Do ACOG guidelines protect us from liability?

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Do ACOG guidelines protect us from liability?

“THE SGR IS ABOLISHED! WHAT COMES NEXT?”
LUCIA DIVENERE, MA (PRACTICE MANAGEMENT; JUNE 2015)

Do ACOG guidelines protect us from liability?
I read Ms. DiVenere’s June article with interest, but I found this point she quoted confusing: "The law protects physicians from liability from federal or state standards of care. No health care guideline or other standard developed under federal or state requirements associated with this law may be used as a standard of care or duty of care owed by a health care professional to a patient in a medical liability lawsuit."

I have 2 questions: How do you interpret the use of guidelines by the American College of Obstetricians and Gynecologists (ACOG), since they are developed independently by a specialty society rather than by federal or state “requirements”? Does this only pertain to liability lawsuits concerning billing of fees, or does it pertain to medical malpractice civil lawsuits?

In the Medicare Access and CHIP Reauthorization Act, I find this section that seems to contradict the protection1:

(3) NO PREEMPTION.—Nothing in paragraph (1) or any provision of the Patient Protection and Affordable Care Act (Public Law 111–148), title I or subtitle B of title II of the Health Care and Education Reconciliation Act of 2010 (Public Law 111–152), or title XVIII or XIX of the Social Security Act (42 U.S.C. 1395 et seq., 42 U.S.C. 1396 et seq.) shall be construed to preempt any State or common law governing medical professional or medical product liability actions or claims.

What is the bottom line? No law can protect and provide immunity to a physician for true medical malpractice. This federal law says “no preemption.”
Arnold D. Wharton, MD

Tyler, Texas

Reference
1. Pub L No. 114–10. Medicare Access and CHIP Reauthorization Act of 2015. 114th Congress. Title 1—SGR repeal and Medicare Provider Payment Modernization. §106. Reducing administrative burden and other provisions. 129 STAT.143. http://www.gpo.gov/fdsys/pkg/PLAW-114publ10/pdf/PLAW-114publ10.pdf. Accessed June 10, 2015.

Ms. DiVenere responds
I thank Dr. Wharton for his interesting perspective. To answer the first questions, this section of the law only applies to guidelines and standards created by a federal or state entity, not to ACOG guidelines, and is intended to provide one area of protection from medical malpractice lawsuits. Interestingly, legislation has been introduced in the US House by Congressman Andy Barr (R-KY), with ACOG’s support, to create liability safe harbors for physicians who follow care guidelines developed by their relevant specialty society.  

As for the question about preemption, this section of the law allows stronger state laws to stand; this federal law would not preempt state laws. 

“HOW DO YOU DISMISS A PATIENT FROM YOUR PRACTICE’S CARE?”
JOSEPH S. SANFILIPPO, MD, MBA, AND STEVEN R. SMITH, JD (WHAT’S THE VERDICT?; JUNE 2015)

Statute of limitations still in effect; contact your insurer
While the end result to dismiss the patient was achieved, the statute of limitations for a possible malpractice suit had not fully run. I would suggest that the physician contact his/her insurer so that they can open a file and be alerted for a possible suit. Insurers generally require physicians to notify them of any potential suits.
Lynn Frame, MD, JD
Tulsa, Oklahoma

Dr. Sanfilippo and Mr. Smith respond
Our thanks to Dr. Frame for the good reminder that physicians should always remember the obligation to inform malpractice insurance carriers when a malpractice claim is being, or may be, filed. Insurance contracts vary somewhat regarding when notice must be given.

In the hypothetical case, there was an angry patient but no formal threat of legal action. Some lawyers take the sensible position that “when in doubt, notify.” Others are reluctant to “over notify” carriers. Our view is that this is one of the areas in which it may be beneficial for a physician to have an ongoing professional relationship with an attorney to allow for advice on when to provide insurance carrier notification.

“SURGICAL REMOVAL OF MALPOSITIONED IUDs”
BENJAMIN MARGOLIS, MD; MIREILLE D. TRUONG, MD; JULIA KEARNEY; SARAH SCHECHTER; JEANNIE KIM, MD; AND ARNOLD P. ADVINCULA, MD (VIDEO; JUNE 2015)

Videos show very useful techniques for malpositioned IUDs
I have placed somewhere in the ballpark of 2,000 intrauterine devices (IUDs) and have had 2 perforations that I am aware of (and probably many more malpositioned IUDs that I am unaware of). Some of those were likely the cause of a patient’s pain and were either removed or hysteroscopically repositioned. Dr. ­Advincula’s edited video from several cases demonstrates very useful techniques in the surgical management of these problems.
Philip Ivey, MD
Casa Grande, Arizona

 

 

The IUD might not stay where I put it
For the past several years I have performed the majority (more than 95%) of IUD insertions with ultrasound guidance and have been very thankful at times for the assistance of my sonographer. Despite my knowledge of accurate placement, there are still patients who return months or years later with a malpositioned IUD. I have come to realize that the uterus is a dynamic organ—not a piece of concrete. Just because I put the IUD in the right place does not ensure that it will stay there. Fortunately, I have not yet had a perforation into the abdominal cavity.

I really enjoyed the videos and advice, as always!
Elizabeth Street, MD

Marietta, Georgia

“EBOLA IN THE UNITED STATES: MANAGEMENT CONSIDERATIONS DURING PREGNANCY”
STEPHANIE L. BAKAYSA, MD, MPH; JEANNIE C. KELLY, MD; AND ERROL R. NORWITZ, MD, PHD
(JUNE 2015)

Improved care for pregnant women during Ebola crisis
The article on Ebola in pregnancy noted how little we actually know about the Ebola virus. The Ebola virus was first documented in 1976 in Sudan and the Democratic Republic of the Congo,1 not in 1967 as the article stated. The Marburg virus outbreak occurred in 1967. Closely related, both viruses are filo viruses that cause hemorrhagic fever. A significant difference between the 2 is that the natural reservoir for the ­Marburg virus was identified. The outbreak in Marburg, Germany, which the virus is named for, was linked to African green monkeys imported from Uganda, East Africa.2 Bats also have been identified as a reservoir for the Marburg virus.3 However, there is only speculation as to whether the natural reservoir for the Ebola virus is fruit bats. A 3-month research study following the 1995 outbreak of Ebola virus in Kikwit, Democratic Republic of the Congo, tested more than 3,000 vertebrate species and was still unable to identify a natural carrier for the virus.4

The Ebola virus was first documented nearly 40 years ago and yet we know so little about it. This demonstrates the ongoing disparity in funding and research devoted to disease conditions that most often affect only third-world nations.

Also, I’d like to point out that the article’s comment that pregnant patients are triaged “last” during the current Ebola virus outbreak may not be completely accurate. Yes, pregnant women have a significantly higher rate of mortality with Ebola viral infection. I spoke with a nurse (name and location withheld for confidentiality) who is currently the Clinical Lead at an Ebola Holding Unit for pregnant and lactating women in a West African nation. According to her, improved resources were quickly mobilized by nongovernment organizations and other foreign health care volunteers following the initial reports of disease, a factor that significantly increased access to care for pregnant women and improved outcomes. Erin Kiser, DNP, FNP-BC, WHNP-BC
Fayetteville, North Carolina

References
1. World Health Organization. Ebola virus disease. Fact sheet No. 103. http://www.who.int/mediacentre/factsheets/fs103/en/. Updated April 2015. Accessed July 6, 2015.
2. World Health Organization. Marburg haemorrhagic fever. Fact sheet. http://www.who.int/mediacentre/factsheets/fs_marburg/en/. Published November 2012. Accessed July 8, 2015.
3. Towner JS, Pourrut X, Albariño CG, et al. Marburg virus infection detected in a common African bat. PLoS One. 2007;2(8):e764. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0000764.
4. Leirs H, Mills JN, Krebs JW, et al. Search for the Ebola virus reservoir in Kikwit, Democratic Republic of the Congo: Reflections on a vertebrate collection. J Infect Dis. 1999;179(suppl 1):S155–S163.

“WHY IS OBSTETRICS AND GYNECOLOGY A POPULAR CAREER CHOICE FOR MEDICAL STUDENTS?”
ROBERT L. BARBIERI, MD (EDITORIAL; MAY 2015)

Had the chance to change my specialty, but didn’t
I trained in Mexico, where I was a board certified ObGyn and a maternal-fetal medicine specialist. When I came to the United States I had the opportunity to change my specialty, and I didn’t. As a “free agent” international medical graduate, I had to go through many hurdles. My gate to enter the American medical world was through a family practice residency. After a year, I realized my love was still obstetrics and gynecology. In 1996, I finished an ObGyn residency at Loma Linda University Medical Center in California, and have been board certified since 1998.

There are many things I like about this specialty. Mainly, it’s the diversity. A well-rounded ObGyn has to know internal medicine, pediatrics, and surgery and apply this knowledge to the pregnant patient—a feat somehow exclusive to ObGyns.

I have enjoyed a wonderful career and many rewards. I never stop thanking all those professors and colleagues who helped me develop the set of skills that I now possess.
Tomas A. Hernandez, MD 
Pasco, Washington

 

 

Not again!
I would not go into obstetrics and gynecology again because of many reasons:

  • It is a very difficult life, with no family time and calls 24 hours per day.
  • The specialty is the bread and butter of malpractice attorneys, causing a lot of stress.
  • Insurance companies, health maintenance organizations (HMOs), etc, pay ridiculously low reimbursement for obstetric and gynecologic procedures.
  • Malpractice insurance premiums are so high that you can be forced to be without malpractice and therefore more exposed.
  • Patients are extremely demanding. Because pregnancy is not a ­disease but a natural process, they expect perfect results every time (as if congenital malformations, chromosomal abnormalities, and pregnancy complications are your fault).
  • There is no patient loyalty, or very little. If a patient changes HMOs she changes obstetricians. If a woman has to wait 20 minutes in the waiting room, she changes doctors—to one who doesn’t do obstetrics (too many pregnant women!).

I would like to say that ObGyn is a beautiful specialty, most likely the best of all medical specialties, if it was not for the attorneys’ greed and patients’ lack of understanding that we are not God. We are only doctors, working within a system that contributes to all of the above.
Manuel S. Mendizabal, MD

Miami, Florida

Are men discouraged from entering the ObGyn field?
Dr. Barbieri asks, “Why is obstetrics and gynecology a popular choice for medical students?” The unaddressed question is why is it unpopular for half of medical students? Ninety-three percent of resident graduates in the field are women, while women account for half of medical student graduates. Men rarely go into the specialty today. Perhaps job advertisements touting physician opportunities in “all female groups” discourage males. Perhaps hospitals’ “women’s health centers,” with “women taking care of women,” discourage males. Perhaps receptionists’ asking patients whether they prefer a male or female physician discourages male ObGyns. In the United States, two-thirds of outpatient office visits are made by women, and academic centers and hospitals focus on this demographic in their marketing. The business ends justify the unethical means.

The result of discouraging half your medical students from the field is a lower quality field. If male and female medical students are equally qualified for any field, and I believe this is true, then discouraging half the candidates from a field lowers the quality of the resulting field. This has been the product of all discrimination throughout the ages.
Joe Walsh, MD
Philadelphia, Pennsylvania

Dr. Barbieri responds
Drs. Hernandez and Mendizabal provide 2 divergent perspectives on our field. Dr. Hernandez cherishes the diversity of the clinical work in the field, and Dr. Mendizabal warns that night call and medical malpractice take a toll on a physician. Both perspectives are valid and important, and medical students entering the field should be alerted to these rewards and challenges.

I agree with Dr. Walsh that the majority of residents in obstetrics and gynecology are women. On ­December 31, 2013, of the 4,942 residents in obstetrics and gynecology in the United States, 82.5% were women.1 In the fields of orthopedic surgery, neurosurgery, and urology, male residents dominate the resident complement, constituting 86.3%, 84.1%, and 77.3% of the residents, respectively.1 It is interesting that the fields of obstetrics and gynecology, orthopedic surgery, neurosurgery, and urology are among the most competitive fields in the resident match. Based on personal observation, medical student clerkship directors and obstetrics and gynecology residency programs encourage both women and men to consider a career in obstetrics and gynecology and warmly welcome male applicants. Medical students select their preferred future specialty based on many factors. It is clear that in the past few years the medical students applying to obstetrics and gynecology are extremely capable, and I am confident that the future of women’s health is in the hands ofexcellent clinicians.

Reference
1. Brotherton SE, Etzel SI. Graduate medical education, 2013–2014. JAMA. 2014;312(22):2427–2445.

“IS IT TIME TO REVIVE ROTATIONAL FORCEPS?” WILLIAM H. BARTH JR, MD (EXAMINING THE EVIDENCE; MAY 2015)

Who will teach this dying art to a new generation?
The article on rotational forceps has what I consider one glaring defect—who will teach this dying art to a new generation?

Now retired, I was military-residency trained in the 1970s when you had to do your own regional and conduction anesthesia as well as operative forceps delivery—and that did not mean a silastic cup vacuum extractor, though we had just started using the Malstrom vacuum. Breech forceps, Kielland rotations, occipito-transverse forceps application—you name it and we did it as we had to keep our cesarean delivery rate down. All of us were well skilled in operative vaginal delivery.

 

 

When I stopped practicing obstetrics, the fresh-out-of-residency people coming into our practice couldn’t do a low forceps delivery. If there is to be a reteaching of rotational forceps, they’d better catch us old codgers fast before we die off (I am 72) and grant us malpractice relief (I no longer have insurance). This is an art, not a science, and can’t be taught from a book or a computer model. Set up a crash course to teach this dying art, pay us well, and perhaps we will be able to pass this skill along. Otherwise it will be gone forever.

I have always said that forceps are like a shoehorn—used correctly, they make things so much easier.
Robert Frischer, MD


Wichita Falls, Texas

“IS SUPPLEMENTAL ULTRASONO­G-RAPHY A VALUABLE ADDITION TO BREAST CANCER SCREENING FOR WOMEN WITH DENSE BREASTS?”
MARK D. PEARLMAN, MD (EXAMINING THE EVIDENCE; MARCH 2015)

Why I now recommend 3D ultrasonography to my high-risk patients
In 2012, I attended a medical staff meeting where Dr. Ruby Chang spoke about a newly available modality at our hospital: 3D ultrasonography. Her slideshow included some impressive images of cancers that were not seen on mammogram but were unmistakable on sonography.

I decided to have a 3D ultrasound for myself in order to tell my patients what it was like. I also have “heterogeneously dense breasts” on mammogram. For the previous 10 years, my annual screening mammograms had all been negative. The 3D ultrasound showed an 8-mm cancer in my left breast—not palpable to me. A subsequent mammogram was still negative for cancer.

Luckily, the breast cancer was Stage 1 at surgery, and I did not need chemotherapy or radiation, opting for skin- and nipple-sparing double mastectomy. I had a double mastectomy because I believed that I could no longer trust screening mammo­graphy for a timely diagnosis.

To this day, I explain breast density to all of my higher-risk patients who have either heterogeneously or extremely dense breasts. I tell them that their mammograms may miss a cancer and that there is another test that might help detect cancer early. It’s a good thing to have another way to evaluate the breast, especially when our patients are being sent letters about their “dense breasts.” (The majority of my patients do not understand what this means.)

I realize that data may show that this modality isn’t the perfect solution and may lead to more testing and procedures, but in my case, it was worth it!

Strangely, to this day, I have not had one patient who had breast cancer diagnosed in this way.

It’s a shame that insurance companies don’t cover even partial cost for eligible patients.
Bettina Zatuchni, MD

Pleasanton, California

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References

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Lucia DiVenere, Arnold D. Wharton MD, Joseph S. Sanfilippo MD, Steven R. Smith JD, Lynn Frame MD JD, Arnold P. Advincula MD, Benjamin Margolis MD, Philip Ivey MD, Elizabeth Street MD, Stephanie Bakaysa MD, Jeannie C. Kelly MD, Errol R. Norwitz MD, Erin Kiser DNP, Robert L. Barbieri MD, Tomas A. Hernandez MD, Manuel Mendizabal MD, Joe Walsh MD, William H. Barth Jr MD, Robert Frischer MD, Mark D. Pearlman MD, Bettina Zatuchni MD, SGR, sustainable growth rate, ACOG guidelines, statute of limitations, malpractice insurance, malpositioned IUDs, intrauterine device, Ebola during pregnancy, obstetrics and gynecology, residents in ObGyn, rotational forceps, supplemental ultrasonography, breast cancer screening, dense breasts, 3D ultrasonography
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Related Articles

“THE SGR IS ABOLISHED! WHAT COMES NEXT?”
LUCIA DIVENERE, MA (PRACTICE MANAGEMENT; JUNE 2015)

Do ACOG guidelines protect us from liability?
I read Ms. DiVenere’s June article with interest, but I found this point she quoted confusing: "The law protects physicians from liability from federal or state standards of care. No health care guideline or other standard developed under federal or state requirements associated with this law may be used as a standard of care or duty of care owed by a health care professional to a patient in a medical liability lawsuit."

I have 2 questions: How do you interpret the use of guidelines by the American College of Obstetricians and Gynecologists (ACOG), since they are developed independently by a specialty society rather than by federal or state “requirements”? Does this only pertain to liability lawsuits concerning billing of fees, or does it pertain to medical malpractice civil lawsuits?

In the Medicare Access and CHIP Reauthorization Act, I find this section that seems to contradict the protection1:

(3) NO PREEMPTION.—Nothing in paragraph (1) or any provision of the Patient Protection and Affordable Care Act (Public Law 111–148), title I or subtitle B of title II of the Health Care and Education Reconciliation Act of 2010 (Public Law 111–152), or title XVIII or XIX of the Social Security Act (42 U.S.C. 1395 et seq., 42 U.S.C. 1396 et seq.) shall be construed to preempt any State or common law governing medical professional or medical product liability actions or claims.

What is the bottom line? No law can protect and provide immunity to a physician for true medical malpractice. This federal law says “no preemption.”
Arnold D. Wharton, MD

Tyler, Texas

Reference
1. Pub L No. 114–10. Medicare Access and CHIP Reauthorization Act of 2015. 114th Congress. Title 1—SGR repeal and Medicare Provider Payment Modernization. §106. Reducing administrative burden and other provisions. 129 STAT.143. http://www.gpo.gov/fdsys/pkg/PLAW-114publ10/pdf/PLAW-114publ10.pdf. Accessed June 10, 2015.

Ms. DiVenere responds
I thank Dr. Wharton for his interesting perspective. To answer the first questions, this section of the law only applies to guidelines and standards created by a federal or state entity, not to ACOG guidelines, and is intended to provide one area of protection from medical malpractice lawsuits. Interestingly, legislation has been introduced in the US House by Congressman Andy Barr (R-KY), with ACOG’s support, to create liability safe harbors for physicians who follow care guidelines developed by their relevant specialty society.  

As for the question about preemption, this section of the law allows stronger state laws to stand; this federal law would not preempt state laws. 

“HOW DO YOU DISMISS A PATIENT FROM YOUR PRACTICE’S CARE?”
JOSEPH S. SANFILIPPO, MD, MBA, AND STEVEN R. SMITH, JD (WHAT’S THE VERDICT?; JUNE 2015)

Statute of limitations still in effect; contact your insurer
While the end result to dismiss the patient was achieved, the statute of limitations for a possible malpractice suit had not fully run. I would suggest that the physician contact his/her insurer so that they can open a file and be alerted for a possible suit. Insurers generally require physicians to notify them of any potential suits.
Lynn Frame, MD, JD
Tulsa, Oklahoma

Dr. Sanfilippo and Mr. Smith respond
Our thanks to Dr. Frame for the good reminder that physicians should always remember the obligation to inform malpractice insurance carriers when a malpractice claim is being, or may be, filed. Insurance contracts vary somewhat regarding when notice must be given.

In the hypothetical case, there was an angry patient but no formal threat of legal action. Some lawyers take the sensible position that “when in doubt, notify.” Others are reluctant to “over notify” carriers. Our view is that this is one of the areas in which it may be beneficial for a physician to have an ongoing professional relationship with an attorney to allow for advice on when to provide insurance carrier notification.

“SURGICAL REMOVAL OF MALPOSITIONED IUDs”
BENJAMIN MARGOLIS, MD; MIREILLE D. TRUONG, MD; JULIA KEARNEY; SARAH SCHECHTER; JEANNIE KIM, MD; AND ARNOLD P. ADVINCULA, MD (VIDEO; JUNE 2015)

Videos show very useful techniques for malpositioned IUDs
I have placed somewhere in the ballpark of 2,000 intrauterine devices (IUDs) and have had 2 perforations that I am aware of (and probably many more malpositioned IUDs that I am unaware of). Some of those were likely the cause of a patient’s pain and were either removed or hysteroscopically repositioned. Dr. ­Advincula’s edited video from several cases demonstrates very useful techniques in the surgical management of these problems.
Philip Ivey, MD
Casa Grande, Arizona

 

 

The IUD might not stay where I put it
For the past several years I have performed the majority (more than 95%) of IUD insertions with ultrasound guidance and have been very thankful at times for the assistance of my sonographer. Despite my knowledge of accurate placement, there are still patients who return months or years later with a malpositioned IUD. I have come to realize that the uterus is a dynamic organ—not a piece of concrete. Just because I put the IUD in the right place does not ensure that it will stay there. Fortunately, I have not yet had a perforation into the abdominal cavity.

I really enjoyed the videos and advice, as always!
Elizabeth Street, MD

Marietta, Georgia

“EBOLA IN THE UNITED STATES: MANAGEMENT CONSIDERATIONS DURING PREGNANCY”
STEPHANIE L. BAKAYSA, MD, MPH; JEANNIE C. KELLY, MD; AND ERROL R. NORWITZ, MD, PHD
(JUNE 2015)

Improved care for pregnant women during Ebola crisis
The article on Ebola in pregnancy noted how little we actually know about the Ebola virus. The Ebola virus was first documented in 1976 in Sudan and the Democratic Republic of the Congo,1 not in 1967 as the article stated. The Marburg virus outbreak occurred in 1967. Closely related, both viruses are filo viruses that cause hemorrhagic fever. A significant difference between the 2 is that the natural reservoir for the ­Marburg virus was identified. The outbreak in Marburg, Germany, which the virus is named for, was linked to African green monkeys imported from Uganda, East Africa.2 Bats also have been identified as a reservoir for the Marburg virus.3 However, there is only speculation as to whether the natural reservoir for the Ebola virus is fruit bats. A 3-month research study following the 1995 outbreak of Ebola virus in Kikwit, Democratic Republic of the Congo, tested more than 3,000 vertebrate species and was still unable to identify a natural carrier for the virus.4

The Ebola virus was first documented nearly 40 years ago and yet we know so little about it. This demonstrates the ongoing disparity in funding and research devoted to disease conditions that most often affect only third-world nations.

Also, I’d like to point out that the article’s comment that pregnant patients are triaged “last” during the current Ebola virus outbreak may not be completely accurate. Yes, pregnant women have a significantly higher rate of mortality with Ebola viral infection. I spoke with a nurse (name and location withheld for confidentiality) who is currently the Clinical Lead at an Ebola Holding Unit for pregnant and lactating women in a West African nation. According to her, improved resources were quickly mobilized by nongovernment organizations and other foreign health care volunteers following the initial reports of disease, a factor that significantly increased access to care for pregnant women and improved outcomes. Erin Kiser, DNP, FNP-BC, WHNP-BC
Fayetteville, North Carolina

References
1. World Health Organization. Ebola virus disease. Fact sheet No. 103. http://www.who.int/mediacentre/factsheets/fs103/en/. Updated April 2015. Accessed July 6, 2015.
2. World Health Organization. Marburg haemorrhagic fever. Fact sheet. http://www.who.int/mediacentre/factsheets/fs_marburg/en/. Published November 2012. Accessed July 8, 2015.
3. Towner JS, Pourrut X, Albariño CG, et al. Marburg virus infection detected in a common African bat. PLoS One. 2007;2(8):e764. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0000764.
4. Leirs H, Mills JN, Krebs JW, et al. Search for the Ebola virus reservoir in Kikwit, Democratic Republic of the Congo: Reflections on a vertebrate collection. J Infect Dis. 1999;179(suppl 1):S155–S163.

“WHY IS OBSTETRICS AND GYNECOLOGY A POPULAR CAREER CHOICE FOR MEDICAL STUDENTS?”
ROBERT L. BARBIERI, MD (EDITORIAL; MAY 2015)

Had the chance to change my specialty, but didn’t
I trained in Mexico, where I was a board certified ObGyn and a maternal-fetal medicine specialist. When I came to the United States I had the opportunity to change my specialty, and I didn’t. As a “free agent” international medical graduate, I had to go through many hurdles. My gate to enter the American medical world was through a family practice residency. After a year, I realized my love was still obstetrics and gynecology. In 1996, I finished an ObGyn residency at Loma Linda University Medical Center in California, and have been board certified since 1998.

There are many things I like about this specialty. Mainly, it’s the diversity. A well-rounded ObGyn has to know internal medicine, pediatrics, and surgery and apply this knowledge to the pregnant patient—a feat somehow exclusive to ObGyns.

I have enjoyed a wonderful career and many rewards. I never stop thanking all those professors and colleagues who helped me develop the set of skills that I now possess.
Tomas A. Hernandez, MD 
Pasco, Washington

 

 

Not again!
I would not go into obstetrics and gynecology again because of many reasons:

  • It is a very difficult life, with no family time and calls 24 hours per day.
  • The specialty is the bread and butter of malpractice attorneys, causing a lot of stress.
  • Insurance companies, health maintenance organizations (HMOs), etc, pay ridiculously low reimbursement for obstetric and gynecologic procedures.
  • Malpractice insurance premiums are so high that you can be forced to be without malpractice and therefore more exposed.
  • Patients are extremely demanding. Because pregnancy is not a ­disease but a natural process, they expect perfect results every time (as if congenital malformations, chromosomal abnormalities, and pregnancy complications are your fault).
  • There is no patient loyalty, or very little. If a patient changes HMOs she changes obstetricians. If a woman has to wait 20 minutes in the waiting room, she changes doctors—to one who doesn’t do obstetrics (too many pregnant women!).

I would like to say that ObGyn is a beautiful specialty, most likely the best of all medical specialties, if it was not for the attorneys’ greed and patients’ lack of understanding that we are not God. We are only doctors, working within a system that contributes to all of the above.
Manuel S. Mendizabal, MD

Miami, Florida

Are men discouraged from entering the ObGyn field?
Dr. Barbieri asks, “Why is obstetrics and gynecology a popular choice for medical students?” The unaddressed question is why is it unpopular for half of medical students? Ninety-three percent of resident graduates in the field are women, while women account for half of medical student graduates. Men rarely go into the specialty today. Perhaps job advertisements touting physician opportunities in “all female groups” discourage males. Perhaps hospitals’ “women’s health centers,” with “women taking care of women,” discourage males. Perhaps receptionists’ asking patients whether they prefer a male or female physician discourages male ObGyns. In the United States, two-thirds of outpatient office visits are made by women, and academic centers and hospitals focus on this demographic in their marketing. The business ends justify the unethical means.

The result of discouraging half your medical students from the field is a lower quality field. If male and female medical students are equally qualified for any field, and I believe this is true, then discouraging half the candidates from a field lowers the quality of the resulting field. This has been the product of all discrimination throughout the ages.
Joe Walsh, MD
Philadelphia, Pennsylvania

Dr. Barbieri responds
Drs. Hernandez and Mendizabal provide 2 divergent perspectives on our field. Dr. Hernandez cherishes the diversity of the clinical work in the field, and Dr. Mendizabal warns that night call and medical malpractice take a toll on a physician. Both perspectives are valid and important, and medical students entering the field should be alerted to these rewards and challenges.

I agree with Dr. Walsh that the majority of residents in obstetrics and gynecology are women. On ­December 31, 2013, of the 4,942 residents in obstetrics and gynecology in the United States, 82.5% were women.1 In the fields of orthopedic surgery, neurosurgery, and urology, male residents dominate the resident complement, constituting 86.3%, 84.1%, and 77.3% of the residents, respectively.1 It is interesting that the fields of obstetrics and gynecology, orthopedic surgery, neurosurgery, and urology are among the most competitive fields in the resident match. Based on personal observation, medical student clerkship directors and obstetrics and gynecology residency programs encourage both women and men to consider a career in obstetrics and gynecology and warmly welcome male applicants. Medical students select their preferred future specialty based on many factors. It is clear that in the past few years the medical students applying to obstetrics and gynecology are extremely capable, and I am confident that the future of women’s health is in the hands ofexcellent clinicians.

Reference
1. Brotherton SE, Etzel SI. Graduate medical education, 2013–2014. JAMA. 2014;312(22):2427–2445.

“IS IT TIME TO REVIVE ROTATIONAL FORCEPS?” WILLIAM H. BARTH JR, MD (EXAMINING THE EVIDENCE; MAY 2015)

Who will teach this dying art to a new generation?
The article on rotational forceps has what I consider one glaring defect—who will teach this dying art to a new generation?

Now retired, I was military-residency trained in the 1970s when you had to do your own regional and conduction anesthesia as well as operative forceps delivery—and that did not mean a silastic cup vacuum extractor, though we had just started using the Malstrom vacuum. Breech forceps, Kielland rotations, occipito-transverse forceps application—you name it and we did it as we had to keep our cesarean delivery rate down. All of us were well skilled in operative vaginal delivery.

 

 

When I stopped practicing obstetrics, the fresh-out-of-residency people coming into our practice couldn’t do a low forceps delivery. If there is to be a reteaching of rotational forceps, they’d better catch us old codgers fast before we die off (I am 72) and grant us malpractice relief (I no longer have insurance). This is an art, not a science, and can’t be taught from a book or a computer model. Set up a crash course to teach this dying art, pay us well, and perhaps we will be able to pass this skill along. Otherwise it will be gone forever.

I have always said that forceps are like a shoehorn—used correctly, they make things so much easier.
Robert Frischer, MD


Wichita Falls, Texas

“IS SUPPLEMENTAL ULTRASONO­G-RAPHY A VALUABLE ADDITION TO BREAST CANCER SCREENING FOR WOMEN WITH DENSE BREASTS?”
MARK D. PEARLMAN, MD (EXAMINING THE EVIDENCE; MARCH 2015)

Why I now recommend 3D ultrasonography to my high-risk patients
In 2012, I attended a medical staff meeting where Dr. Ruby Chang spoke about a newly available modality at our hospital: 3D ultrasonography. Her slideshow included some impressive images of cancers that were not seen on mammogram but were unmistakable on sonography.

I decided to have a 3D ultrasound for myself in order to tell my patients what it was like. I also have “heterogeneously dense breasts” on mammogram. For the previous 10 years, my annual screening mammograms had all been negative. The 3D ultrasound showed an 8-mm cancer in my left breast—not palpable to me. A subsequent mammogram was still negative for cancer.

Luckily, the breast cancer was Stage 1 at surgery, and I did not need chemotherapy or radiation, opting for skin- and nipple-sparing double mastectomy. I had a double mastectomy because I believed that I could no longer trust screening mammo­graphy for a timely diagnosis.

To this day, I explain breast density to all of my higher-risk patients who have either heterogeneously or extremely dense breasts. I tell them that their mammograms may miss a cancer and that there is another test that might help detect cancer early. It’s a good thing to have another way to evaluate the breast, especially when our patients are being sent letters about their “dense breasts.” (The majority of my patients do not understand what this means.)

I realize that data may show that this modality isn’t the perfect solution and may lead to more testing and procedures, but in my case, it was worth it!

Strangely, to this day, I have not had one patient who had breast cancer diagnosed in this way.

It’s a shame that insurance companies don’t cover even partial cost for eligible patients.
Bettina Zatuchni, MD

Pleasanton, California

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

“THE SGR IS ABOLISHED! WHAT COMES NEXT?”
LUCIA DIVENERE, MA (PRACTICE MANAGEMENT; JUNE 2015)

Do ACOG guidelines protect us from liability?
I read Ms. DiVenere’s June article with interest, but I found this point she quoted confusing: "The law protects physicians from liability from federal or state standards of care. No health care guideline or other standard developed under federal or state requirements associated with this law may be used as a standard of care or duty of care owed by a health care professional to a patient in a medical liability lawsuit."

I have 2 questions: How do you interpret the use of guidelines by the American College of Obstetricians and Gynecologists (ACOG), since they are developed independently by a specialty society rather than by federal or state “requirements”? Does this only pertain to liability lawsuits concerning billing of fees, or does it pertain to medical malpractice civil lawsuits?

In the Medicare Access and CHIP Reauthorization Act, I find this section that seems to contradict the protection1:

(3) NO PREEMPTION.—Nothing in paragraph (1) or any provision of the Patient Protection and Affordable Care Act (Public Law 111–148), title I or subtitle B of title II of the Health Care and Education Reconciliation Act of 2010 (Public Law 111–152), or title XVIII or XIX of the Social Security Act (42 U.S.C. 1395 et seq., 42 U.S.C. 1396 et seq.) shall be construed to preempt any State or common law governing medical professional or medical product liability actions or claims.

What is the bottom line? No law can protect and provide immunity to a physician for true medical malpractice. This federal law says “no preemption.”
Arnold D. Wharton, MD

Tyler, Texas

Reference
1. Pub L No. 114–10. Medicare Access and CHIP Reauthorization Act of 2015. 114th Congress. Title 1—SGR repeal and Medicare Provider Payment Modernization. §106. Reducing administrative burden and other provisions. 129 STAT.143. http://www.gpo.gov/fdsys/pkg/PLAW-114publ10/pdf/PLAW-114publ10.pdf. Accessed June 10, 2015.

Ms. DiVenere responds
I thank Dr. Wharton for his interesting perspective. To answer the first questions, this section of the law only applies to guidelines and standards created by a federal or state entity, not to ACOG guidelines, and is intended to provide one area of protection from medical malpractice lawsuits. Interestingly, legislation has been introduced in the US House by Congressman Andy Barr (R-KY), with ACOG’s support, to create liability safe harbors for physicians who follow care guidelines developed by their relevant specialty society.  

As for the question about preemption, this section of the law allows stronger state laws to stand; this federal law would not preempt state laws. 

“HOW DO YOU DISMISS A PATIENT FROM YOUR PRACTICE’S CARE?”
JOSEPH S. SANFILIPPO, MD, MBA, AND STEVEN R. SMITH, JD (WHAT’S THE VERDICT?; JUNE 2015)

Statute of limitations still in effect; contact your insurer
While the end result to dismiss the patient was achieved, the statute of limitations for a possible malpractice suit had not fully run. I would suggest that the physician contact his/her insurer so that they can open a file and be alerted for a possible suit. Insurers generally require physicians to notify them of any potential suits.
Lynn Frame, MD, JD
Tulsa, Oklahoma

Dr. Sanfilippo and Mr. Smith respond
Our thanks to Dr. Frame for the good reminder that physicians should always remember the obligation to inform malpractice insurance carriers when a malpractice claim is being, or may be, filed. Insurance contracts vary somewhat regarding when notice must be given.

In the hypothetical case, there was an angry patient but no formal threat of legal action. Some lawyers take the sensible position that “when in doubt, notify.” Others are reluctant to “over notify” carriers. Our view is that this is one of the areas in which it may be beneficial for a physician to have an ongoing professional relationship with an attorney to allow for advice on when to provide insurance carrier notification.

“SURGICAL REMOVAL OF MALPOSITIONED IUDs”
BENJAMIN MARGOLIS, MD; MIREILLE D. TRUONG, MD; JULIA KEARNEY; SARAH SCHECHTER; JEANNIE KIM, MD; AND ARNOLD P. ADVINCULA, MD (VIDEO; JUNE 2015)

Videos show very useful techniques for malpositioned IUDs
I have placed somewhere in the ballpark of 2,000 intrauterine devices (IUDs) and have had 2 perforations that I am aware of (and probably many more malpositioned IUDs that I am unaware of). Some of those were likely the cause of a patient’s pain and were either removed or hysteroscopically repositioned. Dr. ­Advincula’s edited video from several cases demonstrates very useful techniques in the surgical management of these problems.
Philip Ivey, MD
Casa Grande, Arizona

 

 

The IUD might not stay where I put it
For the past several years I have performed the majority (more than 95%) of IUD insertions with ultrasound guidance and have been very thankful at times for the assistance of my sonographer. Despite my knowledge of accurate placement, there are still patients who return months or years later with a malpositioned IUD. I have come to realize that the uterus is a dynamic organ—not a piece of concrete. Just because I put the IUD in the right place does not ensure that it will stay there. Fortunately, I have not yet had a perforation into the abdominal cavity.

I really enjoyed the videos and advice, as always!
Elizabeth Street, MD

Marietta, Georgia

“EBOLA IN THE UNITED STATES: MANAGEMENT CONSIDERATIONS DURING PREGNANCY”
STEPHANIE L. BAKAYSA, MD, MPH; JEANNIE C. KELLY, MD; AND ERROL R. NORWITZ, MD, PHD
(JUNE 2015)

Improved care for pregnant women during Ebola crisis
The article on Ebola in pregnancy noted how little we actually know about the Ebola virus. The Ebola virus was first documented in 1976 in Sudan and the Democratic Republic of the Congo,1 not in 1967 as the article stated. The Marburg virus outbreak occurred in 1967. Closely related, both viruses are filo viruses that cause hemorrhagic fever. A significant difference between the 2 is that the natural reservoir for the ­Marburg virus was identified. The outbreak in Marburg, Germany, which the virus is named for, was linked to African green monkeys imported from Uganda, East Africa.2 Bats also have been identified as a reservoir for the Marburg virus.3 However, there is only speculation as to whether the natural reservoir for the Ebola virus is fruit bats. A 3-month research study following the 1995 outbreak of Ebola virus in Kikwit, Democratic Republic of the Congo, tested more than 3,000 vertebrate species and was still unable to identify a natural carrier for the virus.4

The Ebola virus was first documented nearly 40 years ago and yet we know so little about it. This demonstrates the ongoing disparity in funding and research devoted to disease conditions that most often affect only third-world nations.

Also, I’d like to point out that the article’s comment that pregnant patients are triaged “last” during the current Ebola virus outbreak may not be completely accurate. Yes, pregnant women have a significantly higher rate of mortality with Ebola viral infection. I spoke with a nurse (name and location withheld for confidentiality) who is currently the Clinical Lead at an Ebola Holding Unit for pregnant and lactating women in a West African nation. According to her, improved resources were quickly mobilized by nongovernment organizations and other foreign health care volunteers following the initial reports of disease, a factor that significantly increased access to care for pregnant women and improved outcomes. Erin Kiser, DNP, FNP-BC, WHNP-BC
Fayetteville, North Carolina

References
1. World Health Organization. Ebola virus disease. Fact sheet No. 103. http://www.who.int/mediacentre/factsheets/fs103/en/. Updated April 2015. Accessed July 6, 2015.
2. World Health Organization. Marburg haemorrhagic fever. Fact sheet. http://www.who.int/mediacentre/factsheets/fs_marburg/en/. Published November 2012. Accessed July 8, 2015.
3. Towner JS, Pourrut X, Albariño CG, et al. Marburg virus infection detected in a common African bat. PLoS One. 2007;2(8):e764. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0000764.
4. Leirs H, Mills JN, Krebs JW, et al. Search for the Ebola virus reservoir in Kikwit, Democratic Republic of the Congo: Reflections on a vertebrate collection. J Infect Dis. 1999;179(suppl 1):S155–S163.

“WHY IS OBSTETRICS AND GYNECOLOGY A POPULAR CAREER CHOICE FOR MEDICAL STUDENTS?”
ROBERT L. BARBIERI, MD (EDITORIAL; MAY 2015)

Had the chance to change my specialty, but didn’t
I trained in Mexico, where I was a board certified ObGyn and a maternal-fetal medicine specialist. When I came to the United States I had the opportunity to change my specialty, and I didn’t. As a “free agent” international medical graduate, I had to go through many hurdles. My gate to enter the American medical world was through a family practice residency. After a year, I realized my love was still obstetrics and gynecology. In 1996, I finished an ObGyn residency at Loma Linda University Medical Center in California, and have been board certified since 1998.

There are many things I like about this specialty. Mainly, it’s the diversity. A well-rounded ObGyn has to know internal medicine, pediatrics, and surgery and apply this knowledge to the pregnant patient—a feat somehow exclusive to ObGyns.

I have enjoyed a wonderful career and many rewards. I never stop thanking all those professors and colleagues who helped me develop the set of skills that I now possess.
Tomas A. Hernandez, MD 
Pasco, Washington

 

 

Not again!
I would not go into obstetrics and gynecology again because of many reasons:

  • It is a very difficult life, with no family time and calls 24 hours per day.
  • The specialty is the bread and butter of malpractice attorneys, causing a lot of stress.
  • Insurance companies, health maintenance organizations (HMOs), etc, pay ridiculously low reimbursement for obstetric and gynecologic procedures.
  • Malpractice insurance premiums are so high that you can be forced to be without malpractice and therefore more exposed.
  • Patients are extremely demanding. Because pregnancy is not a ­disease but a natural process, they expect perfect results every time (as if congenital malformations, chromosomal abnormalities, and pregnancy complications are your fault).
  • There is no patient loyalty, or very little. If a patient changes HMOs she changes obstetricians. If a woman has to wait 20 minutes in the waiting room, she changes doctors—to one who doesn’t do obstetrics (too many pregnant women!).

I would like to say that ObGyn is a beautiful specialty, most likely the best of all medical specialties, if it was not for the attorneys’ greed and patients’ lack of understanding that we are not God. We are only doctors, working within a system that contributes to all of the above.
Manuel S. Mendizabal, MD

Miami, Florida

Are men discouraged from entering the ObGyn field?
Dr. Barbieri asks, “Why is obstetrics and gynecology a popular choice for medical students?” The unaddressed question is why is it unpopular for half of medical students? Ninety-three percent of resident graduates in the field are women, while women account for half of medical student graduates. Men rarely go into the specialty today. Perhaps job advertisements touting physician opportunities in “all female groups” discourage males. Perhaps hospitals’ “women’s health centers,” with “women taking care of women,” discourage males. Perhaps receptionists’ asking patients whether they prefer a male or female physician discourages male ObGyns. In the United States, two-thirds of outpatient office visits are made by women, and academic centers and hospitals focus on this demographic in their marketing. The business ends justify the unethical means.

The result of discouraging half your medical students from the field is a lower quality field. If male and female medical students are equally qualified for any field, and I believe this is true, then discouraging half the candidates from a field lowers the quality of the resulting field. This has been the product of all discrimination throughout the ages.
Joe Walsh, MD
Philadelphia, Pennsylvania

Dr. Barbieri responds
Drs. Hernandez and Mendizabal provide 2 divergent perspectives on our field. Dr. Hernandez cherishes the diversity of the clinical work in the field, and Dr. Mendizabal warns that night call and medical malpractice take a toll on a physician. Both perspectives are valid and important, and medical students entering the field should be alerted to these rewards and challenges.

I agree with Dr. Walsh that the majority of residents in obstetrics and gynecology are women. On ­December 31, 2013, of the 4,942 residents in obstetrics and gynecology in the United States, 82.5% were women.1 In the fields of orthopedic surgery, neurosurgery, and urology, male residents dominate the resident complement, constituting 86.3%, 84.1%, and 77.3% of the residents, respectively.1 It is interesting that the fields of obstetrics and gynecology, orthopedic surgery, neurosurgery, and urology are among the most competitive fields in the resident match. Based on personal observation, medical student clerkship directors and obstetrics and gynecology residency programs encourage both women and men to consider a career in obstetrics and gynecology and warmly welcome male applicants. Medical students select their preferred future specialty based on many factors. It is clear that in the past few years the medical students applying to obstetrics and gynecology are extremely capable, and I am confident that the future of women’s health is in the hands ofexcellent clinicians.

Reference
1. Brotherton SE, Etzel SI. Graduate medical education, 2013–2014. JAMA. 2014;312(22):2427–2445.

“IS IT TIME TO REVIVE ROTATIONAL FORCEPS?” WILLIAM H. BARTH JR, MD (EXAMINING THE EVIDENCE; MAY 2015)

Who will teach this dying art to a new generation?
The article on rotational forceps has what I consider one glaring defect—who will teach this dying art to a new generation?

Now retired, I was military-residency trained in the 1970s when you had to do your own regional and conduction anesthesia as well as operative forceps delivery—and that did not mean a silastic cup vacuum extractor, though we had just started using the Malstrom vacuum. Breech forceps, Kielland rotations, occipito-transverse forceps application—you name it and we did it as we had to keep our cesarean delivery rate down. All of us were well skilled in operative vaginal delivery.

 

 

When I stopped practicing obstetrics, the fresh-out-of-residency people coming into our practice couldn’t do a low forceps delivery. If there is to be a reteaching of rotational forceps, they’d better catch us old codgers fast before we die off (I am 72) and grant us malpractice relief (I no longer have insurance). This is an art, not a science, and can’t be taught from a book or a computer model. Set up a crash course to teach this dying art, pay us well, and perhaps we will be able to pass this skill along. Otherwise it will be gone forever.

I have always said that forceps are like a shoehorn—used correctly, they make things so much easier.
Robert Frischer, MD


Wichita Falls, Texas

“IS SUPPLEMENTAL ULTRASONO­G-RAPHY A VALUABLE ADDITION TO BREAST CANCER SCREENING FOR WOMEN WITH DENSE BREASTS?”
MARK D. PEARLMAN, MD (EXAMINING THE EVIDENCE; MARCH 2015)

Why I now recommend 3D ultrasonography to my high-risk patients
In 2012, I attended a medical staff meeting where Dr. Ruby Chang spoke about a newly available modality at our hospital: 3D ultrasonography. Her slideshow included some impressive images of cancers that were not seen on mammogram but were unmistakable on sonography.

I decided to have a 3D ultrasound for myself in order to tell my patients what it was like. I also have “heterogeneously dense breasts” on mammogram. For the previous 10 years, my annual screening mammograms had all been negative. The 3D ultrasound showed an 8-mm cancer in my left breast—not palpable to me. A subsequent mammogram was still negative for cancer.

Luckily, the breast cancer was Stage 1 at surgery, and I did not need chemotherapy or radiation, opting for skin- and nipple-sparing double mastectomy. I had a double mastectomy because I believed that I could no longer trust screening mammo­graphy for a timely diagnosis.

To this day, I explain breast density to all of my higher-risk patients who have either heterogeneously or extremely dense breasts. I tell them that their mammograms may miss a cancer and that there is another test that might help detect cancer early. It’s a good thing to have another way to evaluate the breast, especially when our patients are being sent letters about their “dense breasts.” (The majority of my patients do not understand what this means.)

I realize that data may show that this modality isn’t the perfect solution and may lead to more testing and procedures, but in my case, it was worth it!

Strangely, to this day, I have not had one patient who had breast cancer diagnosed in this way.

It’s a shame that insurance companies don’t cover even partial cost for eligible patients.
Bettina Zatuchni, MD

Pleasanton, California

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

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Do ACOG guidelines protect us from liability?
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Lucia DiVenere, Arnold D. Wharton MD, Joseph S. Sanfilippo MD, Steven R. Smith JD, Lynn Frame MD JD, Arnold P. Advincula MD, Benjamin Margolis MD, Philip Ivey MD, Elizabeth Street MD, Stephanie Bakaysa MD, Jeannie C. Kelly MD, Errol R. Norwitz MD, Erin Kiser DNP, Robert L. Barbieri MD, Tomas A. Hernandez MD, Manuel Mendizabal MD, Joe Walsh MD, William H. Barth Jr MD, Robert Frischer MD, Mark D. Pearlman MD, Bettina Zatuchni MD, SGR, sustainable growth rate, ACOG guidelines, statute of limitations, malpractice insurance, malpositioned IUDs, intrauterine device, Ebola during pregnancy, obstetrics and gynecology, residents in ObGyn, rotational forceps, supplemental ultrasonography, breast cancer screening, dense breasts, 3D ultrasonography
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Lucia DiVenere, Arnold D. Wharton MD, Joseph S. Sanfilippo MD, Steven R. Smith JD, Lynn Frame MD JD, Arnold P. Advincula MD, Benjamin Margolis MD, Philip Ivey MD, Elizabeth Street MD, Stephanie Bakaysa MD, Jeannie C. Kelly MD, Errol R. Norwitz MD, Erin Kiser DNP, Robert L. Barbieri MD, Tomas A. Hernandez MD, Manuel Mendizabal MD, Joe Walsh MD, William H. Barth Jr MD, Robert Frischer MD, Mark D. Pearlman MD, Bettina Zatuchni MD, SGR, sustainable growth rate, ACOG guidelines, statute of limitations, malpractice insurance, malpositioned IUDs, intrauterine device, Ebola during pregnancy, obstetrics and gynecology, residents in ObGyn, rotational forceps, supplemental ultrasonography, breast cancer screening, dense breasts, 3D ultrasonography
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‘Medicar’– shared decision making? part III

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Recently, my daughter asked my opinion of a salesperson’s suggestion that she spend extra for additional safety features on a new car she was buying. I recommended that the more safety features the better – after all it was her life that was at stake.

This led me to a stunning revelation. That unlike a car salesperson, when I work in my outpatient endovascular suite I don’t provide my patients with any information about added safety or long-term benefit of the devices in my armamentarium. Further, unlike car dealers who mark up prices for additional features, Medicare regulations oblige me to bear the cost of safer or more durable devices.

Imagine then a car-buying scenario similar to how my endosuite works. My daughter walks into the dealership and the salesperson, being a highly ethical chap, tells her that the base model costs $15,000 but the safest model has forward collision warning, a rear camera, and lane departure warnings; and it can even apply the brakes if it senses a collision. She asks him how much extra she needs to pay for these features, and is informed that according to government regulations under ‘Medicar’ he is not permitted to charge any extra. He will just throw them in at the base price!

Now I know most vascular surgeons would not like to be equated with car salespersons, but are we not also selling a product that may be improved by adding features that could be life or limb saving? For example a vascular surgeon might deploy a basic stent or a more expensive covered or drug-eluting stent. The premise is, of course, that these more costly stents offer a more durable result with less need for revisions which are associated with additional risk of complications. However, if we believe that is the case, is it not our obligation to advise the patient accordingly? More importantly is it not our obligation to actually use that device? But is it also our obligation to pay the premium? Rather, shouldn’t it have been reimbursed appropriately? And if not, why is it that we cannot offer the patient the option to purchase the improved stent just as if they were offered the opportunity to purchase an added safety feature for their new car? I am sure most would agree that many patients who could afford it would readily agree to pay for a stent that could limit the need for a repeat procedure. I am assured that this would be likely as the same restrictions do not apply in the pharmaceutical industry. Patients with cancer or another life-threatening condition often commit their entire savings to the cost of a new drug that may offer only a few months of extra life.

But in the convoluted system that we work in, Medicare and many insurance companies do not allow us to charge anything more than a predetermined amount usually based on the least expensive device. Until such time that a new device is definitively proven to be more efficacious, a process that usually takes many years, reimbursement will be so low as to make it financially unsustainable for physicians to use these devices in their outpatient facilities. The result is that patients remain uninformed, are left out of the decision-making process, and may be receiving an inferior product.

Inpatients may also be kept in the dark about alternative devices since hospital administrators may be making cost-saving decisions that limit various devices. Even if these devices are available hospital-employed vascular surgeons are encouraged to be cost conscious and to limit use of expensive items. Given these circumstances I doubt that many vascular surgeons discuss their technical choices with their patients.

I understand the rationale for government, insurance companies, and hospitals to limit paying for expensive and unproven equipment. But surely patients should be given the opportunity to be part of the discussion and, if they so desire, to pay for a novel device that they believe may provide a better outcome. Of course, that assumes that they have the financial ability to pay such a supplement. Further, there is the moral dilemma on servicing the indigent or those with limited funds? Must they “drive the base model” or be forced to “take the bus” as there is currently no alternative solution?

Clearly the system is flawed, and it is time for change. I have three proposals. Firstly, require Industry and CMS to speed up evaluation of new products and if they appear beneficial, but more costly, make sure that hospitals and endovascular centers are appropriately reimbursed for their use. Second, legislate that devices proven to be inferior can no longer be marketed except in special circumstances such as patients with limited life expectancy. It may be economically necessary for automobile manufacturers to build cars without expensive enhanced features. But even they must make some safety features available in their basic models. Surely medical equipment companies should be held to an even higher standard? Third, following on the automobile analogy, if patients are ultimately allowed to purchase a more expensive product, the government could levy a “Luxury Tax” just as they do with expensive gas-guzzler cars. These funds could be used to help offset the costs of providing more expensive devices for patients with limited means.

 

 

Until such time as these changes come about a physician should always use the devices that are most trustworthy despite financial constraints. Where appropriate we should educate patients as to the reasons that one device was selected over another. More importantly we should inform them as to why current reimbursement practices have excluded them from decisions that could potentially save their life or limbs. Change will occur only when our educated, concerned patients pressure their legislators and complain that current reimbursement practices are forcing them to travel the road to health in an unsafe vehicle.

Dr. Samson is a clinical professor of surgery (vascular) at Florida State University Medical School, is president, Mote Vascular Foundation, and is an attending vascular surgeon, Sarasota (Fla.) Vascular Specialists. Dr. Samson also considers himself a member of his proposed American College of Vascular Surgery.

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Recently, my daughter asked my opinion of a salesperson’s suggestion that she spend extra for additional safety features on a new car she was buying. I recommended that the more safety features the better – after all it was her life that was at stake.

This led me to a stunning revelation. That unlike a car salesperson, when I work in my outpatient endovascular suite I don’t provide my patients with any information about added safety or long-term benefit of the devices in my armamentarium. Further, unlike car dealers who mark up prices for additional features, Medicare regulations oblige me to bear the cost of safer or more durable devices.

Imagine then a car-buying scenario similar to how my endosuite works. My daughter walks into the dealership and the salesperson, being a highly ethical chap, tells her that the base model costs $15,000 but the safest model has forward collision warning, a rear camera, and lane departure warnings; and it can even apply the brakes if it senses a collision. She asks him how much extra she needs to pay for these features, and is informed that according to government regulations under ‘Medicar’ he is not permitted to charge any extra. He will just throw them in at the base price!

Now I know most vascular surgeons would not like to be equated with car salespersons, but are we not also selling a product that may be improved by adding features that could be life or limb saving? For example a vascular surgeon might deploy a basic stent or a more expensive covered or drug-eluting stent. The premise is, of course, that these more costly stents offer a more durable result with less need for revisions which are associated with additional risk of complications. However, if we believe that is the case, is it not our obligation to advise the patient accordingly? More importantly is it not our obligation to actually use that device? But is it also our obligation to pay the premium? Rather, shouldn’t it have been reimbursed appropriately? And if not, why is it that we cannot offer the patient the option to purchase the improved stent just as if they were offered the opportunity to purchase an added safety feature for their new car? I am sure most would agree that many patients who could afford it would readily agree to pay for a stent that could limit the need for a repeat procedure. I am assured that this would be likely as the same restrictions do not apply in the pharmaceutical industry. Patients with cancer or another life-threatening condition often commit their entire savings to the cost of a new drug that may offer only a few months of extra life.

But in the convoluted system that we work in, Medicare and many insurance companies do not allow us to charge anything more than a predetermined amount usually based on the least expensive device. Until such time that a new device is definitively proven to be more efficacious, a process that usually takes many years, reimbursement will be so low as to make it financially unsustainable for physicians to use these devices in their outpatient facilities. The result is that patients remain uninformed, are left out of the decision-making process, and may be receiving an inferior product.

Inpatients may also be kept in the dark about alternative devices since hospital administrators may be making cost-saving decisions that limit various devices. Even if these devices are available hospital-employed vascular surgeons are encouraged to be cost conscious and to limit use of expensive items. Given these circumstances I doubt that many vascular surgeons discuss their technical choices with their patients.

I understand the rationale for government, insurance companies, and hospitals to limit paying for expensive and unproven equipment. But surely patients should be given the opportunity to be part of the discussion and, if they so desire, to pay for a novel device that they believe may provide a better outcome. Of course, that assumes that they have the financial ability to pay such a supplement. Further, there is the moral dilemma on servicing the indigent or those with limited funds? Must they “drive the base model” or be forced to “take the bus” as there is currently no alternative solution?

Clearly the system is flawed, and it is time for change. I have three proposals. Firstly, require Industry and CMS to speed up evaluation of new products and if they appear beneficial, but more costly, make sure that hospitals and endovascular centers are appropriately reimbursed for their use. Second, legislate that devices proven to be inferior can no longer be marketed except in special circumstances such as patients with limited life expectancy. It may be economically necessary for automobile manufacturers to build cars without expensive enhanced features. But even they must make some safety features available in their basic models. Surely medical equipment companies should be held to an even higher standard? Third, following on the automobile analogy, if patients are ultimately allowed to purchase a more expensive product, the government could levy a “Luxury Tax” just as they do with expensive gas-guzzler cars. These funds could be used to help offset the costs of providing more expensive devices for patients with limited means.

 

 

Until such time as these changes come about a physician should always use the devices that are most trustworthy despite financial constraints. Where appropriate we should educate patients as to the reasons that one device was selected over another. More importantly we should inform them as to why current reimbursement practices have excluded them from decisions that could potentially save their life or limbs. Change will occur only when our educated, concerned patients pressure their legislators and complain that current reimbursement practices are forcing them to travel the road to health in an unsafe vehicle.

Dr. Samson is a clinical professor of surgery (vascular) at Florida State University Medical School, is president, Mote Vascular Foundation, and is an attending vascular surgeon, Sarasota (Fla.) Vascular Specialists. Dr. Samson also considers himself a member of his proposed American College of Vascular Surgery.

Recently, my daughter asked my opinion of a salesperson’s suggestion that she spend extra for additional safety features on a new car she was buying. I recommended that the more safety features the better – after all it was her life that was at stake.

This led me to a stunning revelation. That unlike a car salesperson, when I work in my outpatient endovascular suite I don’t provide my patients with any information about added safety or long-term benefit of the devices in my armamentarium. Further, unlike car dealers who mark up prices for additional features, Medicare regulations oblige me to bear the cost of safer or more durable devices.

Imagine then a car-buying scenario similar to how my endosuite works. My daughter walks into the dealership and the salesperson, being a highly ethical chap, tells her that the base model costs $15,000 but the safest model has forward collision warning, a rear camera, and lane departure warnings; and it can even apply the brakes if it senses a collision. She asks him how much extra she needs to pay for these features, and is informed that according to government regulations under ‘Medicar’ he is not permitted to charge any extra. He will just throw them in at the base price!

Now I know most vascular surgeons would not like to be equated with car salespersons, but are we not also selling a product that may be improved by adding features that could be life or limb saving? For example a vascular surgeon might deploy a basic stent or a more expensive covered or drug-eluting stent. The premise is, of course, that these more costly stents offer a more durable result with less need for revisions which are associated with additional risk of complications. However, if we believe that is the case, is it not our obligation to advise the patient accordingly? More importantly is it not our obligation to actually use that device? But is it also our obligation to pay the premium? Rather, shouldn’t it have been reimbursed appropriately? And if not, why is it that we cannot offer the patient the option to purchase the improved stent just as if they were offered the opportunity to purchase an added safety feature for their new car? I am sure most would agree that many patients who could afford it would readily agree to pay for a stent that could limit the need for a repeat procedure. I am assured that this would be likely as the same restrictions do not apply in the pharmaceutical industry. Patients with cancer or another life-threatening condition often commit their entire savings to the cost of a new drug that may offer only a few months of extra life.

But in the convoluted system that we work in, Medicare and many insurance companies do not allow us to charge anything more than a predetermined amount usually based on the least expensive device. Until such time that a new device is definitively proven to be more efficacious, a process that usually takes many years, reimbursement will be so low as to make it financially unsustainable for physicians to use these devices in their outpatient facilities. The result is that patients remain uninformed, are left out of the decision-making process, and may be receiving an inferior product.

Inpatients may also be kept in the dark about alternative devices since hospital administrators may be making cost-saving decisions that limit various devices. Even if these devices are available hospital-employed vascular surgeons are encouraged to be cost conscious and to limit use of expensive items. Given these circumstances I doubt that many vascular surgeons discuss their technical choices with their patients.

I understand the rationale for government, insurance companies, and hospitals to limit paying for expensive and unproven equipment. But surely patients should be given the opportunity to be part of the discussion and, if they so desire, to pay for a novel device that they believe may provide a better outcome. Of course, that assumes that they have the financial ability to pay such a supplement. Further, there is the moral dilemma on servicing the indigent or those with limited funds? Must they “drive the base model” or be forced to “take the bus” as there is currently no alternative solution?

Clearly the system is flawed, and it is time for change. I have three proposals. Firstly, require Industry and CMS to speed up evaluation of new products and if they appear beneficial, but more costly, make sure that hospitals and endovascular centers are appropriately reimbursed for their use. Second, legislate that devices proven to be inferior can no longer be marketed except in special circumstances such as patients with limited life expectancy. It may be economically necessary for automobile manufacturers to build cars without expensive enhanced features. But even they must make some safety features available in their basic models. Surely medical equipment companies should be held to an even higher standard? Third, following on the automobile analogy, if patients are ultimately allowed to purchase a more expensive product, the government could levy a “Luxury Tax” just as they do with expensive gas-guzzler cars. These funds could be used to help offset the costs of providing more expensive devices for patients with limited means.

 

 

Until such time as these changes come about a physician should always use the devices that are most trustworthy despite financial constraints. Where appropriate we should educate patients as to the reasons that one device was selected over another. More importantly we should inform them as to why current reimbursement practices have excluded them from decisions that could potentially save their life or limbs. Change will occur only when our educated, concerned patients pressure their legislators and complain that current reimbursement practices are forcing them to travel the road to health in an unsafe vehicle.

Dr. Samson is a clinical professor of surgery (vascular) at Florida State University Medical School, is president, Mote Vascular Foundation, and is an attending vascular surgeon, Sarasota (Fla.) Vascular Specialists. Dr. Samson also considers himself a member of his proposed American College of Vascular Surgery.

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Commentary to "The Burden of Craft in Arthroscopic Rotator Cuff Repair: Where We Have Been and Where We Are Going"

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“The Burden of Craft in Arthroscopic Rotator Cuff Repair” is a summary of the annual Neer Lecture that was delivered by Stephen S. Burkhart, MD, at the 2014 annual meeting of American Shoulder and Elbow Surgeons. It is a fascinating personal story of the 35-year evolution of arthroscopic rotator cuff surgery presented by one of the most respected arthroscopic innovators of our times. I especially enjoyed his apt citations of classic leaders—Churchill and Gandhi—but 3 points I believe deserve special comment.

First, Steve describes the challenges he faced bringing new products to market in the 1980s. How do we resolve the inherent conflict between innovation that introduces new technology and the “tried and true” standards of established practice? Do the hard work that Steve has done over the years: pose a hypothesis, design a study to answer the question, publish results in peer-reviewed journals, and embrace the techniques that demonstrate better outcomes for patients.

My second point relates to surgeon–device industry relationships, a subject of great interest to The American Journal of Orthopedics dating back to 2006.1-3 Dr. Burkhart learned early on that he could not fashion new arthroscopic instruments in his garage. Nor could a company develop useful instruments without a knowledgeable surgeon’s input. Hence, a partnership between the innovator-surgeon and the device industry is essential to bring new and effective “tools” to market. Dr. Burkhart’s partnership with Arthrex has benefited many thousands of patients.

The agreements announced in 2007 between the US Department of Justice and 5 orthopedic device manufacturers (interestingly, current presidential candidate and Governor of New Jersey Chris Christie was the lead US Attorney on the case!) dramatically altered the surgeon–industry interaction and established strict guidelines that governed these relationships.4 These were needed reforms. However, the changes did not preclude an entrepreneurial surgeon with great ideas and a device manufacturer from profiting from excellent products that advanced patient care, provided, quoting from my editorial of 2006, “that these partnerships comply with legal and ethical standards” and are transparent as well as fully disclosed.1

Finally, Steve’s last point focuses on the “burden of craft,” a topic dear to all orthopedic surgeons and our professional societies. All of us are committed to improving our surgical skills and, as a profession, we are consistently engaged in learning from our talented colleagues, who are only too willing to share their expertise. The burden of craft requires eager students and dedicated teachers, all committed to the same goal—better outcomes for our patients. We are indeed fortunate that, as orthopedic surgeons, we fundamentally support a culture of continued learning.

I thank Steve for his eloquent paper on this important principle.

References

1.    McCann PD. Are surgeons accepting bribes? Am J Orthop. 2006;35(3):114.

2.    Byrd AB, Tearney MB. Are you being bribed? Health care ethics and compliance in the AdvaMed Code era. Part I. Am J Orthop. 2006;35(3):117-120.

3.    Byrd AB, Tearney MB. Are you being bribed? Health care ethics and compliance in the AdvaMed Code era. Part II. Am J Orthop. 2006;35(4):166-171.

4      Five companies in hip and knee replacement industry avoid prosecution by agreeing to compliance rules and monitoring [press release]. US Department of Justice website. http://www.justice.gov/usao/nj/Press/files/pdffiles/Older/hips0927.rel.pdf. Published September 27, 2007. Accessed July 14, 2015.

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“The Burden of Craft in Arthroscopic Rotator Cuff Repair” is a summary of the annual Neer Lecture that was delivered by Stephen S. Burkhart, MD, at the 2014 annual meeting of American Shoulder and Elbow Surgeons. It is a fascinating personal story of the 35-year evolution of arthroscopic rotator cuff surgery presented by one of the most respected arthroscopic innovators of our times. I especially enjoyed his apt citations of classic leaders—Churchill and Gandhi—but 3 points I believe deserve special comment.

First, Steve describes the challenges he faced bringing new products to market in the 1980s. How do we resolve the inherent conflict between innovation that introduces new technology and the “tried and true” standards of established practice? Do the hard work that Steve has done over the years: pose a hypothesis, design a study to answer the question, publish results in peer-reviewed journals, and embrace the techniques that demonstrate better outcomes for patients.

My second point relates to surgeon–device industry relationships, a subject of great interest to The American Journal of Orthopedics dating back to 2006.1-3 Dr. Burkhart learned early on that he could not fashion new arthroscopic instruments in his garage. Nor could a company develop useful instruments without a knowledgeable surgeon’s input. Hence, a partnership between the innovator-surgeon and the device industry is essential to bring new and effective “tools” to market. Dr. Burkhart’s partnership with Arthrex has benefited many thousands of patients.

The agreements announced in 2007 between the US Department of Justice and 5 orthopedic device manufacturers (interestingly, current presidential candidate and Governor of New Jersey Chris Christie was the lead US Attorney on the case!) dramatically altered the surgeon–industry interaction and established strict guidelines that governed these relationships.4 These were needed reforms. However, the changes did not preclude an entrepreneurial surgeon with great ideas and a device manufacturer from profiting from excellent products that advanced patient care, provided, quoting from my editorial of 2006, “that these partnerships comply with legal and ethical standards” and are transparent as well as fully disclosed.1

Finally, Steve’s last point focuses on the “burden of craft,” a topic dear to all orthopedic surgeons and our professional societies. All of us are committed to improving our surgical skills and, as a profession, we are consistently engaged in learning from our talented colleagues, who are only too willing to share their expertise. The burden of craft requires eager students and dedicated teachers, all committed to the same goal—better outcomes for our patients. We are indeed fortunate that, as orthopedic surgeons, we fundamentally support a culture of continued learning.

I thank Steve for his eloquent paper on this important principle.

“The Burden of Craft in Arthroscopic Rotator Cuff Repair” is a summary of the annual Neer Lecture that was delivered by Stephen S. Burkhart, MD, at the 2014 annual meeting of American Shoulder and Elbow Surgeons. It is a fascinating personal story of the 35-year evolution of arthroscopic rotator cuff surgery presented by one of the most respected arthroscopic innovators of our times. I especially enjoyed his apt citations of classic leaders—Churchill and Gandhi—but 3 points I believe deserve special comment.

First, Steve describes the challenges he faced bringing new products to market in the 1980s. How do we resolve the inherent conflict between innovation that introduces new technology and the “tried and true” standards of established practice? Do the hard work that Steve has done over the years: pose a hypothesis, design a study to answer the question, publish results in peer-reviewed journals, and embrace the techniques that demonstrate better outcomes for patients.

My second point relates to surgeon–device industry relationships, a subject of great interest to The American Journal of Orthopedics dating back to 2006.1-3 Dr. Burkhart learned early on that he could not fashion new arthroscopic instruments in his garage. Nor could a company develop useful instruments without a knowledgeable surgeon’s input. Hence, a partnership between the innovator-surgeon and the device industry is essential to bring new and effective “tools” to market. Dr. Burkhart’s partnership with Arthrex has benefited many thousands of patients.

The agreements announced in 2007 between the US Department of Justice and 5 orthopedic device manufacturers (interestingly, current presidential candidate and Governor of New Jersey Chris Christie was the lead US Attorney on the case!) dramatically altered the surgeon–industry interaction and established strict guidelines that governed these relationships.4 These were needed reforms. However, the changes did not preclude an entrepreneurial surgeon with great ideas and a device manufacturer from profiting from excellent products that advanced patient care, provided, quoting from my editorial of 2006, “that these partnerships comply with legal and ethical standards” and are transparent as well as fully disclosed.1

Finally, Steve’s last point focuses on the “burden of craft,” a topic dear to all orthopedic surgeons and our professional societies. All of us are committed to improving our surgical skills and, as a profession, we are consistently engaged in learning from our talented colleagues, who are only too willing to share their expertise. The burden of craft requires eager students and dedicated teachers, all committed to the same goal—better outcomes for our patients. We are indeed fortunate that, as orthopedic surgeons, we fundamentally support a culture of continued learning.

I thank Steve for his eloquent paper on this important principle.

References

1.    McCann PD. Are surgeons accepting bribes? Am J Orthop. 2006;35(3):114.

2.    Byrd AB, Tearney MB. Are you being bribed? Health care ethics and compliance in the AdvaMed Code era. Part I. Am J Orthop. 2006;35(3):117-120.

3.    Byrd AB, Tearney MB. Are you being bribed? Health care ethics and compliance in the AdvaMed Code era. Part II. Am J Orthop. 2006;35(4):166-171.

4      Five companies in hip and knee replacement industry avoid prosecution by agreeing to compliance rules and monitoring [press release]. US Department of Justice website. http://www.justice.gov/usao/nj/Press/files/pdffiles/Older/hips0927.rel.pdf. Published September 27, 2007. Accessed July 14, 2015.

References

1.    McCann PD. Are surgeons accepting bribes? Am J Orthop. 2006;35(3):114.

2.    Byrd AB, Tearney MB. Are you being bribed? Health care ethics and compliance in the AdvaMed Code era. Part I. Am J Orthop. 2006;35(3):117-120.

3.    Byrd AB, Tearney MB. Are you being bribed? Health care ethics and compliance in the AdvaMed Code era. Part II. Am J Orthop. 2006;35(4):166-171.

4      Five companies in hip and knee replacement industry avoid prosecution by agreeing to compliance rules and monitoring [press release]. US Department of Justice website. http://www.justice.gov/usao/nj/Press/files/pdffiles/Older/hips0927.rel.pdf. Published September 27, 2007. Accessed July 14, 2015.

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Encourage good nutrition and exercise

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With lots of opportunity to run and play, and an abundance of fresh, seasonal fruits and vegetables, summer is the perfect time to talk with families about developing healthy habits for a lifetime. Add to that the large volume of children seen in the summer for school physicals, and the string of recent reports about the importance of fostering good habits, and this is a timely topic to bring up in your practice.

In July, the American Academy of Pediatrics released a clinical report, “The Role of the Pediatrician in Primary Prevention of Obesity,” encouraging the support of healthy eating, exercise, and good screen time habits from an early age, with practical tips for the pediatrician (Pediatrics 2015 [doi:10.1542/peds.2015-1558]).

As an illustration of why these things are important, just 1 month earlier an article in Pediatrics, “Active Play Opportunities in Child Care,” demonstrated decreased opportunities for preschoolers in child care to engage in active play (Pediatrics 2015 [doi:10.1542/peds.2014-2750]). Earlier this winter, another paper described how televisions and “small screens” (for example, smartphones and tablets) in the room at night can decrease sleep duration and restfulness (Pediatrics 2015 [doi:10.1542/peds.2014-2306]).

Dr. Lee Savio Beers

Understandably, many parents – myself included – have a lot to worry about every day and cringe at the thought of just one more thing to do or think about. I think it is helpful to have a few key tips you can share with parents to help them make small but meaningful changes, or – even better – set up good habits from the start. I share a few of my own below, and I am sure all of you have many more great ideas!

• No (or, realistically, very little) juice. This is a hard one, and often an uphill battle, as juice is available at child care centers, through the WIC program, and at every birthday party or class celebration you go to. This is advice I give parents very early on, given that if their child develops the habit from the beginning of drinking water and milk only, and doesn’t have regular access to juice, it is much easier to make it just an occasional, special thing. I tell parents that juice is high in sugar and calories, but because it tastes good, kids (and adults) are prone to drink way too much of it. I also share tips for making water taste a little more appealing – add a lemon slice, a squirt of lemon juice, or a sprig of mint, or offer sparkling water (without added sugar – all drinks except milk should be 10 calories or less per serving) as a treat.

• Limit screen time. Really. I know as much as anyone how hard that is to do, and sometimes there are times when your kids watch way more TV than you know they should, but that should be the exception rather than the rule. Make sure there are lots of books available, all the time. Books can be expensive, so regular library trips are a great way to keep a wide variety of interesting books around the house. Stash little buckets or baskets of small toys and puzzles throughout the house so that no matter where you are, when your kids say “I’m bored,” you can say, “Why don’t you pull out that basket over there and find something to play with?” (And be willing to listen to a little whining while your kids do find something else to do). Get out of the house – if you are not in the room with the TV, it is easier to say no – even if it is just to take the kids grocery shopping, get the car washed, or run a few errands (but don’t let them play with your phone while you are out…). Think long and hard about when your children need their own phones, and if it has to be a smartphone or can just be an old-fashioned flip phone. You will find it is probably not as soon as you think. Keep “small screens” and TVs out of your kid’s room. And – this one is hard for me too – put your own devices down anytime you can while your kids are awake.

• Stay active. Find time every day to move a little. Think about how you can alter your schedule to walk places instead of drive, stop by the playground after school, or find after-school activities that keep kids moving (many of these activities, especially if they are sponsored by the school, are free, so definitely take advantage of them). My daughter and I have started running together every Sunday morning; it is wonderful exercise for both of us and has been a really nice opportunity to have some quiet time together, talking about her week and the things going on in her life.

 

 

I think it also is important to tell parents that no one is perfect all the time. They should do their best to implement and model healthy habits, but should not beat themselves up if they find they are not where they want to be. They should just regroup, make a few changes, and keep moving forward. Then, not only will they model healthy habits for their kids, but they will model for them how to manage the expected ups and downs of life, another important lifelong lesson!

Dr. Beers is assistant professor of pediatrics at Children’s National Medical Center and the George Washington University Medical Center, Washington. She is chair of the American Academy of Pediatrics Committee on Residency Scholarships and immediate past president of the District of Columbia chapter of the American Academy of Pediatrics. E-mail Dr. Beers at [email protected].

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With lots of opportunity to run and play, and an abundance of fresh, seasonal fruits and vegetables, summer is the perfect time to talk with families about developing healthy habits for a lifetime. Add to that the large volume of children seen in the summer for school physicals, and the string of recent reports about the importance of fostering good habits, and this is a timely topic to bring up in your practice.

In July, the American Academy of Pediatrics released a clinical report, “The Role of the Pediatrician in Primary Prevention of Obesity,” encouraging the support of healthy eating, exercise, and good screen time habits from an early age, with practical tips for the pediatrician (Pediatrics 2015 [doi:10.1542/peds.2015-1558]).

As an illustration of why these things are important, just 1 month earlier an article in Pediatrics, “Active Play Opportunities in Child Care,” demonstrated decreased opportunities for preschoolers in child care to engage in active play (Pediatrics 2015 [doi:10.1542/peds.2014-2750]). Earlier this winter, another paper described how televisions and “small screens” (for example, smartphones and tablets) in the room at night can decrease sleep duration and restfulness (Pediatrics 2015 [doi:10.1542/peds.2014-2306]).

Dr. Lee Savio Beers

Understandably, many parents – myself included – have a lot to worry about every day and cringe at the thought of just one more thing to do or think about. I think it is helpful to have a few key tips you can share with parents to help them make small but meaningful changes, or – even better – set up good habits from the start. I share a few of my own below, and I am sure all of you have many more great ideas!

• No (or, realistically, very little) juice. This is a hard one, and often an uphill battle, as juice is available at child care centers, through the WIC program, and at every birthday party or class celebration you go to. This is advice I give parents very early on, given that if their child develops the habit from the beginning of drinking water and milk only, and doesn’t have regular access to juice, it is much easier to make it just an occasional, special thing. I tell parents that juice is high in sugar and calories, but because it tastes good, kids (and adults) are prone to drink way too much of it. I also share tips for making water taste a little more appealing – add a lemon slice, a squirt of lemon juice, or a sprig of mint, or offer sparkling water (without added sugar – all drinks except milk should be 10 calories or less per serving) as a treat.

• Limit screen time. Really. I know as much as anyone how hard that is to do, and sometimes there are times when your kids watch way more TV than you know they should, but that should be the exception rather than the rule. Make sure there are lots of books available, all the time. Books can be expensive, so regular library trips are a great way to keep a wide variety of interesting books around the house. Stash little buckets or baskets of small toys and puzzles throughout the house so that no matter where you are, when your kids say “I’m bored,” you can say, “Why don’t you pull out that basket over there and find something to play with?” (And be willing to listen to a little whining while your kids do find something else to do). Get out of the house – if you are not in the room with the TV, it is easier to say no – even if it is just to take the kids grocery shopping, get the car washed, or run a few errands (but don’t let them play with your phone while you are out…). Think long and hard about when your children need their own phones, and if it has to be a smartphone or can just be an old-fashioned flip phone. You will find it is probably not as soon as you think. Keep “small screens” and TVs out of your kid’s room. And – this one is hard for me too – put your own devices down anytime you can while your kids are awake.

• Stay active. Find time every day to move a little. Think about how you can alter your schedule to walk places instead of drive, stop by the playground after school, or find after-school activities that keep kids moving (many of these activities, especially if they are sponsored by the school, are free, so definitely take advantage of them). My daughter and I have started running together every Sunday morning; it is wonderful exercise for both of us and has been a really nice opportunity to have some quiet time together, talking about her week and the things going on in her life.

 

 

I think it also is important to tell parents that no one is perfect all the time. They should do their best to implement and model healthy habits, but should not beat themselves up if they find they are not where they want to be. They should just regroup, make a few changes, and keep moving forward. Then, not only will they model healthy habits for their kids, but they will model for them how to manage the expected ups and downs of life, another important lifelong lesson!

Dr. Beers is assistant professor of pediatrics at Children’s National Medical Center and the George Washington University Medical Center, Washington. She is chair of the American Academy of Pediatrics Committee on Residency Scholarships and immediate past president of the District of Columbia chapter of the American Academy of Pediatrics. E-mail Dr. Beers at [email protected].

With lots of opportunity to run and play, and an abundance of fresh, seasonal fruits and vegetables, summer is the perfect time to talk with families about developing healthy habits for a lifetime. Add to that the large volume of children seen in the summer for school physicals, and the string of recent reports about the importance of fostering good habits, and this is a timely topic to bring up in your practice.

In July, the American Academy of Pediatrics released a clinical report, “The Role of the Pediatrician in Primary Prevention of Obesity,” encouraging the support of healthy eating, exercise, and good screen time habits from an early age, with practical tips for the pediatrician (Pediatrics 2015 [doi:10.1542/peds.2015-1558]).

As an illustration of why these things are important, just 1 month earlier an article in Pediatrics, “Active Play Opportunities in Child Care,” demonstrated decreased opportunities for preschoolers in child care to engage in active play (Pediatrics 2015 [doi:10.1542/peds.2014-2750]). Earlier this winter, another paper described how televisions and “small screens” (for example, smartphones and tablets) in the room at night can decrease sleep duration and restfulness (Pediatrics 2015 [doi:10.1542/peds.2014-2306]).

Dr. Lee Savio Beers

Understandably, many parents – myself included – have a lot to worry about every day and cringe at the thought of just one more thing to do or think about. I think it is helpful to have a few key tips you can share with parents to help them make small but meaningful changes, or – even better – set up good habits from the start. I share a few of my own below, and I am sure all of you have many more great ideas!

• No (or, realistically, very little) juice. This is a hard one, and often an uphill battle, as juice is available at child care centers, through the WIC program, and at every birthday party or class celebration you go to. This is advice I give parents very early on, given that if their child develops the habit from the beginning of drinking water and milk only, and doesn’t have regular access to juice, it is much easier to make it just an occasional, special thing. I tell parents that juice is high in sugar and calories, but because it tastes good, kids (and adults) are prone to drink way too much of it. I also share tips for making water taste a little more appealing – add a lemon slice, a squirt of lemon juice, or a sprig of mint, or offer sparkling water (without added sugar – all drinks except milk should be 10 calories or less per serving) as a treat.

• Limit screen time. Really. I know as much as anyone how hard that is to do, and sometimes there are times when your kids watch way more TV than you know they should, but that should be the exception rather than the rule. Make sure there are lots of books available, all the time. Books can be expensive, so regular library trips are a great way to keep a wide variety of interesting books around the house. Stash little buckets or baskets of small toys and puzzles throughout the house so that no matter where you are, when your kids say “I’m bored,” you can say, “Why don’t you pull out that basket over there and find something to play with?” (And be willing to listen to a little whining while your kids do find something else to do). Get out of the house – if you are not in the room with the TV, it is easier to say no – even if it is just to take the kids grocery shopping, get the car washed, or run a few errands (but don’t let them play with your phone while you are out…). Think long and hard about when your children need their own phones, and if it has to be a smartphone or can just be an old-fashioned flip phone. You will find it is probably not as soon as you think. Keep “small screens” and TVs out of your kid’s room. And – this one is hard for me too – put your own devices down anytime you can while your kids are awake.

• Stay active. Find time every day to move a little. Think about how you can alter your schedule to walk places instead of drive, stop by the playground after school, or find after-school activities that keep kids moving (many of these activities, especially if they are sponsored by the school, are free, so definitely take advantage of them). My daughter and I have started running together every Sunday morning; it is wonderful exercise for both of us and has been a really nice opportunity to have some quiet time together, talking about her week and the things going on in her life.

 

 

I think it also is important to tell parents that no one is perfect all the time. They should do their best to implement and model healthy habits, but should not beat themselves up if they find they are not where they want to be. They should just regroup, make a few changes, and keep moving forward. Then, not only will they model healthy habits for their kids, but they will model for them how to manage the expected ups and downs of life, another important lifelong lesson!

Dr. Beers is assistant professor of pediatrics at Children’s National Medical Center and the George Washington University Medical Center, Washington. She is chair of the American Academy of Pediatrics Committee on Residency Scholarships and immediate past president of the District of Columbia chapter of the American Academy of Pediatrics. E-mail Dr. Beers at [email protected].

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A Summer Bonanza of Upper Extremity Articles

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A Summer Bonanza of Upper Extremity Articles

This issue of The American Journal of Orthopedics has several very interesting articles for the upper extremity surgeon. The first one that I would like to talk about is “Trends in Thumb Carpometacarpal Interposition Arthroplasty in the United States, 2005–2011” by Dr. Werner and colleagues (pages 363-368). This is a condition that has deep penetration in the US population. As a group, surgical treatments have been evolving, with a number of innovations over the last few decades. Like many things in orthopedics, it is not easy to get “head to head” comparisons between different treatment arms. Nonetheless, although there are some studies that have indicated no particular advantage of 1 mechanism to another, it is interesting as a physician to review this data and follow these trends. This article indicates that, despite lack of strong evidence, individual surgeons have the impression that the operative treatments for basal joint or thumb arthritis are functioning better overall. I share that belief. 

I also enjoyed the article “5 Points on Shoulder Examination of the Overhead Athlete” by Dr. Makhni and Dr. Ahmad (pages 347-352). I think that the care of the musculoskeletal patient is important both in terms of screening and in terms of establishing reasonable indications and goals for rehabilitation as well as for surgical treatment. In this light, I found a lot of illuminating information in this review of the approach to the overhead athlete by these authors with deep experience in this arena. 

The next article that I would like to address is that on thoracic outlet syndrome by Dr. Buller and colleagues (pages 376-382). It has amazed me during my 3 decades in practice how common the condition of thoracic outlet syndrome is and how frequently the diagnosis is made in my own upper extremity practice. Unfortunately, these patients don’t come “labeled,” as this diagnosis remains somewhat mysterious and, certainly, the treatment somewhat controversial. However, identification and recognition of this clinical entity as well as being able to perform an adequate history and do the physical examination maneuvers to elicit the “nerve tension signs” around the thoracic outlet and brachial plexus are important. The descriptions of the history and physical examimation in this article are excellent. Certainly, advanced imaging and diagnostics can be helpful, but I feel that these tests are not adequate as screening tests, and the index of suspicion by you, the clinician, remains paramount in identifying and managing these patients. In my own practice, the vast majority of patients respond to physical therapy and home exercise programs when adequately performed and monitored.

I was fascinated to read Dr. Steve Burkhart’s Neer Guest Lecture, “The Burden of Craft in Arthroscopic Rotator Cuff Repair: Where We Have Been and Where We Are Going” (pages 353-358). He touches on many things in this lecture. Certainly he talks about the innovations that he has been responsible for and how some of these have come about. Interestingly enough, he has views on the role of the private practitioner and those outside of the “shoulder establishment” in contributing to a paradigm shift in treatment from open to arthroscopic techniques, of which he was certainly at the forefront. Additionally, he has some interesting thoughts on the limitations of level I evidence studies. This is a huge issue in orthopedics as it becomes very difficult to try to “randomize” patients into various treatment arms. Most people take their own bodies and the health of their bodies seriously enough to not want to determine treatment with a “flip of the coin.” I think this is quite different than taking a “red pill” or a “blue pill” in a drug study. Dr. Burkhart emphasizes the role of technical expertise as a variable that is not really adequately considered in level I evidence studies, and I wholeheartedly agree with him.

This issue of The American Journal of Orthopedics is rich in terms of its content, and I hope you enjoy reading these articles as much as I have enjoyed commenting on them.  ◾

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This issue of The American Journal of Orthopedics has several very interesting articles for the upper extremity surgeon. The first one that I would like to talk about is “Trends in Thumb Carpometacarpal Interposition Arthroplasty in the United States, 2005–2011” by Dr. Werner and colleagues (pages 363-368). This is a condition that has deep penetration in the US population. As a group, surgical treatments have been evolving, with a number of innovations over the last few decades. Like many things in orthopedics, it is not easy to get “head to head” comparisons between different treatment arms. Nonetheless, although there are some studies that have indicated no particular advantage of 1 mechanism to another, it is interesting as a physician to review this data and follow these trends. This article indicates that, despite lack of strong evidence, individual surgeons have the impression that the operative treatments for basal joint or thumb arthritis are functioning better overall. I share that belief. 

I also enjoyed the article “5 Points on Shoulder Examination of the Overhead Athlete” by Dr. Makhni and Dr. Ahmad (pages 347-352). I think that the care of the musculoskeletal patient is important both in terms of screening and in terms of establishing reasonable indications and goals for rehabilitation as well as for surgical treatment. In this light, I found a lot of illuminating information in this review of the approach to the overhead athlete by these authors with deep experience in this arena. 

The next article that I would like to address is that on thoracic outlet syndrome by Dr. Buller and colleagues (pages 376-382). It has amazed me during my 3 decades in practice how common the condition of thoracic outlet syndrome is and how frequently the diagnosis is made in my own upper extremity practice. Unfortunately, these patients don’t come “labeled,” as this diagnosis remains somewhat mysterious and, certainly, the treatment somewhat controversial. However, identification and recognition of this clinical entity as well as being able to perform an adequate history and do the physical examination maneuvers to elicit the “nerve tension signs” around the thoracic outlet and brachial plexus are important. The descriptions of the history and physical examimation in this article are excellent. Certainly, advanced imaging and diagnostics can be helpful, but I feel that these tests are not adequate as screening tests, and the index of suspicion by you, the clinician, remains paramount in identifying and managing these patients. In my own practice, the vast majority of patients respond to physical therapy and home exercise programs when adequately performed and monitored.

I was fascinated to read Dr. Steve Burkhart’s Neer Guest Lecture, “The Burden of Craft in Arthroscopic Rotator Cuff Repair: Where We Have Been and Where We Are Going” (pages 353-358). He touches on many things in this lecture. Certainly he talks about the innovations that he has been responsible for and how some of these have come about. Interestingly enough, he has views on the role of the private practitioner and those outside of the “shoulder establishment” in contributing to a paradigm shift in treatment from open to arthroscopic techniques, of which he was certainly at the forefront. Additionally, he has some interesting thoughts on the limitations of level I evidence studies. This is a huge issue in orthopedics as it becomes very difficult to try to “randomize” patients into various treatment arms. Most people take their own bodies and the health of their bodies seriously enough to not want to determine treatment with a “flip of the coin.” I think this is quite different than taking a “red pill” or a “blue pill” in a drug study. Dr. Burkhart emphasizes the role of technical expertise as a variable that is not really adequately considered in level I evidence studies, and I wholeheartedly agree with him.

This issue of The American Journal of Orthopedics is rich in terms of its content, and I hope you enjoy reading these articles as much as I have enjoyed commenting on them.  ◾

This issue of The American Journal of Orthopedics has several very interesting articles for the upper extremity surgeon. The first one that I would like to talk about is “Trends in Thumb Carpometacarpal Interposition Arthroplasty in the United States, 2005–2011” by Dr. Werner and colleagues (pages 363-368). This is a condition that has deep penetration in the US population. As a group, surgical treatments have been evolving, with a number of innovations over the last few decades. Like many things in orthopedics, it is not easy to get “head to head” comparisons between different treatment arms. Nonetheless, although there are some studies that have indicated no particular advantage of 1 mechanism to another, it is interesting as a physician to review this data and follow these trends. This article indicates that, despite lack of strong evidence, individual surgeons have the impression that the operative treatments for basal joint or thumb arthritis are functioning better overall. I share that belief. 

I also enjoyed the article “5 Points on Shoulder Examination of the Overhead Athlete” by Dr. Makhni and Dr. Ahmad (pages 347-352). I think that the care of the musculoskeletal patient is important both in terms of screening and in terms of establishing reasonable indications and goals for rehabilitation as well as for surgical treatment. In this light, I found a lot of illuminating information in this review of the approach to the overhead athlete by these authors with deep experience in this arena. 

The next article that I would like to address is that on thoracic outlet syndrome by Dr. Buller and colleagues (pages 376-382). It has amazed me during my 3 decades in practice how common the condition of thoracic outlet syndrome is and how frequently the diagnosis is made in my own upper extremity practice. Unfortunately, these patients don’t come “labeled,” as this diagnosis remains somewhat mysterious and, certainly, the treatment somewhat controversial. However, identification and recognition of this clinical entity as well as being able to perform an adequate history and do the physical examination maneuvers to elicit the “nerve tension signs” around the thoracic outlet and brachial plexus are important. The descriptions of the history and physical examimation in this article are excellent. Certainly, advanced imaging and diagnostics can be helpful, but I feel that these tests are not adequate as screening tests, and the index of suspicion by you, the clinician, remains paramount in identifying and managing these patients. In my own practice, the vast majority of patients respond to physical therapy and home exercise programs when adequately performed and monitored.

I was fascinated to read Dr. Steve Burkhart’s Neer Guest Lecture, “The Burden of Craft in Arthroscopic Rotator Cuff Repair: Where We Have Been and Where We Are Going” (pages 353-358). He touches on many things in this lecture. Certainly he talks about the innovations that he has been responsible for and how some of these have come about. Interestingly enough, he has views on the role of the private practitioner and those outside of the “shoulder establishment” in contributing to a paradigm shift in treatment from open to arthroscopic techniques, of which he was certainly at the forefront. Additionally, he has some interesting thoughts on the limitations of level I evidence studies. This is a huge issue in orthopedics as it becomes very difficult to try to “randomize” patients into various treatment arms. Most people take their own bodies and the health of their bodies seriously enough to not want to determine treatment with a “flip of the coin.” I think this is quite different than taking a “red pill” or a “blue pill” in a drug study. Dr. Burkhart emphasizes the role of technical expertise as a variable that is not really adequately considered in level I evidence studies, and I wholeheartedly agree with him.

This issue of The American Journal of Orthopedics is rich in terms of its content, and I hope you enjoy reading these articles as much as I have enjoyed commenting on them.  ◾

References

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Better treatment for chronic mental illness is long overdue

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News reports about tragedies involving people with chronic mental illness flash across our iPad and television screens with disturbing regularity.

We are constantly reminded that mental disorders are not on par with physical disorders. Instead, those with chronic mental illness are unfairly ignored and inadequately treated, and many continue to sleep in doorways, and live on the streets and in homeless shelters.

Dr. Robert T. London

This has been the scenario for those with chronic mental illness for quite some time. The advent of antipsychotics such as the prototype phenothiazine (Thorazine) and butyrophenones (Haloperidol) in the 1950s led to the discharging by the 1960s of more and more people with chronic mental illness into the community.

With many of their symptoms decreased, they were deemed ready to live in the community, and thousands were sent to outpatient care throughout the 1960s and 1970s, and continue to be. This trend continued as the number of antipsychotics and antidepressants grew, and became part of treatment protocols for psychotic and mood disorders. Institutional life also proved costly.

Psychiatrists, as well as other humanitarians and politicians, supported the idea of community-based psychiatric care. It would be aimed at allowing people with chronic mental illness to have housing and ongoing care, which, of course, included good medication management and psychosocial rehabilitation.

These ideas appeared compelling – at least on paper. However, as it turns out, the mass discharges from long-term mental health facilities cut costs at a high price. Money saved from deinstitutionalization seldom got put into the community for the proper care, treatment, and maintenance of people with chronic mental illness. Not only that, but patients who needed active care in a crisis usually had acute care short-term hospitalizations and did not have the networking for proper follow-up. Often, they relapsed again while facing everyday challenges.

I spoke recently with Robin Allen Kaynor, a New York City social worker who has spent years assessing clients with chronic mental illness. To her dismay and disappointment, little organized rehabilitative care is provided for these patients. As Ms. Kaynor pointed out, the care patients with chronic mental illness may receive often is administered weeks after their initial visits, if at all. Further complicating their prospects is not having a place to live, and poor nutrition and general health.

What can be done to improve the quality of life for patients with chronic mental illness? First, the psychiatric/psychological community needs to exert influence on policymakers and business leaders so that outpatient care is brought up to the standards envisioned decades ago. The court system and mental health advocates must work together to find ways to monitor those in need of care and to ensure that those who need care continue to receive it. We also must make sure that patients’ civil liberties remain intact.

Secondly, since “reinstitutionalization” has taken the form of shelters and prisons for so many people with chronic mental illness, why not develop more housing in well-staffed and humanistic therapeutic communities? Many of the psychiatric institutions abandoned years ago remain either partly occupied or unoccupied today. Why not modernize, expand, and use those spaces to provide long-term care for those with mental illness and develop a network of mental health rehabilitation centers? This approach would provide these patients with better therapeutic environments and the potential for rehabilitation. It also would lead to financial savings not only in psychiatric care but for physical care as well.

Again, if we implemented these ideas, we would need to make sure that outpatients’ civil liberties remained intact. It is worth noting, however, that today’s improved provider/patient communication might make such voluntary treatments increasingly possible.

Much is at stake, including patients’ physical health. Dr. Fazil Hussain, a New York City internist and infectious disease specialist, said in an interview that people with chronic mental illnesses suffer far more physical illnesses and a much shorter life span than do those in the general population. A recent meta-analysis of reviews and studies about people with serious mental illness found that the mortality gap between patients with serious mental illness and the general population ranges from 13 to 30 years (World Psychiatry 2011;10:52-77).

Longer-term rehabilitation treatments are used routinely in medicine today, particularly after certain surgeries and accidents. It’s time to reexamine the resources taken away decades ago from those with chronic mental illness. Expanding, modernizing, humanizing, and offering genuine long-term inpatient care, better use of medications, and rehabilitation over a longer period of time would be a great beginning to creating successful outpatient community-based treatment. All patients could get individualized psychiatric/medical management, and the psychosocial skills and confidence needed to live and thrive in the community. Psychiatric patients, who are among the most vulnerable people in our society, deserve this.

 

 

Dr. London is a psychiatrist who trained at NYU Langone Medical Center and Bellevue Hospital, both in New York, and developed and ran a short-term psychotherapy program at the medical center from 1975 through 1995. He has been a newspaper columnist for more than 30 years. He has no conflicts of interest.

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News reports about tragedies involving people with chronic mental illness flash across our iPad and television screens with disturbing regularity.

We are constantly reminded that mental disorders are not on par with physical disorders. Instead, those with chronic mental illness are unfairly ignored and inadequately treated, and many continue to sleep in doorways, and live on the streets and in homeless shelters.

Dr. Robert T. London

This has been the scenario for those with chronic mental illness for quite some time. The advent of antipsychotics such as the prototype phenothiazine (Thorazine) and butyrophenones (Haloperidol) in the 1950s led to the discharging by the 1960s of more and more people with chronic mental illness into the community.

With many of their symptoms decreased, they were deemed ready to live in the community, and thousands were sent to outpatient care throughout the 1960s and 1970s, and continue to be. This trend continued as the number of antipsychotics and antidepressants grew, and became part of treatment protocols for psychotic and mood disorders. Institutional life also proved costly.

Psychiatrists, as well as other humanitarians and politicians, supported the idea of community-based psychiatric care. It would be aimed at allowing people with chronic mental illness to have housing and ongoing care, which, of course, included good medication management and psychosocial rehabilitation.

These ideas appeared compelling – at least on paper. However, as it turns out, the mass discharges from long-term mental health facilities cut costs at a high price. Money saved from deinstitutionalization seldom got put into the community for the proper care, treatment, and maintenance of people with chronic mental illness. Not only that, but patients who needed active care in a crisis usually had acute care short-term hospitalizations and did not have the networking for proper follow-up. Often, they relapsed again while facing everyday challenges.

I spoke recently with Robin Allen Kaynor, a New York City social worker who has spent years assessing clients with chronic mental illness. To her dismay and disappointment, little organized rehabilitative care is provided for these patients. As Ms. Kaynor pointed out, the care patients with chronic mental illness may receive often is administered weeks after their initial visits, if at all. Further complicating their prospects is not having a place to live, and poor nutrition and general health.

What can be done to improve the quality of life for patients with chronic mental illness? First, the psychiatric/psychological community needs to exert influence on policymakers and business leaders so that outpatient care is brought up to the standards envisioned decades ago. The court system and mental health advocates must work together to find ways to monitor those in need of care and to ensure that those who need care continue to receive it. We also must make sure that patients’ civil liberties remain intact.

Secondly, since “reinstitutionalization” has taken the form of shelters and prisons for so many people with chronic mental illness, why not develop more housing in well-staffed and humanistic therapeutic communities? Many of the psychiatric institutions abandoned years ago remain either partly occupied or unoccupied today. Why not modernize, expand, and use those spaces to provide long-term care for those with mental illness and develop a network of mental health rehabilitation centers? This approach would provide these patients with better therapeutic environments and the potential for rehabilitation. It also would lead to financial savings not only in psychiatric care but for physical care as well.

Again, if we implemented these ideas, we would need to make sure that outpatients’ civil liberties remained intact. It is worth noting, however, that today’s improved provider/patient communication might make such voluntary treatments increasingly possible.

Much is at stake, including patients’ physical health. Dr. Fazil Hussain, a New York City internist and infectious disease specialist, said in an interview that people with chronic mental illnesses suffer far more physical illnesses and a much shorter life span than do those in the general population. A recent meta-analysis of reviews and studies about people with serious mental illness found that the mortality gap between patients with serious mental illness and the general population ranges from 13 to 30 years (World Psychiatry 2011;10:52-77).

Longer-term rehabilitation treatments are used routinely in medicine today, particularly after certain surgeries and accidents. It’s time to reexamine the resources taken away decades ago from those with chronic mental illness. Expanding, modernizing, humanizing, and offering genuine long-term inpatient care, better use of medications, and rehabilitation over a longer period of time would be a great beginning to creating successful outpatient community-based treatment. All patients could get individualized psychiatric/medical management, and the psychosocial skills and confidence needed to live and thrive in the community. Psychiatric patients, who are among the most vulnerable people in our society, deserve this.

 

 

Dr. London is a psychiatrist who trained at NYU Langone Medical Center and Bellevue Hospital, both in New York, and developed and ran a short-term psychotherapy program at the medical center from 1975 through 1995. He has been a newspaper columnist for more than 30 years. He has no conflicts of interest.

News reports about tragedies involving people with chronic mental illness flash across our iPad and television screens with disturbing regularity.

We are constantly reminded that mental disorders are not on par with physical disorders. Instead, those with chronic mental illness are unfairly ignored and inadequately treated, and many continue to sleep in doorways, and live on the streets and in homeless shelters.

Dr. Robert T. London

This has been the scenario for those with chronic mental illness for quite some time. The advent of antipsychotics such as the prototype phenothiazine (Thorazine) and butyrophenones (Haloperidol) in the 1950s led to the discharging by the 1960s of more and more people with chronic mental illness into the community.

With many of their symptoms decreased, they were deemed ready to live in the community, and thousands were sent to outpatient care throughout the 1960s and 1970s, and continue to be. This trend continued as the number of antipsychotics and antidepressants grew, and became part of treatment protocols for psychotic and mood disorders. Institutional life also proved costly.

Psychiatrists, as well as other humanitarians and politicians, supported the idea of community-based psychiatric care. It would be aimed at allowing people with chronic mental illness to have housing and ongoing care, which, of course, included good medication management and psychosocial rehabilitation.

These ideas appeared compelling – at least on paper. However, as it turns out, the mass discharges from long-term mental health facilities cut costs at a high price. Money saved from deinstitutionalization seldom got put into the community for the proper care, treatment, and maintenance of people with chronic mental illness. Not only that, but patients who needed active care in a crisis usually had acute care short-term hospitalizations and did not have the networking for proper follow-up. Often, they relapsed again while facing everyday challenges.

I spoke recently with Robin Allen Kaynor, a New York City social worker who has spent years assessing clients with chronic mental illness. To her dismay and disappointment, little organized rehabilitative care is provided for these patients. As Ms. Kaynor pointed out, the care patients with chronic mental illness may receive often is administered weeks after their initial visits, if at all. Further complicating their prospects is not having a place to live, and poor nutrition and general health.

What can be done to improve the quality of life for patients with chronic mental illness? First, the psychiatric/psychological community needs to exert influence on policymakers and business leaders so that outpatient care is brought up to the standards envisioned decades ago. The court system and mental health advocates must work together to find ways to monitor those in need of care and to ensure that those who need care continue to receive it. We also must make sure that patients’ civil liberties remain intact.

Secondly, since “reinstitutionalization” has taken the form of shelters and prisons for so many people with chronic mental illness, why not develop more housing in well-staffed and humanistic therapeutic communities? Many of the psychiatric institutions abandoned years ago remain either partly occupied or unoccupied today. Why not modernize, expand, and use those spaces to provide long-term care for those with mental illness and develop a network of mental health rehabilitation centers? This approach would provide these patients with better therapeutic environments and the potential for rehabilitation. It also would lead to financial savings not only in psychiatric care but for physical care as well.

Again, if we implemented these ideas, we would need to make sure that outpatients’ civil liberties remained intact. It is worth noting, however, that today’s improved provider/patient communication might make such voluntary treatments increasingly possible.

Much is at stake, including patients’ physical health. Dr. Fazil Hussain, a New York City internist and infectious disease specialist, said in an interview that people with chronic mental illnesses suffer far more physical illnesses and a much shorter life span than do those in the general population. A recent meta-analysis of reviews and studies about people with serious mental illness found that the mortality gap between patients with serious mental illness and the general population ranges from 13 to 30 years (World Psychiatry 2011;10:52-77).

Longer-term rehabilitation treatments are used routinely in medicine today, particularly after certain surgeries and accidents. It’s time to reexamine the resources taken away decades ago from those with chronic mental illness. Expanding, modernizing, humanizing, and offering genuine long-term inpatient care, better use of medications, and rehabilitation over a longer period of time would be a great beginning to creating successful outpatient community-based treatment. All patients could get individualized psychiatric/medical management, and the psychosocial skills and confidence needed to live and thrive in the community. Psychiatric patients, who are among the most vulnerable people in our society, deserve this.

 

 

Dr. London is a psychiatrist who trained at NYU Langone Medical Center and Bellevue Hospital, both in New York, and developed and ran a short-term psychotherapy program at the medical center from 1975 through 1995. He has been a newspaper columnist for more than 30 years. He has no conflicts of interest.

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Fighting the myth of the superdoctor

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I remember waking up with my left hand swollen, red, in excruciating pain, and difficult to move. For several months prior, I had been exhausted, achy, and stiff. As a relatively new mother attempting to manage the age-old balance of family life with the rigors of fellowship training, I attributed those physical changes to personal and professional circumstances.

Yet, that morning, faced with a new rather troubling symptom, I did what my husband had suggested numerous times before and finally visited a doctor. After an emergency evaluation and referral to a rheumatologist, my diagnosis was clear: I had mixed connective tissue disease.

Dr. Tanya Thomas

I became frantic – not because of the pain I was experiencing but because I would miss an important Grand Rounds that all of the fellows were expected to attend. I had struggled to decide if I should see the doctor or deal with it and head to Grand Rounds. In retrospect, the decision should not have been that agonizing. Most people would not have hesitated about making a choice between risking their health or pleasing their superiors. However, I am not most people; I am a doctor, and we do not get sick.

This is the message heard throughout medical school and training. Often, the message is not overt but communicated in a manner that no trainee could question: Take care of yourself, but do not take time off. It is fine to be sick but not so sick that you are unable to work.

For example, many programs have systems in place in which in case of illness or emergency, a trainee can call and another trainee can take her place – no questions asked. Yet, almost as quickly as this policy is described, it is followed with the disclaimer: “No one ever uses it.”

Why does this happen? Trainees are not immune to illness, but the expectation is that work supersedes personal concerns.

Despite receiving much support during my own training, my experience was often tainted by the need to push through. How could I be comfortable assuming the role of patient when at work I would hear my colleagues say things like, “I went to rounds at the hospital while I had pneumonia,” and, “I had conjunctivitis, put a patch on my eye, and went to work,” and, “she worked while getting chemo several times a week.”

For us, it seems that to be sick and to continue working is a badge of honor.

The U.S. health care system is under stress like never before. Newly insured people are coming into the system by the millions amid a shortage of physicians in primary care (Healthcare 2013;1:8-11) and across many specialties, including my own of psychiatry.

Against this backdrop are the expectations for physicians to be superheroes. It seems as if our profession is unlike any other. We are supposed to be healers of others but not ourselves.

After I became sick, I checked the literature in an effort to find support and insight into how medicine supports its own. But I found that discussions about these kinds of issues don’t seem to be available.

It’s time to discuss why support seems to be limited in residency programs, and why physicians feel a need to hide their illnesses for fear of losing employment. Why do the cultural expectations of our profession make us feel like we are less of a physician because of our illnesses?

Medicine needs to change so that we are treated not as flawless perfectionists but as humans who dedicated ourselves to healing and saving lives.

Dr. Thomas is a psychiatrist living in Warwick, R.I.

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I remember waking up with my left hand swollen, red, in excruciating pain, and difficult to move. For several months prior, I had been exhausted, achy, and stiff. As a relatively new mother attempting to manage the age-old balance of family life with the rigors of fellowship training, I attributed those physical changes to personal and professional circumstances.

Yet, that morning, faced with a new rather troubling symptom, I did what my husband had suggested numerous times before and finally visited a doctor. After an emergency evaluation and referral to a rheumatologist, my diagnosis was clear: I had mixed connective tissue disease.

Dr. Tanya Thomas

I became frantic – not because of the pain I was experiencing but because I would miss an important Grand Rounds that all of the fellows were expected to attend. I had struggled to decide if I should see the doctor or deal with it and head to Grand Rounds. In retrospect, the decision should not have been that agonizing. Most people would not have hesitated about making a choice between risking their health or pleasing their superiors. However, I am not most people; I am a doctor, and we do not get sick.

This is the message heard throughout medical school and training. Often, the message is not overt but communicated in a manner that no trainee could question: Take care of yourself, but do not take time off. It is fine to be sick but not so sick that you are unable to work.

For example, many programs have systems in place in which in case of illness or emergency, a trainee can call and another trainee can take her place – no questions asked. Yet, almost as quickly as this policy is described, it is followed with the disclaimer: “No one ever uses it.”

Why does this happen? Trainees are not immune to illness, but the expectation is that work supersedes personal concerns.

Despite receiving much support during my own training, my experience was often tainted by the need to push through. How could I be comfortable assuming the role of patient when at work I would hear my colleagues say things like, “I went to rounds at the hospital while I had pneumonia,” and, “I had conjunctivitis, put a patch on my eye, and went to work,” and, “she worked while getting chemo several times a week.”

For us, it seems that to be sick and to continue working is a badge of honor.

The U.S. health care system is under stress like never before. Newly insured people are coming into the system by the millions amid a shortage of physicians in primary care (Healthcare 2013;1:8-11) and across many specialties, including my own of psychiatry.

Against this backdrop are the expectations for physicians to be superheroes. It seems as if our profession is unlike any other. We are supposed to be healers of others but not ourselves.

After I became sick, I checked the literature in an effort to find support and insight into how medicine supports its own. But I found that discussions about these kinds of issues don’t seem to be available.

It’s time to discuss why support seems to be limited in residency programs, and why physicians feel a need to hide their illnesses for fear of losing employment. Why do the cultural expectations of our profession make us feel like we are less of a physician because of our illnesses?

Medicine needs to change so that we are treated not as flawless perfectionists but as humans who dedicated ourselves to healing and saving lives.

Dr. Thomas is a psychiatrist living in Warwick, R.I.

I remember waking up with my left hand swollen, red, in excruciating pain, and difficult to move. For several months prior, I had been exhausted, achy, and stiff. As a relatively new mother attempting to manage the age-old balance of family life with the rigors of fellowship training, I attributed those physical changes to personal and professional circumstances.

Yet, that morning, faced with a new rather troubling symptom, I did what my husband had suggested numerous times before and finally visited a doctor. After an emergency evaluation and referral to a rheumatologist, my diagnosis was clear: I had mixed connective tissue disease.

Dr. Tanya Thomas

I became frantic – not because of the pain I was experiencing but because I would miss an important Grand Rounds that all of the fellows were expected to attend. I had struggled to decide if I should see the doctor or deal with it and head to Grand Rounds. In retrospect, the decision should not have been that agonizing. Most people would not have hesitated about making a choice between risking their health or pleasing their superiors. However, I am not most people; I am a doctor, and we do not get sick.

This is the message heard throughout medical school and training. Often, the message is not overt but communicated in a manner that no trainee could question: Take care of yourself, but do not take time off. It is fine to be sick but not so sick that you are unable to work.

For example, many programs have systems in place in which in case of illness or emergency, a trainee can call and another trainee can take her place – no questions asked. Yet, almost as quickly as this policy is described, it is followed with the disclaimer: “No one ever uses it.”

Why does this happen? Trainees are not immune to illness, but the expectation is that work supersedes personal concerns.

Despite receiving much support during my own training, my experience was often tainted by the need to push through. How could I be comfortable assuming the role of patient when at work I would hear my colleagues say things like, “I went to rounds at the hospital while I had pneumonia,” and, “I had conjunctivitis, put a patch on my eye, and went to work,” and, “she worked while getting chemo several times a week.”

For us, it seems that to be sick and to continue working is a badge of honor.

The U.S. health care system is under stress like never before. Newly insured people are coming into the system by the millions amid a shortage of physicians in primary care (Healthcare 2013;1:8-11) and across many specialties, including my own of psychiatry.

Against this backdrop are the expectations for physicians to be superheroes. It seems as if our profession is unlike any other. We are supposed to be healers of others but not ourselves.

After I became sick, I checked the literature in an effort to find support and insight into how medicine supports its own. But I found that discussions about these kinds of issues don’t seem to be available.

It’s time to discuss why support seems to be limited in residency programs, and why physicians feel a need to hide their illnesses for fear of losing employment. Why do the cultural expectations of our profession make us feel like we are less of a physician because of our illnesses?

Medicine needs to change so that we are treated not as flawless perfectionists but as humans who dedicated ourselves to healing and saving lives.

Dr. Thomas is a psychiatrist living in Warwick, R.I.

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Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of human pregnancy experience. The new Food and Drug Administration prescription drug information format may increase the amount of information available, at least from registries conducted by drug manufacturers, because they will be required to list all substantive changes made within the year. Although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.

 

©PhotoDisk

The strengths of pregnancy registries are their prospective nature and enrollment across a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions).

Registries can identify early signals of teratogenicity, but they have several limitations, including voluntary reporting that results in selection bias, pregnancies lost to follow-up that may have had different outcomes than those with documented outcomes, and a lack of control groups (with some exceptions).

Other limitations are that registry cases are not representative of target populations, and pregnancies lost to follow-up lack details on elective terminations and fetal deaths without birth defects, as well as all spontaneous abortions. Additionally, publication of results may be delayed and does not appear in a peer-reviewed journal.

Since the total number of exposed pregnancies is unknown, registry data cannot be used to calculate prevalence, but can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports, which are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. However, they may be helpful in detecting unusual patterns of birth defects.

MothertoBaby Registry

The large Organization of Teratology Information Specialists (OTIS) MothertoBaby registry (877-311-8972) involves four different categories: autoimmune diseases(rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma; antiviral agents; and vaccines.

 

Gerald G. Briggs

The drugs for autoimmune diseases are tocilizumab (Actemra), leflunomide (Arava), teriflunomide (Aubagio), certolizumab pegol (Cimzia), etanercept (Enbrel), adalimumab (Humira), abatacept (Orencia), apremilast (Otezla), ustekinumab (Stelara), tofacitinib (Xeljanz), infliximab (Remicade), and methotrexate.

The asthma drugs are formoterol (Foradil, Perforomist, Symbicort, Dulera), albuterol, levalbuterol, metaproterenol, pirbuterol (Maxair), and terbutaline.

The antiviral agents are oseltamivir (Tamiflu) and zanamivir (Relenza).

The vaccines include pertussis (Tdap), seasonal influenza, and meningococcal disease (Menveo). In addition to a control group in each category, a unique aspect of this registry is that many exposed infants will undergo dysmorphology examinations.

Vaccine registries

A second vaccine for meningococcal disease (Menactra) is being studied in the Menactra vaccine Pregnancy Registry (800-822-2463 / www.sanofipasteurpregnancy.com).

Two other registries also include influenza vaccines: Flu vaccine Pregnancy Registry, PPD (Flucelvax) (877-413-4759 / email: [email protected]) and the GSK Seasonal Influenza Vaccine Pregnancy Registry, GlaxoSmithKline (888-825-5249 / pregnancyregistry.gsk.com/seasonalinfluenzavaccines.html), which includes the Fluarix and FluLaval vaccines.

Asthma

Women with asthma who are being treated with omalizumab (Xolair) are the target population for the EXPECT Pregnancy Registry (866-496-5247 Option 3 / www.xolairpregnancyregistry.com).

 

GSK registries

GlaxoSmithKline is also conducting three other registries: the Belimumab (Benlysta) Pregnancy Registry for patients with systemic lupus erythematosus treated with belimumab (877-681-6296 / [email protected]); and the Twinrix Pregnancy Registry for women who have received the Twinrix hepatitis A and B vaccine (888-825-5249).

 

Atypical antipsychotics

TheNational Pregnancy Registry for Atypical Antipsychotics (866-961-2388 / registry@womens mentalhealth.org) is studying 10 drugs: aripiprazole (Abilify), clozapine (Clozaril), iloperidone (Fanapt), paliperidone (Invega), lurasidone (Latuda), risperidone (Risperdal), asenapine (Saphris), quetiapine (Seroquel), ziprasidone (Geodon), and olanzapine (Zyprexa).

 

TAPP registry

Acitretin is under study by the Take Action to Prevent Pregnancy (T.A.P.P.) registry (855-850-2138 / www.tevagenerics.com/acitretin).

 

MPS I registry

The MPS I (Mucopolysaccharidosis I) Registry, Genzyme Corp (617-591-5500 / [email protected]), is studying the use of laronidase (Aldurazyme) for Hurler syndrome, Scheie syndrome, and Hurler-Scheie syndrome.

 

MPS VI registry

The use of galsulfase (Naglazyme) for Maroteaux-Lamy syndrome during pregnancy is under study by the Mucopolysaccharidosis VI (MPS VI) Clinical Surveillance Program(415-506-6849 or 415-506-6703)

 

Epilepsy drugs

The Antiepileptic Drug Pregnancy Registry (888-233-2334 / www.aedpregnancyregistry.org) is studying antiepileptic drugs.

 

Type 2 diabetes

The Exenatide Pregnancy Registry, conducted by INC Research for AstraZeneca (800-633-9081 / www.exenatidepregnancyregistry.com), examines the use of exenatide (Byetta, Bydureon) for the treatment of type 2 diabetes.

 

Renal transplant

Renal transplant patients exposed to mycophenolate (Cellcept) can be enrolled in the Mycophenolate Pregnancy Registry (800-617-8191) or the National Transplantation Pregnancy Registry (877-955-6877). The NTPR is enrolling renal transplant patients exposed to belatacept (Nulojix).

 

Cymbalta

The antidepressant duloxetine (Cymbalta), when used for major depressive or generalized anxiety disorders, diabetic peripheral neuropathic pain, or fibromyalgia is being studied by the Cymbalta Pregnancy Registry, INC Research ([email protected] / www.cymbaltapregancyregistry.com).

 

 

 

Fabry disease

The Fabry Registry, Genzyme Corp (617-581-5500 / [email protected]) is studying the use in pregnancy of agalsidase beta (Fabrazyme) for Fabry disease.

 

MS registry

Novartis Pharmaceuticals is conducting the Gilenya (fingolimod) Pregnancy Registry (877-598-7237 / [email protected]) for patients with multiple sclerosis who are taking fingolimod (Gilenya).

Cancer

The MotHER Pregnancy Registry, INC Research (800-690-6720 / [email protected] / themotherpregnancyregistry.com) is enrolling breast cancer patients who have been treated during pregnancy with ado-trastuzumab (Kadcyla), trastuzumab (Herceptin), or pertuzumab (Perjeta).

 

Merck registries

Merck Pregnancy Registries (800-986-8999) include a registry for type 2 diabetes – sitagliptin/metformin (Janumet) or sitagliptin (Januvia) (www.merckpregancyregistries.com/januvia.html); a registry for rizatriptan (Maxalt) (www.merckpregancyregistries.com/maxalt.html), for migraine headaches; and a registry for the 9-valent human papillomavirus (HPV) (Gardasil 9) vaccine (www.merckpregnancyregistries.com/gardasil9.html).

The registry for the asthma drug montelukast (Singulair) and the registry for Gardasil, the quadrivalent HPV vaccine, are now closed to new enrollment, but new cases of pregnancy exposures can be reported to the company at: 877-888-4231.

Osteoporosis

Amgen’s Pregnancy Surveillance Program (800-772-6436) is enrolling pregnant subjects with osteoporosis who are being treated with denosumab (Prolia).

 

Hepatitis C

The Ribavirin Pregnancy Registry, INC Research (800-593-2214/ [email protected] / ribavirinpregnancyregistry.com) is looking for subjects with hepatitis C who have been treated with ribavirin (Copegus).

 

Fibromyalgia

The Savella Pregnancy Registry (877-643-3010/ [email protected] / savellapregnancyregistry.com) is looking for patients with fibromyalgia who are being treated with milnacipran (Savella).

 

Skin infections

An antibacterial, telavancin (Vibativ), indicated for skin infections is being studied by the Vibativ Pregnancy Registry (888-658-4228 / www.clinicaltrial.gov).

 

Pompe disease

Pregnant women treated with alglucosidase alfa (Myozyme) for Pompe disease can enroll in the Pompe Registry (800-745-4447 x 15500 / www.pompe.com/en/healthcare-professionals/pompe-registry.aspx).

 

Sleep disorders

Armodafinil (Nuvigil) used to treat excessive sleepiness associated with narcolepsy and other sleep disorders is being studied in the Nuvigil Pregnancy Registry (866-404-4106 / www.nuvigilpregnancyregistry.com). A second drug with the same indication and telephone number, modafinil (Provigil), is in the Provigil Pregnancy Registry (provigilpregnancyregistry.com).

Additional details, including fax numbers and addresses of the registries reviewed above, can be obtained from the FDA website, List of Pregnancy Exposure Registries. Since the strength of a registry is based on numbers, health care professionals are encouraged to enroll potential subjects or have their patients call to enroll themselves.

Before retirement, Mr. Briggs was a pharmacist clinical specialist at the outpatient clinics of Memorial Care Center for Women at Miller Children’s Hospital in Long Beach, Calif.; he remains a clinical professor of pharmacy at the University of California, San Francisco; and adjunct professor of pharmacy at the University of Southern California, Los Angeles, and Washington State University, Spokane. He also is coauthor of “Drugs in Pregnancy and Lactation,” and coeditor of “Diseases, Complications, and Drug Therapy in Obstetrics.” He had no relevant financial disclosures. Contact him at [email protected].

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Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of human pregnancy experience. The new Food and Drug Administration prescription drug information format may increase the amount of information available, at least from registries conducted by drug manufacturers, because they will be required to list all substantive changes made within the year. Although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.

 

©PhotoDisk

The strengths of pregnancy registries are their prospective nature and enrollment across a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions).

Registries can identify early signals of teratogenicity, but they have several limitations, including voluntary reporting that results in selection bias, pregnancies lost to follow-up that may have had different outcomes than those with documented outcomes, and a lack of control groups (with some exceptions).

Other limitations are that registry cases are not representative of target populations, and pregnancies lost to follow-up lack details on elective terminations and fetal deaths without birth defects, as well as all spontaneous abortions. Additionally, publication of results may be delayed and does not appear in a peer-reviewed journal.

Since the total number of exposed pregnancies is unknown, registry data cannot be used to calculate prevalence, but can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports, which are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. However, they may be helpful in detecting unusual patterns of birth defects.

MothertoBaby Registry

The large Organization of Teratology Information Specialists (OTIS) MothertoBaby registry (877-311-8972) involves four different categories: autoimmune diseases(rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma; antiviral agents; and vaccines.

 

Gerald G. Briggs

The drugs for autoimmune diseases are tocilizumab (Actemra), leflunomide (Arava), teriflunomide (Aubagio), certolizumab pegol (Cimzia), etanercept (Enbrel), adalimumab (Humira), abatacept (Orencia), apremilast (Otezla), ustekinumab (Stelara), tofacitinib (Xeljanz), infliximab (Remicade), and methotrexate.

The asthma drugs are formoterol (Foradil, Perforomist, Symbicort, Dulera), albuterol, levalbuterol, metaproterenol, pirbuterol (Maxair), and terbutaline.

The antiviral agents are oseltamivir (Tamiflu) and zanamivir (Relenza).

The vaccines include pertussis (Tdap), seasonal influenza, and meningococcal disease (Menveo). In addition to a control group in each category, a unique aspect of this registry is that many exposed infants will undergo dysmorphology examinations.

Vaccine registries

A second vaccine for meningococcal disease (Menactra) is being studied in the Menactra vaccine Pregnancy Registry (800-822-2463 / www.sanofipasteurpregnancy.com).

Two other registries also include influenza vaccines: Flu vaccine Pregnancy Registry, PPD (Flucelvax) (877-413-4759 / email: [email protected]) and the GSK Seasonal Influenza Vaccine Pregnancy Registry, GlaxoSmithKline (888-825-5249 / pregnancyregistry.gsk.com/seasonalinfluenzavaccines.html), which includes the Fluarix and FluLaval vaccines.

Asthma

Women with asthma who are being treated with omalizumab (Xolair) are the target population for the EXPECT Pregnancy Registry (866-496-5247 Option 3 / www.xolairpregnancyregistry.com).

 

GSK registries

GlaxoSmithKline is also conducting three other registries: the Belimumab (Benlysta) Pregnancy Registry for patients with systemic lupus erythematosus treated with belimumab (877-681-6296 / [email protected]); and the Twinrix Pregnancy Registry for women who have received the Twinrix hepatitis A and B vaccine (888-825-5249).

 

Atypical antipsychotics

TheNational Pregnancy Registry for Atypical Antipsychotics (866-961-2388 / registry@womens mentalhealth.org) is studying 10 drugs: aripiprazole (Abilify), clozapine (Clozaril), iloperidone (Fanapt), paliperidone (Invega), lurasidone (Latuda), risperidone (Risperdal), asenapine (Saphris), quetiapine (Seroquel), ziprasidone (Geodon), and olanzapine (Zyprexa).

 

TAPP registry

Acitretin is under study by the Take Action to Prevent Pregnancy (T.A.P.P.) registry (855-850-2138 / www.tevagenerics.com/acitretin).

 

MPS I registry

The MPS I (Mucopolysaccharidosis I) Registry, Genzyme Corp (617-591-5500 / [email protected]), is studying the use of laronidase (Aldurazyme) for Hurler syndrome, Scheie syndrome, and Hurler-Scheie syndrome.

 

MPS VI registry

The use of galsulfase (Naglazyme) for Maroteaux-Lamy syndrome during pregnancy is under study by the Mucopolysaccharidosis VI (MPS VI) Clinical Surveillance Program(415-506-6849 or 415-506-6703)

 

Epilepsy drugs

The Antiepileptic Drug Pregnancy Registry (888-233-2334 / www.aedpregnancyregistry.org) is studying antiepileptic drugs.

 

Type 2 diabetes

The Exenatide Pregnancy Registry, conducted by INC Research for AstraZeneca (800-633-9081 / www.exenatidepregnancyregistry.com), examines the use of exenatide (Byetta, Bydureon) for the treatment of type 2 diabetes.

 

Renal transplant

Renal transplant patients exposed to mycophenolate (Cellcept) can be enrolled in the Mycophenolate Pregnancy Registry (800-617-8191) or the National Transplantation Pregnancy Registry (877-955-6877). The NTPR is enrolling renal transplant patients exposed to belatacept (Nulojix).

 

Cymbalta

The antidepressant duloxetine (Cymbalta), when used for major depressive or generalized anxiety disorders, diabetic peripheral neuropathic pain, or fibromyalgia is being studied by the Cymbalta Pregnancy Registry, INC Research ([email protected] / www.cymbaltapregancyregistry.com).

 

 

 

Fabry disease

The Fabry Registry, Genzyme Corp (617-581-5500 / [email protected]) is studying the use in pregnancy of agalsidase beta (Fabrazyme) for Fabry disease.

 

MS registry

Novartis Pharmaceuticals is conducting the Gilenya (fingolimod) Pregnancy Registry (877-598-7237 / [email protected]) for patients with multiple sclerosis who are taking fingolimod (Gilenya).

Cancer

The MotHER Pregnancy Registry, INC Research (800-690-6720 / [email protected] / themotherpregnancyregistry.com) is enrolling breast cancer patients who have been treated during pregnancy with ado-trastuzumab (Kadcyla), trastuzumab (Herceptin), or pertuzumab (Perjeta).

 

Merck registries

Merck Pregnancy Registries (800-986-8999) include a registry for type 2 diabetes – sitagliptin/metformin (Janumet) or sitagliptin (Januvia) (www.merckpregancyregistries.com/januvia.html); a registry for rizatriptan (Maxalt) (www.merckpregancyregistries.com/maxalt.html), for migraine headaches; and a registry for the 9-valent human papillomavirus (HPV) (Gardasil 9) vaccine (www.merckpregnancyregistries.com/gardasil9.html).

The registry for the asthma drug montelukast (Singulair) and the registry for Gardasil, the quadrivalent HPV vaccine, are now closed to new enrollment, but new cases of pregnancy exposures can be reported to the company at: 877-888-4231.

Osteoporosis

Amgen’s Pregnancy Surveillance Program (800-772-6436) is enrolling pregnant subjects with osteoporosis who are being treated with denosumab (Prolia).

 

Hepatitis C

The Ribavirin Pregnancy Registry, INC Research (800-593-2214/ [email protected] / ribavirinpregnancyregistry.com) is looking for subjects with hepatitis C who have been treated with ribavirin (Copegus).

 

Fibromyalgia

The Savella Pregnancy Registry (877-643-3010/ [email protected] / savellapregnancyregistry.com) is looking for patients with fibromyalgia who are being treated with milnacipran (Savella).

 

Skin infections

An antibacterial, telavancin (Vibativ), indicated for skin infections is being studied by the Vibativ Pregnancy Registry (888-658-4228 / www.clinicaltrial.gov).

 

Pompe disease

Pregnant women treated with alglucosidase alfa (Myozyme) for Pompe disease can enroll in the Pompe Registry (800-745-4447 x 15500 / www.pompe.com/en/healthcare-professionals/pompe-registry.aspx).

 

Sleep disorders

Armodafinil (Nuvigil) used to treat excessive sleepiness associated with narcolepsy and other sleep disorders is being studied in the Nuvigil Pregnancy Registry (866-404-4106 / www.nuvigilpregnancyregistry.com). A second drug with the same indication and telephone number, modafinil (Provigil), is in the Provigil Pregnancy Registry (provigilpregnancyregistry.com).

Additional details, including fax numbers and addresses of the registries reviewed above, can be obtained from the FDA website, List of Pregnancy Exposure Registries. Since the strength of a registry is based on numbers, health care professionals are encouraged to enroll potential subjects or have their patients call to enroll themselves.

Before retirement, Mr. Briggs was a pharmacist clinical specialist at the outpatient clinics of Memorial Care Center for Women at Miller Children’s Hospital in Long Beach, Calif.; he remains a clinical professor of pharmacy at the University of California, San Francisco; and adjunct professor of pharmacy at the University of Southern California, Los Angeles, and Washington State University, Spokane. He also is coauthor of “Drugs in Pregnancy and Lactation,” and coeditor of “Diseases, Complications, and Drug Therapy in Obstetrics.” He had no relevant financial disclosures. Contact him at [email protected].

Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of human pregnancy experience. The new Food and Drug Administration prescription drug information format may increase the amount of information available, at least from registries conducted by drug manufacturers, because they will be required to list all substantive changes made within the year. Although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.

 

©PhotoDisk

The strengths of pregnancy registries are their prospective nature and enrollment across a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions).

Registries can identify early signals of teratogenicity, but they have several limitations, including voluntary reporting that results in selection bias, pregnancies lost to follow-up that may have had different outcomes than those with documented outcomes, and a lack of control groups (with some exceptions).

Other limitations are that registry cases are not representative of target populations, and pregnancies lost to follow-up lack details on elective terminations and fetal deaths without birth defects, as well as all spontaneous abortions. Additionally, publication of results may be delayed and does not appear in a peer-reviewed journal.

Since the total number of exposed pregnancies is unknown, registry data cannot be used to calculate prevalence, but can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports, which are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. However, they may be helpful in detecting unusual patterns of birth defects.

MothertoBaby Registry

The large Organization of Teratology Information Specialists (OTIS) MothertoBaby registry (877-311-8972) involves four different categories: autoimmune diseases(rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma; antiviral agents; and vaccines.

 

Gerald G. Briggs

The drugs for autoimmune diseases are tocilizumab (Actemra), leflunomide (Arava), teriflunomide (Aubagio), certolizumab pegol (Cimzia), etanercept (Enbrel), adalimumab (Humira), abatacept (Orencia), apremilast (Otezla), ustekinumab (Stelara), tofacitinib (Xeljanz), infliximab (Remicade), and methotrexate.

The asthma drugs are formoterol (Foradil, Perforomist, Symbicort, Dulera), albuterol, levalbuterol, metaproterenol, pirbuterol (Maxair), and terbutaline.

The antiviral agents are oseltamivir (Tamiflu) and zanamivir (Relenza).

The vaccines include pertussis (Tdap), seasonal influenza, and meningococcal disease (Menveo). In addition to a control group in each category, a unique aspect of this registry is that many exposed infants will undergo dysmorphology examinations.

Vaccine registries

A second vaccine for meningococcal disease (Menactra) is being studied in the Menactra vaccine Pregnancy Registry (800-822-2463 / www.sanofipasteurpregnancy.com).

Two other registries also include influenza vaccines: Flu vaccine Pregnancy Registry, PPD (Flucelvax) (877-413-4759 / email: [email protected]) and the GSK Seasonal Influenza Vaccine Pregnancy Registry, GlaxoSmithKline (888-825-5249 / pregnancyregistry.gsk.com/seasonalinfluenzavaccines.html), which includes the Fluarix and FluLaval vaccines.

Asthma

Women with asthma who are being treated with omalizumab (Xolair) are the target population for the EXPECT Pregnancy Registry (866-496-5247 Option 3 / www.xolairpregnancyregistry.com).

 

GSK registries

GlaxoSmithKline is also conducting three other registries: the Belimumab (Benlysta) Pregnancy Registry for patients with systemic lupus erythematosus treated with belimumab (877-681-6296 / [email protected]); and the Twinrix Pregnancy Registry for women who have received the Twinrix hepatitis A and B vaccine (888-825-5249).

 

Atypical antipsychotics

TheNational Pregnancy Registry for Atypical Antipsychotics (866-961-2388 / registry@womens mentalhealth.org) is studying 10 drugs: aripiprazole (Abilify), clozapine (Clozaril), iloperidone (Fanapt), paliperidone (Invega), lurasidone (Latuda), risperidone (Risperdal), asenapine (Saphris), quetiapine (Seroquel), ziprasidone (Geodon), and olanzapine (Zyprexa).

 

TAPP registry

Acitretin is under study by the Take Action to Prevent Pregnancy (T.A.P.P.) registry (855-850-2138 / www.tevagenerics.com/acitretin).

 

MPS I registry

The MPS I (Mucopolysaccharidosis I) Registry, Genzyme Corp (617-591-5500 / [email protected]), is studying the use of laronidase (Aldurazyme) for Hurler syndrome, Scheie syndrome, and Hurler-Scheie syndrome.

 

MPS VI registry

The use of galsulfase (Naglazyme) for Maroteaux-Lamy syndrome during pregnancy is under study by the Mucopolysaccharidosis VI (MPS VI) Clinical Surveillance Program(415-506-6849 or 415-506-6703)

 

Epilepsy drugs

The Antiepileptic Drug Pregnancy Registry (888-233-2334 / www.aedpregnancyregistry.org) is studying antiepileptic drugs.

 

Type 2 diabetes

The Exenatide Pregnancy Registry, conducted by INC Research for AstraZeneca (800-633-9081 / www.exenatidepregnancyregistry.com), examines the use of exenatide (Byetta, Bydureon) for the treatment of type 2 diabetes.

 

Renal transplant

Renal transplant patients exposed to mycophenolate (Cellcept) can be enrolled in the Mycophenolate Pregnancy Registry (800-617-8191) or the National Transplantation Pregnancy Registry (877-955-6877). The NTPR is enrolling renal transplant patients exposed to belatacept (Nulojix).

 

Cymbalta

The antidepressant duloxetine (Cymbalta), when used for major depressive or generalized anxiety disorders, diabetic peripheral neuropathic pain, or fibromyalgia is being studied by the Cymbalta Pregnancy Registry, INC Research ([email protected] / www.cymbaltapregancyregistry.com).

 

 

 

Fabry disease

The Fabry Registry, Genzyme Corp (617-581-5500 / [email protected]) is studying the use in pregnancy of agalsidase beta (Fabrazyme) for Fabry disease.

 

MS registry

Novartis Pharmaceuticals is conducting the Gilenya (fingolimod) Pregnancy Registry (877-598-7237 / [email protected]) for patients with multiple sclerosis who are taking fingolimod (Gilenya).

Cancer

The MotHER Pregnancy Registry, INC Research (800-690-6720 / [email protected] / themotherpregnancyregistry.com) is enrolling breast cancer patients who have been treated during pregnancy with ado-trastuzumab (Kadcyla), trastuzumab (Herceptin), or pertuzumab (Perjeta).

 

Merck registries

Merck Pregnancy Registries (800-986-8999) include a registry for type 2 diabetes – sitagliptin/metformin (Janumet) or sitagliptin (Januvia) (www.merckpregancyregistries.com/januvia.html); a registry for rizatriptan (Maxalt) (www.merckpregancyregistries.com/maxalt.html), for migraine headaches; and a registry for the 9-valent human papillomavirus (HPV) (Gardasil 9) vaccine (www.merckpregnancyregistries.com/gardasil9.html).

The registry for the asthma drug montelukast (Singulair) and the registry for Gardasil, the quadrivalent HPV vaccine, are now closed to new enrollment, but new cases of pregnancy exposures can be reported to the company at: 877-888-4231.

Osteoporosis

Amgen’s Pregnancy Surveillance Program (800-772-6436) is enrolling pregnant subjects with osteoporosis who are being treated with denosumab (Prolia).

 

Hepatitis C

The Ribavirin Pregnancy Registry, INC Research (800-593-2214/ [email protected] / ribavirinpregnancyregistry.com) is looking for subjects with hepatitis C who have been treated with ribavirin (Copegus).

 

Fibromyalgia

The Savella Pregnancy Registry (877-643-3010/ [email protected] / savellapregnancyregistry.com) is looking for patients with fibromyalgia who are being treated with milnacipran (Savella).

 

Skin infections

An antibacterial, telavancin (Vibativ), indicated for skin infections is being studied by the Vibativ Pregnancy Registry (888-658-4228 / www.clinicaltrial.gov).

 

Pompe disease

Pregnant women treated with alglucosidase alfa (Myozyme) for Pompe disease can enroll in the Pompe Registry (800-745-4447 x 15500 / www.pompe.com/en/healthcare-professionals/pompe-registry.aspx).

 

Sleep disorders

Armodafinil (Nuvigil) used to treat excessive sleepiness associated with narcolepsy and other sleep disorders is being studied in the Nuvigil Pregnancy Registry (866-404-4106 / www.nuvigilpregnancyregistry.com). A second drug with the same indication and telephone number, modafinil (Provigil), is in the Provigil Pregnancy Registry (provigilpregnancyregistry.com).

Additional details, including fax numbers and addresses of the registries reviewed above, can be obtained from the FDA website, List of Pregnancy Exposure Registries. Since the strength of a registry is based on numbers, health care professionals are encouraged to enroll potential subjects or have their patients call to enroll themselves.

Before retirement, Mr. Briggs was a pharmacist clinical specialist at the outpatient clinics of Memorial Care Center for Women at Miller Children’s Hospital in Long Beach, Calif.; he remains a clinical professor of pharmacy at the University of California, San Francisco; and adjunct professor of pharmacy at the University of Southern California, Los Angeles, and Washington State University, Spokane. He also is coauthor of “Drugs in Pregnancy and Lactation,” and coeditor of “Diseases, Complications, and Drug Therapy in Obstetrics.” He had no relevant financial disclosures. Contact him at [email protected].

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Underlying psychology of ‘lone wolf’ terrorism is complex

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The recent attack in Chattanooga, Tenn., on two military facilities in which four Marines and one Naval Academy midshipman were killed has the hallmarks of a lone wolf attack. Muhammad Youssef Abdulazeez, age 24, reportedly said 3 days before his attack that “life is short and bitter” and that Muslims should submit to Allah, for the time “may pass you by.” Abdulazeez's parents were increasingly concerned by his drug abuse and depression, and sent him to Jordan last year to break the downward spiral in his life, according to news reports.

A sharp increase in Islamic State sympathizers plotting against U.S. targets occurred after a communiqué circulated widely on the radical Internet called for waging jihad against the United States in retaliation for the bombing of ISIS positions. Although Abdulazeez reportedly said ISIS was "a stupid group and it was completely against Islam," he was particularly influenced by Anwar al-Awlaki, former senior al-Qaeda official, and had his sermons in his possession.

Dr. Jerrold M. Post

Al-Awlaki, dubbed “the Bin Laden of the Internet” before his killing in a drone attack in 2011, was gifted in providing externalizing rhetoric to the many frustrated, alienated Muslim youth not feeling accepted into American society. Three themes can be found in Al-Awlaki’s sermons: 1. Muslims are victims. Their economic and social difficulties are caused by “them.” 2. “They” – the enemy out to humiliate and defeat Muslims – refers to the West, especially the United States, Great Britain, and Israel. 3. Therefore, jihad is required by all Muslims to defend Islam, which is under attack by “them.” These repetitive messages on the Internet were attractive to the rising number of alienated Muslims and are present in al-Qaeda and ISIS messaging today.

The New York Times recounted the story of a woman it called “Alex,” a 23-year-old college dropout living in rural Washington state who communicated with Islamic State supporters online for several months.

Mr. Cody McGinnis

Alex, who filled her time babysitting a couple of days a week, teaching Sunday school, “streaming movies on Netflix, and updating her social media timelines,” came dangerously close to boarding a plane – with her 11-year-old brother – for Austria, where her virtual community promised her a Muslim husband. What psychological patterns were at work with Alex, and what are the underlying psychological patterns of “lone wolf” terrorism?

Our studies of this phenomenon reflect not one but four different patterns, suggesting a typology of motivations. Based on an extensive review of open-source journalistic reports, we examined the available psychobiographic information and histories of 43 lone wolf terrorists and have been able to differentiate four types of lone wolves: glory seekers, hero worshipers, lonely romantics, and radical altruists (Behav. Sci. Law 2014;32:306-34).

Glory seekers are individuals who feel the world does not understand or appreciate their talents. This frustration generally stems from unrealized expectations of success, acceptance, and recognition from within their new community. An example of a lone wolf glory seeker is Abu Khalid Abdul-Latif, who became increasingly isolated and radical, and converted to Islam in prison. He reportedly confided to an FBI informant that he hoped to carry out an attack at a military processing station even more devastating than Maj. Nidal Malik Hasan’s massacre at Fort Hood, Tex. “We’re trying to send a message; We’re trying to get something that’s gonna be on CNN and over the world,” he was quoted as saying.

Dr. Kristen Moody

The hero worshipers who, by an idealized other, are persuaded to enter the path of radicalization and carry out an act of violent jihad. Because of the emptiness they feel in their own lives, they seek to emulate an idealized other who is seen as embodying all they would like to become. Before his death, Anwar al-Awlaki served as this idealized figure for many of the hero worshipers.

Typically immature and naive, the lonely romantics are isolated individuals entranced by promises of inclusion into a larger group (for example, al-Qaeda and ISIS). Their own personal struggles with self-identity make them susceptible to violent jihadist propaganda that sells a romanticized notion of “revolution,” one that promises inclusion into a global, violent jihadist brotherhood. Before the rise of ISIS, the Somali terrorist group, Al-Shabaab was adept in recruiting these lonely romantics as exemplified by a wolf pack of nearly 50 people from the Somali diaspora in Minnesota.

Radical altruists perceive themselves, or their Muslim community, as victims of Western oppression. Convinced that they are acting for the greater good, they plan or carry out acts of violent jihad out of a sense of moral outrage against the United States and the West. Fueled by narcissistic rage and an inflated sense of self-worth, they position themselves as victims of injustice. Would-be Times Square bomber Faisal Shahzad was an example of a radical altruist.

 

 

Ms. Jessica Zayas

The recent arrest of Justin Nojan Sullivan, a 19-year-old from North Carolina, illustrates the psychology of a “wannabe” terrorist, showing tendencies of a glory seeker and lonely romantic. He had grandiose aspirations and reportedly talked of killing up to 1,000 Americans by using guns, bombs, and chemical weapons. He planned to recruit others to the “Islamic State of North America.” In an email to an undercover agent, he said: “Our attacks need to be as big as possible … we can do minor assassinations before the big attack ....” He wanted to make a video of some of the killings and send them to the terrorist group, seeking to impress ISIS with his elaborate plan. His plans were cut short when his father called the police with concerns about his son’s change in behavior.

Familial intervention by Alex’s grandmother was instrumental in preventing her from traveling overseas to fulfill her goal of supporting the Islamic State by helping to bear the next generation of fighters. Alex embodied the features of a lonely romantic with altruistic justifications. She did not exhibit outwardly noticeable changes in appearance or attitude, as she was instructed to lead a double life, which included her continuing to teach Sunday school throughout her online radicalization. Her grandmother became concerned over the amount of time Alex was spending on social media and contacted the FBI.

A recent study by Fordham Law School’s Center on National Security, in New York, showed an increase in individuals wishing to conduct attacks in the United States, although most still seek to become foreign fighters for ISIS. As author Gabriel Weimann recently observed, these people are not truly lone wolves, as social media provides a coherent attractive message to these lonely, isolated individuals who feel a sense of belonging to the virtual community of hatred. An absorption in radical social media is increasingly the pathway to joining the virtual community of hatred, and this is a daunting challenge for counterterrorism.

Dr. Post is the founding director of the political psychology program at the Elliott School of International Affairs, The George Washington University, Washington. He is the author of “The Mind of the Terrorist” (New York: Palgrave Macmillan, 2008). Mr. McGinnis, a former Air Force intelligence, surveillance, and reconnaissance operator, is a doctoral candidate in clinical psychology at the university. Dr. Moody, a graduate of the program, is a forensic psychologist in the federal prison service. Ms. Zayas is Dr. Post’s director of research and has a master of arts in security policy studies from the university.

*This story was updated 7/24/2015.

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The recent attack in Chattanooga, Tenn., on two military facilities in which four Marines and one Naval Academy midshipman were killed has the hallmarks of a lone wolf attack. Muhammad Youssef Abdulazeez, age 24, reportedly said 3 days before his attack that “life is short and bitter” and that Muslims should submit to Allah, for the time “may pass you by.” Abdulazeez's parents were increasingly concerned by his drug abuse and depression, and sent him to Jordan last year to break the downward spiral in his life, according to news reports.

A sharp increase in Islamic State sympathizers plotting against U.S. targets occurred after a communiqué circulated widely on the radical Internet called for waging jihad against the United States in retaliation for the bombing of ISIS positions. Although Abdulazeez reportedly said ISIS was "a stupid group and it was completely against Islam," he was particularly influenced by Anwar al-Awlaki, former senior al-Qaeda official, and had his sermons in his possession.

Dr. Jerrold M. Post

Al-Awlaki, dubbed “the Bin Laden of the Internet” before his killing in a drone attack in 2011, was gifted in providing externalizing rhetoric to the many frustrated, alienated Muslim youth not feeling accepted into American society. Three themes can be found in Al-Awlaki’s sermons: 1. Muslims are victims. Their economic and social difficulties are caused by “them.” 2. “They” – the enemy out to humiliate and defeat Muslims – refers to the West, especially the United States, Great Britain, and Israel. 3. Therefore, jihad is required by all Muslims to defend Islam, which is under attack by “them.” These repetitive messages on the Internet were attractive to the rising number of alienated Muslims and are present in al-Qaeda and ISIS messaging today.

The New York Times recounted the story of a woman it called “Alex,” a 23-year-old college dropout living in rural Washington state who communicated with Islamic State supporters online for several months.

Mr. Cody McGinnis

Alex, who filled her time babysitting a couple of days a week, teaching Sunday school, “streaming movies on Netflix, and updating her social media timelines,” came dangerously close to boarding a plane – with her 11-year-old brother – for Austria, where her virtual community promised her a Muslim husband. What psychological patterns were at work with Alex, and what are the underlying psychological patterns of “lone wolf” terrorism?

Our studies of this phenomenon reflect not one but four different patterns, suggesting a typology of motivations. Based on an extensive review of open-source journalistic reports, we examined the available psychobiographic information and histories of 43 lone wolf terrorists and have been able to differentiate four types of lone wolves: glory seekers, hero worshipers, lonely romantics, and radical altruists (Behav. Sci. Law 2014;32:306-34).

Glory seekers are individuals who feel the world does not understand or appreciate their talents. This frustration generally stems from unrealized expectations of success, acceptance, and recognition from within their new community. An example of a lone wolf glory seeker is Abu Khalid Abdul-Latif, who became increasingly isolated and radical, and converted to Islam in prison. He reportedly confided to an FBI informant that he hoped to carry out an attack at a military processing station even more devastating than Maj. Nidal Malik Hasan’s massacre at Fort Hood, Tex. “We’re trying to send a message; We’re trying to get something that’s gonna be on CNN and over the world,” he was quoted as saying.

Dr. Kristen Moody

The hero worshipers who, by an idealized other, are persuaded to enter the path of radicalization and carry out an act of violent jihad. Because of the emptiness they feel in their own lives, they seek to emulate an idealized other who is seen as embodying all they would like to become. Before his death, Anwar al-Awlaki served as this idealized figure for many of the hero worshipers.

Typically immature and naive, the lonely romantics are isolated individuals entranced by promises of inclusion into a larger group (for example, al-Qaeda and ISIS). Their own personal struggles with self-identity make them susceptible to violent jihadist propaganda that sells a romanticized notion of “revolution,” one that promises inclusion into a global, violent jihadist brotherhood. Before the rise of ISIS, the Somali terrorist group, Al-Shabaab was adept in recruiting these lonely romantics as exemplified by a wolf pack of nearly 50 people from the Somali diaspora in Minnesota.

Radical altruists perceive themselves, or their Muslim community, as victims of Western oppression. Convinced that they are acting for the greater good, they plan or carry out acts of violent jihad out of a sense of moral outrage against the United States and the West. Fueled by narcissistic rage and an inflated sense of self-worth, they position themselves as victims of injustice. Would-be Times Square bomber Faisal Shahzad was an example of a radical altruist.

 

 

Ms. Jessica Zayas

The recent arrest of Justin Nojan Sullivan, a 19-year-old from North Carolina, illustrates the psychology of a “wannabe” terrorist, showing tendencies of a glory seeker and lonely romantic. He had grandiose aspirations and reportedly talked of killing up to 1,000 Americans by using guns, bombs, and chemical weapons. He planned to recruit others to the “Islamic State of North America.” In an email to an undercover agent, he said: “Our attacks need to be as big as possible … we can do minor assassinations before the big attack ....” He wanted to make a video of some of the killings and send them to the terrorist group, seeking to impress ISIS with his elaborate plan. His plans were cut short when his father called the police with concerns about his son’s change in behavior.

Familial intervention by Alex’s grandmother was instrumental in preventing her from traveling overseas to fulfill her goal of supporting the Islamic State by helping to bear the next generation of fighters. Alex embodied the features of a lonely romantic with altruistic justifications. She did not exhibit outwardly noticeable changes in appearance or attitude, as she was instructed to lead a double life, which included her continuing to teach Sunday school throughout her online radicalization. Her grandmother became concerned over the amount of time Alex was spending on social media and contacted the FBI.

A recent study by Fordham Law School’s Center on National Security, in New York, showed an increase in individuals wishing to conduct attacks in the United States, although most still seek to become foreign fighters for ISIS. As author Gabriel Weimann recently observed, these people are not truly lone wolves, as social media provides a coherent attractive message to these lonely, isolated individuals who feel a sense of belonging to the virtual community of hatred. An absorption in radical social media is increasingly the pathway to joining the virtual community of hatred, and this is a daunting challenge for counterterrorism.

Dr. Post is the founding director of the political psychology program at the Elliott School of International Affairs, The George Washington University, Washington. He is the author of “The Mind of the Terrorist” (New York: Palgrave Macmillan, 2008). Mr. McGinnis, a former Air Force intelligence, surveillance, and reconnaissance operator, is a doctoral candidate in clinical psychology at the university. Dr. Moody, a graduate of the program, is a forensic psychologist in the federal prison service. Ms. Zayas is Dr. Post’s director of research and has a master of arts in security policy studies from the university.

*This story was updated 7/24/2015.

The recent attack in Chattanooga, Tenn., on two military facilities in which four Marines and one Naval Academy midshipman were killed has the hallmarks of a lone wolf attack. Muhammad Youssef Abdulazeez, age 24, reportedly said 3 days before his attack that “life is short and bitter” and that Muslims should submit to Allah, for the time “may pass you by.” Abdulazeez's parents were increasingly concerned by his drug abuse and depression, and sent him to Jordan last year to break the downward spiral in his life, according to news reports.

A sharp increase in Islamic State sympathizers plotting against U.S. targets occurred after a communiqué circulated widely on the radical Internet called for waging jihad against the United States in retaliation for the bombing of ISIS positions. Although Abdulazeez reportedly said ISIS was "a stupid group and it was completely against Islam," he was particularly influenced by Anwar al-Awlaki, former senior al-Qaeda official, and had his sermons in his possession.

Dr. Jerrold M. Post

Al-Awlaki, dubbed “the Bin Laden of the Internet” before his killing in a drone attack in 2011, was gifted in providing externalizing rhetoric to the many frustrated, alienated Muslim youth not feeling accepted into American society. Three themes can be found in Al-Awlaki’s sermons: 1. Muslims are victims. Their economic and social difficulties are caused by “them.” 2. “They” – the enemy out to humiliate and defeat Muslims – refers to the West, especially the United States, Great Britain, and Israel. 3. Therefore, jihad is required by all Muslims to defend Islam, which is under attack by “them.” These repetitive messages on the Internet were attractive to the rising number of alienated Muslims and are present in al-Qaeda and ISIS messaging today.

The New York Times recounted the story of a woman it called “Alex,” a 23-year-old college dropout living in rural Washington state who communicated with Islamic State supporters online for several months.

Mr. Cody McGinnis

Alex, who filled her time babysitting a couple of days a week, teaching Sunday school, “streaming movies on Netflix, and updating her social media timelines,” came dangerously close to boarding a plane – with her 11-year-old brother – for Austria, where her virtual community promised her a Muslim husband. What psychological patterns were at work with Alex, and what are the underlying psychological patterns of “lone wolf” terrorism?

Our studies of this phenomenon reflect not one but four different patterns, suggesting a typology of motivations. Based on an extensive review of open-source journalistic reports, we examined the available psychobiographic information and histories of 43 lone wolf terrorists and have been able to differentiate four types of lone wolves: glory seekers, hero worshipers, lonely romantics, and radical altruists (Behav. Sci. Law 2014;32:306-34).

Glory seekers are individuals who feel the world does not understand or appreciate their talents. This frustration generally stems from unrealized expectations of success, acceptance, and recognition from within their new community. An example of a lone wolf glory seeker is Abu Khalid Abdul-Latif, who became increasingly isolated and radical, and converted to Islam in prison. He reportedly confided to an FBI informant that he hoped to carry out an attack at a military processing station even more devastating than Maj. Nidal Malik Hasan’s massacre at Fort Hood, Tex. “We’re trying to send a message; We’re trying to get something that’s gonna be on CNN and over the world,” he was quoted as saying.

Dr. Kristen Moody

The hero worshipers who, by an idealized other, are persuaded to enter the path of radicalization and carry out an act of violent jihad. Because of the emptiness they feel in their own lives, they seek to emulate an idealized other who is seen as embodying all they would like to become. Before his death, Anwar al-Awlaki served as this idealized figure for many of the hero worshipers.

Typically immature and naive, the lonely romantics are isolated individuals entranced by promises of inclusion into a larger group (for example, al-Qaeda and ISIS). Their own personal struggles with self-identity make them susceptible to violent jihadist propaganda that sells a romanticized notion of “revolution,” one that promises inclusion into a global, violent jihadist brotherhood. Before the rise of ISIS, the Somali terrorist group, Al-Shabaab was adept in recruiting these lonely romantics as exemplified by a wolf pack of nearly 50 people from the Somali diaspora in Minnesota.

Radical altruists perceive themselves, or their Muslim community, as victims of Western oppression. Convinced that they are acting for the greater good, they plan or carry out acts of violent jihad out of a sense of moral outrage against the United States and the West. Fueled by narcissistic rage and an inflated sense of self-worth, they position themselves as victims of injustice. Would-be Times Square bomber Faisal Shahzad was an example of a radical altruist.

 

 

Ms. Jessica Zayas

The recent arrest of Justin Nojan Sullivan, a 19-year-old from North Carolina, illustrates the psychology of a “wannabe” terrorist, showing tendencies of a glory seeker and lonely romantic. He had grandiose aspirations and reportedly talked of killing up to 1,000 Americans by using guns, bombs, and chemical weapons. He planned to recruit others to the “Islamic State of North America.” In an email to an undercover agent, he said: “Our attacks need to be as big as possible … we can do minor assassinations before the big attack ....” He wanted to make a video of some of the killings and send them to the terrorist group, seeking to impress ISIS with his elaborate plan. His plans were cut short when his father called the police with concerns about his son’s change in behavior.

Familial intervention by Alex’s grandmother was instrumental in preventing her from traveling overseas to fulfill her goal of supporting the Islamic State by helping to bear the next generation of fighters. Alex embodied the features of a lonely romantic with altruistic justifications. She did not exhibit outwardly noticeable changes in appearance or attitude, as she was instructed to lead a double life, which included her continuing to teach Sunday school throughout her online radicalization. Her grandmother became concerned over the amount of time Alex was spending on social media and contacted the FBI.

A recent study by Fordham Law School’s Center on National Security, in New York, showed an increase in individuals wishing to conduct attacks in the United States, although most still seek to become foreign fighters for ISIS. As author Gabriel Weimann recently observed, these people are not truly lone wolves, as social media provides a coherent attractive message to these lonely, isolated individuals who feel a sense of belonging to the virtual community of hatred. An absorption in radical social media is increasingly the pathway to joining the virtual community of hatred, and this is a daunting challenge for counterterrorism.

Dr. Post is the founding director of the political psychology program at the Elliott School of International Affairs, The George Washington University, Washington. He is the author of “The Mind of the Terrorist” (New York: Palgrave Macmillan, 2008). Mr. McGinnis, a former Air Force intelligence, surveillance, and reconnaissance operator, is a doctoral candidate in clinical psychology at the university. Dr. Moody, a graduate of the program, is a forensic psychologist in the federal prison service. Ms. Zayas is Dr. Post’s director of research and has a master of arts in security policy studies from the university.

*This story was updated 7/24/2015.

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GRAPPA initiatives continue to chart the way for psoriasis, psoriatic arthritis

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The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) meeting was held in Stockholm this year on July 7 and 8. This year’s meeting was packed with updates regarding numerous projects, including, but not limited to, educational initiatives, research work streams, inclusion of patients in the research process in psoriasis and psoriatic arthritis (PsA), and updating of the core set of outcome measures to be included in both psoriasis and PsA clinical trials through Outcome Measures in Rheumatology (OMERACT) and International Dermatology Outcome Measures (IDEOM) initiatives.

Among the most exciting initiatives was the review of the 2015 GRAPPA PsA Treatment Recommendations. The new treatment recommendations began 2 years ago and have included extensive literature reviews, small group discussions, and large group surveys. The final manuscript includes overarching principles and specific recommendations broken down by disease manifestations (for example, peripheral arthritis, axial disease, enthesitis, dactylitis, skin psoriasis, and nail disease). Changes from the 2009 GRAPPA Treatment Recommendations (Ann. Rheum. Dis. 2009;68:1387-94) include addition of new therapies (for example, phosphodiesterase-4 inhibitors, interleukin (IL) 12/23 inhibitors, IL-17 inhibitors) and recommendations for screening for comorbidities, as well as a table noting the influence of comorbidities on therapy selection. Each recommendation is supported as “weak” or “strong” depending on the level of evidence. Patient research partners were involved in all steps of the process. The final manuscript has been submitted for publication.

Dr. Alexis R. Ogdie-Beatty

In addition to treating the disease, better defining the disease is also of critical importance. In particular, defining a “flare” of rheumatoid arthritis or PsA has been quite difficult, and there has been great interest in building an assessment tool to measure the occurrence of flare. During the meeting, Dr. Anna Moverley and Dr. Philip Helliwell, both from the NIHR Musculoskeletal Biomedical Research Unit, Leeds (England) Institute of Rheumatic & Musculoskeletal Medicine, presented their work to date on defining PsA flares. They began their work by conducting a qualitative analysis of 18 patient interviews to identify themes related to having a PsA flare. Domains (or themes) identified included physical, psychological, social withdrawal, fatigue, and loss of function. In addition, patients described flare triggers, timing of flares, preflare management, and flare management. The results of this study were recently published in a paper titled, “It’s not just the joints, it’s the whole thing: qualitative analysis of patients’ experience of flare in psoriatic arthritis” (Rheumatology 2015;54:1448-54). The team then used these themes to create a Delphi survey, which was sent to both patients and physicians. Working groups at GRAPPA were used to determine the next steps, in particular whether a physician or patient tool (or both) should be developed.

Care of the patient with PsA from a multispecialty perspective was discussed in the “combined clinics” presentation. Several academic centers across North America have developed combined dermatology-rheumatology clinics. The functioning of these clinics varies widely from monthly dual clinics in which the dermatologist and rheumatologist see the patient together for virtual combined clinics in which time is set aside for discussion of shared patients. The advantages of these dual clinics include rich educational opportunities for medical students, residents, and fellows; the ideal clinical care model for patients; enhanced patient satisfaction with their care; improved patient care and quicker transition to a disease-modifying agent when indicated; and physician satisfaction and learning opportunities through collaborative work. Institutions using these collaborative models have combined to form the Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network (PPACMAN). The group has had two meetings and has developed research initiatives that are moving forward. Another goal of the group is to assist others centers interested in creating similar collaborative clinics.

The GRAPPA PsA BioDam (Psoriatic Arthritis Biomarkers for Joint Damage) initiative was also discussed at the meeting. The goal of this initiative is to examine soluble biomarkers as predictors of structural damage in PsA. Blood samples are taken at enrollment and then patients are followed prospectively. At 24 months of follow-up, repeat radiographs are obtained to monitor the development of new erosions. In addition to plain film radiographs, three sites are now also including MRI to assess for erosions. The study team, led by Dr. Oliver FitzGerald, hopes to begin analyzing some of the results from the study in the next 1-2 years.

Dr. Ogdie-Beatty is director of the Penn Psoriatic Arthritis Clinic at the University of Pennsylvania, Philadelphia, and is a member of the GRAPPA Steering Committee.

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The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) meeting was held in Stockholm this year on July 7 and 8. This year’s meeting was packed with updates regarding numerous projects, including, but not limited to, educational initiatives, research work streams, inclusion of patients in the research process in psoriasis and psoriatic arthritis (PsA), and updating of the core set of outcome measures to be included in both psoriasis and PsA clinical trials through Outcome Measures in Rheumatology (OMERACT) and International Dermatology Outcome Measures (IDEOM) initiatives.

Among the most exciting initiatives was the review of the 2015 GRAPPA PsA Treatment Recommendations. The new treatment recommendations began 2 years ago and have included extensive literature reviews, small group discussions, and large group surveys. The final manuscript includes overarching principles and specific recommendations broken down by disease manifestations (for example, peripheral arthritis, axial disease, enthesitis, dactylitis, skin psoriasis, and nail disease). Changes from the 2009 GRAPPA Treatment Recommendations (Ann. Rheum. Dis. 2009;68:1387-94) include addition of new therapies (for example, phosphodiesterase-4 inhibitors, interleukin (IL) 12/23 inhibitors, IL-17 inhibitors) and recommendations for screening for comorbidities, as well as a table noting the influence of comorbidities on therapy selection. Each recommendation is supported as “weak” or “strong” depending on the level of evidence. Patient research partners were involved in all steps of the process. The final manuscript has been submitted for publication.

Dr. Alexis R. Ogdie-Beatty

In addition to treating the disease, better defining the disease is also of critical importance. In particular, defining a “flare” of rheumatoid arthritis or PsA has been quite difficult, and there has been great interest in building an assessment tool to measure the occurrence of flare. During the meeting, Dr. Anna Moverley and Dr. Philip Helliwell, both from the NIHR Musculoskeletal Biomedical Research Unit, Leeds (England) Institute of Rheumatic & Musculoskeletal Medicine, presented their work to date on defining PsA flares. They began their work by conducting a qualitative analysis of 18 patient interviews to identify themes related to having a PsA flare. Domains (or themes) identified included physical, psychological, social withdrawal, fatigue, and loss of function. In addition, patients described flare triggers, timing of flares, preflare management, and flare management. The results of this study were recently published in a paper titled, “It’s not just the joints, it’s the whole thing: qualitative analysis of patients’ experience of flare in psoriatic arthritis” (Rheumatology 2015;54:1448-54). The team then used these themes to create a Delphi survey, which was sent to both patients and physicians. Working groups at GRAPPA were used to determine the next steps, in particular whether a physician or patient tool (or both) should be developed.

Care of the patient with PsA from a multispecialty perspective was discussed in the “combined clinics” presentation. Several academic centers across North America have developed combined dermatology-rheumatology clinics. The functioning of these clinics varies widely from monthly dual clinics in which the dermatologist and rheumatologist see the patient together for virtual combined clinics in which time is set aside for discussion of shared patients. The advantages of these dual clinics include rich educational opportunities for medical students, residents, and fellows; the ideal clinical care model for patients; enhanced patient satisfaction with their care; improved patient care and quicker transition to a disease-modifying agent when indicated; and physician satisfaction and learning opportunities through collaborative work. Institutions using these collaborative models have combined to form the Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network (PPACMAN). The group has had two meetings and has developed research initiatives that are moving forward. Another goal of the group is to assist others centers interested in creating similar collaborative clinics.

The GRAPPA PsA BioDam (Psoriatic Arthritis Biomarkers for Joint Damage) initiative was also discussed at the meeting. The goal of this initiative is to examine soluble biomarkers as predictors of structural damage in PsA. Blood samples are taken at enrollment and then patients are followed prospectively. At 24 months of follow-up, repeat radiographs are obtained to monitor the development of new erosions. In addition to plain film radiographs, three sites are now also including MRI to assess for erosions. The study team, led by Dr. Oliver FitzGerald, hopes to begin analyzing some of the results from the study in the next 1-2 years.

Dr. Ogdie-Beatty is director of the Penn Psoriatic Arthritis Clinic at the University of Pennsylvania, Philadelphia, and is a member of the GRAPPA Steering Committee.

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) meeting was held in Stockholm this year on July 7 and 8. This year’s meeting was packed with updates regarding numerous projects, including, but not limited to, educational initiatives, research work streams, inclusion of patients in the research process in psoriasis and psoriatic arthritis (PsA), and updating of the core set of outcome measures to be included in both psoriasis and PsA clinical trials through Outcome Measures in Rheumatology (OMERACT) and International Dermatology Outcome Measures (IDEOM) initiatives.

Among the most exciting initiatives was the review of the 2015 GRAPPA PsA Treatment Recommendations. The new treatment recommendations began 2 years ago and have included extensive literature reviews, small group discussions, and large group surveys. The final manuscript includes overarching principles and specific recommendations broken down by disease manifestations (for example, peripheral arthritis, axial disease, enthesitis, dactylitis, skin psoriasis, and nail disease). Changes from the 2009 GRAPPA Treatment Recommendations (Ann. Rheum. Dis. 2009;68:1387-94) include addition of new therapies (for example, phosphodiesterase-4 inhibitors, interleukin (IL) 12/23 inhibitors, IL-17 inhibitors) and recommendations for screening for comorbidities, as well as a table noting the influence of comorbidities on therapy selection. Each recommendation is supported as “weak” or “strong” depending on the level of evidence. Patient research partners were involved in all steps of the process. The final manuscript has been submitted for publication.

Dr. Alexis R. Ogdie-Beatty

In addition to treating the disease, better defining the disease is also of critical importance. In particular, defining a “flare” of rheumatoid arthritis or PsA has been quite difficult, and there has been great interest in building an assessment tool to measure the occurrence of flare. During the meeting, Dr. Anna Moverley and Dr. Philip Helliwell, both from the NIHR Musculoskeletal Biomedical Research Unit, Leeds (England) Institute of Rheumatic & Musculoskeletal Medicine, presented their work to date on defining PsA flares. They began their work by conducting a qualitative analysis of 18 patient interviews to identify themes related to having a PsA flare. Domains (or themes) identified included physical, psychological, social withdrawal, fatigue, and loss of function. In addition, patients described flare triggers, timing of flares, preflare management, and flare management. The results of this study were recently published in a paper titled, “It’s not just the joints, it’s the whole thing: qualitative analysis of patients’ experience of flare in psoriatic arthritis” (Rheumatology 2015;54:1448-54). The team then used these themes to create a Delphi survey, which was sent to both patients and physicians. Working groups at GRAPPA were used to determine the next steps, in particular whether a physician or patient tool (or both) should be developed.

Care of the patient with PsA from a multispecialty perspective was discussed in the “combined clinics” presentation. Several academic centers across North America have developed combined dermatology-rheumatology clinics. The functioning of these clinics varies widely from monthly dual clinics in which the dermatologist and rheumatologist see the patient together for virtual combined clinics in which time is set aside for discussion of shared patients. The advantages of these dual clinics include rich educational opportunities for medical students, residents, and fellows; the ideal clinical care model for patients; enhanced patient satisfaction with their care; improved patient care and quicker transition to a disease-modifying agent when indicated; and physician satisfaction and learning opportunities through collaborative work. Institutions using these collaborative models have combined to form the Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network (PPACMAN). The group has had two meetings and has developed research initiatives that are moving forward. Another goal of the group is to assist others centers interested in creating similar collaborative clinics.

The GRAPPA PsA BioDam (Psoriatic Arthritis Biomarkers for Joint Damage) initiative was also discussed at the meeting. The goal of this initiative is to examine soluble biomarkers as predictors of structural damage in PsA. Blood samples are taken at enrollment and then patients are followed prospectively. At 24 months of follow-up, repeat radiographs are obtained to monitor the development of new erosions. In addition to plain film radiographs, three sites are now also including MRI to assess for erosions. The study team, led by Dr. Oliver FitzGerald, hopes to begin analyzing some of the results from the study in the next 1-2 years.

Dr. Ogdie-Beatty is director of the Penn Psoriatic Arthritis Clinic at the University of Pennsylvania, Philadelphia, and is a member of the GRAPPA Steering Committee.

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