Commentary

In a recent letter to the editors, we were queried as to the ratio of NP authors to PA authors represented in this journal and whether Clinician Reviews was changing its focus to PAs. Let me assure you, my NP colleagues, the journal always has been and always will be written for both professions. However, the query did give me pause—and the opportunity to encourage (as I have in the past) all NPs to pick up their pen (or keyboard) and start writing.

I often hear my NP colleagues diminish the work they do, the care they provide, the advocacy they undertake on behalf of patients and their families. Yet the stories of clinical problems they solve, access barriers they mitigate, or professional advances they have fostered are fascinating—and we want to read about them!

When I marvel at the accomplishments, and ask if the NP in question would write about his/her experience, the response is frequently “Oh, I can’t write” or “I could never author an article,” or (as most of us could say) “I’m too busy.”

I fully understand the hesitance of many with regard to penning an article (or being a lead for one of our clinical departments); many of us have been out of school for a bit and are so used to dictating clinical notes that we cringe at the thought of “trying” to write. I once had an NP tell me that she was not sure whether she could compose a full sentence anymore. Trust me, I could relate to her angst. I am reasonably confident that some of you are saying to yourself, “Yeah, sure.” Well, dear readers, it’s true.

When I was approached to undertake the position as NP Editor-in-Chief, I had much trepidation. I, too, lacked confidence in my writing ability and faith that anyone cared to read about what I thought or what I considered important. However, with the support of my colleagues and mentors, I was quickly disabused of those self-doubts.

We write every day—in one fashion or another. Think about it. Those of you with children: I am sure you have coached, restructured sentences, researched subject matter, and edited at least one book report. And what about e-mail?  Surely, you compose at least one professional e-mail per day to a colleague or a patient. Is it ready for peer review, or does it meet the standard required for publication? Who knows? But it is writing. Moreover, the passion with which you communicate the information is why people read what you have to “say.”

It is said that a journey of a thousand miles begins with a single step (Lao Tsu, Chinese philosopher, 571-531 BC). So, too, does an article begin with one word or a single thought. If you are a regular reader of my editorials, you know that many of them (including this one!) start with a comment from a colleague, or something I read or heard in the news, or an occurrence that raised my ire. And so the seed of a column (limited to 1,000 words, by the way) is planted. Each of you has the seed of an article in you; I know you do.

This year, we celebrate the 50th anniversary of the NP profession, which was established because Loretta Ford and Henry Silva saw the need for better access to care for children. From the seed that they planted, the profession has grown and brought with it a monumental change in health care. (They likely weren’t thinking that far ahead at the time, but rather striving to address what they saw as an immediate and vital need.)

In 1985, a group of NPs saw the need for an organization dedicated to mitigating barriers to practice. A handful of people initiated a change—better representation for NPs—and a little entity named AANP began. As we know, the organization has flourished—all because a small group of people saw an opportunity to improve the status quo and stepped in to make a change. (To read more about the origins of AANP, “From the CR-chive”.)

My point is perhaps best summed up by a quote I read in an interview in the NY Times Book Review in the late 1960s. It stuck with me, to the extent that it became my mantra: “You can’t sit on the outside and complain if you don’t like something—go in and change it.”

Those of you willing to rise to this challenge will find that every publication posts its “guidelines for authors” on its website (and sometimes in the print edition). Take a few extra minutes when you are reading the journal or visiting the site to review those guidelines. Check out the types of articles or other submissions the editors accept and consider what you might contribute, based on your particular experiences, knowledge, and interest.

Do you have a particular specialty area or a “pet” disease state or condition that you want to share your expertise on? Have you learned something you wish you’d known sooner? Have you maneuvered through or around a particular barrier to practice or access? Others might benefit from knowing the keys to your accomplishment. We are quick to bemoan our plights; instead, share your success!

Start by jotting down a few words—the rest will follow. The great thing about writing is that you can do it anywhere, anytime. (For example, this editorial was written in an airport!) And please note: If you have the idea and the passion—and the wherewithal to start the writing process—there are dedicated editorial staff who will work with you to polish your submission for publication. Writing begins as a solitary pursuit, but you are not alone through the process.

So here is my challenge to you: Be an agent of change to increase the number of NP-authored columns in this publication. Have faith in your ability to write. Take it one word at a time; a few words form a sentence, a few sentences a paragraph—and before you know it, you’ve written an entire column or article.

Write from your head, your heart, or your outrage—but write! You can start by sending your thoughts on this editorial to [email protected].

In a recent letter to the editors, we were queried as to the ratio of NP authors to PA authors represented in this journal and whether Clinician Reviews was changing its focus to PAs. Let me assure you, my NP colleagues, the journal always has been and always will be written for both professions. However, the query did give me pause—and the opportunity to encourage (as I have in the past) all NPs to pick up their pen (or keyboard) and start writing.

I often hear my NP colleagues diminish the work they do, the care they provide, the advocacy they undertake on behalf of patients and their families. Yet the stories of clinical problems they solve, access barriers they mitigate, or professional advances they have fostered are fascinating—and we want to read about them!

When I marvel at the accomplishments, and ask if the NP in question would write about his/her experience, the response is frequently “Oh, I can’t write” or “I could never author an article,” or (as most of us could say) “I’m too busy.”

I fully understand the hesitance of many with regard to penning an article (or being a lead for one of our clinical departments); many of us have been out of school for a bit and are so used to dictating clinical notes that we cringe at the thought of “trying” to write. I once had an NP tell me that she was not sure whether she could compose a full sentence anymore. Trust me, I could relate to her angst. I am reasonably confident that some of you are saying to yourself, “Yeah, sure.” Well, dear readers, it’s true.

When I was approached to undertake the position as NP Editor-in-Chief, I had much trepidation. I, too, lacked confidence in my writing ability and faith that anyone cared to read about what I thought or what I considered important. However, with the support of my colleagues and mentors, I was quickly disabused of those self-doubts.

We write every day—in one fashion or another. Think about it. Those of you with children: I am sure you have coached, restructured sentences, researched subject matter, and edited at least one book report. And what about e-mail?  Surely, you compose at least one professional e-mail per day to a colleague or a patient. Is it ready for peer review, or does it meet the standard required for publication? Who knows? But it is writing. Moreover, the passion with which you communicate the information is why people read what you have to “say.”

It is said that a journey of a thousand miles begins with a single step (Lao Tsu, Chinese philosopher, 571-531 BC). So, too, does an article begin with one word or a single thought. If you are a regular reader of my editorials, you know that many of them (including this one!) start with a comment from a colleague, or something I read or heard in the news, or an occurrence that raised my ire. And so the seed of a column (limited to 1,000 words, by the way) is planted. Each of you has the seed of an article in you; I know you do.

This year, we celebrate the 50th anniversary of the NP profession, which was established because Loretta Ford and Henry Silva saw the need for better access to care for children. From the seed that they planted, the profession has grown and brought with it a monumental change in health care. (They likely weren’t thinking that far ahead at the time, but rather striving to address what they saw as an immediate and vital need.)

In 1985, a group of NPs saw the need for an organization dedicated to mitigating barriers to practice. A handful of people initiated a change—better representation for NPs—and a little entity named AANP began. As we know, the organization has flourished—all because a small group of people saw an opportunity to improve the status quo and stepped in to make a change. (To read more about the origins of AANP, “From the CR-chive”.)

My point is perhaps best summed up by a quote I read in an interview in the NY Times Book Review in the late 1960s. It stuck with me, to the extent that it became my mantra: “You can’t sit on the outside and complain if you don’t like something—go in and change it.”

Those of you willing to rise to this challenge will find that every publication posts its “guidelines for authors” on its website (and sometimes in the print edition). Take a few extra minutes when you are reading the journal or visiting the site to review those guidelines. Check out the types of articles or other submissions the editors accept and consider what you might contribute, based on your particular experiences, knowledge, and interest.

Do you have a particular specialty area or a “pet” disease state or condition that you want to share your expertise on? Have you learned something you wish you’d known sooner? Have you maneuvered through or around a particular barrier to practice or access? Others might benefit from knowing the keys to your accomplishment. We are quick to bemoan our plights; instead, share your success!

Start by jotting down a few words—the rest will follow. The great thing about writing is that you can do it anywhere, anytime. (For example, this editorial was written in an airport!) And please note: If you have the idea and the passion—and the wherewithal to start the writing process—there are dedicated editorial staff who will work with you to polish your submission for publication. Writing begins as a solitary pursuit, but you are not alone through the process.

So here is my challenge to you: Be an agent of change to increase the number of NP-authored columns in this publication. Have faith in your ability to write. Take it one word at a time; a few words form a sentence, a few sentences a paragraph—and before you know it, you’ve written an entire column or article.

Write from your head, your heart, or your outrage—but write! You can start by sending your thoughts on this editorial to [email protected].

In a recent letter to the editors, we were queried as to the ratio of NP authors to PA authors represented in this journal and whether Clinician Reviews was changing its focus to PAs. Let me assure you, my NP colleagues, the journal always has been and always will be written for both professions. However, the query did give me pause—and the opportunity to encourage (as I have in the past) all NPs to pick up their pen (or keyboard) and start writing.

I often hear my NP colleagues diminish the work they do, the care they provide, the advocacy they undertake on behalf of patients and their families. Yet the stories of clinical problems they solve, access barriers they mitigate, or professional advances they have fostered are fascinating—and we want to read about them!

When I marvel at the accomplishments, and ask if the NP in question would write about his/her experience, the response is frequently “Oh, I can’t write” or “I could never author an article,” or (as most of us could say) “I’m too busy.”

I fully understand the hesitance of many with regard to penning an article (or being a lead for one of our clinical departments); many of us have been out of school for a bit and are so used to dictating clinical notes that we cringe at the thought of “trying” to write. I once had an NP tell me that she was not sure whether she could compose a full sentence anymore. Trust me, I could relate to her angst. I am reasonably confident that some of you are saying to yourself, “Yeah, sure.” Well, dear readers, it’s true.

When I was approached to undertake the position as NP Editor-in-Chief, I had much trepidation. I, too, lacked confidence in my writing ability and faith that anyone cared to read about what I thought or what I considered important. However, with the support of my colleagues and mentors, I was quickly disabused of those self-doubts.

We write every day—in one fashion or another. Think about it. Those of you with children: I am sure you have coached, restructured sentences, researched subject matter, and edited at least one book report. And what about e-mail?  Surely, you compose at least one professional e-mail per day to a colleague or a patient. Is it ready for peer review, or does it meet the standard required for publication? Who knows? But it is writing. Moreover, the passion with which you communicate the information is why people read what you have to “say.”

It is said that a journey of a thousand miles begins with a single step (Lao Tsu, Chinese philosopher, 571-531 BC). So, too, does an article begin with one word or a single thought. If you are a regular reader of my editorials, you know that many of them (including this one!) start with a comment from a colleague, or something I read or heard in the news, or an occurrence that raised my ire. And so the seed of a column (limited to 1,000 words, by the way) is planted. Each of you has the seed of an article in you; I know you do.

This year, we celebrate the 50th anniversary of the NP profession, which was established because Loretta Ford and Henry Silva saw the need for better access to care for children. From the seed that they planted, the profession has grown and brought with it a monumental change in health care. (They likely weren’t thinking that far ahead at the time, but rather striving to address what they saw as an immediate and vital need.)

In 1985, a group of NPs saw the need for an organization dedicated to mitigating barriers to practice. A handful of people initiated a change—better representation for NPs—and a little entity named AANP began. As we know, the organization has flourished—all because a small group of people saw an opportunity to improve the status quo and stepped in to make a change. (To read more about the origins of AANP, “From the CR-chive”.)

My point is perhaps best summed up by a quote I read in an interview in the NY Times Book Review in the late 1960s. It stuck with me, to the extent that it became my mantra: “You can’t sit on the outside and complain if you don’t like something—go in and change it.”

Those of you willing to rise to this challenge will find that every publication posts its “guidelines for authors” on its website (and sometimes in the print edition). Take a few extra minutes when you are reading the journal or visiting the site to review those guidelines. Check out the types of articles or other submissions the editors accept and consider what you might contribute, based on your particular experiences, knowledge, and interest.

Do you have a particular specialty area or a “pet” disease state or condition that you want to share your expertise on? Have you learned something you wish you’d known sooner? Have you maneuvered through or around a particular barrier to practice or access? Others might benefit from knowing the keys to your accomplishment. We are quick to bemoan our plights; instead, share your success!

Start by jotting down a few words—the rest will follow. The great thing about writing is that you can do it anywhere, anytime. (For example, this editorial was written in an airport!) And please note: If you have the idea and the passion—and the wherewithal to start the writing process—there are dedicated editorial staff who will work with you to polish your submission for publication. Writing begins as a solitary pursuit, but you are not alone through the process.

So here is my challenge to you: Be an agent of change to increase the number of NP-authored columns in this publication. Have faith in your ability to write. Take it one word at a time; a few words form a sentence, a few sentences a paragraph—and before you know it, you’ve written an entire column or article.

Write from your head, your heart, or your outrage—but write! You can start by sending your thoughts on this editorial to [email protected].

[Updating an editorial that first appeared in the August 2012 issue.]

Until recently, shortages of critically needed medications in this country were rare and unthinkable. But now, the unthinkable has become commonplace. In August 2012, I wrote about the seemingly endless supply problems and proposed some possible remedies, but in the 3 years since, not much has changed.

Cold War era images of empty Soviet Russia supermarket shelves still remain vivid reminders of a failed system of government. So, who would have predicted that in the 21st century, the United States of America, winner of the Cold War, would have hospital pharmacy shelves bereft of essential medications, including many of the sterile, injectable, crashcart meds we rely on during resuscitations? According to a November 2011 U.S. Government Accountability Office report (GAO-12-116), there were 1,190 drug shortages between 2001-2011 with the number increasing annually since 2006. Drug shortages have not escaped physician or public attention, and a lot of finger pointing among government agencies, manufacturers, and distributors, have made most of us feel like a parent trying to break up a loud argument between siblings: “I don’t care who started it, just stop it NOW!”

One of the most critical types of shortages involves sterile, injectable, generic meds (such as epinephrine), accounting for more than half the shortages since 2009. During resuscitations, physicians and paramedics rely on the immediate availability of premixed, ready-to-use unit doses packaged in sealed, prefilled syringes. All such preparations must be sterile and most are generic, necessitating short expiration dates and tightly controlled inventories to maintain sterility of properly produced preparations, while contamination during the manufacturing process itself results in nationwide recalls and production halts. Because these generic medications have no patent protection and do not command the higher prices of newer, brand-name drugs, there is little incentive for manufacturers to make costly changes in production methods aimed at reducing future shortages. As noted in an August 2010 NEJM article on a shortage of propofol (2010;363[9]:806-807), most such drugs are manufactured by only two or three companies Should a manufacturer suspend or discontinue production, widespread shortages are felt immediately. Although the FDA has the authority to regulate pharmaceutical production to ensure safety, it cannot mandate continued production.

Relying on information from the Utah Drug Information Service, the GAO (http://www.gao.gov/products/GAO-14-194) found that the total number of shortages increased each year since 2007, even in years (2012, 2013) when the rate of new shortages decreased, because ongoing shortages were slow to resolve. Disturbingly, current shortages include such basics as saline, dextrose, nitroglycerin, anti-emetics, and epinephrine packaged for use in resuscitations, all affecting large numbers of patients. Manufacturer-provided information to the Utah Drug Information Service (http://www.ashp.org/DocLibrary/Policy/DrugShortages/Drug-Shortages-Statistics.pdf) regarding the reasons for shortages in 2014 indicate “manufacturing problems” were responsible for 25%, “supply/demand” for 17%, “business decisions/ discontinue” for 9%, with 47% listed as “unknown.”

What can be done to avoid shortages? First, a short list of “never event” drug shortages should be identified. For established medications and formulations too essential to be allowed to fail, the federal government should consider relaxing or delaying requirements for new, costly changes in their manufacture, or should pay for the mandated changes. The government should also consider offering incentives for pharmaceutical companies to continue producing critically-needed, low-profit generics that require costly manufacturing changes, perhaps by extending patent protection for one of the company’s more profitable products. As a last resort, the government should consider manufacturing the medication itself.

In the almost 15 years since an Annals of Emergency Medicine article appeared on “the challenge of drug shortages for emergency medicine” (2002;40[8]:598-602),—enough time for three Soviet-style “5 year plans”—new shortages and their deleterious effects on patient care have continued. 

[Updating an editorial that first appeared in the August 2012 issue.]

Until recently, shortages of critically needed medications in this country were rare and unthinkable. But now, the unthinkable has become commonplace. In August 2012, I wrote about the seemingly endless supply problems and proposed some possible remedies, but in the 3 years since, not much has changed.

Cold War era images of empty Soviet Russia supermarket shelves still remain vivid reminders of a failed system of government. So, who would have predicted that in the 21st century, the United States of America, winner of the Cold War, would have hospital pharmacy shelves bereft of essential medications, including many of the sterile, injectable, crashcart meds we rely on during resuscitations? According to a November 2011 U.S. Government Accountability Office report (GAO-12-116), there were 1,190 drug shortages between 2001-2011 with the number increasing annually since 2006. Drug shortages have not escaped physician or public attention, and a lot of finger pointing among government agencies, manufacturers, and distributors, have made most of us feel like a parent trying to break up a loud argument between siblings: “I don’t care who started it, just stop it NOW!”

One of the most critical types of shortages involves sterile, injectable, generic meds (such as epinephrine), accounting for more than half the shortages since 2009. During resuscitations, physicians and paramedics rely on the immediate availability of premixed, ready-to-use unit doses packaged in sealed, prefilled syringes. All such preparations must be sterile and most are generic, necessitating short expiration dates and tightly controlled inventories to maintain sterility of properly produced preparations, while contamination during the manufacturing process itself results in nationwide recalls and production halts. Because these generic medications have no patent protection and do not command the higher prices of newer, brand-name drugs, there is little incentive for manufacturers to make costly changes in production methods aimed at reducing future shortages. As noted in an August 2010 NEJM article on a shortage of propofol (2010;363[9]:806-807), most such drugs are manufactured by only two or three companies Should a manufacturer suspend or discontinue production, widespread shortages are felt immediately. Although the FDA has the authority to regulate pharmaceutical production to ensure safety, it cannot mandate continued production.

Relying on information from the Utah Drug Information Service, the GAO (http://www.gao.gov/products/GAO-14-194) found that the total number of shortages increased each year since 2007, even in years (2012, 2013) when the rate of new shortages decreased, because ongoing shortages were slow to resolve. Disturbingly, current shortages include such basics as saline, dextrose, nitroglycerin, anti-emetics, and epinephrine packaged for use in resuscitations, all affecting large numbers of patients. Manufacturer-provided information to the Utah Drug Information Service (http://www.ashp.org/DocLibrary/Policy/DrugShortages/Drug-Shortages-Statistics.pdf) regarding the reasons for shortages in 2014 indicate “manufacturing problems” were responsible for 25%, “supply/demand” for 17%, “business decisions/ discontinue” for 9%, with 47% listed as “unknown.”

What can be done to avoid shortages? First, a short list of “never event” drug shortages should be identified. For established medications and formulations too essential to be allowed to fail, the federal government should consider relaxing or delaying requirements for new, costly changes in their manufacture, or should pay for the mandated changes. The government should also consider offering incentives for pharmaceutical companies to continue producing critically-needed, low-profit generics that require costly manufacturing changes, perhaps by extending patent protection for one of the company’s more profitable products. As a last resort, the government should consider manufacturing the medication itself.

In the almost 15 years since an Annals of Emergency Medicine article appeared on “the challenge of drug shortages for emergency medicine” (2002;40[8]:598-602),—enough time for three Soviet-style “5 year plans”—new shortages and their deleterious effects on patient care have continued. 

[Updating an editorial that first appeared in the August 2012 issue.]

Until recently, shortages of critically needed medications in this country were rare and unthinkable. But now, the unthinkable has become commonplace. In August 2012, I wrote about the seemingly endless supply problems and proposed some possible remedies, but in the 3 years since, not much has changed.

Cold War era images of empty Soviet Russia supermarket shelves still remain vivid reminders of a failed system of government. So, who would have predicted that in the 21st century, the United States of America, winner of the Cold War, would have hospital pharmacy shelves bereft of essential medications, including many of the sterile, injectable, crashcart meds we rely on during resuscitations? According to a November 2011 U.S. Government Accountability Office report (GAO-12-116), there were 1,190 drug shortages between 2001-2011 with the number increasing annually since 2006. Drug shortages have not escaped physician or public attention, and a lot of finger pointing among government agencies, manufacturers, and distributors, have made most of us feel like a parent trying to break up a loud argument between siblings: “I don’t care who started it, just stop it NOW!”

One of the most critical types of shortages involves sterile, injectable, generic meds (such as epinephrine), accounting for more than half the shortages since 2009. During resuscitations, physicians and paramedics rely on the immediate availability of premixed, ready-to-use unit doses packaged in sealed, prefilled syringes. All such preparations must be sterile and most are generic, necessitating short expiration dates and tightly controlled inventories to maintain sterility of properly produced preparations, while contamination during the manufacturing process itself results in nationwide recalls and production halts. Because these generic medications have no patent protection and do not command the higher prices of newer, brand-name drugs, there is little incentive for manufacturers to make costly changes in production methods aimed at reducing future shortages. As noted in an August 2010 NEJM article on a shortage of propofol (2010;363[9]:806-807), most such drugs are manufactured by only two or three companies Should a manufacturer suspend or discontinue production, widespread shortages are felt immediately. Although the FDA has the authority to regulate pharmaceutical production to ensure safety, it cannot mandate continued production.

Relying on information from the Utah Drug Information Service, the GAO (http://www.gao.gov/products/GAO-14-194) found that the total number of shortages increased each year since 2007, even in years (2012, 2013) when the rate of new shortages decreased, because ongoing shortages were slow to resolve. Disturbingly, current shortages include such basics as saline, dextrose, nitroglycerin, anti-emetics, and epinephrine packaged for use in resuscitations, all affecting large numbers of patients. Manufacturer-provided information to the Utah Drug Information Service (http://www.ashp.org/DocLibrary/Policy/DrugShortages/Drug-Shortages-Statistics.pdf) regarding the reasons for shortages in 2014 indicate “manufacturing problems” were responsible for 25%, “supply/demand” for 17%, “business decisions/ discontinue” for 9%, with 47% listed as “unknown.”

What can be done to avoid shortages? First, a short list of “never event” drug shortages should be identified. For established medications and formulations too essential to be allowed to fail, the federal government should consider relaxing or delaying requirements for new, costly changes in their manufacture, or should pay for the mandated changes. The government should also consider offering incentives for pharmaceutical companies to continue producing critically-needed, low-profit generics that require costly manufacturing changes, perhaps by extending patent protection for one of the company’s more profitable products. As a last resort, the government should consider manufacturing the medication itself.

In the almost 15 years since an Annals of Emergency Medicine article appeared on “the challenge of drug shortages for emergency medicine” (2002;40[8]:598-602),—enough time for three Soviet-style “5 year plans”—new shortages and their deleterious effects on patient care have continued. 

We are pleased to welcome Dr. Nathaniel Savio Beers to the Pediatric News Editorial Advisory Board.

Dr. Beers is currently chief operating officer for the District of Columbia Public Schools and a general and developmental behavioral pediatrician at Children’s National Health System in Washington. At DCPS, he was previously the Chief of Specialized Instruction from 2011 to 2015. Previously, he was director of the Children’s Health Center, the largest provider of primary care in Washington, deputy director for the Community Health Administration in Washington, and Title V director for the D.C. Health Department.

He has served on the Washington Mayor’s Advisory Committee on Child Welfare, the Mayor’s Early Childhood Advisory Council, and the Children with Special Health Care Needs Advisory Board. Dr. Beers has served as president of the D.C. Chapter of the American Academy of Pediatrics, chair of the National AAP Committee on Membership, and chair of the AAP Section on Residents.

He is newly elected to the Council on School Health for the AAP. Dr. Beers graduated from George Washington University medical school and completed his pediatric residency at Children’s National. Dr. Beers was the Anne E. Dyson Child Advocacy Fellow at Children’s Hospital of Boston and Chief Fellow of General Pediatrics. He received a Master’s Degree of Public Administration at the Harvard Kennedy School, Boston.

[email protected]

We are pleased to welcome Dr. Nathaniel Savio Beers to the Pediatric News Editorial Advisory Board.

Dr. Beers is currently chief operating officer for the District of Columbia Public Schools and a general and developmental behavioral pediatrician at Children’s National Health System in Washington. At DCPS, he was previously the Chief of Specialized Instruction from 2011 to 2015. Previously, he was director of the Children’s Health Center, the largest provider of primary care in Washington, deputy director for the Community Health Administration in Washington, and Title V director for the D.C. Health Department.

He has served on the Washington Mayor’s Advisory Committee on Child Welfare, the Mayor’s Early Childhood Advisory Council, and the Children with Special Health Care Needs Advisory Board. Dr. Beers has served as president of the D.C. Chapter of the American Academy of Pediatrics, chair of the National AAP Committee on Membership, and chair of the AAP Section on Residents.

He is newly elected to the Council on School Health for the AAP. Dr. Beers graduated from George Washington University medical school and completed his pediatric residency at Children’s National. Dr. Beers was the Anne E. Dyson Child Advocacy Fellow at Children’s Hospital of Boston and Chief Fellow of General Pediatrics. He received a Master’s Degree of Public Administration at the Harvard Kennedy School, Boston.

[email protected]

We are pleased to welcome Dr. Nathaniel Savio Beers to the Pediatric News Editorial Advisory Board.

Dr. Beers is currently chief operating officer for the District of Columbia Public Schools and a general and developmental behavioral pediatrician at Children’s National Health System in Washington. At DCPS, he was previously the Chief of Specialized Instruction from 2011 to 2015. Previously, he was director of the Children’s Health Center, the largest provider of primary care in Washington, deputy director for the Community Health Administration in Washington, and Title V director for the D.C. Health Department.

He has served on the Washington Mayor’s Advisory Committee on Child Welfare, the Mayor’s Early Childhood Advisory Council, and the Children with Special Health Care Needs Advisory Board. Dr. Beers has served as president of the D.C. Chapter of the American Academy of Pediatrics, chair of the National AAP Committee on Membership, and chair of the AAP Section on Residents.

He is newly elected to the Council on School Health for the AAP. Dr. Beers graduated from George Washington University medical school and completed his pediatric residency at Children’s National. Dr. Beers was the Anne E. Dyson Child Advocacy Fellow at Children’s Hospital of Boston and Chief Fellow of General Pediatrics. He received a Master’s Degree of Public Administration at the Harvard Kennedy School, Boston.

[email protected]

An emerging market of molecular markers for thyroid cancer diagnostic and prognostic evaluation challenges current medical and surgical management; however, here is a strong word of caution; Unless the markers have been tested in the context of clinical and surgical management their true efficacy has not been accurately assessed.

We must always ask two questions before ordering these tests that can cost more than $3,000: 1) Does the use of a molecular test add any additional information that would otherwise change our recommendations; in other words, is the clinical information already known enough for appropriate clinical decision making? 2) What is the basis upon which recommendations for its use have been made; in other words, how were the studies conducted and interpreted? Are they valid?

By way of background, the gene expression clarifier (GEC) Afirma is marketed as a diagnostic tool for the differential diagnosis of indeterminate thyroid cytology (atypical cells of undetermined significance or follicular neoplasm, Bethesda categories III and IV, respectively).

Most importantly, it has been tested and is marketed as a negative predictor only. It is also only useful if used in the appropriate setting and if the test result is negative; a positive Afirma test can tell us only that the nodule is indeterminate, something, by definition, already determined by fine needle aspiration (FNA). Furthermore, any study examining its efficacy must be conducted within the context of clinical scenarios. For example, for a patient with an indeterminate lesion and a symptomatic multinodular goiter, neither a negative nor positive Afirma result would have any impact on surgical decision making and yet would have cost the patient more than $3,000. The latter patient simply needs a thyroidectomy. A patient who has a nodule that is approaching 4 cm or is increasing in size or a patient who has undergone several FNAs, ultrasounds, and endocrinology consultations similarly would likely choose surgery regardless of the GEC test result.

The only scenario in which Afirma testing is useful is in a patient with otherwise no indications for surgery except an indeterminate FNA; for instance for a patient with an asymptomatic < 4cm, stable, single nodule. In this scenario only a negative result could be helpful and would obviate the need for surgical intervention. One also must ask what is the likelihood of the patient undergoing repeat FNA, having repeat indeterminate cytology and repeat Afirma testing over the ensuing years and at what point should we consider these costs prohibitive compared with the patient undergoing a thyroidectomy instead?

Similar concerns exist with regard to somatic mutation panels, the most commonly marketed and used being Asuragen. The mutation panel consists of Ras and BRAF mutation and RET/PTC and PAX8/PPAR-gamma chromosomal rearrangement analyses. Importantly, the expanding literature on molecular markers for thyroid cancer, however, has lost track of a vast body of literature that reports Ras mutations present in up to 30% of benign thyroid nodules; RET/PTC in 24% and PAX8/PPAR-gamma in 14%, dramatically challenging the validity of the panel purported to accurately identify thyroid malignancy. We know that BRAF mutation is exclusively found in papillary thyroid cancer, but generally a BRAF-positive tumor is one in which a cytological diagnosis is already clear; it is either suspicious or definitively malignant on FNA. One might suggest that these aforementioned markers might indicate a harbinger of malignancy or identify a precancerous lesion; however, there is no study that supports this theory. Furthermore, it is important to note that even among pathology experts the diagnoses of follicular adenoma, follicular cancer, and follicular variant of papillary thyroid cancer have significant and documented inter- and intra- observer variability, thus challenging the gold standard upon which these markers have been tested.

With regard to BRAF, Ras, RET/PTC and PAX8/PPAR-gamma as prognostic markers there are many considerations, the least of which includes the differential diagnosis of follicular lesions addressed above and the known presence of these abnormalities in benign tumors. The majority of studies to date have conducted only univariate analyses without consideration of the clinical variables already available to us to make needed clinical decisions. In order to examine the usefulness of any marker panel a multivariable study is required, incorporating the available clinical variables such as size, lymph node metastases, and extra-thyroidal extension. For instance, the majority of studies examining the presence of lymph node metastases in BRAF-negative vs. BRAF-positive tumors were almost uniformly conducted on patients in whom routine lymph node dissection was not performed, thereby skewing the results. Only patients with suspicious nodes underwent a lymph node dissection; thus for those patients who had no suspicious nodes there was no information about their nodal status. Furthermore, several studies that included patients who underwent routine lymph node dissections and, importantly, included patients who underwent prophylactic dissections for whom a marker would be most useful, did not find that BRAF mutation was associated with aggressive features, including the presence of lymph node metastases. The same can be stated for a panel that includes Ras, RET/PTC, & PAX8/PPAR-gamma. “Follicular variant of papillary thyroid cancer and follicular cancer” will more likely harbor Ras and PAX8/PPAR-gamma mutations and will, by definition, include some tumors that would be considered benign by other pathologists.

There is an emerging market for molecular markers for thyroid cancer diagnosis and prognosis, but many of the studies driving this market are lacking in scientific rigor with regard to design and interpretation of results. Furthermore, the use of the marker panel requires scrutiny of its true impact on clinical management as well as its cost-effectiveness. GEC provides a negative predictor of malignancy and should be used to obviate surgery only; if the patient requires surgery its use provides no added information. BRAF is specific for thyroid cancer diagnosis, but is often not required as FNA evaluation in BRAF-positive tumors is usually already suspicious or malignant. Finally, molecular marker panels for thyroid cancer prognosis may be promising, but scrutiny for true accuracy and true clinical impact is necessary in order to make logical and useful recommendations for our patients.

Dr. Zeiger is professor of surgery, oncology, cellular, and molecular medicine, associate vice chair for faculty development, and associate dean for postdoctoral affairs at Johns Hopkins University in Baltimore. Dr. Zeiger consults for Interpace Diagnostics.

An emerging market of molecular markers for thyroid cancer diagnostic and prognostic evaluation challenges current medical and surgical management; however, here is a strong word of caution; Unless the markers have been tested in the context of clinical and surgical management their true efficacy has not been accurately assessed.

We must always ask two questions before ordering these tests that can cost more than $3,000: 1) Does the use of a molecular test add any additional information that would otherwise change our recommendations; in other words, is the clinical information already known enough for appropriate clinical decision making? 2) What is the basis upon which recommendations for its use have been made; in other words, how were the studies conducted and interpreted? Are they valid?

By way of background, the gene expression clarifier (GEC) Afirma is marketed as a diagnostic tool for the differential diagnosis of indeterminate thyroid cytology (atypical cells of undetermined significance or follicular neoplasm, Bethesda categories III and IV, respectively).

Most importantly, it has been tested and is marketed as a negative predictor only. It is also only useful if used in the appropriate setting and if the test result is negative; a positive Afirma test can tell us only that the nodule is indeterminate, something, by definition, already determined by fine needle aspiration (FNA). Furthermore, any study examining its efficacy must be conducted within the context of clinical scenarios. For example, for a patient with an indeterminate lesion and a symptomatic multinodular goiter, neither a negative nor positive Afirma result would have any impact on surgical decision making and yet would have cost the patient more than $3,000. The latter patient simply needs a thyroidectomy. A patient who has a nodule that is approaching 4 cm or is increasing in size or a patient who has undergone several FNAs, ultrasounds, and endocrinology consultations similarly would likely choose surgery regardless of the GEC test result.

The only scenario in which Afirma testing is useful is in a patient with otherwise no indications for surgery except an indeterminate FNA; for instance for a patient with an asymptomatic < 4cm, stable, single nodule. In this scenario only a negative result could be helpful and would obviate the need for surgical intervention. One also must ask what is the likelihood of the patient undergoing repeat FNA, having repeat indeterminate cytology and repeat Afirma testing over the ensuing years and at what point should we consider these costs prohibitive compared with the patient undergoing a thyroidectomy instead?

Similar concerns exist with regard to somatic mutation panels, the most commonly marketed and used being Asuragen. The mutation panel consists of Ras and BRAF mutation and RET/PTC and PAX8/PPAR-gamma chromosomal rearrangement analyses. Importantly, the expanding literature on molecular markers for thyroid cancer, however, has lost track of a vast body of literature that reports Ras mutations present in up to 30% of benign thyroid nodules; RET/PTC in 24% and PAX8/PPAR-gamma in 14%, dramatically challenging the validity of the panel purported to accurately identify thyroid malignancy. We know that BRAF mutation is exclusively found in papillary thyroid cancer, but generally a BRAF-positive tumor is one in which a cytological diagnosis is already clear; it is either suspicious or definitively malignant on FNA. One might suggest that these aforementioned markers might indicate a harbinger of malignancy or identify a precancerous lesion; however, there is no study that supports this theory. Furthermore, it is important to note that even among pathology experts the diagnoses of follicular adenoma, follicular cancer, and follicular variant of papillary thyroid cancer have significant and documented inter- and intra- observer variability, thus challenging the gold standard upon which these markers have been tested.

With regard to BRAF, Ras, RET/PTC and PAX8/PPAR-gamma as prognostic markers there are many considerations, the least of which includes the differential diagnosis of follicular lesions addressed above and the known presence of these abnormalities in benign tumors. The majority of studies to date have conducted only univariate analyses without consideration of the clinical variables already available to us to make needed clinical decisions. In order to examine the usefulness of any marker panel a multivariable study is required, incorporating the available clinical variables such as size, lymph node metastases, and extra-thyroidal extension. For instance, the majority of studies examining the presence of lymph node metastases in BRAF-negative vs. BRAF-positive tumors were almost uniformly conducted on patients in whom routine lymph node dissection was not performed, thereby skewing the results. Only patients with suspicious nodes underwent a lymph node dissection; thus for those patients who had no suspicious nodes there was no information about their nodal status. Furthermore, several studies that included patients who underwent routine lymph node dissections and, importantly, included patients who underwent prophylactic dissections for whom a marker would be most useful, did not find that BRAF mutation was associated with aggressive features, including the presence of lymph node metastases. The same can be stated for a panel that includes Ras, RET/PTC, & PAX8/PPAR-gamma. “Follicular variant of papillary thyroid cancer and follicular cancer” will more likely harbor Ras and PAX8/PPAR-gamma mutations and will, by definition, include some tumors that would be considered benign by other pathologists.

There is an emerging market for molecular markers for thyroid cancer diagnosis and prognosis, but many of the studies driving this market are lacking in scientific rigor with regard to design and interpretation of results. Furthermore, the use of the marker panel requires scrutiny of its true impact on clinical management as well as its cost-effectiveness. GEC provides a negative predictor of malignancy and should be used to obviate surgery only; if the patient requires surgery its use provides no added information. BRAF is specific for thyroid cancer diagnosis, but is often not required as FNA evaluation in BRAF-positive tumors is usually already suspicious or malignant. Finally, molecular marker panels for thyroid cancer prognosis may be promising, but scrutiny for true accuracy and true clinical impact is necessary in order to make logical and useful recommendations for our patients.

Dr. Zeiger is professor of surgery, oncology, cellular, and molecular medicine, associate vice chair for faculty development, and associate dean for postdoctoral affairs at Johns Hopkins University in Baltimore. Dr. Zeiger consults for Interpace Diagnostics.

An emerging market of molecular markers for thyroid cancer diagnostic and prognostic evaluation challenges current medical and surgical management; however, here is a strong word of caution; Unless the markers have been tested in the context of clinical and surgical management their true efficacy has not been accurately assessed.

We must always ask two questions before ordering these tests that can cost more than $3,000: 1) Does the use of a molecular test add any additional information that would otherwise change our recommendations; in other words, is the clinical information already known enough for appropriate clinical decision making? 2) What is the basis upon which recommendations for its use have been made; in other words, how were the studies conducted and interpreted? Are they valid?

By way of background, the gene expression clarifier (GEC) Afirma is marketed as a diagnostic tool for the differential diagnosis of indeterminate thyroid cytology (atypical cells of undetermined significance or follicular neoplasm, Bethesda categories III and IV, respectively).

Most importantly, it has been tested and is marketed as a negative predictor only. It is also only useful if used in the appropriate setting and if the test result is negative; a positive Afirma test can tell us only that the nodule is indeterminate, something, by definition, already determined by fine needle aspiration (FNA). Furthermore, any study examining its efficacy must be conducted within the context of clinical scenarios. For example, for a patient with an indeterminate lesion and a symptomatic multinodular goiter, neither a negative nor positive Afirma result would have any impact on surgical decision making and yet would have cost the patient more than $3,000. The latter patient simply needs a thyroidectomy. A patient who has a nodule that is approaching 4 cm or is increasing in size or a patient who has undergone several FNAs, ultrasounds, and endocrinology consultations similarly would likely choose surgery regardless of the GEC test result.

The only scenario in which Afirma testing is useful is in a patient with otherwise no indications for surgery except an indeterminate FNA; for instance for a patient with an asymptomatic < 4cm, stable, single nodule. In this scenario only a negative result could be helpful and would obviate the need for surgical intervention. One also must ask what is the likelihood of the patient undergoing repeat FNA, having repeat indeterminate cytology and repeat Afirma testing over the ensuing years and at what point should we consider these costs prohibitive compared with the patient undergoing a thyroidectomy instead?

Similar concerns exist with regard to somatic mutation panels, the most commonly marketed and used being Asuragen. The mutation panel consists of Ras and BRAF mutation and RET/PTC and PAX8/PPAR-gamma chromosomal rearrangement analyses. Importantly, the expanding literature on molecular markers for thyroid cancer, however, has lost track of a vast body of literature that reports Ras mutations present in up to 30% of benign thyroid nodules; RET/PTC in 24% and PAX8/PPAR-gamma in 14%, dramatically challenging the validity of the panel purported to accurately identify thyroid malignancy. We know that BRAF mutation is exclusively found in papillary thyroid cancer, but generally a BRAF-positive tumor is one in which a cytological diagnosis is already clear; it is either suspicious or definitively malignant on FNA. One might suggest that these aforementioned markers might indicate a harbinger of malignancy or identify a precancerous lesion; however, there is no study that supports this theory. Furthermore, it is important to note that even among pathology experts the diagnoses of follicular adenoma, follicular cancer, and follicular variant of papillary thyroid cancer have significant and documented inter- and intra- observer variability, thus challenging the gold standard upon which these markers have been tested.

With regard to BRAF, Ras, RET/PTC and PAX8/PPAR-gamma as prognostic markers there are many considerations, the least of which includes the differential diagnosis of follicular lesions addressed above and the known presence of these abnormalities in benign tumors. The majority of studies to date have conducted only univariate analyses without consideration of the clinical variables already available to us to make needed clinical decisions. In order to examine the usefulness of any marker panel a multivariable study is required, incorporating the available clinical variables such as size, lymph node metastases, and extra-thyroidal extension. For instance, the majority of studies examining the presence of lymph node metastases in BRAF-negative vs. BRAF-positive tumors were almost uniformly conducted on patients in whom routine lymph node dissection was not performed, thereby skewing the results. Only patients with suspicious nodes underwent a lymph node dissection; thus for those patients who had no suspicious nodes there was no information about their nodal status. Furthermore, several studies that included patients who underwent routine lymph node dissections and, importantly, included patients who underwent prophylactic dissections for whom a marker would be most useful, did not find that BRAF mutation was associated with aggressive features, including the presence of lymph node metastases. The same can be stated for a panel that includes Ras, RET/PTC, & PAX8/PPAR-gamma. “Follicular variant of papillary thyroid cancer and follicular cancer” will more likely harbor Ras and PAX8/PPAR-gamma mutations and will, by definition, include some tumors that would be considered benign by other pathologists.

There is an emerging market for molecular markers for thyroid cancer diagnosis and prognosis, but many of the studies driving this market are lacking in scientific rigor with regard to design and interpretation of results. Furthermore, the use of the marker panel requires scrutiny of its true impact on clinical management as well as its cost-effectiveness. GEC provides a negative predictor of malignancy and should be used to obviate surgery only; if the patient requires surgery its use provides no added information. BRAF is specific for thyroid cancer diagnosis, but is often not required as FNA evaluation in BRAF-positive tumors is usually already suspicious or malignant. Finally, molecular marker panels for thyroid cancer prognosis may be promising, but scrutiny for true accuracy and true clinical impact is necessary in order to make logical and useful recommendations for our patients.

Dr. Zeiger is professor of surgery, oncology, cellular, and molecular medicine, associate vice chair for faculty development, and associate dean for postdoctoral affairs at Johns Hopkins University in Baltimore. Dr. Zeiger consults for Interpace Diagnostics.

An emerging market of molecular markers for thyroid cancer diagnostic and prognostic evaluation challenges current medical and surgical management; however, here is a strong word of caution; Unless the markers have been tested in the context of clinical and surgical management their true efficacy has not been accurately assessed.

We must always ask two questions before ordering these tests that can cost more than $3,000: 1) Does the use of a molecular test add any additional information that would otherwise change our recommendations; in other words, is the clinical information already known enough for appropriate clinical decision making? 2) What is the basis upon which recommendations for its use have been made; in other words, how were the studies conducted and interpreted? Are they valid?

By way of background, the gene expression clarifier (GEC) Afirma is marketed as a diagnostic tool for the differential diagnosis of indeterminate thyroid cytology (atypical cells of undetermined significance or follicular neoplasm, Bethesda categories III and IV, respectively).

Most importantly, it has been tested and is marketed as a negative predictor only. It is also only useful if used in the appropriate setting and if the test result is negative; a positive Afirma test can tell us only that the nodule is indeterminate, something, by definition, already determined by fine needle aspiration (FNA). Furthermore, any study examining its efficacy must be conducted within the context of clinical scenarios. For example, for a patient with an indeterminate lesion and a symptomatic multinodular goiter, neither a negative nor positive Afirma result would have any impact on surgical decision making and yet would have cost the patient more than $3,000. The latter patient simply needs a thyroidectomy. A patient who has a nodule that is approaching 4 cm or is increasing in size or a patient who has undergone several FNAs, ultrasounds, and endocrinology consultations similarly would likely choose surgery regardless of the GEC test result.

The only scenario in which Afirma testing is useful is in a patient with otherwise no indications for surgery except an indeterminate FNA; for instance for a patient with an asymptomatic < 4cm, stable, single nodule. In this scenario only a negative result could be helpful and would obviate the need for surgical intervention. One also must ask what is the likelihood of the patient undergoing repeat FNA, having repeat indeterminate cytology and repeat Afirma testing over the ensuing years and at what point should we consider these costs prohibitive compared with the patient undergoing a thyroidectomy instead?

Similar concerns exist with regard to somatic mutation panels, the most commonly marketed and used being Asuragen. The mutation panel consists of Ras and BRAF mutation and RET/PTC and PAX8/PPAR-gamma chromosomal rearrangement analyses. Importantly, the expanding literature on molecular markers for thyroid cancer, however, has lost track of a vast body of literature that reports Ras mutations present in up to 30% of benign thyroid nodules; RET/PTC in 24% and PAX8/PPAR-gamma in 14%, dramatically challenging the validity of the panel purported to accurately identify thyroid malignancy. We know that BRAF mutation is exclusively found in papillary thyroid cancer, but generally a BRAF-positive tumor is one in which a cytological diagnosis is already clear; it is either suspicious or definitively malignant on FNA. One might suggest that these aforementioned markers might indicate a harbinger of malignancy or identify a precancerous lesion; however, there is no study that supports this theory. Furthermore, it is important to note that even among pathology experts the diagnoses of follicular adenoma, follicular cancer, and follicular variant of papillary thyroid cancer have significant and documented inter- and intra- observer variability, thus challenging the gold standard upon which these markers have been tested.

With regard to BRAF, Ras, RET/PTC and PAX8/PPAR-gamma as prognostic markers there are many considerations, the least of which includes the differential diagnosis of follicular lesions addressed above and the known presence of these abnormalities in benign tumors. The majority of studies to date have conducted only univariate analyses without consideration of the clinical variables already available to us to make needed clinical decisions. In order to examine the usefulness of any marker panel a multivariable study is required, incorporating the available clinical variables such as size, lymph node metastases, and extra-thyroidal extension. For instance, the majority of studies examining the presence of lymph node metastases in BRAF-negative vs. BRAF-positive tumors were almost uniformly conducted on patients in whom routine lymph node dissection was not performed, thereby skewing the results. Only patients with suspicious nodes underwent a lymph node dissection; thus for those patients who had no suspicious nodes there was no information about their nodal status. Furthermore, several studies that included patients who underwent routine lymph node dissections and, importantly, included patients who underwent prophylactic dissections for whom a marker would be most useful, did not find that BRAF mutation was associated with aggressive features, including the presence of lymph node metastases. The same can be stated for a panel that includes Ras, RET/PTC, & PAX8/PPAR-gamma. “Follicular variant of papillary thyroid cancer and follicular cancer” will more likely harbor Ras and PAX8/PPAR-gamma mutations and will, by definition, include some tumors that would be considered benign by other pathologists.

There is an emerging market for molecular markers for thyroid cancer diagnosis and prognosis, but many of the studies driving this market are lacking in scientific rigor with regard to design and interpretation of results. Furthermore, the use of the marker panel requires scrutiny of its true impact on clinical management as well as its cost-effectiveness. GEC provides a negative predictor of malignancy and should be used to obviate surgery only; if the patient requires surgery its use provides no added information. BRAF is specific for thyroid cancer diagnosis, but is often not required as FNA evaluation in BRAF-positive tumors is usually already suspicious or malignant. Finally, molecular marker panels for thyroid cancer prognosis may be promising, but scrutiny for true accuracy and true clinical impact is necessary in order to make logical and useful recommendations for our patients.

Dr. Zeiger is professor of surgery, oncology, cellular, and molecular medicine, associate vice chair for faculty development, and associate dean for postdoctoral affairs at Johns Hopkins University in Baltimore. Dr. Zeiger consults for Interpace Diagnostics.

An emerging market of molecular markers for thyroid cancer diagnostic and prognostic evaluation challenges current medical and surgical management; however, here is a strong word of caution; Unless the markers have been tested in the context of clinical and surgical management their true efficacy has not been accurately assessed.

We must always ask two questions before ordering these tests that can cost more than $3,000: 1) Does the use of a molecular test add any additional information that would otherwise change our recommendations; in other words, is the clinical information already known enough for appropriate clinical decision making? 2) What is the basis upon which recommendations for its use have been made; in other words, how were the studies conducted and interpreted? Are they valid?

By way of background, the gene expression clarifier (GEC) Afirma is marketed as a diagnostic tool for the differential diagnosis of indeterminate thyroid cytology (atypical cells of undetermined significance or follicular neoplasm, Bethesda categories III and IV, respectively).

Most importantly, it has been tested and is marketed as a negative predictor only. It is also only useful if used in the appropriate setting and if the test result is negative; a positive Afirma test can tell us only that the nodule is indeterminate, something, by definition, already determined by fine needle aspiration (FNA). Furthermore, any study examining its efficacy must be conducted within the context of clinical scenarios. For example, for a patient with an indeterminate lesion and a symptomatic multinodular goiter, neither a negative nor positive Afirma result would have any impact on surgical decision making and yet would have cost the patient more than $3,000. The latter patient simply needs a thyroidectomy. A patient who has a nodule that is approaching 4 cm or is increasing in size or a patient who has undergone several FNAs, ultrasounds, and endocrinology consultations similarly would likely choose surgery regardless of the GEC test result.

The only scenario in which Afirma testing is useful is in a patient with otherwise no indications for surgery except an indeterminate FNA; for instance for a patient with an asymptomatic < 4cm, stable, single nodule. In this scenario only a negative result could be helpful and would obviate the need for surgical intervention. One also must ask what is the likelihood of the patient undergoing repeat FNA, having repeat indeterminate cytology and repeat Afirma testing over the ensuing years and at what point should we consider these costs prohibitive compared with the patient undergoing a thyroidectomy instead?

Similar concerns exist with regard to somatic mutation panels, the most commonly marketed and used being Asuragen. The mutation panel consists of Ras and BRAF mutation and RET/PTC and PAX8/PPAR-gamma chromosomal rearrangement analyses. Importantly, the expanding literature on molecular markers for thyroid cancer, however, has lost track of a vast body of literature that reports Ras mutations present in up to 30% of benign thyroid nodules; RET/PTC in 24% and PAX8/PPAR-gamma in 14%, dramatically challenging the validity of the panel purported to accurately identify thyroid malignancy. We know that BRAF mutation is exclusively found in papillary thyroid cancer, but generally a BRAF-positive tumor is one in which a cytological diagnosis is already clear; it is either suspicious or definitively malignant on FNA. One might suggest that these aforementioned markers might indicate a harbinger of malignancy or identify a precancerous lesion; however, there is no study that supports this theory. Furthermore, it is important to note that even among pathology experts the diagnoses of follicular adenoma, follicular cancer, and follicular variant of papillary thyroid cancer have significant and documented inter- and intra- observer variability, thus challenging the gold standard upon which these markers have been tested.

With regard to BRAF, Ras, RET/PTC and PAX8/PPAR-gamma as prognostic markers there are many considerations, the least of which includes the differential diagnosis of follicular lesions addressed above and the known presence of these abnormalities in benign tumors. The majority of studies to date have conducted only univariate analyses without consideration of the clinical variables already available to us to make needed clinical decisions. In order to examine the usefulness of any marker panel a multivariable study is required, incorporating the available clinical variables such as size, lymph node metastases, and extra-thyroidal extension. For instance, the majority of studies examining the presence of lymph node metastases in BRAF-negative vs. BRAF-positive tumors were almost uniformly conducted on patients in whom routine lymph node dissection was not performed, thereby skewing the results. Only patients with suspicious nodes underwent a lymph node dissection; thus for those patients who had no suspicious nodes there was no information about their nodal status. Furthermore, several studies that included patients who underwent routine lymph node dissections and, importantly, included patients who underwent prophylactic dissections for whom a marker would be most useful, did not find that BRAF mutation was associated with aggressive features, including the presence of lymph node metastases. The same can be stated for a panel that includes Ras, RET/PTC, & PAX8/PPAR-gamma. “Follicular variant of papillary thyroid cancer and follicular cancer” will more likely harbor Ras and PAX8/PPAR-gamma mutations and will, by definition, include some tumors that would be considered benign by other pathologists.

There is an emerging market for molecular markers for thyroid cancer diagnosis and prognosis, but many of the studies driving this market are lacking in scientific rigor with regard to design and interpretation of results. Furthermore, the use of the marker panel requires scrutiny of its true impact on clinical management as well as its cost-effectiveness. GEC provides a negative predictor of malignancy and should be used to obviate surgery only; if the patient requires surgery its use provides no added information. BRAF is specific for thyroid cancer diagnosis, but is often not required as FNA evaluation in BRAF-positive tumors is usually already suspicious or malignant. Finally, molecular marker panels for thyroid cancer prognosis may be promising, but scrutiny for true accuracy and true clinical impact is necessary in order to make logical and useful recommendations for our patients.

Dr. Zeiger is professor of surgery, oncology, cellular, and molecular medicine, associate vice chair for faculty development, and associate dean for postdoctoral affairs at Johns Hopkins University in Baltimore. Dr. Zeiger consults for Interpace Diagnostics.

An emerging market of molecular markers for thyroid cancer diagnostic and prognostic evaluation challenges current medical and surgical management; however, here is a strong word of caution; Unless the markers have been tested in the context of clinical and surgical management their true efficacy has not been accurately assessed.

We must always ask two questions before ordering these tests that can cost more than $3,000: 1) Does the use of a molecular test add any additional information that would otherwise change our recommendations; in other words, is the clinical information already known enough for appropriate clinical decision making? 2) What is the basis upon which recommendations for its use have been made; in other words, how were the studies conducted and interpreted? Are they valid?

By way of background, the gene expression clarifier (GEC) Afirma is marketed as a diagnostic tool for the differential diagnosis of indeterminate thyroid cytology (atypical cells of undetermined significance or follicular neoplasm, Bethesda categories III and IV, respectively).

Most importantly, it has been tested and is marketed as a negative predictor only. It is also only useful if used in the appropriate setting and if the test result is negative; a positive Afirma test can tell us only that the nodule is indeterminate, something, by definition, already determined by fine needle aspiration (FNA). Furthermore, any study examining its efficacy must be conducted within the context of clinical scenarios. For example, for a patient with an indeterminate lesion and a symptomatic multinodular goiter, neither a negative nor positive Afirma result would have any impact on surgical decision making and yet would have cost the patient more than $3,000. The latter patient simply needs a thyroidectomy. A patient who has a nodule that is approaching 4 cm or is increasing in size or a patient who has undergone several FNAs, ultrasounds, and endocrinology consultations similarly would likely choose surgery regardless of the GEC test result.

The only scenario in which Afirma testing is useful is in a patient with otherwise no indications for surgery except an indeterminate FNA; for instance for a patient with an asymptomatic < 4cm, stable, single nodule. In this scenario only a negative result could be helpful and would obviate the need for surgical intervention. One also must ask what is the likelihood of the patient undergoing repeat FNA, having repeat indeterminate cytology and repeat Afirma testing over the ensuing years and at what point should we consider these costs prohibitive compared with the patient undergoing a thyroidectomy instead?

Similar concerns exist with regard to somatic mutation panels, the most commonly marketed and used being Asuragen. The mutation panel consists of Ras and BRAF mutation and RET/PTC and PAX8/PPAR-gamma chromosomal rearrangement analyses. Importantly, the expanding literature on molecular markers for thyroid cancer, however, has lost track of a vast body of literature that reports Ras mutations present in up to 30% of benign thyroid nodules; RET/PTC in 24% and PAX8/PPAR-gamma in 14%, dramatically challenging the validity of the panel purported to accurately identify thyroid malignancy. We know that BRAF mutation is exclusively found in papillary thyroid cancer, but generally a BRAF-positive tumor is one in which a cytological diagnosis is already clear; it is either suspicious or definitively malignant on FNA. One might suggest that these aforementioned markers might indicate a harbinger of malignancy or identify a precancerous lesion; however, there is no study that supports this theory. Furthermore, it is important to note that even among pathology experts the diagnoses of follicular adenoma, follicular cancer, and follicular variant of papillary thyroid cancer have significant and documented inter- and intra- observer variability, thus challenging the gold standard upon which these markers have been tested.

With regard to BRAF, Ras, RET/PTC and PAX8/PPAR-gamma as prognostic markers there are many considerations, the least of which includes the differential diagnosis of follicular lesions addressed above and the known presence of these abnormalities in benign tumors. The majority of studies to date have conducted only univariate analyses without consideration of the clinical variables already available to us to make needed clinical decisions. In order to examine the usefulness of any marker panel a multivariable study is required, incorporating the available clinical variables such as size, lymph node metastases, and extra-thyroidal extension. For instance, the majority of studies examining the presence of lymph node metastases in BRAF-negative vs. BRAF-positive tumors were almost uniformly conducted on patients in whom routine lymph node dissection was not performed, thereby skewing the results. Only patients with suspicious nodes underwent a lymph node dissection; thus for those patients who had no suspicious nodes there was no information about their nodal status. Furthermore, several studies that included patients who underwent routine lymph node dissections and, importantly, included patients who underwent prophylactic dissections for whom a marker would be most useful, did not find that BRAF mutation was associated with aggressive features, including the presence of lymph node metastases. The same can be stated for a panel that includes Ras, RET/PTC, & PAX8/PPAR-gamma. “Follicular variant of papillary thyroid cancer and follicular cancer” will more likely harbor Ras and PAX8/PPAR-gamma mutations and will, by definition, include some tumors that would be considered benign by other pathologists.

There is an emerging market for molecular markers for thyroid cancer diagnosis and prognosis, but many of the studies driving this market are lacking in scientific rigor with regard to design and interpretation of results. Furthermore, the use of the marker panel requires scrutiny of its true impact on clinical management as well as its cost-effectiveness. GEC provides a negative predictor of malignancy and should be used to obviate surgery only; if the patient requires surgery its use provides no added information. BRAF is specific for thyroid cancer diagnosis, but is often not required as FNA evaluation in BRAF-positive tumors is usually already suspicious or malignant. Finally, molecular marker panels for thyroid cancer prognosis may be promising, but scrutiny for true accuracy and true clinical impact is necessary in order to make logical and useful recommendations for our patients.

Dr. Zeiger is professor of surgery, oncology, cellular, and molecular medicine, associate vice chair for faculty development, and associate dean for postdoctoral affairs at Johns Hopkins University in Baltimore. Dr. Zeiger consults for Interpace Diagnostics.

In continuing with the series, An Update in Acute Care Surgery, the following section highlights the evolution of the training process for the Acute Care Surgery fellowship.

Grace S. Rozycki, MD, FACS

The Willis D. Gatch Professor of Surgery

Associate Chair, Department of Surgery, Indiana University

Chief of Surgery, IUH-Methodist Hospital, Indianapolis

Acute Care Surgery: The Training Paradigm

BY CLAY COTHREN BURLEW, MD, FACS, AND GREGORY J. JURKOVICH, MD., FACS

The acute care surgery fellowships are designed to follow core training in general surgery (J. Trauma 2007;62:553-6). Currently, this means the acute care surgery fellowship follows the completion of an Accreditation Council for Graduate Medical Education general surgery residency program and is in alignment with the core competencies of the general surgery residency. The 2-year curriculum was defined by the AAST, and incorporates the requirements of an ACGME-approved surgical critical care fellowship.

Although there are mandatory components of this fellowship, a certain amount of latitude and creativity are encouraged so to capitalize on the strength of the individual program as well as to meet the individual needs of the fellow.

The basic principles of the training paradigm include the followi

1. The program is 2 years in length.

2. The acute care surgery fellowship programs must have the ACGME approved surgical critical care residency.

3.The fellowship must include specific surgical technical training in hepatobiliary disorders, thoracic surgery, and vascular surgery.

4. Trainees should participate in acute care surgery call for at least 12 months and 52 nights of acute care surgery call (trauma and emergency general surgery).

5. Flexibility in the rotations should be used to optimize the fellow’s training.

6. The rationale for out-of-system rotations and the structure of the 24-month training should be used to optimize the fellow’s training.

7. Participation in elective surgery, both to supplement general surgery training and experience and to serve in a supervisory role to residents, is an essential component of this fellowship training.

8. An academic environment is necessary and the fellows should be trained to teach others and conduct research in acute care surgery.

The rationale for the rotations of Thoracic Surgery, Transplant/Hepatobiliary/ Pancreatic, and Vascular (including vascular interventional) is twofold: 1) Many complex operative cases in these areas are infrequently encountered in modern trauma centers; and, 2) experts in these areas can provide mentorship and operative expertise and teaching for the fellow who obtains a focused, quality operative experience in these areas. Further, these rotations have specific competency related goals so that the fellow has specific requirements to meet. The AAST is currently revising its method of confirming this training expertise by examining specific components of operative technique and exposure as well as length of time on specific rotations (see below).

Program Application and Approval

The required background and expectations for the acute care surgery fellowship include the following: 1) Fellows must have successfully completed the core training requirements of an RRC-approved residency in General Surgery; and 2) the acute care surgery fellowship programs must provide the necessary education to qualify the fellow as an acute care surgical specialist in clinical, education, and research areas. Each program must have support from its parent institution, including administrative personnel, the chairman of the department of surgery, division chief, and participating acute care surgery faculty. The program should have all of the necessary resources to fulfill the training requirements and create an environment of inquiry and scholarship while allowing for progressive responsibility throughout the training period.

The process of becoming an approved acute care surgery fellowship program can be divided into the following steps:

1. The Program Director completes the Program Information Form (PIF) form (downloaded from the AAST website, http://www.aast.org).

2. The PIF is reviewed by three members of the AAST Acute Care Surgery Committee to determine whether it is complete and if it meets the essential requirements. If the initial review is successful, then a site visit of the program is scheduled.

3. The site visit is conducted by two members of AAST Acute Care Surgery Committee. The site visit consists of an evening business dinner meeting with the following personnel: the program director for the acute care surgery fellowship, the program director for the general surgery residency program, select administrators, and division chiefs. Current fellows in the program are also invited to participate. The following day, the site visitors tour the institution, and conduct one-on-one interviews with the personnel who were present at the site visit dinner. A chart review is conducted to assess the operative case load and the involvement of the faculty, residents, and fellows in the care of the patients. At the conclusion of the day, a summation interview is conducted with the acute care surgery fellowship program director.

4. Following the site visit, a written assessment of the program is performed, which covers an overview/program description, strengths/weaknesses, major deficiencies, and a summary with recommendations.

5. If no major deficiencies are noted, the senior site visitor presents the highlights of the program to the members of the AAST Acute Care Surgery Committee and, if approved subsequently to the AAST Board of Managers for final approval.

Acute Care Surgery Committee and Curriculum

BY CLAY COTHREN BURLEW, MD

With the development of a fellowship-based training paradigm in acute care surgery, the AAST also developed an oversight committee. This committee, aptly named the Acute Care Surgery Committee, is comprised of 25 appointed AAST members. The committee represents a varied group of stakeholders including members of the senior leadership of the AAST and fellowship program directors. The Acute Care Surgery Committee’s role has evolved over the past decade. Initially the members of the Committee formulated and implemented the training paradigm for the fellowship, including the requirements enumerated above. Following the certification of several successful training fellowships in 2008-2009, the Committee encouraged additional institutions to initiate training fellows by assisting with educational development. This led to the expansion of acute care surgery training in 19 accredited programs. (see Table).

Throughout this decade of growth, the Acute Care Surgery committee has also been dedicated to the oversight and continual evaluation of the training process. Two specific measures were implemented in this regard.

First, each fellowship graduate must take not only the American Board of Surgery examination for certification in Surgical Critical Care, but also the examination in acute care surgery written by the AAST. The Acute Care Surgery Committee formed a subcommittee that has spent innumerable hours researching and writing test questions for this examination. That subcommittee is now reviewing each of the questions from the originally produced examination and reformatting the test. New questions are being created by the subcommittee, and the examination will become electronically administered.

Second, acute care surgery fellows must track their operative experience through the AAST-supported on-line case log system. Although fellows have been provided with a list of essential and desired operative cases, the case log system permits specific delineation of each fellow’s experience. Using the case log system, the Acute Care Surgery Committee was able to analyze the fellows’ experience, identify gaps in operative training, and refine the curriculum as indicated. The Committee has performed two such analyses and, based on the findings of those reports, modification of the curriculum is now underway. (J. Trauma Acute Care Surg. 2014;76:329-39.; J. Trauma Acute Care Surg. 2015;78:259-64).

One of the current initiatives of the Acute Care Surgery Committee is the revision of the acute care surgery fellowship curriculum. In revising the curriculum, several key points were considered. One observation, derived from the case log review, was that the original case list captured only a portion of the operative experience of acute care surgery fellows. Additionally, it was apparent that operative trauma cases alone do not provide adequate exposure to some of the more complex cases thought to be essential components of this specialty. Therefore, the Committee determined that incorporating specific surgical approaches or anatomic exposures performed during elective and urgent cases are valuable experiences for the fellow. The totality of training in advanced operative techniques over the breadth of anatomic locations remains the unique feature of our specialty.(J. Trauma Acute Care Surg. 2015; 78:192-196).

Based upon these observations, the new curriculum is now organized by anatomic subsections (Head/Neck, Thoracic, Abdominal, Vascular), as well as organ-based management. Each section of the curriculum now lists specific case numbers required for surgical approaches or exposures, and also addresses organ-based management. For example, within the thoracic section of the curriculum, required case numbers now exist for thoracotomy, thoracoscopy, sternotomy, and pericardotomy (exposures) as well as lung, diaphragm, heart, esophagus, and intrathoracic great vessels. In each anatomic subsection, simulation may be used to satisfy a requirement.

Opportunities to accomplish these requirements may be through the American College of Surgeons Advanced Trauma Operative Management or the Advanced Surgical Skills for Exposure in Trauma courses. Organ harvest exposures may also be used for less common surgical exposures. Fellows can choose both the exposure and the organ-based procedure code for each operative case performed when logging their cases.(J. Trauma Acute Care Surg. 2014;76:329-39). Identification of a minimum number of operative cases needed in specific body regions reflects the defined case volumes in general surgery as required by the Accreditation Council for Graduate Medical Education.

The Acute Care Surgery Committee considered that the implementation of the required case volumes would serve two purposes: First, the list would provide guidance to the fellows as to the types of cases they should actively identify and in which they should participate; and, second, it would provide guidance to program directors and subspecialty colleagues as to the cases deemed important for fellowship training. Ongoing review of the fellows’ case logs with implementation of the new curriculum will remain a focus of the Acute Care Surgery Committee as it transitions to a new case log system soon.

An earlier version of the graphic misstated the name of Clay Cothren Burlew.

In continuing with the series, An Update in Acute Care Surgery, the following section highlights the evolution of the training process for the Acute Care Surgery fellowship.

Grace S. Rozycki, MD, FACS

The Willis D. Gatch Professor of Surgery

Associate Chair, Department of Surgery, Indiana University

Chief of Surgery, IUH-Methodist Hospital, Indianapolis

Acute Care Surgery: The Training Paradigm

BY CLAY COTHREN BURLEW, MD, FACS, AND GREGORY J. JURKOVICH, MD., FACS

The acute care surgery fellowships are designed to follow core training in general surgery (J. Trauma 2007;62:553-6). Currently, this means the acute care surgery fellowship follows the completion of an Accreditation Council for Graduate Medical Education general surgery residency program and is in alignment with the core competencies of the general surgery residency. The 2-year curriculum was defined by the AAST, and incorporates the requirements of an ACGME-approved surgical critical care fellowship.

Although there are mandatory components of this fellowship, a certain amount of latitude and creativity are encouraged so to capitalize on the strength of the individual program as well as to meet the individual needs of the fellow.

The basic principles of the training paradigm include the followi

1. The program is 2 years in length.

2. The acute care surgery fellowship programs must have the ACGME approved surgical critical care residency.

3.The fellowship must include specific surgical technical training in hepatobiliary disorders, thoracic surgery, and vascular surgery.

4. Trainees should participate in acute care surgery call for at least 12 months and 52 nights of acute care surgery call (trauma and emergency general surgery).

5. Flexibility in the rotations should be used to optimize the fellow’s training.

6. The rationale for out-of-system rotations and the structure of the 24-month training should be used to optimize the fellow’s training.

7. Participation in elective surgery, both to supplement general surgery training and experience and to serve in a supervisory role to residents, is an essential component of this fellowship training.

8. An academic environment is necessary and the fellows should be trained to teach others and conduct research in acute care surgery.

The rationale for the rotations of Thoracic Surgery, Transplant/Hepatobiliary/ Pancreatic, and Vascular (including vascular interventional) is twofold: 1) Many complex operative cases in these areas are infrequently encountered in modern trauma centers; and, 2) experts in these areas can provide mentorship and operative expertise and teaching for the fellow who obtains a focused, quality operative experience in these areas. Further, these rotations have specific competency related goals so that the fellow has specific requirements to meet. The AAST is currently revising its method of confirming this training expertise by examining specific components of operative technique and exposure as well as length of time on specific rotations (see below).

Program Application and Approval

The required background and expectations for the acute care surgery fellowship include the following: 1) Fellows must have successfully completed the core training requirements of an RRC-approved residency in General Surgery; and 2) the acute care surgery fellowship programs must provide the necessary education to qualify the fellow as an acute care surgical specialist in clinical, education, and research areas. Each program must have support from its parent institution, including administrative personnel, the chairman of the department of surgery, division chief, and participating acute care surgery faculty. The program should have all of the necessary resources to fulfill the training requirements and create an environment of inquiry and scholarship while allowing for progressive responsibility throughout the training period.

The process of becoming an approved acute care surgery fellowship program can be divided into the following steps:

1. The Program Director completes the Program Information Form (PIF) form (downloaded from the AAST website, http://www.aast.org).

2. The PIF is reviewed by three members of the AAST Acute Care Surgery Committee to determine whether it is complete and if it meets the essential requirements. If the initial review is successful, then a site visit of the program is scheduled.

3. The site visit is conducted by two members of AAST Acute Care Surgery Committee. The site visit consists of an evening business dinner meeting with the following personnel: the program director for the acute care surgery fellowship, the program director for the general surgery residency program, select administrators, and division chiefs. Current fellows in the program are also invited to participate. The following day, the site visitors tour the institution, and conduct one-on-one interviews with the personnel who were present at the site visit dinner. A chart review is conducted to assess the operative case load and the involvement of the faculty, residents, and fellows in the care of the patients. At the conclusion of the day, a summation interview is conducted with the acute care surgery fellowship program director.

4. Following the site visit, a written assessment of the program is performed, which covers an overview/program description, strengths/weaknesses, major deficiencies, and a summary with recommendations.

5. If no major deficiencies are noted, the senior site visitor presents the highlights of the program to the members of the AAST Acute Care Surgery Committee and, if approved subsequently to the AAST Board of Managers for final approval.

Acute Care Surgery Committee and Curriculum

BY CLAY COTHREN BURLEW, MD

With the development of a fellowship-based training paradigm in acute care surgery, the AAST also developed an oversight committee. This committee, aptly named the Acute Care Surgery Committee, is comprised of 25 appointed AAST members. The committee represents a varied group of stakeholders including members of the senior leadership of the AAST and fellowship program directors. The Acute Care Surgery Committee’s role has evolved over the past decade. Initially the members of the Committee formulated and implemented the training paradigm for the fellowship, including the requirements enumerated above. Following the certification of several successful training fellowships in 2008-2009, the Committee encouraged additional institutions to initiate training fellows by assisting with educational development. This led to the expansion of acute care surgery training in 19 accredited programs. (see Table).

Throughout this decade of growth, the Acute Care Surgery committee has also been dedicated to the oversight and continual evaluation of the training process. Two specific measures were implemented in this regard.

First, each fellowship graduate must take not only the American Board of Surgery examination for certification in Surgical Critical Care, but also the examination in acute care surgery written by the AAST. The Acute Care Surgery Committee formed a subcommittee that has spent innumerable hours researching and writing test questions for this examination. That subcommittee is now reviewing each of the questions from the originally produced examination and reformatting the test. New questions are being created by the subcommittee, and the examination will become electronically administered.

Second, acute care surgery fellows must track their operative experience through the AAST-supported on-line case log system. Although fellows have been provided with a list of essential and desired operative cases, the case log system permits specific delineation of each fellow’s experience. Using the case log system, the Acute Care Surgery Committee was able to analyze the fellows’ experience, identify gaps in operative training, and refine the curriculum as indicated. The Committee has performed two such analyses and, based on the findings of those reports, modification of the curriculum is now underway. (J. Trauma Acute Care Surg. 2014;76:329-39.; J. Trauma Acute Care Surg. 2015;78:259-64).

One of the current initiatives of the Acute Care Surgery Committee is the revision of the acute care surgery fellowship curriculum. In revising the curriculum, several key points were considered. One observation, derived from the case log review, was that the original case list captured only a portion of the operative experience of acute care surgery fellows. Additionally, it was apparent that operative trauma cases alone do not provide adequate exposure to some of the more complex cases thought to be essential components of this specialty. Therefore, the Committee determined that incorporating specific surgical approaches or anatomic exposures performed during elective and urgent cases are valuable experiences for the fellow. The totality of training in advanced operative techniques over the breadth of anatomic locations remains the unique feature of our specialty.(J. Trauma Acute Care Surg. 2015; 78:192-196).

Based upon these observations, the new curriculum is now organized by anatomic subsections (Head/Neck, Thoracic, Abdominal, Vascular), as well as organ-based management. Each section of the curriculum now lists specific case numbers required for surgical approaches or exposures, and also addresses organ-based management. For example, within the thoracic section of the curriculum, required case numbers now exist for thoracotomy, thoracoscopy, sternotomy, and pericardotomy (exposures) as well as lung, diaphragm, heart, esophagus, and intrathoracic great vessels. In each anatomic subsection, simulation may be used to satisfy a requirement.

Opportunities to accomplish these requirements may be through the American College of Surgeons Advanced Trauma Operative Management or the Advanced Surgical Skills for Exposure in Trauma courses. Organ harvest exposures may also be used for less common surgical exposures. Fellows can choose both the exposure and the organ-based procedure code for each operative case performed when logging their cases.(J. Trauma Acute Care Surg. 2014;76:329-39). Identification of a minimum number of operative cases needed in specific body regions reflects the defined case volumes in general surgery as required by the Accreditation Council for Graduate Medical Education.

The Acute Care Surgery Committee considered that the implementation of the required case volumes would serve two purposes: First, the list would provide guidance to the fellows as to the types of cases they should actively identify and in which they should participate; and, second, it would provide guidance to program directors and subspecialty colleagues as to the cases deemed important for fellowship training. Ongoing review of the fellows’ case logs with implementation of the new curriculum will remain a focus of the Acute Care Surgery Committee as it transitions to a new case log system soon.

An earlier version of the graphic misstated the name of Clay Cothren Burlew.

In continuing with the series, An Update in Acute Care Surgery, the following section highlights the evolution of the training process for the Acute Care Surgery fellowship.

Grace S. Rozycki, MD, FACS

The Willis D. Gatch Professor of Surgery

Associate Chair, Department of Surgery, Indiana University

Chief of Surgery, IUH-Methodist Hospital, Indianapolis

Acute Care Surgery: The Training Paradigm

BY CLAY COTHREN BURLEW, MD, FACS, AND GREGORY J. JURKOVICH, MD., FACS

The acute care surgery fellowships are designed to follow core training in general surgery (J. Trauma 2007;62:553-6). Currently, this means the acute care surgery fellowship follows the completion of an Accreditation Council for Graduate Medical Education general surgery residency program and is in alignment with the core competencies of the general surgery residency. The 2-year curriculum was defined by the AAST, and incorporates the requirements of an ACGME-approved surgical critical care fellowship.

Although there are mandatory components of this fellowship, a certain amount of latitude and creativity are encouraged so to capitalize on the strength of the individual program as well as to meet the individual needs of the fellow.

The basic principles of the training paradigm include the followi

1. The program is 2 years in length.

2. The acute care surgery fellowship programs must have the ACGME approved surgical critical care residency.

3.The fellowship must include specific surgical technical training in hepatobiliary disorders, thoracic surgery, and vascular surgery.

4. Trainees should participate in acute care surgery call for at least 12 months and 52 nights of acute care surgery call (trauma and emergency general surgery).

5. Flexibility in the rotations should be used to optimize the fellow’s training.

6. The rationale for out-of-system rotations and the structure of the 24-month training should be used to optimize the fellow’s training.

7. Participation in elective surgery, both to supplement general surgery training and experience and to serve in a supervisory role to residents, is an essential component of this fellowship training.

8. An academic environment is necessary and the fellows should be trained to teach others and conduct research in acute care surgery.

The rationale for the rotations of Thoracic Surgery, Transplant/Hepatobiliary/ Pancreatic, and Vascular (including vascular interventional) is twofold: 1) Many complex operative cases in these areas are infrequently encountered in modern trauma centers; and, 2) experts in these areas can provide mentorship and operative expertise and teaching for the fellow who obtains a focused, quality operative experience in these areas. Further, these rotations have specific competency related goals so that the fellow has specific requirements to meet. The AAST is currently revising its method of confirming this training expertise by examining specific components of operative technique and exposure as well as length of time on specific rotations (see below).

Program Application and Approval

The required background and expectations for the acute care surgery fellowship include the following: 1) Fellows must have successfully completed the core training requirements of an RRC-approved residency in General Surgery; and 2) the acute care surgery fellowship programs must provide the necessary education to qualify the fellow as an acute care surgical specialist in clinical, education, and research areas. Each program must have support from its parent institution, including administrative personnel, the chairman of the department of surgery, division chief, and participating acute care surgery faculty. The program should have all of the necessary resources to fulfill the training requirements and create an environment of inquiry and scholarship while allowing for progressive responsibility throughout the training period.

The process of becoming an approved acute care surgery fellowship program can be divided into the following steps:

1. The Program Director completes the Program Information Form (PIF) form (downloaded from the AAST website, http://www.aast.org).

2. The PIF is reviewed by three members of the AAST Acute Care Surgery Committee to determine whether it is complete and if it meets the essential requirements. If the initial review is successful, then a site visit of the program is scheduled.

3. The site visit is conducted by two members of AAST Acute Care Surgery Committee. The site visit consists of an evening business dinner meeting with the following personnel: the program director for the acute care surgery fellowship, the program director for the general surgery residency program, select administrators, and division chiefs. Current fellows in the program are also invited to participate. The following day, the site visitors tour the institution, and conduct one-on-one interviews with the personnel who were present at the site visit dinner. A chart review is conducted to assess the operative case load and the involvement of the faculty, residents, and fellows in the care of the patients. At the conclusion of the day, a summation interview is conducted with the acute care surgery fellowship program director.

4. Following the site visit, a written assessment of the program is performed, which covers an overview/program description, strengths/weaknesses, major deficiencies, and a summary with recommendations.

5. If no major deficiencies are noted, the senior site visitor presents the highlights of the program to the members of the AAST Acute Care Surgery Committee and, if approved subsequently to the AAST Board of Managers for final approval.

Acute Care Surgery Committee and Curriculum

BY CLAY COTHREN BURLEW, MD

With the development of a fellowship-based training paradigm in acute care surgery, the AAST also developed an oversight committee. This committee, aptly named the Acute Care Surgery Committee, is comprised of 25 appointed AAST members. The committee represents a varied group of stakeholders including members of the senior leadership of the AAST and fellowship program directors. The Acute Care Surgery Committee’s role has evolved over the past decade. Initially the members of the Committee formulated and implemented the training paradigm for the fellowship, including the requirements enumerated above. Following the certification of several successful training fellowships in 2008-2009, the Committee encouraged additional institutions to initiate training fellows by assisting with educational development. This led to the expansion of acute care surgery training in 19 accredited programs. (see Table).

Throughout this decade of growth, the Acute Care Surgery committee has also been dedicated to the oversight and continual evaluation of the training process. Two specific measures were implemented in this regard.

First, each fellowship graduate must take not only the American Board of Surgery examination for certification in Surgical Critical Care, but also the examination in acute care surgery written by the AAST. The Acute Care Surgery Committee formed a subcommittee that has spent innumerable hours researching and writing test questions for this examination. That subcommittee is now reviewing each of the questions from the originally produced examination and reformatting the test. New questions are being created by the subcommittee, and the examination will become electronically administered.

Second, acute care surgery fellows must track their operative experience through the AAST-supported on-line case log system. Although fellows have been provided with a list of essential and desired operative cases, the case log system permits specific delineation of each fellow’s experience. Using the case log system, the Acute Care Surgery Committee was able to analyze the fellows’ experience, identify gaps in operative training, and refine the curriculum as indicated. The Committee has performed two such analyses and, based on the findings of those reports, modification of the curriculum is now underway. (J. Trauma Acute Care Surg. 2014;76:329-39.; J. Trauma Acute Care Surg. 2015;78:259-64).

One of the current initiatives of the Acute Care Surgery Committee is the revision of the acute care surgery fellowship curriculum. In revising the curriculum, several key points were considered. One observation, derived from the case log review, was that the original case list captured only a portion of the operative experience of acute care surgery fellows. Additionally, it was apparent that operative trauma cases alone do not provide adequate exposure to some of the more complex cases thought to be essential components of this specialty. Therefore, the Committee determined that incorporating specific surgical approaches or anatomic exposures performed during elective and urgent cases are valuable experiences for the fellow. The totality of training in advanced operative techniques over the breadth of anatomic locations remains the unique feature of our specialty.(J. Trauma Acute Care Surg. 2015; 78:192-196).

Based upon these observations, the new curriculum is now organized by anatomic subsections (Head/Neck, Thoracic, Abdominal, Vascular), as well as organ-based management. Each section of the curriculum now lists specific case numbers required for surgical approaches or exposures, and also addresses organ-based management. For example, within the thoracic section of the curriculum, required case numbers now exist for thoracotomy, thoracoscopy, sternotomy, and pericardotomy (exposures) as well as lung, diaphragm, heart, esophagus, and intrathoracic great vessels. In each anatomic subsection, simulation may be used to satisfy a requirement.

Opportunities to accomplish these requirements may be through the American College of Surgeons Advanced Trauma Operative Management or the Advanced Surgical Skills for Exposure in Trauma courses. Organ harvest exposures may also be used for less common surgical exposures. Fellows can choose both the exposure and the organ-based procedure code for each operative case performed when logging their cases.(J. Trauma Acute Care Surg. 2014;76:329-39). Identification of a minimum number of operative cases needed in specific body regions reflects the defined case volumes in general surgery as required by the Accreditation Council for Graduate Medical Education.

The Acute Care Surgery Committee considered that the implementation of the required case volumes would serve two purposes: First, the list would provide guidance to the fellows as to the types of cases they should actively identify and in which they should participate; and, second, it would provide guidance to program directors and subspecialty colleagues as to the cases deemed important for fellowship training. Ongoing review of the fellows’ case logs with implementation of the new curriculum will remain a focus of the Acute Care Surgery Committee as it transitions to a new case log system soon.

An earlier version of the graphic misstated the name of Clay Cothren Burlew.

Dear Dr. Danielsen,

Thank you for addressing this latest controversy in PA/NP issues in the June 2015 Clinician Reviews. I appreciate your candor and your objectiveness in presenting this "hot topic."  

I am a currently retired Certified Family Nurse Practitioner after more than 20 years in practice; I graduated from my RN program 40 years ago this month! During my career, I was a clinical instructor in an RN program, as well as a hospital nurse for most of my first two decades of nursing.

After obtaining my MSN/NP education, I preceptored NP students in a master’s prepared program for 20 years. The difference in students who were enrolled in the accelerated programs and those who were in traditional RN to BSN to MSN/NP programs were astonishing to me. They had little to no experience in how to relate to patients or how to take a history, and they certainly were not comfortable with patients.

Another concern is the growing number of "for profit" private schools now offering NP/PA programs, where enrollment seems to be at the price of well-qualified students. Those who cannot meet the requirements of a traditional university setting are now flooding these programs. Just look at the pass rates on exams and the attrition rates along with the high cost they charge.  

I am concerned about the move toward e-learning programs. Anybody can memorize pathophysiology, statistics, and biochemistry, but not everyone can learn how to interact with patients and develop critical-thinking and problem-solving skills without direct supervision and experience.  

Adequate clinical experience is imperative, and I suggest an internship for NPs and PAs fresh out of school. If we are going to advance our respect in the medical world with our physician colleagues, and continue to provide excellent care in this new era of medicine, then we need to make sure we do not jeopardize the hard work we have all done to bring the current high standards to PA and NP programs. 

Janet Evans Emery, RN, MSN, CFNP
Irvine, California 

Dear Dr. Danielsen,

Thank you for addressing this latest controversy in PA/NP issues in the June 2015 Clinician Reviews. I appreciate your candor and your objectiveness in presenting this "hot topic."  

I am a currently retired Certified Family Nurse Practitioner after more than 20 years in practice; I graduated from my RN program 40 years ago this month! During my career, I was a clinical instructor in an RN program, as well as a hospital nurse for most of my first two decades of nursing.

After obtaining my MSN/NP education, I preceptored NP students in a master’s prepared program for 20 years. The difference in students who were enrolled in the accelerated programs and those who were in traditional RN to BSN to MSN/NP programs were astonishing to me. They had little to no experience in how to relate to patients or how to take a history, and they certainly were not comfortable with patients.

Another concern is the growing number of "for profit" private schools now offering NP/PA programs, where enrollment seems to be at the price of well-qualified students. Those who cannot meet the requirements of a traditional university setting are now flooding these programs. Just look at the pass rates on exams and the attrition rates along with the high cost they charge.  

I am concerned about the move toward e-learning programs. Anybody can memorize pathophysiology, statistics, and biochemistry, but not everyone can learn how to interact with patients and develop critical-thinking and problem-solving skills without direct supervision and experience.  

Adequate clinical experience is imperative, and I suggest an internship for NPs and PAs fresh out of school. If we are going to advance our respect in the medical world with our physician colleagues, and continue to provide excellent care in this new era of medicine, then we need to make sure we do not jeopardize the hard work we have all done to bring the current high standards to PA and NP programs. 

Janet Evans Emery, RN, MSN, CFNP
Irvine, California 

Dear Dr. Danielsen,

Thank you for addressing this latest controversy in PA/NP issues in the June 2015 Clinician Reviews. I appreciate your candor and your objectiveness in presenting this "hot topic."  

I am a currently retired Certified Family Nurse Practitioner after more than 20 years in practice; I graduated from my RN program 40 years ago this month! During my career, I was a clinical instructor in an RN program, as well as a hospital nurse for most of my first two decades of nursing.

After obtaining my MSN/NP education, I preceptored NP students in a master’s prepared program for 20 years. The difference in students who were enrolled in the accelerated programs and those who were in traditional RN to BSN to MSN/NP programs were astonishing to me. They had little to no experience in how to relate to patients or how to take a history, and they certainly were not comfortable with patients.

Another concern is the growing number of "for profit" private schools now offering NP/PA programs, where enrollment seems to be at the price of well-qualified students. Those who cannot meet the requirements of a traditional university setting are now flooding these programs. Just look at the pass rates on exams and the attrition rates along with the high cost they charge.  

I am concerned about the move toward e-learning programs. Anybody can memorize pathophysiology, statistics, and biochemistry, but not everyone can learn how to interact with patients and develop critical-thinking and problem-solving skills without direct supervision and experience.  

Adequate clinical experience is imperative, and I suggest an internship for NPs and PAs fresh out of school. If we are going to advance our respect in the medical world with our physician colleagues, and continue to provide excellent care in this new era of medicine, then we need to make sure we do not jeopardize the hard work we have all done to bring the current high standards to PA and NP programs. 

Janet Evans Emery, RN, MSN, CFNP
Irvine, California