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Dispelling four myths about the FDA
Does the U.S. Food and Drug Administration control the price of drugs? Do other countries approve drugs faster than the United States? Can the FDA tell doctors how to prescribe drugs? There is a lot of misinformation about exactly what the FDA does and doesn’t do. Here are the top four FDA myths … BUSTED!
Myth 1: Patients cannot get access to drugs they need because the FDA is too slow in approving drugs.
FACT: The FDA approves drugs faster on average than all other developed nations. That is 40 days faster than Japan; 70 days faster than Canada; and 174 days faster than the European Union (EU).1
People often say that drugs are being developed and made available to patients in other countries before they are marketed here in the United States. Physicians often gripe that their patients can’t get access to medicines that are available to others overseas. These anecdotes have led to the urban legend that the FDA evaluates and approves drugs at a slower rate than foreign agencies, especially the European Medicines Agency (EMA).
In a recent report by the British-based Centre for Innovation in Regulatory Science, “over 75% of the new drugs approved by Japan, EU, Canada, Australia, Switzerland, and FDA, from 2004 to 2013, were approved first by FDA.” The FDA continues to lead among regulatory agencies in drug approvals that ensure patients get access to the lifesaving medicines they need.
The U.S. Food and Drug Administration has significantly increased the speed by which new drugs reach patients in need. Between 2006 and 2010, three out of four new drugs approved in both Europe and the U.S. were first approved by the FDA. In the specific example of cancer, the FDA also approved 32 of the 35 prospective cancer drugs between 2003-2010, whereas the EMA only approved 26. Among those cancer drugs approved, over 90% were first approved by the FDA. Just last year, almost two-thirds of the novel drugs approved by the FDA (26 of 41 or about 63%) were approved in the United States before receiving approval in any other country.2
Myth 2: The FDA controls drug prices.
FACT: The FDA has no legal authority whatsoever to investigate or control the prices charged for marketed drugs. Manufacturers, distributors, and retailers establish these prices.
Drug prices do have a direct impact on the ability of people to cope with their illnesses as well as meet other expenses and the FDA recognizes that other factors beyond its purview, including insurance coverage and drug pricing, can determine patient access to drugs. However, the FDA has no legal authority whatsoever to investigate or control the prices charged for marketed drugs. Manufacturers, distributors, and retailers establish these prices.
The FDA is responsible for assuring the American public that the drugs approved today are safe and effective. In carrying out this responsibility, the FDA also works under the law to make medicines accessible to doctors and their patients through strategies such as expanding access to generic medicines, reducing the time and cost of bringing new medicines to market, as well as ensuring safe use practices and the most up-to-date information for health care professionals and patients.
Myth 3: The FDA conducts clinical trials.
FACT: The FDA does not develop, manufacture, or test drugs. The FDA does oversee the testing of new drugs to evaluate the safety and effectiveness profile in clinical trials.
Drug manufacturers submit full reports on the drug so that the FDA can evaluate their data. These studies are conducted to answer whether the drug in study works for the proposed indication. By completing a full review and analysis of the submitted data, the FDA assesses the benefit and risk of each drug to determine if the drug will be approved.
Companies must submit an investigational new drug (IND) application to the FDA before testing can begin. The IND is the means through which the sponsor obtains an exemption from the FDA to begin testing and legally transporting or distributing a drug under investigation across state lines.
The FDA’s role in the development of a new drug begins when the drug sponsor (usually the manufacturer or potential marketer) wants to test the diagnostic or therapeutic potential in humans (after having screened the new molecule for pharmacological activity and acute toxicity potential in animals). It is at this point that the molecule changes in legal status under the Federal Food, Drug, and Cosmetic Act and becomes a new drug subject to specific requirements of the drug regulatory system.3
Myth 4: The FDA regulates the practice of medicine.
FACT: The FDA regulates the approval of a drug, but not how it is prescribed. Doctors are permitted to prescribe a drug for any reason they think is medically appropriate.
The FDA creates the “drug label” in conjunction with the drug company to ensure that promotional claims are not false or misleading. The drug label of FDA-approved drugs provides information about the drug, including the approved doses and how the drug should be given to treat the medical condition for which it was approved.
However, physicians often use drugs in a way that is different from that described in the FDA-approved drug label, an “off-label” use. This can mean that the drug is:
• Used for a different disease or medical condition.
• Given in a different way (such as by a different route).
• Given in a different dose.
Off-label is also called “nonapproved” or “unapproved” use of a drug. Because drug makers have not put their drugs through the studies required by the FDA to officially approve the drug for new uses, new uses for these drugs should be taken with caution as the FDA has not reviewed the clinical evidence to support the new use. Any off-label drug usage should include a detailed conversation between physician and patient.4
Dr. John J. Whyte is the director of Professional Affairs and Stakeholder Engagement (PASE) in the FDA’s Center for Drug Evaluation and Research (CDER).
Does the U.S. Food and Drug Administration control the price of drugs? Do other countries approve drugs faster than the United States? Can the FDA tell doctors how to prescribe drugs? There is a lot of misinformation about exactly what the FDA does and doesn’t do. Here are the top four FDA myths … BUSTED!
Myth 1: Patients cannot get access to drugs they need because the FDA is too slow in approving drugs.
FACT: The FDA approves drugs faster on average than all other developed nations. That is 40 days faster than Japan; 70 days faster than Canada; and 174 days faster than the European Union (EU).1
People often say that drugs are being developed and made available to patients in other countries before they are marketed here in the United States. Physicians often gripe that their patients can’t get access to medicines that are available to others overseas. These anecdotes have led to the urban legend that the FDA evaluates and approves drugs at a slower rate than foreign agencies, especially the European Medicines Agency (EMA).
In a recent report by the British-based Centre for Innovation in Regulatory Science, “over 75% of the new drugs approved by Japan, EU, Canada, Australia, Switzerland, and FDA, from 2004 to 2013, were approved first by FDA.” The FDA continues to lead among regulatory agencies in drug approvals that ensure patients get access to the lifesaving medicines they need.
The U.S. Food and Drug Administration has significantly increased the speed by which new drugs reach patients in need. Between 2006 and 2010, three out of four new drugs approved in both Europe and the U.S. were first approved by the FDA. In the specific example of cancer, the FDA also approved 32 of the 35 prospective cancer drugs between 2003-2010, whereas the EMA only approved 26. Among those cancer drugs approved, over 90% were first approved by the FDA. Just last year, almost two-thirds of the novel drugs approved by the FDA (26 of 41 or about 63%) were approved in the United States before receiving approval in any other country.2
Myth 2: The FDA controls drug prices.
FACT: The FDA has no legal authority whatsoever to investigate or control the prices charged for marketed drugs. Manufacturers, distributors, and retailers establish these prices.
Drug prices do have a direct impact on the ability of people to cope with their illnesses as well as meet other expenses and the FDA recognizes that other factors beyond its purview, including insurance coverage and drug pricing, can determine patient access to drugs. However, the FDA has no legal authority whatsoever to investigate or control the prices charged for marketed drugs. Manufacturers, distributors, and retailers establish these prices.
The FDA is responsible for assuring the American public that the drugs approved today are safe and effective. In carrying out this responsibility, the FDA also works under the law to make medicines accessible to doctors and their patients through strategies such as expanding access to generic medicines, reducing the time and cost of bringing new medicines to market, as well as ensuring safe use practices and the most up-to-date information for health care professionals and patients.
Myth 3: The FDA conducts clinical trials.
FACT: The FDA does not develop, manufacture, or test drugs. The FDA does oversee the testing of new drugs to evaluate the safety and effectiveness profile in clinical trials.
Drug manufacturers submit full reports on the drug so that the FDA can evaluate their data. These studies are conducted to answer whether the drug in study works for the proposed indication. By completing a full review and analysis of the submitted data, the FDA assesses the benefit and risk of each drug to determine if the drug will be approved.
Companies must submit an investigational new drug (IND) application to the FDA before testing can begin. The IND is the means through which the sponsor obtains an exemption from the FDA to begin testing and legally transporting or distributing a drug under investigation across state lines.
The FDA’s role in the development of a new drug begins when the drug sponsor (usually the manufacturer or potential marketer) wants to test the diagnostic or therapeutic potential in humans (after having screened the new molecule for pharmacological activity and acute toxicity potential in animals). It is at this point that the molecule changes in legal status under the Federal Food, Drug, and Cosmetic Act and becomes a new drug subject to specific requirements of the drug regulatory system.3
Myth 4: The FDA regulates the practice of medicine.
FACT: The FDA regulates the approval of a drug, but not how it is prescribed. Doctors are permitted to prescribe a drug for any reason they think is medically appropriate.
The FDA creates the “drug label” in conjunction with the drug company to ensure that promotional claims are not false or misleading. The drug label of FDA-approved drugs provides information about the drug, including the approved doses and how the drug should be given to treat the medical condition for which it was approved.
However, physicians often use drugs in a way that is different from that described in the FDA-approved drug label, an “off-label” use. This can mean that the drug is:
• Used for a different disease or medical condition.
• Given in a different way (such as by a different route).
• Given in a different dose.
Off-label is also called “nonapproved” or “unapproved” use of a drug. Because drug makers have not put their drugs through the studies required by the FDA to officially approve the drug for new uses, new uses for these drugs should be taken with caution as the FDA has not reviewed the clinical evidence to support the new use. Any off-label drug usage should include a detailed conversation between physician and patient.4
Dr. John J. Whyte is the director of Professional Affairs and Stakeholder Engagement (PASE) in the FDA’s Center for Drug Evaluation and Research (CDER).
Does the U.S. Food and Drug Administration control the price of drugs? Do other countries approve drugs faster than the United States? Can the FDA tell doctors how to prescribe drugs? There is a lot of misinformation about exactly what the FDA does and doesn’t do. Here are the top four FDA myths … BUSTED!
Myth 1: Patients cannot get access to drugs they need because the FDA is too slow in approving drugs.
FACT: The FDA approves drugs faster on average than all other developed nations. That is 40 days faster than Japan; 70 days faster than Canada; and 174 days faster than the European Union (EU).1
People often say that drugs are being developed and made available to patients in other countries before they are marketed here in the United States. Physicians often gripe that their patients can’t get access to medicines that are available to others overseas. These anecdotes have led to the urban legend that the FDA evaluates and approves drugs at a slower rate than foreign agencies, especially the European Medicines Agency (EMA).
In a recent report by the British-based Centre for Innovation in Regulatory Science, “over 75% of the new drugs approved by Japan, EU, Canada, Australia, Switzerland, and FDA, from 2004 to 2013, were approved first by FDA.” The FDA continues to lead among regulatory agencies in drug approvals that ensure patients get access to the lifesaving medicines they need.
The U.S. Food and Drug Administration has significantly increased the speed by which new drugs reach patients in need. Between 2006 and 2010, three out of four new drugs approved in both Europe and the U.S. were first approved by the FDA. In the specific example of cancer, the FDA also approved 32 of the 35 prospective cancer drugs between 2003-2010, whereas the EMA only approved 26. Among those cancer drugs approved, over 90% were first approved by the FDA. Just last year, almost two-thirds of the novel drugs approved by the FDA (26 of 41 or about 63%) were approved in the United States before receiving approval in any other country.2
Myth 2: The FDA controls drug prices.
FACT: The FDA has no legal authority whatsoever to investigate or control the prices charged for marketed drugs. Manufacturers, distributors, and retailers establish these prices.
Drug prices do have a direct impact on the ability of people to cope with their illnesses as well as meet other expenses and the FDA recognizes that other factors beyond its purview, including insurance coverage and drug pricing, can determine patient access to drugs. However, the FDA has no legal authority whatsoever to investigate or control the prices charged for marketed drugs. Manufacturers, distributors, and retailers establish these prices.
The FDA is responsible for assuring the American public that the drugs approved today are safe and effective. In carrying out this responsibility, the FDA also works under the law to make medicines accessible to doctors and their patients through strategies such as expanding access to generic medicines, reducing the time and cost of bringing new medicines to market, as well as ensuring safe use practices and the most up-to-date information for health care professionals and patients.
Myth 3: The FDA conducts clinical trials.
FACT: The FDA does not develop, manufacture, or test drugs. The FDA does oversee the testing of new drugs to evaluate the safety and effectiveness profile in clinical trials.
Drug manufacturers submit full reports on the drug so that the FDA can evaluate their data. These studies are conducted to answer whether the drug in study works for the proposed indication. By completing a full review and analysis of the submitted data, the FDA assesses the benefit and risk of each drug to determine if the drug will be approved.
Companies must submit an investigational new drug (IND) application to the FDA before testing can begin. The IND is the means through which the sponsor obtains an exemption from the FDA to begin testing and legally transporting or distributing a drug under investigation across state lines.
The FDA’s role in the development of a new drug begins when the drug sponsor (usually the manufacturer or potential marketer) wants to test the diagnostic or therapeutic potential in humans (after having screened the new molecule for pharmacological activity and acute toxicity potential in animals). It is at this point that the molecule changes in legal status under the Federal Food, Drug, and Cosmetic Act and becomes a new drug subject to specific requirements of the drug regulatory system.3
Myth 4: The FDA regulates the practice of medicine.
FACT: The FDA regulates the approval of a drug, but not how it is prescribed. Doctors are permitted to prescribe a drug for any reason they think is medically appropriate.
The FDA creates the “drug label” in conjunction with the drug company to ensure that promotional claims are not false or misleading. The drug label of FDA-approved drugs provides information about the drug, including the approved doses and how the drug should be given to treat the medical condition for which it was approved.
However, physicians often use drugs in a way that is different from that described in the FDA-approved drug label, an “off-label” use. This can mean that the drug is:
• Used for a different disease or medical condition.
• Given in a different way (such as by a different route).
• Given in a different dose.
Off-label is also called “nonapproved” or “unapproved” use of a drug. Because drug makers have not put their drugs through the studies required by the FDA to officially approve the drug for new uses, new uses for these drugs should be taken with caution as the FDA has not reviewed the clinical evidence to support the new use. Any off-label drug usage should include a detailed conversation between physician and patient.4
Dr. John J. Whyte is the director of Professional Affairs and Stakeholder Engagement (PASE) in the FDA’s Center for Drug Evaluation and Research (CDER).
What if we are all they have?
I recently attended a CME conference at Johns Hopkins University titled “Infectious Diseases Update for Primary Care and Hospital Medicine.” As one would assume, some things were highly germane to my practice as a hospitalist, while others were, well, not relevant at all.
Don’t get me wrong, the conference was excellent and very thought provoking. It not only taught me clinically useful information, it challenged me to do more than I am used to doing for my patients; thus, I pass this challenge along to you.
One expert presented a case of an otherwise healthy patient who was found to have mildly elevated liver function tests on routine lab work done for life insurance purposes. His ALT and AST were 73 and 36, respectively, numbers that many of us would simply defer to the primary care provider to follow. But what if there is no primary care doctor? What if we are all they have?
Upon further evaluation, this patient was found to have hepatitis C. A more detailed history revealed that he had injected drugs with friends a few times over 20 years ago. The conference presenter shared statistics showing there are 2.7 million to 5 million people living with chronic HCV in America, and an estimated 45% to 60% of them are unaware of their disease – a disease that responds so well to treatment that simply screening baby boomers has the potential to prevent over 120,000 HCV-related deaths! It’s mind boggling to imagine how many people of all ages will die from this disease alone, completely oblivious to its existence.
Many people have obtained health insurance as a direct result of the Affordable Care Act, yet there are still many Americans who remain uninsured. When they are hospitalized for an acute illness, it may be the only encounter they have had with a medical professional in years. So, I ask the question again: What if we are all they have?
We can design all the elaborate hand-offs, discharge summaries, and patient instruction forms we want, but what if patients are unable to actually act on our “easy-to-understand” recommendations? Many of our patients will, out of embarrassment, nod their heads in agreement when we stress the extreme importance of following up with a primary care doctor and getting their prescriptions filled, knowing all the while that they simply don’t have the means to do so. I don’t think I will ever forget how out of touch I felt after giving a patient my spiel about taking his medication as prescribed to decrease his risk of a heart attack. He looked straight into my eyes and frankly, yet ever so respectively said, “Dr. Hester, I can either buy my medicine or I can eat.”
Sometimes it’s just that simple.
We all feel the urgency to provide high-quality care while keeping that care cost effective and time efficient, but hospitalists have a unique opportunity to not only serve our patients’ acute needs when they present via EMS to the ED, but to protect them from unforeseen catastrophes in the future. An extra (needed) test here and there, a little more time spent counseling on lifestyle changes, a few more minutes spent trying to help coordinate affordable (or free) follow-up care can all pay big dividends, and you may never have to see those patients in the hospital again. Isn’t that the goal?
Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at healthsavvy@aol.com.
I recently attended a CME conference at Johns Hopkins University titled “Infectious Diseases Update for Primary Care and Hospital Medicine.” As one would assume, some things were highly germane to my practice as a hospitalist, while others were, well, not relevant at all.
Don’t get me wrong, the conference was excellent and very thought provoking. It not only taught me clinically useful information, it challenged me to do more than I am used to doing for my patients; thus, I pass this challenge along to you.
One expert presented a case of an otherwise healthy patient who was found to have mildly elevated liver function tests on routine lab work done for life insurance purposes. His ALT and AST were 73 and 36, respectively, numbers that many of us would simply defer to the primary care provider to follow. But what if there is no primary care doctor? What if we are all they have?
Upon further evaluation, this patient was found to have hepatitis C. A more detailed history revealed that he had injected drugs with friends a few times over 20 years ago. The conference presenter shared statistics showing there are 2.7 million to 5 million people living with chronic HCV in America, and an estimated 45% to 60% of them are unaware of their disease – a disease that responds so well to treatment that simply screening baby boomers has the potential to prevent over 120,000 HCV-related deaths! It’s mind boggling to imagine how many people of all ages will die from this disease alone, completely oblivious to its existence.
Many people have obtained health insurance as a direct result of the Affordable Care Act, yet there are still many Americans who remain uninsured. When they are hospitalized for an acute illness, it may be the only encounter they have had with a medical professional in years. So, I ask the question again: What if we are all they have?
We can design all the elaborate hand-offs, discharge summaries, and patient instruction forms we want, but what if patients are unable to actually act on our “easy-to-understand” recommendations? Many of our patients will, out of embarrassment, nod their heads in agreement when we stress the extreme importance of following up with a primary care doctor and getting their prescriptions filled, knowing all the while that they simply don’t have the means to do so. I don’t think I will ever forget how out of touch I felt after giving a patient my spiel about taking his medication as prescribed to decrease his risk of a heart attack. He looked straight into my eyes and frankly, yet ever so respectively said, “Dr. Hester, I can either buy my medicine or I can eat.”
Sometimes it’s just that simple.
We all feel the urgency to provide high-quality care while keeping that care cost effective and time efficient, but hospitalists have a unique opportunity to not only serve our patients’ acute needs when they present via EMS to the ED, but to protect them from unforeseen catastrophes in the future. An extra (needed) test here and there, a little more time spent counseling on lifestyle changes, a few more minutes spent trying to help coordinate affordable (or free) follow-up care can all pay big dividends, and you may never have to see those patients in the hospital again. Isn’t that the goal?
Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at healthsavvy@aol.com.
I recently attended a CME conference at Johns Hopkins University titled “Infectious Diseases Update for Primary Care and Hospital Medicine.” As one would assume, some things were highly germane to my practice as a hospitalist, while others were, well, not relevant at all.
Don’t get me wrong, the conference was excellent and very thought provoking. It not only taught me clinically useful information, it challenged me to do more than I am used to doing for my patients; thus, I pass this challenge along to you.
One expert presented a case of an otherwise healthy patient who was found to have mildly elevated liver function tests on routine lab work done for life insurance purposes. His ALT and AST were 73 and 36, respectively, numbers that many of us would simply defer to the primary care provider to follow. But what if there is no primary care doctor? What if we are all they have?
Upon further evaluation, this patient was found to have hepatitis C. A more detailed history revealed that he had injected drugs with friends a few times over 20 years ago. The conference presenter shared statistics showing there are 2.7 million to 5 million people living with chronic HCV in America, and an estimated 45% to 60% of them are unaware of their disease – a disease that responds so well to treatment that simply screening baby boomers has the potential to prevent over 120,000 HCV-related deaths! It’s mind boggling to imagine how many people of all ages will die from this disease alone, completely oblivious to its existence.
Many people have obtained health insurance as a direct result of the Affordable Care Act, yet there are still many Americans who remain uninsured. When they are hospitalized for an acute illness, it may be the only encounter they have had with a medical professional in years. So, I ask the question again: What if we are all they have?
We can design all the elaborate hand-offs, discharge summaries, and patient instruction forms we want, but what if patients are unable to actually act on our “easy-to-understand” recommendations? Many of our patients will, out of embarrassment, nod their heads in agreement when we stress the extreme importance of following up with a primary care doctor and getting their prescriptions filled, knowing all the while that they simply don’t have the means to do so. I don’t think I will ever forget how out of touch I felt after giving a patient my spiel about taking his medication as prescribed to decrease his risk of a heart attack. He looked straight into my eyes and frankly, yet ever so respectively said, “Dr. Hester, I can either buy my medicine or I can eat.”
Sometimes it’s just that simple.
We all feel the urgency to provide high-quality care while keeping that care cost effective and time efficient, but hospitalists have a unique opportunity to not only serve our patients’ acute needs when they present via EMS to the ED, but to protect them from unforeseen catastrophes in the future. An extra (needed) test here and there, a little more time spent counseling on lifestyle changes, a few more minutes spent trying to help coordinate affordable (or free) follow-up care can all pay big dividends, and you may never have to see those patients in the hospital again. Isn’t that the goal?
Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at healthsavvy@aol.com.
Finally, an extra set of hands
In September 2015, the Centers for Medicare & Medicaid Services (CMS) launched a promising 4-year program called the "Transforming Clinical Practice Initiative" to lighten the load for family physicians.1 The central figures in this program are skilled and trained quality improvement advisors (QIA) who will work directly with physicians and their staffs to assist with the heavy lifting of practice improvement. The Oklahoma Physicians Research and Resources Network has used QIAs, which it calls practice enhancement assistants (PEAs), for more than 20 years to help Oklahoma family physicians improve various aspects of their practices, including testing processes, diabetes care, and preventive services. The PEAs have been enormously helpful.2
For this new CMS program, the feds awarded $685 million to 39 national and regional collaborative health care transformation networks and supporting organizations to develop peer-based learning networks to facilitate practice improvements.1 The program is designed to help more than 140,000 primary care physicians improve their practices by providing an extra set of skilled hands.
The American Board of Family Medicine (ABFM) and the American Academy of Family Physicians (AAFP) have teamed up to assist with this national effort. ABFM will cover the cost for the first 6000 family physicians who enroll in one of the regional Practice Transformation Networks to use their newly developed chronic disease registry called PRIME. This registry will extract clinical quality data from diverse electronic health records and report back to practices. The registry will meet the new federal quality measures reporting requirements and will also be a path for maintenance of certification.
The CMS Transforming Clinical Practice Initiative is a great opportunity to get that extra set of skilled hands you need to help meet new quality mandates and make your office more efficient and enjoyable for you, your staff, and your patients. Contact the ABFM (www.theabfm.org) to find out which organization is running the Practice Transformation Network in your area.
1. Centers for Medicare & Medicaid Services (CMS). Transforming clinical practice initiative awards. CMS Web site. Available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-09-29.html. Accessed December 15, 2015.
2. Nagykaldi Z, Mold JW, Robinson A, et al. Practice facilitators and practice-based research networks. J Am Board Fam Med. 2006;19:506-510.
In September 2015, the Centers for Medicare & Medicaid Services (CMS) launched a promising 4-year program called the "Transforming Clinical Practice Initiative" to lighten the load for family physicians.1 The central figures in this program are skilled and trained quality improvement advisors (QIA) who will work directly with physicians and their staffs to assist with the heavy lifting of practice improvement. The Oklahoma Physicians Research and Resources Network has used QIAs, which it calls practice enhancement assistants (PEAs), for more than 20 years to help Oklahoma family physicians improve various aspects of their practices, including testing processes, diabetes care, and preventive services. The PEAs have been enormously helpful.2
For this new CMS program, the feds awarded $685 million to 39 national and regional collaborative health care transformation networks and supporting organizations to develop peer-based learning networks to facilitate practice improvements.1 The program is designed to help more than 140,000 primary care physicians improve their practices by providing an extra set of skilled hands.
The American Board of Family Medicine (ABFM) and the American Academy of Family Physicians (AAFP) have teamed up to assist with this national effort. ABFM will cover the cost for the first 6000 family physicians who enroll in one of the regional Practice Transformation Networks to use their newly developed chronic disease registry called PRIME. This registry will extract clinical quality data from diverse electronic health records and report back to practices. The registry will meet the new federal quality measures reporting requirements and will also be a path for maintenance of certification.
The CMS Transforming Clinical Practice Initiative is a great opportunity to get that extra set of skilled hands you need to help meet new quality mandates and make your office more efficient and enjoyable for you, your staff, and your patients. Contact the ABFM (www.theabfm.org) to find out which organization is running the Practice Transformation Network in your area.
In September 2015, the Centers for Medicare & Medicaid Services (CMS) launched a promising 4-year program called the "Transforming Clinical Practice Initiative" to lighten the load for family physicians.1 The central figures in this program are skilled and trained quality improvement advisors (QIA) who will work directly with physicians and their staffs to assist with the heavy lifting of practice improvement. The Oklahoma Physicians Research and Resources Network has used QIAs, which it calls practice enhancement assistants (PEAs), for more than 20 years to help Oklahoma family physicians improve various aspects of their practices, including testing processes, diabetes care, and preventive services. The PEAs have been enormously helpful.2
For this new CMS program, the feds awarded $685 million to 39 national and regional collaborative health care transformation networks and supporting organizations to develop peer-based learning networks to facilitate practice improvements.1 The program is designed to help more than 140,000 primary care physicians improve their practices by providing an extra set of skilled hands.
The American Board of Family Medicine (ABFM) and the American Academy of Family Physicians (AAFP) have teamed up to assist with this national effort. ABFM will cover the cost for the first 6000 family physicians who enroll in one of the regional Practice Transformation Networks to use their newly developed chronic disease registry called PRIME. This registry will extract clinical quality data from diverse electronic health records and report back to practices. The registry will meet the new federal quality measures reporting requirements and will also be a path for maintenance of certification.
The CMS Transforming Clinical Practice Initiative is a great opportunity to get that extra set of skilled hands you need to help meet new quality mandates and make your office more efficient and enjoyable for you, your staff, and your patients. Contact the ABFM (www.theabfm.org) to find out which organization is running the Practice Transformation Network in your area.
1. Centers for Medicare & Medicaid Services (CMS). Transforming clinical practice initiative awards. CMS Web site. Available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-09-29.html. Accessed December 15, 2015.
2. Nagykaldi Z, Mold JW, Robinson A, et al. Practice facilitators and practice-based research networks. J Am Board Fam Med. 2006;19:506-510.
1. Centers for Medicare & Medicaid Services (CMS). Transforming clinical practice initiative awards. CMS Web site. Available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-09-29.html. Accessed December 15, 2015.
2. Nagykaldi Z, Mold JW, Robinson A, et al. Practice facilitators and practice-based research networks. J Am Board Fam Med. 2006;19:506-510.
Try to Remember …
How often do you misplace your keys or forget why you walked into a room? When I was younger, I dismissed things such as losing my train of thought (my nephew calls that a brain fart), a neglected errand (probably not important enough), or getting lost trying to go somewhere (never was good at directions anyway).
Know that I was never a “list maker.” I gave that up—because I often could not remember where I’d put it. Usually, once I wrote something down, I would eventually (in the same day) recall whatever was on it, so I wouldn’t fret about where I left that list.
Names? I could always tell you where we met, what you were wearing, and where you were sitting. But your name? Forget about it. (Those who have met me know the truth in that statement!)
During particularly stressful or busy times, if I found myself a bit more “absentminded” than usual, I would joke, “Of all the things I’ve lost, I miss my mind the most.”
Now I wonder: Just how serious are those instances of memory lapse? Yes, occasional memory lapses are part of normal aging. Just like our joints, our brains are not as young as they used to be. Even a 90-year-old with a healthy brain has experienced a loss of 10% brain cell volume.1 And let’s be honest, in celebrating major accomplishments (or failures), some of us have killed a few additional brain cells along the way (wink, wink).
We know that as we age, just as our stride has slowed, so too has the sharpness of our recall dulled. However, at what point are those misfires of our brain no longer a minor nuisance?
Data from the Administration on Aging document that in 2013, an estimated 44.7 million US residents were 65 or older.2 An estimated 5 million of them had Alzheimer disease. That translates to one in nine people—scary! This number, researchers predict, will increase to 13.8 million by 2050.3
Moreover, these statistics become more startling as we recognize that the cost of providing long-term and hospice care to people with Alzheimer disease (and other forms of dementia) is estimated to increase from $203 billion in 2013 to $1.2 trillion in 2050 (in 2013 dollars).4 Therefore, it is imperative for us, both as individuals and as health care professionals, to know the warning signs of dementia and be attentive to even seemingly subtle changes in behavior.
Early recognition that these changes are more than minor lapses in memory is important. Delays in diagnosis can result in a reduction of access to available treatments and resources. Yet, at what point do we start to consider those minor instances of forgetfulness not as normal but as indications of developing cognitive problems? My colleagues in gerontology tell us it is when those changes negatively affect activities of daily living and ability to function.
Continue for the difference between my lifelong “geographic handicap” and a form of dementia >>
What is the difference between my lifelong “geographic handicap” and a form of dementia? Would I (or any of my family or friends) recognize it? The diagnosis of dementia is not based on a sole symptom; rather, it requires the existence of at least two types of impairment that are significant and interfere with daily life.
Thankfully, I have adjusted to being “temporarily misplaced” (I don’t call it lost) and smiling at you whilst I try to remember your name. It may seem I jest or am insensitive to a grave health issue—but I am very serious about our need to pay attention to ourselves, to those we care for, and to those we care about (including neighbors). I now live in an area where a “silver alert” (missing elder) is an almost daily occurrence.
The table provides a comparison of normal-aging memory changes versus dementia symptoms; this is a tool we can use in practice and provide to our patients and their families.5 However, when changes in memory become so pervasive and severe that they are disrupting work, hobbies, social activities, and family relationships, we must recognize that they are the warning signs of Alzheimer disease.6 After reading multiple reports and guides, and witnessing the disease progression in neighbors, I share the three most significant hallmarks of the disease: impaired judgment, difficulty in recalling new information, and unusual behavior.7
It is important to remember—and to communicate to our patients—that memory loss itself does not meet the criteria for dementia. While some may be quick to fear that diagnosis, other factors that can contribute to cognitive problems are stress, depression, vitamin deficiency, thyroid disease, and even dehydration. All of these can be managed, with a resultant reversal of symptoms of memory loss.8 As always, a good health history, review of symptoms, and physical examination will guide us to an accurate diagnosis and plan of care.
There are multiple resources available for patients and families who receive a diagnosis of dementia or Alzheimer disease. Fear of the diagnosis need not blind us to the early warning signs. As NPs and PAs, despite our busy schedules, we must stop and listen to both the patient and the family, and ask the difficult questions about judgment and behavior in our aging patients.
REFERENCES
1. Doty L. Caregiving topics: early signs of dementia. http://alzonline.phhp.ufl.edu/en/reading/EarlySignsFeb08.pdf. Accessed December 11, 2015.
2. CDC. Older persons’ health. www.cdc.gov/nchs/fastats/older-american-health.htm. Accessed December 11, 2015.
3. Hebert LE, Weuve J, Scherr PA, Evans DL. Alzheimer disease in the United States (2010–2050) estimated using the 2010 census. Neurology. 2013;80:1778-1783.
4. Alzheimer’s Association. 2013 Alzheimer’s disease facts and figures. Alzheimers Dement. 2013;9(2):20-245.
5. Wayne M, White M, Smith M. Understanding dementia. www.helpguide.org/articles/alzheimers-dementia/understanding-dementia.htm. Accessed December 11, 2015.
6. Smith M, Robinson L, Segal R. Age-related memory loss. www.helpguide.org/articles/memory/age-related-memory-loss.htm. Accessed December 11, 2015.
7. A guide to coping with Alzheimer’s disease: a Harvard Medical School Special Health Report. www.health.harvard.edu/special-health-reports/a-guide-to-coping-with-alzheimers-disease. Accessed December 11, 2015.
8. HelpGuide.org. What’s causing your memory loss? www.helpguide.org/harvard/whats-causing-your-memory-loss.htm. Accessed December 11, 2015.
How often do you misplace your keys or forget why you walked into a room? When I was younger, I dismissed things such as losing my train of thought (my nephew calls that a brain fart), a neglected errand (probably not important enough), or getting lost trying to go somewhere (never was good at directions anyway).
Know that I was never a “list maker.” I gave that up—because I often could not remember where I’d put it. Usually, once I wrote something down, I would eventually (in the same day) recall whatever was on it, so I wouldn’t fret about where I left that list.
Names? I could always tell you where we met, what you were wearing, and where you were sitting. But your name? Forget about it. (Those who have met me know the truth in that statement!)
During particularly stressful or busy times, if I found myself a bit more “absentminded” than usual, I would joke, “Of all the things I’ve lost, I miss my mind the most.”
Now I wonder: Just how serious are those instances of memory lapse? Yes, occasional memory lapses are part of normal aging. Just like our joints, our brains are not as young as they used to be. Even a 90-year-old with a healthy brain has experienced a loss of 10% brain cell volume.1 And let’s be honest, in celebrating major accomplishments (or failures), some of us have killed a few additional brain cells along the way (wink, wink).
We know that as we age, just as our stride has slowed, so too has the sharpness of our recall dulled. However, at what point are those misfires of our brain no longer a minor nuisance?
Data from the Administration on Aging document that in 2013, an estimated 44.7 million US residents were 65 or older.2 An estimated 5 million of them had Alzheimer disease. That translates to one in nine people—scary! This number, researchers predict, will increase to 13.8 million by 2050.3
Moreover, these statistics become more startling as we recognize that the cost of providing long-term and hospice care to people with Alzheimer disease (and other forms of dementia) is estimated to increase from $203 billion in 2013 to $1.2 trillion in 2050 (in 2013 dollars).4 Therefore, it is imperative for us, both as individuals and as health care professionals, to know the warning signs of dementia and be attentive to even seemingly subtle changes in behavior.
Early recognition that these changes are more than minor lapses in memory is important. Delays in diagnosis can result in a reduction of access to available treatments and resources. Yet, at what point do we start to consider those minor instances of forgetfulness not as normal but as indications of developing cognitive problems? My colleagues in gerontology tell us it is when those changes negatively affect activities of daily living and ability to function.
Continue for the difference between my lifelong “geographic handicap” and a form of dementia >>
What is the difference between my lifelong “geographic handicap” and a form of dementia? Would I (or any of my family or friends) recognize it? The diagnosis of dementia is not based on a sole symptom; rather, it requires the existence of at least two types of impairment that are significant and interfere with daily life.
Thankfully, I have adjusted to being “temporarily misplaced” (I don’t call it lost) and smiling at you whilst I try to remember your name. It may seem I jest or am insensitive to a grave health issue—but I am very serious about our need to pay attention to ourselves, to those we care for, and to those we care about (including neighbors). I now live in an area where a “silver alert” (missing elder) is an almost daily occurrence.
The table provides a comparison of normal-aging memory changes versus dementia symptoms; this is a tool we can use in practice and provide to our patients and their families.5 However, when changes in memory become so pervasive and severe that they are disrupting work, hobbies, social activities, and family relationships, we must recognize that they are the warning signs of Alzheimer disease.6 After reading multiple reports and guides, and witnessing the disease progression in neighbors, I share the three most significant hallmarks of the disease: impaired judgment, difficulty in recalling new information, and unusual behavior.7
It is important to remember—and to communicate to our patients—that memory loss itself does not meet the criteria for dementia. While some may be quick to fear that diagnosis, other factors that can contribute to cognitive problems are stress, depression, vitamin deficiency, thyroid disease, and even dehydration. All of these can be managed, with a resultant reversal of symptoms of memory loss.8 As always, a good health history, review of symptoms, and physical examination will guide us to an accurate diagnosis and plan of care.
There are multiple resources available for patients and families who receive a diagnosis of dementia or Alzheimer disease. Fear of the diagnosis need not blind us to the early warning signs. As NPs and PAs, despite our busy schedules, we must stop and listen to both the patient and the family, and ask the difficult questions about judgment and behavior in our aging patients.
REFERENCES
1. Doty L. Caregiving topics: early signs of dementia. http://alzonline.phhp.ufl.edu/en/reading/EarlySignsFeb08.pdf. Accessed December 11, 2015.
2. CDC. Older persons’ health. www.cdc.gov/nchs/fastats/older-american-health.htm. Accessed December 11, 2015.
3. Hebert LE, Weuve J, Scherr PA, Evans DL. Alzheimer disease in the United States (2010–2050) estimated using the 2010 census. Neurology. 2013;80:1778-1783.
4. Alzheimer’s Association. 2013 Alzheimer’s disease facts and figures. Alzheimers Dement. 2013;9(2):20-245.
5. Wayne M, White M, Smith M. Understanding dementia. www.helpguide.org/articles/alzheimers-dementia/understanding-dementia.htm. Accessed December 11, 2015.
6. Smith M, Robinson L, Segal R. Age-related memory loss. www.helpguide.org/articles/memory/age-related-memory-loss.htm. Accessed December 11, 2015.
7. A guide to coping with Alzheimer’s disease: a Harvard Medical School Special Health Report. www.health.harvard.edu/special-health-reports/a-guide-to-coping-with-alzheimers-disease. Accessed December 11, 2015.
8. HelpGuide.org. What’s causing your memory loss? www.helpguide.org/harvard/whats-causing-your-memory-loss.htm. Accessed December 11, 2015.
How often do you misplace your keys or forget why you walked into a room? When I was younger, I dismissed things such as losing my train of thought (my nephew calls that a brain fart), a neglected errand (probably not important enough), or getting lost trying to go somewhere (never was good at directions anyway).
Know that I was never a “list maker.” I gave that up—because I often could not remember where I’d put it. Usually, once I wrote something down, I would eventually (in the same day) recall whatever was on it, so I wouldn’t fret about where I left that list.
Names? I could always tell you where we met, what you were wearing, and where you were sitting. But your name? Forget about it. (Those who have met me know the truth in that statement!)
During particularly stressful or busy times, if I found myself a bit more “absentminded” than usual, I would joke, “Of all the things I’ve lost, I miss my mind the most.”
Now I wonder: Just how serious are those instances of memory lapse? Yes, occasional memory lapses are part of normal aging. Just like our joints, our brains are not as young as they used to be. Even a 90-year-old with a healthy brain has experienced a loss of 10% brain cell volume.1 And let’s be honest, in celebrating major accomplishments (or failures), some of us have killed a few additional brain cells along the way (wink, wink).
We know that as we age, just as our stride has slowed, so too has the sharpness of our recall dulled. However, at what point are those misfires of our brain no longer a minor nuisance?
Data from the Administration on Aging document that in 2013, an estimated 44.7 million US residents were 65 or older.2 An estimated 5 million of them had Alzheimer disease. That translates to one in nine people—scary! This number, researchers predict, will increase to 13.8 million by 2050.3
Moreover, these statistics become more startling as we recognize that the cost of providing long-term and hospice care to people with Alzheimer disease (and other forms of dementia) is estimated to increase from $203 billion in 2013 to $1.2 trillion in 2050 (in 2013 dollars).4 Therefore, it is imperative for us, both as individuals and as health care professionals, to know the warning signs of dementia and be attentive to even seemingly subtle changes in behavior.
Early recognition that these changes are more than minor lapses in memory is important. Delays in diagnosis can result in a reduction of access to available treatments and resources. Yet, at what point do we start to consider those minor instances of forgetfulness not as normal but as indications of developing cognitive problems? My colleagues in gerontology tell us it is when those changes negatively affect activities of daily living and ability to function.
Continue for the difference between my lifelong “geographic handicap” and a form of dementia >>
What is the difference between my lifelong “geographic handicap” and a form of dementia? Would I (or any of my family or friends) recognize it? The diagnosis of dementia is not based on a sole symptom; rather, it requires the existence of at least two types of impairment that are significant and interfere with daily life.
Thankfully, I have adjusted to being “temporarily misplaced” (I don’t call it lost) and smiling at you whilst I try to remember your name. It may seem I jest or am insensitive to a grave health issue—but I am very serious about our need to pay attention to ourselves, to those we care for, and to those we care about (including neighbors). I now live in an area where a “silver alert” (missing elder) is an almost daily occurrence.
The table provides a comparison of normal-aging memory changes versus dementia symptoms; this is a tool we can use in practice and provide to our patients and their families.5 However, when changes in memory become so pervasive and severe that they are disrupting work, hobbies, social activities, and family relationships, we must recognize that they are the warning signs of Alzheimer disease.6 After reading multiple reports and guides, and witnessing the disease progression in neighbors, I share the three most significant hallmarks of the disease: impaired judgment, difficulty in recalling new information, and unusual behavior.7
It is important to remember—and to communicate to our patients—that memory loss itself does not meet the criteria for dementia. While some may be quick to fear that diagnosis, other factors that can contribute to cognitive problems are stress, depression, vitamin deficiency, thyroid disease, and even dehydration. All of these can be managed, with a resultant reversal of symptoms of memory loss.8 As always, a good health history, review of symptoms, and physical examination will guide us to an accurate diagnosis and plan of care.
There are multiple resources available for patients and families who receive a diagnosis of dementia or Alzheimer disease. Fear of the diagnosis need not blind us to the early warning signs. As NPs and PAs, despite our busy schedules, we must stop and listen to both the patient and the family, and ask the difficult questions about judgment and behavior in our aging patients.
REFERENCES
1. Doty L. Caregiving topics: early signs of dementia. http://alzonline.phhp.ufl.edu/en/reading/EarlySignsFeb08.pdf. Accessed December 11, 2015.
2. CDC. Older persons’ health. www.cdc.gov/nchs/fastats/older-american-health.htm. Accessed December 11, 2015.
3. Hebert LE, Weuve J, Scherr PA, Evans DL. Alzheimer disease in the United States (2010–2050) estimated using the 2010 census. Neurology. 2013;80:1778-1783.
4. Alzheimer’s Association. 2013 Alzheimer’s disease facts and figures. Alzheimers Dement. 2013;9(2):20-245.
5. Wayne M, White M, Smith M. Understanding dementia. www.helpguide.org/articles/alzheimers-dementia/understanding-dementia.htm. Accessed December 11, 2015.
6. Smith M, Robinson L, Segal R. Age-related memory loss. www.helpguide.org/articles/memory/age-related-memory-loss.htm. Accessed December 11, 2015.
7. A guide to coping with Alzheimer’s disease: a Harvard Medical School Special Health Report. www.health.harvard.edu/special-health-reports/a-guide-to-coping-with-alzheimers-disease. Accessed December 11, 2015.
8. HelpGuide.org. What’s causing your memory loss? www.helpguide.org/harvard/whats-causing-your-memory-loss.htm. Accessed December 11, 2015.
Chutzpah
Chutzpah is a Yiddish word that entered American English, joining bagel and nosh. The usual translations of chutzpah – “nerve” or “effrontery” – are correct enough, but leave out the zest implied by chutzpah’s classic case: a man who kills his parents and throws himself on the mercy of the court because he is an orphan.
We all meet patients with chutzpah, which can be amusing, impressive – even breathtaking.
Take for instance the woman who paged me one evening last month. “I visit your nurse for cosmetic stuff,” she said when I called her back. “Your prices for laser hair removal were high, though, so I went to a spa where I could use a Groupon.”
How nice, I thought.
“Anyhow,” she continued, “I went for a treatment at the spa today, and now I have little red bumps all over my thighs. I thought it might be a reaction, and since you are my dermatologist I called to ask what to do.”
Good to be needed.
Then the next week I got another call, this time from a man I hadn’t seen in a long time. “I really like you as a dermatologist,” he began.
“Thank you,” I murmured.
“I saw this spot on my leg that worried me,” he said. “I was going to show it to you, but your office is in an old building, and old buildings don’t agree with me.”
As I scratched my head, he went on. “So I went to another dermatologist who works in a newer building. He did a biopsy and told me I have skin cancer. He said I should have surgery to take it off. I consider you my dermatologist, though, so I called to ask whether you think surgery is a good idea.”
I said I thought it was. I did not add that he should look for an old surgeon in a new building.
These patients are fresh in my mind, but it doesn’t take much effort to come up with others.
“Mr. Skillman wants a refill on his steroid cream,” says my secretary.
“Sure,” I tell her. “E-scribe it over.”
“No,” she says. “He wants a hard copy mailed to him.”
“Does he have one of those mail order pharmacies that requires a written script?”
“No.”
“But it’s so much simpler to call it in or do it by computer. Why does he have to have a hard copy?”
“I don’t know. But he insists on having one.”
I could go on and on. So could you, I’m sure.
When confronted with chutzpah, you have two options: challenge the person showing it and refuse to go along with his demands, or just sigh, comply, and move on. In general, I go with option #2.
First of all, anyone pushy enough to act this way will not react well to being pushed back. (“What’s your problem? Are you too busy to write a prescription? Too stingy to mail it?”)
Second, and perhaps more to the point, many people who display chutzpah don’t know that’s what they are doing. The woman who went for laser at the Groupon spa really has no idea I’d think it odd for her to call me about a complication instead of the spa personnel who lasered her legs. On some level, she figures that they probably don’t know (look how cheap they are), and thinks I should be flattered to be asked. After all, I’m her dermatologist.
Some people with chutzpah are aggressive and difficult and don’t care if they’re being offensive. A lot more are just clueless. The fellow who bores the daylights out of everyone at dinner parties with long, pointless stories doesn’t know he’s being tedious. He just doesn’t pick up social cues.
Most patients, like most people, are polite and deferential. The rest, though, are more memorable.
My building is indeed old. One hundred years ago it was the swankiest apartment house around. Every flat had rooms for a butler, a maid, and a chauffeur for their Packard motorcar. Then the builder went belly-up during the Depression, and the new owner converted it to medical offices. Downward mobility works for me.
Faced with chutzpah, I shrug, smile, and get on with it. Enough people can still tolerate old buildings, and old dermatologists.
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. Write to him at dermnews@frontlinemedcom.com.
Chutzpah is a Yiddish word that entered American English, joining bagel and nosh. The usual translations of chutzpah – “nerve” or “effrontery” – are correct enough, but leave out the zest implied by chutzpah’s classic case: a man who kills his parents and throws himself on the mercy of the court because he is an orphan.
We all meet patients with chutzpah, which can be amusing, impressive – even breathtaking.
Take for instance the woman who paged me one evening last month. “I visit your nurse for cosmetic stuff,” she said when I called her back. “Your prices for laser hair removal were high, though, so I went to a spa where I could use a Groupon.”
How nice, I thought.
“Anyhow,” she continued, “I went for a treatment at the spa today, and now I have little red bumps all over my thighs. I thought it might be a reaction, and since you are my dermatologist I called to ask what to do.”
Good to be needed.
Then the next week I got another call, this time from a man I hadn’t seen in a long time. “I really like you as a dermatologist,” he began.
“Thank you,” I murmured.
“I saw this spot on my leg that worried me,” he said. “I was going to show it to you, but your office is in an old building, and old buildings don’t agree with me.”
As I scratched my head, he went on. “So I went to another dermatologist who works in a newer building. He did a biopsy and told me I have skin cancer. He said I should have surgery to take it off. I consider you my dermatologist, though, so I called to ask whether you think surgery is a good idea.”
I said I thought it was. I did not add that he should look for an old surgeon in a new building.
These patients are fresh in my mind, but it doesn’t take much effort to come up with others.
“Mr. Skillman wants a refill on his steroid cream,” says my secretary.
“Sure,” I tell her. “E-scribe it over.”
“No,” she says. “He wants a hard copy mailed to him.”
“Does he have one of those mail order pharmacies that requires a written script?”
“No.”
“But it’s so much simpler to call it in or do it by computer. Why does he have to have a hard copy?”
“I don’t know. But he insists on having one.”
I could go on and on. So could you, I’m sure.
When confronted with chutzpah, you have two options: challenge the person showing it and refuse to go along with his demands, or just sigh, comply, and move on. In general, I go with option #2.
First of all, anyone pushy enough to act this way will not react well to being pushed back. (“What’s your problem? Are you too busy to write a prescription? Too stingy to mail it?”)
Second, and perhaps more to the point, many people who display chutzpah don’t know that’s what they are doing. The woman who went for laser at the Groupon spa really has no idea I’d think it odd for her to call me about a complication instead of the spa personnel who lasered her legs. On some level, she figures that they probably don’t know (look how cheap they are), and thinks I should be flattered to be asked. After all, I’m her dermatologist.
Some people with chutzpah are aggressive and difficult and don’t care if they’re being offensive. A lot more are just clueless. The fellow who bores the daylights out of everyone at dinner parties with long, pointless stories doesn’t know he’s being tedious. He just doesn’t pick up social cues.
Most patients, like most people, are polite and deferential. The rest, though, are more memorable.
My building is indeed old. One hundred years ago it was the swankiest apartment house around. Every flat had rooms for a butler, a maid, and a chauffeur for their Packard motorcar. Then the builder went belly-up during the Depression, and the new owner converted it to medical offices. Downward mobility works for me.
Faced with chutzpah, I shrug, smile, and get on with it. Enough people can still tolerate old buildings, and old dermatologists.
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. Write to him at dermnews@frontlinemedcom.com.
Chutzpah is a Yiddish word that entered American English, joining bagel and nosh. The usual translations of chutzpah – “nerve” or “effrontery” – are correct enough, but leave out the zest implied by chutzpah’s classic case: a man who kills his parents and throws himself on the mercy of the court because he is an orphan.
We all meet patients with chutzpah, which can be amusing, impressive – even breathtaking.
Take for instance the woman who paged me one evening last month. “I visit your nurse for cosmetic stuff,” she said when I called her back. “Your prices for laser hair removal were high, though, so I went to a spa where I could use a Groupon.”
How nice, I thought.
“Anyhow,” she continued, “I went for a treatment at the spa today, and now I have little red bumps all over my thighs. I thought it might be a reaction, and since you are my dermatologist I called to ask what to do.”
Good to be needed.
Then the next week I got another call, this time from a man I hadn’t seen in a long time. “I really like you as a dermatologist,” he began.
“Thank you,” I murmured.
“I saw this spot on my leg that worried me,” he said. “I was going to show it to you, but your office is in an old building, and old buildings don’t agree with me.”
As I scratched my head, he went on. “So I went to another dermatologist who works in a newer building. He did a biopsy and told me I have skin cancer. He said I should have surgery to take it off. I consider you my dermatologist, though, so I called to ask whether you think surgery is a good idea.”
I said I thought it was. I did not add that he should look for an old surgeon in a new building.
These patients are fresh in my mind, but it doesn’t take much effort to come up with others.
“Mr. Skillman wants a refill on his steroid cream,” says my secretary.
“Sure,” I tell her. “E-scribe it over.”
“No,” she says. “He wants a hard copy mailed to him.”
“Does he have one of those mail order pharmacies that requires a written script?”
“No.”
“But it’s so much simpler to call it in or do it by computer. Why does he have to have a hard copy?”
“I don’t know. But he insists on having one.”
I could go on and on. So could you, I’m sure.
When confronted with chutzpah, you have two options: challenge the person showing it and refuse to go along with his demands, or just sigh, comply, and move on. In general, I go with option #2.
First of all, anyone pushy enough to act this way will not react well to being pushed back. (“What’s your problem? Are you too busy to write a prescription? Too stingy to mail it?”)
Second, and perhaps more to the point, many people who display chutzpah don’t know that’s what they are doing. The woman who went for laser at the Groupon spa really has no idea I’d think it odd for her to call me about a complication instead of the spa personnel who lasered her legs. On some level, she figures that they probably don’t know (look how cheap they are), and thinks I should be flattered to be asked. After all, I’m her dermatologist.
Some people with chutzpah are aggressive and difficult and don’t care if they’re being offensive. A lot more are just clueless. The fellow who bores the daylights out of everyone at dinner parties with long, pointless stories doesn’t know he’s being tedious. He just doesn’t pick up social cues.
Most patients, like most people, are polite and deferential. The rest, though, are more memorable.
My building is indeed old. One hundred years ago it was the swankiest apartment house around. Every flat had rooms for a butler, a maid, and a chauffeur for their Packard motorcar. Then the builder went belly-up during the Depression, and the new owner converted it to medical offices. Downward mobility works for me.
Faced with chutzpah, I shrug, smile, and get on with it. Enough people can still tolerate old buildings, and old dermatologists.
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. Write to him at dermnews@frontlinemedcom.com.
Self-directed learning
Never before in history has medicine progressed as quickly as it does today. The half-life of knowledge and practices is shortening, and the ocean of literature continues to amass every day. In this context, it is simply not possible for training programs to teach in didactics everything residents must know to become competent, much less excellent, doctors. Self-directed learning has become a critical part of residents’ education.
How can we make self-directed learning a more successful process? Attending physicians are likely to answer with the old saying, ‘You can lead a horse to water, but you can’t make it drink!’ While this saying points to the fact that self-directed learning requires a thirsty horse, it takes for granted the role of the guide in showing where water is plentiful. We argue that residents’ self-directed learning can be made more successful by recognizing the role of attendings in this process.
In an era of infinite resources, the limiting factor to learning has become time. The more we learn, the more humbled we are by the vastness of what we don’t know. Self-directed learners must be smart in deciding what should be learned. Herein lies the value of attendings, who, whether we are aware or not, shape our learning simply by virtue of their example. We would do well to pay closer attention to them. No textbook can replace their vast experience, which allows them to hone in on relevant details, to quickly develop comprehensive differentials, or revise plans.
But this learning cannot be based on simply observing and blindly emulating our teachers. We refer to Dr. Bloom’s taxonomy for levels of cognitive learning, in saying that these steps will only get us to the most basic levels of learning, which is “knowing” a disease to the extent that we can apply that knowledge in patient care. These can be acquired without significant mental effort; just by listening to morning reports, reading quick tidbits in between taking care of patients, etc. The goal, however, should be utilizing this basic knowledge as a foundation to develop higher levels of learning, namely Analysis, Synthesis, and Evaluation.
An example for analysis would be quickly going over each of the differentials in a disease and learning what distinguishes them. Synthesis is integrating different ideas and creating a customized plan for the particular patient that is found in no book. Lastly, evaluation is the level of cognition needed to be able to appraise and critique the large volume of opinion that we come across, establish our own opinion, and be able to defend it.
Here again our attendings are valuable resources who can guide us in reaching each of these levels. We must be willing to challenge ourselves by challenging our attendings when things do not make sense. It means always questioning why your attending physician made one medical decision versus another. It means also to challenge what we think we know, in order to discover what we don’t know. … Returning to the old adage, perhaps the key to self-directed learning is for the horse to learn his masters’ ways to the well, so he may adapt to an ever-changing environment.
Dr. Hung and Dr. Ramakrishna are pediatric residents at the Metrohealth Medical Center in Cleveland, Ohio. Email them at pdnews@frontlinemedcom.com.
Never before in history has medicine progressed as quickly as it does today. The half-life of knowledge and practices is shortening, and the ocean of literature continues to amass every day. In this context, it is simply not possible for training programs to teach in didactics everything residents must know to become competent, much less excellent, doctors. Self-directed learning has become a critical part of residents’ education.
How can we make self-directed learning a more successful process? Attending physicians are likely to answer with the old saying, ‘You can lead a horse to water, but you can’t make it drink!’ While this saying points to the fact that self-directed learning requires a thirsty horse, it takes for granted the role of the guide in showing where water is plentiful. We argue that residents’ self-directed learning can be made more successful by recognizing the role of attendings in this process.
In an era of infinite resources, the limiting factor to learning has become time. The more we learn, the more humbled we are by the vastness of what we don’t know. Self-directed learners must be smart in deciding what should be learned. Herein lies the value of attendings, who, whether we are aware or not, shape our learning simply by virtue of their example. We would do well to pay closer attention to them. No textbook can replace their vast experience, which allows them to hone in on relevant details, to quickly develop comprehensive differentials, or revise plans.
But this learning cannot be based on simply observing and blindly emulating our teachers. We refer to Dr. Bloom’s taxonomy for levels of cognitive learning, in saying that these steps will only get us to the most basic levels of learning, which is “knowing” a disease to the extent that we can apply that knowledge in patient care. These can be acquired without significant mental effort; just by listening to morning reports, reading quick tidbits in between taking care of patients, etc. The goal, however, should be utilizing this basic knowledge as a foundation to develop higher levels of learning, namely Analysis, Synthesis, and Evaluation.
An example for analysis would be quickly going over each of the differentials in a disease and learning what distinguishes them. Synthesis is integrating different ideas and creating a customized plan for the particular patient that is found in no book. Lastly, evaluation is the level of cognition needed to be able to appraise and critique the large volume of opinion that we come across, establish our own opinion, and be able to defend it.
Here again our attendings are valuable resources who can guide us in reaching each of these levels. We must be willing to challenge ourselves by challenging our attendings when things do not make sense. It means always questioning why your attending physician made one medical decision versus another. It means also to challenge what we think we know, in order to discover what we don’t know. … Returning to the old adage, perhaps the key to self-directed learning is for the horse to learn his masters’ ways to the well, so he may adapt to an ever-changing environment.
Dr. Hung and Dr. Ramakrishna are pediatric residents at the Metrohealth Medical Center in Cleveland, Ohio. Email them at pdnews@frontlinemedcom.com.
Never before in history has medicine progressed as quickly as it does today. The half-life of knowledge and practices is shortening, and the ocean of literature continues to amass every day. In this context, it is simply not possible for training programs to teach in didactics everything residents must know to become competent, much less excellent, doctors. Self-directed learning has become a critical part of residents’ education.
How can we make self-directed learning a more successful process? Attending physicians are likely to answer with the old saying, ‘You can lead a horse to water, but you can’t make it drink!’ While this saying points to the fact that self-directed learning requires a thirsty horse, it takes for granted the role of the guide in showing where water is plentiful. We argue that residents’ self-directed learning can be made more successful by recognizing the role of attendings in this process.
In an era of infinite resources, the limiting factor to learning has become time. The more we learn, the more humbled we are by the vastness of what we don’t know. Self-directed learners must be smart in deciding what should be learned. Herein lies the value of attendings, who, whether we are aware or not, shape our learning simply by virtue of their example. We would do well to pay closer attention to them. No textbook can replace their vast experience, which allows them to hone in on relevant details, to quickly develop comprehensive differentials, or revise plans.
But this learning cannot be based on simply observing and blindly emulating our teachers. We refer to Dr. Bloom’s taxonomy for levels of cognitive learning, in saying that these steps will only get us to the most basic levels of learning, which is “knowing” a disease to the extent that we can apply that knowledge in patient care. These can be acquired without significant mental effort; just by listening to morning reports, reading quick tidbits in between taking care of patients, etc. The goal, however, should be utilizing this basic knowledge as a foundation to develop higher levels of learning, namely Analysis, Synthesis, and Evaluation.
An example for analysis would be quickly going over each of the differentials in a disease and learning what distinguishes them. Synthesis is integrating different ideas and creating a customized plan for the particular patient that is found in no book. Lastly, evaluation is the level of cognition needed to be able to appraise and critique the large volume of opinion that we come across, establish our own opinion, and be able to defend it.
Here again our attendings are valuable resources who can guide us in reaching each of these levels. We must be willing to challenge ourselves by challenging our attendings when things do not make sense. It means always questioning why your attending physician made one medical decision versus another. It means also to challenge what we think we know, in order to discover what we don’t know. … Returning to the old adage, perhaps the key to self-directed learning is for the horse to learn his masters’ ways to the well, so he may adapt to an ever-changing environment.
Dr. Hung and Dr. Ramakrishna are pediatric residents at the Metrohealth Medical Center in Cleveland, Ohio. Email them at pdnews@frontlinemedcom.com.
Guidance for parents of LGBT youth
Two years ago, a mother of one of my patients asked me for advice. She knew that her daughter identified as lesbian, and she was fully supportive. One day, her daughter wanted to go to a sleepover at a female friend’s house. Her first reaction was to say yes, but then she had second thoughts: If her daughter were straight, and this friend were male, she would not allow her to go because of the potential for sexual activity. When she told her daughter she could not attend the sleepover, her daughter accused her of not letting her go because of her sexual orientation. And now, the dilemma: In her effort to be fair and consistent with her values, the mother is being accused of discrimination. What should she do?
Parents play an irreplaceable role in the life of any teen, especially in the lives of teens that identify as lesbian, gay, bisexual, or transgender (LGBT). But many LGBT youth face serious challenges with their parents. They face the potential of parental rejection of their sexual or gender identity. At the very worst, teens may face homelessness if they come out to homophobic parents.1 Youth whose parents are accepting, nevertheless, are less likely to have mental health problems or engage in substance use.2
As a clinical provider for children and adolescents, caregivers will ask you for advice on how to address parenting challenges. Because LGBT youth are at risk for many adverse health outcomes, and parental support is paramount in preventing them, this is an opportunity for you to help this vulnerable population.
If parents ask you how to be supportive of their LGBT children, here are some recommendations, which are based on an intervention by colleagues at the University of Utah:3
1. Let their affection show. Receiving news that a child is LGBT can be emotionally intense for parents.4 Because of this emotional intensity, parents may react negatively and neglect to show their love for their child, which is what the child is seeking. Parents showing affection is the first step in supporting their LGBT child. Remind parents to tell their child that they love them no matter what.
2. Avoid rejecting behaviors. This is sometimes hard, because some forms of rejection can be quite subtle. Avoid saying anything that may indicate a negative view of LGBT people, even if it is not intended. For example, saying that something is “gay” may seem innocent enough, but it sends the message that being gay is something to be ashamed of.
3. Express their pain away from their child. Evidence shows that minimizing a child’s exposure to parental conflict and stress is associated with better coping with these devastating events.5 Parents should avoid telling their children that news of their sexual orientation or gender identity upsets them, as this is another form of rejecting behavior.
4. Do good before they feel good. Previous studies suggest that changes in behavior can occur even though a person may feel otherwise.6 Negative feelings about a child’s sexual orientation or gender identity can last months or years.7 It’s okay to have these feelings, but showing support such as telling their child how they still love them can ultimately lead to acceptance.
Although it is important for parents to accept their child, it is only half the battle. If you remember Baumrind’s theory on parenting, there are two sides of parenting. The first side involves parents showing their affection, love, and support for their children, which I described earlier. The other side involves managing a child’s behaviors, whether parents create an environment that makes it difficult to engage in behaviors they disapprove of or teach their children how to make the right decision.8 Many LGBT youth engage in risky behaviors because it’s a way of coping in a homophobic environment. The parents’ job is to teach their children healthier coping strategies.
Research on this aspect of parenting in LGBT youth is still at its infancy, and some of it is not reassuring. One important behavior, parental monitoring, which is “a set of correlated parenting behaviors involving attention to and tracking of the child’s whereabouts, activities, and adaptations,”9 can prevent conduct disorders, substance use, and mental health problems in the typical teenager.10 Unfortunately, we don’t find the same results for sexual minorities. One study suggests that parental monitoring may not prevent high-risk sexual behavior for young gay males, even if the parent is aware of the young man’s sexual orientation.11
This doesn’t mean that parental monitoring isn’t helpful. This just means that parenting LGBT youth is different than parenting heterosexual youth. It’s not enough for parents to just accept their child’s sexual orientation. They also must help them make the right decisions taking into consideration the effect of stigma and discrimination on sexual minorities. There are a couple of things you can suggest to your parents to help them raise their LGBT children:
1. Be proactive. Join organizations that support parents of LGBT youth such as Parents, Families, and Friends of Lesbians and Gays (PFLAG). Also, parents must be aware of their children’s behavior. If they are acting depressed, seek help. Having depression or anxiety increases the chances of engaging in risky behaviors, so the earlier parents address this, the better.
2. Make their child know what their views are on high risk-behaviors, such as substance use or having unprotected sex. They need to communicate their expectations clearly. If parents believe that drinking alcohol before the legal age is wrong, they should clearly let their children know that.
3. Make it easier for their child to tell parents what’s going on in their lives. Parents have to gain their children’s trust, be accessible (don’t answer texts while talking to them!), and be an active listener. LGBT youth may not ask parents for advice because they feel that because their parents are straight or cisgender, their life experiences do not apply. Being a member of an organization like PLFAG can be helpful, because parents can ask other parents who have experience raising LGBT youth for advice that works.
4. If parents’ children do something wrong, they should talk to them about how their actions were risky. Children will listen to parents if they view their parenting as legitimate and fair, which can only happen if there is a strong parent-child relationship. Being supportive of a child’s sexual orientation or gender identity is key here. And for the next time, it’s always good to role-play a scenario (for example, what to do if someone tries to make them drink at a party).
Parents of LGBT youth face many challenges. You can help these parents by encouraging them to accept and support their child’s sexual orientation or gender identity and provide parenting strategies relevant for LGBT youth. Most important of all, encourage them to seek support through organizations like PFLAG. With this support, parents can encourage healthy development in LGBT youth.
Resources for parents of LGBT youth
• The Centers for Disease Control and Prevention (CDC) has information on the health of LGBT Youth and advice on parental monitoring in general.
• The Family Acceptance Project is a project researching ways to improve parent-child relationships in LGBT Youth.
• PFLAG is an organization that provides support for families of LGBT youth.
• Lead with Love is a film about how various types of families react to their children coming out to them.
References
1. J Sex Res. 2004 Nov;41(4):329-42.
2. Aust N Z J Psychiatry. 2010 Sep;44(9):774-83.
3. Huebner D. “Leading with Love: Interventions to Support Families of Lesbian, Gay, and Bisexual Adolescents,” The Register Report, Vol. 39. National Register of Health Service Psychologists, Spring 2013.
4. J GLBT Fam Stud. 2014 Jan;10(1-2):36-57.
5. Prof Psychol Res Pr. 2008 Apr;39(2):113-21.
6. “Behaviorism: Classic Studies” (Casper, Wyo: Endeavor Books/Mountain States Litho, 2009).
7. Journal of LGBT Issues in Counseling. 2008;2(2):126-58.
8. Genet Psychol Monogr. 1967;75(1):43-88.
9. Clin Child Fam Psychol Rev. 1998 Mar;1(1):61-75.
10. “Parental Monitoring of Adolescents: Current Perspectives for Researchers and Practitioners” (New York: Columbia University Press, 2010).
11. AIDS Behav. 2014 Aug;18(8):1604-14.
Dr. Montano is an adolescent medicine fellow at Children’s Hospital of Pittsburgh of UPMC and a postdoctoral fellow in the department of pediatrics at the University of Pittsburgh. Email him at pdnews@frontlinemedcom.com.
Two years ago, a mother of one of my patients asked me for advice. She knew that her daughter identified as lesbian, and she was fully supportive. One day, her daughter wanted to go to a sleepover at a female friend’s house. Her first reaction was to say yes, but then she had second thoughts: If her daughter were straight, and this friend were male, she would not allow her to go because of the potential for sexual activity. When she told her daughter she could not attend the sleepover, her daughter accused her of not letting her go because of her sexual orientation. And now, the dilemma: In her effort to be fair and consistent with her values, the mother is being accused of discrimination. What should she do?
Parents play an irreplaceable role in the life of any teen, especially in the lives of teens that identify as lesbian, gay, bisexual, or transgender (LGBT). But many LGBT youth face serious challenges with their parents. They face the potential of parental rejection of their sexual or gender identity. At the very worst, teens may face homelessness if they come out to homophobic parents.1 Youth whose parents are accepting, nevertheless, are less likely to have mental health problems or engage in substance use.2
As a clinical provider for children and adolescents, caregivers will ask you for advice on how to address parenting challenges. Because LGBT youth are at risk for many adverse health outcomes, and parental support is paramount in preventing them, this is an opportunity for you to help this vulnerable population.
If parents ask you how to be supportive of their LGBT children, here are some recommendations, which are based on an intervention by colleagues at the University of Utah:3
1. Let their affection show. Receiving news that a child is LGBT can be emotionally intense for parents.4 Because of this emotional intensity, parents may react negatively and neglect to show their love for their child, which is what the child is seeking. Parents showing affection is the first step in supporting their LGBT child. Remind parents to tell their child that they love them no matter what.
2. Avoid rejecting behaviors. This is sometimes hard, because some forms of rejection can be quite subtle. Avoid saying anything that may indicate a negative view of LGBT people, even if it is not intended. For example, saying that something is “gay” may seem innocent enough, but it sends the message that being gay is something to be ashamed of.
3. Express their pain away from their child. Evidence shows that minimizing a child’s exposure to parental conflict and stress is associated with better coping with these devastating events.5 Parents should avoid telling their children that news of their sexual orientation or gender identity upsets them, as this is another form of rejecting behavior.
4. Do good before they feel good. Previous studies suggest that changes in behavior can occur even though a person may feel otherwise.6 Negative feelings about a child’s sexual orientation or gender identity can last months or years.7 It’s okay to have these feelings, but showing support such as telling their child how they still love them can ultimately lead to acceptance.
Although it is important for parents to accept their child, it is only half the battle. If you remember Baumrind’s theory on parenting, there are two sides of parenting. The first side involves parents showing their affection, love, and support for their children, which I described earlier. The other side involves managing a child’s behaviors, whether parents create an environment that makes it difficult to engage in behaviors they disapprove of or teach their children how to make the right decision.8 Many LGBT youth engage in risky behaviors because it’s a way of coping in a homophobic environment. The parents’ job is to teach their children healthier coping strategies.
Research on this aspect of parenting in LGBT youth is still at its infancy, and some of it is not reassuring. One important behavior, parental monitoring, which is “a set of correlated parenting behaviors involving attention to and tracking of the child’s whereabouts, activities, and adaptations,”9 can prevent conduct disorders, substance use, and mental health problems in the typical teenager.10 Unfortunately, we don’t find the same results for sexual minorities. One study suggests that parental monitoring may not prevent high-risk sexual behavior for young gay males, even if the parent is aware of the young man’s sexual orientation.11
This doesn’t mean that parental monitoring isn’t helpful. This just means that parenting LGBT youth is different than parenting heterosexual youth. It’s not enough for parents to just accept their child’s sexual orientation. They also must help them make the right decisions taking into consideration the effect of stigma and discrimination on sexual minorities. There are a couple of things you can suggest to your parents to help them raise their LGBT children:
1. Be proactive. Join organizations that support parents of LGBT youth such as Parents, Families, and Friends of Lesbians and Gays (PFLAG). Also, parents must be aware of their children’s behavior. If they are acting depressed, seek help. Having depression or anxiety increases the chances of engaging in risky behaviors, so the earlier parents address this, the better.
2. Make their child know what their views are on high risk-behaviors, such as substance use or having unprotected sex. They need to communicate their expectations clearly. If parents believe that drinking alcohol before the legal age is wrong, they should clearly let their children know that.
3. Make it easier for their child to tell parents what’s going on in their lives. Parents have to gain their children’s trust, be accessible (don’t answer texts while talking to them!), and be an active listener. LGBT youth may not ask parents for advice because they feel that because their parents are straight or cisgender, their life experiences do not apply. Being a member of an organization like PLFAG can be helpful, because parents can ask other parents who have experience raising LGBT youth for advice that works.
4. If parents’ children do something wrong, they should talk to them about how their actions were risky. Children will listen to parents if they view their parenting as legitimate and fair, which can only happen if there is a strong parent-child relationship. Being supportive of a child’s sexual orientation or gender identity is key here. And for the next time, it’s always good to role-play a scenario (for example, what to do if someone tries to make them drink at a party).
Parents of LGBT youth face many challenges. You can help these parents by encouraging them to accept and support their child’s sexual orientation or gender identity and provide parenting strategies relevant for LGBT youth. Most important of all, encourage them to seek support through organizations like PFLAG. With this support, parents can encourage healthy development in LGBT youth.
Resources for parents of LGBT youth
• The Centers for Disease Control and Prevention (CDC) has information on the health of LGBT Youth and advice on parental monitoring in general.
• The Family Acceptance Project is a project researching ways to improve parent-child relationships in LGBT Youth.
• PFLAG is an organization that provides support for families of LGBT youth.
• Lead with Love is a film about how various types of families react to their children coming out to them.
References
1. J Sex Res. 2004 Nov;41(4):329-42.
2. Aust N Z J Psychiatry. 2010 Sep;44(9):774-83.
3. Huebner D. “Leading with Love: Interventions to Support Families of Lesbian, Gay, and Bisexual Adolescents,” The Register Report, Vol. 39. National Register of Health Service Psychologists, Spring 2013.
4. J GLBT Fam Stud. 2014 Jan;10(1-2):36-57.
5. Prof Psychol Res Pr. 2008 Apr;39(2):113-21.
6. “Behaviorism: Classic Studies” (Casper, Wyo: Endeavor Books/Mountain States Litho, 2009).
7. Journal of LGBT Issues in Counseling. 2008;2(2):126-58.
8. Genet Psychol Monogr. 1967;75(1):43-88.
9. Clin Child Fam Psychol Rev. 1998 Mar;1(1):61-75.
10. “Parental Monitoring of Adolescents: Current Perspectives for Researchers and Practitioners” (New York: Columbia University Press, 2010).
11. AIDS Behav. 2014 Aug;18(8):1604-14.
Dr. Montano is an adolescent medicine fellow at Children’s Hospital of Pittsburgh of UPMC and a postdoctoral fellow in the department of pediatrics at the University of Pittsburgh. Email him at pdnews@frontlinemedcom.com.
Two years ago, a mother of one of my patients asked me for advice. She knew that her daughter identified as lesbian, and she was fully supportive. One day, her daughter wanted to go to a sleepover at a female friend’s house. Her first reaction was to say yes, but then she had second thoughts: If her daughter were straight, and this friend were male, she would not allow her to go because of the potential for sexual activity. When she told her daughter she could not attend the sleepover, her daughter accused her of not letting her go because of her sexual orientation. And now, the dilemma: In her effort to be fair and consistent with her values, the mother is being accused of discrimination. What should she do?
Parents play an irreplaceable role in the life of any teen, especially in the lives of teens that identify as lesbian, gay, bisexual, or transgender (LGBT). But many LGBT youth face serious challenges with their parents. They face the potential of parental rejection of their sexual or gender identity. At the very worst, teens may face homelessness if they come out to homophobic parents.1 Youth whose parents are accepting, nevertheless, are less likely to have mental health problems or engage in substance use.2
As a clinical provider for children and adolescents, caregivers will ask you for advice on how to address parenting challenges. Because LGBT youth are at risk for many adverse health outcomes, and parental support is paramount in preventing them, this is an opportunity for you to help this vulnerable population.
If parents ask you how to be supportive of their LGBT children, here are some recommendations, which are based on an intervention by colleagues at the University of Utah:3
1. Let their affection show. Receiving news that a child is LGBT can be emotionally intense for parents.4 Because of this emotional intensity, parents may react negatively and neglect to show their love for their child, which is what the child is seeking. Parents showing affection is the first step in supporting their LGBT child. Remind parents to tell their child that they love them no matter what.
2. Avoid rejecting behaviors. This is sometimes hard, because some forms of rejection can be quite subtle. Avoid saying anything that may indicate a negative view of LGBT people, even if it is not intended. For example, saying that something is “gay” may seem innocent enough, but it sends the message that being gay is something to be ashamed of.
3. Express their pain away from their child. Evidence shows that minimizing a child’s exposure to parental conflict and stress is associated with better coping with these devastating events.5 Parents should avoid telling their children that news of their sexual orientation or gender identity upsets them, as this is another form of rejecting behavior.
4. Do good before they feel good. Previous studies suggest that changes in behavior can occur even though a person may feel otherwise.6 Negative feelings about a child’s sexual orientation or gender identity can last months or years.7 It’s okay to have these feelings, but showing support such as telling their child how they still love them can ultimately lead to acceptance.
Although it is important for parents to accept their child, it is only half the battle. If you remember Baumrind’s theory on parenting, there are two sides of parenting. The first side involves parents showing their affection, love, and support for their children, which I described earlier. The other side involves managing a child’s behaviors, whether parents create an environment that makes it difficult to engage in behaviors they disapprove of or teach their children how to make the right decision.8 Many LGBT youth engage in risky behaviors because it’s a way of coping in a homophobic environment. The parents’ job is to teach their children healthier coping strategies.
Research on this aspect of parenting in LGBT youth is still at its infancy, and some of it is not reassuring. One important behavior, parental monitoring, which is “a set of correlated parenting behaviors involving attention to and tracking of the child’s whereabouts, activities, and adaptations,”9 can prevent conduct disorders, substance use, and mental health problems in the typical teenager.10 Unfortunately, we don’t find the same results for sexual minorities. One study suggests that parental monitoring may not prevent high-risk sexual behavior for young gay males, even if the parent is aware of the young man’s sexual orientation.11
This doesn’t mean that parental monitoring isn’t helpful. This just means that parenting LGBT youth is different than parenting heterosexual youth. It’s not enough for parents to just accept their child’s sexual orientation. They also must help them make the right decisions taking into consideration the effect of stigma and discrimination on sexual minorities. There are a couple of things you can suggest to your parents to help them raise their LGBT children:
1. Be proactive. Join organizations that support parents of LGBT youth such as Parents, Families, and Friends of Lesbians and Gays (PFLAG). Also, parents must be aware of their children’s behavior. If they are acting depressed, seek help. Having depression or anxiety increases the chances of engaging in risky behaviors, so the earlier parents address this, the better.
2. Make their child know what their views are on high risk-behaviors, such as substance use or having unprotected sex. They need to communicate their expectations clearly. If parents believe that drinking alcohol before the legal age is wrong, they should clearly let their children know that.
3. Make it easier for their child to tell parents what’s going on in their lives. Parents have to gain their children’s trust, be accessible (don’t answer texts while talking to them!), and be an active listener. LGBT youth may not ask parents for advice because they feel that because their parents are straight or cisgender, their life experiences do not apply. Being a member of an organization like PLFAG can be helpful, because parents can ask other parents who have experience raising LGBT youth for advice that works.
4. If parents’ children do something wrong, they should talk to them about how their actions were risky. Children will listen to parents if they view their parenting as legitimate and fair, which can only happen if there is a strong parent-child relationship. Being supportive of a child’s sexual orientation or gender identity is key here. And for the next time, it’s always good to role-play a scenario (for example, what to do if someone tries to make them drink at a party).
Parents of LGBT youth face many challenges. You can help these parents by encouraging them to accept and support their child’s sexual orientation or gender identity and provide parenting strategies relevant for LGBT youth. Most important of all, encourage them to seek support through organizations like PFLAG. With this support, parents can encourage healthy development in LGBT youth.
Resources for parents of LGBT youth
• The Centers for Disease Control and Prevention (CDC) has information on the health of LGBT Youth and advice on parental monitoring in general.
• The Family Acceptance Project is a project researching ways to improve parent-child relationships in LGBT Youth.
• PFLAG is an organization that provides support for families of LGBT youth.
• Lead with Love is a film about how various types of families react to their children coming out to them.
References
1. J Sex Res. 2004 Nov;41(4):329-42.
2. Aust N Z J Psychiatry. 2010 Sep;44(9):774-83.
3. Huebner D. “Leading with Love: Interventions to Support Families of Lesbian, Gay, and Bisexual Adolescents,” The Register Report, Vol. 39. National Register of Health Service Psychologists, Spring 2013.
4. J GLBT Fam Stud. 2014 Jan;10(1-2):36-57.
5. Prof Psychol Res Pr. 2008 Apr;39(2):113-21.
6. “Behaviorism: Classic Studies” (Casper, Wyo: Endeavor Books/Mountain States Litho, 2009).
7. Journal of LGBT Issues in Counseling. 2008;2(2):126-58.
8. Genet Psychol Monogr. 1967;75(1):43-88.
9. Clin Child Fam Psychol Rev. 1998 Mar;1(1):61-75.
10. “Parental Monitoring of Adolescents: Current Perspectives for Researchers and Practitioners” (New York: Columbia University Press, 2010).
11. AIDS Behav. 2014 Aug;18(8):1604-14.
Dr. Montano is an adolescent medicine fellow at Children’s Hospital of Pittsburgh of UPMC and a postdoctoral fellow in the department of pediatrics at the University of Pittsburgh. Email him at pdnews@frontlinemedcom.com.
The HPV vaccine
As physicians, we play a unique role in medicine. Drawing on research data, we provide a gateway of information to patients and families. Governing agencies use that data to make recommendations so that we can promote treatment with confidence. But we also have a responsibility if there is an ill outcome, so being well versed on vaccines and treatments is imperative.
Since the human papillomavirus (HPV) vaccines (Gardasil, Cervarix) were approved for the prevention of HPV, there has been controversy. Despite the ongoing reports of the vaccine’s success in lowering cervical cancer rates, many parents still feel that it puts their children at risk.
A 2012 study – a systematic review of parents’ knowledge of HPV – showed a decline from 2001 to 2011, with a rise in parents’ safety concerns, and fewer parents opting to have their children vaccinated (Obstet Gynecol Int. 2012. doi: 10.1155/2012/921236).
Several studies have shown the overwhelming decline in cervical cancer that is directly related to the implementation of the HPV vaccines. But there has been growing concern, as postural orthostatic hypotension (POTS), complex regional pain syndrome (CRPS), and sudden death have been cited as side effects of theses vaccines. POTS and CRPS have been in the headlines recently, since a report came out linking the vaccine to these syndromes. Although a review by the European Medicines Agency found that the evidence does not support the notion of the HPV vaccine causing POTS or CRPS, many groups still promote a ban of the vaccine.
In 2013, Japan withdrew its recommendation for administration of the HPV vaccine after reports that many girls had been seriously harmed by it, and now calls for follow-up for patients who believe they are having side effects. Researchers argue that the basis for this action is poorly founded, and that many young women are being deprived of a vaccine that would be protective. But just as many say that more investigation needs to be done before the recommendation can be reinstated, given the number of reports about women being seriously injured from the vaccine. The Japan Society of Obstetrics and Gynecology is pleading with the Japanese Health Ministry to commence recommending the HPV cancer-preventing vaccineonce again.
An Internet search of this topic shows there are several articles questioning the safety of the vaccine, and throughout the world, concerns are forcing more research to be done to ensure its safety. Although the research overwhelmingly shows that the risk-to-benefit ratio is in favor of the HPV vaccine, several sites are reporting injury.
In a study of 997,585 girls aged 10-17 years in Denmark and Sweden, among whom 296,826 received a total of 696,420 quadrivalent HPV vaccine doses, 1,043 (less than 1%) were found to have adverse reactions, compared with 11,944 (2%) of unvaccinated girls (BMJ 2013;347:f5906). Although some relationship between HPV vaccine and autoimmune disorders such as Behçet’s syndrome, Raynaud’s disease, and type 1 diabetes was apparent, no consistent evidence for a causal association was found.
“Analysis of data reported to the Vaccine Adverse Event Reporting System revealed disproportionate reporting of venous thromboembolism,” noted Dr. Lisen Arnheim-Dahlström of the Karolinska Institutet, Stockholm, lead author of the BMJ study, and associates. “A study by the Vaccine Safety Datalink, which involved eight outcomes, identified a nonsignificantly increased relative risk (1.98) of venous thromboembolism; medical record review could confirm five of the eight cases identified from databases using international classification of diseases codes, and all five had known risk factors for venous thromboembolism. In our analysis, based on 21 vaccine exposed cases, there was no significant association with venous thromboembolism within 90 days after exposure to [quadrivalent] HPV vaccine.”
These rising concerns are resulting in more parents declining the HPV vaccine, and more questions for the primary care physician to answer. Not only are parents alarmed, but so are the physicians who make the recommendations. Being aware of the most current research and reports for and against the vaccine’s use, and being able to discuss with the family the validity of this information, will help to dispel much of the anxiety.
Dr. Pearce is a pediatrician in Frankfort, Ill. To contact her, send email to pdnews@frontlinemedcom.com.
As physicians, we play a unique role in medicine. Drawing on research data, we provide a gateway of information to patients and families. Governing agencies use that data to make recommendations so that we can promote treatment with confidence. But we also have a responsibility if there is an ill outcome, so being well versed on vaccines and treatments is imperative.
Since the human papillomavirus (HPV) vaccines (Gardasil, Cervarix) were approved for the prevention of HPV, there has been controversy. Despite the ongoing reports of the vaccine’s success in lowering cervical cancer rates, many parents still feel that it puts their children at risk.
A 2012 study – a systematic review of parents’ knowledge of HPV – showed a decline from 2001 to 2011, with a rise in parents’ safety concerns, and fewer parents opting to have their children vaccinated (Obstet Gynecol Int. 2012. doi: 10.1155/2012/921236).
Several studies have shown the overwhelming decline in cervical cancer that is directly related to the implementation of the HPV vaccines. But there has been growing concern, as postural orthostatic hypotension (POTS), complex regional pain syndrome (CRPS), and sudden death have been cited as side effects of theses vaccines. POTS and CRPS have been in the headlines recently, since a report came out linking the vaccine to these syndromes. Although a review by the European Medicines Agency found that the evidence does not support the notion of the HPV vaccine causing POTS or CRPS, many groups still promote a ban of the vaccine.
In 2013, Japan withdrew its recommendation for administration of the HPV vaccine after reports that many girls had been seriously harmed by it, and now calls for follow-up for patients who believe they are having side effects. Researchers argue that the basis for this action is poorly founded, and that many young women are being deprived of a vaccine that would be protective. But just as many say that more investigation needs to be done before the recommendation can be reinstated, given the number of reports about women being seriously injured from the vaccine. The Japan Society of Obstetrics and Gynecology is pleading with the Japanese Health Ministry to commence recommending the HPV cancer-preventing vaccineonce again.
An Internet search of this topic shows there are several articles questioning the safety of the vaccine, and throughout the world, concerns are forcing more research to be done to ensure its safety. Although the research overwhelmingly shows that the risk-to-benefit ratio is in favor of the HPV vaccine, several sites are reporting injury.
In a study of 997,585 girls aged 10-17 years in Denmark and Sweden, among whom 296,826 received a total of 696,420 quadrivalent HPV vaccine doses, 1,043 (less than 1%) were found to have adverse reactions, compared with 11,944 (2%) of unvaccinated girls (BMJ 2013;347:f5906). Although some relationship between HPV vaccine and autoimmune disorders such as Behçet’s syndrome, Raynaud’s disease, and type 1 diabetes was apparent, no consistent evidence for a causal association was found.
“Analysis of data reported to the Vaccine Adverse Event Reporting System revealed disproportionate reporting of venous thromboembolism,” noted Dr. Lisen Arnheim-Dahlström of the Karolinska Institutet, Stockholm, lead author of the BMJ study, and associates. “A study by the Vaccine Safety Datalink, which involved eight outcomes, identified a nonsignificantly increased relative risk (1.98) of venous thromboembolism; medical record review could confirm five of the eight cases identified from databases using international classification of diseases codes, and all five had known risk factors for venous thromboembolism. In our analysis, based on 21 vaccine exposed cases, there was no significant association with venous thromboembolism within 90 days after exposure to [quadrivalent] HPV vaccine.”
These rising concerns are resulting in more parents declining the HPV vaccine, and more questions for the primary care physician to answer. Not only are parents alarmed, but so are the physicians who make the recommendations. Being aware of the most current research and reports for and against the vaccine’s use, and being able to discuss with the family the validity of this information, will help to dispel much of the anxiety.
Dr. Pearce is a pediatrician in Frankfort, Ill. To contact her, send email to pdnews@frontlinemedcom.com.
As physicians, we play a unique role in medicine. Drawing on research data, we provide a gateway of information to patients and families. Governing agencies use that data to make recommendations so that we can promote treatment with confidence. But we also have a responsibility if there is an ill outcome, so being well versed on vaccines and treatments is imperative.
Since the human papillomavirus (HPV) vaccines (Gardasil, Cervarix) were approved for the prevention of HPV, there has been controversy. Despite the ongoing reports of the vaccine’s success in lowering cervical cancer rates, many parents still feel that it puts their children at risk.
A 2012 study – a systematic review of parents’ knowledge of HPV – showed a decline from 2001 to 2011, with a rise in parents’ safety concerns, and fewer parents opting to have their children vaccinated (Obstet Gynecol Int. 2012. doi: 10.1155/2012/921236).
Several studies have shown the overwhelming decline in cervical cancer that is directly related to the implementation of the HPV vaccines. But there has been growing concern, as postural orthostatic hypotension (POTS), complex regional pain syndrome (CRPS), and sudden death have been cited as side effects of theses vaccines. POTS and CRPS have been in the headlines recently, since a report came out linking the vaccine to these syndromes. Although a review by the European Medicines Agency found that the evidence does not support the notion of the HPV vaccine causing POTS or CRPS, many groups still promote a ban of the vaccine.
In 2013, Japan withdrew its recommendation for administration of the HPV vaccine after reports that many girls had been seriously harmed by it, and now calls for follow-up for patients who believe they are having side effects. Researchers argue that the basis for this action is poorly founded, and that many young women are being deprived of a vaccine that would be protective. But just as many say that more investigation needs to be done before the recommendation can be reinstated, given the number of reports about women being seriously injured from the vaccine. The Japan Society of Obstetrics and Gynecology is pleading with the Japanese Health Ministry to commence recommending the HPV cancer-preventing vaccineonce again.
An Internet search of this topic shows there are several articles questioning the safety of the vaccine, and throughout the world, concerns are forcing more research to be done to ensure its safety. Although the research overwhelmingly shows that the risk-to-benefit ratio is in favor of the HPV vaccine, several sites are reporting injury.
In a study of 997,585 girls aged 10-17 years in Denmark and Sweden, among whom 296,826 received a total of 696,420 quadrivalent HPV vaccine doses, 1,043 (less than 1%) were found to have adverse reactions, compared with 11,944 (2%) of unvaccinated girls (BMJ 2013;347:f5906). Although some relationship between HPV vaccine and autoimmune disorders such as Behçet’s syndrome, Raynaud’s disease, and type 1 diabetes was apparent, no consistent evidence for a causal association was found.
“Analysis of data reported to the Vaccine Adverse Event Reporting System revealed disproportionate reporting of venous thromboembolism,” noted Dr. Lisen Arnheim-Dahlström of the Karolinska Institutet, Stockholm, lead author of the BMJ study, and associates. “A study by the Vaccine Safety Datalink, which involved eight outcomes, identified a nonsignificantly increased relative risk (1.98) of venous thromboembolism; medical record review could confirm five of the eight cases identified from databases using international classification of diseases codes, and all five had known risk factors for venous thromboembolism. In our analysis, based on 21 vaccine exposed cases, there was no significant association with venous thromboembolism within 90 days after exposure to [quadrivalent] HPV vaccine.”
These rising concerns are resulting in more parents declining the HPV vaccine, and more questions for the primary care physician to answer. Not only are parents alarmed, but so are the physicians who make the recommendations. Being aware of the most current research and reports for and against the vaccine’s use, and being able to discuss with the family the validity of this information, will help to dispel much of the anxiety.
Dr. Pearce is a pediatrician in Frankfort, Ill. To contact her, send email to pdnews@frontlinemedcom.com.
Reader discussions regarding trends in minimally invasive hysterectomy
AN OPEN LETTER TO THE FDA ON MORCELLATION FOR PRESUMED UTERINE FIBROIDS
On December 8, 2015, 46 minimally invasive surgeons, gynecologic oncologists, and other experts spoke out in unison when they sent an open letter to the US Food and Drug Administration (FDA). They called into question the FDA’s estimate of the likelihood of occult leiomyosarcoma (LMS) and recommended continued use of power morcellation in appropriate cases.
An excerpt from this letter is published here. To read the letter in its entirety and the names of the signees, click here.
Letter excerpt:
If abdominal hysterectomy is recommended to women with fibroids, will women be better off?
By focusing exclusively on the risk of LMS, the FDA failed to take into account other risks associated with surgery. Laparoscopic surgery uses small incisions, is performed as an outpatient procedure (or overnight stay), has a faster recovery (2 weeks vs 4–6 weeks for open surgery), and is associated with lower mortality and fewer complications. These benefits of minimally invasive surgery are now well established in gynecologic and general surgery.
Using published best-evidence data, a recent decision analysis1 showed that, comparing 100,000 women undergoing laparoscopic hysterectomy with 100,000 undergoing open hysterectomy, the group undergoing laparoscopic surgery would experience 20 fewer perioperative deaths, 150 fewer pulmonary or venous embolus, and 4,800 fewer wound infections. Importantly, women having open surgery would have 8,000 fewer quality-of-life years.
A recently published study2 found that, in the 8 months following the FDA safety communication, utilization of laparoscopic hysterectomies decreased by 4.1% (P = .005), and abdominal and vaginal hysterectomies increased by 1.7% (P = .112) and 2.4% (P = .012), respectively. Major surgical complications (not including blood transfusions) increased from 2.2% to 2.8% (P = .015), and the rate of hospital readmission within 30 days also increased from 3.4% to 4.2% (P = .025). These observations merit consideration as women weigh the pros and cons of minimally invasive surgery with morcellation versus open surgery.
Clinical recommendations
Recent attention to surgical options for women with uterine leiomyomas and the risk of an occult LMS are positive developments in that the gynecologic community is reexamining relevant issues. We respectfully suggest that the following clinical recommendations be considered:
- The risk of LMS is higher in older postmenopausal women; greater caution should be exercised prior to recommending morcellation procedures for these women.
- Preoperative consideration of LMS is important. Women aged 35 years and older with irregular uterine bleeding and presumed fibroids should have an endometrial biopsy, which occasionally may detect LMS prior to surgery. Women should have normal results of cervical cancer screening.
- Ultrasound or MRI findings of a large irregular vascular mass, often with irregular anechoic (cystic) areas reflecting necrosis, may cause suspicion of LMS.
- Women wishing minimally invasive procedures with morcellation, including scalpel morcellation via the vagina or mini-laparotomy, or power morcellation using laparoscopic guidance, should understand the potential risk of decreased survival should LMS be present. Open procedures should be offered to all women who are considering minimally invasive procedures for “fibroids.”
- Following morcellation, careful inspection for tissue fragments should be undertaken and copious irrigation of the pelvic and abdominal cavities should be performed to minimize the risk of retained
tissue. - Further investigations of a means to identify LMS preoperatively should be supported. Likewise, investigation into the biology of LMS should be funded to better understand the propensity of tissue fragments or cells to implant and grow. With that knowledge, minimally invasive procedures could be avoided for women with LMS and women choosing minimally invasive surgery could be reassured that they do not have LMS.
Respecting women who suffer from LMS, we conclude that the FDA directive was based on a misleading analysis. Consequently, more accurate estimates regarding the prevalence of LMS among women having surgery for fibroids should be issued. Women have a right to self determination. Modification of the FDA’s current restrictive guidance regarding power morcellation would empower each woman to consider the pertinent issues and have the freedom to undertake shared decision making with her surgeon in order to select the procedure that is most appropriate for her.
References
1. Siedhoff MT, Wheeler SB, Rutstein SE, et al. Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroid tumors in premenopausal women: a decision analysis. Am J Obstet Gynecol. 2015;212(5):591.e1–e8.
2. Harris JA, Swenson CW, Uppal S, et al. Practice patterns and postoperative complications before and after Food and Drug Administration Safety Communication on power morcellation [published online ahead of print August 24, 2015]. Am J Obstet Gynecol. doi:10.1016/j.ajog.2015.08.047.
Choose the best approach for the patient
I cannot decrease the number of abdominal hysterectomies I perform—all of them are indicated.
Richard Hatch, MD
Augusta, Georgia
Supracervical hysterectomy: simplest is best
Supracervical hysterectomy (SCH) via a Pfannenstiel incision in women with a body mass index less than 25 kg/m2 is a great procedure for uterine pathology. SCH addresses only the uterine pathology and preserves the cervix, is a sterile procedure, requires no ancillary equipment, should take less than 30 minutes, preserves the full length of the vagina, requires only an overnight hospitalization, and has a short learning curve.
Removal of the cervix in any hysterectomy is the procedure that results in bladder and ureter injury and infection from contamination. Patients should be driving and back to nonphysical jobs in less than 1 week. As medical care becomes a truly transparent market-based business, patients will opt for SCH over higher priced alternatives. Sometimes the simplest procedures are still the best.
Joe Walsh, MD
Philadelphia, Pennsylvania
Continue to teach abdominal hysterectomy
No one can disagree with the statistics of shorter recovery and less morbidity for laparoscopic and vaginal procedures. In fact, what separates a gynecologist from other surgeons is the ability to operate in and through the vagina. There is still a place for abdominal hysterectomy for benign disease in modern gynecology.
Most programs produce good laparoscopic surgeons but ill prepared abdominal and vaginal surgeons. No gynecologist should be operating in the pelvis unless he or she is comfortable going into the retroperitoneal space if necessary. Many of the total laparoscopic hysterectomies that are performed could be done vaginally without abdominal incisions.
Now we have a generation of gynecologic surgeons who believe a robotic hysterectomy (at great extra expense) offers the patient an advantage, despite longer anesthesia and procedure times. We know morbidity has a direct correlation to operating and anesthesia time. Although I am impressed with what the next generation can do through a laparoscope, I would hate to let them continue without the experience or the ability to do an open abdominal procedure.
Allan N. Boruszak, MD
Washington, North Carolina
Dr. Barbieri’s response
I appreciate the perspectives of Drs. Hatch, Walsh, and Boruszak on the important issue of improving hysterectomy outcomes. Dr. Hatch raises the important point that gynecologists routinely select the best surgical approach for the unique needs of their patients. Based on a given gynecologist’s panel of patients and their unique medical issues, it may be difficult to change the distribution of surgical approaches to hysterectomy. Dr. Walsh advocates for a “minimally invasive” abdominal SCH, which is a valid approach to improving the outcomes of the abdominal approach. Dr. Boruszak rightly highlights the importance of teaching gynecologists to access the retroperitoneum, paravesical, and pararectal spaces in order to improve patient outcomes.
“VAGINAL HYSTERECTOMY WITH BASIC INSTRUMENTATION”
BARBARA S. LEVY, MD (OCTOBER, 2015)
Appreciates the instrument review
Dr. Levy’s article on vaginal hysterectomy using basic instruments is really wonderful. The segment on uterine reduction strategies will be especially useful. I appreciate her preference to use the Ligasure vessel-sealing device over suturing pedicles. Before we take steps to debulk the uterus, it is always essential, and better, to ligate uterine vessels, as this minimizes blood loss and makes the surgical field clearer.
R. Sasirekha
Puducherry, India
Skill should be rewarded
When I trained, vaginal hysterectomy was reserved for prolapse. After joining the Army, my eyes were opened by physicians who could morcellate a 16-week uterus or perform a 20-minute vaginal hysterectomy on a nulliparous woman for sterilization (which, of course, is controversial).
Once in private practice, incorporating these new skills into my own techniques was challenging and rewarding. Imagine my disappointment when I found out that reimbursement was a disincentive. It is easy to be altruistic, but one has to consider the incentives, too. Skill should be rewarded.
Mark B. Vizer, MD
Lansdale, Pennsylvania
A long-time proponent of vaginal hysterectomy
I appreciate the articles by Drs. Levy and Gebhart on vaginal surgical techniques. I have long been a proponent of vaginal hysterectomy as the preferred route for removal of the uterus (and tubes and ovaries, if indicated). I do most of my hysterectomies vaginally, with salpingectomies and oophorectomies if indicated. As an older surgeon, I now refer patients with uteri larger than 16 weeks, endometriosis, or suspected cancer.
Doug Tolley, MD
Yuba City, California
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
AN OPEN LETTER TO THE FDA ON MORCELLATION FOR PRESUMED UTERINE FIBROIDS
On December 8, 2015, 46 minimally invasive surgeons, gynecologic oncologists, and other experts spoke out in unison when they sent an open letter to the US Food and Drug Administration (FDA). They called into question the FDA’s estimate of the likelihood of occult leiomyosarcoma (LMS) and recommended continued use of power morcellation in appropriate cases.
An excerpt from this letter is published here. To read the letter in its entirety and the names of the signees, click here.
Letter excerpt:
If abdominal hysterectomy is recommended to women with fibroids, will women be better off?
By focusing exclusively on the risk of LMS, the FDA failed to take into account other risks associated with surgery. Laparoscopic surgery uses small incisions, is performed as an outpatient procedure (or overnight stay), has a faster recovery (2 weeks vs 4–6 weeks for open surgery), and is associated with lower mortality and fewer complications. These benefits of minimally invasive surgery are now well established in gynecologic and general surgery.
Using published best-evidence data, a recent decision analysis1 showed that, comparing 100,000 women undergoing laparoscopic hysterectomy with 100,000 undergoing open hysterectomy, the group undergoing laparoscopic surgery would experience 20 fewer perioperative deaths, 150 fewer pulmonary or venous embolus, and 4,800 fewer wound infections. Importantly, women having open surgery would have 8,000 fewer quality-of-life years.
A recently published study2 found that, in the 8 months following the FDA safety communication, utilization of laparoscopic hysterectomies decreased by 4.1% (P = .005), and abdominal and vaginal hysterectomies increased by 1.7% (P = .112) and 2.4% (P = .012), respectively. Major surgical complications (not including blood transfusions) increased from 2.2% to 2.8% (P = .015), and the rate of hospital readmission within 30 days also increased from 3.4% to 4.2% (P = .025). These observations merit consideration as women weigh the pros and cons of minimally invasive surgery with morcellation versus open surgery.
Clinical recommendations
Recent attention to surgical options for women with uterine leiomyomas and the risk of an occult LMS are positive developments in that the gynecologic community is reexamining relevant issues. We respectfully suggest that the following clinical recommendations be considered:
- The risk of LMS is higher in older postmenopausal women; greater caution should be exercised prior to recommending morcellation procedures for these women.
- Preoperative consideration of LMS is important. Women aged 35 years and older with irregular uterine bleeding and presumed fibroids should have an endometrial biopsy, which occasionally may detect LMS prior to surgery. Women should have normal results of cervical cancer screening.
- Ultrasound or MRI findings of a large irregular vascular mass, often with irregular anechoic (cystic) areas reflecting necrosis, may cause suspicion of LMS.
- Women wishing minimally invasive procedures with morcellation, including scalpel morcellation via the vagina or mini-laparotomy, or power morcellation using laparoscopic guidance, should understand the potential risk of decreased survival should LMS be present. Open procedures should be offered to all women who are considering minimally invasive procedures for “fibroids.”
- Following morcellation, careful inspection for tissue fragments should be undertaken and copious irrigation of the pelvic and abdominal cavities should be performed to minimize the risk of retained
tissue. - Further investigations of a means to identify LMS preoperatively should be supported. Likewise, investigation into the biology of LMS should be funded to better understand the propensity of tissue fragments or cells to implant and grow. With that knowledge, minimally invasive procedures could be avoided for women with LMS and women choosing minimally invasive surgery could be reassured that they do not have LMS.
Respecting women who suffer from LMS, we conclude that the FDA directive was based on a misleading analysis. Consequently, more accurate estimates regarding the prevalence of LMS among women having surgery for fibroids should be issued. Women have a right to self determination. Modification of the FDA’s current restrictive guidance regarding power morcellation would empower each woman to consider the pertinent issues and have the freedom to undertake shared decision making with her surgeon in order to select the procedure that is most appropriate for her.
References
1. Siedhoff MT, Wheeler SB, Rutstein SE, et al. Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroid tumors in premenopausal women: a decision analysis. Am J Obstet Gynecol. 2015;212(5):591.e1–e8.
2. Harris JA, Swenson CW, Uppal S, et al. Practice patterns and postoperative complications before and after Food and Drug Administration Safety Communication on power morcellation [published online ahead of print August 24, 2015]. Am J Obstet Gynecol. doi:10.1016/j.ajog.2015.08.047.
Choose the best approach for the patient
I cannot decrease the number of abdominal hysterectomies I perform—all of them are indicated.
Richard Hatch, MD
Augusta, Georgia
Supracervical hysterectomy: simplest is best
Supracervical hysterectomy (SCH) via a Pfannenstiel incision in women with a body mass index less than 25 kg/m2 is a great procedure for uterine pathology. SCH addresses only the uterine pathology and preserves the cervix, is a sterile procedure, requires no ancillary equipment, should take less than 30 minutes, preserves the full length of the vagina, requires only an overnight hospitalization, and has a short learning curve.
Removal of the cervix in any hysterectomy is the procedure that results in bladder and ureter injury and infection from contamination. Patients should be driving and back to nonphysical jobs in less than 1 week. As medical care becomes a truly transparent market-based business, patients will opt for SCH over higher priced alternatives. Sometimes the simplest procedures are still the best.
Joe Walsh, MD
Philadelphia, Pennsylvania
Continue to teach abdominal hysterectomy
No one can disagree with the statistics of shorter recovery and less morbidity for laparoscopic and vaginal procedures. In fact, what separates a gynecologist from other surgeons is the ability to operate in and through the vagina. There is still a place for abdominal hysterectomy for benign disease in modern gynecology.
Most programs produce good laparoscopic surgeons but ill prepared abdominal and vaginal surgeons. No gynecologist should be operating in the pelvis unless he or she is comfortable going into the retroperitoneal space if necessary. Many of the total laparoscopic hysterectomies that are performed could be done vaginally without abdominal incisions.
Now we have a generation of gynecologic surgeons who believe a robotic hysterectomy (at great extra expense) offers the patient an advantage, despite longer anesthesia and procedure times. We know morbidity has a direct correlation to operating and anesthesia time. Although I am impressed with what the next generation can do through a laparoscope, I would hate to let them continue without the experience or the ability to do an open abdominal procedure.
Allan N. Boruszak, MD
Washington, North Carolina
Dr. Barbieri’s response
I appreciate the perspectives of Drs. Hatch, Walsh, and Boruszak on the important issue of improving hysterectomy outcomes. Dr. Hatch raises the important point that gynecologists routinely select the best surgical approach for the unique needs of their patients. Based on a given gynecologist’s panel of patients and their unique medical issues, it may be difficult to change the distribution of surgical approaches to hysterectomy. Dr. Walsh advocates for a “minimally invasive” abdominal SCH, which is a valid approach to improving the outcomes of the abdominal approach. Dr. Boruszak rightly highlights the importance of teaching gynecologists to access the retroperitoneum, paravesical, and pararectal spaces in order to improve patient outcomes.
“VAGINAL HYSTERECTOMY WITH BASIC INSTRUMENTATION”
BARBARA S. LEVY, MD (OCTOBER, 2015)
Appreciates the instrument review
Dr. Levy’s article on vaginal hysterectomy using basic instruments is really wonderful. The segment on uterine reduction strategies will be especially useful. I appreciate her preference to use the Ligasure vessel-sealing device over suturing pedicles. Before we take steps to debulk the uterus, it is always essential, and better, to ligate uterine vessels, as this minimizes blood loss and makes the surgical field clearer.
R. Sasirekha
Puducherry, India
Skill should be rewarded
When I trained, vaginal hysterectomy was reserved for prolapse. After joining the Army, my eyes were opened by physicians who could morcellate a 16-week uterus or perform a 20-minute vaginal hysterectomy on a nulliparous woman for sterilization (which, of course, is controversial).
Once in private practice, incorporating these new skills into my own techniques was challenging and rewarding. Imagine my disappointment when I found out that reimbursement was a disincentive. It is easy to be altruistic, but one has to consider the incentives, too. Skill should be rewarded.
Mark B. Vizer, MD
Lansdale, Pennsylvania
A long-time proponent of vaginal hysterectomy
I appreciate the articles by Drs. Levy and Gebhart on vaginal surgical techniques. I have long been a proponent of vaginal hysterectomy as the preferred route for removal of the uterus (and tubes and ovaries, if indicated). I do most of my hysterectomies vaginally, with salpingectomies and oophorectomies if indicated. As an older surgeon, I now refer patients with uteri larger than 16 weeks, endometriosis, or suspected cancer.
Doug Tolley, MD
Yuba City, California
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
AN OPEN LETTER TO THE FDA ON MORCELLATION FOR PRESUMED UTERINE FIBROIDS
On December 8, 2015, 46 minimally invasive surgeons, gynecologic oncologists, and other experts spoke out in unison when they sent an open letter to the US Food and Drug Administration (FDA). They called into question the FDA’s estimate of the likelihood of occult leiomyosarcoma (LMS) and recommended continued use of power morcellation in appropriate cases.
An excerpt from this letter is published here. To read the letter in its entirety and the names of the signees, click here.
Letter excerpt:
If abdominal hysterectomy is recommended to women with fibroids, will women be better off?
By focusing exclusively on the risk of LMS, the FDA failed to take into account other risks associated with surgery. Laparoscopic surgery uses small incisions, is performed as an outpatient procedure (or overnight stay), has a faster recovery (2 weeks vs 4–6 weeks for open surgery), and is associated with lower mortality and fewer complications. These benefits of minimally invasive surgery are now well established in gynecologic and general surgery.
Using published best-evidence data, a recent decision analysis1 showed that, comparing 100,000 women undergoing laparoscopic hysterectomy with 100,000 undergoing open hysterectomy, the group undergoing laparoscopic surgery would experience 20 fewer perioperative deaths, 150 fewer pulmonary or venous embolus, and 4,800 fewer wound infections. Importantly, women having open surgery would have 8,000 fewer quality-of-life years.
A recently published study2 found that, in the 8 months following the FDA safety communication, utilization of laparoscopic hysterectomies decreased by 4.1% (P = .005), and abdominal and vaginal hysterectomies increased by 1.7% (P = .112) and 2.4% (P = .012), respectively. Major surgical complications (not including blood transfusions) increased from 2.2% to 2.8% (P = .015), and the rate of hospital readmission within 30 days also increased from 3.4% to 4.2% (P = .025). These observations merit consideration as women weigh the pros and cons of minimally invasive surgery with morcellation versus open surgery.
Clinical recommendations
Recent attention to surgical options for women with uterine leiomyomas and the risk of an occult LMS are positive developments in that the gynecologic community is reexamining relevant issues. We respectfully suggest that the following clinical recommendations be considered:
- The risk of LMS is higher in older postmenopausal women; greater caution should be exercised prior to recommending morcellation procedures for these women.
- Preoperative consideration of LMS is important. Women aged 35 years and older with irregular uterine bleeding and presumed fibroids should have an endometrial biopsy, which occasionally may detect LMS prior to surgery. Women should have normal results of cervical cancer screening.
- Ultrasound or MRI findings of a large irregular vascular mass, often with irregular anechoic (cystic) areas reflecting necrosis, may cause suspicion of LMS.
- Women wishing minimally invasive procedures with morcellation, including scalpel morcellation via the vagina or mini-laparotomy, or power morcellation using laparoscopic guidance, should understand the potential risk of decreased survival should LMS be present. Open procedures should be offered to all women who are considering minimally invasive procedures for “fibroids.”
- Following morcellation, careful inspection for tissue fragments should be undertaken and copious irrigation of the pelvic and abdominal cavities should be performed to minimize the risk of retained
tissue. - Further investigations of a means to identify LMS preoperatively should be supported. Likewise, investigation into the biology of LMS should be funded to better understand the propensity of tissue fragments or cells to implant and grow. With that knowledge, minimally invasive procedures could be avoided for women with LMS and women choosing minimally invasive surgery could be reassured that they do not have LMS.
Respecting women who suffer from LMS, we conclude that the FDA directive was based on a misleading analysis. Consequently, more accurate estimates regarding the prevalence of LMS among women having surgery for fibroids should be issued. Women have a right to self determination. Modification of the FDA’s current restrictive guidance regarding power morcellation would empower each woman to consider the pertinent issues and have the freedom to undertake shared decision making with her surgeon in order to select the procedure that is most appropriate for her.
References
1. Siedhoff MT, Wheeler SB, Rutstein SE, et al. Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroid tumors in premenopausal women: a decision analysis. Am J Obstet Gynecol. 2015;212(5):591.e1–e8.
2. Harris JA, Swenson CW, Uppal S, et al. Practice patterns and postoperative complications before and after Food and Drug Administration Safety Communication on power morcellation [published online ahead of print August 24, 2015]. Am J Obstet Gynecol. doi:10.1016/j.ajog.2015.08.047.
Choose the best approach for the patient
I cannot decrease the number of abdominal hysterectomies I perform—all of them are indicated.
Richard Hatch, MD
Augusta, Georgia
Supracervical hysterectomy: simplest is best
Supracervical hysterectomy (SCH) via a Pfannenstiel incision in women with a body mass index less than 25 kg/m2 is a great procedure for uterine pathology. SCH addresses only the uterine pathology and preserves the cervix, is a sterile procedure, requires no ancillary equipment, should take less than 30 minutes, preserves the full length of the vagina, requires only an overnight hospitalization, and has a short learning curve.
Removal of the cervix in any hysterectomy is the procedure that results in bladder and ureter injury and infection from contamination. Patients should be driving and back to nonphysical jobs in less than 1 week. As medical care becomes a truly transparent market-based business, patients will opt for SCH over higher priced alternatives. Sometimes the simplest procedures are still the best.
Joe Walsh, MD
Philadelphia, Pennsylvania
Continue to teach abdominal hysterectomy
No one can disagree with the statistics of shorter recovery and less morbidity for laparoscopic and vaginal procedures. In fact, what separates a gynecologist from other surgeons is the ability to operate in and through the vagina. There is still a place for abdominal hysterectomy for benign disease in modern gynecology.
Most programs produce good laparoscopic surgeons but ill prepared abdominal and vaginal surgeons. No gynecologist should be operating in the pelvis unless he or she is comfortable going into the retroperitoneal space if necessary. Many of the total laparoscopic hysterectomies that are performed could be done vaginally without abdominal incisions.
Now we have a generation of gynecologic surgeons who believe a robotic hysterectomy (at great extra expense) offers the patient an advantage, despite longer anesthesia and procedure times. We know morbidity has a direct correlation to operating and anesthesia time. Although I am impressed with what the next generation can do through a laparoscope, I would hate to let them continue without the experience or the ability to do an open abdominal procedure.
Allan N. Boruszak, MD
Washington, North Carolina
Dr. Barbieri’s response
I appreciate the perspectives of Drs. Hatch, Walsh, and Boruszak on the important issue of improving hysterectomy outcomes. Dr. Hatch raises the important point that gynecologists routinely select the best surgical approach for the unique needs of their patients. Based on a given gynecologist’s panel of patients and their unique medical issues, it may be difficult to change the distribution of surgical approaches to hysterectomy. Dr. Walsh advocates for a “minimally invasive” abdominal SCH, which is a valid approach to improving the outcomes of the abdominal approach. Dr. Boruszak rightly highlights the importance of teaching gynecologists to access the retroperitoneum, paravesical, and pararectal spaces in order to improve patient outcomes.
“VAGINAL HYSTERECTOMY WITH BASIC INSTRUMENTATION”
BARBARA S. LEVY, MD (OCTOBER, 2015)
Appreciates the instrument review
Dr. Levy’s article on vaginal hysterectomy using basic instruments is really wonderful. The segment on uterine reduction strategies will be especially useful. I appreciate her preference to use the Ligasure vessel-sealing device over suturing pedicles. Before we take steps to debulk the uterus, it is always essential, and better, to ligate uterine vessels, as this minimizes blood loss and makes the surgical field clearer.
R. Sasirekha
Puducherry, India
Skill should be rewarded
When I trained, vaginal hysterectomy was reserved for prolapse. After joining the Army, my eyes were opened by physicians who could morcellate a 16-week uterus or perform a 20-minute vaginal hysterectomy on a nulliparous woman for sterilization (which, of course, is controversial).
Once in private practice, incorporating these new skills into my own techniques was challenging and rewarding. Imagine my disappointment when I found out that reimbursement was a disincentive. It is easy to be altruistic, but one has to consider the incentives, too. Skill should be rewarded.
Mark B. Vizer, MD
Lansdale, Pennsylvania
A long-time proponent of vaginal hysterectomy
I appreciate the articles by Drs. Levy and Gebhart on vaginal surgical techniques. I have long been a proponent of vaginal hysterectomy as the preferred route for removal of the uterus (and tubes and ovaries, if indicated). I do most of my hysterectomies vaginally, with salpingectomies and oophorectomies if indicated. As an older surgeon, I now refer patients with uteri larger than 16 weeks, endometriosis, or suspected cancer.
Doug Tolley, MD
Yuba City, California
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
READ THESE LETTERS:
An open letter to the FDA on morcellation for presumed uterine fibroids
Choose the best approach for the patient
Continue to teach abdominal hysterectomy
Appreciates the instrument review
Skill should be rewarded
A long-time proponent of hysterectomy
Stewardship at 3 a.m.
The 3-month-old infant presents to the emergency department with a fever of 101° F. The emergency physician decides the infant looks ill enough to warrant some investigation. A urinalysis indicates a urinary tract infection. I am consulted to complete the admission to the hospital. The question arises, “Is a lumbar puncture indicated to rule out meningitis?”
I’ve been down this pathway many times. For years I have relied on a meta-analysis which corrected the bias of an old article from 1972.1 Multiple studies in the 2000-2010 time frame have shown that the risk of concurrent meningitis in a young infant with a UTI is vanishingly small. It is much less than 2%, with many studies finding 0%. So on a typical day, my answer is no tap if there is no clinical suggestion of meningitis.
Hospital medicine has recently focused on reducing overdiagnosis and overtreatment. When you only occasionally admit patients to the hospital, untoward events appear random and uncommon. When you work there day in and day out, you appreciate that all medical interventions have risks and costs.
A recent editorial raised the question of stewardship in medicine.2 It asked why physicians would choose a very expensive drug when there is little evidence of its superiority over a much cheaper predecessor. Physicians, whose actions influence a $3 trillion industry, have not embraced stewardship as a major component of their professional responsibilities. The physician does have a fiduciary duty toward the patient. The physician recommends the best care possible to achieve the patient’s goals of care. Dentistry is distinctly different in this regard. Dentists often have several ways of repairing decayed teeth. Various types of fillings are available. Gold fillings are more expensive. Newer implants are several times more expensive than crowns. Dentists routinely adjust their treatment plan based on what the patient can afford.
While most other industries have market competition and profitability as incentives to avoid extravagance, U.S. health care seems unbridled by fiscal responsibility. The news that a small pharmaceutical company had raised the price of an old generic antibiotic by 5000%3 exposed the irrationality and capriciousness4 of the pricing of medications in the United States. Many politicians decried the behavior but to little effect. Most consumer products, especially computers, become more powerful and cheaper with each decade. Health care does not follow this pattern
There are many factors that influence physician behavior. Concerns about malpractice may bias physicians toward expensive overtreatment. Modern medical research is usually published expounding on the benefits of a new technology over a previous therapy without any acknowledgment that the newer and more expensive treatment may have a downside. This biases people to use the latest and greatest treatment even though it may have only demonstrated noninferiority in its trials.
I try to use evidence-based medicine when it is available. In the clinical case described earlier, I indicate to the emergency doctor that unless there is a clinical impression of coexisting meningitis, the lumbar puncture is not indicated. I cite the meta-analysis as I have many times before. But this night is different. I am simultaneously admitting a teenager whose gastrostomy tube had become dislodged and couldn’t be replaced. This neurologically devastated child had had meningitis as an infant. He is a stark reminder of the consequences of a missed diagnosis.
The parents of that child have provided him wonderful care. His skin is in excellent condition. His moderate contractures are testimony to dedicated stretching regimens at home. It is evident that the parents love the child as he is. But I am sure they would give anything to have avoided this scenario and to reverse the consequences of that meningitis. And so, the best evidence we have, that the risk of meningitis in an infant is low, is not as reassuring to me on this night. At 3 a.m., the juxtaposition of the two patients is unsettling. Is the risk low enough? Would that new test5, serum procalcitonin, help me to make a better decision? How certain must I be that an intervention is unnecessary?
Health care policy, economics, and practice guidelines can be debated with detached objectivity around a conference table in the middle of the day. The trepidation in an emergency room at 3 a.m. is different. This is my patient. I am his doctor. That is the heart of medical ethics.
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.
References
1. “How common is co-existing meningitis in infants with urinary tract infection?” on Bestbets.org.
2. “Why do doctors choose a $2,000 cure when a $50 one is just as good?” by Andrew Lam, Washington Post, Dec. 10, 2015.
3. “Drug Goes From $13.50 a Tablet to $750, Overnight” by Andrew Pollack, New York Times, Sept. 20, 2015.
4. “How an $84,000 drug got its price: ‘Let’s hold our position … whatever the headlines’ ” by Carolyn Y. Johnson and Brady Dennis, Washington Post, Dec. 1, 2015.
5. JAMA Pediatr. Published online, 2015 Nov 23. doi:10.1001/jamapediatrics.2015.3267.
The 3-month-old infant presents to the emergency department with a fever of 101° F. The emergency physician decides the infant looks ill enough to warrant some investigation. A urinalysis indicates a urinary tract infection. I am consulted to complete the admission to the hospital. The question arises, “Is a lumbar puncture indicated to rule out meningitis?”
I’ve been down this pathway many times. For years I have relied on a meta-analysis which corrected the bias of an old article from 1972.1 Multiple studies in the 2000-2010 time frame have shown that the risk of concurrent meningitis in a young infant with a UTI is vanishingly small. It is much less than 2%, with many studies finding 0%. So on a typical day, my answer is no tap if there is no clinical suggestion of meningitis.
Hospital medicine has recently focused on reducing overdiagnosis and overtreatment. When you only occasionally admit patients to the hospital, untoward events appear random and uncommon. When you work there day in and day out, you appreciate that all medical interventions have risks and costs.
A recent editorial raised the question of stewardship in medicine.2 It asked why physicians would choose a very expensive drug when there is little evidence of its superiority over a much cheaper predecessor. Physicians, whose actions influence a $3 trillion industry, have not embraced stewardship as a major component of their professional responsibilities. The physician does have a fiduciary duty toward the patient. The physician recommends the best care possible to achieve the patient’s goals of care. Dentistry is distinctly different in this regard. Dentists often have several ways of repairing decayed teeth. Various types of fillings are available. Gold fillings are more expensive. Newer implants are several times more expensive than crowns. Dentists routinely adjust their treatment plan based on what the patient can afford.
While most other industries have market competition and profitability as incentives to avoid extravagance, U.S. health care seems unbridled by fiscal responsibility. The news that a small pharmaceutical company had raised the price of an old generic antibiotic by 5000%3 exposed the irrationality and capriciousness4 of the pricing of medications in the United States. Many politicians decried the behavior but to little effect. Most consumer products, especially computers, become more powerful and cheaper with each decade. Health care does not follow this pattern
There are many factors that influence physician behavior. Concerns about malpractice may bias physicians toward expensive overtreatment. Modern medical research is usually published expounding on the benefits of a new technology over a previous therapy without any acknowledgment that the newer and more expensive treatment may have a downside. This biases people to use the latest and greatest treatment even though it may have only demonstrated noninferiority in its trials.
I try to use evidence-based medicine when it is available. In the clinical case described earlier, I indicate to the emergency doctor that unless there is a clinical impression of coexisting meningitis, the lumbar puncture is not indicated. I cite the meta-analysis as I have many times before. But this night is different. I am simultaneously admitting a teenager whose gastrostomy tube had become dislodged and couldn’t be replaced. This neurologically devastated child had had meningitis as an infant. He is a stark reminder of the consequences of a missed diagnosis.
The parents of that child have provided him wonderful care. His skin is in excellent condition. His moderate contractures are testimony to dedicated stretching regimens at home. It is evident that the parents love the child as he is. But I am sure they would give anything to have avoided this scenario and to reverse the consequences of that meningitis. And so, the best evidence we have, that the risk of meningitis in an infant is low, is not as reassuring to me on this night. At 3 a.m., the juxtaposition of the two patients is unsettling. Is the risk low enough? Would that new test5, serum procalcitonin, help me to make a better decision? How certain must I be that an intervention is unnecessary?
Health care policy, economics, and practice guidelines can be debated with detached objectivity around a conference table in the middle of the day. The trepidation in an emergency room at 3 a.m. is different. This is my patient. I am his doctor. That is the heart of medical ethics.
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.
References
1. “How common is co-existing meningitis in infants with urinary tract infection?” on Bestbets.org.
2. “Why do doctors choose a $2,000 cure when a $50 one is just as good?” by Andrew Lam, Washington Post, Dec. 10, 2015.
3. “Drug Goes From $13.50 a Tablet to $750, Overnight” by Andrew Pollack, New York Times, Sept. 20, 2015.
4. “How an $84,000 drug got its price: ‘Let’s hold our position … whatever the headlines’ ” by Carolyn Y. Johnson and Brady Dennis, Washington Post, Dec. 1, 2015.
5. JAMA Pediatr. Published online, 2015 Nov 23. doi:10.1001/jamapediatrics.2015.3267.
The 3-month-old infant presents to the emergency department with a fever of 101° F. The emergency physician decides the infant looks ill enough to warrant some investigation. A urinalysis indicates a urinary tract infection. I am consulted to complete the admission to the hospital. The question arises, “Is a lumbar puncture indicated to rule out meningitis?”
I’ve been down this pathway many times. For years I have relied on a meta-analysis which corrected the bias of an old article from 1972.1 Multiple studies in the 2000-2010 time frame have shown that the risk of concurrent meningitis in a young infant with a UTI is vanishingly small. It is much less than 2%, with many studies finding 0%. So on a typical day, my answer is no tap if there is no clinical suggestion of meningitis.
Hospital medicine has recently focused on reducing overdiagnosis and overtreatment. When you only occasionally admit patients to the hospital, untoward events appear random and uncommon. When you work there day in and day out, you appreciate that all medical interventions have risks and costs.
A recent editorial raised the question of stewardship in medicine.2 It asked why physicians would choose a very expensive drug when there is little evidence of its superiority over a much cheaper predecessor. Physicians, whose actions influence a $3 trillion industry, have not embraced stewardship as a major component of their professional responsibilities. The physician does have a fiduciary duty toward the patient. The physician recommends the best care possible to achieve the patient’s goals of care. Dentistry is distinctly different in this regard. Dentists often have several ways of repairing decayed teeth. Various types of fillings are available. Gold fillings are more expensive. Newer implants are several times more expensive than crowns. Dentists routinely adjust their treatment plan based on what the patient can afford.
While most other industries have market competition and profitability as incentives to avoid extravagance, U.S. health care seems unbridled by fiscal responsibility. The news that a small pharmaceutical company had raised the price of an old generic antibiotic by 5000%3 exposed the irrationality and capriciousness4 of the pricing of medications in the United States. Many politicians decried the behavior but to little effect. Most consumer products, especially computers, become more powerful and cheaper with each decade. Health care does not follow this pattern
There are many factors that influence physician behavior. Concerns about malpractice may bias physicians toward expensive overtreatment. Modern medical research is usually published expounding on the benefits of a new technology over a previous therapy without any acknowledgment that the newer and more expensive treatment may have a downside. This biases people to use the latest and greatest treatment even though it may have only demonstrated noninferiority in its trials.
I try to use evidence-based medicine when it is available. In the clinical case described earlier, I indicate to the emergency doctor that unless there is a clinical impression of coexisting meningitis, the lumbar puncture is not indicated. I cite the meta-analysis as I have many times before. But this night is different. I am simultaneously admitting a teenager whose gastrostomy tube had become dislodged and couldn’t be replaced. This neurologically devastated child had had meningitis as an infant. He is a stark reminder of the consequences of a missed diagnosis.
The parents of that child have provided him wonderful care. His skin is in excellent condition. His moderate contractures are testimony to dedicated stretching regimens at home. It is evident that the parents love the child as he is. But I am sure they would give anything to have avoided this scenario and to reverse the consequences of that meningitis. And so, the best evidence we have, that the risk of meningitis in an infant is low, is not as reassuring to me on this night. At 3 a.m., the juxtaposition of the two patients is unsettling. Is the risk low enough? Would that new test5, serum procalcitonin, help me to make a better decision? How certain must I be that an intervention is unnecessary?
Health care policy, economics, and practice guidelines can be debated with detached objectivity around a conference table in the middle of the day. The trepidation in an emergency room at 3 a.m. is different. This is my patient. I am his doctor. That is the heart of medical ethics.
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.
References
1. “How common is co-existing meningitis in infants with urinary tract infection?” on Bestbets.org.
2. “Why do doctors choose a $2,000 cure when a $50 one is just as good?” by Andrew Lam, Washington Post, Dec. 10, 2015.
3. “Drug Goes From $13.50 a Tablet to $750, Overnight” by Andrew Pollack, New York Times, Sept. 20, 2015.
4. “How an $84,000 drug got its price: ‘Let’s hold our position … whatever the headlines’ ” by Carolyn Y. Johnson and Brady Dennis, Washington Post, Dec. 1, 2015.
5. JAMA Pediatr. Published online, 2015 Nov 23. doi:10.1001/jamapediatrics.2015.3267.
