program is no slam dunk. It’s a great idea that will surely encounter logistic issues. But it received praise and support from leaders of several constituency groups, a key factor that should help it succeed. For example, the statement announcing the program quoted Benjamin Bashein, acting executive director of the AIDS Community Research Initiative of America, as saying, "ACRIA applauds Governor Cuomo for his bold plan to end AIDS in New York state. We now have the knowledge and the means to dramatically reduce new infections and promote optimal health for those with HIV. Governor Cuomo’s leadership will make New York a model for ending AIDS across the country and around the globe."
On Twitter @mitchelzoler
The give and take on explaining drug side effects
"What are the side effects?" How many times a day do you get asked that? Plenty, I’m sure. I certainly hear it.
The list of side effects (small print on the product insert) is enormous. No one can possibly cover them in the few minutes we have during a visit, so I just try to hit the ones that are most likely and those that are most serious.
Of course, most patients still go home and look them up. The majority of patients are fine with it, but some immediately develop every side effect imaginable through the power of suggestion. While I’m all for "empowered patients," the Internet is full of both useful and insanely inaccurate information. It’s often hard to tell them apart.
I still get asked for drugs "without any side effects" and try to explain that there is no such thing and never will be. The vagaries of human biochemistry are such that everyone will have a negative reaction to something sooner or later. And it generally can’t be predicted in advance.
I try to reassure people that just because a drug can cause an adverse reaction doesn’t mean that it will. I explain how most side effects were reported in a minority of patients, go over how the data are collected during trials, and so on. Most people are reasonable and understand that there’s a benefit-to-risk calculation we’re making, like anything else.
But some patients are quite adamant that as long as there’s even the slightest chance of them having a side effect, they don’t want to take it. They want help, but won’t let me help them. Those appointments are frustrating and make me wonder why the patient bothered to come in at all. They’re the reason I keep a wand next to my desk.
There is no shortage of treatments for at least some of the many conditions that neurologists treat, but at the same time there is always the chance that side effects will occur. Medicine, like everything else in life, has benefits and risks.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
"What are the side effects?" How many times a day do you get asked that? Plenty, I’m sure. I certainly hear it.
The list of side effects (small print on the product insert) is enormous. No one can possibly cover them in the few minutes we have during a visit, so I just try to hit the ones that are most likely and those that are most serious.
Of course, most patients still go home and look them up. The majority of patients are fine with it, but some immediately develop every side effect imaginable through the power of suggestion. While I’m all for "empowered patients," the Internet is full of both useful and insanely inaccurate information. It’s often hard to tell them apart.
I still get asked for drugs "without any side effects" and try to explain that there is no such thing and never will be. The vagaries of human biochemistry are such that everyone will have a negative reaction to something sooner or later. And it generally can’t be predicted in advance.
I try to reassure people that just because a drug can cause an adverse reaction doesn’t mean that it will. I explain how most side effects were reported in a minority of patients, go over how the data are collected during trials, and so on. Most people are reasonable and understand that there’s a benefit-to-risk calculation we’re making, like anything else.
But some patients are quite adamant that as long as there’s even the slightest chance of them having a side effect, they don’t want to take it. They want help, but won’t let me help them. Those appointments are frustrating and make me wonder why the patient bothered to come in at all. They’re the reason I keep a wand next to my desk.
There is no shortage of treatments for at least some of the many conditions that neurologists treat, but at the same time there is always the chance that side effects will occur. Medicine, like everything else in life, has benefits and risks.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
"What are the side effects?" How many times a day do you get asked that? Plenty, I’m sure. I certainly hear it.
The list of side effects (small print on the product insert) is enormous. No one can possibly cover them in the few minutes we have during a visit, so I just try to hit the ones that are most likely and those that are most serious.
Of course, most patients still go home and look them up. The majority of patients are fine with it, but some immediately develop every side effect imaginable through the power of suggestion. While I’m all for "empowered patients," the Internet is full of both useful and insanely inaccurate information. It’s often hard to tell them apart.
I still get asked for drugs "without any side effects" and try to explain that there is no such thing and never will be. The vagaries of human biochemistry are such that everyone will have a negative reaction to something sooner or later. And it generally can’t be predicted in advance.
I try to reassure people that just because a drug can cause an adverse reaction doesn’t mean that it will. I explain how most side effects were reported in a minority of patients, go over how the data are collected during trials, and so on. Most people are reasonable and understand that there’s a benefit-to-risk calculation we’re making, like anything else.
But some patients are quite adamant that as long as there’s even the slightest chance of them having a side effect, they don’t want to take it. They want help, but won’t let me help them. Those appointments are frustrating and make me wonder why the patient bothered to come in at all. They’re the reason I keep a wand next to my desk.
There is no shortage of treatments for at least some of the many conditions that neurologists treat, but at the same time there is always the chance that side effects will occur. Medicine, like everything else in life, has benefits and risks.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
