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Mental health care is ‘Code Black’
The initial explanation for why the teenager needed to be admitted seemed very flimsy to me. Finally, the office pediatrician came clean. The girl is an honor roll student, high achieving but currently overwhelmed by events in her life. She cannot handle being at home, but there is nowhere else for her to go for the weekend. Come Monday morning, the primary care physician (PCP) has arranged for her acceptance into a local mental health facility where she could get the care she needs. The prognosis was excellent. Her entire future could be markedly improved with just a little help getting through these current troubles. I thought about the patient down the hall. My partner had admitted her 2 days ago for acute-on-chronic abdominal pain, shortly after her third normal CT scan in 6 months. I strongly doubted that that patient had any more business being in a hospital than this latest admission – except, of course, for all the profit the hospital was making on the imaging. On reflection, I decided the PCP’s request no longer seemed so out of place.
The latest emergency department drama on TV has a tagline, “In the ER when there are more patients than resources, it’s called Code Black.” It contains scenes of mopping up bloody floors in the trauma bay. I’ve worked in an ED that was a major portal into a nearby pediatric mental health facility. The major traumas I cared for didn’t bleed from their life-threatening emotional wounds. Multiple times per week, children from across the city were brought in for evaluation. A few needed a toxicology work-up for ingestions. A few more needed some glue or sutures for very superficial self-inflicted forearm lacerations. Mostly I provided a medical screening before getting those teenagers moved as quickly as possible to a team of specialists who could help them. In some parts of this country that can take days.
On Oct. 5, 2015, California’s governor signed a state law permitting physician-assisted suicide. It is now the fifth state allowing that option. The pros and cons have been endlessly debated by ethicists. A brief Google search can find the philosophical arguments. I recommend a June 22, 2015, New Yorker article entitled, “The Death Treatment” by Rachel Aviv to provide a broad narrative perspective. Oregon’s Death With Dignity Act was passed 20 years ago, so it provides some scientific data. There are now 100 deaths per year under that Oregon act. The state also has 700 suicides yearly. So the leading method of suicide in Oregon, by a wide margin, continues to be used by people who are not terminally ill. That was the method of choice recently for my cousin. There was nothing dignified about it. My favorite actor, Robin Williams, in the movie “World’s Greatest Dad,” had the line, “If you’re that depressed, reach out to someone, and remember suicide is a permanent solution to temporary problems.” Five years later he took his own life.
I do enjoy debating the nuances of physician-assisted suicide with other ethicists, but I don’t confuse those academic exercises with addressing the real world problem of endemic suicide. Nationwide, there are 41,000 suicides each year, with about 5,000 in the 15- to 24-year age group. In comparison, 10,000 children annually will get cancer, but only 1,250 children will die of it. There will be about 900 pediatric recipients of lifesaving heart or liver transplants. With all this wealth, knowledge, and technology, the United States should be able to provide better treatment of mental illness. Parity of mental health services became law under President Clinton in 1996, repeated as law under President Bush in 2008, and affirmed again under President Obama. But those political promises have yet to bear fruit in real life. The system remains overloaded. For the sake of the children and young adults, pediatricians must promote expansion of mental health services.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Dr. Powell said he had no relevant financial disclosures or conflicts of interest.
The initial explanation for why the teenager needed to be admitted seemed very flimsy to me. Finally, the office pediatrician came clean. The girl is an honor roll student, high achieving but currently overwhelmed by events in her life. She cannot handle being at home, but there is nowhere else for her to go for the weekend. Come Monday morning, the primary care physician (PCP) has arranged for her acceptance into a local mental health facility where she could get the care she needs. The prognosis was excellent. Her entire future could be markedly improved with just a little help getting through these current troubles. I thought about the patient down the hall. My partner had admitted her 2 days ago for acute-on-chronic abdominal pain, shortly after her third normal CT scan in 6 months. I strongly doubted that that patient had any more business being in a hospital than this latest admission – except, of course, for all the profit the hospital was making on the imaging. On reflection, I decided the PCP’s request no longer seemed so out of place.
The latest emergency department drama on TV has a tagline, “In the ER when there are more patients than resources, it’s called Code Black.” It contains scenes of mopping up bloody floors in the trauma bay. I’ve worked in an ED that was a major portal into a nearby pediatric mental health facility. The major traumas I cared for didn’t bleed from their life-threatening emotional wounds. Multiple times per week, children from across the city were brought in for evaluation. A few needed a toxicology work-up for ingestions. A few more needed some glue or sutures for very superficial self-inflicted forearm lacerations. Mostly I provided a medical screening before getting those teenagers moved as quickly as possible to a team of specialists who could help them. In some parts of this country that can take days.
On Oct. 5, 2015, California’s governor signed a state law permitting physician-assisted suicide. It is now the fifth state allowing that option. The pros and cons have been endlessly debated by ethicists. A brief Google search can find the philosophical arguments. I recommend a June 22, 2015, New Yorker article entitled, “The Death Treatment” by Rachel Aviv to provide a broad narrative perspective. Oregon’s Death With Dignity Act was passed 20 years ago, so it provides some scientific data. There are now 100 deaths per year under that Oregon act. The state also has 700 suicides yearly. So the leading method of suicide in Oregon, by a wide margin, continues to be used by people who are not terminally ill. That was the method of choice recently for my cousin. There was nothing dignified about it. My favorite actor, Robin Williams, in the movie “World’s Greatest Dad,” had the line, “If you’re that depressed, reach out to someone, and remember suicide is a permanent solution to temporary problems.” Five years later he took his own life.
I do enjoy debating the nuances of physician-assisted suicide with other ethicists, but I don’t confuse those academic exercises with addressing the real world problem of endemic suicide. Nationwide, there are 41,000 suicides each year, with about 5,000 in the 15- to 24-year age group. In comparison, 10,000 children annually will get cancer, but only 1,250 children will die of it. There will be about 900 pediatric recipients of lifesaving heart or liver transplants. With all this wealth, knowledge, and technology, the United States should be able to provide better treatment of mental illness. Parity of mental health services became law under President Clinton in 1996, repeated as law under President Bush in 2008, and affirmed again under President Obama. But those political promises have yet to bear fruit in real life. The system remains overloaded. For the sake of the children and young adults, pediatricians must promote expansion of mental health services.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Dr. Powell said he had no relevant financial disclosures or conflicts of interest.
The initial explanation for why the teenager needed to be admitted seemed very flimsy to me. Finally, the office pediatrician came clean. The girl is an honor roll student, high achieving but currently overwhelmed by events in her life. She cannot handle being at home, but there is nowhere else for her to go for the weekend. Come Monday morning, the primary care physician (PCP) has arranged for her acceptance into a local mental health facility where she could get the care she needs. The prognosis was excellent. Her entire future could be markedly improved with just a little help getting through these current troubles. I thought about the patient down the hall. My partner had admitted her 2 days ago for acute-on-chronic abdominal pain, shortly after her third normal CT scan in 6 months. I strongly doubted that that patient had any more business being in a hospital than this latest admission – except, of course, for all the profit the hospital was making on the imaging. On reflection, I decided the PCP’s request no longer seemed so out of place.
The latest emergency department drama on TV has a tagline, “In the ER when there are more patients than resources, it’s called Code Black.” It contains scenes of mopping up bloody floors in the trauma bay. I’ve worked in an ED that was a major portal into a nearby pediatric mental health facility. The major traumas I cared for didn’t bleed from their life-threatening emotional wounds. Multiple times per week, children from across the city were brought in for evaluation. A few needed a toxicology work-up for ingestions. A few more needed some glue or sutures for very superficial self-inflicted forearm lacerations. Mostly I provided a medical screening before getting those teenagers moved as quickly as possible to a team of specialists who could help them. In some parts of this country that can take days.
On Oct. 5, 2015, California’s governor signed a state law permitting physician-assisted suicide. It is now the fifth state allowing that option. The pros and cons have been endlessly debated by ethicists. A brief Google search can find the philosophical arguments. I recommend a June 22, 2015, New Yorker article entitled, “The Death Treatment” by Rachel Aviv to provide a broad narrative perspective. Oregon’s Death With Dignity Act was passed 20 years ago, so it provides some scientific data. There are now 100 deaths per year under that Oregon act. The state also has 700 suicides yearly. So the leading method of suicide in Oregon, by a wide margin, continues to be used by people who are not terminally ill. That was the method of choice recently for my cousin. There was nothing dignified about it. My favorite actor, Robin Williams, in the movie “World’s Greatest Dad,” had the line, “If you’re that depressed, reach out to someone, and remember suicide is a permanent solution to temporary problems.” Five years later he took his own life.
I do enjoy debating the nuances of physician-assisted suicide with other ethicists, but I don’t confuse those academic exercises with addressing the real world problem of endemic suicide. Nationwide, there are 41,000 suicides each year, with about 5,000 in the 15- to 24-year age group. In comparison, 10,000 children annually will get cancer, but only 1,250 children will die of it. There will be about 900 pediatric recipients of lifesaving heart or liver transplants. With all this wealth, knowledge, and technology, the United States should be able to provide better treatment of mental illness. Parity of mental health services became law under President Clinton in 1996, repeated as law under President Bush in 2008, and affirmed again under President Obama. But those political promises have yet to bear fruit in real life. The system remains overloaded. For the sake of the children and young adults, pediatricians must promote expansion of mental health services.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Dr. Powell said he had no relevant financial disclosures or conflicts of interest.
The modern physician-communicator
Forty years ago, the revered physician was a walking textbook able to recall vast amounts of information. Things have changed. A photographic memory is less valuable since Google was created. Medical knowledge has a much shorter shelf life. Specialization has become increasingly fragmented. The orthopedic surgeon who replaced my hip 5 years ago would not see me for a shoulder problem. He only does hips and knees. Ingrown toenails are referred to a podiatrist. Now the ideal physician is a team player able to communicate well with many other physicians and allied health care providers so that the patches of individual expertise combine to create a quilt that covers the patient’s needs. Poor communicators are like odd-shaped and frayed pieces of fabric that are hard to fit into the quilt.
Medical errors were identified by the Institute of Medicine (IOM) in 1999 as a major cause of preventable deaths. What has become clear in research since then is that most of these errors are not caused by deficits in knowledge or to carelessness. They are partly because of communication skills and because of attitudes that impede collaborative comanagement. Errors are mostly systemic problems and should be addressed in that paradigm.
Since that first IOM report, several other areas have been identified as major causes of preventable deaths in hospitals. These problems include nosocomial infections, antibiotic stewardship, medication list reconciliation, overdiagnosis, and the handoff of care at discharge (N Engl J Med. 2014 Nov 6;371[19]:1803-12). The lack of a cure for Ebola is a minor problem, compared with these weaknesses in the hospital care system. Too much futile care and the delay of palliative care also are frequent problems, more so with adults than pediatrics. Pediatric hospitalists have been more focused on value (Pediatrics 2015 Aug 1. [doi: 10.1542/peds.2015-1549A]).
Most of these issues were never discussed in the pathophysiology courses of medical school. They are outside the biological sciences. As a result, it has become a major part of graduate Continuing Medical Education. The schedule for the recent Pediatric Hospital Medicine 2015 conference reflects this. The 830 attendees could choose from 12 simultaneous breakout sessions, but typically only 3 or 4 were primarily about clinical medicine. Quality improvement, education, research, and practice management made up the lion’s share of the topics.
This emphasis on systems is the core of hospital medicine. It isn’t about knowing which antibiotic is best for a given patient with a particular pneumonia because usually we don’t know the organism. It is about saying, “We will admit 300 patients with pneumonia to this hospital this year. What are best practices?” In pediatrics, many pneumonias will be viral. The vast majority of bacterial pneumonia will be pneumococcal. Staphylococcus aureus is involved in less than 1% and most of those cases present differently. So what criteria do we use to determine who gets narrow-spectrum antibiotics, who gets broad spectrum, who gets mycoplasma coverage, and who gets supportive care without unnecessary antibiotics? Practice guidelines for the provision of oxygen, intravenous fluids, and the use of continuous pulse oximetry monitoring each were covered in other presentations at the 2015 pediatric hospitalist meeting. More importantly, as Dr. Brian K. Alverson, director, division of pediatric hospital medicine, Hasbro Children’s Hospital in Providence, R.I., explained, guidelines are meant to cover only 95% of patients. It is the job of the patient’s physician to decide whether that patient fits into the 95% or is one of the 5% who need customized, less evidence-based plans of care. Perhaps most importantly, the guidelines themselves are undergoing continuous quality improvement. The Infectious Diseases Society of American (IDSA) guidelines for pediatric community-acquired pneumonia were published just 4 years ago, but already have recommendations that are refuted by more recent research.
Author Robert Fulghum is right. Most of the lessons I learned in kindergarten are still applicable. Medical school – not so much.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@frontlinemedcom.com. Dr. Powell said he had no relevant financial disclosures.
Forty years ago, the revered physician was a walking textbook able to recall vast amounts of information. Things have changed. A photographic memory is less valuable since Google was created. Medical knowledge has a much shorter shelf life. Specialization has become increasingly fragmented. The orthopedic surgeon who replaced my hip 5 years ago would not see me for a shoulder problem. He only does hips and knees. Ingrown toenails are referred to a podiatrist. Now the ideal physician is a team player able to communicate well with many other physicians and allied health care providers so that the patches of individual expertise combine to create a quilt that covers the patient’s needs. Poor communicators are like odd-shaped and frayed pieces of fabric that are hard to fit into the quilt.
Medical errors were identified by the Institute of Medicine (IOM) in 1999 as a major cause of preventable deaths. What has become clear in research since then is that most of these errors are not caused by deficits in knowledge or to carelessness. They are partly because of communication skills and because of attitudes that impede collaborative comanagement. Errors are mostly systemic problems and should be addressed in that paradigm.
Since that first IOM report, several other areas have been identified as major causes of preventable deaths in hospitals. These problems include nosocomial infections, antibiotic stewardship, medication list reconciliation, overdiagnosis, and the handoff of care at discharge (N Engl J Med. 2014 Nov 6;371[19]:1803-12). The lack of a cure for Ebola is a minor problem, compared with these weaknesses in the hospital care system. Too much futile care and the delay of palliative care also are frequent problems, more so with adults than pediatrics. Pediatric hospitalists have been more focused on value (Pediatrics 2015 Aug 1. [doi: 10.1542/peds.2015-1549A]).
Most of these issues were never discussed in the pathophysiology courses of medical school. They are outside the biological sciences. As a result, it has become a major part of graduate Continuing Medical Education. The schedule for the recent Pediatric Hospital Medicine 2015 conference reflects this. The 830 attendees could choose from 12 simultaneous breakout sessions, but typically only 3 or 4 were primarily about clinical medicine. Quality improvement, education, research, and practice management made up the lion’s share of the topics.
This emphasis on systems is the core of hospital medicine. It isn’t about knowing which antibiotic is best for a given patient with a particular pneumonia because usually we don’t know the organism. It is about saying, “We will admit 300 patients with pneumonia to this hospital this year. What are best practices?” In pediatrics, many pneumonias will be viral. The vast majority of bacterial pneumonia will be pneumococcal. Staphylococcus aureus is involved in less than 1% and most of those cases present differently. So what criteria do we use to determine who gets narrow-spectrum antibiotics, who gets broad spectrum, who gets mycoplasma coverage, and who gets supportive care without unnecessary antibiotics? Practice guidelines for the provision of oxygen, intravenous fluids, and the use of continuous pulse oximetry monitoring each were covered in other presentations at the 2015 pediatric hospitalist meeting. More importantly, as Dr. Brian K. Alverson, director, division of pediatric hospital medicine, Hasbro Children’s Hospital in Providence, R.I., explained, guidelines are meant to cover only 95% of patients. It is the job of the patient’s physician to decide whether that patient fits into the 95% or is one of the 5% who need customized, less evidence-based plans of care. Perhaps most importantly, the guidelines themselves are undergoing continuous quality improvement. The Infectious Diseases Society of American (IDSA) guidelines for pediatric community-acquired pneumonia were published just 4 years ago, but already have recommendations that are refuted by more recent research.
Author Robert Fulghum is right. Most of the lessons I learned in kindergarten are still applicable. Medical school – not so much.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@frontlinemedcom.com. Dr. Powell said he had no relevant financial disclosures.
Forty years ago, the revered physician was a walking textbook able to recall vast amounts of information. Things have changed. A photographic memory is less valuable since Google was created. Medical knowledge has a much shorter shelf life. Specialization has become increasingly fragmented. The orthopedic surgeon who replaced my hip 5 years ago would not see me for a shoulder problem. He only does hips and knees. Ingrown toenails are referred to a podiatrist. Now the ideal physician is a team player able to communicate well with many other physicians and allied health care providers so that the patches of individual expertise combine to create a quilt that covers the patient’s needs. Poor communicators are like odd-shaped and frayed pieces of fabric that are hard to fit into the quilt.
Medical errors were identified by the Institute of Medicine (IOM) in 1999 as a major cause of preventable deaths. What has become clear in research since then is that most of these errors are not caused by deficits in knowledge or to carelessness. They are partly because of communication skills and because of attitudes that impede collaborative comanagement. Errors are mostly systemic problems and should be addressed in that paradigm.
Since that first IOM report, several other areas have been identified as major causes of preventable deaths in hospitals. These problems include nosocomial infections, antibiotic stewardship, medication list reconciliation, overdiagnosis, and the handoff of care at discharge (N Engl J Med. 2014 Nov 6;371[19]:1803-12). The lack of a cure for Ebola is a minor problem, compared with these weaknesses in the hospital care system. Too much futile care and the delay of palliative care also are frequent problems, more so with adults than pediatrics. Pediatric hospitalists have been more focused on value (Pediatrics 2015 Aug 1. [doi: 10.1542/peds.2015-1549A]).
Most of these issues were never discussed in the pathophysiology courses of medical school. They are outside the biological sciences. As a result, it has become a major part of graduate Continuing Medical Education. The schedule for the recent Pediatric Hospital Medicine 2015 conference reflects this. The 830 attendees could choose from 12 simultaneous breakout sessions, but typically only 3 or 4 were primarily about clinical medicine. Quality improvement, education, research, and practice management made up the lion’s share of the topics.
This emphasis on systems is the core of hospital medicine. It isn’t about knowing which antibiotic is best for a given patient with a particular pneumonia because usually we don’t know the organism. It is about saying, “We will admit 300 patients with pneumonia to this hospital this year. What are best practices?” In pediatrics, many pneumonias will be viral. The vast majority of bacterial pneumonia will be pneumococcal. Staphylococcus aureus is involved in less than 1% and most of those cases present differently. So what criteria do we use to determine who gets narrow-spectrum antibiotics, who gets broad spectrum, who gets mycoplasma coverage, and who gets supportive care without unnecessary antibiotics? Practice guidelines for the provision of oxygen, intravenous fluids, and the use of continuous pulse oximetry monitoring each were covered in other presentations at the 2015 pediatric hospitalist meeting. More importantly, as Dr. Brian K. Alverson, director, division of pediatric hospital medicine, Hasbro Children’s Hospital in Providence, R.I., explained, guidelines are meant to cover only 95% of patients. It is the job of the patient’s physician to decide whether that patient fits into the 95% or is one of the 5% who need customized, less evidence-based plans of care. Perhaps most importantly, the guidelines themselves are undergoing continuous quality improvement. The Infectious Diseases Society of American (IDSA) guidelines for pediatric community-acquired pneumonia were published just 4 years ago, but already have recommendations that are refuted by more recent research.
Author Robert Fulghum is right. Most of the lessons I learned in kindergarten are still applicable. Medical school – not so much.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@frontlinemedcom.com. Dr. Powell said he had no relevant financial disclosures.
Perfect is the enemy of good
Urban legends never seem to die. They haunt those who chase the truth because most legends have a kernel of truth. Reflux nephropathy is one of those legends.
In the 1970s, neurosurgeons began treating children with spina bifida rather than allowing them to die shortly after birth. As these children entered their second and third decade of life, episodes of renal failure were noted. The reflux and recurring urinary tract infections (UTIs) from neurogenic bladders damaged kidneys. Self-catheter programs were invented and were effective. Surgical correction of anatomic urinary obstructions and severe reflux yielded similar benefits. By the 1990s, this paradigm had been extrapolated to all children with vesicoureteral reflux (VUR) and codified in the 1999 practice parameter. The unproven hope was that aggressive antibiotic prophylaxis to protect young, growing kidneys from infections would reduce the incidence of renal failure and hypertension in adults.
This is a common methodology for quality improvement at a Mortality and Morbidity conference. A problem is identified. A solution is developed to prevent the bad outcome. The solution is implemented without fully proving that the obvious, customized intervention truly works. No one ever assesses whether the remedy causes more mischief than benefit.
VUR has a pyramid shaped spectrum. Few children have the severe grade V reflux which responds to surgical intervention. At the base of the pyramid are a much larger group of children with mild reflux that usually resolves spontaneously by age 5 years. This pyramid is a setup for overdiagnosis and overtreatment of mild disease. Pediatricians soon recognized that the small portion of the 1999 practice parameter addressing reflux nephropathy was overly aggressive and based on unsound science. However, that same lack of clear evidence delayed creating a new consensus until 2011.
The recent efforts to prove the benefit of prophylaxis used exemplary evidence-based medicine. The RIVUR study over 4 years assessed 10,000 children in a multicenter study involving 19 locations. It enrolled 600 children in a prospective, double-blind, randomized, controlled trial with a placebo control. It followed the children for 2 years. Even by modern standards, this was a huge, prolonged and well-designed trial. It did demonstrate a benefit. About 20% of children on placebo had a recurrent UTI in that 2-year time frame. There was a 50% reduction in the number of UTIs in the children treated with antibiotic prophylaxis. Phrased that way, it was a success. But the numbers can be spun differently. The article duly noted a number needed to treat of eight. Eight children treated for 2 years at 365 days per year and one dose per day, means that 6,000 doses of antibiotics were necessary to prevent one UTI. There was no demonstrated benefit in renal scarring, renal failure, or other long-term outcomes. There was a downside. The rate of antibiotic-resistant organisms in the breakthrough UTIs tripled from 19% of the placebo group to 63% of the prophylaxis group. As large as this study was, it wasn’t able to measure the rate of other known adverse outcomes, such as Stevens-Johnson syndrome from the use of sulfa medications or the impact on resistant infections elsewhere in the body.
With the 2011 practice parameter, pediatricians became less aggressive at working up first UTIs. Urologists disagreed. The May 2015 issue of AAP News had a full page article by Dr. Saul Greenfield, who is the chairperson-elect for the Executive Committee of the American Academy of Pediatrics Section on Urology, a urologist in Buffalo, N.Y., and one of the RIVUR trial’s investigators (AAP News 2015;36:13). He rehashed the RIVUR study results emphasizing the reduction in UTIs, but offered no quantitative assessment of the risks, costs, and harms of prophylaxis.
A June 2015 article in Pediatrics gives the results of the CUTIE study, which ran in parallel with the RIVUR study (Pediatrics 2015 [doi:10.1542/peds.2015-0409]). The conclusions: “VUR and BBD [bladder and bowel dysfunction] are risk factors for recurrent UTI, especially when they appear in combination. Strategies for preventing recurrent UTI include antimicrobial prophylaxis and treatment of BBD.”
The article concludes with, “Therefore, clinicians must help families decide whether the benefits of prophylaxis outweigh the risks and inconvenience. … Additional research is needed to validate the risk factors and profiles that we identified.”
But six pages of discussing renal scarring (which is only a proxy for a small risk of future renal failure or hypertension), followed by a couple paragraphs, without numbers, about the risks of prophylaxis, does not provide the balanced presentation clinicians need to help families make wise decisions. In the new era of Choosing Wisely, scientific articles making clinical recommendations should not be published without an accompanying risk-benefit analysis, either in the article or in an editorial. The maxim in surgery, channeling Voltaire, is that “perfect is the enemy of good.”
There is mounting evidence that giving any antibiotics to young infants is harmful. Even 2 days of antibiotics before 1 month of age leads to measurable changes in the gut microbiota 6 months later. Antibiotics in infancy are associated with obesity at 24 months and at 48 months of age. All medical treatments introduce a substantial risk of harm. As Shakespeare wrote 400 years ago, “Striving to better, oft we mar what’s well.” I don’t doubt the conclusion that prophylaxis reduces UTIs, but giving 6,000 doses to prevent one UTI?! Even Kaley Cuoco can’t sell that.
Ultimately, this choice is not up to the hospitalist, the emergency department doctor, or the urologist. The decision belongs to the parents guided by a primary care doctor they trust. Our professional duty, ethically and legally, is to communicate the risks and benefits to the parents in a manner which they can understand and to provide them the support and counseling necessary to make a wise choice for their child. By focusing on the child and that duty, medical professionals can defuse any clashes of egos, departmental power struggles, or autocratic hierarchy that might interfere. Doctors educate and recommend, but the parent decides what is best for his or her child.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Dr. Powell said he had no relevant financial disclosures or conflicts of interest. E-mail him at pdnews@frontlinemedcom.com.
Urban legends never seem to die. They haunt those who chase the truth because most legends have a kernel of truth. Reflux nephropathy is one of those legends.
In the 1970s, neurosurgeons began treating children with spina bifida rather than allowing them to die shortly after birth. As these children entered their second and third decade of life, episodes of renal failure were noted. The reflux and recurring urinary tract infections (UTIs) from neurogenic bladders damaged kidneys. Self-catheter programs were invented and were effective. Surgical correction of anatomic urinary obstructions and severe reflux yielded similar benefits. By the 1990s, this paradigm had been extrapolated to all children with vesicoureteral reflux (VUR) and codified in the 1999 practice parameter. The unproven hope was that aggressive antibiotic prophylaxis to protect young, growing kidneys from infections would reduce the incidence of renal failure and hypertension in adults.
This is a common methodology for quality improvement at a Mortality and Morbidity conference. A problem is identified. A solution is developed to prevent the bad outcome. The solution is implemented without fully proving that the obvious, customized intervention truly works. No one ever assesses whether the remedy causes more mischief than benefit.
VUR has a pyramid shaped spectrum. Few children have the severe grade V reflux which responds to surgical intervention. At the base of the pyramid are a much larger group of children with mild reflux that usually resolves spontaneously by age 5 years. This pyramid is a setup for overdiagnosis and overtreatment of mild disease. Pediatricians soon recognized that the small portion of the 1999 practice parameter addressing reflux nephropathy was overly aggressive and based on unsound science. However, that same lack of clear evidence delayed creating a new consensus until 2011.
The recent efforts to prove the benefit of prophylaxis used exemplary evidence-based medicine. The RIVUR study over 4 years assessed 10,000 children in a multicenter study involving 19 locations. It enrolled 600 children in a prospective, double-blind, randomized, controlled trial with a placebo control. It followed the children for 2 years. Even by modern standards, this was a huge, prolonged and well-designed trial. It did demonstrate a benefit. About 20% of children on placebo had a recurrent UTI in that 2-year time frame. There was a 50% reduction in the number of UTIs in the children treated with antibiotic prophylaxis. Phrased that way, it was a success. But the numbers can be spun differently. The article duly noted a number needed to treat of eight. Eight children treated for 2 years at 365 days per year and one dose per day, means that 6,000 doses of antibiotics were necessary to prevent one UTI. There was no demonstrated benefit in renal scarring, renal failure, or other long-term outcomes. There was a downside. The rate of antibiotic-resistant organisms in the breakthrough UTIs tripled from 19% of the placebo group to 63% of the prophylaxis group. As large as this study was, it wasn’t able to measure the rate of other known adverse outcomes, such as Stevens-Johnson syndrome from the use of sulfa medications or the impact on resistant infections elsewhere in the body.
With the 2011 practice parameter, pediatricians became less aggressive at working up first UTIs. Urologists disagreed. The May 2015 issue of AAP News had a full page article by Dr. Saul Greenfield, who is the chairperson-elect for the Executive Committee of the American Academy of Pediatrics Section on Urology, a urologist in Buffalo, N.Y., and one of the RIVUR trial’s investigators (AAP News 2015;36:13). He rehashed the RIVUR study results emphasizing the reduction in UTIs, but offered no quantitative assessment of the risks, costs, and harms of prophylaxis.
A June 2015 article in Pediatrics gives the results of the CUTIE study, which ran in parallel with the RIVUR study (Pediatrics 2015 [doi:10.1542/peds.2015-0409]). The conclusions: “VUR and BBD [bladder and bowel dysfunction] are risk factors for recurrent UTI, especially when they appear in combination. Strategies for preventing recurrent UTI include antimicrobial prophylaxis and treatment of BBD.”
The article concludes with, “Therefore, clinicians must help families decide whether the benefits of prophylaxis outweigh the risks and inconvenience. … Additional research is needed to validate the risk factors and profiles that we identified.”
But six pages of discussing renal scarring (which is only a proxy for a small risk of future renal failure or hypertension), followed by a couple paragraphs, without numbers, about the risks of prophylaxis, does not provide the balanced presentation clinicians need to help families make wise decisions. In the new era of Choosing Wisely, scientific articles making clinical recommendations should not be published without an accompanying risk-benefit analysis, either in the article or in an editorial. The maxim in surgery, channeling Voltaire, is that “perfect is the enemy of good.”
There is mounting evidence that giving any antibiotics to young infants is harmful. Even 2 days of antibiotics before 1 month of age leads to measurable changes in the gut microbiota 6 months later. Antibiotics in infancy are associated with obesity at 24 months and at 48 months of age. All medical treatments introduce a substantial risk of harm. As Shakespeare wrote 400 years ago, “Striving to better, oft we mar what’s well.” I don’t doubt the conclusion that prophylaxis reduces UTIs, but giving 6,000 doses to prevent one UTI?! Even Kaley Cuoco can’t sell that.
Ultimately, this choice is not up to the hospitalist, the emergency department doctor, or the urologist. The decision belongs to the parents guided by a primary care doctor they trust. Our professional duty, ethically and legally, is to communicate the risks and benefits to the parents in a manner which they can understand and to provide them the support and counseling necessary to make a wise choice for their child. By focusing on the child and that duty, medical professionals can defuse any clashes of egos, departmental power struggles, or autocratic hierarchy that might interfere. Doctors educate and recommend, but the parent decides what is best for his or her child.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Dr. Powell said he had no relevant financial disclosures or conflicts of interest. E-mail him at pdnews@frontlinemedcom.com.
Urban legends never seem to die. They haunt those who chase the truth because most legends have a kernel of truth. Reflux nephropathy is one of those legends.
In the 1970s, neurosurgeons began treating children with spina bifida rather than allowing them to die shortly after birth. As these children entered their second and third decade of life, episodes of renal failure were noted. The reflux and recurring urinary tract infections (UTIs) from neurogenic bladders damaged kidneys. Self-catheter programs were invented and were effective. Surgical correction of anatomic urinary obstructions and severe reflux yielded similar benefits. By the 1990s, this paradigm had been extrapolated to all children with vesicoureteral reflux (VUR) and codified in the 1999 practice parameter. The unproven hope was that aggressive antibiotic prophylaxis to protect young, growing kidneys from infections would reduce the incidence of renal failure and hypertension in adults.
This is a common methodology for quality improvement at a Mortality and Morbidity conference. A problem is identified. A solution is developed to prevent the bad outcome. The solution is implemented without fully proving that the obvious, customized intervention truly works. No one ever assesses whether the remedy causes more mischief than benefit.
VUR has a pyramid shaped spectrum. Few children have the severe grade V reflux which responds to surgical intervention. At the base of the pyramid are a much larger group of children with mild reflux that usually resolves spontaneously by age 5 years. This pyramid is a setup for overdiagnosis and overtreatment of mild disease. Pediatricians soon recognized that the small portion of the 1999 practice parameter addressing reflux nephropathy was overly aggressive and based on unsound science. However, that same lack of clear evidence delayed creating a new consensus until 2011.
The recent efforts to prove the benefit of prophylaxis used exemplary evidence-based medicine. The RIVUR study over 4 years assessed 10,000 children in a multicenter study involving 19 locations. It enrolled 600 children in a prospective, double-blind, randomized, controlled trial with a placebo control. It followed the children for 2 years. Even by modern standards, this was a huge, prolonged and well-designed trial. It did demonstrate a benefit. About 20% of children on placebo had a recurrent UTI in that 2-year time frame. There was a 50% reduction in the number of UTIs in the children treated with antibiotic prophylaxis. Phrased that way, it was a success. But the numbers can be spun differently. The article duly noted a number needed to treat of eight. Eight children treated for 2 years at 365 days per year and one dose per day, means that 6,000 doses of antibiotics were necessary to prevent one UTI. There was no demonstrated benefit in renal scarring, renal failure, or other long-term outcomes. There was a downside. The rate of antibiotic-resistant organisms in the breakthrough UTIs tripled from 19% of the placebo group to 63% of the prophylaxis group. As large as this study was, it wasn’t able to measure the rate of other known adverse outcomes, such as Stevens-Johnson syndrome from the use of sulfa medications or the impact on resistant infections elsewhere in the body.
With the 2011 practice parameter, pediatricians became less aggressive at working up first UTIs. Urologists disagreed. The May 2015 issue of AAP News had a full page article by Dr. Saul Greenfield, who is the chairperson-elect for the Executive Committee of the American Academy of Pediatrics Section on Urology, a urologist in Buffalo, N.Y., and one of the RIVUR trial’s investigators (AAP News 2015;36:13). He rehashed the RIVUR study results emphasizing the reduction in UTIs, but offered no quantitative assessment of the risks, costs, and harms of prophylaxis.
A June 2015 article in Pediatrics gives the results of the CUTIE study, which ran in parallel with the RIVUR study (Pediatrics 2015 [doi:10.1542/peds.2015-0409]). The conclusions: “VUR and BBD [bladder and bowel dysfunction] are risk factors for recurrent UTI, especially when they appear in combination. Strategies for preventing recurrent UTI include antimicrobial prophylaxis and treatment of BBD.”
The article concludes with, “Therefore, clinicians must help families decide whether the benefits of prophylaxis outweigh the risks and inconvenience. … Additional research is needed to validate the risk factors and profiles that we identified.”
But six pages of discussing renal scarring (which is only a proxy for a small risk of future renal failure or hypertension), followed by a couple paragraphs, without numbers, about the risks of prophylaxis, does not provide the balanced presentation clinicians need to help families make wise decisions. In the new era of Choosing Wisely, scientific articles making clinical recommendations should not be published without an accompanying risk-benefit analysis, either in the article or in an editorial. The maxim in surgery, channeling Voltaire, is that “perfect is the enemy of good.”
There is mounting evidence that giving any antibiotics to young infants is harmful. Even 2 days of antibiotics before 1 month of age leads to measurable changes in the gut microbiota 6 months later. Antibiotics in infancy are associated with obesity at 24 months and at 48 months of age. All medical treatments introduce a substantial risk of harm. As Shakespeare wrote 400 years ago, “Striving to better, oft we mar what’s well.” I don’t doubt the conclusion that prophylaxis reduces UTIs, but giving 6,000 doses to prevent one UTI?! Even Kaley Cuoco can’t sell that.
Ultimately, this choice is not up to the hospitalist, the emergency department doctor, or the urologist. The decision belongs to the parents guided by a primary care doctor they trust. Our professional duty, ethically and legally, is to communicate the risks and benefits to the parents in a manner which they can understand and to provide them the support and counseling necessary to make a wise choice for their child. By focusing on the child and that duty, medical professionals can defuse any clashes of egos, departmental power struggles, or autocratic hierarchy that might interfere. Doctors educate and recommend, but the parent decides what is best for his or her child.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Dr. Powell said he had no relevant financial disclosures or conflicts of interest. E-mail him at pdnews@frontlinemedcom.com.
Selling the better mousetrap
Despite all the hoopla about Ebola and measles this winter, the most common reason for admitting an infant or young child to the hospital continues to be bronchiolitis. Yet clinical practice guidelines for diagnosing and treating this common infection have not been incorporated into clinical practice.
The use of over-the-counter cold medications to treat upper respiratory infections in young children was shown by meta-analysis in the mid-1990’s to be ineffective, but that use continued until the Food and Drug Administration mandated revisions to packaging in 2008. Antibiotics have been commonly prescribed to treat the ear infections and sinusitis that frequently occur with bronchiolitis. But over the past 20 years, the use of antibiotics has become less prevalent. I date that trend to the work of Dr. Jack Paradise, professor emeritus of pediatrics at the University of Pittsburgh, and Dr. Ellen Wald, now chair of pediatrics at the University of Wisconsin, Madison, in the mid-1990’s. RespiGam was approved in 1996, then supplanted with palivizumab, as a medication to reduce the burden of respiratory syncytial virus disease. In the summer of 2014, an updated analysis of the costs, risks, and benefits of RSV prophylaxis led to new recommendations that curtailed the indications for that treatment (Pediatrics 2014:134;415-20). What do these trends have in common? The time frame.
It is often cited that it takes 17 years for new evidence to be assimilated into clinical practice (J.R. Soc. Med. 2011;104:510-20). An Institute of Medicine report in 2001, “Crossing the Quality Chasm,” emphasized the importance of becoming more efficient at making progress. Those recommendations themselves are now 14 years old, and I’m not expecting a revolution in human behavior within the next 3 years.
In the new clinical practice guideline issued by the American Academy of Pediatrics in November 2014 for the treatment of young children with bronchiolitis, Dr. Shawn L. Ralston and her colleagues assessed various treatment modalities, found many to be ineffective, and recommended discontinuing their routine use (Pediatrics 2014;134:e1474-e1502). Beta-agonists were at the forefront of this. Was the new guideline based on new data? For the most part, no. In my reading, itmostly reiterated the concerns about effectiveness that were expressed at the time of the prior guidelines from 2006, but removed the weasel words. I admire the dedication of this committee to evidence-based medicine. But will this revised clinical practice guideline actually change practice?
The saying is, “Build a better mousetrap and the world will beat a path to your door.” That quote has been attributed (without adequate documentation) to Ralph Waldo Emerson. He was a great poet, but not a scientist.
During the same month that the new bronchiolitis guidelinewas being released, America held some elections. In the post mortem, President Obama said, “There is a tendency sometimes for me to start thinking: As long as I get the policy right, then that’s what should matter.” He elaborated that “one thing that I do need to constantly remind myself and my team of is it’s not enough just to build the better mousetrap. People don’t automatically come beating to your door. We’ve got to sell it; we’ve got to reach out to the other side and where possible, persuade” (The Wall Street Journal, Nov. 10, 2014).
That isn’t poetry, but the President’s idea is probably more accurate than Emerson’s.
The bronchiolitis clinical practice guidelinewas written in a standardized fashion with 14 key action statements and 242 references. That makes for a good evidence-based medicine document, but is not the best sales pitch.
What will it take to translate these new guidelines into practice? One option is to teach new residents the new guidelines and expect dinosaurs such as myself to retire. If the average pediatrician works for about 34 years, then over a period of 17 years, we will have replaced half the miscreants simply by attrition.
A program of reaching out to the other side and persuading them to change is a better option.
In discussions about this topic on a listserv for pediatric hospitalists, I focused on my concerns. We need to clarify the harms associated with therapies such as beta-agonists, deep nasal suctioning, and continuous pulse oximetry. We need to clarify the goals of treatment, which might include a shorter length of stay, patient comfort, meeting parents’ expectations that we will do something, and/or explaining why we are contradicting any previous recommendations made to the parents. We need to mesh these bronchiolitis guidelines with the asthma action plans and medication lists advocated for wheezing children who are 24 months of age. My colleagues pointed out that all of that is just continuing to refine the policy.
Getting the policy right is necessary but insufficient. What we are really missing is a campaign strategy to sell it.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He is also listserv moderator for the American Academy of Pediatrics Section on Hospital Medicine.
Despite all the hoopla about Ebola and measles this winter, the most common reason for admitting an infant or young child to the hospital continues to be bronchiolitis. Yet clinical practice guidelines for diagnosing and treating this common infection have not been incorporated into clinical practice.
The use of over-the-counter cold medications to treat upper respiratory infections in young children was shown by meta-analysis in the mid-1990’s to be ineffective, but that use continued until the Food and Drug Administration mandated revisions to packaging in 2008. Antibiotics have been commonly prescribed to treat the ear infections and sinusitis that frequently occur with bronchiolitis. But over the past 20 years, the use of antibiotics has become less prevalent. I date that trend to the work of Dr. Jack Paradise, professor emeritus of pediatrics at the University of Pittsburgh, and Dr. Ellen Wald, now chair of pediatrics at the University of Wisconsin, Madison, in the mid-1990’s. RespiGam was approved in 1996, then supplanted with palivizumab, as a medication to reduce the burden of respiratory syncytial virus disease. In the summer of 2014, an updated analysis of the costs, risks, and benefits of RSV prophylaxis led to new recommendations that curtailed the indications for that treatment (Pediatrics 2014:134;415-20). What do these trends have in common? The time frame.
It is often cited that it takes 17 years for new evidence to be assimilated into clinical practice (J.R. Soc. Med. 2011;104:510-20). An Institute of Medicine report in 2001, “Crossing the Quality Chasm,” emphasized the importance of becoming more efficient at making progress. Those recommendations themselves are now 14 years old, and I’m not expecting a revolution in human behavior within the next 3 years.
In the new clinical practice guideline issued by the American Academy of Pediatrics in November 2014 for the treatment of young children with bronchiolitis, Dr. Shawn L. Ralston and her colleagues assessed various treatment modalities, found many to be ineffective, and recommended discontinuing their routine use (Pediatrics 2014;134:e1474-e1502). Beta-agonists were at the forefront of this. Was the new guideline based on new data? For the most part, no. In my reading, itmostly reiterated the concerns about effectiveness that were expressed at the time of the prior guidelines from 2006, but removed the weasel words. I admire the dedication of this committee to evidence-based medicine. But will this revised clinical practice guideline actually change practice?
The saying is, “Build a better mousetrap and the world will beat a path to your door.” That quote has been attributed (without adequate documentation) to Ralph Waldo Emerson. He was a great poet, but not a scientist.
During the same month that the new bronchiolitis guidelinewas being released, America held some elections. In the post mortem, President Obama said, “There is a tendency sometimes for me to start thinking: As long as I get the policy right, then that’s what should matter.” He elaborated that “one thing that I do need to constantly remind myself and my team of is it’s not enough just to build the better mousetrap. People don’t automatically come beating to your door. We’ve got to sell it; we’ve got to reach out to the other side and where possible, persuade” (The Wall Street Journal, Nov. 10, 2014).
That isn’t poetry, but the President’s idea is probably more accurate than Emerson’s.
The bronchiolitis clinical practice guidelinewas written in a standardized fashion with 14 key action statements and 242 references. That makes for a good evidence-based medicine document, but is not the best sales pitch.
What will it take to translate these new guidelines into practice? One option is to teach new residents the new guidelines and expect dinosaurs such as myself to retire. If the average pediatrician works for about 34 years, then over a period of 17 years, we will have replaced half the miscreants simply by attrition.
A program of reaching out to the other side and persuading them to change is a better option.
In discussions about this topic on a listserv for pediatric hospitalists, I focused on my concerns. We need to clarify the harms associated with therapies such as beta-agonists, deep nasal suctioning, and continuous pulse oximetry. We need to clarify the goals of treatment, which might include a shorter length of stay, patient comfort, meeting parents’ expectations that we will do something, and/or explaining why we are contradicting any previous recommendations made to the parents. We need to mesh these bronchiolitis guidelines with the asthma action plans and medication lists advocated for wheezing children who are 24 months of age. My colleagues pointed out that all of that is just continuing to refine the policy.
Getting the policy right is necessary but insufficient. What we are really missing is a campaign strategy to sell it.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He is also listserv moderator for the American Academy of Pediatrics Section on Hospital Medicine.
Despite all the hoopla about Ebola and measles this winter, the most common reason for admitting an infant or young child to the hospital continues to be bronchiolitis. Yet clinical practice guidelines for diagnosing and treating this common infection have not been incorporated into clinical practice.
The use of over-the-counter cold medications to treat upper respiratory infections in young children was shown by meta-analysis in the mid-1990’s to be ineffective, but that use continued until the Food and Drug Administration mandated revisions to packaging in 2008. Antibiotics have been commonly prescribed to treat the ear infections and sinusitis that frequently occur with bronchiolitis. But over the past 20 years, the use of antibiotics has become less prevalent. I date that trend to the work of Dr. Jack Paradise, professor emeritus of pediatrics at the University of Pittsburgh, and Dr. Ellen Wald, now chair of pediatrics at the University of Wisconsin, Madison, in the mid-1990’s. RespiGam was approved in 1996, then supplanted with palivizumab, as a medication to reduce the burden of respiratory syncytial virus disease. In the summer of 2014, an updated analysis of the costs, risks, and benefits of RSV prophylaxis led to new recommendations that curtailed the indications for that treatment (Pediatrics 2014:134;415-20). What do these trends have in common? The time frame.
It is often cited that it takes 17 years for new evidence to be assimilated into clinical practice (J.R. Soc. Med. 2011;104:510-20). An Institute of Medicine report in 2001, “Crossing the Quality Chasm,” emphasized the importance of becoming more efficient at making progress. Those recommendations themselves are now 14 years old, and I’m not expecting a revolution in human behavior within the next 3 years.
In the new clinical practice guideline issued by the American Academy of Pediatrics in November 2014 for the treatment of young children with bronchiolitis, Dr. Shawn L. Ralston and her colleagues assessed various treatment modalities, found many to be ineffective, and recommended discontinuing their routine use (Pediatrics 2014;134:e1474-e1502). Beta-agonists were at the forefront of this. Was the new guideline based on new data? For the most part, no. In my reading, itmostly reiterated the concerns about effectiveness that were expressed at the time of the prior guidelines from 2006, but removed the weasel words. I admire the dedication of this committee to evidence-based medicine. But will this revised clinical practice guideline actually change practice?
The saying is, “Build a better mousetrap and the world will beat a path to your door.” That quote has been attributed (without adequate documentation) to Ralph Waldo Emerson. He was a great poet, but not a scientist.
During the same month that the new bronchiolitis guidelinewas being released, America held some elections. In the post mortem, President Obama said, “There is a tendency sometimes for me to start thinking: As long as I get the policy right, then that’s what should matter.” He elaborated that “one thing that I do need to constantly remind myself and my team of is it’s not enough just to build the better mousetrap. People don’t automatically come beating to your door. We’ve got to sell it; we’ve got to reach out to the other side and where possible, persuade” (The Wall Street Journal, Nov. 10, 2014).
That isn’t poetry, but the President’s idea is probably more accurate than Emerson’s.
The bronchiolitis clinical practice guidelinewas written in a standardized fashion with 14 key action statements and 242 references. That makes for a good evidence-based medicine document, but is not the best sales pitch.
What will it take to translate these new guidelines into practice? One option is to teach new residents the new guidelines and expect dinosaurs such as myself to retire. If the average pediatrician works for about 34 years, then over a period of 17 years, we will have replaced half the miscreants simply by attrition.
A program of reaching out to the other side and persuading them to change is a better option.
In discussions about this topic on a listserv for pediatric hospitalists, I focused on my concerns. We need to clarify the harms associated with therapies such as beta-agonists, deep nasal suctioning, and continuous pulse oximetry. We need to clarify the goals of treatment, which might include a shorter length of stay, patient comfort, meeting parents’ expectations that we will do something, and/or explaining why we are contradicting any previous recommendations made to the parents. We need to mesh these bronchiolitis guidelines with the asthma action plans and medication lists advocated for wheezing children who are 24 months of age. My colleagues pointed out that all of that is just continuing to refine the policy.
Getting the policy right is necessary but insufficient. What we are really missing is a campaign strategy to sell it.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He is also listserv moderator for the American Academy of Pediatrics Section on Hospital Medicine.
Avoiding disillusionment
The holiday season, despite the hustle and bustle, can be a time of reflection. Thanksgiving is a time to reflect on what you have. The secular version of Christmas is a deep plunge into materialism and getting the things you desire. Then come those New Year’s resolutions in which you swear off material things and promise yourself you will become the person you have always wanted to be.
For those in academic settings educating the next cohort of physicians, this time of year has its own rituals. Undergraduate and medical school applications are being reviewed. Medical students are interviewing for residencies. Match day for residents seeking subspecialty fellowships occurs in mid-December. The other residents are starting to interview for real jobs. Overall, a vast undertaking occurs in which talents and aspirations are matched with finite and practical opportunities.
My goal is to advocate for the health of children, so I am concerned about how well pediatrics attracts the best and brightest minds. The best training programs in the world are still going to produce mediocre doctors if we start with mediocre talent. The stakes in recruiting talent are huge. The Washington Post has been running a series on the disappearance of the middle class. Some articles have lamented that the finance sector has recently siphoned off the best and brightest minds to make money by pushing money, rather than creating new technology, products, and jobs (“A black hole for our best and brightest,” by Jim Tankersley on Dec. 14, 2014). My second concern is nourishing the ideals and aspirations of those physician seedlings. Few people keep all their New Year’s resolutions for the entire year, but even partial credit can be important progress in a balanced life.
First, we need to attract people to science. There is a recognized shortage of high school students going into STEM fields (science, technology, engineering, and math). Various programs have been created to attract high school students, and particularly women, to those fields (“Women flocking to statistics, the newly hot, high-tech field of data science,” by Brigid Schulte, the Washington Post, Dec. 19, 2014). This then needs to be reinforced in college. For instance, the analysis of big data in health care is a burgeoning field. We need statisticians who can do the work.
Then we need to attract people to medicine. I’ve been in a few conversations recently about a book titled “Doctored: The Disillusionment of the American Physician,” by Dr. Sandeep Jauhar. I haven’t read more than a few excerpts from the book. An abbreviated version is the author’s essay, “Why Doctors Are Sick of Their Profession,” in the Wall Street Journal (Aug. 29, 2014).
There were enough inaccuracies in that article to dissuade me from reading further, but your mileage may differ. There are data to both support and refute most of his assertions. I believe he is correct that there have been some Faustian bargains made by the past two generations of doctors. Medicine welcomed the improved revenues from Medicare and Medicaid coverage. Those programs improved access, justice, health outcomes, and especially doctors’ incomes, but at a steep price to society. The Golden Goose Dr. Jauhar cited was indeed killed. The following generation of doctors has had to deal with managed care, preapprovals, and denials of payment, along with other cost controls. It was irrational to think that all that money from the government to physicians was going to flow indefinitely without strings. In a related development, the resulting paperwork has crushed solo office practice. Rather than being entrepreneurs, recently boarded pediatricians are trending toward larger group practices and salaried positions. So that affects the degree of independence in a medical career.
In pediatrics, physicians invest considerable time to open career paths into subspecialty areas that interest them, even if the income and lifestyle aren’t better and don’t justify the time and expense of further training. Pediatric hospital medicine is progressing toward becoming a boarded subspecialty with 2-year fellowships. Will that attract the best and brightest of the residents?
Continuing medical education is needed to maintain a knowledge base and a skill set. I assert there also needs to be continuing examination and reinforcement of one’s ideals and life goals. As a pediatrician, I am biased toward believing that maintaining a recommended daily allowance of that activity outperforms making New Year’s resolutions. We all know that crash diets rarely work in the long run.
What practical steps can be taken in the pediatrician’s office? Put up posters that encourage STEM education. Ask adolescents about their plans. The health and life expectancy of your patient will be related far more to his or her career choice than to the discovery of the next medicine to treat chronic hepatitis C. Spending just a moment of each adolescent well visit to explore his/her aspirations also may be just the medicine you need to avoid disillusionment. Maybe you will even inspire a bright teenager to become a pediatrician.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He is also listserv moderator for the American Academy of Pediatrics Section on Hospital Medicine. E-mail him at pdnews@frontlinemedcom.com.
The holiday season, despite the hustle and bustle, can be a time of reflection. Thanksgiving is a time to reflect on what you have. The secular version of Christmas is a deep plunge into materialism and getting the things you desire. Then come those New Year’s resolutions in which you swear off material things and promise yourself you will become the person you have always wanted to be.
For those in academic settings educating the next cohort of physicians, this time of year has its own rituals. Undergraduate and medical school applications are being reviewed. Medical students are interviewing for residencies. Match day for residents seeking subspecialty fellowships occurs in mid-December. The other residents are starting to interview for real jobs. Overall, a vast undertaking occurs in which talents and aspirations are matched with finite and practical opportunities.
My goal is to advocate for the health of children, so I am concerned about how well pediatrics attracts the best and brightest minds. The best training programs in the world are still going to produce mediocre doctors if we start with mediocre talent. The stakes in recruiting talent are huge. The Washington Post has been running a series on the disappearance of the middle class. Some articles have lamented that the finance sector has recently siphoned off the best and brightest minds to make money by pushing money, rather than creating new technology, products, and jobs (“A black hole for our best and brightest,” by Jim Tankersley on Dec. 14, 2014). My second concern is nourishing the ideals and aspirations of those physician seedlings. Few people keep all their New Year’s resolutions for the entire year, but even partial credit can be important progress in a balanced life.
First, we need to attract people to science. There is a recognized shortage of high school students going into STEM fields (science, technology, engineering, and math). Various programs have been created to attract high school students, and particularly women, to those fields (“Women flocking to statistics, the newly hot, high-tech field of data science,” by Brigid Schulte, the Washington Post, Dec. 19, 2014). This then needs to be reinforced in college. For instance, the analysis of big data in health care is a burgeoning field. We need statisticians who can do the work.
Then we need to attract people to medicine. I’ve been in a few conversations recently about a book titled “Doctored: The Disillusionment of the American Physician,” by Dr. Sandeep Jauhar. I haven’t read more than a few excerpts from the book. An abbreviated version is the author’s essay, “Why Doctors Are Sick of Their Profession,” in the Wall Street Journal (Aug. 29, 2014).
There were enough inaccuracies in that article to dissuade me from reading further, but your mileage may differ. There are data to both support and refute most of his assertions. I believe he is correct that there have been some Faustian bargains made by the past two generations of doctors. Medicine welcomed the improved revenues from Medicare and Medicaid coverage. Those programs improved access, justice, health outcomes, and especially doctors’ incomes, but at a steep price to society. The Golden Goose Dr. Jauhar cited was indeed killed. The following generation of doctors has had to deal with managed care, preapprovals, and denials of payment, along with other cost controls. It was irrational to think that all that money from the government to physicians was going to flow indefinitely without strings. In a related development, the resulting paperwork has crushed solo office practice. Rather than being entrepreneurs, recently boarded pediatricians are trending toward larger group practices and salaried positions. So that affects the degree of independence in a medical career.
In pediatrics, physicians invest considerable time to open career paths into subspecialty areas that interest them, even if the income and lifestyle aren’t better and don’t justify the time and expense of further training. Pediatric hospital medicine is progressing toward becoming a boarded subspecialty with 2-year fellowships. Will that attract the best and brightest of the residents?
Continuing medical education is needed to maintain a knowledge base and a skill set. I assert there also needs to be continuing examination and reinforcement of one’s ideals and life goals. As a pediatrician, I am biased toward believing that maintaining a recommended daily allowance of that activity outperforms making New Year’s resolutions. We all know that crash diets rarely work in the long run.
What practical steps can be taken in the pediatrician’s office? Put up posters that encourage STEM education. Ask adolescents about their plans. The health and life expectancy of your patient will be related far more to his or her career choice than to the discovery of the next medicine to treat chronic hepatitis C. Spending just a moment of each adolescent well visit to explore his/her aspirations also may be just the medicine you need to avoid disillusionment. Maybe you will even inspire a bright teenager to become a pediatrician.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He is also listserv moderator for the American Academy of Pediatrics Section on Hospital Medicine. E-mail him at pdnews@frontlinemedcom.com.
The holiday season, despite the hustle and bustle, can be a time of reflection. Thanksgiving is a time to reflect on what you have. The secular version of Christmas is a deep plunge into materialism and getting the things you desire. Then come those New Year’s resolutions in which you swear off material things and promise yourself you will become the person you have always wanted to be.
For those in academic settings educating the next cohort of physicians, this time of year has its own rituals. Undergraduate and medical school applications are being reviewed. Medical students are interviewing for residencies. Match day for residents seeking subspecialty fellowships occurs in mid-December. The other residents are starting to interview for real jobs. Overall, a vast undertaking occurs in which talents and aspirations are matched with finite and practical opportunities.
My goal is to advocate for the health of children, so I am concerned about how well pediatrics attracts the best and brightest minds. The best training programs in the world are still going to produce mediocre doctors if we start with mediocre talent. The stakes in recruiting talent are huge. The Washington Post has been running a series on the disappearance of the middle class. Some articles have lamented that the finance sector has recently siphoned off the best and brightest minds to make money by pushing money, rather than creating new technology, products, and jobs (“A black hole for our best and brightest,” by Jim Tankersley on Dec. 14, 2014). My second concern is nourishing the ideals and aspirations of those physician seedlings. Few people keep all their New Year’s resolutions for the entire year, but even partial credit can be important progress in a balanced life.
First, we need to attract people to science. There is a recognized shortage of high school students going into STEM fields (science, technology, engineering, and math). Various programs have been created to attract high school students, and particularly women, to those fields (“Women flocking to statistics, the newly hot, high-tech field of data science,” by Brigid Schulte, the Washington Post, Dec. 19, 2014). This then needs to be reinforced in college. For instance, the analysis of big data in health care is a burgeoning field. We need statisticians who can do the work.
Then we need to attract people to medicine. I’ve been in a few conversations recently about a book titled “Doctored: The Disillusionment of the American Physician,” by Dr. Sandeep Jauhar. I haven’t read more than a few excerpts from the book. An abbreviated version is the author’s essay, “Why Doctors Are Sick of Their Profession,” in the Wall Street Journal (Aug. 29, 2014).
There were enough inaccuracies in that article to dissuade me from reading further, but your mileage may differ. There are data to both support and refute most of his assertions. I believe he is correct that there have been some Faustian bargains made by the past two generations of doctors. Medicine welcomed the improved revenues from Medicare and Medicaid coverage. Those programs improved access, justice, health outcomes, and especially doctors’ incomes, but at a steep price to society. The Golden Goose Dr. Jauhar cited was indeed killed. The following generation of doctors has had to deal with managed care, preapprovals, and denials of payment, along with other cost controls. It was irrational to think that all that money from the government to physicians was going to flow indefinitely without strings. In a related development, the resulting paperwork has crushed solo office practice. Rather than being entrepreneurs, recently boarded pediatricians are trending toward larger group practices and salaried positions. So that affects the degree of independence in a medical career.
In pediatrics, physicians invest considerable time to open career paths into subspecialty areas that interest them, even if the income and lifestyle aren’t better and don’t justify the time and expense of further training. Pediatric hospital medicine is progressing toward becoming a boarded subspecialty with 2-year fellowships. Will that attract the best and brightest of the residents?
Continuing medical education is needed to maintain a knowledge base and a skill set. I assert there also needs to be continuing examination and reinforcement of one’s ideals and life goals. As a pediatrician, I am biased toward believing that maintaining a recommended daily allowance of that activity outperforms making New Year’s resolutions. We all know that crash diets rarely work in the long run.
What practical steps can be taken in the pediatrician’s office? Put up posters that encourage STEM education. Ask adolescents about their plans. The health and life expectancy of your patient will be related far more to his or her career choice than to the discovery of the next medicine to treat chronic hepatitis C. Spending just a moment of each adolescent well visit to explore his/her aspirations also may be just the medicine you need to avoid disillusionment. Maybe you will even inspire a bright teenager to become a pediatrician.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He is also listserv moderator for the American Academy of Pediatrics Section on Hospital Medicine. E-mail him at pdnews@frontlinemedcom.com.
For whom the Ebola tolls
Infectious diseases have been common topics in the news these past 2 months. Enterovirus EV-D68 and Ebola were the focus of sessions and plenary talks at this year’s American Academy of Pediatrics National Conference and Exposition. The new respiratory syncytial virus prophylaxis guidelines for this winter markedly narrowed the recommended recipient population (Pediatrics 2014;134:415-20). The revision of the 2006 bronchiolitis care guideline was released (Pediatrics 2014 [doi: 10.1542/peds.2014-2742]). And there has been an indictment in an alleged fraud involving HIV vaccine research.
As a moderator of a Listserv for pediatric hospitalists, I am interested in both the content of these discussions and the process by which they occur. Pediatric hospitalists could grouse a bit about the Centers for Disease Control and Prevention (CDC) being a few days slow in disseminating information about the EV-D68 epidemic, but we had no reason to doubt the veracity of that information. Our Listserv had posts from pediatric hospitalists in various cities. We discussed the utility of diagnostic tests; the treatment options and their effectiveness compared with other cases of bronchiolitis; and the impact on emergency department and inpatient census. When the virus 2 weeks later was tenuously associated with a rare paralytic syndrome, the Listserv activity peaked again.
Public reaction to Ebola seems to be at the other extreme. The contagion to two nurses and exposure of a lab supervisor at a Dallas hospital have expanded to impact hundreds of airline passengers and cruise ship passengers. Governors in New York and New Jersey took actions to increase monitoring at airports and establish quarantines. Now Maine is involved. Those actions did not always agree with the suggestions of the CDC. Between the Department of Veterans Affairs scandal, the CDC mishandling of small pox and anthrax in its labs, Wikileaks, and celebrities dissing vaccines, the general public’s trust in health information provided by the U.S. government must be near an all-time low just when credibility is needed most.
Does this sound familiar? George Santayana said, “Those who cannot remember the past are condemned to repeat it.” AIDS in 1981 was a new, lethal contagious disease without an effective treatment. Five cases of unusual pneumonia reported in 1981 have become a million people living with the infection. There were fear, stigmatization, recriminations, political posturing, and many deaths. In response, patient isolation practices changed dramatically. A massive research program ensued that has failed to find a vaccine or cure for HIV, but has developed an expensive ongoing treatment regimen that controls the disease in most people who can afford it. That has left out most people in Africa.
The United States now has an Ebola czar. Ron Klain has no experience with tropical infectious diseases. He was selected because he knows how things get done in Washington, D.C. I don’t see him becoming another C. Everett Koop, credible and comforting. For that status, the New York Times was impressed with the local version of that official.
“People need to feel like they are being given information, that things aren’t being kept from them, that they are being apprised of what’s known, and that we’re being honest. ...”
“Fear is a powerful thing,” she added, “and it’s often not rational. That’s when reliance on science and fact really has to be our North Star.” –Dr. Mary Travis Bassett, New York City Health Commissioner
On the spectrum between these two experiences with EV-D68 and Ebola lie the battles over respiratory syncytial virus prophylaxis and treatment. At the AAP National Conference and Exposition session discussing the 2014 palivizumab recommendations, there was great attention paid to having speakers from the audience identify any conflicts of interest they might have. The new guideline on caring for infants with bronchiolitis has emphasized the methodology of evidence-based medicine. Both these approaches (conflicts of interest and evidence-based medicine) are recent tools in the quest for truth and credibility.
Jack Nicholson said, “You can’t handle the truth!” Woodward and Bernstein, the investigative reporters of Watergate, recently eulogized their editor Ben Bradlee with “His one unbending principle was the quest for the truth and the necessity of that pursuit.”
I can’t add anything at this time to the search for truth in dealing with Ebola and what sort of quarantine policies should be in place. The credibility problem is in the hands of politicos. The balancing of communal safety and individual rights is in the hands of judges. But whatever choices are made, medical ethics requires that they be implemented with respect and with compassion, which includes WiFi access. That is in the hands of nurses and doctors. So I will close with a quote from a meditation written nearly 400 years ago by John Donne, an English poet and cleric, during his own 3-week battle with a near-fatal illness.
“No man is an island, entire of itself; ... any man’s death diminishes me, ... therefore never send to know for whom the bell tolls; it tolls for thee.”
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Dr. Powell said he had no relevant financial disclosures. E-mail him at pdnews@frontlinemedcom.com.
Infectious diseases have been common topics in the news these past 2 months. Enterovirus EV-D68 and Ebola were the focus of sessions and plenary talks at this year’s American Academy of Pediatrics National Conference and Exposition. The new respiratory syncytial virus prophylaxis guidelines for this winter markedly narrowed the recommended recipient population (Pediatrics 2014;134:415-20). The revision of the 2006 bronchiolitis care guideline was released (Pediatrics 2014 [doi: 10.1542/peds.2014-2742]). And there has been an indictment in an alleged fraud involving HIV vaccine research.
As a moderator of a Listserv for pediatric hospitalists, I am interested in both the content of these discussions and the process by which they occur. Pediatric hospitalists could grouse a bit about the Centers for Disease Control and Prevention (CDC) being a few days slow in disseminating information about the EV-D68 epidemic, but we had no reason to doubt the veracity of that information. Our Listserv had posts from pediatric hospitalists in various cities. We discussed the utility of diagnostic tests; the treatment options and their effectiveness compared with other cases of bronchiolitis; and the impact on emergency department and inpatient census. When the virus 2 weeks later was tenuously associated with a rare paralytic syndrome, the Listserv activity peaked again.
Public reaction to Ebola seems to be at the other extreme. The contagion to two nurses and exposure of a lab supervisor at a Dallas hospital have expanded to impact hundreds of airline passengers and cruise ship passengers. Governors in New York and New Jersey took actions to increase monitoring at airports and establish quarantines. Now Maine is involved. Those actions did not always agree with the suggestions of the CDC. Between the Department of Veterans Affairs scandal, the CDC mishandling of small pox and anthrax in its labs, Wikileaks, and celebrities dissing vaccines, the general public’s trust in health information provided by the U.S. government must be near an all-time low just when credibility is needed most.
Does this sound familiar? George Santayana said, “Those who cannot remember the past are condemned to repeat it.” AIDS in 1981 was a new, lethal contagious disease without an effective treatment. Five cases of unusual pneumonia reported in 1981 have become a million people living with the infection. There were fear, stigmatization, recriminations, political posturing, and many deaths. In response, patient isolation practices changed dramatically. A massive research program ensued that has failed to find a vaccine or cure for HIV, but has developed an expensive ongoing treatment regimen that controls the disease in most people who can afford it. That has left out most people in Africa.
The United States now has an Ebola czar. Ron Klain has no experience with tropical infectious diseases. He was selected because he knows how things get done in Washington, D.C. I don’t see him becoming another C. Everett Koop, credible and comforting. For that status, the New York Times was impressed with the local version of that official.
“People need to feel like they are being given information, that things aren’t being kept from them, that they are being apprised of what’s known, and that we’re being honest. ...”
“Fear is a powerful thing,” she added, “and it’s often not rational. That’s when reliance on science and fact really has to be our North Star.” –Dr. Mary Travis Bassett, New York City Health Commissioner
On the spectrum between these two experiences with EV-D68 and Ebola lie the battles over respiratory syncytial virus prophylaxis and treatment. At the AAP National Conference and Exposition session discussing the 2014 palivizumab recommendations, there was great attention paid to having speakers from the audience identify any conflicts of interest they might have. The new guideline on caring for infants with bronchiolitis has emphasized the methodology of evidence-based medicine. Both these approaches (conflicts of interest and evidence-based medicine) are recent tools in the quest for truth and credibility.
Jack Nicholson said, “You can’t handle the truth!” Woodward and Bernstein, the investigative reporters of Watergate, recently eulogized their editor Ben Bradlee with “His one unbending principle was the quest for the truth and the necessity of that pursuit.”
I can’t add anything at this time to the search for truth in dealing with Ebola and what sort of quarantine policies should be in place. The credibility problem is in the hands of politicos. The balancing of communal safety and individual rights is in the hands of judges. But whatever choices are made, medical ethics requires that they be implemented with respect and with compassion, which includes WiFi access. That is in the hands of nurses and doctors. So I will close with a quote from a meditation written nearly 400 years ago by John Donne, an English poet and cleric, during his own 3-week battle with a near-fatal illness.
“No man is an island, entire of itself; ... any man’s death diminishes me, ... therefore never send to know for whom the bell tolls; it tolls for thee.”
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Dr. Powell said he had no relevant financial disclosures. E-mail him at pdnews@frontlinemedcom.com.
Infectious diseases have been common topics in the news these past 2 months. Enterovirus EV-D68 and Ebola were the focus of sessions and plenary talks at this year’s American Academy of Pediatrics National Conference and Exposition. The new respiratory syncytial virus prophylaxis guidelines for this winter markedly narrowed the recommended recipient population (Pediatrics 2014;134:415-20). The revision of the 2006 bronchiolitis care guideline was released (Pediatrics 2014 [doi: 10.1542/peds.2014-2742]). And there has been an indictment in an alleged fraud involving HIV vaccine research.
As a moderator of a Listserv for pediatric hospitalists, I am interested in both the content of these discussions and the process by which they occur. Pediatric hospitalists could grouse a bit about the Centers for Disease Control and Prevention (CDC) being a few days slow in disseminating information about the EV-D68 epidemic, but we had no reason to doubt the veracity of that information. Our Listserv had posts from pediatric hospitalists in various cities. We discussed the utility of diagnostic tests; the treatment options and their effectiveness compared with other cases of bronchiolitis; and the impact on emergency department and inpatient census. When the virus 2 weeks later was tenuously associated with a rare paralytic syndrome, the Listserv activity peaked again.
Public reaction to Ebola seems to be at the other extreme. The contagion to two nurses and exposure of a lab supervisor at a Dallas hospital have expanded to impact hundreds of airline passengers and cruise ship passengers. Governors in New York and New Jersey took actions to increase monitoring at airports and establish quarantines. Now Maine is involved. Those actions did not always agree with the suggestions of the CDC. Between the Department of Veterans Affairs scandal, the CDC mishandling of small pox and anthrax in its labs, Wikileaks, and celebrities dissing vaccines, the general public’s trust in health information provided by the U.S. government must be near an all-time low just when credibility is needed most.
Does this sound familiar? George Santayana said, “Those who cannot remember the past are condemned to repeat it.” AIDS in 1981 was a new, lethal contagious disease without an effective treatment. Five cases of unusual pneumonia reported in 1981 have become a million people living with the infection. There were fear, stigmatization, recriminations, political posturing, and many deaths. In response, patient isolation practices changed dramatically. A massive research program ensued that has failed to find a vaccine or cure for HIV, but has developed an expensive ongoing treatment regimen that controls the disease in most people who can afford it. That has left out most people in Africa.
The United States now has an Ebola czar. Ron Klain has no experience with tropical infectious diseases. He was selected because he knows how things get done in Washington, D.C. I don’t see him becoming another C. Everett Koop, credible and comforting. For that status, the New York Times was impressed with the local version of that official.
“People need to feel like they are being given information, that things aren’t being kept from them, that they are being apprised of what’s known, and that we’re being honest. ...”
“Fear is a powerful thing,” she added, “and it’s often not rational. That’s when reliance on science and fact really has to be our North Star.” –Dr. Mary Travis Bassett, New York City Health Commissioner
On the spectrum between these two experiences with EV-D68 and Ebola lie the battles over respiratory syncytial virus prophylaxis and treatment. At the AAP National Conference and Exposition session discussing the 2014 palivizumab recommendations, there was great attention paid to having speakers from the audience identify any conflicts of interest they might have. The new guideline on caring for infants with bronchiolitis has emphasized the methodology of evidence-based medicine. Both these approaches (conflicts of interest and evidence-based medicine) are recent tools in the quest for truth and credibility.
Jack Nicholson said, “You can’t handle the truth!” Woodward and Bernstein, the investigative reporters of Watergate, recently eulogized their editor Ben Bradlee with “His one unbending principle was the quest for the truth and the necessity of that pursuit.”
I can’t add anything at this time to the search for truth in dealing with Ebola and what sort of quarantine policies should be in place. The credibility problem is in the hands of politicos. The balancing of communal safety and individual rights is in the hands of judges. But whatever choices are made, medical ethics requires that they be implemented with respect and with compassion, which includes WiFi access. That is in the hands of nurses and doctors. So I will close with a quote from a meditation written nearly 400 years ago by John Donne, an English poet and cleric, during his own 3-week battle with a near-fatal illness.
“No man is an island, entire of itself; ... any man’s death diminishes me, ... therefore never send to know for whom the bell tolls; it tolls for thee.”
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Dr. Powell said he had no relevant financial disclosures. E-mail him at pdnews@frontlinemedcom.com.
Catheter or bag?
It is such a common situation that you would think it would be a cut-and-dried decision. But in some ways it reflects at the core of medical professionalism. A 2-month-old infant presents to the emergency department with a 101.6° F fever. The history provides no hint at a specific diagnosis and the physical exam is unremarkable with a well-appearing baby. I’ve been using the Rochester criteria in this situation for nigh on 20 years. I need a CBC and urinalysis. Then I can decide on whether to do a lumbar puncture. The mother, however, resists the idea of doing a catheter for a urine sample. Now what?
The merits of bagged vs. catheter urine specimens have been debated for decades. In the United States, the experts have been in agreement for many years that catheter specimens are recommended.
My cause for skepticism has been that experts elsewhere have made contrary recommendations.
For many illnesses, I find the online resources of the Royal Children’s Hospital in Melbourne to be very helpful because they are so specific yet thorough, including those for urinary tract infections (UTIs).
Those guidelines were last updated in 2011. These are only two pages of bulleted items, so I strongly recommend reading them. You may find them eye opening. Those guidelines believe suprapubic aspiration remains the preferred method, at least in sick children. They also state that there is no indication for culture of urine from a bag specimen.
In Britain, the National Institute for Health and Care Excellence (NICE) guidelines have taken another approach. For them, "Noninvasive methods such as pads or bags should be used before trying to gain a sample by invasive methods," such as catheter or suprapubic aspiration. Those were 2007 NICE guidelines, referenced and reaffirmed in a 2013 guideline at the Royal Cornwall Hospitals Trust.
The British also have a protocol in which the baby is left undiapered and a parent waits to catch the urine in a sterile cup with the next void.
Furthermore, at least in the recent past, decisions in Britain about treating UTIs often were made based on dipstick alone if the child was well appearing. This made sterile collection less stringent. The costs of culture were thought excessive, compared with the improvement in accuracy of the diagnosis. This was analogous to the ongoing debate over whether to always test for strep throats before treating vs. treating empirically. The United States has moved strongly in the other direction. The 2011 American Academy of Pediatrics guidelines now require both a positive culture and a positive urinalysis to diagnose a UTI (Pediatrics 2011;128:595-610).
Why this difference? Because the diagnosis of a UTI in a young child in the United States under the now-discredited 1999 guidelines led to unnecessary admissions, intravenous therapy, renal ultrasounds, repeated voiding cystourethrograms, and long-term antibiotic prophylaxis. Invasive overtreatment certainly can be used to justify overly invasive diagnostic tests. The wiser course would be to stop the overtreatment.
All this knowledge and perspective didn’t help me in the ED with this mother. I suggested that to a control-freak toddler wearing a urine bag can be perceived as at least as invasive as the quick catheterization. I was not persuasive. Fortunately, the ED was empty at 3 a.m. So, if mom wanted to spend those extra 3 hours waiting for the child to pee into a bag, I could accommodate her autonomy.
My colleagues have differing opinions on what to do in this situation. One is a strong advocate for evidence-based medicine (EBM). Because the guidelines state that catheterization is the recommended method, he would argue that that is the only option that should be presented to the parent. That emphasis on EBM becomes his definition of professionalism. Other colleagues are less dogmatic. They will point out that at 10 p.m. with all the ED rooms full and the waiting room overflowing, accommodating this situation would be more problematic.
I think my experiences working in so many different parts of the country have shaped me to value flexibility and accommodation. I’ve seen many situations where differing locations are dogmatic in differing directions in how the local doctors believe care should be delivered. I’ve also anxiously received minor medical treatment while overseas when I didn’t speak the local language, so the phrase "delivering care" is a particularly meaningful concept.
I think I could have used my knowledge and status to bully this mother into permitting her infant to be catheterized. Perhaps that is the scientifically ideal approach. I worry, though, that it would not be the most compassionate approach. The risk to the infant in both scenarios is very small. So to me, it wasn’t a choice of catheter vs. bag. It was a choice of expressing compassion rather than expertise.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Dr. Powell said he had no relevant financial disclosures.
It is such a common situation that you would think it would be a cut-and-dried decision. But in some ways it reflects at the core of medical professionalism. A 2-month-old infant presents to the emergency department with a 101.6° F fever. The history provides no hint at a specific diagnosis and the physical exam is unremarkable with a well-appearing baby. I’ve been using the Rochester criteria in this situation for nigh on 20 years. I need a CBC and urinalysis. Then I can decide on whether to do a lumbar puncture. The mother, however, resists the idea of doing a catheter for a urine sample. Now what?
The merits of bagged vs. catheter urine specimens have been debated for decades. In the United States, the experts have been in agreement for many years that catheter specimens are recommended.
My cause for skepticism has been that experts elsewhere have made contrary recommendations.
For many illnesses, I find the online resources of the Royal Children’s Hospital in Melbourne to be very helpful because they are so specific yet thorough, including those for urinary tract infections (UTIs).
Those guidelines were last updated in 2011. These are only two pages of bulleted items, so I strongly recommend reading them. You may find them eye opening. Those guidelines believe suprapubic aspiration remains the preferred method, at least in sick children. They also state that there is no indication for culture of urine from a bag specimen.
In Britain, the National Institute for Health and Care Excellence (NICE) guidelines have taken another approach. For them, "Noninvasive methods such as pads or bags should be used before trying to gain a sample by invasive methods," such as catheter or suprapubic aspiration. Those were 2007 NICE guidelines, referenced and reaffirmed in a 2013 guideline at the Royal Cornwall Hospitals Trust.
The British also have a protocol in which the baby is left undiapered and a parent waits to catch the urine in a sterile cup with the next void.
Furthermore, at least in the recent past, decisions in Britain about treating UTIs often were made based on dipstick alone if the child was well appearing. This made sterile collection less stringent. The costs of culture were thought excessive, compared with the improvement in accuracy of the diagnosis. This was analogous to the ongoing debate over whether to always test for strep throats before treating vs. treating empirically. The United States has moved strongly in the other direction. The 2011 American Academy of Pediatrics guidelines now require both a positive culture and a positive urinalysis to diagnose a UTI (Pediatrics 2011;128:595-610).
Why this difference? Because the diagnosis of a UTI in a young child in the United States under the now-discredited 1999 guidelines led to unnecessary admissions, intravenous therapy, renal ultrasounds, repeated voiding cystourethrograms, and long-term antibiotic prophylaxis. Invasive overtreatment certainly can be used to justify overly invasive diagnostic tests. The wiser course would be to stop the overtreatment.
All this knowledge and perspective didn’t help me in the ED with this mother. I suggested that to a control-freak toddler wearing a urine bag can be perceived as at least as invasive as the quick catheterization. I was not persuasive. Fortunately, the ED was empty at 3 a.m. So, if mom wanted to spend those extra 3 hours waiting for the child to pee into a bag, I could accommodate her autonomy.
My colleagues have differing opinions on what to do in this situation. One is a strong advocate for evidence-based medicine (EBM). Because the guidelines state that catheterization is the recommended method, he would argue that that is the only option that should be presented to the parent. That emphasis on EBM becomes his definition of professionalism. Other colleagues are less dogmatic. They will point out that at 10 p.m. with all the ED rooms full and the waiting room overflowing, accommodating this situation would be more problematic.
I think my experiences working in so many different parts of the country have shaped me to value flexibility and accommodation. I’ve seen many situations where differing locations are dogmatic in differing directions in how the local doctors believe care should be delivered. I’ve also anxiously received minor medical treatment while overseas when I didn’t speak the local language, so the phrase "delivering care" is a particularly meaningful concept.
I think I could have used my knowledge and status to bully this mother into permitting her infant to be catheterized. Perhaps that is the scientifically ideal approach. I worry, though, that it would not be the most compassionate approach. The risk to the infant in both scenarios is very small. So to me, it wasn’t a choice of catheter vs. bag. It was a choice of expressing compassion rather than expertise.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Dr. Powell said he had no relevant financial disclosures.
It is such a common situation that you would think it would be a cut-and-dried decision. But in some ways it reflects at the core of medical professionalism. A 2-month-old infant presents to the emergency department with a 101.6° F fever. The history provides no hint at a specific diagnosis and the physical exam is unremarkable with a well-appearing baby. I’ve been using the Rochester criteria in this situation for nigh on 20 years. I need a CBC and urinalysis. Then I can decide on whether to do a lumbar puncture. The mother, however, resists the idea of doing a catheter for a urine sample. Now what?
The merits of bagged vs. catheter urine specimens have been debated for decades. In the United States, the experts have been in agreement for many years that catheter specimens are recommended.
My cause for skepticism has been that experts elsewhere have made contrary recommendations.
For many illnesses, I find the online resources of the Royal Children’s Hospital in Melbourne to be very helpful because they are so specific yet thorough, including those for urinary tract infections (UTIs).
Those guidelines were last updated in 2011. These are only two pages of bulleted items, so I strongly recommend reading them. You may find them eye opening. Those guidelines believe suprapubic aspiration remains the preferred method, at least in sick children. They also state that there is no indication for culture of urine from a bag specimen.
In Britain, the National Institute for Health and Care Excellence (NICE) guidelines have taken another approach. For them, "Noninvasive methods such as pads or bags should be used before trying to gain a sample by invasive methods," such as catheter or suprapubic aspiration. Those were 2007 NICE guidelines, referenced and reaffirmed in a 2013 guideline at the Royal Cornwall Hospitals Trust.
The British also have a protocol in which the baby is left undiapered and a parent waits to catch the urine in a sterile cup with the next void.
Furthermore, at least in the recent past, decisions in Britain about treating UTIs often were made based on dipstick alone if the child was well appearing. This made sterile collection less stringent. The costs of culture were thought excessive, compared with the improvement in accuracy of the diagnosis. This was analogous to the ongoing debate over whether to always test for strep throats before treating vs. treating empirically. The United States has moved strongly in the other direction. The 2011 American Academy of Pediatrics guidelines now require both a positive culture and a positive urinalysis to diagnose a UTI (Pediatrics 2011;128:595-610).
Why this difference? Because the diagnosis of a UTI in a young child in the United States under the now-discredited 1999 guidelines led to unnecessary admissions, intravenous therapy, renal ultrasounds, repeated voiding cystourethrograms, and long-term antibiotic prophylaxis. Invasive overtreatment certainly can be used to justify overly invasive diagnostic tests. The wiser course would be to stop the overtreatment.
All this knowledge and perspective didn’t help me in the ED with this mother. I suggested that to a control-freak toddler wearing a urine bag can be perceived as at least as invasive as the quick catheterization. I was not persuasive. Fortunately, the ED was empty at 3 a.m. So, if mom wanted to spend those extra 3 hours waiting for the child to pee into a bag, I could accommodate her autonomy.
My colleagues have differing opinions on what to do in this situation. One is a strong advocate for evidence-based medicine (EBM). Because the guidelines state that catheterization is the recommended method, he would argue that that is the only option that should be presented to the parent. That emphasis on EBM becomes his definition of professionalism. Other colleagues are less dogmatic. They will point out that at 10 p.m. with all the ED rooms full and the waiting room overflowing, accommodating this situation would be more problematic.
I think my experiences working in so many different parts of the country have shaped me to value flexibility and accommodation. I’ve seen many situations where differing locations are dogmatic in differing directions in how the local doctors believe care should be delivered. I’ve also anxiously received minor medical treatment while overseas when I didn’t speak the local language, so the phrase "delivering care" is a particularly meaningful concept.
I think I could have used my knowledge and status to bully this mother into permitting her infant to be catheterized. Perhaps that is the scientifically ideal approach. I worry, though, that it would not be the most compassionate approach. The risk to the infant in both scenarios is very small. So to me, it wasn’t a choice of catheter vs. bag. It was a choice of expressing compassion rather than expertise.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Dr. Powell said he had no relevant financial disclosures.
Scandals, focus, leadership, and honesty
The biggest news in ethics recently is the Veterans Affairs scandal, in which secret wait lists were allegedly kept to obscure the long delays for appointments. I seem to have a different perspective than the president, who said:
"How do we make sure that there is no slippage between somebody making a phone call and them getting an appointment scheduled. And let’s have a realistic time for how soon they’re going to get an appointment. Those are things that don’t require rocket science. It requires execution; it requires discipline; it requires focus."1
Execution, discipline, focus. I think the word the president was looking for was honesty.
Meanwhile, a VA whistleblower who told CNN about the problems at the Phoenix facility said Friday he was saddened by [Gen. Eric] Shinseki’s resignation under such circumstances.
"The VA administrators got way too focused on having good numbers, and they forgot the most important mandate, the reason we all work at the VA – to take care of veterans, to save their lives and give them good medical care," Dr. Sam Foote said.
"The next secretary’s biggest challenge will be to get that refocused and make sure the number one job is taking care of veterans – not worrying about their bureaucratic careers," Dr. Foote added.2
This analysis of being "too focused" echoes the analysis 4 months ago of a scandal involving cheating on proficiency tests at missile bases in Montana. In that situation, people were similarly focused on meeting numbers and lost track of the big picture.
"Leadership’s focus on perfection led commanders to micromanage their people," said [Lt. Gen. Stephen Wilson, the commander of the Air Force’s Global Strike Command,] pointing to pressure to get 100% scores on monthly proficiency exams when only 90% was necessary to pass. ... Leaders lost sight of the fact that execution in the field is more important than what happens in the classroom."3
"This is absolutely unacceptable behavior and it is completely contrary to our core values in the Air Force, and as everybody here knows, the No. 1 core value for us is integrity," Air Force Secretary Deborah Lee James told reporters.4
I’ll accept integrity as equivalent to honesty.
As in the VA scandal, the missile scandal initially seemed isolated, but on further investigation was determined to be widespread, with up to 20% of the 190-member force implicated at one point. Equally concerning to leadership was the fact that many more people were aware cheating was going on, but did not act on it. I’ve often seen the term teamwork used to justify that behavior or lack thereof.
Are the delays at the VA hospitals unique? Not in my experience. Just last month while making an appointment to see a sub-subspecialist, I was told they were scheduling 5 months out. I called back to my primary care physician, who made a call, and I was soon contacted with an appointment for about a week later. Did I get any preferential consideration as a professional courtesy because I’m a physician? I don’t know. Very possibly. Did I benefit from knowing the system and anticipating that if I called my doctor, an earlier appointment would be arranged? Absolutely. I’ve made those calls myself advocating for my own patients when I hear about a delay that seems too long. It is part of being a patient advocate.
This is a fairly (that may be a poor choice of adjective) common practice when access is limited, but it can become a significant source of injustice. I’m aware of one health care system with long delays in scheduling subspecialty appointments after hospitalizations, up to 4-5 months. However, they do a great job, when called by a member of their panel of frequently referring primary doctors, at fitting people in early. The impact is that patients who have a personal physician (which correlates with good insurance) routinely jump the queue and get seen promptly. Patients who don’t have an advocate, or who go to one of the low-income clinics, may not get care or get frustrated and look elsewhere. This arrangement allows the system to claim it sees Medicaid patients while actually seeing only a limited fraction. Despicably evil, but effective. Is there discriminatory intent? Unknown and hard to prove. Disparate impact? Absolutely. Public outrage? Nope. Public ignorance, apathy, and a good public relations department seem to avert scandal.
Focusing on the numbers, pay for performance, Press Ganey scores, getting the top box checkmark – do these take focus away from providing the best clinical therapies? One would hope professionalism would keep pediatricians focused on the noble pursuit of providing health care for children. But leadership and an occasional emphasis on honesty couldn’t hurt.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis.
References
1. http://www.whitehouse.gov/the-press-office/2014/05/30/statement-president
2. http://www.cnn.com/2014/05/30/politics/va-hospitals-shinseki/index.html
3. http://www.cnn.com/2014/03/27/us/air-force-cheating-investigation
4. http://www.cnn.com/2014/01/15/politics/air-force-nuclear-scandal
The biggest news in ethics recently is the Veterans Affairs scandal, in which secret wait lists were allegedly kept to obscure the long delays for appointments. I seem to have a different perspective than the president, who said:
"How do we make sure that there is no slippage between somebody making a phone call and them getting an appointment scheduled. And let’s have a realistic time for how soon they’re going to get an appointment. Those are things that don’t require rocket science. It requires execution; it requires discipline; it requires focus."1
Execution, discipline, focus. I think the word the president was looking for was honesty.
Meanwhile, a VA whistleblower who told CNN about the problems at the Phoenix facility said Friday he was saddened by [Gen. Eric] Shinseki’s resignation under such circumstances.
"The VA administrators got way too focused on having good numbers, and they forgot the most important mandate, the reason we all work at the VA – to take care of veterans, to save their lives and give them good medical care," Dr. Sam Foote said.
"The next secretary’s biggest challenge will be to get that refocused and make sure the number one job is taking care of veterans – not worrying about their bureaucratic careers," Dr. Foote added.2
This analysis of being "too focused" echoes the analysis 4 months ago of a scandal involving cheating on proficiency tests at missile bases in Montana. In that situation, people were similarly focused on meeting numbers and lost track of the big picture.
"Leadership’s focus on perfection led commanders to micromanage their people," said [Lt. Gen. Stephen Wilson, the commander of the Air Force’s Global Strike Command,] pointing to pressure to get 100% scores on monthly proficiency exams when only 90% was necessary to pass. ... Leaders lost sight of the fact that execution in the field is more important than what happens in the classroom."3
"This is absolutely unacceptable behavior and it is completely contrary to our core values in the Air Force, and as everybody here knows, the No. 1 core value for us is integrity," Air Force Secretary Deborah Lee James told reporters.4
I’ll accept integrity as equivalent to honesty.
As in the VA scandal, the missile scandal initially seemed isolated, but on further investigation was determined to be widespread, with up to 20% of the 190-member force implicated at one point. Equally concerning to leadership was the fact that many more people were aware cheating was going on, but did not act on it. I’ve often seen the term teamwork used to justify that behavior or lack thereof.
Are the delays at the VA hospitals unique? Not in my experience. Just last month while making an appointment to see a sub-subspecialist, I was told they were scheduling 5 months out. I called back to my primary care physician, who made a call, and I was soon contacted with an appointment for about a week later. Did I get any preferential consideration as a professional courtesy because I’m a physician? I don’t know. Very possibly. Did I benefit from knowing the system and anticipating that if I called my doctor, an earlier appointment would be arranged? Absolutely. I’ve made those calls myself advocating for my own patients when I hear about a delay that seems too long. It is part of being a patient advocate.
This is a fairly (that may be a poor choice of adjective) common practice when access is limited, but it can become a significant source of injustice. I’m aware of one health care system with long delays in scheduling subspecialty appointments after hospitalizations, up to 4-5 months. However, they do a great job, when called by a member of their panel of frequently referring primary doctors, at fitting people in early. The impact is that patients who have a personal physician (which correlates with good insurance) routinely jump the queue and get seen promptly. Patients who don’t have an advocate, or who go to one of the low-income clinics, may not get care or get frustrated and look elsewhere. This arrangement allows the system to claim it sees Medicaid patients while actually seeing only a limited fraction. Despicably evil, but effective. Is there discriminatory intent? Unknown and hard to prove. Disparate impact? Absolutely. Public outrage? Nope. Public ignorance, apathy, and a good public relations department seem to avert scandal.
Focusing on the numbers, pay for performance, Press Ganey scores, getting the top box checkmark – do these take focus away from providing the best clinical therapies? One would hope professionalism would keep pediatricians focused on the noble pursuit of providing health care for children. But leadership and an occasional emphasis on honesty couldn’t hurt.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis.
References
1. http://www.whitehouse.gov/the-press-office/2014/05/30/statement-president
2. http://www.cnn.com/2014/05/30/politics/va-hospitals-shinseki/index.html
3. http://www.cnn.com/2014/03/27/us/air-force-cheating-investigation
4. http://www.cnn.com/2014/01/15/politics/air-force-nuclear-scandal
The biggest news in ethics recently is the Veterans Affairs scandal, in which secret wait lists were allegedly kept to obscure the long delays for appointments. I seem to have a different perspective than the president, who said:
"How do we make sure that there is no slippage between somebody making a phone call and them getting an appointment scheduled. And let’s have a realistic time for how soon they’re going to get an appointment. Those are things that don’t require rocket science. It requires execution; it requires discipline; it requires focus."1
Execution, discipline, focus. I think the word the president was looking for was honesty.
Meanwhile, a VA whistleblower who told CNN about the problems at the Phoenix facility said Friday he was saddened by [Gen. Eric] Shinseki’s resignation under such circumstances.
"The VA administrators got way too focused on having good numbers, and they forgot the most important mandate, the reason we all work at the VA – to take care of veterans, to save their lives and give them good medical care," Dr. Sam Foote said.
"The next secretary’s biggest challenge will be to get that refocused and make sure the number one job is taking care of veterans – not worrying about their bureaucratic careers," Dr. Foote added.2
This analysis of being "too focused" echoes the analysis 4 months ago of a scandal involving cheating on proficiency tests at missile bases in Montana. In that situation, people were similarly focused on meeting numbers and lost track of the big picture.
"Leadership’s focus on perfection led commanders to micromanage their people," said [Lt. Gen. Stephen Wilson, the commander of the Air Force’s Global Strike Command,] pointing to pressure to get 100% scores on monthly proficiency exams when only 90% was necessary to pass. ... Leaders lost sight of the fact that execution in the field is more important than what happens in the classroom."3
"This is absolutely unacceptable behavior and it is completely contrary to our core values in the Air Force, and as everybody here knows, the No. 1 core value for us is integrity," Air Force Secretary Deborah Lee James told reporters.4
I’ll accept integrity as equivalent to honesty.
As in the VA scandal, the missile scandal initially seemed isolated, but on further investigation was determined to be widespread, with up to 20% of the 190-member force implicated at one point. Equally concerning to leadership was the fact that many more people were aware cheating was going on, but did not act on it. I’ve often seen the term teamwork used to justify that behavior or lack thereof.
Are the delays at the VA hospitals unique? Not in my experience. Just last month while making an appointment to see a sub-subspecialist, I was told they were scheduling 5 months out. I called back to my primary care physician, who made a call, and I was soon contacted with an appointment for about a week later. Did I get any preferential consideration as a professional courtesy because I’m a physician? I don’t know. Very possibly. Did I benefit from knowing the system and anticipating that if I called my doctor, an earlier appointment would be arranged? Absolutely. I’ve made those calls myself advocating for my own patients when I hear about a delay that seems too long. It is part of being a patient advocate.
This is a fairly (that may be a poor choice of adjective) common practice when access is limited, but it can become a significant source of injustice. I’m aware of one health care system with long delays in scheduling subspecialty appointments after hospitalizations, up to 4-5 months. However, they do a great job, when called by a member of their panel of frequently referring primary doctors, at fitting people in early. The impact is that patients who have a personal physician (which correlates with good insurance) routinely jump the queue and get seen promptly. Patients who don’t have an advocate, or who go to one of the low-income clinics, may not get care or get frustrated and look elsewhere. This arrangement allows the system to claim it sees Medicaid patients while actually seeing only a limited fraction. Despicably evil, but effective. Is there discriminatory intent? Unknown and hard to prove. Disparate impact? Absolutely. Public outrage? Nope. Public ignorance, apathy, and a good public relations department seem to avert scandal.
Focusing on the numbers, pay for performance, Press Ganey scores, getting the top box checkmark – do these take focus away from providing the best clinical therapies? One would hope professionalism would keep pediatricians focused on the noble pursuit of providing health care for children. But leadership and an occasional emphasis on honesty couldn’t hurt.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis.
References
1. http://www.whitehouse.gov/the-press-office/2014/05/30/statement-president
2. http://www.cnn.com/2014/05/30/politics/va-hospitals-shinseki/index.html
3. http://www.cnn.com/2014/03/27/us/air-force-cheating-investigation
4. http://www.cnn.com/2014/01/15/politics/air-force-nuclear-scandal
Death by neurological criteria
On Dec. 9, 2013, a 13-year-old California girl underwent a tonsillectomy to alleviate obstructive sleep apnea. It’s a procedure performed a half-million times a year in the United States. She had postoperative bleeding. On Dec. 12th, she was declared dead by neurological criteria, colloquially called brain death. She remains on a ventilator. Her parents refuse to accept the diagnosis and obtained judicial injunctions ordering the physicians to not withdraw the ventilator. The tests to confirm death by neurological criteria have been repeated by several physicians, including one selected by the court, and the local coroner has issued a death certificate.
Death after tonsillectomy is rare but a known risk. A quick Google search finds many newspaper accounts of these heart-wrenching events. The most often cited risk of mortality is 1/15,000. That calculates out as 30 deaths per year in the United States related to the procedure. The mechanism is usually postoperative bleeding or allergy to the anesthesia.
The exact events that occurred in the California case of Jahi McMath, are protected by HIPAA. I have no access to facts other than what is being reported in the general media. When events like this occur, there often are allegations or suspicions of negligence. This is a natural emotional reaction stemming from disbelief, denial, and the desire to blame somebody for a highly unexpected tragedy. Sometimes those allegations are true, but that is for a court to decide. What has been unusual in this case is the prolonged legal battle over accepting the declaration of death.
The process of declaring death by neurological criteria is usually set in policies at each hospital in accordance with local resources, compliance with state laws that regulate medical practice, and nationally accepted criteria. These date back to a 1968 Harvard committee that created the criteria to deal with advances in medical technology, particularly ventilators, as well as the desire for facilitating organ donation (JAMA 1968;205:337-40). These criteria, and process for documenting them, have met widespread acceptance for 45 years, even within antiabortion circles such as the Catholic Church. Among Halacha-observant Jews, some rabbis do not accept these criteria while others affirm them. That difference of opinion is partly responsible for New Jersey being the only state with statutory recognition of a religious objection to the Harvard criteria. The most recent New York regulation calls for "reasonable accommodation" of those with religious objections and lays out the process of extensive testing.
In all other states, virtues of compassion and respect are the primary motivations for accommodating nonacceptance of the declaration of brain death. Many ICU doctors can tell stories of a case in which they delayed withdrawal of the ventilator and other technology from a brain-dead patient. Usually, it’s a delay of a few hours while some next of kin travels to bedside to be present at "the moment of death." In those instances, my practice has been to complete the death certificate using the earlier time at which death was determined by neurological criteria. This is important if organ harvest is involved.
Clarity amid care
There are fine points on the criteria and process of declaring brain death that are the subject of debate among medical ethicists, who are generally ready, willing, and able to argue about minutiae. One listserv for medical ethicists generated 280 postings in 5 days on this topic while the legal back and forth was occurring in California. I wish to emphasize two take-home messages.
First, this case is not about withdrawing life support or artificial nutrition and hydration from a patient in a coma or a persistent vegetative state.
A person in PVS is alive and has brain activity. Legal precedents, starting with the case of Karen Ann Quinlan in 1976 through Nancy Cruzan in 1990, established the legality and appropriateness of withdrawing life support from patients in PVS if that was their preference. Those precedents were revived and reaffirmed in the battle over Terry Schiavo in 2005. There are accounts of rare events in which people, after being in a deep coma (though less deep than PVS) for years, regained some awareness and ability to communicate. That is not the situation for properly diagnosed brain death. It is irreversible. There is no brain activity. There is no responsiveness other than spinal reflex, which can be misinterpreted by family members. Those movements are a source of moral distress for nurses required to care for a patient while the diagnosis of death is being confirmed.
Second, there are things that can be done to avoid the situation unfolding in California.
• Often these battles occur after some event has already broken the trust between the family and the medical staff. The unexpected death after a tonsillectomy could trigger this. It may take an outside resource, such as a mediator, or the ethics committee, to help bridge the distrust. Early involvement of these resources will usually prevent the adversarial relationship generated by going to court.
• Perform the neuro exam with the family present. They can see for themselves the large number of tests and reflexes, such as a blink reflex, none of which are present. This helps counteract what their eyes are telling them about a beating heart and warm skin.
• Imaging studies are not required to declare brain death but can help the family visualize what has happened. The black void of a cerebral blood flow study is quite stark, as is a massive stroke imaged by CT or MRI. The flat line of a patient’s EEG alongside a normal EEG conveys what a thousand words cannot.
• It is important to be respectful of dissenting opinions without implying agreement or acceptance of them. Too much deference to a family’s denial or delusions, which can easily occur if there is the overhanging threat of malpractice litigation, can be interpreted by the family as confirmation that there really was an unspoken ambiguity in the declaration of death by neurological criteria. The goal is to guide the family to acceptance of a tragic reality. It is neither wise nor compassionate to end up in a 3-week legal battle.
Dr. Powell practices as a hospitalist at SSM Cardinal Glennon Children’s Medical Center in St. Louis. He is associate professor of pediatrics at Saint Louis University. He is also listserv moderator for the AAP Section on Hospital Medicine and is a member of the Law and Bioethics Affinity Group of the American Society for Bioethics and Humanities. E-mail him at pdnews@frontlinemedcom.com.
On Dec. 9, 2013, a 13-year-old California girl underwent a tonsillectomy to alleviate obstructive sleep apnea. It’s a procedure performed a half-million times a year in the United States. She had postoperative bleeding. On Dec. 12th, she was declared dead by neurological criteria, colloquially called brain death. She remains on a ventilator. Her parents refuse to accept the diagnosis and obtained judicial injunctions ordering the physicians to not withdraw the ventilator. The tests to confirm death by neurological criteria have been repeated by several physicians, including one selected by the court, and the local coroner has issued a death certificate.
Death after tonsillectomy is rare but a known risk. A quick Google search finds many newspaper accounts of these heart-wrenching events. The most often cited risk of mortality is 1/15,000. That calculates out as 30 deaths per year in the United States related to the procedure. The mechanism is usually postoperative bleeding or allergy to the anesthesia.
The exact events that occurred in the California case of Jahi McMath, are protected by HIPAA. I have no access to facts other than what is being reported in the general media. When events like this occur, there often are allegations or suspicions of negligence. This is a natural emotional reaction stemming from disbelief, denial, and the desire to blame somebody for a highly unexpected tragedy. Sometimes those allegations are true, but that is for a court to decide. What has been unusual in this case is the prolonged legal battle over accepting the declaration of death.
The process of declaring death by neurological criteria is usually set in policies at each hospital in accordance with local resources, compliance with state laws that regulate medical practice, and nationally accepted criteria. These date back to a 1968 Harvard committee that created the criteria to deal with advances in medical technology, particularly ventilators, as well as the desire for facilitating organ donation (JAMA 1968;205:337-40). These criteria, and process for documenting them, have met widespread acceptance for 45 years, even within antiabortion circles such as the Catholic Church. Among Halacha-observant Jews, some rabbis do not accept these criteria while others affirm them. That difference of opinion is partly responsible for New Jersey being the only state with statutory recognition of a religious objection to the Harvard criteria. The most recent New York regulation calls for "reasonable accommodation" of those with religious objections and lays out the process of extensive testing.
In all other states, virtues of compassion and respect are the primary motivations for accommodating nonacceptance of the declaration of brain death. Many ICU doctors can tell stories of a case in which they delayed withdrawal of the ventilator and other technology from a brain-dead patient. Usually, it’s a delay of a few hours while some next of kin travels to bedside to be present at "the moment of death." In those instances, my practice has been to complete the death certificate using the earlier time at which death was determined by neurological criteria. This is important if organ harvest is involved.
Clarity amid care
There are fine points on the criteria and process of declaring brain death that are the subject of debate among medical ethicists, who are generally ready, willing, and able to argue about minutiae. One listserv for medical ethicists generated 280 postings in 5 days on this topic while the legal back and forth was occurring in California. I wish to emphasize two take-home messages.
First, this case is not about withdrawing life support or artificial nutrition and hydration from a patient in a coma or a persistent vegetative state.
A person in PVS is alive and has brain activity. Legal precedents, starting with the case of Karen Ann Quinlan in 1976 through Nancy Cruzan in 1990, established the legality and appropriateness of withdrawing life support from patients in PVS if that was their preference. Those precedents were revived and reaffirmed in the battle over Terry Schiavo in 2005. There are accounts of rare events in which people, after being in a deep coma (though less deep than PVS) for years, regained some awareness and ability to communicate. That is not the situation for properly diagnosed brain death. It is irreversible. There is no brain activity. There is no responsiveness other than spinal reflex, which can be misinterpreted by family members. Those movements are a source of moral distress for nurses required to care for a patient while the diagnosis of death is being confirmed.
Second, there are things that can be done to avoid the situation unfolding in California.
• Often these battles occur after some event has already broken the trust between the family and the medical staff. The unexpected death after a tonsillectomy could trigger this. It may take an outside resource, such as a mediator, or the ethics committee, to help bridge the distrust. Early involvement of these resources will usually prevent the adversarial relationship generated by going to court.
• Perform the neuro exam with the family present. They can see for themselves the large number of tests and reflexes, such as a blink reflex, none of which are present. This helps counteract what their eyes are telling them about a beating heart and warm skin.
• Imaging studies are not required to declare brain death but can help the family visualize what has happened. The black void of a cerebral blood flow study is quite stark, as is a massive stroke imaged by CT or MRI. The flat line of a patient’s EEG alongside a normal EEG conveys what a thousand words cannot.
• It is important to be respectful of dissenting opinions without implying agreement or acceptance of them. Too much deference to a family’s denial or delusions, which can easily occur if there is the overhanging threat of malpractice litigation, can be interpreted by the family as confirmation that there really was an unspoken ambiguity in the declaration of death by neurological criteria. The goal is to guide the family to acceptance of a tragic reality. It is neither wise nor compassionate to end up in a 3-week legal battle.
Dr. Powell practices as a hospitalist at SSM Cardinal Glennon Children’s Medical Center in St. Louis. He is associate professor of pediatrics at Saint Louis University. He is also listserv moderator for the AAP Section on Hospital Medicine and is a member of the Law and Bioethics Affinity Group of the American Society for Bioethics and Humanities. E-mail him at pdnews@frontlinemedcom.com.
On Dec. 9, 2013, a 13-year-old California girl underwent a tonsillectomy to alleviate obstructive sleep apnea. It’s a procedure performed a half-million times a year in the United States. She had postoperative bleeding. On Dec. 12th, she was declared dead by neurological criteria, colloquially called brain death. She remains on a ventilator. Her parents refuse to accept the diagnosis and obtained judicial injunctions ordering the physicians to not withdraw the ventilator. The tests to confirm death by neurological criteria have been repeated by several physicians, including one selected by the court, and the local coroner has issued a death certificate.
Death after tonsillectomy is rare but a known risk. A quick Google search finds many newspaper accounts of these heart-wrenching events. The most often cited risk of mortality is 1/15,000. That calculates out as 30 deaths per year in the United States related to the procedure. The mechanism is usually postoperative bleeding or allergy to the anesthesia.
The exact events that occurred in the California case of Jahi McMath, are protected by HIPAA. I have no access to facts other than what is being reported in the general media. When events like this occur, there often are allegations or suspicions of negligence. This is a natural emotional reaction stemming from disbelief, denial, and the desire to blame somebody for a highly unexpected tragedy. Sometimes those allegations are true, but that is for a court to decide. What has been unusual in this case is the prolonged legal battle over accepting the declaration of death.
The process of declaring death by neurological criteria is usually set in policies at each hospital in accordance with local resources, compliance with state laws that regulate medical practice, and nationally accepted criteria. These date back to a 1968 Harvard committee that created the criteria to deal with advances in medical technology, particularly ventilators, as well as the desire for facilitating organ donation (JAMA 1968;205:337-40). These criteria, and process for documenting them, have met widespread acceptance for 45 years, even within antiabortion circles such as the Catholic Church. Among Halacha-observant Jews, some rabbis do not accept these criteria while others affirm them. That difference of opinion is partly responsible for New Jersey being the only state with statutory recognition of a religious objection to the Harvard criteria. The most recent New York regulation calls for "reasonable accommodation" of those with religious objections and lays out the process of extensive testing.
In all other states, virtues of compassion and respect are the primary motivations for accommodating nonacceptance of the declaration of brain death. Many ICU doctors can tell stories of a case in which they delayed withdrawal of the ventilator and other technology from a brain-dead patient. Usually, it’s a delay of a few hours while some next of kin travels to bedside to be present at "the moment of death." In those instances, my practice has been to complete the death certificate using the earlier time at which death was determined by neurological criteria. This is important if organ harvest is involved.
Clarity amid care
There are fine points on the criteria and process of declaring brain death that are the subject of debate among medical ethicists, who are generally ready, willing, and able to argue about minutiae. One listserv for medical ethicists generated 280 postings in 5 days on this topic while the legal back and forth was occurring in California. I wish to emphasize two take-home messages.
First, this case is not about withdrawing life support or artificial nutrition and hydration from a patient in a coma or a persistent vegetative state.
A person in PVS is alive and has brain activity. Legal precedents, starting with the case of Karen Ann Quinlan in 1976 through Nancy Cruzan in 1990, established the legality and appropriateness of withdrawing life support from patients in PVS if that was their preference. Those precedents were revived and reaffirmed in the battle over Terry Schiavo in 2005. There are accounts of rare events in which people, after being in a deep coma (though less deep than PVS) for years, regained some awareness and ability to communicate. That is not the situation for properly diagnosed brain death. It is irreversible. There is no brain activity. There is no responsiveness other than spinal reflex, which can be misinterpreted by family members. Those movements are a source of moral distress for nurses required to care for a patient while the diagnosis of death is being confirmed.
Second, there are things that can be done to avoid the situation unfolding in California.
• Often these battles occur after some event has already broken the trust between the family and the medical staff. The unexpected death after a tonsillectomy could trigger this. It may take an outside resource, such as a mediator, or the ethics committee, to help bridge the distrust. Early involvement of these resources will usually prevent the adversarial relationship generated by going to court.
• Perform the neuro exam with the family present. They can see for themselves the large number of tests and reflexes, such as a blink reflex, none of which are present. This helps counteract what their eyes are telling them about a beating heart and warm skin.
• Imaging studies are not required to declare brain death but can help the family visualize what has happened. The black void of a cerebral blood flow study is quite stark, as is a massive stroke imaged by CT or MRI. The flat line of a patient’s EEG alongside a normal EEG conveys what a thousand words cannot.
• It is important to be respectful of dissenting opinions without implying agreement or acceptance of them. Too much deference to a family’s denial or delusions, which can easily occur if there is the overhanging threat of malpractice litigation, can be interpreted by the family as confirmation that there really was an unspoken ambiguity in the declaration of death by neurological criteria. The goal is to guide the family to acceptance of a tragic reality. It is neither wise nor compassionate to end up in a 3-week legal battle.
Dr. Powell practices as a hospitalist at SSM Cardinal Glennon Children’s Medical Center in St. Louis. He is associate professor of pediatrics at Saint Louis University. He is also listserv moderator for the AAP Section on Hospital Medicine and is a member of the Law and Bioethics Affinity Group of the American Society for Bioethics and Humanities. E-mail him at pdnews@frontlinemedcom.com.
Innovative therapy
Years ago, at a departmental meeting, the neurologists informed the general pediatricians that they were going to try out a new therapy for autism. Autism recently had been linked to inflammation of the gastrointestinal system. One of the articles that asserted that link is the now retracted Lancet article by Andrew Wakefield et al., which also falsely linked MMR and autism (Lancet 1998;35:637-41).
At the time, the misrepresentations in that article had not yet been fully revealed.
The treatment the neurologists were considering would utilize the hormone secretin. [Please note that the most recent Cochrane Review in 2012 reaffirmed the 2005 review repudiating this therapy (Cochrane Database Syst. Rev..2012 ;4 [doi: 10.1002/14651858.CD003495.pub3]). However, Mr. Wakefield is still advocating some form of therapy.] Secretin was first isolated in 1902 and has the distinction of being the first hormone isolated by Western science. A synthetic polypeptide analogue has been created. The local neurologists had read about this new therapy for autism and wanted to see if and how it worked. It is not unusual for new therapies to be adopted by subspecialists and then make their way into the armamentarium of general pediatricians. Most drugs I prescribe are not Food and Drug Administration approved in children, but have been adopted for use by other pediatricians and subspecialists.
The aforementioned multispecialty group did not participate in much clinical research. There was an active local institutional review board (IRB). However, in one of the strange paradoxes of medical law, as long as the neurologists were going to haphazardly try the secretin in a few cases, without any scientific control group and without any intention of publishing their results, they were free to do so if, in their professional opinion, they felt the innovative use of the medication might help. I warned them that if they made any attempt to compare results with other patients in an organized, scientific fashion, then IRB approval would be required. I expected that would be very difficult, if not impossible, to obtain.
There is a long and sad history of inadequate protection of research subjects in U.S. medicine. Some protections were put in place in the 1970s. Principles for those protections were outlined in the Belmont Report in 1978. From that report: "When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is ‘experimental,’ in the sense of new, untested or different, does not automatically place it in the category of research."
And so, we really have a three-tier system. Those who claim to be doing research should be following strict ethical guidelines, using carefully reviewed methodologies, publishing in peer-reviewed journals, and be overseen by the local IRB. The second tier consists of physicians who are taking FDA-approved medications and using them in off-label ways. A medical license grants a physician that right. It is, however, illegal for a pharmaceutical company to detail physicians on these off-label uses. The FDA has cracked down on that recently, including fining Pfizer $2.3 billion 4 years ago. Finally, in the bottom tier, we have late-night infomercials promising for 30 minutes how all these complementary therapies, nutraceuticals, and dietary supplements will make ailments go away while flashing for a few seconds on the screen the disclaimer: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."
People who watch late-night TV are fully availing themselves of their liberty, guaranteed by congressional action, to listen to ridiculous claims unfiltered by the science and conventional wisdom of the medical establishment. At the other extreme, the IRB protects research subjects, sometimes to excess. A group of hospitalists at 12 hospitals each sent surveys to 20 local physicians asking which details they would like to find in a discharge summary. That activity required each local investigator to take 3 hours of training on research protections. It also required approval by the local IRBs at each hospital.
In between these extremes, in everyday clinical practice, the primary form of protection is informed consent. Physicians have an obligation to provide the information that a reasonable patient would want to know in order to make a rational decision about embarking on a course of treatment. Failure to provide this is a breach of the standard of care, which means, if the patient suffers harm, they may have a good case for claiming malpractice.
There have been two recent news articles on this subject that caught my eye.
In the Oregon case, a physician denied wrongdoing but agreed in the future to inform his patients that he gets what could be construed as a kickback from the medical supply company for implanting a particular brand of pacemaker.
In the Sacramento case, two neurosurgeons resigned from the University of California, Davis, after a controversy over the inadequacy of research subject protections in their trial of a novel approach for treating a highly malignant brain cancer with "probiotic intracranial therapy," or the introduction of live bowel bacteria, Enterobacter aerogenes, directly into their patients’ brains or bone flaps. The doctors theorized that an infection might stimulate the patients’ immune systems and prolong their lives.
Physicians who use medications for off-label uses are well advised to be sure they are obtaining and documenting informed consent from their patients. Informed consent requires the physician to have provided all relevant details that a reasonable patient would want to know before making a decision. IRBs are in place to protect research subjects. There is a problem, however, with having a higher tier of protection and the associated burdensome paperwork. Powell’s 4th rule of medical ethics: If you raise the bar high enough, people walk under it.
Dr. Powell practices as a hospitalist at SSM Cardinal Glennon Children’s Medical Center in St. Louis. He is associate professor of pediatrics at Saint Louis University. He is also listserv moderator for the AAP Section on Hospital Medicine and is a member of the Law and Bioethics Affinity Group of the American Society for Bioethics and Humanities. He said that he had no financial conflicts of interest. Readers can e-mail Dr. Powell at pdnews@frontlinemedcom.com.
Years ago, at a departmental meeting, the neurologists informed the general pediatricians that they were going to try out a new therapy for autism. Autism recently had been linked to inflammation of the gastrointestinal system. One of the articles that asserted that link is the now retracted Lancet article by Andrew Wakefield et al., which also falsely linked MMR and autism (Lancet 1998;35:637-41).
At the time, the misrepresentations in that article had not yet been fully revealed.
The treatment the neurologists were considering would utilize the hormone secretin. [Please note that the most recent Cochrane Review in 2012 reaffirmed the 2005 review repudiating this therapy (Cochrane Database Syst. Rev..2012 ;4 [doi: 10.1002/14651858.CD003495.pub3]). However, Mr. Wakefield is still advocating some form of therapy.] Secretin was first isolated in 1902 and has the distinction of being the first hormone isolated by Western science. A synthetic polypeptide analogue has been created. The local neurologists had read about this new therapy for autism and wanted to see if and how it worked. It is not unusual for new therapies to be adopted by subspecialists and then make their way into the armamentarium of general pediatricians. Most drugs I prescribe are not Food and Drug Administration approved in children, but have been adopted for use by other pediatricians and subspecialists.
The aforementioned multispecialty group did not participate in much clinical research. There was an active local institutional review board (IRB). However, in one of the strange paradoxes of medical law, as long as the neurologists were going to haphazardly try the secretin in a few cases, without any scientific control group and without any intention of publishing their results, they were free to do so if, in their professional opinion, they felt the innovative use of the medication might help. I warned them that if they made any attempt to compare results with other patients in an organized, scientific fashion, then IRB approval would be required. I expected that would be very difficult, if not impossible, to obtain.
There is a long and sad history of inadequate protection of research subjects in U.S. medicine. Some protections were put in place in the 1970s. Principles for those protections were outlined in the Belmont Report in 1978. From that report: "When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is ‘experimental,’ in the sense of new, untested or different, does not automatically place it in the category of research."
And so, we really have a three-tier system. Those who claim to be doing research should be following strict ethical guidelines, using carefully reviewed methodologies, publishing in peer-reviewed journals, and be overseen by the local IRB. The second tier consists of physicians who are taking FDA-approved medications and using them in off-label ways. A medical license grants a physician that right. It is, however, illegal for a pharmaceutical company to detail physicians on these off-label uses. The FDA has cracked down on that recently, including fining Pfizer $2.3 billion 4 years ago. Finally, in the bottom tier, we have late-night infomercials promising for 30 minutes how all these complementary therapies, nutraceuticals, and dietary supplements will make ailments go away while flashing for a few seconds on the screen the disclaimer: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."
People who watch late-night TV are fully availing themselves of their liberty, guaranteed by congressional action, to listen to ridiculous claims unfiltered by the science and conventional wisdom of the medical establishment. At the other extreme, the IRB protects research subjects, sometimes to excess. A group of hospitalists at 12 hospitals each sent surveys to 20 local physicians asking which details they would like to find in a discharge summary. That activity required each local investigator to take 3 hours of training on research protections. It also required approval by the local IRBs at each hospital.
In between these extremes, in everyday clinical practice, the primary form of protection is informed consent. Physicians have an obligation to provide the information that a reasonable patient would want to know in order to make a rational decision about embarking on a course of treatment. Failure to provide this is a breach of the standard of care, which means, if the patient suffers harm, they may have a good case for claiming malpractice.
There have been two recent news articles on this subject that caught my eye.
In the Oregon case, a physician denied wrongdoing but agreed in the future to inform his patients that he gets what could be construed as a kickback from the medical supply company for implanting a particular brand of pacemaker.
In the Sacramento case, two neurosurgeons resigned from the University of California, Davis, after a controversy over the inadequacy of research subject protections in their trial of a novel approach for treating a highly malignant brain cancer with "probiotic intracranial therapy," or the introduction of live bowel bacteria, Enterobacter aerogenes, directly into their patients’ brains or bone flaps. The doctors theorized that an infection might stimulate the patients’ immune systems and prolong their lives.
Physicians who use medications for off-label uses are well advised to be sure they are obtaining and documenting informed consent from their patients. Informed consent requires the physician to have provided all relevant details that a reasonable patient would want to know before making a decision. IRBs are in place to protect research subjects. There is a problem, however, with having a higher tier of protection and the associated burdensome paperwork. Powell’s 4th rule of medical ethics: If you raise the bar high enough, people walk under it.
Dr. Powell practices as a hospitalist at SSM Cardinal Glennon Children’s Medical Center in St. Louis. He is associate professor of pediatrics at Saint Louis University. He is also listserv moderator for the AAP Section on Hospital Medicine and is a member of the Law and Bioethics Affinity Group of the American Society for Bioethics and Humanities. He said that he had no financial conflicts of interest. Readers can e-mail Dr. Powell at pdnews@frontlinemedcom.com.
Years ago, at a departmental meeting, the neurologists informed the general pediatricians that they were going to try out a new therapy for autism. Autism recently had been linked to inflammation of the gastrointestinal system. One of the articles that asserted that link is the now retracted Lancet article by Andrew Wakefield et al., which also falsely linked MMR and autism (Lancet 1998;35:637-41).
At the time, the misrepresentations in that article had not yet been fully revealed.
The treatment the neurologists were considering would utilize the hormone secretin. [Please note that the most recent Cochrane Review in 2012 reaffirmed the 2005 review repudiating this therapy (Cochrane Database Syst. Rev..2012 ;4 [doi: 10.1002/14651858.CD003495.pub3]). However, Mr. Wakefield is still advocating some form of therapy.] Secretin was first isolated in 1902 and has the distinction of being the first hormone isolated by Western science. A synthetic polypeptide analogue has been created. The local neurologists had read about this new therapy for autism and wanted to see if and how it worked. It is not unusual for new therapies to be adopted by subspecialists and then make their way into the armamentarium of general pediatricians. Most drugs I prescribe are not Food and Drug Administration approved in children, but have been adopted for use by other pediatricians and subspecialists.
The aforementioned multispecialty group did not participate in much clinical research. There was an active local institutional review board (IRB). However, in one of the strange paradoxes of medical law, as long as the neurologists were going to haphazardly try the secretin in a few cases, without any scientific control group and without any intention of publishing their results, they were free to do so if, in their professional opinion, they felt the innovative use of the medication might help. I warned them that if they made any attempt to compare results with other patients in an organized, scientific fashion, then IRB approval would be required. I expected that would be very difficult, if not impossible, to obtain.
There is a long and sad history of inadequate protection of research subjects in U.S. medicine. Some protections were put in place in the 1970s. Principles for those protections were outlined in the Belmont Report in 1978. From that report: "When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is ‘experimental,’ in the sense of new, untested or different, does not automatically place it in the category of research."
And so, we really have a three-tier system. Those who claim to be doing research should be following strict ethical guidelines, using carefully reviewed methodologies, publishing in peer-reviewed journals, and be overseen by the local IRB. The second tier consists of physicians who are taking FDA-approved medications and using them in off-label ways. A medical license grants a physician that right. It is, however, illegal for a pharmaceutical company to detail physicians on these off-label uses. The FDA has cracked down on that recently, including fining Pfizer $2.3 billion 4 years ago. Finally, in the bottom tier, we have late-night infomercials promising for 30 minutes how all these complementary therapies, nutraceuticals, and dietary supplements will make ailments go away while flashing for a few seconds on the screen the disclaimer: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."
People who watch late-night TV are fully availing themselves of their liberty, guaranteed by congressional action, to listen to ridiculous claims unfiltered by the science and conventional wisdom of the medical establishment. At the other extreme, the IRB protects research subjects, sometimes to excess. A group of hospitalists at 12 hospitals each sent surveys to 20 local physicians asking which details they would like to find in a discharge summary. That activity required each local investigator to take 3 hours of training on research protections. It also required approval by the local IRBs at each hospital.
In between these extremes, in everyday clinical practice, the primary form of protection is informed consent. Physicians have an obligation to provide the information that a reasonable patient would want to know in order to make a rational decision about embarking on a course of treatment. Failure to provide this is a breach of the standard of care, which means, if the patient suffers harm, they may have a good case for claiming malpractice.
There have been two recent news articles on this subject that caught my eye.
In the Oregon case, a physician denied wrongdoing but agreed in the future to inform his patients that he gets what could be construed as a kickback from the medical supply company for implanting a particular brand of pacemaker.
In the Sacramento case, two neurosurgeons resigned from the University of California, Davis, after a controversy over the inadequacy of research subject protections in their trial of a novel approach for treating a highly malignant brain cancer with "probiotic intracranial therapy," or the introduction of live bowel bacteria, Enterobacter aerogenes, directly into their patients’ brains or bone flaps. The doctors theorized that an infection might stimulate the patients’ immune systems and prolong their lives.
Physicians who use medications for off-label uses are well advised to be sure they are obtaining and documenting informed consent from their patients. Informed consent requires the physician to have provided all relevant details that a reasonable patient would want to know before making a decision. IRBs are in place to protect research subjects. There is a problem, however, with having a higher tier of protection and the associated burdensome paperwork. Powell’s 4th rule of medical ethics: If you raise the bar high enough, people walk under it.
Dr. Powell practices as a hospitalist at SSM Cardinal Glennon Children’s Medical Center in St. Louis. He is associate professor of pediatrics at Saint Louis University. He is also listserv moderator for the AAP Section on Hospital Medicine and is a member of the Law and Bioethics Affinity Group of the American Society for Bioethics and Humanities. He said that he had no financial conflicts of interest. Readers can e-mail Dr. Powell at pdnews@frontlinemedcom.com.
