Antibiotic resistance remains a challenge for hospitals

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The Centers for Disease Control and Prevention just released a surveillance report describing national estimates of antimicrobial resistance among health care–associated infections (HAIs) in hospitals. The report compiles HAI data submitted to the CDC’s National Healthcare Safety Network (NHSN) from almost all short-term acute care hospitals, inpatient rehabilitation facilities, and long-term acute care hospitals in the country.

These data highlight the broad reach and urgent nature of the drug resistance problem challenging clinicians today; resistance is occurring across different types of infections and patient populations, and dangerous resistance profiles such as carbapenem-resistant Enterobacteriaceae, or CRE, are not going away.

Lindsey Weiner


The report highlights the percentage of HAI organisms that were resistant to select antibiotics for 21 different bug-drug combinations from 2011 to 2014. Most noticeable across this time period was an increase in the percentage of Escherichia coli that tested resistant to extended-spectrum cephalosporins, fluoroquinolones, and were identified as multidrug resistant (Infect Control Hosp Epidemiol. 2016 Aug 30. doi: 10.1017/ice.2016.174).

In 2011, 41.1% of E. coli central line–associated bloodstream infections (CLABSIs) were resistant to fluoroquinolones; this percentage increased to 49.3% by 2014. And, among catheter-associated UTIs (CAUTIs), 8% of E. coli were identified as multidrug resistant in 2014, an increase from 5.5% in 2011.

Hospitals continue to report CRE infections, which are often untreatable and represent a serious public health threat. Across the major HAI types analyzed in this report, CRE were found in CLABSIs (7.1% of Enterobacteriaceae were resistant to carbapenems), CAUTIs (4.0% resistant), and surgical site infections (1.8% resistant). After taking a closer look at individual species of bacteria, we found that almost 11% of CLABSIs caused by Klebsiella species were resistant to carbapenems, which was the highest resistance among all Enterobacteriaceae species. Furthermore, Enterobacter species showed increasing resistance to carbapenems, as the percentage resistant in CLABSIs increased from 3.0% in 2011 to 6.6% in 2014.

These data underscore the urgent nature of CRE prevention efforts, and fighting back against these deadly bacteria will require collaborative efforts from the entire health care community including health care facility leaders, health care providers, and state and local health departments.

Antibiotic-resistant infections are an important patient safety issue and continue to pose a threat to modern medicine. There are small improvements in some phenotypes such as multidrug-resistant Acinetobacter, in which the percentage resistant in CLABSIs decreased from 60.9% in 2011 to 43.7% in 2014. Multidrug-resistant Klebsiella appears to be declining as well, from 20.9% resistant to 17.2%. Despite some improvements, the data in this report support the conclusion that much more work is needed to combat antibiotic resistance. The CDC has identified three critical efforts to slow the spread of resistant HAIs:

• Prevent infections related to devices and surgeries.

• Prevent the spread of bacteria between patients and between facilities.

• Improve antibiotic use in health care settings.

In addition to drug resistance, this report looked at the frequency of pathogens causing HAIs. The No. 1 and No. 3 most common pathogens among all HAIs were E.coli and Klebsiella, both of which are gram-negative bacteria with the propensity to develop antibiotic resistance.

The data also help identify important differences in the causes of HAIs across each of the infection types. For example, CLABSIs were more commonly due to gram positive organisms and Candida (a fungus), while surgical site infections (SSIs) were most frequently caused by Staph aureus. NHSN tracks SSIs following 39 different types of procedures, and while Staph aureus was the most common pathogen reported overall, the pathogen distributions did vary by surgery site. For example, almost 30% of SSIs following transplant procedures were caused by a species of Enterococcus.

Obviously, there’s far more data in the report than we can discuss here. Fortunately, the CDC’s new Antibiotic Resistance Patient Safety Atlas gives everyone an opportunity to explore these resistance patterns further; color-coded maps and charts included within the Atlas can help you identify common resistance phenotypes in your state and region. While these data give us a national snapshot of resistance profiles, we know there is wide variation among individual health care settings. It is important for providers to become familiar with the common pathogens and resistance profiles in their hospitals and recognize that common infecting organisms vary across different types of infections.

This report underscores the important challenges posed by resistant organisms in hospitals. Combating antibiotic resistance is a top public health priority in the United States and around the world, and having data to direct action is a key part of tackling the problem.

The CDC will continue to use and expand its efforts to monitor antibiotic resistance through surveillance systems such as NHSN, and will remain committed to providing data to support the health care community in efforts to reduce the spread of resistance and improve antibiotic use.
 

 

 

Lindsey Weiner, MPH, is an epidemiologist and associate service fellow in the Surveillance Branch, Division of Healthcare Quality Promotion, at the Centers for Disease Control and Prevention.

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The Centers for Disease Control and Prevention just released a surveillance report describing national estimates of antimicrobial resistance among health care–associated infections (HAIs) in hospitals. The report compiles HAI data submitted to the CDC’s National Healthcare Safety Network (NHSN) from almost all short-term acute care hospitals, inpatient rehabilitation facilities, and long-term acute care hospitals in the country.

These data highlight the broad reach and urgent nature of the drug resistance problem challenging clinicians today; resistance is occurring across different types of infections and patient populations, and dangerous resistance profiles such as carbapenem-resistant Enterobacteriaceae, or CRE, are not going away.

Lindsey Weiner


The report highlights the percentage of HAI organisms that were resistant to select antibiotics for 21 different bug-drug combinations from 2011 to 2014. Most noticeable across this time period was an increase in the percentage of Escherichia coli that tested resistant to extended-spectrum cephalosporins, fluoroquinolones, and were identified as multidrug resistant (Infect Control Hosp Epidemiol. 2016 Aug 30. doi: 10.1017/ice.2016.174).

In 2011, 41.1% of E. coli central line–associated bloodstream infections (CLABSIs) were resistant to fluoroquinolones; this percentage increased to 49.3% by 2014. And, among catheter-associated UTIs (CAUTIs), 8% of E. coli were identified as multidrug resistant in 2014, an increase from 5.5% in 2011.

Hospitals continue to report CRE infections, which are often untreatable and represent a serious public health threat. Across the major HAI types analyzed in this report, CRE were found in CLABSIs (7.1% of Enterobacteriaceae were resistant to carbapenems), CAUTIs (4.0% resistant), and surgical site infections (1.8% resistant). After taking a closer look at individual species of bacteria, we found that almost 11% of CLABSIs caused by Klebsiella species were resistant to carbapenems, which was the highest resistance among all Enterobacteriaceae species. Furthermore, Enterobacter species showed increasing resistance to carbapenems, as the percentage resistant in CLABSIs increased from 3.0% in 2011 to 6.6% in 2014.

These data underscore the urgent nature of CRE prevention efforts, and fighting back against these deadly bacteria will require collaborative efforts from the entire health care community including health care facility leaders, health care providers, and state and local health departments.

Antibiotic-resistant infections are an important patient safety issue and continue to pose a threat to modern medicine. There are small improvements in some phenotypes such as multidrug-resistant Acinetobacter, in which the percentage resistant in CLABSIs decreased from 60.9% in 2011 to 43.7% in 2014. Multidrug-resistant Klebsiella appears to be declining as well, from 20.9% resistant to 17.2%. Despite some improvements, the data in this report support the conclusion that much more work is needed to combat antibiotic resistance. The CDC has identified three critical efforts to slow the spread of resistant HAIs:

• Prevent infections related to devices and surgeries.

• Prevent the spread of bacteria between patients and between facilities.

• Improve antibiotic use in health care settings.

In addition to drug resistance, this report looked at the frequency of pathogens causing HAIs. The No. 1 and No. 3 most common pathogens among all HAIs were E.coli and Klebsiella, both of which are gram-negative bacteria with the propensity to develop antibiotic resistance.

The data also help identify important differences in the causes of HAIs across each of the infection types. For example, CLABSIs were more commonly due to gram positive organisms and Candida (a fungus), while surgical site infections (SSIs) were most frequently caused by Staph aureus. NHSN tracks SSIs following 39 different types of procedures, and while Staph aureus was the most common pathogen reported overall, the pathogen distributions did vary by surgery site. For example, almost 30% of SSIs following transplant procedures were caused by a species of Enterococcus.

Obviously, there’s far more data in the report than we can discuss here. Fortunately, the CDC’s new Antibiotic Resistance Patient Safety Atlas gives everyone an opportunity to explore these resistance patterns further; color-coded maps and charts included within the Atlas can help you identify common resistance phenotypes in your state and region. While these data give us a national snapshot of resistance profiles, we know there is wide variation among individual health care settings. It is important for providers to become familiar with the common pathogens and resistance profiles in their hospitals and recognize that common infecting organisms vary across different types of infections.

This report underscores the important challenges posed by resistant organisms in hospitals. Combating antibiotic resistance is a top public health priority in the United States and around the world, and having data to direct action is a key part of tackling the problem.

The CDC will continue to use and expand its efforts to monitor antibiotic resistance through surveillance systems such as NHSN, and will remain committed to providing data to support the health care community in efforts to reduce the spread of resistance and improve antibiotic use.
 

 

 

Lindsey Weiner, MPH, is an epidemiologist and associate service fellow in the Surveillance Branch, Division of Healthcare Quality Promotion, at the Centers for Disease Control and Prevention.

The Centers for Disease Control and Prevention just released a surveillance report describing national estimates of antimicrobial resistance among health care–associated infections (HAIs) in hospitals. The report compiles HAI data submitted to the CDC’s National Healthcare Safety Network (NHSN) from almost all short-term acute care hospitals, inpatient rehabilitation facilities, and long-term acute care hospitals in the country.

These data highlight the broad reach and urgent nature of the drug resistance problem challenging clinicians today; resistance is occurring across different types of infections and patient populations, and dangerous resistance profiles such as carbapenem-resistant Enterobacteriaceae, or CRE, are not going away.

Lindsey Weiner


The report highlights the percentage of HAI organisms that were resistant to select antibiotics for 21 different bug-drug combinations from 2011 to 2014. Most noticeable across this time period was an increase in the percentage of Escherichia coli that tested resistant to extended-spectrum cephalosporins, fluoroquinolones, and were identified as multidrug resistant (Infect Control Hosp Epidemiol. 2016 Aug 30. doi: 10.1017/ice.2016.174).

In 2011, 41.1% of E. coli central line–associated bloodstream infections (CLABSIs) were resistant to fluoroquinolones; this percentage increased to 49.3% by 2014. And, among catheter-associated UTIs (CAUTIs), 8% of E. coli were identified as multidrug resistant in 2014, an increase from 5.5% in 2011.

Hospitals continue to report CRE infections, which are often untreatable and represent a serious public health threat. Across the major HAI types analyzed in this report, CRE were found in CLABSIs (7.1% of Enterobacteriaceae were resistant to carbapenems), CAUTIs (4.0% resistant), and surgical site infections (1.8% resistant). After taking a closer look at individual species of bacteria, we found that almost 11% of CLABSIs caused by Klebsiella species were resistant to carbapenems, which was the highest resistance among all Enterobacteriaceae species. Furthermore, Enterobacter species showed increasing resistance to carbapenems, as the percentage resistant in CLABSIs increased from 3.0% in 2011 to 6.6% in 2014.

These data underscore the urgent nature of CRE prevention efforts, and fighting back against these deadly bacteria will require collaborative efforts from the entire health care community including health care facility leaders, health care providers, and state and local health departments.

Antibiotic-resistant infections are an important patient safety issue and continue to pose a threat to modern medicine. There are small improvements in some phenotypes such as multidrug-resistant Acinetobacter, in which the percentage resistant in CLABSIs decreased from 60.9% in 2011 to 43.7% in 2014. Multidrug-resistant Klebsiella appears to be declining as well, from 20.9% resistant to 17.2%. Despite some improvements, the data in this report support the conclusion that much more work is needed to combat antibiotic resistance. The CDC has identified three critical efforts to slow the spread of resistant HAIs:

• Prevent infections related to devices and surgeries.

• Prevent the spread of bacteria between patients and between facilities.

• Improve antibiotic use in health care settings.

In addition to drug resistance, this report looked at the frequency of pathogens causing HAIs. The No. 1 and No. 3 most common pathogens among all HAIs were E.coli and Klebsiella, both of which are gram-negative bacteria with the propensity to develop antibiotic resistance.

The data also help identify important differences in the causes of HAIs across each of the infection types. For example, CLABSIs were more commonly due to gram positive organisms and Candida (a fungus), while surgical site infections (SSIs) were most frequently caused by Staph aureus. NHSN tracks SSIs following 39 different types of procedures, and while Staph aureus was the most common pathogen reported overall, the pathogen distributions did vary by surgery site. For example, almost 30% of SSIs following transplant procedures were caused by a species of Enterococcus.

Obviously, there’s far more data in the report than we can discuss here. Fortunately, the CDC’s new Antibiotic Resistance Patient Safety Atlas gives everyone an opportunity to explore these resistance patterns further; color-coded maps and charts included within the Atlas can help you identify common resistance phenotypes in your state and region. While these data give us a national snapshot of resistance profiles, we know there is wide variation among individual health care settings. It is important for providers to become familiar with the common pathogens and resistance profiles in their hospitals and recognize that common infecting organisms vary across different types of infections.

This report underscores the important challenges posed by resistant organisms in hospitals. Combating antibiotic resistance is a top public health priority in the United States and around the world, and having data to direct action is a key part of tackling the problem.

The CDC will continue to use and expand its efforts to monitor antibiotic resistance through surveillance systems such as NHSN, and will remain committed to providing data to support the health care community in efforts to reduce the spread of resistance and improve antibiotic use.
 

 

 

Lindsey Weiner, MPH, is an epidemiologist and associate service fellow in the Surveillance Branch, Division of Healthcare Quality Promotion, at the Centers for Disease Control and Prevention.

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New book tackles complex issues involved in treating depression

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Fri, 01/18/2019 - 16:25

 

“Still Down: What to Do When Antidepressants Fail” by Dean F. MacKinnon, MD, is a compact little book that recently was released by Johns Hopkins University Press. The title, “Still Down,” says it all. At 152 pages, the book is short, but not because it isn’t jammed full of information, but because – like the title – the writing is succinct and straight to the point; there’s no flowery detail, and Dr. MacKinnon doesn’t parse words. He tells the reader up front what his mission is, how the book is organized, and who his audience is. He’s an organized writer who captures the reader while getting his point across.

Dr. Dinah Miller
Dr. Dinah Miller
So how organized is Dr. MacKinnon? Each chapter is a clinical vignette, and the patients and doctors are given pseudonyms in alphabetical order: Ann sees Dr. Abernathy in chapter 1; then Bob sees Dr. Beasly in chapter 2. While “Still Down” is a series of nine short stories that make for a quick and interesting read, it provides enough information for a book twice the size. And in case the reader misses the point of the story (which is hard to imagine), each chapter ends with a summary of bullet points followed by case notes to clarify and expand on the points that were made during the vignette, and to add important commentary on the variety of decisions that might have been made for that particular patient’s story. Each chapter is short – a matter of pages, and there is no opportunity for the reader to get bored or tune out.

The book is divided into three distinct parts. In chapter 1, Ann suffers from “textbook depression.” Dr. MacKinnon uses this as an opportunity to educate the reader on the signs and symptoms of major depression, and the fact that treatment takes several weeks, during which side effects may occur before the resolution of symptoms. He talks about depression as a recurring medical illness, lists the available antidepressants by their class, and mentions that depression can be a result of other medical illnesses such as thyroid disease. In chapter 2, college student Bob remains depressed until he takes the medications as prescribed at a steady dose on a daily basis. This involves some coaxing, education, and even outreach by the school nurse, all while being cognizant of things that can go wrong in a young person on antidepressants.

In chapter 3, Carla is a patient of both Dr. Cohen and Dr. Clark, and she is a sensitive soul who sees herself as beyond help. In addition, she has difficulty tolerating medications, and it is only with much support that she is able to get an antidepressant up to a therapeutic dose that gives her relief from her distress. In fact, Dr. Clark resorts to using an older tricyclic antidepressant so he can monitor levels, and he discovers that Carla’s levels run much higher than expected from the dose she’s on, explaining some of her sensitivity to medication and propensity to side effects.

Part 2 of “Still Down” takes on the sticky issue of misdiagnosis. Darius sees Dr. Dennis for treatment of depression during a distressing period of his life when treatment with another doctor had already failed. After careful assessment, Dr. Dennis concludes that while antidepressants weren’t unreasonable to try, Darius is actually suffering from demoralization from losing his business, a miserable divorce, and a child custody battle. Dr. Dennis suggests therapy instead of medications at this point. This was where I found that, I, as a clinician, swayed from Dr. MacKinnon’s treatment approach: He emphasizes an inability to function and to feel pleasure as necessary elements of major depression, and Darius could do both to some extent. But still, his sleep was poor from shift work. He’d gained 30 pounds; he had little energy for activities besides work; and he was in a rut, unhappy, and having trouble entertaining his children when they visited and feeling too lazy to make changes. I thought Darius was depressed and demoralized, and while I agreed with the author that he needed psychotherapy, I also would have continued with medication trials. Dr. MacKinnon certainly doesn’t dismiss the idea of medication, and I found it helpful to revisit demoralization as a state responsible for many psychiatric symptoms.

Moving on in the section on misdiagnoses, the author talks about Evelyn, who turns out to have bipolar versus unipolar depression, and Frances, who carries an incorrect diagnosis of bipolar disorder, and has been overmedicated into a state of delirium. They both do well with time, thoughtful assessment, and treatment. Clinical pearls are threaded through these chapters.

“Depression-plus” is the title of the final section. Gary has major depression superimposed on his dysthymia, or persistent depressive disorder, and Dr. MacKinnon notes that people with constitutionally gloomy moods may have persistent sadness even after successful treatment of major depression. Here, there is a need for accommodation to a given personality state, and therapy can be helpful. Hannah, a patient of Dr. Hernandez, has what the author calls “depressed functioning.” This part I found most interesting, because I see this often in practice – a patient with a long history of being unmotivated and underfunctioning does not get fully (or any) better with antidepressants. Here, the functioning must improve before mood and self-esteem lift, and this is not an easy task. Finally, Irma has treatment-resistant depression, and with her doctor, considers a variety of augmentation medications as well as more novel strategies.

Simply stated, this book is a gem. It’s a very understandable guide to a very complex and frustrating issue, one that needs more time-consuming and thoughtful evaluation, and more intensive resources than a simple episode of depression usually entails.

Finally, I have to admit that I enjoyed Dr. MacKinnon’s quiet jabs at electronic medical records.
 

 

 

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has known Dr. MacKinnon for many years.

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“Still Down: What to Do When Antidepressants Fail” by Dean F. MacKinnon, MD, is a compact little book that recently was released by Johns Hopkins University Press. The title, “Still Down,” says it all. At 152 pages, the book is short, but not because it isn’t jammed full of information, but because – like the title – the writing is succinct and straight to the point; there’s no flowery detail, and Dr. MacKinnon doesn’t parse words. He tells the reader up front what his mission is, how the book is organized, and who his audience is. He’s an organized writer who captures the reader while getting his point across.

Dr. Dinah Miller
Dr. Dinah Miller
So how organized is Dr. MacKinnon? Each chapter is a clinical vignette, and the patients and doctors are given pseudonyms in alphabetical order: Ann sees Dr. Abernathy in chapter 1; then Bob sees Dr. Beasly in chapter 2. While “Still Down” is a series of nine short stories that make for a quick and interesting read, it provides enough information for a book twice the size. And in case the reader misses the point of the story (which is hard to imagine), each chapter ends with a summary of bullet points followed by case notes to clarify and expand on the points that were made during the vignette, and to add important commentary on the variety of decisions that might have been made for that particular patient’s story. Each chapter is short – a matter of pages, and there is no opportunity for the reader to get bored or tune out.

The book is divided into three distinct parts. In chapter 1, Ann suffers from “textbook depression.” Dr. MacKinnon uses this as an opportunity to educate the reader on the signs and symptoms of major depression, and the fact that treatment takes several weeks, during which side effects may occur before the resolution of symptoms. He talks about depression as a recurring medical illness, lists the available antidepressants by their class, and mentions that depression can be a result of other medical illnesses such as thyroid disease. In chapter 2, college student Bob remains depressed until he takes the medications as prescribed at a steady dose on a daily basis. This involves some coaxing, education, and even outreach by the school nurse, all while being cognizant of things that can go wrong in a young person on antidepressants.

In chapter 3, Carla is a patient of both Dr. Cohen and Dr. Clark, and she is a sensitive soul who sees herself as beyond help. In addition, she has difficulty tolerating medications, and it is only with much support that she is able to get an antidepressant up to a therapeutic dose that gives her relief from her distress. In fact, Dr. Clark resorts to using an older tricyclic antidepressant so he can monitor levels, and he discovers that Carla’s levels run much higher than expected from the dose she’s on, explaining some of her sensitivity to medication and propensity to side effects.

Part 2 of “Still Down” takes on the sticky issue of misdiagnosis. Darius sees Dr. Dennis for treatment of depression during a distressing period of his life when treatment with another doctor had already failed. After careful assessment, Dr. Dennis concludes that while antidepressants weren’t unreasonable to try, Darius is actually suffering from demoralization from losing his business, a miserable divorce, and a child custody battle. Dr. Dennis suggests therapy instead of medications at this point. This was where I found that, I, as a clinician, swayed from Dr. MacKinnon’s treatment approach: He emphasizes an inability to function and to feel pleasure as necessary elements of major depression, and Darius could do both to some extent. But still, his sleep was poor from shift work. He’d gained 30 pounds; he had little energy for activities besides work; and he was in a rut, unhappy, and having trouble entertaining his children when they visited and feeling too lazy to make changes. I thought Darius was depressed and demoralized, and while I agreed with the author that he needed psychotherapy, I also would have continued with medication trials. Dr. MacKinnon certainly doesn’t dismiss the idea of medication, and I found it helpful to revisit demoralization as a state responsible for many psychiatric symptoms.

Moving on in the section on misdiagnoses, the author talks about Evelyn, who turns out to have bipolar versus unipolar depression, and Frances, who carries an incorrect diagnosis of bipolar disorder, and has been overmedicated into a state of delirium. They both do well with time, thoughtful assessment, and treatment. Clinical pearls are threaded through these chapters.

“Depression-plus” is the title of the final section. Gary has major depression superimposed on his dysthymia, or persistent depressive disorder, and Dr. MacKinnon notes that people with constitutionally gloomy moods may have persistent sadness even after successful treatment of major depression. Here, there is a need for accommodation to a given personality state, and therapy can be helpful. Hannah, a patient of Dr. Hernandez, has what the author calls “depressed functioning.” This part I found most interesting, because I see this often in practice – a patient with a long history of being unmotivated and underfunctioning does not get fully (or any) better with antidepressants. Here, the functioning must improve before mood and self-esteem lift, and this is not an easy task. Finally, Irma has treatment-resistant depression, and with her doctor, considers a variety of augmentation medications as well as more novel strategies.

Simply stated, this book is a gem. It’s a very understandable guide to a very complex and frustrating issue, one that needs more time-consuming and thoughtful evaluation, and more intensive resources than a simple episode of depression usually entails.

Finally, I have to admit that I enjoyed Dr. MacKinnon’s quiet jabs at electronic medical records.
 

 

 

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has known Dr. MacKinnon for many years.

 

“Still Down: What to Do When Antidepressants Fail” by Dean F. MacKinnon, MD, is a compact little book that recently was released by Johns Hopkins University Press. The title, “Still Down,” says it all. At 152 pages, the book is short, but not because it isn’t jammed full of information, but because – like the title – the writing is succinct and straight to the point; there’s no flowery detail, and Dr. MacKinnon doesn’t parse words. He tells the reader up front what his mission is, how the book is organized, and who his audience is. He’s an organized writer who captures the reader while getting his point across.

Dr. Dinah Miller
Dr. Dinah Miller
So how organized is Dr. MacKinnon? Each chapter is a clinical vignette, and the patients and doctors are given pseudonyms in alphabetical order: Ann sees Dr. Abernathy in chapter 1; then Bob sees Dr. Beasly in chapter 2. While “Still Down” is a series of nine short stories that make for a quick and interesting read, it provides enough information for a book twice the size. And in case the reader misses the point of the story (which is hard to imagine), each chapter ends with a summary of bullet points followed by case notes to clarify and expand on the points that were made during the vignette, and to add important commentary on the variety of decisions that might have been made for that particular patient’s story. Each chapter is short – a matter of pages, and there is no opportunity for the reader to get bored or tune out.

The book is divided into three distinct parts. In chapter 1, Ann suffers from “textbook depression.” Dr. MacKinnon uses this as an opportunity to educate the reader on the signs and symptoms of major depression, and the fact that treatment takes several weeks, during which side effects may occur before the resolution of symptoms. He talks about depression as a recurring medical illness, lists the available antidepressants by their class, and mentions that depression can be a result of other medical illnesses such as thyroid disease. In chapter 2, college student Bob remains depressed until he takes the medications as prescribed at a steady dose on a daily basis. This involves some coaxing, education, and even outreach by the school nurse, all while being cognizant of things that can go wrong in a young person on antidepressants.

In chapter 3, Carla is a patient of both Dr. Cohen and Dr. Clark, and she is a sensitive soul who sees herself as beyond help. In addition, she has difficulty tolerating medications, and it is only with much support that she is able to get an antidepressant up to a therapeutic dose that gives her relief from her distress. In fact, Dr. Clark resorts to using an older tricyclic antidepressant so he can monitor levels, and he discovers that Carla’s levels run much higher than expected from the dose she’s on, explaining some of her sensitivity to medication and propensity to side effects.

Part 2 of “Still Down” takes on the sticky issue of misdiagnosis. Darius sees Dr. Dennis for treatment of depression during a distressing period of his life when treatment with another doctor had already failed. After careful assessment, Dr. Dennis concludes that while antidepressants weren’t unreasonable to try, Darius is actually suffering from demoralization from losing his business, a miserable divorce, and a child custody battle. Dr. Dennis suggests therapy instead of medications at this point. This was where I found that, I, as a clinician, swayed from Dr. MacKinnon’s treatment approach: He emphasizes an inability to function and to feel pleasure as necessary elements of major depression, and Darius could do both to some extent. But still, his sleep was poor from shift work. He’d gained 30 pounds; he had little energy for activities besides work; and he was in a rut, unhappy, and having trouble entertaining his children when they visited and feeling too lazy to make changes. I thought Darius was depressed and demoralized, and while I agreed with the author that he needed psychotherapy, I also would have continued with medication trials. Dr. MacKinnon certainly doesn’t dismiss the idea of medication, and I found it helpful to revisit demoralization as a state responsible for many psychiatric symptoms.

Moving on in the section on misdiagnoses, the author talks about Evelyn, who turns out to have bipolar versus unipolar depression, and Frances, who carries an incorrect diagnosis of bipolar disorder, and has been overmedicated into a state of delirium. They both do well with time, thoughtful assessment, and treatment. Clinical pearls are threaded through these chapters.

“Depression-plus” is the title of the final section. Gary has major depression superimposed on his dysthymia, or persistent depressive disorder, and Dr. MacKinnon notes that people with constitutionally gloomy moods may have persistent sadness even after successful treatment of major depression. Here, there is a need for accommodation to a given personality state, and therapy can be helpful. Hannah, a patient of Dr. Hernandez, has what the author calls “depressed functioning.” This part I found most interesting, because I see this often in practice – a patient with a long history of being unmotivated and underfunctioning does not get fully (or any) better with antidepressants. Here, the functioning must improve before mood and self-esteem lift, and this is not an easy task. Finally, Irma has treatment-resistant depression, and with her doctor, considers a variety of augmentation medications as well as more novel strategies.

Simply stated, this book is a gem. It’s a very understandable guide to a very complex and frustrating issue, one that needs more time-consuming and thoughtful evaluation, and more intensive resources than a simple episode of depression usually entails.

Finally, I have to admit that I enjoyed Dr. MacKinnon’s quiet jabs at electronic medical records.
 

 

 

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has known Dr. MacKinnon for many years.

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Idle intravenous catheters are associated with preventable complications

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Wed, 12/12/2018 - 20:54

Intravenous catheters (ICs) are common and necessary for inpatient care. However, peripheral and especially central venous catheters (CVCs) are associated with increased risk for local and systemic complications, including bloodstream infections and endocarditis.

University of Wisconsin School of Medicine and Public Health
Dr. Daniel Shirley

Prevention of these complications is important and should be a major focus of infection control and patient safety practices. There are three main points of focus on infection prevention with regard to ICs – proper insertion techniques, proper care of the catheter, and prompt removal when it is no longer necessary.

We focused our review, published in the American Journal of Infection Control (2016 Oct. doi: 10.1016/j.ajic.2016.03.073), on the final point – determining the prevalence, risk factors, and outcomes related to idle intravenous catheters. To accomplish this, we conducted an integrative review of published studies related to idle catheters, excluding reviews, abstracts, and commentaries. Thirteen studies met the inclusion criteria and four of these focused on CVCs.

Generally, an idle catheter is one that remains in place even though it is not being used for patient care. However, the definition of an “idle” catheter varied amongst the reviewed studies, as did the unit of measure, especially for peripheral catheters. Central venous catheter-focused studies were more consistent in using “idle catheter days” and “catheter days.”

Studies of peripheral catheters revealed that 16%-50% of patients had an idle catheter of some type. For the studies focused on CVCs, the percentage of patients with idle catheters ranged from 2.7% in one intensive care unit to 26.2% in a different study. Interestingly, in the study with 2.7% idle CVCs in the ICU, there was a higher percentage of idle CVCs outside of the ICU in the same hospital.

The major reasons for leaving catheters in place in studies where reasons were noted were convenience, future intention to use intravenous medication, and inappropriate use of intravenous medications when oral could be used.

Although data are scarce, complications in the reviewed studies were relatively common with idle peripheral catheters, where 9%-12% suffered thrombophlebitis. Obviously, the risk for catheter-related bloodstream infection increases as the number of catheter days increases – this is especially important with regard to idle CVCs.
 

 

Decreasing the prevalence of idle catheters is likely to decrease the risk for infection and improve patient safety. Based on our review of the data, a standardized definition of an “idle catheter” is needed. At the very least, a standard definition should be developed at each institution. This would allow an individual hospital the ability to identify and track the presence of these lines, and implement targeted interventions to decrease the proportion of idle lines. Ideally, a common definition would be created and validated so that data and interventions could be comparable across institutions and guidelines could be developed.

The goal of targeted interventions should be zero idle lines. Prevention of idle peripheral catheters should also be pursued, but because CVC-related complications are often more serious, these lines are often the focus of efforts. Use of peripherally inserted central catheters (PICCs) has increased and while these catheters in some settings may have decreased complication risk, compared with femoral/internal jugular/subclavian CVCs, prevention of idle catheter days is paramount for these catheters as well.

Many ICUs, including at our own institution, have instituted programs to closely monitor for ongoing need for CVCs. This increased focus on the CVC likely explains the lower rates of idle catheters in ICUs noted in the reviewed studies. This close surveillance can be done outside of the ICU as well, and could include peripheral catheters.

At our own institution, the need for catheters is reviewed on some units as part of formalized patient safety rounds. Another potential group of interventions could focus on electronic medical record (EMR)-based changes such as limits on the duration of the order, requirement for renewal of the order, or on-screen reminders of the presence of a catheter. This sort of intervention could possibly be expanded as EMR use becomes more common and robust. For instance, if intravenous medications have not been ordered or given in a certain amount of time, an alert might be triggered. Another EMR-based mechanism could be to require an indication for ongoing catheter use.

Education about the potential adverse outcomes of idle catheters is important. Promoting a team-based approach to interventions, where all involved team members can discuss patient safety issues on equal ground is paramount to successfully decreasing idle catheters and improving patient care and safety in general. As with other hospital-wide initiatives, engagement of hospital administration is important to decrease barriers to implementation.

Intravenous catheter use will remain an integral part of patient care, but efforts should be made to create standardization around the definition of an idle catheter, standardize units of measure, and institute programs to prevent idle catheters.

 

 

Daniel Shirley, MD, MS, is assistant professor in the division of infectious disease at the University of Wisconsin–Madison School of Medicine and Public Health and the William S. Middleton Memorial Veterans Hospital. Nasia Safdar, MD, PhD, is associate professor in the division of infectious disease at the University of Wisconsin–Madison School of Medicine and Public Health and the William S. Middleton Memorial Veterans Hospital.

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Intravenous catheters (ICs) are common and necessary for inpatient care. However, peripheral and especially central venous catheters (CVCs) are associated with increased risk for local and systemic complications, including bloodstream infections and endocarditis.

University of Wisconsin School of Medicine and Public Health
Dr. Daniel Shirley

Prevention of these complications is important and should be a major focus of infection control and patient safety practices. There are three main points of focus on infection prevention with regard to ICs – proper insertion techniques, proper care of the catheter, and prompt removal when it is no longer necessary.

We focused our review, published in the American Journal of Infection Control (2016 Oct. doi: 10.1016/j.ajic.2016.03.073), on the final point – determining the prevalence, risk factors, and outcomes related to idle intravenous catheters. To accomplish this, we conducted an integrative review of published studies related to idle catheters, excluding reviews, abstracts, and commentaries. Thirteen studies met the inclusion criteria and four of these focused on CVCs.

Generally, an idle catheter is one that remains in place even though it is not being used for patient care. However, the definition of an “idle” catheter varied amongst the reviewed studies, as did the unit of measure, especially for peripheral catheters. Central venous catheter-focused studies were more consistent in using “idle catheter days” and “catheter days.”

Studies of peripheral catheters revealed that 16%-50% of patients had an idle catheter of some type. For the studies focused on CVCs, the percentage of patients with idle catheters ranged from 2.7% in one intensive care unit to 26.2% in a different study. Interestingly, in the study with 2.7% idle CVCs in the ICU, there was a higher percentage of idle CVCs outside of the ICU in the same hospital.

The major reasons for leaving catheters in place in studies where reasons were noted were convenience, future intention to use intravenous medication, and inappropriate use of intravenous medications when oral could be used.

Although data are scarce, complications in the reviewed studies were relatively common with idle peripheral catheters, where 9%-12% suffered thrombophlebitis. Obviously, the risk for catheter-related bloodstream infection increases as the number of catheter days increases – this is especially important with regard to idle CVCs.
 

 

Decreasing the prevalence of idle catheters is likely to decrease the risk for infection and improve patient safety. Based on our review of the data, a standardized definition of an “idle catheter” is needed. At the very least, a standard definition should be developed at each institution. This would allow an individual hospital the ability to identify and track the presence of these lines, and implement targeted interventions to decrease the proportion of idle lines. Ideally, a common definition would be created and validated so that data and interventions could be comparable across institutions and guidelines could be developed.

The goal of targeted interventions should be zero idle lines. Prevention of idle peripheral catheters should also be pursued, but because CVC-related complications are often more serious, these lines are often the focus of efforts. Use of peripherally inserted central catheters (PICCs) has increased and while these catheters in some settings may have decreased complication risk, compared with femoral/internal jugular/subclavian CVCs, prevention of idle catheter days is paramount for these catheters as well.

Many ICUs, including at our own institution, have instituted programs to closely monitor for ongoing need for CVCs. This increased focus on the CVC likely explains the lower rates of idle catheters in ICUs noted in the reviewed studies. This close surveillance can be done outside of the ICU as well, and could include peripheral catheters.

At our own institution, the need for catheters is reviewed on some units as part of formalized patient safety rounds. Another potential group of interventions could focus on electronic medical record (EMR)-based changes such as limits on the duration of the order, requirement for renewal of the order, or on-screen reminders of the presence of a catheter. This sort of intervention could possibly be expanded as EMR use becomes more common and robust. For instance, if intravenous medications have not been ordered or given in a certain amount of time, an alert might be triggered. Another EMR-based mechanism could be to require an indication for ongoing catheter use.

Education about the potential adverse outcomes of idle catheters is important. Promoting a team-based approach to interventions, where all involved team members can discuss patient safety issues on equal ground is paramount to successfully decreasing idle catheters and improving patient care and safety in general. As with other hospital-wide initiatives, engagement of hospital administration is important to decrease barriers to implementation.

Intravenous catheter use will remain an integral part of patient care, but efforts should be made to create standardization around the definition of an idle catheter, standardize units of measure, and institute programs to prevent idle catheters.

 

 

Daniel Shirley, MD, MS, is assistant professor in the division of infectious disease at the University of Wisconsin–Madison School of Medicine and Public Health and the William S. Middleton Memorial Veterans Hospital. Nasia Safdar, MD, PhD, is associate professor in the division of infectious disease at the University of Wisconsin–Madison School of Medicine and Public Health and the William S. Middleton Memorial Veterans Hospital.

Intravenous catheters (ICs) are common and necessary for inpatient care. However, peripheral and especially central venous catheters (CVCs) are associated with increased risk for local and systemic complications, including bloodstream infections and endocarditis.

University of Wisconsin School of Medicine and Public Health
Dr. Daniel Shirley

Prevention of these complications is important and should be a major focus of infection control and patient safety practices. There are three main points of focus on infection prevention with regard to ICs – proper insertion techniques, proper care of the catheter, and prompt removal when it is no longer necessary.

We focused our review, published in the American Journal of Infection Control (2016 Oct. doi: 10.1016/j.ajic.2016.03.073), on the final point – determining the prevalence, risk factors, and outcomes related to idle intravenous catheters. To accomplish this, we conducted an integrative review of published studies related to idle catheters, excluding reviews, abstracts, and commentaries. Thirteen studies met the inclusion criteria and four of these focused on CVCs.

Generally, an idle catheter is one that remains in place even though it is not being used for patient care. However, the definition of an “idle” catheter varied amongst the reviewed studies, as did the unit of measure, especially for peripheral catheters. Central venous catheter-focused studies were more consistent in using “idle catheter days” and “catheter days.”

Studies of peripheral catheters revealed that 16%-50% of patients had an idle catheter of some type. For the studies focused on CVCs, the percentage of patients with idle catheters ranged from 2.7% in one intensive care unit to 26.2% in a different study. Interestingly, in the study with 2.7% idle CVCs in the ICU, there was a higher percentage of idle CVCs outside of the ICU in the same hospital.

The major reasons for leaving catheters in place in studies where reasons were noted were convenience, future intention to use intravenous medication, and inappropriate use of intravenous medications when oral could be used.

Although data are scarce, complications in the reviewed studies were relatively common with idle peripheral catheters, where 9%-12% suffered thrombophlebitis. Obviously, the risk for catheter-related bloodstream infection increases as the number of catheter days increases – this is especially important with regard to idle CVCs.
 

 

Decreasing the prevalence of idle catheters is likely to decrease the risk for infection and improve patient safety. Based on our review of the data, a standardized definition of an “idle catheter” is needed. At the very least, a standard definition should be developed at each institution. This would allow an individual hospital the ability to identify and track the presence of these lines, and implement targeted interventions to decrease the proportion of idle lines. Ideally, a common definition would be created and validated so that data and interventions could be comparable across institutions and guidelines could be developed.

The goal of targeted interventions should be zero idle lines. Prevention of idle peripheral catheters should also be pursued, but because CVC-related complications are often more serious, these lines are often the focus of efforts. Use of peripherally inserted central catheters (PICCs) has increased and while these catheters in some settings may have decreased complication risk, compared with femoral/internal jugular/subclavian CVCs, prevention of idle catheter days is paramount for these catheters as well.

Many ICUs, including at our own institution, have instituted programs to closely monitor for ongoing need for CVCs. This increased focus on the CVC likely explains the lower rates of idle catheters in ICUs noted in the reviewed studies. This close surveillance can be done outside of the ICU as well, and could include peripheral catheters.

At our own institution, the need for catheters is reviewed on some units as part of formalized patient safety rounds. Another potential group of interventions could focus on electronic medical record (EMR)-based changes such as limits on the duration of the order, requirement for renewal of the order, or on-screen reminders of the presence of a catheter. This sort of intervention could possibly be expanded as EMR use becomes more common and robust. For instance, if intravenous medications have not been ordered or given in a certain amount of time, an alert might be triggered. Another EMR-based mechanism could be to require an indication for ongoing catheter use.

Education about the potential adverse outcomes of idle catheters is important. Promoting a team-based approach to interventions, where all involved team members can discuss patient safety issues on equal ground is paramount to successfully decreasing idle catheters and improving patient care and safety in general. As with other hospital-wide initiatives, engagement of hospital administration is important to decrease barriers to implementation.

Intravenous catheter use will remain an integral part of patient care, but efforts should be made to create standardization around the definition of an idle catheter, standardize units of measure, and institute programs to prevent idle catheters.

 

 

Daniel Shirley, MD, MS, is assistant professor in the division of infectious disease at the University of Wisconsin–Madison School of Medicine and Public Health and the William S. Middleton Memorial Veterans Hospital. Nasia Safdar, MD, PhD, is associate professor in the division of infectious disease at the University of Wisconsin–Madison School of Medicine and Public Health and the William S. Middleton Memorial Veterans Hospital.

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Into the Wild: PA Edition

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The island of Adak is Alaska’s last frontier. There are no stores, doctors, streetlights, traffic lights, or even a need for license plates. Just the lonely cry of a bald eagle and the howl of the arctic wind accompany you along the dark streets of this ghost town on the edge of the earth, where the North Pacific and the Bering Sea collide. The frigid Arctic front travels down the west coast, while the warmer Japanese current comes up the Pacific side. The low tundra does little to block the winds generated by that confluence, which often whip at 90 mph or more for days on end. Otherwise, the weather is generally gray and misty, and temperatures range from about 20°F to 65°F.

The weather matches the ambience and surroundings—decaying shambles of a once grand Navy base with facilities designed to make life as pleasant as possible for service members. But the Navy left in the late 1990s. By the time I arrived to practice here in 2013, only a few hundred people inhabited the island. There was virtually no economy, and almost all the roads and buildings were deserted. Man’s creation had fallen victim to vandals and nature.

My practice claimed a converted high school principal’s office and a two-bed emergency department (ED) that had some nice equipment—but with no medical aid, x-ray technician, phlebotomist, or lab technician, there was only me to operate it.

One of the oddities of the Alaskan bush is that medical providers often perform as All Species Providers; my first patient, Sadie, was a very well-behaved black Labrador retriever. Unable to anesthetize her, I was thankful for her even-tempered, patient breed (and for my experience as a veterinarian). Sadie lay calmly on the ED bed, her head in her owner’s hands, while I sutured her forepaw. In hindsight, she was one of my easier cases.

Adak’s isolated location (450 miles from the nearest settled outpost), rugged terrain, and vast wildlife come with an elevated risk for injuries and no shortage of challenges in treating them. During my first week, an autistic child presented with a foot laceration. There was no electricity when he arrived, as was often the case due to the wind; the only available light came through the open door. It was dusk and snow was gently falling, but we huddled in the doorway, as the patient’s mother and my husband held the boy while I sutured him. I just managed to get the last stitch in before the child entered his incoherent world.

Credit: iStockphoto.com/mbarrettimages
Anchorage, the nearest evacuation location, was 1,200 miles away. In the absolute best case (ie, the weather conditions were suitable for planes to take off and land), it was a 3.5-hour flight—that is, it would take 3.5 hours for a plane to arrive from Anchorage (if one happened to be ready) and then another 3.5 hours to transport the patient back. This fact was always in the back of my mind, but you can imagine how nerve-wracked I was in my first week (I had quite an initiation, as you can see) when a COPD patient presented in a cyanotic, dyspneic, and agitated state (SpO2, 80%). I immediately inserted an IV, administered oxygen, and got the nebulizer going. That was all I could do—other than pray that he would be able to breathe while we awaited transport, which was potentially days away.

 

 

 

Not surprisingly for an island, the surrounding seas brought many of my patients. Workers on commercial fishing vessels frequently sustained injuries that the conditions at sea would exacerbate. Hand injuries were common, as were slip-and-fall injuries such as dislocations and broken bones. It could take hours to get them into port. The most memorable was a fisherman who had lost the end of his thumb when it was crushed between the gunwale and a swinging, loaded crab pot being hoisted aboard. The electricity (surprise) was out, so I was forced to treat him by flashlight. He was a young man (early 30s) but especially nice. What I remember most is that he declined a digital block. I debrided the devitalized tissue via sharp dissection, but he never once cursed. So much for all those jokes about cussing like a sailor.

On a seemingly calm Saturday in my third week, one of the supervisors from the fish processing plant came in with two of his workers. One had bilateral ocular exposure to a cleaning solvent, while the other was stumbling and disoriented. My triage skills were put to the test as I anesthetized Worker 1’s eyes with proparacaine, then inserted Morgan lenses (which, thankfully, came with instructions in the packaging!). The supervisor, who was keeping Worker 2 calm simultaneously, held a basin below the patient’s eyes to catch runoff as I quickly attached a liter of saline to each lens and opened the valve full bore. With that situation under control for the moment, I switched gears to assess Worker 2, who was markedly incoherent and unable to give a history. What I did know was that he was ataxic and nauseous, with a temperature of 104°F. I flashed my penlight into his eyes, and he reacted like Dracula faced with a crucifix. In addition to his exquisite photophobia, he had marked neck stiffness. The diagnosis was my first case of human meningitis. I inserted an IV providing ceftriaxone, acyclovir, and ondansetron. He required 2.5 L of IV fluid, but he gradually recovered over the next two days.

Why, with all these challenges, did I go to Alaska? Because I felt that there I could be of most service; if ever there was an underserved community, Adak was it. Ironically, the other job offer I considered was on the Hawaiian island of Kauai. As idyllic as that might have been, it wasn’t quite the adventure that Adak turned out to be—and it wasn’t as desperately in need of a provider.

When I took the Adak post, I didn’t realize how much I would learn. Above all, I realized that a complete and meticulous physical exam is king. If I missed any life-threatening conditions, the ramifications would be extreme. There were no referrals or second opinions, just me with the patient, and I had to make the right decisions.

The bonds I formed with the people on this remote island, and the paths I trod through this unusual land, made for a unique experience. It was a thrill to look out toward the horizon and know that everything I could see had remained unchanged since the birth of these volcanic islands. In time, I came to recognize that I was not in charge. The planes carrying supplies in or patients out would come if the weather allowed. What was on the island was what I had to work with, and if I didn’t have what I wanted, it was only because I didn’t want what I had. The waves would come as they will. I could either surf them or be tossed by them. I chose to dive in.

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The island of Adak is Alaska’s last frontier. There are no stores, doctors, streetlights, traffic lights, or even a need for license plates. Just the lonely cry of a bald eagle and the howl of the arctic wind accompany you along the dark streets of this ghost town on the edge of the earth, where the North Pacific and the Bering Sea collide. The frigid Arctic front travels down the west coast, while the warmer Japanese current comes up the Pacific side. The low tundra does little to block the winds generated by that confluence, which often whip at 90 mph or more for days on end. Otherwise, the weather is generally gray and misty, and temperatures range from about 20°F to 65°F.

The weather matches the ambience and surroundings—decaying shambles of a once grand Navy base with facilities designed to make life as pleasant as possible for service members. But the Navy left in the late 1990s. By the time I arrived to practice here in 2013, only a few hundred people inhabited the island. There was virtually no economy, and almost all the roads and buildings were deserted. Man’s creation had fallen victim to vandals and nature.

My practice claimed a converted high school principal’s office and a two-bed emergency department (ED) that had some nice equipment—but with no medical aid, x-ray technician, phlebotomist, or lab technician, there was only me to operate it.

One of the oddities of the Alaskan bush is that medical providers often perform as All Species Providers; my first patient, Sadie, was a very well-behaved black Labrador retriever. Unable to anesthetize her, I was thankful for her even-tempered, patient breed (and for my experience as a veterinarian). Sadie lay calmly on the ED bed, her head in her owner’s hands, while I sutured her forepaw. In hindsight, she was one of my easier cases.

Adak’s isolated location (450 miles from the nearest settled outpost), rugged terrain, and vast wildlife come with an elevated risk for injuries and no shortage of challenges in treating them. During my first week, an autistic child presented with a foot laceration. There was no electricity when he arrived, as was often the case due to the wind; the only available light came through the open door. It was dusk and snow was gently falling, but we huddled in the doorway, as the patient’s mother and my husband held the boy while I sutured him. I just managed to get the last stitch in before the child entered his incoherent world.

Credit: iStockphoto.com/mbarrettimages
Anchorage, the nearest evacuation location, was 1,200 miles away. In the absolute best case (ie, the weather conditions were suitable for planes to take off and land), it was a 3.5-hour flight—that is, it would take 3.5 hours for a plane to arrive from Anchorage (if one happened to be ready) and then another 3.5 hours to transport the patient back. This fact was always in the back of my mind, but you can imagine how nerve-wracked I was in my first week (I had quite an initiation, as you can see) when a COPD patient presented in a cyanotic, dyspneic, and agitated state (SpO2, 80%). I immediately inserted an IV, administered oxygen, and got the nebulizer going. That was all I could do—other than pray that he would be able to breathe while we awaited transport, which was potentially days away.

 

 

 

Not surprisingly for an island, the surrounding seas brought many of my patients. Workers on commercial fishing vessels frequently sustained injuries that the conditions at sea would exacerbate. Hand injuries were common, as were slip-and-fall injuries such as dislocations and broken bones. It could take hours to get them into port. The most memorable was a fisherman who had lost the end of his thumb when it was crushed between the gunwale and a swinging, loaded crab pot being hoisted aboard. The electricity (surprise) was out, so I was forced to treat him by flashlight. He was a young man (early 30s) but especially nice. What I remember most is that he declined a digital block. I debrided the devitalized tissue via sharp dissection, but he never once cursed. So much for all those jokes about cussing like a sailor.

On a seemingly calm Saturday in my third week, one of the supervisors from the fish processing plant came in with two of his workers. One had bilateral ocular exposure to a cleaning solvent, while the other was stumbling and disoriented. My triage skills were put to the test as I anesthetized Worker 1’s eyes with proparacaine, then inserted Morgan lenses (which, thankfully, came with instructions in the packaging!). The supervisor, who was keeping Worker 2 calm simultaneously, held a basin below the patient’s eyes to catch runoff as I quickly attached a liter of saline to each lens and opened the valve full bore. With that situation under control for the moment, I switched gears to assess Worker 2, who was markedly incoherent and unable to give a history. What I did know was that he was ataxic and nauseous, with a temperature of 104°F. I flashed my penlight into his eyes, and he reacted like Dracula faced with a crucifix. In addition to his exquisite photophobia, he had marked neck stiffness. The diagnosis was my first case of human meningitis. I inserted an IV providing ceftriaxone, acyclovir, and ondansetron. He required 2.5 L of IV fluid, but he gradually recovered over the next two days.

Why, with all these challenges, did I go to Alaska? Because I felt that there I could be of most service; if ever there was an underserved community, Adak was it. Ironically, the other job offer I considered was on the Hawaiian island of Kauai. As idyllic as that might have been, it wasn’t quite the adventure that Adak turned out to be—and it wasn’t as desperately in need of a provider.

When I took the Adak post, I didn’t realize how much I would learn. Above all, I realized that a complete and meticulous physical exam is king. If I missed any life-threatening conditions, the ramifications would be extreme. There were no referrals or second opinions, just me with the patient, and I had to make the right decisions.

The bonds I formed with the people on this remote island, and the paths I trod through this unusual land, made for a unique experience. It was a thrill to look out toward the horizon and know that everything I could see had remained unchanged since the birth of these volcanic islands. In time, I came to recognize that I was not in charge. The planes carrying supplies in or patients out would come if the weather allowed. What was on the island was what I had to work with, and if I didn’t have what I wanted, it was only because I didn’t want what I had. The waves would come as they will. I could either surf them or be tossed by them. I chose to dive in.

 

The island of Adak is Alaska’s last frontier. There are no stores, doctors, streetlights, traffic lights, or even a need for license plates. Just the lonely cry of a bald eagle and the howl of the arctic wind accompany you along the dark streets of this ghost town on the edge of the earth, where the North Pacific and the Bering Sea collide. The frigid Arctic front travels down the west coast, while the warmer Japanese current comes up the Pacific side. The low tundra does little to block the winds generated by that confluence, which often whip at 90 mph or more for days on end. Otherwise, the weather is generally gray and misty, and temperatures range from about 20°F to 65°F.

The weather matches the ambience and surroundings—decaying shambles of a once grand Navy base with facilities designed to make life as pleasant as possible for service members. But the Navy left in the late 1990s. By the time I arrived to practice here in 2013, only a few hundred people inhabited the island. There was virtually no economy, and almost all the roads and buildings were deserted. Man’s creation had fallen victim to vandals and nature.

My practice claimed a converted high school principal’s office and a two-bed emergency department (ED) that had some nice equipment—but with no medical aid, x-ray technician, phlebotomist, or lab technician, there was only me to operate it.

One of the oddities of the Alaskan bush is that medical providers often perform as All Species Providers; my first patient, Sadie, was a very well-behaved black Labrador retriever. Unable to anesthetize her, I was thankful for her even-tempered, patient breed (and for my experience as a veterinarian). Sadie lay calmly on the ED bed, her head in her owner’s hands, while I sutured her forepaw. In hindsight, she was one of my easier cases.

Adak’s isolated location (450 miles from the nearest settled outpost), rugged terrain, and vast wildlife come with an elevated risk for injuries and no shortage of challenges in treating them. During my first week, an autistic child presented with a foot laceration. There was no electricity when he arrived, as was often the case due to the wind; the only available light came through the open door. It was dusk and snow was gently falling, but we huddled in the doorway, as the patient’s mother and my husband held the boy while I sutured him. I just managed to get the last stitch in before the child entered his incoherent world.

Credit: iStockphoto.com/mbarrettimages
Anchorage, the nearest evacuation location, was 1,200 miles away. In the absolute best case (ie, the weather conditions were suitable for planes to take off and land), it was a 3.5-hour flight—that is, it would take 3.5 hours for a plane to arrive from Anchorage (if one happened to be ready) and then another 3.5 hours to transport the patient back. This fact was always in the back of my mind, but you can imagine how nerve-wracked I was in my first week (I had quite an initiation, as you can see) when a COPD patient presented in a cyanotic, dyspneic, and agitated state (SpO2, 80%). I immediately inserted an IV, administered oxygen, and got the nebulizer going. That was all I could do—other than pray that he would be able to breathe while we awaited transport, which was potentially days away.

 

 

 

Not surprisingly for an island, the surrounding seas brought many of my patients. Workers on commercial fishing vessels frequently sustained injuries that the conditions at sea would exacerbate. Hand injuries were common, as were slip-and-fall injuries such as dislocations and broken bones. It could take hours to get them into port. The most memorable was a fisherman who had lost the end of his thumb when it was crushed between the gunwale and a swinging, loaded crab pot being hoisted aboard. The electricity (surprise) was out, so I was forced to treat him by flashlight. He was a young man (early 30s) but especially nice. What I remember most is that he declined a digital block. I debrided the devitalized tissue via sharp dissection, but he never once cursed. So much for all those jokes about cussing like a sailor.

On a seemingly calm Saturday in my third week, one of the supervisors from the fish processing plant came in with two of his workers. One had bilateral ocular exposure to a cleaning solvent, while the other was stumbling and disoriented. My triage skills were put to the test as I anesthetized Worker 1’s eyes with proparacaine, then inserted Morgan lenses (which, thankfully, came with instructions in the packaging!). The supervisor, who was keeping Worker 2 calm simultaneously, held a basin below the patient’s eyes to catch runoff as I quickly attached a liter of saline to each lens and opened the valve full bore. With that situation under control for the moment, I switched gears to assess Worker 2, who was markedly incoherent and unable to give a history. What I did know was that he was ataxic and nauseous, with a temperature of 104°F. I flashed my penlight into his eyes, and he reacted like Dracula faced with a crucifix. In addition to his exquisite photophobia, he had marked neck stiffness. The diagnosis was my first case of human meningitis. I inserted an IV providing ceftriaxone, acyclovir, and ondansetron. He required 2.5 L of IV fluid, but he gradually recovered over the next two days.

Why, with all these challenges, did I go to Alaska? Because I felt that there I could be of most service; if ever there was an underserved community, Adak was it. Ironically, the other job offer I considered was on the Hawaiian island of Kauai. As idyllic as that might have been, it wasn’t quite the adventure that Adak turned out to be—and it wasn’t as desperately in need of a provider.

When I took the Adak post, I didn’t realize how much I would learn. Above all, I realized that a complete and meticulous physical exam is king. If I missed any life-threatening conditions, the ramifications would be extreme. There were no referrals or second opinions, just me with the patient, and I had to make the right decisions.

The bonds I formed with the people on this remote island, and the paths I trod through this unusual land, made for a unique experience. It was a thrill to look out toward the horizon and know that everything I could see had remained unchanged since the birth of these volcanic islands. In time, I came to recognize that I was not in charge. The planes carrying supplies in or patients out would come if the weather allowed. What was on the island was what I had to work with, and if I didn’t have what I wanted, it was only because I didn’t want what I had. The waves would come as they will. I could either surf them or be tossed by them. I chose to dive in.

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Impact of Medicaid expansion on inpatient outcomes

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The Affordable Care Act (ACA) has greatly increased the number of Medicaid enrollees since it expanded eligibility criteria on Jan. 1, 2014. Nearly 9 million additional U.S. adults now have Medicaid coverage, mostly in the 31 states and Washington, which have opted into Medicaid expansion.

The ACA has also had an important impact on hospital payer mix, mainly by decreasing the amount of uncompensated care in Medicaid-expansion states. Previous studies have shown disparities in the quality of inpatient care based on insurance type. Patients with Medicaid insurance often have longer hospitalizations and higher in-hospital mortality than commercially-insured patients and occasionally even than uninsured patients.

University of Colorado Hospital
Dr. Mary E. Anderson
As hospitalists, we were interested in how Medicaid expansion under the ACA might have affected these inpatient outcomes.

In our study published in the Journal of Hospital Medicine (2016 Dec. doi: 10.1002/jhm.2649), we evaluated the impact of state Medicaid expansion status on payer mix, length of stay, and in-hospital mortality for general medicine patients discharged from U.S. academic medical centers. We considered Jan. 1, 2014, to be the date of ACA implementation for all states except Michigan, New Hampshire, Pennsylvania, and Indiana, which had unique dates of Medicaid expansion.

We were able to identify 3,144,488 discharges from 156 hospitals in 24 Medicaid-expansion states and Washington, and 1,114,464 discharges from 55 hospitals in 14 nonexpansion states between October 2012 and September 2015.

Dr. Christine D. Jones
As expected, hospitals in Medicaid-expansion states experienced a significant 3.7% increase in Medicaid discharges and 2.9% decrease in uninsured discharges after ACA implementation. This represented a relative 19% jump in Medicaid and 60% drop in uninsured discharges. Hospitals in nonexpansion states did not see a significant change in payer mix after ACA implementation.

Despite this difference in payer mix trends, state Medicaid expansion status was not associated with differences in overall length of stay or in-hospital mortality in our study. More precisely, we looked at the length of stay and mortality indices, or ratio of observed to expected values, to control for such potential confounders as disease severity and comorbid conditions.

One possible explanation for our findings is that the higher proportion of Medicare and commercially-insured patients overshadowed the contribution of Medicaid patients to the overall length of stay and mortality indices.

To our knowledge, our study is the first to look at the effect of ACA implementation on inpatient outcomes. Early evidence suggests that Medicaid expansion has improved outpatient outcomes. Low-income adults in Medicaid-expansion states have shown greater gains in access to primary care clinics and medications and in the diagnosis of certain chronic health conditions than those in non-expansion states. However, these changes would not necessarily lead to improvements in the length of stay or mortality indices for Medicaid-expansion hospitals, since the measures account for patient acuity on admission.

The take-home message from our study for health policy makers is that state Medicaid expansion status had a neutral effect on both length of stay and mortality indices. This should be reassuring for states considering expansion of their Medicaid programs in the future.

As a next step, it would be useful to see research on the impact of ACA implementation on other inpatient outcomes that may vary with insurance type, such as readmissions or hospital-acquired complications.

The take-home message for hospitalists is that there is more work to be done in reducing disparities in inpatient care based on payer status. Though not a primary focus of our study, we did see variation in the length of stay and mortality indices based on insurance type.

It is unclear whether these differences occurred because of variation in the expertise of inpatient providers, access to invasive procedures or medical therapies, the timeliness of discharge to post-acute care facilities, or other patient- or system-level factors. However, these disparities warrant our improvement efforts moving forward.

Mary Anderson, MD, and Christine Jones, MD, are hospitalists at the University of Colorado (Aurora) Hospital and assistant professors in the department of medicine at the University of Colorado.

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The Affordable Care Act (ACA) has greatly increased the number of Medicaid enrollees since it expanded eligibility criteria on Jan. 1, 2014. Nearly 9 million additional U.S. adults now have Medicaid coverage, mostly in the 31 states and Washington, which have opted into Medicaid expansion.

The ACA has also had an important impact on hospital payer mix, mainly by decreasing the amount of uncompensated care in Medicaid-expansion states. Previous studies have shown disparities in the quality of inpatient care based on insurance type. Patients with Medicaid insurance often have longer hospitalizations and higher in-hospital mortality than commercially-insured patients and occasionally even than uninsured patients.

University of Colorado Hospital
Dr. Mary E. Anderson
As hospitalists, we were interested in how Medicaid expansion under the ACA might have affected these inpatient outcomes.

In our study published in the Journal of Hospital Medicine (2016 Dec. doi: 10.1002/jhm.2649), we evaluated the impact of state Medicaid expansion status on payer mix, length of stay, and in-hospital mortality for general medicine patients discharged from U.S. academic medical centers. We considered Jan. 1, 2014, to be the date of ACA implementation for all states except Michigan, New Hampshire, Pennsylvania, and Indiana, which had unique dates of Medicaid expansion.

We were able to identify 3,144,488 discharges from 156 hospitals in 24 Medicaid-expansion states and Washington, and 1,114,464 discharges from 55 hospitals in 14 nonexpansion states between October 2012 and September 2015.

Dr. Christine D. Jones
As expected, hospitals in Medicaid-expansion states experienced a significant 3.7% increase in Medicaid discharges and 2.9% decrease in uninsured discharges after ACA implementation. This represented a relative 19% jump in Medicaid and 60% drop in uninsured discharges. Hospitals in nonexpansion states did not see a significant change in payer mix after ACA implementation.

Despite this difference in payer mix trends, state Medicaid expansion status was not associated with differences in overall length of stay or in-hospital mortality in our study. More precisely, we looked at the length of stay and mortality indices, or ratio of observed to expected values, to control for such potential confounders as disease severity and comorbid conditions.

One possible explanation for our findings is that the higher proportion of Medicare and commercially-insured patients overshadowed the contribution of Medicaid patients to the overall length of stay and mortality indices.

To our knowledge, our study is the first to look at the effect of ACA implementation on inpatient outcomes. Early evidence suggests that Medicaid expansion has improved outpatient outcomes. Low-income adults in Medicaid-expansion states have shown greater gains in access to primary care clinics and medications and in the diagnosis of certain chronic health conditions than those in non-expansion states. However, these changes would not necessarily lead to improvements in the length of stay or mortality indices for Medicaid-expansion hospitals, since the measures account for patient acuity on admission.

The take-home message from our study for health policy makers is that state Medicaid expansion status had a neutral effect on both length of stay and mortality indices. This should be reassuring for states considering expansion of their Medicaid programs in the future.

As a next step, it would be useful to see research on the impact of ACA implementation on other inpatient outcomes that may vary with insurance type, such as readmissions or hospital-acquired complications.

The take-home message for hospitalists is that there is more work to be done in reducing disparities in inpatient care based on payer status. Though not a primary focus of our study, we did see variation in the length of stay and mortality indices based on insurance type.

It is unclear whether these differences occurred because of variation in the expertise of inpatient providers, access to invasive procedures or medical therapies, the timeliness of discharge to post-acute care facilities, or other patient- or system-level factors. However, these disparities warrant our improvement efforts moving forward.

Mary Anderson, MD, and Christine Jones, MD, are hospitalists at the University of Colorado (Aurora) Hospital and assistant professors in the department of medicine at the University of Colorado.

 

The Affordable Care Act (ACA) has greatly increased the number of Medicaid enrollees since it expanded eligibility criteria on Jan. 1, 2014. Nearly 9 million additional U.S. adults now have Medicaid coverage, mostly in the 31 states and Washington, which have opted into Medicaid expansion.

The ACA has also had an important impact on hospital payer mix, mainly by decreasing the amount of uncompensated care in Medicaid-expansion states. Previous studies have shown disparities in the quality of inpatient care based on insurance type. Patients with Medicaid insurance often have longer hospitalizations and higher in-hospital mortality than commercially-insured patients and occasionally even than uninsured patients.

University of Colorado Hospital
Dr. Mary E. Anderson
As hospitalists, we were interested in how Medicaid expansion under the ACA might have affected these inpatient outcomes.

In our study published in the Journal of Hospital Medicine (2016 Dec. doi: 10.1002/jhm.2649), we evaluated the impact of state Medicaid expansion status on payer mix, length of stay, and in-hospital mortality for general medicine patients discharged from U.S. academic medical centers. We considered Jan. 1, 2014, to be the date of ACA implementation for all states except Michigan, New Hampshire, Pennsylvania, and Indiana, which had unique dates of Medicaid expansion.

We were able to identify 3,144,488 discharges from 156 hospitals in 24 Medicaid-expansion states and Washington, and 1,114,464 discharges from 55 hospitals in 14 nonexpansion states between October 2012 and September 2015.

Dr. Christine D. Jones
As expected, hospitals in Medicaid-expansion states experienced a significant 3.7% increase in Medicaid discharges and 2.9% decrease in uninsured discharges after ACA implementation. This represented a relative 19% jump in Medicaid and 60% drop in uninsured discharges. Hospitals in nonexpansion states did not see a significant change in payer mix after ACA implementation.

Despite this difference in payer mix trends, state Medicaid expansion status was not associated with differences in overall length of stay or in-hospital mortality in our study. More precisely, we looked at the length of stay and mortality indices, or ratio of observed to expected values, to control for such potential confounders as disease severity and comorbid conditions.

One possible explanation for our findings is that the higher proportion of Medicare and commercially-insured patients overshadowed the contribution of Medicaid patients to the overall length of stay and mortality indices.

To our knowledge, our study is the first to look at the effect of ACA implementation on inpatient outcomes. Early evidence suggests that Medicaid expansion has improved outpatient outcomes. Low-income adults in Medicaid-expansion states have shown greater gains in access to primary care clinics and medications and in the diagnosis of certain chronic health conditions than those in non-expansion states. However, these changes would not necessarily lead to improvements in the length of stay or mortality indices for Medicaid-expansion hospitals, since the measures account for patient acuity on admission.

The take-home message from our study for health policy makers is that state Medicaid expansion status had a neutral effect on both length of stay and mortality indices. This should be reassuring for states considering expansion of their Medicaid programs in the future.

As a next step, it would be useful to see research on the impact of ACA implementation on other inpatient outcomes that may vary with insurance type, such as readmissions or hospital-acquired complications.

The take-home message for hospitalists is that there is more work to be done in reducing disparities in inpatient care based on payer status. Though not a primary focus of our study, we did see variation in the length of stay and mortality indices based on insurance type.

It is unclear whether these differences occurred because of variation in the expertise of inpatient providers, access to invasive procedures or medical therapies, the timeliness of discharge to post-acute care facilities, or other patient- or system-level factors. However, these disparities warrant our improvement efforts moving forward.

Mary Anderson, MD, and Christine Jones, MD, are hospitalists at the University of Colorado (Aurora) Hospital and assistant professors in the department of medicine at the University of Colorado.

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OA drug development needs patient-focused approach to biomarkers and outcome measures

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Fri, 01/18/2019 - 16:25

 

Advances in our understanding of the development and treatment of osteoarthritis have led to renewed interest in leveraging these insights to establish more ways to evaluate potential drug candidates in clinical trials, particularly through the use of qualified biomarkers as meaningful outcome measures.

It is with this goal in mind that the Arthritis Foundation and the Food and Drug Administration held the Accelerating Osteoarthritis Clinical Trials Workshop in Atlanta in February 2016,1 to discuss ways of enhancing the likelihood of successful OA trials, including possible “qualification” of biomarkers that can be used as endpoints in trials of OA treatments. Clinical trial endpoints would ideally be known to be clinically meaningful to the patient (such as pain, fatigue, functional status, etc.)2 and would reflect treatments that enable patients to feel and function better.

Dr. Amanda Niskar
Workshop participants recognized that involving patients as early as the study design phase of trials is a priority for identifying clinically meaningful outcomes and trial endpoints, and it is important that the rationale for their use is clearly delineated in the study protocol.2 The participants also noted the importance of finding points in the research and development continuum where clinical trial sponsors and regulators can engage patients from the bench to the bedside and back.3

Patient engagement in different steps of the development process might be possible through patient registries, social media communities, smart phones, and wearable devices to be used as tools for capturing patient perceptions and mobility. These means for capturing dynamic data about domains of high interest to OA patients may lead to the development of better outcome measures that can be used as clinical trial endpoints.4 Researchers at the workshop presented new ways in which they are beginning to specialize in these techniques and methods that will be useful for turning the patient experience into usable data to aid in precision medicine.

Dr. Sarah Yim
Participants discussed how informed patients who are trained in the clinical trial approach are uniquely positioned to inform our understanding of benefit expectations, risk tolerance, and attitudes toward uncertainty. Clinical benefit results when a patient experiences improvement in quality of life. Endpoints in trials of OA treatments, whether symptomatic or disease-modifying, need to demonstrate the clinical benefit directly or at least be interpretable with respect to the clinical benefit to be expected. Drugs approved for OA to date have been approved based on pain and function patient reported outcomes (PROs), such as the Western Ontario and McMaster Universities Osteoarthritis Index (pain, function, stiffness), Visual Analogue Scale function and pain ratings, patient global, investigator’s global, Lequesne score, knee injury and OA outcome score, and the International Knee Documentation Committee knee examination form. The FDA is open to other PROs and recommends discussing other PRO options ahead of time.

Imaging outcomes and biomarkers are attractive for their potential to demonstrate an effect on the structural and pathophysiologic elements of OA in the time frame of a clinical trial, but rely on well-characterized relationships between those structural and pathophysiologic elements of OA and the clinical outcomes of OA. A recent advance is data showing that semiquantitative knee joint features, including cartilage thickness and surface area, meniscal morphology, and bone marrow lesions, were associated with clinically relevant OA progression and could be potentially useful as measures of efficacy in clinical trials of disease-modifying interventions.5 Being able to describe the clinical benefit to be expected from such changes is essential to use these outcomes in the benefit-risk assessment. How to include structural outcomes in OA trials will depend on the level of information available to characterize clinical benefit. With less information, structural outcomes may still be useful as adjunct or secondary endpoints. To be used as the primary endpoint to support approval, a high level of characterization would be needed about the relationship of the endpoint to anticipated clinical benefit. The FDA recommends that sponsors proposing such a primary endpoint should engage with the agency early in the development program.

Dr. Virginia Kraus
Workshop participants suggested potential strategies to take advantage of information gathered in future OA drug development clinical trials. One option might be to seek initial approval based on OA signs and symptoms, with structural endpoints potentially described in the label as a pharmacodynamic assessment. The clinical relevance of the structural endpoint would not be known or described pending further data characterizing the link between structure and long-term outcomes.

Another option discussed was to study an accelerated OA population, that is, subjects (prior to joint replacement) with a history of trauma to a joint and other injuries predictive of early OA. In that setting, the study duration needed to demonstrate the relationship of structural and clinical outcomes may be more feasible.

A third option discussed was an end-stage OA trial that could enroll subjects who meet criteria for joint replacement. Such a study could possibly have outcomes that include delay in time to surgery, reduction in need for surgery, and clinical outcomes, such as need for concomitant analgesics, patient pain, and patient function. In any OA population, demonstrating a treatment’s effectiveness on clinical outcomes could be the sole basis for approval, in the context of an acceptable safety profile.

Dr. Rocky Tuan
As a direct result of the workshop, the Arthritis Foundation is convening a series of events culminating in an Arthritis Foundation–led OA Patient-Focused Drug Development meeting on March 8, 2017. The meeting is expected to identify clinical trial endpoints that are clinically meaningful to patients living with OA.
 

Dr. Niskar is national scientific director of the Arthritis Foundation. Dr. Yim is supervisory associate director of the division of pulmonary, allergy, and rheumatology products in the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research. Dr. Kraus is professor of medicine, pathology, and orthopedic surgery at Duke University, Durham, N.C., and is a faculty member of the Duke Molecular Physiology Institute. Dr. Tuan is director of the Center for Cellular and Molecular Engineering and Distinguished Professor of Orthopedic Surgery at the University of Pittsburgh.

Dr. Niskar reports that the Arthritis Foundation received a donation from Samumed and a cosponsorship grant from the FDA to implement the Accelerating OA Clinical Trials Workshop. Dr. Kraus reports an Arthritis Foundation Delivering on Discovery Award that is outside of this editorial. Dr. Yim and Dr. Tuan disclosed no conflicts. Dr. Yim is relaying her personal views in this editorial, and they are not intended to convey official FDA policy, and no official support or endorsement by the FDA is provided or should be inferred. Samumed did not have a role in the writing of this editorial.

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Advances in our understanding of the development and treatment of osteoarthritis have led to renewed interest in leveraging these insights to establish more ways to evaluate potential drug candidates in clinical trials, particularly through the use of qualified biomarkers as meaningful outcome measures.

It is with this goal in mind that the Arthritis Foundation and the Food and Drug Administration held the Accelerating Osteoarthritis Clinical Trials Workshop in Atlanta in February 2016,1 to discuss ways of enhancing the likelihood of successful OA trials, including possible “qualification” of biomarkers that can be used as endpoints in trials of OA treatments. Clinical trial endpoints would ideally be known to be clinically meaningful to the patient (such as pain, fatigue, functional status, etc.)2 and would reflect treatments that enable patients to feel and function better.

Dr. Amanda Niskar
Workshop participants recognized that involving patients as early as the study design phase of trials is a priority for identifying clinically meaningful outcomes and trial endpoints, and it is important that the rationale for their use is clearly delineated in the study protocol.2 The participants also noted the importance of finding points in the research and development continuum where clinical trial sponsors and regulators can engage patients from the bench to the bedside and back.3

Patient engagement in different steps of the development process might be possible through patient registries, social media communities, smart phones, and wearable devices to be used as tools for capturing patient perceptions and mobility. These means for capturing dynamic data about domains of high interest to OA patients may lead to the development of better outcome measures that can be used as clinical trial endpoints.4 Researchers at the workshop presented new ways in which they are beginning to specialize in these techniques and methods that will be useful for turning the patient experience into usable data to aid in precision medicine.

Dr. Sarah Yim
Participants discussed how informed patients who are trained in the clinical trial approach are uniquely positioned to inform our understanding of benefit expectations, risk tolerance, and attitudes toward uncertainty. Clinical benefit results when a patient experiences improvement in quality of life. Endpoints in trials of OA treatments, whether symptomatic or disease-modifying, need to demonstrate the clinical benefit directly or at least be interpretable with respect to the clinical benefit to be expected. Drugs approved for OA to date have been approved based on pain and function patient reported outcomes (PROs), such as the Western Ontario and McMaster Universities Osteoarthritis Index (pain, function, stiffness), Visual Analogue Scale function and pain ratings, patient global, investigator’s global, Lequesne score, knee injury and OA outcome score, and the International Knee Documentation Committee knee examination form. The FDA is open to other PROs and recommends discussing other PRO options ahead of time.

Imaging outcomes and biomarkers are attractive for their potential to demonstrate an effect on the structural and pathophysiologic elements of OA in the time frame of a clinical trial, but rely on well-characterized relationships between those structural and pathophysiologic elements of OA and the clinical outcomes of OA. A recent advance is data showing that semiquantitative knee joint features, including cartilage thickness and surface area, meniscal morphology, and bone marrow lesions, were associated with clinically relevant OA progression and could be potentially useful as measures of efficacy in clinical trials of disease-modifying interventions.5 Being able to describe the clinical benefit to be expected from such changes is essential to use these outcomes in the benefit-risk assessment. How to include structural outcomes in OA trials will depend on the level of information available to characterize clinical benefit. With less information, structural outcomes may still be useful as adjunct or secondary endpoints. To be used as the primary endpoint to support approval, a high level of characterization would be needed about the relationship of the endpoint to anticipated clinical benefit. The FDA recommends that sponsors proposing such a primary endpoint should engage with the agency early in the development program.

Dr. Virginia Kraus
Workshop participants suggested potential strategies to take advantage of information gathered in future OA drug development clinical trials. One option might be to seek initial approval based on OA signs and symptoms, with structural endpoints potentially described in the label as a pharmacodynamic assessment. The clinical relevance of the structural endpoint would not be known or described pending further data characterizing the link between structure and long-term outcomes.

Another option discussed was to study an accelerated OA population, that is, subjects (prior to joint replacement) with a history of trauma to a joint and other injuries predictive of early OA. In that setting, the study duration needed to demonstrate the relationship of structural and clinical outcomes may be more feasible.

A third option discussed was an end-stage OA trial that could enroll subjects who meet criteria for joint replacement. Such a study could possibly have outcomes that include delay in time to surgery, reduction in need for surgery, and clinical outcomes, such as need for concomitant analgesics, patient pain, and patient function. In any OA population, demonstrating a treatment’s effectiveness on clinical outcomes could be the sole basis for approval, in the context of an acceptable safety profile.

Dr. Rocky Tuan
As a direct result of the workshop, the Arthritis Foundation is convening a series of events culminating in an Arthritis Foundation–led OA Patient-Focused Drug Development meeting on March 8, 2017. The meeting is expected to identify clinical trial endpoints that are clinically meaningful to patients living with OA.
 

Dr. Niskar is national scientific director of the Arthritis Foundation. Dr. Yim is supervisory associate director of the division of pulmonary, allergy, and rheumatology products in the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research. Dr. Kraus is professor of medicine, pathology, and orthopedic surgery at Duke University, Durham, N.C., and is a faculty member of the Duke Molecular Physiology Institute. Dr. Tuan is director of the Center for Cellular and Molecular Engineering and Distinguished Professor of Orthopedic Surgery at the University of Pittsburgh.

Dr. Niskar reports that the Arthritis Foundation received a donation from Samumed and a cosponsorship grant from the FDA to implement the Accelerating OA Clinical Trials Workshop. Dr. Kraus reports an Arthritis Foundation Delivering on Discovery Award that is outside of this editorial. Dr. Yim and Dr. Tuan disclosed no conflicts. Dr. Yim is relaying her personal views in this editorial, and they are not intended to convey official FDA policy, and no official support or endorsement by the FDA is provided or should be inferred. Samumed did not have a role in the writing of this editorial.

References

 

Advances in our understanding of the development and treatment of osteoarthritis have led to renewed interest in leveraging these insights to establish more ways to evaluate potential drug candidates in clinical trials, particularly through the use of qualified biomarkers as meaningful outcome measures.

It is with this goal in mind that the Arthritis Foundation and the Food and Drug Administration held the Accelerating Osteoarthritis Clinical Trials Workshop in Atlanta in February 2016,1 to discuss ways of enhancing the likelihood of successful OA trials, including possible “qualification” of biomarkers that can be used as endpoints in trials of OA treatments. Clinical trial endpoints would ideally be known to be clinically meaningful to the patient (such as pain, fatigue, functional status, etc.)2 and would reflect treatments that enable patients to feel and function better.

Dr. Amanda Niskar
Workshop participants recognized that involving patients as early as the study design phase of trials is a priority for identifying clinically meaningful outcomes and trial endpoints, and it is important that the rationale for their use is clearly delineated in the study protocol.2 The participants also noted the importance of finding points in the research and development continuum where clinical trial sponsors and regulators can engage patients from the bench to the bedside and back.3

Patient engagement in different steps of the development process might be possible through patient registries, social media communities, smart phones, and wearable devices to be used as tools for capturing patient perceptions and mobility. These means for capturing dynamic data about domains of high interest to OA patients may lead to the development of better outcome measures that can be used as clinical trial endpoints.4 Researchers at the workshop presented new ways in which they are beginning to specialize in these techniques and methods that will be useful for turning the patient experience into usable data to aid in precision medicine.

Dr. Sarah Yim
Participants discussed how informed patients who are trained in the clinical trial approach are uniquely positioned to inform our understanding of benefit expectations, risk tolerance, and attitudes toward uncertainty. Clinical benefit results when a patient experiences improvement in quality of life. Endpoints in trials of OA treatments, whether symptomatic or disease-modifying, need to demonstrate the clinical benefit directly or at least be interpretable with respect to the clinical benefit to be expected. Drugs approved for OA to date have been approved based on pain and function patient reported outcomes (PROs), such as the Western Ontario and McMaster Universities Osteoarthritis Index (pain, function, stiffness), Visual Analogue Scale function and pain ratings, patient global, investigator’s global, Lequesne score, knee injury and OA outcome score, and the International Knee Documentation Committee knee examination form. The FDA is open to other PROs and recommends discussing other PRO options ahead of time.

Imaging outcomes and biomarkers are attractive for their potential to demonstrate an effect on the structural and pathophysiologic elements of OA in the time frame of a clinical trial, but rely on well-characterized relationships between those structural and pathophysiologic elements of OA and the clinical outcomes of OA. A recent advance is data showing that semiquantitative knee joint features, including cartilage thickness and surface area, meniscal morphology, and bone marrow lesions, were associated with clinically relevant OA progression and could be potentially useful as measures of efficacy in clinical trials of disease-modifying interventions.5 Being able to describe the clinical benefit to be expected from such changes is essential to use these outcomes in the benefit-risk assessment. How to include structural outcomes in OA trials will depend on the level of information available to characterize clinical benefit. With less information, structural outcomes may still be useful as adjunct or secondary endpoints. To be used as the primary endpoint to support approval, a high level of characterization would be needed about the relationship of the endpoint to anticipated clinical benefit. The FDA recommends that sponsors proposing such a primary endpoint should engage with the agency early in the development program.

Dr. Virginia Kraus
Workshop participants suggested potential strategies to take advantage of information gathered in future OA drug development clinical trials. One option might be to seek initial approval based on OA signs and symptoms, with structural endpoints potentially described in the label as a pharmacodynamic assessment. The clinical relevance of the structural endpoint would not be known or described pending further data characterizing the link between structure and long-term outcomes.

Another option discussed was to study an accelerated OA population, that is, subjects (prior to joint replacement) with a history of trauma to a joint and other injuries predictive of early OA. In that setting, the study duration needed to demonstrate the relationship of structural and clinical outcomes may be more feasible.

A third option discussed was an end-stage OA trial that could enroll subjects who meet criteria for joint replacement. Such a study could possibly have outcomes that include delay in time to surgery, reduction in need for surgery, and clinical outcomes, such as need for concomitant analgesics, patient pain, and patient function. In any OA population, demonstrating a treatment’s effectiveness on clinical outcomes could be the sole basis for approval, in the context of an acceptable safety profile.

Dr. Rocky Tuan
As a direct result of the workshop, the Arthritis Foundation is convening a series of events culminating in an Arthritis Foundation–led OA Patient-Focused Drug Development meeting on March 8, 2017. The meeting is expected to identify clinical trial endpoints that are clinically meaningful to patients living with OA.
 

Dr. Niskar is national scientific director of the Arthritis Foundation. Dr. Yim is supervisory associate director of the division of pulmonary, allergy, and rheumatology products in the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research. Dr. Kraus is professor of medicine, pathology, and orthopedic surgery at Duke University, Durham, N.C., and is a faculty member of the Duke Molecular Physiology Institute. Dr. Tuan is director of the Center for Cellular and Molecular Engineering and Distinguished Professor of Orthopedic Surgery at the University of Pittsburgh.

Dr. Niskar reports that the Arthritis Foundation received a donation from Samumed and a cosponsorship grant from the FDA to implement the Accelerating OA Clinical Trials Workshop. Dr. Kraus reports an Arthritis Foundation Delivering on Discovery Award that is outside of this editorial. Dr. Yim and Dr. Tuan disclosed no conflicts. Dr. Yim is relaying her personal views in this editorial, and they are not intended to convey official FDA policy, and no official support or endorsement by the FDA is provided or should be inferred. Samumed did not have a role in the writing of this editorial.

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The Death of a Dream: Closing an NP Practice

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Thu, 03/28/2019 - 14:59
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The Death of a Dream: Closing an NP Practice
 

For many nurse practitioners, having your own practice is the culmination of many years of planning and anticipation. I worked as an NP for 14 years in practices operated by others—hospitals and physicians—before I opened my own practice. During those years, I had observed which ways of doing things appeared productive and healing to me and which did not.

When the time came, having seen a need for more affordable health care that was not predicated on the assumption that every patient had health insurance, I opened a cash-only practice in the town where I resided. By eliminating the need for personnel and apparatus dedicated to insurance filing, I was able to charge about half of what other practices in the same location did for identical services. My chief goal was to be of service to the community, not to make the most money possible. I anticipated that volume would make up for the lower prices in the long run.

For about four years, our revenue grew slowly. I decided to risk all and stop teaching part-time in order to focus exclusively on my practice. This proved to be a good decision—for about one year. Then the recession hit my part of the country. Suddenly, the operation of a “cash-only” practice became an oxymoron, as many of the patients with already limited funds lost their jobs. These patients started to seek “free” care at area emergency departments, and the practice income plummeted. My revenue fell by one-half the first year and then one-half of that the next year.

In what would turn out to be my final year of practice ownership, I decided to accept a full-time position as faculty of a distance FNP program. I was practicing “on the side,” although in reality I was in my office full-time and teaching from there. I was already recognizing the difficulties of juggling my roles and responsibilities when a student in one of my classes asked what it would take for me to decide to close my practice, since I was (by this point) making no money from it.

As I pondered that question (my initial response was a quite honest “I don’t know”), I stepped onto the road toward closing my practice. From a business perspective, there was little point in keeping the practice open. However, from an emotional point of view, I had invested so much in building my dream—and, by extension, so had my family—that closing the practice seemed unthinkable.

THE DECISION

Opening a practice is a time of joy, pride, and a sense of accomplishment; closing that same practice induces a period of reflection, sadness, and even anger that circumstances did not allow continued operation. While financial considerations play a significant role in the decision to close a practice, they may not be the only, or the deciding, factor.

In my case, the financial shortfall of the practice led me to accept a teaching position in order to earn living expenses. The result of that decision was that my attention became divided: Sometimes I was in meetings or interacting with students—and for a few weeks per year, I was out of town—which meant less time devoted to seeing patients. Conversely, if I was with a patient, I of course could not be available to my students. Over time, I started to feel that I was not giving my all to either role as I shifted back and forth. Having given 100% to each of these roles at previous points in my career, I now felt that I was cheating my patients and my students.

The decision to close a practice may take months or even years before the actual process is started. I lived with my conundrum for about a year before I made the decision to close. I was exhausted—and while I was relieved to have the burden of deciding off my shoulders, it was now time to do the work of closing a practice.

 

 

 

NOTIFYING YOUR STAKEHOLDERS

Once the decision to close a practice is reached, the provider/owner ceases to exist in a vacuum. There are stakeholders who need to be notified—some obvious, some less so.

I started by breaking the news to my family, the people who had supported me in opening my practice (and even helped me find and refurbish furniture for my waiting room!). Although they had been aware of my internal debate, they had not lived with the decision process as I had. Having resolved at least some of my own emotions, I now had to watch others experience many of those same feelings.

Next, I had to tell my employees of the decision. Through attrition, my staff had already shrunk to two: a receptionist and a part-time licensed vocational nurse (LVN). Like my family, they had to process their own emotions about the closure. I had anticipated that the people who worked for me, concerned about their future, might choose to accept another job before we officially closed. My LVN—who had observed the practice dwindling in the preceding two years—seemed prepared for my decision. She stuck it out with me until the end and was a huge help with the influx of patients requesting records. (My MD—required by Texas law to delegate prescriptive authority to me—had already relocated his practice and was ill, so he was content with my decision.)

Of course, the biggest stakeholders in a practice are the patients. Notifying them of the impending closure is the most important action you will take (aside from making the decision to close). Although you can place notices in the local media (newspapers, TV, radio) to announce the closure of your practice to the community, you should send a notification letter directly to your patients. It should be sent at least 60 to 90 days before the closure date—and certainly not less than 30 days in any case—giving patients adequate time to find new providers and arrange for their records to be transferred.1,2 The letter should include

  • A statement of gratitude for the patient’s business
  • The dates of the transition period
  • What is expected of the patient (eg, does he/she need to come and pick up his/her records?)
  • An explanation for the closure3

I composed a letter to be sent to all patients who had been seen within the past 18 months. In it, I thanked them for being a part of the practice and gave them 60 days’ notice of the intent to close. For many patients, this was an emotional time; many understandably worried how their health care needs would be met in the future. Some responded with sadness that I had not been able to make the practice a success.

AVOIDING “ABANDONMENT”

Ideally, a provider who wants to get out of the business should seek to sell the practice—but this is not always feasible.3,4 When closure is the best (or only) option, it is important to avoid even the appearance of abandonment.

Besides giving adequate notice of practice closure, providers must have a plan for the dispersal of patients.1 Be prepared to give recommendations for new providers. Depending on the practice location (rural or urban), options may vary.

I made a concerted effort to refer patients to new providers, with the caveat that if the patient did not feel a particular provider was a good match, he/she should seek another provider of his/her choosing. Unlike in a purchased practice, where patients “go with” the practice, patients from a closed practice may be referred to one, several, or even many other providers.5

Provisions must be made to store patient records so that they are retrievable for a specified period of time. The requirements vary by state, so consultation of the state board’s rules and regulations—and/or an attorney—is in order.3 In general, the proscribed time period is seven to 10 years for adults and seven to 10 years after the patient turns 18 for pediatric patients.2 In some states, the retention time may be as short as three years for adults.1

OTHER PRACTICAL CONSIDERATIONS

While people will be your priority as you work through the process of closing, you will have “stuff” to deal with. What will you do with the furnishings and equipment? Obviously, anything that was borrowed can be returned. Beyond that, your options are to sell (to another provider or even a patient), donate, or repurpose items.

 

 

 

The orthopedic exam table from my practice went to a private school for their athletic training facility. Screens went to my neighbor, a chiropractor. My preschool-aged grandsons were thrilled to be given the children’s art supplies and books that had once graced my waiting area. One of my patients bought some decorative vases and a bookcase. The painting that had been carefully chosen to pull together my waiting room now hangs in my library at home.

As the closure date approaches, the practice environment may begin to look bare as furnishings are sold or moved. One item you will want to buy, however, is a fresh ink cartridge for your copier/printer. As patients request documents, you’ll use it!

RESPONSE AND AFTERMATH

The practice may be very busy immediately following the receipt of notification letters—but don’t be fooled into thinking you have made the wrong decision. The first month after the letters went out advising of the closure, my practice was busier than it had ever been! This tapered off in the second month, though.

Most patients, once they’ve heard the news, will want prescription refills and/or their records. Some may just want to know what happened to result in the closure. Remember that to the patient, this seems like a sudden decision—no matter how long you have deliberated about it.

What surprised me most, however, was that new patients continued to present to the practice, seeking care for acute issues. While I did provide this, I made them aware from the beginning that the practice was in the process of closing and that I could not assume the responsibility of being their primary provider. I made sure to provide these patients with recommendations for other providers.

Slowly the rush will settle down, as patients start to move on to other providers. A few may drop in to see you socially. On the day I closed my practice, several patients came in just to say goodbye and wish me well.

The last things I did in my practice were turn off the lights and leave a sign on the door stating that the practice was now closed.

RECOVERY

The time needed to recover from the closure of a practice will differ. Factors include how long the practice was open and how the clinician normally deals with a setback.6 For some, relief that the pressures of ownership are over may be the predominant emotion. Having a steady, stable salary in a new position goes a long way toward making the transition easier! Although if possible, take some time between closing the practice and starting a new job.

Do not be surprised if negative emotions manifest at odd times, as feelings of sadness, regret, and even a sense of failure are worked through. Life does go on—and nurse practitioners are resilient. Find a way to use the knowledge gained from your practice in your new endeavors, whatever they may be.

For me, the healing process would have started sooner if I had acknowledged how difficult giving up the dream of having my own practice was. If I had sought out others with similar experience or even talked with a counselor, my journey through this process could have been expedited. When I started to share my story, one frequently asked question was “How did you get through this?” This showed me that others could learn from my experience.

References

1. Tatooles JJ, Brunell A. What you need to know before leaving a medical practice: a primer for moving on. AAOS NOW. 2015;22-23.
2. Kern SI. Take these steps if selling or closing a practice. Med Econ. 2010;87(20):66.
3. Weiss GG. How to close a practice. Med Econ. 2004;81:69.
4. Zaumeyer C. How to Start an Independent Practice: The Nurse Practition­er’s Guide to Success. Philadelphia: F. A. Davis, Publishers; 2003.
5. Barrett W. The legal corner: Eleven essential steps to purchasing or selling a medical practice. J Med Pract Manage. 2014;29(5):275-277.
6. McBride JL. Personal issues to consider before leaving independent practice. Fam Pract Manag. 2013;20(4):9-12.

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For many nurse practitioners, having your own practice is the culmination of many years of planning and anticipation. I worked as an NP for 14 years in practices operated by others—hospitals and physicians—before I opened my own practice. During those years, I had observed which ways of doing things appeared productive and healing to me and which did not.

When the time came, having seen a need for more affordable health care that was not predicated on the assumption that every patient had health insurance, I opened a cash-only practice in the town where I resided. By eliminating the need for personnel and apparatus dedicated to insurance filing, I was able to charge about half of what other practices in the same location did for identical services. My chief goal was to be of service to the community, not to make the most money possible. I anticipated that volume would make up for the lower prices in the long run.

For about four years, our revenue grew slowly. I decided to risk all and stop teaching part-time in order to focus exclusively on my practice. This proved to be a good decision—for about one year. Then the recession hit my part of the country. Suddenly, the operation of a “cash-only” practice became an oxymoron, as many of the patients with already limited funds lost their jobs. These patients started to seek “free” care at area emergency departments, and the practice income plummeted. My revenue fell by one-half the first year and then one-half of that the next year.

In what would turn out to be my final year of practice ownership, I decided to accept a full-time position as faculty of a distance FNP program. I was practicing “on the side,” although in reality I was in my office full-time and teaching from there. I was already recognizing the difficulties of juggling my roles and responsibilities when a student in one of my classes asked what it would take for me to decide to close my practice, since I was (by this point) making no money from it.

As I pondered that question (my initial response was a quite honest “I don’t know”), I stepped onto the road toward closing my practice. From a business perspective, there was little point in keeping the practice open. However, from an emotional point of view, I had invested so much in building my dream—and, by extension, so had my family—that closing the practice seemed unthinkable.

THE DECISION

Opening a practice is a time of joy, pride, and a sense of accomplishment; closing that same practice induces a period of reflection, sadness, and even anger that circumstances did not allow continued operation. While financial considerations play a significant role in the decision to close a practice, they may not be the only, or the deciding, factor.

In my case, the financial shortfall of the practice led me to accept a teaching position in order to earn living expenses. The result of that decision was that my attention became divided: Sometimes I was in meetings or interacting with students—and for a few weeks per year, I was out of town—which meant less time devoted to seeing patients. Conversely, if I was with a patient, I of course could not be available to my students. Over time, I started to feel that I was not giving my all to either role as I shifted back and forth. Having given 100% to each of these roles at previous points in my career, I now felt that I was cheating my patients and my students.

The decision to close a practice may take months or even years before the actual process is started. I lived with my conundrum for about a year before I made the decision to close. I was exhausted—and while I was relieved to have the burden of deciding off my shoulders, it was now time to do the work of closing a practice.

 

 

 

NOTIFYING YOUR STAKEHOLDERS

Once the decision to close a practice is reached, the provider/owner ceases to exist in a vacuum. There are stakeholders who need to be notified—some obvious, some less so.

I started by breaking the news to my family, the people who had supported me in opening my practice (and even helped me find and refurbish furniture for my waiting room!). Although they had been aware of my internal debate, they had not lived with the decision process as I had. Having resolved at least some of my own emotions, I now had to watch others experience many of those same feelings.

Next, I had to tell my employees of the decision. Through attrition, my staff had already shrunk to two: a receptionist and a part-time licensed vocational nurse (LVN). Like my family, they had to process their own emotions about the closure. I had anticipated that the people who worked for me, concerned about their future, might choose to accept another job before we officially closed. My LVN—who had observed the practice dwindling in the preceding two years—seemed prepared for my decision. She stuck it out with me until the end and was a huge help with the influx of patients requesting records. (My MD—required by Texas law to delegate prescriptive authority to me—had already relocated his practice and was ill, so he was content with my decision.)

Of course, the biggest stakeholders in a practice are the patients. Notifying them of the impending closure is the most important action you will take (aside from making the decision to close). Although you can place notices in the local media (newspapers, TV, radio) to announce the closure of your practice to the community, you should send a notification letter directly to your patients. It should be sent at least 60 to 90 days before the closure date—and certainly not less than 30 days in any case—giving patients adequate time to find new providers and arrange for their records to be transferred.1,2 The letter should include

  • A statement of gratitude for the patient’s business
  • The dates of the transition period
  • What is expected of the patient (eg, does he/she need to come and pick up his/her records?)
  • An explanation for the closure3

I composed a letter to be sent to all patients who had been seen within the past 18 months. In it, I thanked them for being a part of the practice and gave them 60 days’ notice of the intent to close. For many patients, this was an emotional time; many understandably worried how their health care needs would be met in the future. Some responded with sadness that I had not been able to make the practice a success.

AVOIDING “ABANDONMENT”

Ideally, a provider who wants to get out of the business should seek to sell the practice—but this is not always feasible.3,4 When closure is the best (or only) option, it is important to avoid even the appearance of abandonment.

Besides giving adequate notice of practice closure, providers must have a plan for the dispersal of patients.1 Be prepared to give recommendations for new providers. Depending on the practice location (rural or urban), options may vary.

I made a concerted effort to refer patients to new providers, with the caveat that if the patient did not feel a particular provider was a good match, he/she should seek another provider of his/her choosing. Unlike in a purchased practice, where patients “go with” the practice, patients from a closed practice may be referred to one, several, or even many other providers.5

Provisions must be made to store patient records so that they are retrievable for a specified period of time. The requirements vary by state, so consultation of the state board’s rules and regulations—and/or an attorney—is in order.3 In general, the proscribed time period is seven to 10 years for adults and seven to 10 years after the patient turns 18 for pediatric patients.2 In some states, the retention time may be as short as three years for adults.1

OTHER PRACTICAL CONSIDERATIONS

While people will be your priority as you work through the process of closing, you will have “stuff” to deal with. What will you do with the furnishings and equipment? Obviously, anything that was borrowed can be returned. Beyond that, your options are to sell (to another provider or even a patient), donate, or repurpose items.

 

 

 

The orthopedic exam table from my practice went to a private school for their athletic training facility. Screens went to my neighbor, a chiropractor. My preschool-aged grandsons were thrilled to be given the children’s art supplies and books that had once graced my waiting area. One of my patients bought some decorative vases and a bookcase. The painting that had been carefully chosen to pull together my waiting room now hangs in my library at home.

As the closure date approaches, the practice environment may begin to look bare as furnishings are sold or moved. One item you will want to buy, however, is a fresh ink cartridge for your copier/printer. As patients request documents, you’ll use it!

RESPONSE AND AFTERMATH

The practice may be very busy immediately following the receipt of notification letters—but don’t be fooled into thinking you have made the wrong decision. The first month after the letters went out advising of the closure, my practice was busier than it had ever been! This tapered off in the second month, though.

Most patients, once they’ve heard the news, will want prescription refills and/or their records. Some may just want to know what happened to result in the closure. Remember that to the patient, this seems like a sudden decision—no matter how long you have deliberated about it.

What surprised me most, however, was that new patients continued to present to the practice, seeking care for acute issues. While I did provide this, I made them aware from the beginning that the practice was in the process of closing and that I could not assume the responsibility of being their primary provider. I made sure to provide these patients with recommendations for other providers.

Slowly the rush will settle down, as patients start to move on to other providers. A few may drop in to see you socially. On the day I closed my practice, several patients came in just to say goodbye and wish me well.

The last things I did in my practice were turn off the lights and leave a sign on the door stating that the practice was now closed.

RECOVERY

The time needed to recover from the closure of a practice will differ. Factors include how long the practice was open and how the clinician normally deals with a setback.6 For some, relief that the pressures of ownership are over may be the predominant emotion. Having a steady, stable salary in a new position goes a long way toward making the transition easier! Although if possible, take some time between closing the practice and starting a new job.

Do not be surprised if negative emotions manifest at odd times, as feelings of sadness, regret, and even a sense of failure are worked through. Life does go on—and nurse practitioners are resilient. Find a way to use the knowledge gained from your practice in your new endeavors, whatever they may be.

For me, the healing process would have started sooner if I had acknowledged how difficult giving up the dream of having my own practice was. If I had sought out others with similar experience or even talked with a counselor, my journey through this process could have been expedited. When I started to share my story, one frequently asked question was “How did you get through this?” This showed me that others could learn from my experience.

 

For many nurse practitioners, having your own practice is the culmination of many years of planning and anticipation. I worked as an NP for 14 years in practices operated by others—hospitals and physicians—before I opened my own practice. During those years, I had observed which ways of doing things appeared productive and healing to me and which did not.

When the time came, having seen a need for more affordable health care that was not predicated on the assumption that every patient had health insurance, I opened a cash-only practice in the town where I resided. By eliminating the need for personnel and apparatus dedicated to insurance filing, I was able to charge about half of what other practices in the same location did for identical services. My chief goal was to be of service to the community, not to make the most money possible. I anticipated that volume would make up for the lower prices in the long run.

For about four years, our revenue grew slowly. I decided to risk all and stop teaching part-time in order to focus exclusively on my practice. This proved to be a good decision—for about one year. Then the recession hit my part of the country. Suddenly, the operation of a “cash-only” practice became an oxymoron, as many of the patients with already limited funds lost their jobs. These patients started to seek “free” care at area emergency departments, and the practice income plummeted. My revenue fell by one-half the first year and then one-half of that the next year.

In what would turn out to be my final year of practice ownership, I decided to accept a full-time position as faculty of a distance FNP program. I was practicing “on the side,” although in reality I was in my office full-time and teaching from there. I was already recognizing the difficulties of juggling my roles and responsibilities when a student in one of my classes asked what it would take for me to decide to close my practice, since I was (by this point) making no money from it.

As I pondered that question (my initial response was a quite honest “I don’t know”), I stepped onto the road toward closing my practice. From a business perspective, there was little point in keeping the practice open. However, from an emotional point of view, I had invested so much in building my dream—and, by extension, so had my family—that closing the practice seemed unthinkable.

THE DECISION

Opening a practice is a time of joy, pride, and a sense of accomplishment; closing that same practice induces a period of reflection, sadness, and even anger that circumstances did not allow continued operation. While financial considerations play a significant role in the decision to close a practice, they may not be the only, or the deciding, factor.

In my case, the financial shortfall of the practice led me to accept a teaching position in order to earn living expenses. The result of that decision was that my attention became divided: Sometimes I was in meetings or interacting with students—and for a few weeks per year, I was out of town—which meant less time devoted to seeing patients. Conversely, if I was with a patient, I of course could not be available to my students. Over time, I started to feel that I was not giving my all to either role as I shifted back and forth. Having given 100% to each of these roles at previous points in my career, I now felt that I was cheating my patients and my students.

The decision to close a practice may take months or even years before the actual process is started. I lived with my conundrum for about a year before I made the decision to close. I was exhausted—and while I was relieved to have the burden of deciding off my shoulders, it was now time to do the work of closing a practice.

 

 

 

NOTIFYING YOUR STAKEHOLDERS

Once the decision to close a practice is reached, the provider/owner ceases to exist in a vacuum. There are stakeholders who need to be notified—some obvious, some less so.

I started by breaking the news to my family, the people who had supported me in opening my practice (and even helped me find and refurbish furniture for my waiting room!). Although they had been aware of my internal debate, they had not lived with the decision process as I had. Having resolved at least some of my own emotions, I now had to watch others experience many of those same feelings.

Next, I had to tell my employees of the decision. Through attrition, my staff had already shrunk to two: a receptionist and a part-time licensed vocational nurse (LVN). Like my family, they had to process their own emotions about the closure. I had anticipated that the people who worked for me, concerned about their future, might choose to accept another job before we officially closed. My LVN—who had observed the practice dwindling in the preceding two years—seemed prepared for my decision. She stuck it out with me until the end and was a huge help with the influx of patients requesting records. (My MD—required by Texas law to delegate prescriptive authority to me—had already relocated his practice and was ill, so he was content with my decision.)

Of course, the biggest stakeholders in a practice are the patients. Notifying them of the impending closure is the most important action you will take (aside from making the decision to close). Although you can place notices in the local media (newspapers, TV, radio) to announce the closure of your practice to the community, you should send a notification letter directly to your patients. It should be sent at least 60 to 90 days before the closure date—and certainly not less than 30 days in any case—giving patients adequate time to find new providers and arrange for their records to be transferred.1,2 The letter should include

  • A statement of gratitude for the patient’s business
  • The dates of the transition period
  • What is expected of the patient (eg, does he/she need to come and pick up his/her records?)
  • An explanation for the closure3

I composed a letter to be sent to all patients who had been seen within the past 18 months. In it, I thanked them for being a part of the practice and gave them 60 days’ notice of the intent to close. For many patients, this was an emotional time; many understandably worried how their health care needs would be met in the future. Some responded with sadness that I had not been able to make the practice a success.

AVOIDING “ABANDONMENT”

Ideally, a provider who wants to get out of the business should seek to sell the practice—but this is not always feasible.3,4 When closure is the best (or only) option, it is important to avoid even the appearance of abandonment.

Besides giving adequate notice of practice closure, providers must have a plan for the dispersal of patients.1 Be prepared to give recommendations for new providers. Depending on the practice location (rural or urban), options may vary.

I made a concerted effort to refer patients to new providers, with the caveat that if the patient did not feel a particular provider was a good match, he/she should seek another provider of his/her choosing. Unlike in a purchased practice, where patients “go with” the practice, patients from a closed practice may be referred to one, several, or even many other providers.5

Provisions must be made to store patient records so that they are retrievable for a specified period of time. The requirements vary by state, so consultation of the state board’s rules and regulations—and/or an attorney—is in order.3 In general, the proscribed time period is seven to 10 years for adults and seven to 10 years after the patient turns 18 for pediatric patients.2 In some states, the retention time may be as short as three years for adults.1

OTHER PRACTICAL CONSIDERATIONS

While people will be your priority as you work through the process of closing, you will have “stuff” to deal with. What will you do with the furnishings and equipment? Obviously, anything that was borrowed can be returned. Beyond that, your options are to sell (to another provider or even a patient), donate, or repurpose items.

 

 

 

The orthopedic exam table from my practice went to a private school for their athletic training facility. Screens went to my neighbor, a chiropractor. My preschool-aged grandsons were thrilled to be given the children’s art supplies and books that had once graced my waiting area. One of my patients bought some decorative vases and a bookcase. The painting that had been carefully chosen to pull together my waiting room now hangs in my library at home.

As the closure date approaches, the practice environment may begin to look bare as furnishings are sold or moved. One item you will want to buy, however, is a fresh ink cartridge for your copier/printer. As patients request documents, you’ll use it!

RESPONSE AND AFTERMATH

The practice may be very busy immediately following the receipt of notification letters—but don’t be fooled into thinking you have made the wrong decision. The first month after the letters went out advising of the closure, my practice was busier than it had ever been! This tapered off in the second month, though.

Most patients, once they’ve heard the news, will want prescription refills and/or their records. Some may just want to know what happened to result in the closure. Remember that to the patient, this seems like a sudden decision—no matter how long you have deliberated about it.

What surprised me most, however, was that new patients continued to present to the practice, seeking care for acute issues. While I did provide this, I made them aware from the beginning that the practice was in the process of closing and that I could not assume the responsibility of being their primary provider. I made sure to provide these patients with recommendations for other providers.

Slowly the rush will settle down, as patients start to move on to other providers. A few may drop in to see you socially. On the day I closed my practice, several patients came in just to say goodbye and wish me well.

The last things I did in my practice were turn off the lights and leave a sign on the door stating that the practice was now closed.

RECOVERY

The time needed to recover from the closure of a practice will differ. Factors include how long the practice was open and how the clinician normally deals with a setback.6 For some, relief that the pressures of ownership are over may be the predominant emotion. Having a steady, stable salary in a new position goes a long way toward making the transition easier! Although if possible, take some time between closing the practice and starting a new job.

Do not be surprised if negative emotions manifest at odd times, as feelings of sadness, regret, and even a sense of failure are worked through. Life does go on—and nurse practitioners are resilient. Find a way to use the knowledge gained from your practice in your new endeavors, whatever they may be.

For me, the healing process would have started sooner if I had acknowledged how difficult giving up the dream of having my own practice was. If I had sought out others with similar experience or even talked with a counselor, my journey through this process could have been expedited. When I started to share my story, one frequently asked question was “How did you get through this?” This showed me that others could learn from my experience.

References

1. Tatooles JJ, Brunell A. What you need to know before leaving a medical practice: a primer for moving on. AAOS NOW. 2015;22-23.
2. Kern SI. Take these steps if selling or closing a practice. Med Econ. 2010;87(20):66.
3. Weiss GG. How to close a practice. Med Econ. 2004;81:69.
4. Zaumeyer C. How to Start an Independent Practice: The Nurse Practition­er’s Guide to Success. Philadelphia: F. A. Davis, Publishers; 2003.
5. Barrett W. The legal corner: Eleven essential steps to purchasing or selling a medical practice. J Med Pract Manage. 2014;29(5):275-277.
6. McBride JL. Personal issues to consider before leaving independent practice. Fam Pract Manag. 2013;20(4):9-12.

References

1. Tatooles JJ, Brunell A. What you need to know before leaving a medical practice: a primer for moving on. AAOS NOW. 2015;22-23.
2. Kern SI. Take these steps if selling or closing a practice. Med Econ. 2010;87(20):66.
3. Weiss GG. How to close a practice. Med Econ. 2004;81:69.
4. Zaumeyer C. How to Start an Independent Practice: The Nurse Practition­er’s Guide to Success. Philadelphia: F. A. Davis, Publishers; 2003.
5. Barrett W. The legal corner: Eleven essential steps to purchasing or selling a medical practice. J Med Pract Manage. 2014;29(5):275-277.
6. McBride JL. Personal issues to consider before leaving independent practice. Fam Pract Manag. 2013;20(4):9-12.

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The war on pain

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When your peer group is dominated by folks in their early 70s, conversations at dinner parties and lobster bakes invariably morph into storytelling competitions between the survivors of recent hospitalizations and medical procedures. I try to redirect this tedious and repetitive chatter with a topic from my standard collection of conversation re-starters that includes “How about those Red Sox?” and “How’s your granddaughter’s soccer season going?” But sadly I am not always successful.

Often embedded in these tales of medical misadventure are stories of unfortunate experiences with pain medications. Sometimes the story includes a description of how prescribed pain medication created symptoms that were far worse than the pain it was intended to treat. Vomiting, constipation, and “feeling goofy” are high on the list of complaints.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff
As a result of these unpleasant side effects or in many cases simply because they didn’t feel the need to take the prescribed medication, most of my friends have accumulated a significant stash of unused opioids. With a quick calculation on a cocktail napkin, I once calculated that a dozen of my friends could keep the addicted population of a small town happy for a week or two with the painkillers they have in their medicine cabinets and sock drawers.

These caches of unused opioids, many of which were never needed in the first place, are evidence of why our health care has become so expensive, and also represent the seeds from which the addiction epidemic has grown. Ironically, they also are collateral damage from an unsuccessful and sometimes misguided war on pain.

It isn’t clear exactly when or where the war on pain began, but I’m sure those who fired the first shots were understandably concerned that many patients with incurable and terminal conditions were suffering needlessly because their pain was being under-treated. Coincidently came the realization that the sooner we could get postoperative patients on their feet and taking deep breaths, the fewer complications we would see. And the more adequately we treated their pain, the sooner we could get those patients moving and breathing optimally.

In a good faith effort to be more “scientific” about pain management, patients were asked to rate their pain and smiley face charts appeared. Unfortunately, somewhere along the line came the mantra that not only should no patient’s pain go unmeasured, but no patient’s pain should go unmedicated.

The federal government entered the war when the Centers for Medicare & Medicaid Services issued the directive that hospitals ask patients who were being discharged if their pain had been well controlled and how often did the hospital staff do what they could to ease their pain? The answers to these questions, along with others, was collected and used in assessing a hospital’s quality of care and determining its level of reimbursement.

So far, there is insufficient data to determine how frequently this directive on pain management induced hospitals to over-prescribe medication, but it certainly hasn’t been associated with a decline in opioid abuse. It is reasonable to suspect that this salvo by the government has resulted in some collateral damage as it encouraged a steady flow of unused and unnecessary prescription narcotics out of the hospital and on to the streets.

The good news is that there has been enough concern voiced about the unintended effect of these pain management questions that the CMS has decided to eliminate financial pressure clinicians might feel to over-prescribe medications by withdrawing the questions from the patient discharge questionnaire.

The bad news is that we continue to fight the war on pain with a limited arsenal. As long as clinicians simply believe that no pain should go unmedicated, they will continue to miss opportunities to use other modalities such as counseling, physical therapy, and education that can be effective without the risk of collateral damage. Instead of asking the patient (who may not know the answer), we should be asking ourselves if we have been doing everything we could to help the patient deal with his pain. The answer is often not written on prescription pads.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.”

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When your peer group is dominated by folks in their early 70s, conversations at dinner parties and lobster bakes invariably morph into storytelling competitions between the survivors of recent hospitalizations and medical procedures. I try to redirect this tedious and repetitive chatter with a topic from my standard collection of conversation re-starters that includes “How about those Red Sox?” and “How’s your granddaughter’s soccer season going?” But sadly I am not always successful.

Often embedded in these tales of medical misadventure are stories of unfortunate experiences with pain medications. Sometimes the story includes a description of how prescribed pain medication created symptoms that were far worse than the pain it was intended to treat. Vomiting, constipation, and “feeling goofy” are high on the list of complaints.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff
As a result of these unpleasant side effects or in many cases simply because they didn’t feel the need to take the prescribed medication, most of my friends have accumulated a significant stash of unused opioids. With a quick calculation on a cocktail napkin, I once calculated that a dozen of my friends could keep the addicted population of a small town happy for a week or two with the painkillers they have in their medicine cabinets and sock drawers.

These caches of unused opioids, many of which were never needed in the first place, are evidence of why our health care has become so expensive, and also represent the seeds from which the addiction epidemic has grown. Ironically, they also are collateral damage from an unsuccessful and sometimes misguided war on pain.

It isn’t clear exactly when or where the war on pain began, but I’m sure those who fired the first shots were understandably concerned that many patients with incurable and terminal conditions were suffering needlessly because their pain was being under-treated. Coincidently came the realization that the sooner we could get postoperative patients on their feet and taking deep breaths, the fewer complications we would see. And the more adequately we treated their pain, the sooner we could get those patients moving and breathing optimally.

In a good faith effort to be more “scientific” about pain management, patients were asked to rate their pain and smiley face charts appeared. Unfortunately, somewhere along the line came the mantra that not only should no patient’s pain go unmeasured, but no patient’s pain should go unmedicated.

The federal government entered the war when the Centers for Medicare & Medicaid Services issued the directive that hospitals ask patients who were being discharged if their pain had been well controlled and how often did the hospital staff do what they could to ease their pain? The answers to these questions, along with others, was collected and used in assessing a hospital’s quality of care and determining its level of reimbursement.

So far, there is insufficient data to determine how frequently this directive on pain management induced hospitals to over-prescribe medication, but it certainly hasn’t been associated with a decline in opioid abuse. It is reasonable to suspect that this salvo by the government has resulted in some collateral damage as it encouraged a steady flow of unused and unnecessary prescription narcotics out of the hospital and on to the streets.

The good news is that there has been enough concern voiced about the unintended effect of these pain management questions that the CMS has decided to eliminate financial pressure clinicians might feel to over-prescribe medications by withdrawing the questions from the patient discharge questionnaire.

The bad news is that we continue to fight the war on pain with a limited arsenal. As long as clinicians simply believe that no pain should go unmedicated, they will continue to miss opportunities to use other modalities such as counseling, physical therapy, and education that can be effective without the risk of collateral damage. Instead of asking the patient (who may not know the answer), we should be asking ourselves if we have been doing everything we could to help the patient deal with his pain. The answer is often not written on prescription pads.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.”

 

When your peer group is dominated by folks in their early 70s, conversations at dinner parties and lobster bakes invariably morph into storytelling competitions between the survivors of recent hospitalizations and medical procedures. I try to redirect this tedious and repetitive chatter with a topic from my standard collection of conversation re-starters that includes “How about those Red Sox?” and “How’s your granddaughter’s soccer season going?” But sadly I am not always successful.

Often embedded in these tales of medical misadventure are stories of unfortunate experiences with pain medications. Sometimes the story includes a description of how prescribed pain medication created symptoms that were far worse than the pain it was intended to treat. Vomiting, constipation, and “feeling goofy” are high on the list of complaints.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff
As a result of these unpleasant side effects or in many cases simply because they didn’t feel the need to take the prescribed medication, most of my friends have accumulated a significant stash of unused opioids. With a quick calculation on a cocktail napkin, I once calculated that a dozen of my friends could keep the addicted population of a small town happy for a week or two with the painkillers they have in their medicine cabinets and sock drawers.

These caches of unused opioids, many of which were never needed in the first place, are evidence of why our health care has become so expensive, and also represent the seeds from which the addiction epidemic has grown. Ironically, they also are collateral damage from an unsuccessful and sometimes misguided war on pain.

It isn’t clear exactly when or where the war on pain began, but I’m sure those who fired the first shots were understandably concerned that many patients with incurable and terminal conditions were suffering needlessly because their pain was being under-treated. Coincidently came the realization that the sooner we could get postoperative patients on their feet and taking deep breaths, the fewer complications we would see. And the more adequately we treated their pain, the sooner we could get those patients moving and breathing optimally.

In a good faith effort to be more “scientific” about pain management, patients were asked to rate their pain and smiley face charts appeared. Unfortunately, somewhere along the line came the mantra that not only should no patient’s pain go unmeasured, but no patient’s pain should go unmedicated.

The federal government entered the war when the Centers for Medicare & Medicaid Services issued the directive that hospitals ask patients who were being discharged if their pain had been well controlled and how often did the hospital staff do what they could to ease their pain? The answers to these questions, along with others, was collected and used in assessing a hospital’s quality of care and determining its level of reimbursement.

So far, there is insufficient data to determine how frequently this directive on pain management induced hospitals to over-prescribe medication, but it certainly hasn’t been associated with a decline in opioid abuse. It is reasonable to suspect that this salvo by the government has resulted in some collateral damage as it encouraged a steady flow of unused and unnecessary prescription narcotics out of the hospital and on to the streets.

The good news is that there has been enough concern voiced about the unintended effect of these pain management questions that the CMS has decided to eliminate financial pressure clinicians might feel to over-prescribe medications by withdrawing the questions from the patient discharge questionnaire.

The bad news is that we continue to fight the war on pain with a limited arsenal. As long as clinicians simply believe that no pain should go unmedicated, they will continue to miss opportunities to use other modalities such as counseling, physical therapy, and education that can be effective without the risk of collateral damage. Instead of asking the patient (who may not know the answer), we should be asking ourselves if we have been doing everything we could to help the patient deal with his pain. The answer is often not written on prescription pads.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.”

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EMTALA – statutory law

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This is the first of a two-part series.

Question: Which of the following statements regarding the Emergency Medical Treatment & Labor Act (EMTALA) is correct?

A. Deals with the standard of care in emergency medicine.

B. Provides safeguards for uninsured and nonpaying patients with an emergency medical condition.

C. Mandates uniform screening and treatment stabilization prior to transfer, irrespective of the hospital’s capability.

D. Is mostly directed at hospitals and emergency department staff doctors, but excludes on-call physicians.

E. Violations can result in fines, loss of Medicare provider participation, or even imprisonment.

Answer: B. In 1985, the CBS investigative news show “60 Minutes” ran an exposé on abuses in the emergency departments of U.S. hospitals, featuring the case of Eugene Barnes, a 32-year-old man brought to the Brookside Hospital emergency department (ED) in San Pablo, Calif., with a penetrating stab wound.

Dr. S.Y. Tan
The on-call neurosurgeon allegedly declined to come in, and three hospitals refused to accept the patient in transfer. The patient was finally sent to San Francisco General 4 hours later but expired.

In another case, William Jenness, injured in an auto accident, died after a delayed transfer to a county hospital, because the original hospital required a $1,000 deposit in advance before initiating treatment.

In response to the widespread perception that uninsured patients were being denied treatment in the nation’s emergency departments, Congress enacted the Emergency Medical Treatment & Labor Act.1

Originally referred to as the “antidumping law,” EMTALA was designed to prevent hospitals from transferring financially undesirable patients to public hospitals without providing a medical screening examination and stabilizing treatment prior to transfer.

The purpose and intent of the law is to ensure that all patients who come to the ED have access to emergency services, although the statute itself is silent on payment ability.

EMTALA is not meant to replace or override state tort law, and does not deal with quality of care issues that may arise in the emergency department. Over the 30-year period since its enactment, EMTALA has received mixed reviews, with one scholar complaining that the statute is sloppily drafted and the premise of the statute, silly at best.2

EMTALA defines an emergency medical condition as:

1. A medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances, and/or symptoms of substance abuse) such that the absence of immediate medical attention could reasonably be expected to result in placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy, cause serious impairment to bodily functions, or result in serious dysfunction of any bodily organ or part.

2. With respect to a pregnant woman who is having contractions, there is inadequate time to effect a safe transfer to another hospital before delivery, or that transfer may pose a threat to the health or safety of the woman or the unborn child.3

Whether an emergency medical condition exists is determined by a medical screening exam (MSE). EMTALA is about a process directed at the well-being and safety of all patients with a medical emergency who come to the ED, defined as being licensed by the state or held out to the public as a place that provides care for emergency medical conditions. Hospital-based outpatient clinics that handle less than one-third of emergency visits and physician offices are exempt.

All patients who present to the ED seeking treatment are entitled to an MSE, and EDs are required to post such notification on their premises. A triage nurse may not be qualified to conduct the MSE unless he or she possesses special competencies, and has approval from the medical staff and the hospital’s governing body.

It is important that the MSE be documented soon after the patient’s arrival to determine if the medical condition warrants immediate treatment. It is definitely not acceptable to delay performing an MSE while awaiting information on insurance coverage, and one cannot “hold” the patient and delay stabilizing treatment because of the carrier’s insistence on using only certain approved facilities.

EMTALA requires that the screening exam be “appropriate,” but the statute does not define the term except to note that it is to be “within the capability of the hospital’s emergency department.” However, it is generally recognized that triage alone is insufficient, and the screening exam should be based on the patient’s symptoms and performed by a qualified person.

The important point is that it is uniformly applied, without discrimination, to all who seek treatment in the ED. The hospital itself is expected to have in place policies addressing the broad aspects of the screening process in a nondisparate manner.

The second key issue under the EMTALA statute concerns treatment and transfer.4 If an emergency medical condition exists, treatment must be provided until the emergency is resolved or stabilized.

Under the law, a patient is considered stable for transfer (or discharge) if the treating physician determines that no material deterioration is reasonably likely to occur during or as a result of the transfer between facilities. A receiving hospital is obligated to report any individual who has been transferred in an unstable condition in violation of EMTALA.

However, in the event the hospital does not have the capability to stabilize the emergency medical condition, EMTALA mandates an appropriate transfer, under prescribed conditions, to another hospital whose specialized capabilities obligate it to cooperate. The ED physician in the sending hospital will directly request acceptance of such a transfer. If the patient is unstable, the physician must certify that the medical benefits expected from the transfer outweigh the risks, unless the patient insists on a transfer in writing after being informed of the hospital’s obligations under EMTALA and the risks of transfer.

Furthermore, the transferring hospital must: 1. provide ongoing care within its capability until transfer to minimize transfer risks, 2. provide copies of medical records, 3. confirm that the receiving facility has space and qualified personnel to treat the condition and has agreed to accept the transfer, and 4. ensure that the transfer is made with qualified personnel and appropriate medical equipment.

On-call physicians at both transferring and accepting facilities are also subject to EMTALA. The U.S. Department of Health & Human Services’ Office of Inspector General (OIG) has promulgated rules regarding on-call physicians, even touching on reimbursement.

The American College of Emergency Physicians subscribes to the view that hospitals, medical staff, and payers share an ethical responsibility for the provision of emergency care, acknowledging that EDs require a reliable on-call system that provides for the availability of medical staff members for consultation and participation in the evaluation and treatment of emergency patients.5

Penalties for EMTALA violations include fines up to $50,000 per violation, and/or nullification of Medicare provider agreements. There is a 2-year statute of limitations for civil enforcement of any violation,6 carried out by the OIG and the Centers for Medicare & Medicaid Services (CMS).

A receiving facility, having suffered financial loss as a result of another hospital’s violation of EMTALA, can bring suit to recover damages, and patients may bring private lawsuits against hospitals, though not against physicians. EMTALA, being a civil rather than a criminal statute, does not impose any prison terms.

Investigations and citations by the OIG/CMS are common, with about half of all hospitals subjected to EMTALA investigations and a quarter receiving a violation citation over a recent 10-year period.

However, a recently published study covering 2002-2015 found that, despite 40% of investigations ending up with EMTALA violations, only 3% of investigations triggered fines – and none resulted in suspension of Medicare provider participation.7

There were a total of 192 settlements, or an average of 14 per year for the 4,000 hospitals in the United States. Most were for failing to provide screening (75%) and stabilization (42%). The vast majority of violations affected hospitals, and only eight physicians were involved.

Fines against hospitals and physicians totaled $6,357,000 (averages, $33,435 and $25,625, respectively). Patient dumping attributable to insurance or financial discrimination accounted for 15.6% of settlements.

References

1. 42 USC §1395dd et seq.

2. Chest. 2015 Jun;147(6):1691-6.

3. 42 USC §1395dd(a).

4. 42 USC §1395dd(b)(c).

5. “EMTALA and On-call Responsibility for Emergency Department Patients,” American College of Emergency Physicians.

6. 42 USC §1395dd(d).

7. West J Emerg Med. 2016 May;17(3):245-51.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

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This is the first of a two-part series.

Question: Which of the following statements regarding the Emergency Medical Treatment & Labor Act (EMTALA) is correct?

A. Deals with the standard of care in emergency medicine.

B. Provides safeguards for uninsured and nonpaying patients with an emergency medical condition.

C. Mandates uniform screening and treatment stabilization prior to transfer, irrespective of the hospital’s capability.

D. Is mostly directed at hospitals and emergency department staff doctors, but excludes on-call physicians.

E. Violations can result in fines, loss of Medicare provider participation, or even imprisonment.

Answer: B. In 1985, the CBS investigative news show “60 Minutes” ran an exposé on abuses in the emergency departments of U.S. hospitals, featuring the case of Eugene Barnes, a 32-year-old man brought to the Brookside Hospital emergency department (ED) in San Pablo, Calif., with a penetrating stab wound.

Dr. S.Y. Tan
The on-call neurosurgeon allegedly declined to come in, and three hospitals refused to accept the patient in transfer. The patient was finally sent to San Francisco General 4 hours later but expired.

In another case, William Jenness, injured in an auto accident, died after a delayed transfer to a county hospital, because the original hospital required a $1,000 deposit in advance before initiating treatment.

In response to the widespread perception that uninsured patients were being denied treatment in the nation’s emergency departments, Congress enacted the Emergency Medical Treatment & Labor Act.1

Originally referred to as the “antidumping law,” EMTALA was designed to prevent hospitals from transferring financially undesirable patients to public hospitals without providing a medical screening examination and stabilizing treatment prior to transfer.

The purpose and intent of the law is to ensure that all patients who come to the ED have access to emergency services, although the statute itself is silent on payment ability.

EMTALA is not meant to replace or override state tort law, and does not deal with quality of care issues that may arise in the emergency department. Over the 30-year period since its enactment, EMTALA has received mixed reviews, with one scholar complaining that the statute is sloppily drafted and the premise of the statute, silly at best.2

EMTALA defines an emergency medical condition as:

1. A medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances, and/or symptoms of substance abuse) such that the absence of immediate medical attention could reasonably be expected to result in placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy, cause serious impairment to bodily functions, or result in serious dysfunction of any bodily organ or part.

2. With respect to a pregnant woman who is having contractions, there is inadequate time to effect a safe transfer to another hospital before delivery, or that transfer may pose a threat to the health or safety of the woman or the unborn child.3

Whether an emergency medical condition exists is determined by a medical screening exam (MSE). EMTALA is about a process directed at the well-being and safety of all patients with a medical emergency who come to the ED, defined as being licensed by the state or held out to the public as a place that provides care for emergency medical conditions. Hospital-based outpatient clinics that handle less than one-third of emergency visits and physician offices are exempt.

All patients who present to the ED seeking treatment are entitled to an MSE, and EDs are required to post such notification on their premises. A triage nurse may not be qualified to conduct the MSE unless he or she possesses special competencies, and has approval from the medical staff and the hospital’s governing body.

It is important that the MSE be documented soon after the patient’s arrival to determine if the medical condition warrants immediate treatment. It is definitely not acceptable to delay performing an MSE while awaiting information on insurance coverage, and one cannot “hold” the patient and delay stabilizing treatment because of the carrier’s insistence on using only certain approved facilities.

EMTALA requires that the screening exam be “appropriate,” but the statute does not define the term except to note that it is to be “within the capability of the hospital’s emergency department.” However, it is generally recognized that triage alone is insufficient, and the screening exam should be based on the patient’s symptoms and performed by a qualified person.

The important point is that it is uniformly applied, without discrimination, to all who seek treatment in the ED. The hospital itself is expected to have in place policies addressing the broad aspects of the screening process in a nondisparate manner.

The second key issue under the EMTALA statute concerns treatment and transfer.4 If an emergency medical condition exists, treatment must be provided until the emergency is resolved or stabilized.

Under the law, a patient is considered stable for transfer (or discharge) if the treating physician determines that no material deterioration is reasonably likely to occur during or as a result of the transfer between facilities. A receiving hospital is obligated to report any individual who has been transferred in an unstable condition in violation of EMTALA.

However, in the event the hospital does not have the capability to stabilize the emergency medical condition, EMTALA mandates an appropriate transfer, under prescribed conditions, to another hospital whose specialized capabilities obligate it to cooperate. The ED physician in the sending hospital will directly request acceptance of such a transfer. If the patient is unstable, the physician must certify that the medical benefits expected from the transfer outweigh the risks, unless the patient insists on a transfer in writing after being informed of the hospital’s obligations under EMTALA and the risks of transfer.

Furthermore, the transferring hospital must: 1. provide ongoing care within its capability until transfer to minimize transfer risks, 2. provide copies of medical records, 3. confirm that the receiving facility has space and qualified personnel to treat the condition and has agreed to accept the transfer, and 4. ensure that the transfer is made with qualified personnel and appropriate medical equipment.

On-call physicians at both transferring and accepting facilities are also subject to EMTALA. The U.S. Department of Health & Human Services’ Office of Inspector General (OIG) has promulgated rules regarding on-call physicians, even touching on reimbursement.

The American College of Emergency Physicians subscribes to the view that hospitals, medical staff, and payers share an ethical responsibility for the provision of emergency care, acknowledging that EDs require a reliable on-call system that provides for the availability of medical staff members for consultation and participation in the evaluation and treatment of emergency patients.5

Penalties for EMTALA violations include fines up to $50,000 per violation, and/or nullification of Medicare provider agreements. There is a 2-year statute of limitations for civil enforcement of any violation,6 carried out by the OIG and the Centers for Medicare & Medicaid Services (CMS).

A receiving facility, having suffered financial loss as a result of another hospital’s violation of EMTALA, can bring suit to recover damages, and patients may bring private lawsuits against hospitals, though not against physicians. EMTALA, being a civil rather than a criminal statute, does not impose any prison terms.

Investigations and citations by the OIG/CMS are common, with about half of all hospitals subjected to EMTALA investigations and a quarter receiving a violation citation over a recent 10-year period.

However, a recently published study covering 2002-2015 found that, despite 40% of investigations ending up with EMTALA violations, only 3% of investigations triggered fines – and none resulted in suspension of Medicare provider participation.7

There were a total of 192 settlements, or an average of 14 per year for the 4,000 hospitals in the United States. Most were for failing to provide screening (75%) and stabilization (42%). The vast majority of violations affected hospitals, and only eight physicians were involved.

Fines against hospitals and physicians totaled $6,357,000 (averages, $33,435 and $25,625, respectively). Patient dumping attributable to insurance or financial discrimination accounted for 15.6% of settlements.

References

1. 42 USC §1395dd et seq.

2. Chest. 2015 Jun;147(6):1691-6.

3. 42 USC §1395dd(a).

4. 42 USC §1395dd(b)(c).

5. “EMTALA and On-call Responsibility for Emergency Department Patients,” American College of Emergency Physicians.

6. 42 USC §1395dd(d).

7. West J Emerg Med. 2016 May;17(3):245-51.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

 

This is the first of a two-part series.

Question: Which of the following statements regarding the Emergency Medical Treatment & Labor Act (EMTALA) is correct?

A. Deals with the standard of care in emergency medicine.

B. Provides safeguards for uninsured and nonpaying patients with an emergency medical condition.

C. Mandates uniform screening and treatment stabilization prior to transfer, irrespective of the hospital’s capability.

D. Is mostly directed at hospitals and emergency department staff doctors, but excludes on-call physicians.

E. Violations can result in fines, loss of Medicare provider participation, or even imprisonment.

Answer: B. In 1985, the CBS investigative news show “60 Minutes” ran an exposé on abuses in the emergency departments of U.S. hospitals, featuring the case of Eugene Barnes, a 32-year-old man brought to the Brookside Hospital emergency department (ED) in San Pablo, Calif., with a penetrating stab wound.

Dr. S.Y. Tan
The on-call neurosurgeon allegedly declined to come in, and three hospitals refused to accept the patient in transfer. The patient was finally sent to San Francisco General 4 hours later but expired.

In another case, William Jenness, injured in an auto accident, died after a delayed transfer to a county hospital, because the original hospital required a $1,000 deposit in advance before initiating treatment.

In response to the widespread perception that uninsured patients were being denied treatment in the nation’s emergency departments, Congress enacted the Emergency Medical Treatment & Labor Act.1

Originally referred to as the “antidumping law,” EMTALA was designed to prevent hospitals from transferring financially undesirable patients to public hospitals without providing a medical screening examination and stabilizing treatment prior to transfer.

The purpose and intent of the law is to ensure that all patients who come to the ED have access to emergency services, although the statute itself is silent on payment ability.

EMTALA is not meant to replace or override state tort law, and does not deal with quality of care issues that may arise in the emergency department. Over the 30-year period since its enactment, EMTALA has received mixed reviews, with one scholar complaining that the statute is sloppily drafted and the premise of the statute, silly at best.2

EMTALA defines an emergency medical condition as:

1. A medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances, and/or symptoms of substance abuse) such that the absence of immediate medical attention could reasonably be expected to result in placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy, cause serious impairment to bodily functions, or result in serious dysfunction of any bodily organ or part.

2. With respect to a pregnant woman who is having contractions, there is inadequate time to effect a safe transfer to another hospital before delivery, or that transfer may pose a threat to the health or safety of the woman or the unborn child.3

Whether an emergency medical condition exists is determined by a medical screening exam (MSE). EMTALA is about a process directed at the well-being and safety of all patients with a medical emergency who come to the ED, defined as being licensed by the state or held out to the public as a place that provides care for emergency medical conditions. Hospital-based outpatient clinics that handle less than one-third of emergency visits and physician offices are exempt.

All patients who present to the ED seeking treatment are entitled to an MSE, and EDs are required to post such notification on their premises. A triage nurse may not be qualified to conduct the MSE unless he or she possesses special competencies, and has approval from the medical staff and the hospital’s governing body.

It is important that the MSE be documented soon after the patient’s arrival to determine if the medical condition warrants immediate treatment. It is definitely not acceptable to delay performing an MSE while awaiting information on insurance coverage, and one cannot “hold” the patient and delay stabilizing treatment because of the carrier’s insistence on using only certain approved facilities.

EMTALA requires that the screening exam be “appropriate,” but the statute does not define the term except to note that it is to be “within the capability of the hospital’s emergency department.” However, it is generally recognized that triage alone is insufficient, and the screening exam should be based on the patient’s symptoms and performed by a qualified person.

The important point is that it is uniformly applied, without discrimination, to all who seek treatment in the ED. The hospital itself is expected to have in place policies addressing the broad aspects of the screening process in a nondisparate manner.

The second key issue under the EMTALA statute concerns treatment and transfer.4 If an emergency medical condition exists, treatment must be provided until the emergency is resolved or stabilized.

Under the law, a patient is considered stable for transfer (or discharge) if the treating physician determines that no material deterioration is reasonably likely to occur during or as a result of the transfer between facilities. A receiving hospital is obligated to report any individual who has been transferred in an unstable condition in violation of EMTALA.

However, in the event the hospital does not have the capability to stabilize the emergency medical condition, EMTALA mandates an appropriate transfer, under prescribed conditions, to another hospital whose specialized capabilities obligate it to cooperate. The ED physician in the sending hospital will directly request acceptance of such a transfer. If the patient is unstable, the physician must certify that the medical benefits expected from the transfer outweigh the risks, unless the patient insists on a transfer in writing after being informed of the hospital’s obligations under EMTALA and the risks of transfer.

Furthermore, the transferring hospital must: 1. provide ongoing care within its capability until transfer to minimize transfer risks, 2. provide copies of medical records, 3. confirm that the receiving facility has space and qualified personnel to treat the condition and has agreed to accept the transfer, and 4. ensure that the transfer is made with qualified personnel and appropriate medical equipment.

On-call physicians at both transferring and accepting facilities are also subject to EMTALA. The U.S. Department of Health & Human Services’ Office of Inspector General (OIG) has promulgated rules regarding on-call physicians, even touching on reimbursement.

The American College of Emergency Physicians subscribes to the view that hospitals, medical staff, and payers share an ethical responsibility for the provision of emergency care, acknowledging that EDs require a reliable on-call system that provides for the availability of medical staff members for consultation and participation in the evaluation and treatment of emergency patients.5

Penalties for EMTALA violations include fines up to $50,000 per violation, and/or nullification of Medicare provider agreements. There is a 2-year statute of limitations for civil enforcement of any violation,6 carried out by the OIG and the Centers for Medicare & Medicaid Services (CMS).

A receiving facility, having suffered financial loss as a result of another hospital’s violation of EMTALA, can bring suit to recover damages, and patients may bring private lawsuits against hospitals, though not against physicians. EMTALA, being a civil rather than a criminal statute, does not impose any prison terms.

Investigations and citations by the OIG/CMS are common, with about half of all hospitals subjected to EMTALA investigations and a quarter receiving a violation citation over a recent 10-year period.

However, a recently published study covering 2002-2015 found that, despite 40% of investigations ending up with EMTALA violations, only 3% of investigations triggered fines – and none resulted in suspension of Medicare provider participation.7

There were a total of 192 settlements, or an average of 14 per year for the 4,000 hospitals in the United States. Most were for failing to provide screening (75%) and stabilization (42%). The vast majority of violations affected hospitals, and only eight physicians were involved.

Fines against hospitals and physicians totaled $6,357,000 (averages, $33,435 and $25,625, respectively). Patient dumping attributable to insurance or financial discrimination accounted for 15.6% of settlements.

References

1. 42 USC §1395dd et seq.

2. Chest. 2015 Jun;147(6):1691-6.

3. 42 USC §1395dd(a).

4. 42 USC §1395dd(b)(c).

5. “EMTALA and On-call Responsibility for Emergency Department Patients,” American College of Emergency Physicians.

6. 42 USC §1395dd(d).

7. West J Emerg Med. 2016 May;17(3):245-51.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

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Tips for avoiding nerve injuries in gynecologic surgery

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Fri, 01/04/2019 - 13:26

Upper- and lower-extremity injuries can occur during gynecologic surgery. The incidence of lower-extremity injury is 1.1%-1.9% and upper-extremity injuries can occur in 0.16% of cases.1-5 Fortunately, most of the injuries are transient, sensory injuries that resolve spontaneously. However, a small percentage of injuries result in long-term sequelae.

 

The pathophysiology of the nerve injuries can be mechanistically separated into three categories: neuropraxia, axonotmesis, and neurotmesis. Neuropraxia results from nerve demyelination at the site of injury because of compression and typically resolves within weeks to months as the nerve is remyelinated. Axonotmesis results from severe compression with axon damage. This may take up to a year to resolve as axonal regeneration proceeds at the rate of 1 mm per day. This can be separated into second and third degree and refers to the severity of damage and the resultant persistent deficit. Neurotmesis results from complete transection and is associated with a poor prognosis without reparative surgery.

Dr. Paola A. Gehrig
Dr. Paola A. Gehrig
Gynecologic surgery can be performed vaginally, via laparotomy or minimally invasive surgery with laparoscopic or robotic assistance. Each mode of surgery is associated with variables risks for each type of nerve injury. Compression and stretch injuries are generally caused by prolonged or improper patient positioning or retractor placement. These are the most common etiology in gynecologic surgery. Transection injuries are less common. Unlike compression-, stretch-, and transection-related injuries, entrapment injuries typically are associated with less functional loss but more pain.5
 

Brachial plexus

Stretch injury is the most common reason for a brachial plexus injury. This can occur if the arm board is extended to greater than 90 degrees from the patient’s torso or if the patient’s arm falls off of the arm board. Careful positioning and securing the patient’s arm on the arm board before draping can avoid this injury. A brachial plexus injury can also occur if shoulder braces are placed too laterally during minimally invasive surgery. Radial nerve injuries can occur if there is too much pressure on the humerus during positioning. Ulnar injuries arise from pressure placed on the medial aspect of the elbow.

Tip #1: When tucking a patient’s arm for minimally invasive surgery, appropriate padding should be placed around the elbow and wrist, and the arm should be in the “thumbs-up” position.

Tip #2: Shoulder blocks should be placed over the acromioclavicular (AC) joint.

Lumbosacral plexus

The femoral nerve is the nerve most commonly injured during gynecologic surgery and this usually occurs because of compression of the nerve from the lateral blades of self-retaining retractors. One study showed an 8% incidence of injury from self-retaining retractors, compared with less than 1% when the retractors were not used.6 The femoral nerve can also be stretched when patients are placed in the lithotomy position and the hip is hyperflexed.

As with brachial injury prevention, patients should be positioned prior to draping and care must be taken to not hyperflex or externally rotate the hip during minimally invasive surgical procedures. With the introduction of robot-assisted surgery, care must be taken when docking the robot and surgeons must resist excessive movement of the stirrups.

Tip #3: During laparotomy, surgeons should use the shortest blades that allow for adequate visualization and check the blades during the procedure to ensure that excessive pressure is not placed on the psoas muscle. Consider intermittently releasing the pressure on the lateral blades during other portions of the procedure.

Tip #4: Make sure the stirrups are at the same height and that the leg is in line with the patient’s contralateral shoulder.

Obturator nerve injuries can occur during retroperitoneal dissection for pelvic lymphadenectomy (obturator nodes) and can be either a transection or a cautery injury. It can also be injured during urogynecologic procedures including paravaginal defect repairs and during the placement of transobturator tapes.

The sciatic nerve and its branch, the common peroneal, are generally injured because of excessive stretch or pressure. Both nerves can be injured from hyperflexion of the thigh and the common peroneal can suffer a pressure injury as it courses around the lateral head of the fibula. Therefore, care during lithotomy positioning with both candy cane and Allen stirrups is critical during vaginal surgery.

Tip #5: Ensure that the lateral fibula is not touching the stirrup or that padding is placed between the fibular head and the stirrup.

The ilioinguinal and iliohypogastric nerves are typically injured via suture entrapment from low transverse skin incisions, though laparoscopic injury has also been reported. The incidence after a Pfannenstiel incision is about 3.7%.7

Tip #6: Avoid extending the low transverse incision beyond the lateral margin of the rectus muscle, and do not extend the fascial closure suture more than 1.5 cm from the lateral edge of the fascial incision to avoid catching the nerve with the suture.

The pudendal nerve is most commonly injured during vaginal procedures such as sacrospinous fixation. Pain is typically worse when seated.

The genitofemoral nerve is typically injured during retroperitoneal lymph node dissection, particularly the external iliac nodes. The nerve is small and runs lateral to the external iliac artery. It can suffer cautery and transection injuries. Usually, the paresthesias over the mons pubis, labia majora, and medial inner thigh are temporary.

Tip #7: Care should be taken to identify and spare the nerve during retroperitoneal dissection or external iliac node removal.

Nerve injuries during gynecologic surgery are common and are a significant cause of potential morbidity. While occasionally unavoidable and inherent to the surgical procedure, many times the injury could be prevented with proper attention and care to patient positioning and retractor use. Gynecologists should be aware of the risks and have a through understanding of the anatomy. However, should an injury occur, the patient can be reassured that most are self-limited and full recovery is generally expected. In a prospective study, the median time to resolution of symptoms was 31.5 days (range, 1 day to 6 months).5

References

1. The Obstetrician & Gynaecologist 2014;16:29-36.

2. Gynecol Oncol. 1988 Nov;31(3):462-6.

3. Fertil Steril. 1993 Oct;60(4):729-32.

4. J Minim Invasive Gynecol. 2007 Sep-Oct;14(5):664-72.

5. Am J Obstet Gynecol. 2009 Nov;201(5):531.e1-7.

6. Eur J Obstet Gynecol Reprod Biol. 1985 Dec;20(6):385-92.

7. Obstet Gynecol. 2008 Apr;111(4):839-46.

Dr. Gehrig is professor and director of gynecologic oncology at the University of North Carolina at Chapel Hill. She reported having no financial disclosures relevant to this column. Email her at [email protected].

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Upper- and lower-extremity injuries can occur during gynecologic surgery. The incidence of lower-extremity injury is 1.1%-1.9% and upper-extremity injuries can occur in 0.16% of cases.1-5 Fortunately, most of the injuries are transient, sensory injuries that resolve spontaneously. However, a small percentage of injuries result in long-term sequelae.

 

The pathophysiology of the nerve injuries can be mechanistically separated into three categories: neuropraxia, axonotmesis, and neurotmesis. Neuropraxia results from nerve demyelination at the site of injury because of compression and typically resolves within weeks to months as the nerve is remyelinated. Axonotmesis results from severe compression with axon damage. This may take up to a year to resolve as axonal regeneration proceeds at the rate of 1 mm per day. This can be separated into second and third degree and refers to the severity of damage and the resultant persistent deficit. Neurotmesis results from complete transection and is associated with a poor prognosis without reparative surgery.

Dr. Paola A. Gehrig
Dr. Paola A. Gehrig
Gynecologic surgery can be performed vaginally, via laparotomy or minimally invasive surgery with laparoscopic or robotic assistance. Each mode of surgery is associated with variables risks for each type of nerve injury. Compression and stretch injuries are generally caused by prolonged or improper patient positioning or retractor placement. These are the most common etiology in gynecologic surgery. Transection injuries are less common. Unlike compression-, stretch-, and transection-related injuries, entrapment injuries typically are associated with less functional loss but more pain.5
 

Brachial plexus

Stretch injury is the most common reason for a brachial plexus injury. This can occur if the arm board is extended to greater than 90 degrees from the patient’s torso or if the patient’s arm falls off of the arm board. Careful positioning and securing the patient’s arm on the arm board before draping can avoid this injury. A brachial plexus injury can also occur if shoulder braces are placed too laterally during minimally invasive surgery. Radial nerve injuries can occur if there is too much pressure on the humerus during positioning. Ulnar injuries arise from pressure placed on the medial aspect of the elbow.

Tip #1: When tucking a patient’s arm for minimally invasive surgery, appropriate padding should be placed around the elbow and wrist, and the arm should be in the “thumbs-up” position.

Tip #2: Shoulder blocks should be placed over the acromioclavicular (AC) joint.

Lumbosacral plexus

The femoral nerve is the nerve most commonly injured during gynecologic surgery and this usually occurs because of compression of the nerve from the lateral blades of self-retaining retractors. One study showed an 8% incidence of injury from self-retaining retractors, compared with less than 1% when the retractors were not used.6 The femoral nerve can also be stretched when patients are placed in the lithotomy position and the hip is hyperflexed.

As with brachial injury prevention, patients should be positioned prior to draping and care must be taken to not hyperflex or externally rotate the hip during minimally invasive surgical procedures. With the introduction of robot-assisted surgery, care must be taken when docking the robot and surgeons must resist excessive movement of the stirrups.

Tip #3: During laparotomy, surgeons should use the shortest blades that allow for adequate visualization and check the blades during the procedure to ensure that excessive pressure is not placed on the psoas muscle. Consider intermittently releasing the pressure on the lateral blades during other portions of the procedure.

Tip #4: Make sure the stirrups are at the same height and that the leg is in line with the patient’s contralateral shoulder.

Obturator nerve injuries can occur during retroperitoneal dissection for pelvic lymphadenectomy (obturator nodes) and can be either a transection or a cautery injury. It can also be injured during urogynecologic procedures including paravaginal defect repairs and during the placement of transobturator tapes.

The sciatic nerve and its branch, the common peroneal, are generally injured because of excessive stretch or pressure. Both nerves can be injured from hyperflexion of the thigh and the common peroneal can suffer a pressure injury as it courses around the lateral head of the fibula. Therefore, care during lithotomy positioning with both candy cane and Allen stirrups is critical during vaginal surgery.

Tip #5: Ensure that the lateral fibula is not touching the stirrup or that padding is placed between the fibular head and the stirrup.

The ilioinguinal and iliohypogastric nerves are typically injured via suture entrapment from low transverse skin incisions, though laparoscopic injury has also been reported. The incidence after a Pfannenstiel incision is about 3.7%.7

Tip #6: Avoid extending the low transverse incision beyond the lateral margin of the rectus muscle, and do not extend the fascial closure suture more than 1.5 cm from the lateral edge of the fascial incision to avoid catching the nerve with the suture.

The pudendal nerve is most commonly injured during vaginal procedures such as sacrospinous fixation. Pain is typically worse when seated.

The genitofemoral nerve is typically injured during retroperitoneal lymph node dissection, particularly the external iliac nodes. The nerve is small and runs lateral to the external iliac artery. It can suffer cautery and transection injuries. Usually, the paresthesias over the mons pubis, labia majora, and medial inner thigh are temporary.

Tip #7: Care should be taken to identify and spare the nerve during retroperitoneal dissection or external iliac node removal.

Nerve injuries during gynecologic surgery are common and are a significant cause of potential morbidity. While occasionally unavoidable and inherent to the surgical procedure, many times the injury could be prevented with proper attention and care to patient positioning and retractor use. Gynecologists should be aware of the risks and have a through understanding of the anatomy. However, should an injury occur, the patient can be reassured that most are self-limited and full recovery is generally expected. In a prospective study, the median time to resolution of symptoms was 31.5 days (range, 1 day to 6 months).5

References

1. The Obstetrician & Gynaecologist 2014;16:29-36.

2. Gynecol Oncol. 1988 Nov;31(3):462-6.

3. Fertil Steril. 1993 Oct;60(4):729-32.

4. J Minim Invasive Gynecol. 2007 Sep-Oct;14(5):664-72.

5. Am J Obstet Gynecol. 2009 Nov;201(5):531.e1-7.

6. Eur J Obstet Gynecol Reprod Biol. 1985 Dec;20(6):385-92.

7. Obstet Gynecol. 2008 Apr;111(4):839-46.

Dr. Gehrig is professor and director of gynecologic oncology at the University of North Carolina at Chapel Hill. She reported having no financial disclosures relevant to this column. Email her at [email protected].

Upper- and lower-extremity injuries can occur during gynecologic surgery. The incidence of lower-extremity injury is 1.1%-1.9% and upper-extremity injuries can occur in 0.16% of cases.1-5 Fortunately, most of the injuries are transient, sensory injuries that resolve spontaneously. However, a small percentage of injuries result in long-term sequelae.

 

The pathophysiology of the nerve injuries can be mechanistically separated into three categories: neuropraxia, axonotmesis, and neurotmesis. Neuropraxia results from nerve demyelination at the site of injury because of compression and typically resolves within weeks to months as the nerve is remyelinated. Axonotmesis results from severe compression with axon damage. This may take up to a year to resolve as axonal regeneration proceeds at the rate of 1 mm per day. This can be separated into second and third degree and refers to the severity of damage and the resultant persistent deficit. Neurotmesis results from complete transection and is associated with a poor prognosis without reparative surgery.

Dr. Paola A. Gehrig
Dr. Paola A. Gehrig
Gynecologic surgery can be performed vaginally, via laparotomy or minimally invasive surgery with laparoscopic or robotic assistance. Each mode of surgery is associated with variables risks for each type of nerve injury. Compression and stretch injuries are generally caused by prolonged or improper patient positioning or retractor placement. These are the most common etiology in gynecologic surgery. Transection injuries are less common. Unlike compression-, stretch-, and transection-related injuries, entrapment injuries typically are associated with less functional loss but more pain.5
 

Brachial plexus

Stretch injury is the most common reason for a brachial plexus injury. This can occur if the arm board is extended to greater than 90 degrees from the patient’s torso or if the patient’s arm falls off of the arm board. Careful positioning and securing the patient’s arm on the arm board before draping can avoid this injury. A brachial plexus injury can also occur if shoulder braces are placed too laterally during minimally invasive surgery. Radial nerve injuries can occur if there is too much pressure on the humerus during positioning. Ulnar injuries arise from pressure placed on the medial aspect of the elbow.

Tip #1: When tucking a patient’s arm for minimally invasive surgery, appropriate padding should be placed around the elbow and wrist, and the arm should be in the “thumbs-up” position.

Tip #2: Shoulder blocks should be placed over the acromioclavicular (AC) joint.

Lumbosacral plexus

The femoral nerve is the nerve most commonly injured during gynecologic surgery and this usually occurs because of compression of the nerve from the lateral blades of self-retaining retractors. One study showed an 8% incidence of injury from self-retaining retractors, compared with less than 1% when the retractors were not used.6 The femoral nerve can also be stretched when patients are placed in the lithotomy position and the hip is hyperflexed.

As with brachial injury prevention, patients should be positioned prior to draping and care must be taken to not hyperflex or externally rotate the hip during minimally invasive surgical procedures. With the introduction of robot-assisted surgery, care must be taken when docking the robot and surgeons must resist excessive movement of the stirrups.

Tip #3: During laparotomy, surgeons should use the shortest blades that allow for adequate visualization and check the blades during the procedure to ensure that excessive pressure is not placed on the psoas muscle. Consider intermittently releasing the pressure on the lateral blades during other portions of the procedure.

Tip #4: Make sure the stirrups are at the same height and that the leg is in line with the patient’s contralateral shoulder.

Obturator nerve injuries can occur during retroperitoneal dissection for pelvic lymphadenectomy (obturator nodes) and can be either a transection or a cautery injury. It can also be injured during urogynecologic procedures including paravaginal defect repairs and during the placement of transobturator tapes.

The sciatic nerve and its branch, the common peroneal, are generally injured because of excessive stretch or pressure. Both nerves can be injured from hyperflexion of the thigh and the common peroneal can suffer a pressure injury as it courses around the lateral head of the fibula. Therefore, care during lithotomy positioning with both candy cane and Allen stirrups is critical during vaginal surgery.

Tip #5: Ensure that the lateral fibula is not touching the stirrup or that padding is placed between the fibular head and the stirrup.

The ilioinguinal and iliohypogastric nerves are typically injured via suture entrapment from low transverse skin incisions, though laparoscopic injury has also been reported. The incidence after a Pfannenstiel incision is about 3.7%.7

Tip #6: Avoid extending the low transverse incision beyond the lateral margin of the rectus muscle, and do not extend the fascial closure suture more than 1.5 cm from the lateral edge of the fascial incision to avoid catching the nerve with the suture.

The pudendal nerve is most commonly injured during vaginal procedures such as sacrospinous fixation. Pain is typically worse when seated.

The genitofemoral nerve is typically injured during retroperitoneal lymph node dissection, particularly the external iliac nodes. The nerve is small and runs lateral to the external iliac artery. It can suffer cautery and transection injuries. Usually, the paresthesias over the mons pubis, labia majora, and medial inner thigh are temporary.

Tip #7: Care should be taken to identify and spare the nerve during retroperitoneal dissection or external iliac node removal.

Nerve injuries during gynecologic surgery are common and are a significant cause of potential morbidity. While occasionally unavoidable and inherent to the surgical procedure, many times the injury could be prevented with proper attention and care to patient positioning and retractor use. Gynecologists should be aware of the risks and have a through understanding of the anatomy. However, should an injury occur, the patient can be reassured that most are self-limited and full recovery is generally expected. In a prospective study, the median time to resolution of symptoms was 31.5 days (range, 1 day to 6 months).5

References

1. The Obstetrician & Gynaecologist 2014;16:29-36.

2. Gynecol Oncol. 1988 Nov;31(3):462-6.

3. Fertil Steril. 1993 Oct;60(4):729-32.

4. J Minim Invasive Gynecol. 2007 Sep-Oct;14(5):664-72.

5. Am J Obstet Gynecol. 2009 Nov;201(5):531.e1-7.

6. Eur J Obstet Gynecol Reprod Biol. 1985 Dec;20(6):385-92.

7. Obstet Gynecol. 2008 Apr;111(4):839-46.

Dr. Gehrig is professor and director of gynecologic oncology at the University of North Carolina at Chapel Hill. She reported having no financial disclosures relevant to this column. Email her at [email protected].

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