Physician burnout is a serious issue, especially in the often high-pressure world of obstetrics and gynecology. In the July 2016 issue of OBG Management, we briefly looked at studies showing that 1) ObGyns experience high rates of burnout, 2) rates of burnout are increasing over time, and 3) women, the majority gender in ObGyn, experience higher rates of burnout than their male counterparts. Between 2011 and 2014, rates of physician burnout increased from 45.5% to 54.4%.¹ In 2016, 51% of ObGyns reported experiencing burnout, with women reporting a rate of 55% compared with 46% for men.²

Numerous studies show that burnout is associated with increased likelihood of physician suicide, decisions to leave the practice of medicine, and poorer health, including obesity. These statistics ring alarm bells that we cannot ignore, especially as they may signal real concern for patient care.

The top causes of physician burnout, according to a Medscape survey, are²:

• too many bureaucratic tasks
• spending too many hours at work
• increasing computerization of practice
• income not high enough.

Physician burnout is not a one-size-fits-all condition. Not everyone experiences it similarly. Likewise, there are many strategies you can use to prevent and overcome burnout.

Experts offer guidance on preventing burnout

The 3 ObGyn leaders profiled in this article offer insight, inspiration, and opportunities to help you regain the joy of practice. The American Medical Association (AMA) also offers an online practice-based initiative that includes strategies to help improve professional satisfaction.

Take burnout by the horns
As Assistant Dean for Graduate Medical Education and Professor of Clinical Biologic Sciences, Charles E. Schmidt College of Medicine, at Florida Atlantic University in Boca Raton, Florida, Roger P. Smith, MD, has developed an authoritative focus on the symptoms and effects of physician burnout. Recently, Dr. Smith taught a clinical seminar titled “Burnout: A constant threat” at the American College of Obstetricians and Gynecologists (ACOG) 2016 Annual Clinical and Scientific Meeting in Washington, DC, where he reviewed the causes and symptoms of burnout as well as strategies to minimize and avoid it. His work shows that burnout is pervasive and is becoming more so. Dr. Smith indicates that burnout is not any more common to one part of the country or one type of ObGyn care than any other, although it is becoming more commonly recognized among younger physicians.

As with other nonphysical ailments, symptoms of burnout may have affected ObGyns over many generations—symptoms that people did not discuss with their families or colleagues or that were easily dismissed.

Dr. Smith is opening the door for unreserved conversations about burnout in the physician community. He suggests ways for practices to focus on physician wellness and for individual ObGyns to recognize and take steps to overcome burnout signs. To hear Dr. Smith’s expert discussion on burnout, tune in to his audio interview, “Is burnout on the rise and what are the signs ObGyns should be on the lookout for?”

Develop a passion outside of medicine
Jeffrey M. Rothenberg, MD, MS, experienced serious burnout in 1997 after 3 infants in his high-risk obstetrical unit died in the same week. Like many ObGyns, he tries to not bring work-related issues home, but that week Dr. Rothenberg’s wife Joani, an accomplished art therapist, recognized her husband’s anguish. Soon, she enrolled him in a glass-blowing class to give him a needed break from the pressures of his practice. Dr. Rothenberg’s life was transformed. “Initially it was an escape,” he says about his venture into the art world. “Unlike the OR or in labor and delivery, no one could get hurt but me; it wasn’t life and death—it was something outside of what I do for a living and allowed me to disconnect from my chosen profession—if even for a little bit.”

Still a practicing ObGyn and currently the Designated Institutional Official at St. Vincent in Indianapolis, Dr. Rothenberg is now an accomplished glass artist with his work in public and private collections around the world. Because he feels so passionately that physicians should have a creative outlet, he helps medical students discover their own forms of self-expression through the Creative Arts Therapy Student Interest Group in the Office of Medical Student Service-Learning at Indiana University, where he serves as a mentor. There, he teaches medical students the importance of taking care of themselves as well as their patients. Dr. Rothenberg has made integrating the arts and humanities an integral part of the Indiana University School of Medicine curricula, and he helped establish the Visual Thinking Strategy program, which teaches nursing and medical students better communication skills using the power of observation gained through the arts. In honor of this work, Dr. Rothenberg received a 2015 Arnold P. Gold Foundation Humanism in Medicine Award.

For Dr. Rothenberg, glass has been the perfect medium. “It’s a very tactile art form, and I like doing things with my hands, as a surgeon—there’s a real affinity there—taking materials that are dangerous to touch and coaxing them into forms and shapes that are either artistic or functional is a challenge—but definitely stress reducing,” he says. He also found striking similarities between the operating room and the glass studio, which both involve teamwork, good communication skills, and repetition.

“I think that every healer needs an avocation in addition to his or her chosen vocation. Especially in medicine, both for patients and healers, we all deal with some amazingly complex and difficult situations—often at the intersection of life and death—that go beyond verbalizing and may have no right or wrong answer—just a bad and a worse choice. Given that backdrop, having another way to express yourself or an avenue for a kind of emotional catharsis... is very, very helpful. I think it’s important for our learners, in particular, to embrace the humanistic side of medicine. After all, medicine is so much more than just a science. It’s more of an art, and I think they can really bond with both patients and other providers alike if they have something else in common—something that they can talk about that is outside of medicine. We have very stressful jobs and we need to model to our trainees and to each other that it is important to take care of ourselves. It’s important for a healer to have a passion, a creative outlet,” he explains.

Be part of the solution
ACOG President Thomas Gellhaus, MD, has dedicated his life to advocating for his specialty and for patient care. His presidential initiatives hold great potential for preventing and overcoming burnout in ObGyns throughout the nation.

Join a mentoring program. Dr. Gellhaus encourages greater participation in mentoring—both as a mentor and a mentee—through an innovative mentor matching program created by Thomas Arnold, MD, and Tamara Helfer, MD, MBA, in ACOG District VI. This program allows physicians to share new ideas and aspirations, connect colleagues, and build lifelong bonds. Young ObGyns find an experienced and trusted advisor; more experienced ObGyns find satisfaction in helping others grow. Helping ObGyns avoid burnout is a key goal of this mentoring program, and Dr. Gellhaus is expanding the program to ACOG Fellows in all Districts.

The District VI mentoring program includes these goals:

• sharing skills, knowledge, and expertise
• demonstrating optimism and enthusiasm about the mentor-mentee relationship and the field of obstetrics and gynecology
• promoting ongoing learning and growth
• providing guidance and constructive feedback
• setting personal and professional goals
• celebrating accomplishments.

Dr. Arnold and Dr. Helfer point out that mentoring opportunities are also critical to help align practice with the future, especially working in collaborative groups, focusing on population health, and incorporating integrated learning. Learn more about bringing this mentorship program to your practice or ACOG section at http://www.acog.org/mentorshipprogram.

Consider going on a global health mission. Dr. Gellhaus and his family have participated in and led many medical missions over the years, braving oppressive heat and discomfort for the opportunity to bring health care to those who have none. He points out, “In areas where health care is out of reach, these missions help people return to economic productivity and retain their dignity.”

Under Dr. Gellhaus’ leadership, ACOG will help connect interested ObGyns with care needs across the globe through the organizations that need physician volunteers for short-term stays.

Already, ACOG is developing an ObGyn educational curriculum for Health Volunteers Overseas, a nonprofit organization that for 30 years has helped educate local health providers in villages in developing nations.

These short-term experiences not only can help physicians break out of their burnout ruts but also transform women’s lives and help build long-term relationships with physicians across the globe.

Become an advocate. Also under the leadership of Dr. Gellhaus, ACOG is investing in the imperative to help members thrive and lead health care into the next generation. Advocacy means getting politicians out of our exam rooms, reducing red tape, and improving payments and participation experiences for practicing ObGyns.

Dr. Gellhaus’ All-in for Advocacy program is designed to increase ACOG’s legislative power while expanding advocacy opportunities throughout the membership. Dr. Gellhaus said in his inaugural presidential address, “I’d like everyone to realize that caring for your patients does not end in the exam room or the surgical suite and everyone is affected by our legislative fights.”

All these initiatives offer alternatives to the pressure of day-to-day practice, and participation can bring back the joy of collegiality and making a difference.

AMA’s initiative to battle burnout

The AMA, too, has responded to physicians’ needs by developing its STEPS Forward interactive practice transformation series (www.stepsforward.org). A 2013 Rand study commissioned by the AMA found that “the satisfaction physicians derive from their work is eroding as they spend more time on grueling administrative rules, regulations and paperwork than caring for patients. The report noted that many physicians say that the bureaucratic obstacles to providing patients with high-quality care are major contributors to symptoms of burnout, including emotional fatigue, depersonalization, loss of enthusiasm and early retirement.”^3,4

The STEPS Forward module Preventing Physician Burnout (www.stepsforward.org/modules/physician-burnout) can help identify if you are at risk for burnout and offers examples of how to implement changes that may restore your work satisfaction and work-life balance (TABLE).⁵ It details practice changes that can improve workflow and reduce administrative barriers, improving both patient and physician satisfaction.

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.

Physician burnout is a serious issue, especially in the often high-pressure world of obstetrics and gynecology. In the July 2016 issue of OBG Management, we briefly looked at studies showing that 1) ObGyns experience high rates of burnout, 2) rates of burnout are increasing over time, and 3) women, the majority gender in ObGyn, experience higher rates of burnout than their male counterparts. Between 2011 and 2014, rates of physician burnout increased from 45.5% to 54.4%.¹ In 2016, 51% of ObGyns reported experiencing burnout, with women reporting a rate of 55% compared with 46% for men.²

Numerous studies show that burnout is associated with increased likelihood of physician suicide, decisions to leave the practice of medicine, and poorer health, including obesity. These statistics ring alarm bells that we cannot ignore, especially as they may signal real concern for patient care.

The top causes of physician burnout, according to a Medscape survey, are²:

• too many bureaucratic tasks
• spending too many hours at work
• increasing computerization of practice
• income not high enough.

Physician burnout is not a one-size-fits-all condition. Not everyone experiences it similarly. Likewise, there are many strategies you can use to prevent and overcome burnout.

Experts offer guidance on preventing burnout

The 3 ObGyn leaders profiled in this article offer insight, inspiration, and opportunities to help you regain the joy of practice. The American Medical Association (AMA) also offers an online practice-based initiative that includes strategies to help improve professional satisfaction.

Take burnout by the horns
As Assistant Dean for Graduate Medical Education and Professor of Clinical Biologic Sciences, Charles E. Schmidt College of Medicine, at Florida Atlantic University in Boca Raton, Florida, Roger P. Smith, MD, has developed an authoritative focus on the symptoms and effects of physician burnout. Recently, Dr. Smith taught a clinical seminar titled “Burnout: A constant threat” at the American College of Obstetricians and Gynecologists (ACOG) 2016 Annual Clinical and Scientific Meeting in Washington, DC, where he reviewed the causes and symptoms of burnout as well as strategies to minimize and avoid it. His work shows that burnout is pervasive and is becoming more so. Dr. Smith indicates that burnout is not any more common to one part of the country or one type of ObGyn care than any other, although it is becoming more commonly recognized among younger physicians.

As with other nonphysical ailments, symptoms of burnout may have affected ObGyns over many generations—symptoms that people did not discuss with their families or colleagues or that were easily dismissed.

Dr. Smith is opening the door for unreserved conversations about burnout in the physician community. He suggests ways for practices to focus on physician wellness and for individual ObGyns to recognize and take steps to overcome burnout signs. To hear Dr. Smith’s expert discussion on burnout, tune in to his audio interview, “Is burnout on the rise and what are the signs ObGyns should be on the lookout for?”

Develop a passion outside of medicine
Jeffrey M. Rothenberg, MD, MS, experienced serious burnout in 1997 after 3 infants in his high-risk obstetrical unit died in the same week. Like many ObGyns, he tries to not bring work-related issues home, but that week Dr. Rothenberg’s wife Joani, an accomplished art therapist, recognized her husband’s anguish. Soon, she enrolled him in a glass-blowing class to give him a needed break from the pressures of his practice. Dr. Rothenberg’s life was transformed. “Initially it was an escape,” he says about his venture into the art world. “Unlike the OR or in labor and delivery, no one could get hurt but me; it wasn’t life and death—it was something outside of what I do for a living and allowed me to disconnect from my chosen profession—if even for a little bit.”

Still a practicing ObGyn and currently the Designated Institutional Official at St. Vincent in Indianapolis, Dr. Rothenberg is now an accomplished glass artist with his work in public and private collections around the world. Because he feels so passionately that physicians should have a creative outlet, he helps medical students discover their own forms of self-expression through the Creative Arts Therapy Student Interest Group in the Office of Medical Student Service-Learning at Indiana University, where he serves as a mentor. There, he teaches medical students the importance of taking care of themselves as well as their patients. Dr. Rothenberg has made integrating the arts and humanities an integral part of the Indiana University School of Medicine curricula, and he helped establish the Visual Thinking Strategy program, which teaches nursing and medical students better communication skills using the power of observation gained through the arts. In honor of this work, Dr. Rothenberg received a 2015 Arnold P. Gold Foundation Humanism in Medicine Award.

For Dr. Rothenberg, glass has been the perfect medium. “It’s a very tactile art form, and I like doing things with my hands, as a surgeon—there’s a real affinity there—taking materials that are dangerous to touch and coaxing them into forms and shapes that are either artistic or functional is a challenge—but definitely stress reducing,” he says. He also found striking similarities between the operating room and the glass studio, which both involve teamwork, good communication skills, and repetition.

“I think that every healer needs an avocation in addition to his or her chosen vocation. Especially in medicine, both for patients and healers, we all deal with some amazingly complex and difficult situations—often at the intersection of life and death—that go beyond verbalizing and may have no right or wrong answer—just a bad and a worse choice. Given that backdrop, having another way to express yourself or an avenue for a kind of emotional catharsis... is very, very helpful. I think it’s important for our learners, in particular, to embrace the humanistic side of medicine. After all, medicine is so much more than just a science. It’s more of an art, and I think they can really bond with both patients and other providers alike if they have something else in common—something that they can talk about that is outside of medicine. We have very stressful jobs and we need to model to our trainees and to each other that it is important to take care of ourselves. It’s important for a healer to have a passion, a creative outlet,” he explains.

Be part of the solution
ACOG President Thomas Gellhaus, MD, has dedicated his life to advocating for his specialty and for patient care. His presidential initiatives hold great potential for preventing and overcoming burnout in ObGyns throughout the nation.

Join a mentoring program. Dr. Gellhaus encourages greater participation in mentoring—both as a mentor and a mentee—through an innovative mentor matching program created by Thomas Arnold, MD, and Tamara Helfer, MD, MBA, in ACOG District VI. This program allows physicians to share new ideas and aspirations, connect colleagues, and build lifelong bonds. Young ObGyns find an experienced and trusted advisor; more experienced ObGyns find satisfaction in helping others grow. Helping ObGyns avoid burnout is a key goal of this mentoring program, and Dr. Gellhaus is expanding the program to ACOG Fellows in all Districts.

The District VI mentoring program includes these goals:

• sharing skills, knowledge, and expertise
• demonstrating optimism and enthusiasm about the mentor-mentee relationship and the field of obstetrics and gynecology
• promoting ongoing learning and growth
• providing guidance and constructive feedback
• setting personal and professional goals
• celebrating accomplishments.

Dr. Arnold and Dr. Helfer point out that mentoring opportunities are also critical to help align practice with the future, especially working in collaborative groups, focusing on population health, and incorporating integrated learning. Learn more about bringing this mentorship program to your practice or ACOG section at http://www.acog.org/mentorshipprogram.

Consider going on a global health mission. Dr. Gellhaus and his family have participated in and led many medical missions over the years, braving oppressive heat and discomfort for the opportunity to bring health care to those who have none. He points out, “In areas where health care is out of reach, these missions help people return to economic productivity and retain their dignity.”

Under Dr. Gellhaus’ leadership, ACOG will help connect interested ObGyns with care needs across the globe through the organizations that need physician volunteers for short-term stays.

Already, ACOG is developing an ObGyn educational curriculum for Health Volunteers Overseas, a nonprofit organization that for 30 years has helped educate local health providers in villages in developing nations.

These short-term experiences not only can help physicians break out of their burnout ruts but also transform women’s lives and help build long-term relationships with physicians across the globe.

Become an advocate. Also under the leadership of Dr. Gellhaus, ACOG is investing in the imperative to help members thrive and lead health care into the next generation. Advocacy means getting politicians out of our exam rooms, reducing red tape, and improving payments and participation experiences for practicing ObGyns.

Dr. Gellhaus’ All-in for Advocacy program is designed to increase ACOG’s legislative power while expanding advocacy opportunities throughout the membership. Dr. Gellhaus said in his inaugural presidential address, “I’d like everyone to realize that caring for your patients does not end in the exam room or the surgical suite and everyone is affected by our legislative fights.”

All these initiatives offer alternatives to the pressure of day-to-day practice, and participation can bring back the joy of collegiality and making a difference.

AMA’s initiative to battle burnout

The AMA, too, has responded to physicians’ needs by developing its STEPS Forward interactive practice transformation series (www.stepsforward.org). A 2013 Rand study commissioned by the AMA found that “the satisfaction physicians derive from their work is eroding as they spend more time on grueling administrative rules, regulations and paperwork than caring for patients. The report noted that many physicians say that the bureaucratic obstacles to providing patients with high-quality care are major contributors to symptoms of burnout, including emotional fatigue, depersonalization, loss of enthusiasm and early retirement.”^3,4

The STEPS Forward module Preventing Physician Burnout (www.stepsforward.org/modules/physician-burnout) can help identify if you are at risk for burnout and offers examples of how to implement changes that may restore your work satisfaction and work-life balance (TABLE).⁵ It details practice changes that can improve workflow and reduce administrative barriers, improving both patient and physician satisfaction.

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.

Physician burnout is a serious issue, especially in the often high-pressure world of obstetrics and gynecology. In the July 2016 issue of OBG Management, we briefly looked at studies showing that 1) ObGyns experience high rates of burnout, 2) rates of burnout are increasing over time, and 3) women, the majority gender in ObGyn, experience higher rates of burnout than their male counterparts. Between 2011 and 2014, rates of physician burnout increased from 45.5% to 54.4%.¹ In 2016, 51% of ObGyns reported experiencing burnout, with women reporting a rate of 55% compared with 46% for men.²

Numerous studies show that burnout is associated with increased likelihood of physician suicide, decisions to leave the practice of medicine, and poorer health, including obesity. These statistics ring alarm bells that we cannot ignore, especially as they may signal real concern for patient care.

The top causes of physician burnout, according to a Medscape survey, are²:

• too many bureaucratic tasks
• spending too many hours at work
• increasing computerization of practice
• income not high enough.

Physician burnout is not a one-size-fits-all condition. Not everyone experiences it similarly. Likewise, there are many strategies you can use to prevent and overcome burnout.

Experts offer guidance on preventing burnout

The 3 ObGyn leaders profiled in this article offer insight, inspiration, and opportunities to help you regain the joy of practice. The American Medical Association (AMA) also offers an online practice-based initiative that includes strategies to help improve professional satisfaction.

Take burnout by the horns
As Assistant Dean for Graduate Medical Education and Professor of Clinical Biologic Sciences, Charles E. Schmidt College of Medicine, at Florida Atlantic University in Boca Raton, Florida, Roger P. Smith, MD, has developed an authoritative focus on the symptoms and effects of physician burnout. Recently, Dr. Smith taught a clinical seminar titled “Burnout: A constant threat” at the American College of Obstetricians and Gynecologists (ACOG) 2016 Annual Clinical and Scientific Meeting in Washington, DC, where he reviewed the causes and symptoms of burnout as well as strategies to minimize and avoid it. His work shows that burnout is pervasive and is becoming more so. Dr. Smith indicates that burnout is not any more common to one part of the country or one type of ObGyn care than any other, although it is becoming more commonly recognized among younger physicians.

As with other nonphysical ailments, symptoms of burnout may have affected ObGyns over many generations—symptoms that people did not discuss with their families or colleagues or that were easily dismissed.

Dr. Smith is opening the door for unreserved conversations about burnout in the physician community. He suggests ways for practices to focus on physician wellness and for individual ObGyns to recognize and take steps to overcome burnout signs. To hear Dr. Smith’s expert discussion on burnout, tune in to his audio interview, “Is burnout on the rise and what are the signs ObGyns should be on the lookout for?”

Develop a passion outside of medicine
Jeffrey M. Rothenberg, MD, MS, experienced serious burnout in 1997 after 3 infants in his high-risk obstetrical unit died in the same week. Like many ObGyns, he tries to not bring work-related issues home, but that week Dr. Rothenberg’s wife Joani, an accomplished art therapist, recognized her husband’s anguish. Soon, she enrolled him in a glass-blowing class to give him a needed break from the pressures of his practice. Dr. Rothenberg’s life was transformed. “Initially it was an escape,” he says about his venture into the art world. “Unlike the OR or in labor and delivery, no one could get hurt but me; it wasn’t life and death—it was something outside of what I do for a living and allowed me to disconnect from my chosen profession—if even for a little bit.”

Still a practicing ObGyn and currently the Designated Institutional Official at St. Vincent in Indianapolis, Dr. Rothenberg is now an accomplished glass artist with his work in public and private collections around the world. Because he feels so passionately that physicians should have a creative outlet, he helps medical students discover their own forms of self-expression through the Creative Arts Therapy Student Interest Group in the Office of Medical Student Service-Learning at Indiana University, where he serves as a mentor. There, he teaches medical students the importance of taking care of themselves as well as their patients. Dr. Rothenberg has made integrating the arts and humanities an integral part of the Indiana University School of Medicine curricula, and he helped establish the Visual Thinking Strategy program, which teaches nursing and medical students better communication skills using the power of observation gained through the arts. In honor of this work, Dr. Rothenberg received a 2015 Arnold P. Gold Foundation Humanism in Medicine Award.

For Dr. Rothenberg, glass has been the perfect medium. “It’s a very tactile art form, and I like doing things with my hands, as a surgeon—there’s a real affinity there—taking materials that are dangerous to touch and coaxing them into forms and shapes that are either artistic or functional is a challenge—but definitely stress reducing,” he says. He also found striking similarities between the operating room and the glass studio, which both involve teamwork, good communication skills, and repetition.

“I think that every healer needs an avocation in addition to his or her chosen vocation. Especially in medicine, both for patients and healers, we all deal with some amazingly complex and difficult situations—often at the intersection of life and death—that go beyond verbalizing and may have no right or wrong answer—just a bad and a worse choice. Given that backdrop, having another way to express yourself or an avenue for a kind of emotional catharsis... is very, very helpful. I think it’s important for our learners, in particular, to embrace the humanistic side of medicine. After all, medicine is so much more than just a science. It’s more of an art, and I think they can really bond with both patients and other providers alike if they have something else in common—something that they can talk about that is outside of medicine. We have very stressful jobs and we need to model to our trainees and to each other that it is important to take care of ourselves. It’s important for a healer to have a passion, a creative outlet,” he explains.

Be part of the solution
ACOG President Thomas Gellhaus, MD, has dedicated his life to advocating for his specialty and for patient care. His presidential initiatives hold great potential for preventing and overcoming burnout in ObGyns throughout the nation.

Join a mentoring program. Dr. Gellhaus encourages greater participation in mentoring—both as a mentor and a mentee—through an innovative mentor matching program created by Thomas Arnold, MD, and Tamara Helfer, MD, MBA, in ACOG District VI. This program allows physicians to share new ideas and aspirations, connect colleagues, and build lifelong bonds. Young ObGyns find an experienced and trusted advisor; more experienced ObGyns find satisfaction in helping others grow. Helping ObGyns avoid burnout is a key goal of this mentoring program, and Dr. Gellhaus is expanding the program to ACOG Fellows in all Districts.

The District VI mentoring program includes these goals:

• sharing skills, knowledge, and expertise
• demonstrating optimism and enthusiasm about the mentor-mentee relationship and the field of obstetrics and gynecology
• promoting ongoing learning and growth
• providing guidance and constructive feedback
• setting personal and professional goals
• celebrating accomplishments.

Dr. Arnold and Dr. Helfer point out that mentoring opportunities are also critical to help align practice with the future, especially working in collaborative groups, focusing on population health, and incorporating integrated learning. Learn more about bringing this mentorship program to your practice or ACOG section at http://www.acog.org/mentorshipprogram.

Consider going on a global health mission. Dr. Gellhaus and his family have participated in and led many medical missions over the years, braving oppressive heat and discomfort for the opportunity to bring health care to those who have none. He points out, “In areas where health care is out of reach, these missions help people return to economic productivity and retain their dignity.”

Under Dr. Gellhaus’ leadership, ACOG will help connect interested ObGyns with care needs across the globe through the organizations that need physician volunteers for short-term stays.

Already, ACOG is developing an ObGyn educational curriculum for Health Volunteers Overseas, a nonprofit organization that for 30 years has helped educate local health providers in villages in developing nations.

These short-term experiences not only can help physicians break out of their burnout ruts but also transform women’s lives and help build long-term relationships with physicians across the globe.

Become an advocate. Also under the leadership of Dr. Gellhaus, ACOG is investing in the imperative to help members thrive and lead health care into the next generation. Advocacy means getting politicians out of our exam rooms, reducing red tape, and improving payments and participation experiences for practicing ObGyns.

Dr. Gellhaus’ All-in for Advocacy program is designed to increase ACOG’s legislative power while expanding advocacy opportunities throughout the membership. Dr. Gellhaus said in his inaugural presidential address, “I’d like everyone to realize that caring for your patients does not end in the exam room or the surgical suite and everyone is affected by our legislative fights.”

All these initiatives offer alternatives to the pressure of day-to-day practice, and participation can bring back the joy of collegiality and making a difference.

AMA’s initiative to battle burnout

The AMA, too, has responded to physicians’ needs by developing its STEPS Forward interactive practice transformation series (www.stepsforward.org). A 2013 Rand study commissioned by the AMA found that “the satisfaction physicians derive from their work is eroding as they spend more time on grueling administrative rules, regulations and paperwork than caring for patients. The report noted that many physicians say that the bureaucratic obstacles to providing patients with high-quality care are major contributors to symptoms of burnout, including emotional fatigue, depersonalization, loss of enthusiasm and early retirement.”^3,4

The STEPS Forward module Preventing Physician Burnout (www.stepsforward.org/modules/physician-burnout) can help identify if you are at risk for burnout and offers examples of how to implement changes that may restore your work satisfaction and work-life balance (TABLE).⁵ It details practice changes that can improve workflow and reduce administrative barriers, improving both patient and physician satisfaction.

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.

 VANCOUVER—“Concussion is a public health epidemic,” said Amaal Starling, MD. “Neurologists are seeing more and more concussed patients every day.” At the 68th Annual Meeting of the American Academy of Neurology, Dr. Starling, who is an Assistant Professor of Neurology at the Mayo Clinic in Phoenix, provided a framework and a template for evaluating concussion in the outpatient setting.

“Prioritizing these patients into clinic is very important,” Dr. Starling said. She recommended expedited appointments for patients with a suspected concussion. “This will limit symptom exacerbation, provide an avenue for appropriate and quick symptomatic treatment, and prevent premature return to learn and return to play,” which may exacerbate symptoms and prolong recovery.

Outpatient Evaluation of Concussion

The patient history should always include the date of the injury and the injury description, which includes the mechanism of the injury, location of the impact, presence or absence of any whiplash injury, altered mental status or amnesia, as well as symptom progression. “How do the symptoms progress from the time of impact to the time the patient presents in the office?” Dr. Starling asked. “This will help you identify not only those immediate symptoms that occur, but also those delayed symptoms that can occur one to two days later. In addition, it will give you a time course of symptoms to determine if the patient has been worsening, improving, or has stayed about the same.”

Concussion has various symptoms that can be categorized in the following four domains: physical, cognitive, emotional, and sleep. The most frequently reported symptom is headache, followed by dizziness. To capture all of those symptom domains, Dr. Starling recommended using a postconcussion graded symptom checklist. “This can be effective at monitoring symptoms over time.”

It is also important to elicit risk factors for prolonged recovery. “If an individual has a personal history of migraine, they are at risk of having a prolonged recovery after the injury,” Dr. Starling said. “Even if they have no personal history of migraine, but if they have a family history of migraine, those individuals, per studies, have demonstrated a prolonged recovery after a concussion.” Other risk factors for a prolonged recovery include a history of learning disabilities, such as attention deficit disorder or dyslexia, and psychiatric disease, such as premorbid anxiety or depression.

A concussion history is also important because a prior concussion increases the risk of another concussion, as well as the risk of having a prolonged recovery. “Not only do you want to know how many concussions have occurred, but also the symptom duration and recovery course for those concussions.”

Since headache is the most common symptom after a concussion, it is important to evaluate headache when present. “In every headache history, it is important to look for red flags,” said Dr. Starling. She suggested using the mnemonic IFLOP to look for headache red flags in the setting of a concussion. IFLOP stands for Intractable vomiting, Focal neurologic symptoms and signs, changes in Level of awareness, Orthostatic headache, and Progressively worsening headache. When present, headache red flags should signal the need for neuroimaging. “For example, if someone is presenting with an orthostatic headache … I am concerned that they might have a CSF leak and I’ll want to get an MRI of the brain with and without contrast to look for diffuse pachymeningeal enhancement that we can see in that setting,” Dr. Starling said.

Management of a Concussed Patient

According to Dr. Starling, posttraumatic headaches should be treated according to their phenotypes. “If [the headache] has a migraine phenotype, treat it with migraine-specific medications. If it has a more cervicogenic phenotype, treat it that way.” The most common posttraumatic headache phenotype is migraine. That finding has been confirmed in the civilian as well as the military population. “But it is important to screen for other phenotypes that may also occur,” Dr. Starling advised.

Because patients with concussion seem to be at higher risk for medication overuse and medication overuse headache, a pre- and postinjury medication history is also important. “If they are using over-the-counter medications, you’ll want to know what they are using and how much.”

During the initial visit, it is also important to determine whether the patient has had any baseline testing. “If they had any computerized neurocognitive testing, obtain those results, Dr. Starling advised. “If they had a King-Devick test at baseline or pre season, obtain those results. If they have undergone gold-standard neuropsychometric testing or had a baseline neurologic examination or imaging, get those results so that you can compare postinjury [performance] to preinjury [performance].”

Regarding the physical examination in the outpatient setting, vitals are vital, Dr. Starling said. Many concussed athletes have autonomic dysfunction that looks like postural orthostatic tachycardia syndrome (POTS), although the prognosis is typically different. “When getting vitals, it is important to get orthostatic vitals—supine and then standing at one, five, and 10 minutes—to monitor for abnormal changes or an increase in the heart rate with standing.” The physical exam should also look for trigger points or any difficulties with range of motion of the neck. “These [findings] can give you avenues for therapeutic intervention,” Dr. Starling said. Additionally, the Dix–Hallpike maneuver can identify cases of benign paroxysmal positional vertigo, which can be treated with the Epley maneuver.

Mental status should be evaluated as part of a detailed neurologic examination. The Mini-Mental State Exam (MMSE), the Montreal Cognitive Assessment (MoCA), and the Kokmen are well-validated tools for the evaluation of mental status. The Standardized Assessment of Concussion (SAC) is another tool that was developed to assess mental status. The SAC was validated on the sideline and is used by a wide array of health care providers from athletic trainers to the team physicians.

During the cranial nerve examination, Dr. Starling tests for anosmia. “That is concerning for gross structural changes on the inferior surface of the frontal lobe where the olfactory nerve lies.” Abnormalities suggest a need for neuroimaging. A typical pupillary assessment with a swinging pen light test also is an essential part of the evaluation, but Dr. Starling commented that in her patients with mild traumatic brain injury or concussion, she has rarely found any clinically significant abnormalities with that test. “But that’s not true for the evaluation of extraocular movement,” she said. “I look for not only nystagmus, abnormalities of smooth pursuit, and horizontal and vertical saccades, but I also look for near point convergence. Near point convergence of greater than 6 cm is abnormal in the majority of individuals that we will evaluate for concussion.” When it is abnormal, it correlates with oculomotor abnormalities in function. So, these people have more difficulty with oculomotor function in day-to-day life—difficulties with reading and motion sensitivity.

The rest of the cranial nerve examination can also help identify subtle focal deficits. Upper motor neuron exam techniques also can detect subtle changes, and abnormalities can suggest a need for neuroimaging. Dr. Starling also recommended a good screening evaluation of balance, such as the timed tandem gait measure.

The Concussion Toolbox

No biomarkers or tests will yield a 100% accurate diagnosis of concussion. “However, studies have repeatedly demonstrated that if we use the tools that are available, and if we use a combination of them, we are nearing 100% sensitivity and specificity,” Dr. Starling said. In her return-to-play clinic, all patients undergo the King–Devick test, neuropsychologic testing, and objective vestibular testing. If patients report autonomic or orthostatic symptoms, they also undergo autonomic testing. “Unless I’m concerned about a skull fracture, I don’t get a CT scan of the head,” Dr. Starling said. “But we do obtain an MRI of the brain in individuals who have focal neurologic deficits, risk factors for prolonged recovery, or who have had prior concussions.” Dr. Starling recommended susceptibility-weighted imaging and diffusion tensor imaging.

Management priorities for patients with concussion include providing symptomatic treatment and preventing reinjury while the brain is healing. “Multidisciplinary symptoms require multidisciplinary treatment,” Dr. Starling said. “In my assessment, I’ll have a list of symptoms and a list of targeted approaches for each individual symptom.”

Posttraumatic Headache

“It is amazing how often I still see individuals two, four, eight weeks post injury who have never received a medication for posttraumatic headache because they’ve been told that the headache is a result of the concussion and as the concussion gets better, the headache will go away,” Dr. Starling said. Treating posttraumatic headache can relieve suffering and help the patient participate in active rehabilitation. Appropriate treatment can also prevent overuse of over-the-counter combination analgesics, which can complicate the problem. Experts in the headache community also suggest that there is a risk of chronification in untreated posttraumatic headache.

While there is a dearth of randomized, prospective, double-blind trials to guide the treatment of posttraumatic headache, “there still is an approach that you can use,” Dr. Starling said. Look for headache red flags first, then identify the phenotype and establish the headache history. If the patient had frequent migraines pre injury, it may be an indication for early initiation of a preventive medication. Initiating acute treatment early—within days—is also a priority, as is strictly monitoring for medication overuse. Also consider the comorbidities. “You don’t want to make comorbid symptoms worse,” Dr. Starling said. “For example, avoid topiramate in a patient who is having cognitive domain symptoms. Avoid sedating medications in someone who is having a lot of fatigue. Avoid steroids in a patient who is having a lot of emotional lability or difficulty with insomnia. Keep comorbid symptoms in mind when picking medications for posttraumatic headache.”

Return-to-Learn and Return-to-Play Decisions

Dr. Starling recommended symptom-limited cognitive and physical activity in the recovery phase, as opposed to total physical and cognitive rest. “There’s actually been a recent study that was done looking at strict rest,” she said. “The control group had one to two days of rest, followed by return to school and gradual return to activity. The intervention group had five days of strict rest.… The group with strict rest had higher symptom severity scores and had a longer symptom recovery. Exaggerated or extreme rest may not be the answer. Rather, we need to gradually reengage individuals back into life and give them a specific plan for graduated return to life, which includes both cognitive, as well as physical, activity.”

Return-to-learn protocols must be individualized, but there are some common goals. Dr. Starling recommended a short period of brain rest. “Not complete sensory deprivation, but rather symptom-limited brain rest. That should be followed by a brain warm-up phase where we initiate some time-limited and symptom-limited reading time—five to 10 minutes, as tolerated—and gradually increase that over time. After that, we reengage that individual back into school with extensive accommodations, which include the number of hours they are in school, as well as the curriculum, so a higher value on quality rather than quantity, and then a lot of environmental adjustments—perhaps a room that is quieter, a room where the lights are a little dimmer, they are allowed to wear a hat in class or sunglasses in class.” To avoid the sensory stimulation that characterizes school hallways between classes, which can make patients feel worse, Dr. Starling recommended that patients leave class five minutes early, spend the passing period in the nurse’s office, and then go to the next class five minutes late.

The next goal in recovery is full-day school with academic accommodations, and finally a return to learn without any accommodations. This requires an education specialist or a neuropsychologist who can get an individualized history from the patient as to what his or her day entails. A detailed recovery plan is then put into writing and provided to the patient and the school. The plan is then revised every one to two weeks as the patient recovers.

Dr. Starling suggested that physical activity could be initiated even when individuals are still having symptoms, but in a symptom-limited manner. “There have been studies looking at controlled exercise as a therapeutic approach for concussion,” she said. In an initial, nonrandomized pilot study, an exertion protocol seemed to improve symptoms, promote a faster rate of recovery, and normalize cerebral blood flow abnormalities during a cognitive task. “Although more rigorous studies are definitely needed, I think we are in the right paradigm,” Dr. Starling said. “After initial rest, but not complete sensory deprivation, active rehabilitation can be initiated, even in the presence of symptoms, as long as we have subthreshold activity.” This strategy, she said, is recommended to reduce symptom severity, speed recovery, and ensure full recovery.

“With active rehabilitation, we have to be prescriptive about what individual patients do. We want to make sure they are not exacerbating their symptoms.” At the Mayo Clinic, Dr. Starling and her team use written, as well as verbal, instructions. “We set in writing a goal heart rate that we want that individual patient to reach. In the clinical setting, we use a recumbent bike to determine a goal heart rate that is subthreshold to their symptoms. We then ask the patient to engage in activity up to that heart rate every day for the next couple of days. As they tolerate this, they can increase it [by] five to 10 beats per minute every three to seven days, and then we reevaluate this every one to two weeks to determine what the next step is.”

Once the exertion protocol is completed, a more sports-specific return-to-play protocol can be initiated. “During a concussion, the player can become deconditioned from their specific sport, so a sport-specific return to play protocol is important in that setting,” Dr. Starling said.

Recommending retirement from high-risk athletic activity is, of course, an individualized decision in which various components of the history come into play. According to Dr. Starling, the red flags for retirement include reduced threshold for concussion, neuroimaging abnormalities, persistent cognitive impairment, and debilitating refractory headaches.

 VANCOUVER—“Concussion is a public health epidemic,” said Amaal Starling, MD. “Neurologists are seeing more and more concussed patients every day.” At the 68th Annual Meeting of the American Academy of Neurology, Dr. Starling, who is an Assistant Professor of Neurology at the Mayo Clinic in Phoenix, provided a framework and a template for evaluating concussion in the outpatient setting.

“Prioritizing these patients into clinic is very important,” Dr. Starling said. She recommended expedited appointments for patients with a suspected concussion. “This will limit symptom exacerbation, provide an avenue for appropriate and quick symptomatic treatment, and prevent premature return to learn and return to play,” which may exacerbate symptoms and prolong recovery.

Outpatient Evaluation of Concussion

The patient history should always include the date of the injury and the injury description, which includes the mechanism of the injury, location of the impact, presence or absence of any whiplash injury, altered mental status or amnesia, as well as symptom progression. “How do the symptoms progress from the time of impact to the time the patient presents in the office?” Dr. Starling asked. “This will help you identify not only those immediate symptoms that occur, but also those delayed symptoms that can occur one to two days later. In addition, it will give you a time course of symptoms to determine if the patient has been worsening, improving, or has stayed about the same.”

Concussion has various symptoms that can be categorized in the following four domains: physical, cognitive, emotional, and sleep. The most frequently reported symptom is headache, followed by dizziness. To capture all of those symptom domains, Dr. Starling recommended using a postconcussion graded symptom checklist. “This can be effective at monitoring symptoms over time.”

It is also important to elicit risk factors for prolonged recovery. “If an individual has a personal history of migraine, they are at risk of having a prolonged recovery after the injury,” Dr. Starling said. “Even if they have no personal history of migraine, but if they have a family history of migraine, those individuals, per studies, have demonstrated a prolonged recovery after a concussion.” Other risk factors for a prolonged recovery include a history of learning disabilities, such as attention deficit disorder or dyslexia, and psychiatric disease, such as premorbid anxiety or depression.

A concussion history is also important because a prior concussion increases the risk of another concussion, as well as the risk of having a prolonged recovery. “Not only do you want to know how many concussions have occurred, but also the symptom duration and recovery course for those concussions.”

Since headache is the most common symptom after a concussion, it is important to evaluate headache when present. “In every headache history, it is important to look for red flags,” said Dr. Starling. She suggested using the mnemonic IFLOP to look for headache red flags in the setting of a concussion. IFLOP stands for Intractable vomiting, Focal neurologic symptoms and signs, changes in Level of awareness, Orthostatic headache, and Progressively worsening headache. When present, headache red flags should signal the need for neuroimaging. “For example, if someone is presenting with an orthostatic headache … I am concerned that they might have a CSF leak and I’ll want to get an MRI of the brain with and without contrast to look for diffuse pachymeningeal enhancement that we can see in that setting,” Dr. Starling said.

Management of a Concussed Patient

According to Dr. Starling, posttraumatic headaches should be treated according to their phenotypes. “If [the headache] has a migraine phenotype, treat it with migraine-specific medications. If it has a more cervicogenic phenotype, treat it that way.” The most common posttraumatic headache phenotype is migraine. That finding has been confirmed in the civilian as well as the military population. “But it is important to screen for other phenotypes that may also occur,” Dr. Starling advised.

Because patients with concussion seem to be at higher risk for medication overuse and medication overuse headache, a pre- and postinjury medication history is also important. “If they are using over-the-counter medications, you’ll want to know what they are using and how much.”

During the initial visit, it is also important to determine whether the patient has had any baseline testing. “If they had any computerized neurocognitive testing, obtain those results, Dr. Starling advised. “If they had a King-Devick test at baseline or pre season, obtain those results. If they have undergone gold-standard neuropsychometric testing or had a baseline neurologic examination or imaging, get those results so that you can compare postinjury [performance] to preinjury [performance].”

Regarding the physical examination in the outpatient setting, vitals are vital, Dr. Starling said. Many concussed athletes have autonomic dysfunction that looks like postural orthostatic tachycardia syndrome (POTS), although the prognosis is typically different. “When getting vitals, it is important to get orthostatic vitals—supine and then standing at one, five, and 10 minutes—to monitor for abnormal changes or an increase in the heart rate with standing.” The physical exam should also look for trigger points or any difficulties with range of motion of the neck. “These [findings] can give you avenues for therapeutic intervention,” Dr. Starling said. Additionally, the Dix–Hallpike maneuver can identify cases of benign paroxysmal positional vertigo, which can be treated with the Epley maneuver.

Mental status should be evaluated as part of a detailed neurologic examination. The Mini-Mental State Exam (MMSE), the Montreal Cognitive Assessment (MoCA), and the Kokmen are well-validated tools for the evaluation of mental status. The Standardized Assessment of Concussion (SAC) is another tool that was developed to assess mental status. The SAC was validated on the sideline and is used by a wide array of health care providers from athletic trainers to the team physicians.

During the cranial nerve examination, Dr. Starling tests for anosmia. “That is concerning for gross structural changes on the inferior surface of the frontal lobe where the olfactory nerve lies.” Abnormalities suggest a need for neuroimaging. A typical pupillary assessment with a swinging pen light test also is an essential part of the evaluation, but Dr. Starling commented that in her patients with mild traumatic brain injury or concussion, she has rarely found any clinically significant abnormalities with that test. “But that’s not true for the evaluation of extraocular movement,” she said. “I look for not only nystagmus, abnormalities of smooth pursuit, and horizontal and vertical saccades, but I also look for near point convergence. Near point convergence of greater than 6 cm is abnormal in the majority of individuals that we will evaluate for concussion.” When it is abnormal, it correlates with oculomotor abnormalities in function. So, these people have more difficulty with oculomotor function in day-to-day life—difficulties with reading and motion sensitivity.

The rest of the cranial nerve examination can also help identify subtle focal deficits. Upper motor neuron exam techniques also can detect subtle changes, and abnormalities can suggest a need for neuroimaging. Dr. Starling also recommended a good screening evaluation of balance, such as the timed tandem gait measure.

The Concussion Toolbox

No biomarkers or tests will yield a 100% accurate diagnosis of concussion. “However, studies have repeatedly demonstrated that if we use the tools that are available, and if we use a combination of them, we are nearing 100% sensitivity and specificity,” Dr. Starling said. In her return-to-play clinic, all patients undergo the King–Devick test, neuropsychologic testing, and objective vestibular testing. If patients report autonomic or orthostatic symptoms, they also undergo autonomic testing. “Unless I’m concerned about a skull fracture, I don’t get a CT scan of the head,” Dr. Starling said. “But we do obtain an MRI of the brain in individuals who have focal neurologic deficits, risk factors for prolonged recovery, or who have had prior concussions.” Dr. Starling recommended susceptibility-weighted imaging and diffusion tensor imaging.

Management priorities for patients with concussion include providing symptomatic treatment and preventing reinjury while the brain is healing. “Multidisciplinary symptoms require multidisciplinary treatment,” Dr. Starling said. “In my assessment, I’ll have a list of symptoms and a list of targeted approaches for each individual symptom.”

Posttraumatic Headache

“It is amazing how often I still see individuals two, four, eight weeks post injury who have never received a medication for posttraumatic headache because they’ve been told that the headache is a result of the concussion and as the concussion gets better, the headache will go away,” Dr. Starling said. Treating posttraumatic headache can relieve suffering and help the patient participate in active rehabilitation. Appropriate treatment can also prevent overuse of over-the-counter combination analgesics, which can complicate the problem. Experts in the headache community also suggest that there is a risk of chronification in untreated posttraumatic headache.

While there is a dearth of randomized, prospective, double-blind trials to guide the treatment of posttraumatic headache, “there still is an approach that you can use,” Dr. Starling said. Look for headache red flags first, then identify the phenotype and establish the headache history. If the patient had frequent migraines pre injury, it may be an indication for early initiation of a preventive medication. Initiating acute treatment early—within days—is also a priority, as is strictly monitoring for medication overuse. Also consider the comorbidities. “You don’t want to make comorbid symptoms worse,” Dr. Starling said. “For example, avoid topiramate in a patient who is having cognitive domain symptoms. Avoid sedating medications in someone who is having a lot of fatigue. Avoid steroids in a patient who is having a lot of emotional lability or difficulty with insomnia. Keep comorbid symptoms in mind when picking medications for posttraumatic headache.”

Return-to-Learn and Return-to-Play Decisions

Dr. Starling recommended symptom-limited cognitive and physical activity in the recovery phase, as opposed to total physical and cognitive rest. “There’s actually been a recent study that was done looking at strict rest,” she said. “The control group had one to two days of rest, followed by return to school and gradual return to activity. The intervention group had five days of strict rest.… The group with strict rest had higher symptom severity scores and had a longer symptom recovery. Exaggerated or extreme rest may not be the answer. Rather, we need to gradually reengage individuals back into life and give them a specific plan for graduated return to life, which includes both cognitive, as well as physical, activity.”

Return-to-learn protocols must be individualized, but there are some common goals. Dr. Starling recommended a short period of brain rest. “Not complete sensory deprivation, but rather symptom-limited brain rest. That should be followed by a brain warm-up phase where we initiate some time-limited and symptom-limited reading time—five to 10 minutes, as tolerated—and gradually increase that over time. After that, we reengage that individual back into school with extensive accommodations, which include the number of hours they are in school, as well as the curriculum, so a higher value on quality rather than quantity, and then a lot of environmental adjustments—perhaps a room that is quieter, a room where the lights are a little dimmer, they are allowed to wear a hat in class or sunglasses in class.” To avoid the sensory stimulation that characterizes school hallways between classes, which can make patients feel worse, Dr. Starling recommended that patients leave class five minutes early, spend the passing period in the nurse’s office, and then go to the next class five minutes late.

The next goal in recovery is full-day school with academic accommodations, and finally a return to learn without any accommodations. This requires an education specialist or a neuropsychologist who can get an individualized history from the patient as to what his or her day entails. A detailed recovery plan is then put into writing and provided to the patient and the school. The plan is then revised every one to two weeks as the patient recovers.

Dr. Starling suggested that physical activity could be initiated even when individuals are still having symptoms, but in a symptom-limited manner. “There have been studies looking at controlled exercise as a therapeutic approach for concussion,” she said. In an initial, nonrandomized pilot study, an exertion protocol seemed to improve symptoms, promote a faster rate of recovery, and normalize cerebral blood flow abnormalities during a cognitive task. “Although more rigorous studies are definitely needed, I think we are in the right paradigm,” Dr. Starling said. “After initial rest, but not complete sensory deprivation, active rehabilitation can be initiated, even in the presence of symptoms, as long as we have subthreshold activity.” This strategy, she said, is recommended to reduce symptom severity, speed recovery, and ensure full recovery.

“With active rehabilitation, we have to be prescriptive about what individual patients do. We want to make sure they are not exacerbating their symptoms.” At the Mayo Clinic, Dr. Starling and her team use written, as well as verbal, instructions. “We set in writing a goal heart rate that we want that individual patient to reach. In the clinical setting, we use a recumbent bike to determine a goal heart rate that is subthreshold to their symptoms. We then ask the patient to engage in activity up to that heart rate every day for the next couple of days. As they tolerate this, they can increase it [by] five to 10 beats per minute every three to seven days, and then we reevaluate this every one to two weeks to determine what the next step is.”

Once the exertion protocol is completed, a more sports-specific return-to-play protocol can be initiated. “During a concussion, the player can become deconditioned from their specific sport, so a sport-specific return to play protocol is important in that setting,” Dr. Starling said.

Recommending retirement from high-risk athletic activity is, of course, an individualized decision in which various components of the history come into play. According to Dr. Starling, the red flags for retirement include reduced threshold for concussion, neuroimaging abnormalities, persistent cognitive impairment, and debilitating refractory headaches.

 VANCOUVER—“Concussion is a public health epidemic,” said Amaal Starling, MD. “Neurologists are seeing more and more concussed patients every day.” At the 68th Annual Meeting of the American Academy of Neurology, Dr. Starling, who is an Assistant Professor of Neurology at the Mayo Clinic in Phoenix, provided a framework and a template for evaluating concussion in the outpatient setting.

“Prioritizing these patients into clinic is very important,” Dr. Starling said. She recommended expedited appointments for patients with a suspected concussion. “This will limit symptom exacerbation, provide an avenue for appropriate and quick symptomatic treatment, and prevent premature return to learn and return to play,” which may exacerbate symptoms and prolong recovery.

Outpatient Evaluation of Concussion

The patient history should always include the date of the injury and the injury description, which includes the mechanism of the injury, location of the impact, presence or absence of any whiplash injury, altered mental status or amnesia, as well as symptom progression. “How do the symptoms progress from the time of impact to the time the patient presents in the office?” Dr. Starling asked. “This will help you identify not only those immediate symptoms that occur, but also those delayed symptoms that can occur one to two days later. In addition, it will give you a time course of symptoms to determine if the patient has been worsening, improving, or has stayed about the same.”

Concussion has various symptoms that can be categorized in the following four domains: physical, cognitive, emotional, and sleep. The most frequently reported symptom is headache, followed by dizziness. To capture all of those symptom domains, Dr. Starling recommended using a postconcussion graded symptom checklist. “This can be effective at monitoring symptoms over time.”

It is also important to elicit risk factors for prolonged recovery. “If an individual has a personal history of migraine, they are at risk of having a prolonged recovery after the injury,” Dr. Starling said. “Even if they have no personal history of migraine, but if they have a family history of migraine, those individuals, per studies, have demonstrated a prolonged recovery after a concussion.” Other risk factors for a prolonged recovery include a history of learning disabilities, such as attention deficit disorder or dyslexia, and psychiatric disease, such as premorbid anxiety or depression.

A concussion history is also important because a prior concussion increases the risk of another concussion, as well as the risk of having a prolonged recovery. “Not only do you want to know how many concussions have occurred, but also the symptom duration and recovery course for those concussions.”

Since headache is the most common symptom after a concussion, it is important to evaluate headache when present. “In every headache history, it is important to look for red flags,” said Dr. Starling. She suggested using the mnemonic IFLOP to look for headache red flags in the setting of a concussion. IFLOP stands for Intractable vomiting, Focal neurologic symptoms and signs, changes in Level of awareness, Orthostatic headache, and Progressively worsening headache. When present, headache red flags should signal the need for neuroimaging. “For example, if someone is presenting with an orthostatic headache … I am concerned that they might have a CSF leak and I’ll want to get an MRI of the brain with and without contrast to look for diffuse pachymeningeal enhancement that we can see in that setting,” Dr. Starling said.

Management of a Concussed Patient

According to Dr. Starling, posttraumatic headaches should be treated according to their phenotypes. “If [the headache] has a migraine phenotype, treat it with migraine-specific medications. If it has a more cervicogenic phenotype, treat it that way.” The most common posttraumatic headache phenotype is migraine. That finding has been confirmed in the civilian as well as the military population. “But it is important to screen for other phenotypes that may also occur,” Dr. Starling advised.

Because patients with concussion seem to be at higher risk for medication overuse and medication overuse headache, a pre- and postinjury medication history is also important. “If they are using over-the-counter medications, you’ll want to know what they are using and how much.”

During the initial visit, it is also important to determine whether the patient has had any baseline testing. “If they had any computerized neurocognitive testing, obtain those results, Dr. Starling advised. “If they had a King-Devick test at baseline or pre season, obtain those results. If they have undergone gold-standard neuropsychometric testing or had a baseline neurologic examination or imaging, get those results so that you can compare postinjury [performance] to preinjury [performance].”

Regarding the physical examination in the outpatient setting, vitals are vital, Dr. Starling said. Many concussed athletes have autonomic dysfunction that looks like postural orthostatic tachycardia syndrome (POTS), although the prognosis is typically different. “When getting vitals, it is important to get orthostatic vitals—supine and then standing at one, five, and 10 minutes—to monitor for abnormal changes or an increase in the heart rate with standing.” The physical exam should also look for trigger points or any difficulties with range of motion of the neck. “These [findings] can give you avenues for therapeutic intervention,” Dr. Starling said. Additionally, the Dix–Hallpike maneuver can identify cases of benign paroxysmal positional vertigo, which can be treated with the Epley maneuver.

Mental status should be evaluated as part of a detailed neurologic examination. The Mini-Mental State Exam (MMSE), the Montreal Cognitive Assessment (MoCA), and the Kokmen are well-validated tools for the evaluation of mental status. The Standardized Assessment of Concussion (SAC) is another tool that was developed to assess mental status. The SAC was validated on the sideline and is used by a wide array of health care providers from athletic trainers to the team physicians.

During the cranial nerve examination, Dr. Starling tests for anosmia. “That is concerning for gross structural changes on the inferior surface of the frontal lobe where the olfactory nerve lies.” Abnormalities suggest a need for neuroimaging. A typical pupillary assessment with a swinging pen light test also is an essential part of the evaluation, but Dr. Starling commented that in her patients with mild traumatic brain injury or concussion, she has rarely found any clinically significant abnormalities with that test. “But that’s not true for the evaluation of extraocular movement,” she said. “I look for not only nystagmus, abnormalities of smooth pursuit, and horizontal and vertical saccades, but I also look for near point convergence. Near point convergence of greater than 6 cm is abnormal in the majority of individuals that we will evaluate for concussion.” When it is abnormal, it correlates with oculomotor abnormalities in function. So, these people have more difficulty with oculomotor function in day-to-day life—difficulties with reading and motion sensitivity.

The rest of the cranial nerve examination can also help identify subtle focal deficits. Upper motor neuron exam techniques also can detect subtle changes, and abnormalities can suggest a need for neuroimaging. Dr. Starling also recommended a good screening evaluation of balance, such as the timed tandem gait measure.

The Concussion Toolbox

No biomarkers or tests will yield a 100% accurate diagnosis of concussion. “However, studies have repeatedly demonstrated that if we use the tools that are available, and if we use a combination of them, we are nearing 100% sensitivity and specificity,” Dr. Starling said. In her return-to-play clinic, all patients undergo the King–Devick test, neuropsychologic testing, and objective vestibular testing. If patients report autonomic or orthostatic symptoms, they also undergo autonomic testing. “Unless I’m concerned about a skull fracture, I don’t get a CT scan of the head,” Dr. Starling said. “But we do obtain an MRI of the brain in individuals who have focal neurologic deficits, risk factors for prolonged recovery, or who have had prior concussions.” Dr. Starling recommended susceptibility-weighted imaging and diffusion tensor imaging.

Management priorities for patients with concussion include providing symptomatic treatment and preventing reinjury while the brain is healing. “Multidisciplinary symptoms require multidisciplinary treatment,” Dr. Starling said. “In my assessment, I’ll have a list of symptoms and a list of targeted approaches for each individual symptom.”

Posttraumatic Headache

“It is amazing how often I still see individuals two, four, eight weeks post injury who have never received a medication for posttraumatic headache because they’ve been told that the headache is a result of the concussion and as the concussion gets better, the headache will go away,” Dr. Starling said. Treating posttraumatic headache can relieve suffering and help the patient participate in active rehabilitation. Appropriate treatment can also prevent overuse of over-the-counter combination analgesics, which can complicate the problem. Experts in the headache community also suggest that there is a risk of chronification in untreated posttraumatic headache.

While there is a dearth of randomized, prospective, double-blind trials to guide the treatment of posttraumatic headache, “there still is an approach that you can use,” Dr. Starling said. Look for headache red flags first, then identify the phenotype and establish the headache history. If the patient had frequent migraines pre injury, it may be an indication for early initiation of a preventive medication. Initiating acute treatment early—within days—is also a priority, as is strictly monitoring for medication overuse. Also consider the comorbidities. “You don’t want to make comorbid symptoms worse,” Dr. Starling said. “For example, avoid topiramate in a patient who is having cognitive domain symptoms. Avoid sedating medications in someone who is having a lot of fatigue. Avoid steroids in a patient who is having a lot of emotional lability or difficulty with insomnia. Keep comorbid symptoms in mind when picking medications for posttraumatic headache.”

Return-to-Learn and Return-to-Play Decisions

Dr. Starling recommended symptom-limited cognitive and physical activity in the recovery phase, as opposed to total physical and cognitive rest. “There’s actually been a recent study that was done looking at strict rest,” she said. “The control group had one to two days of rest, followed by return to school and gradual return to activity. The intervention group had five days of strict rest.… The group with strict rest had higher symptom severity scores and had a longer symptom recovery. Exaggerated or extreme rest may not be the answer. Rather, we need to gradually reengage individuals back into life and give them a specific plan for graduated return to life, which includes both cognitive, as well as physical, activity.”

Return-to-learn protocols must be individualized, but there are some common goals. Dr. Starling recommended a short period of brain rest. “Not complete sensory deprivation, but rather symptom-limited brain rest. That should be followed by a brain warm-up phase where we initiate some time-limited and symptom-limited reading time—five to 10 minutes, as tolerated—and gradually increase that over time. After that, we reengage that individual back into school with extensive accommodations, which include the number of hours they are in school, as well as the curriculum, so a higher value on quality rather than quantity, and then a lot of environmental adjustments—perhaps a room that is quieter, a room where the lights are a little dimmer, they are allowed to wear a hat in class or sunglasses in class.” To avoid the sensory stimulation that characterizes school hallways between classes, which can make patients feel worse, Dr. Starling recommended that patients leave class five minutes early, spend the passing period in the nurse’s office, and then go to the next class five minutes late.

The next goal in recovery is full-day school with academic accommodations, and finally a return to learn without any accommodations. This requires an education specialist or a neuropsychologist who can get an individualized history from the patient as to what his or her day entails. A detailed recovery plan is then put into writing and provided to the patient and the school. The plan is then revised every one to two weeks as the patient recovers.

Dr. Starling suggested that physical activity could be initiated even when individuals are still having symptoms, but in a symptom-limited manner. “There have been studies looking at controlled exercise as a therapeutic approach for concussion,” she said. In an initial, nonrandomized pilot study, an exertion protocol seemed to improve symptoms, promote a faster rate of recovery, and normalize cerebral blood flow abnormalities during a cognitive task. “Although more rigorous studies are definitely needed, I think we are in the right paradigm,” Dr. Starling said. “After initial rest, but not complete sensory deprivation, active rehabilitation can be initiated, even in the presence of symptoms, as long as we have subthreshold activity.” This strategy, she said, is recommended to reduce symptom severity, speed recovery, and ensure full recovery.

“With active rehabilitation, we have to be prescriptive about what individual patients do. We want to make sure they are not exacerbating their symptoms.” At the Mayo Clinic, Dr. Starling and her team use written, as well as verbal, instructions. “We set in writing a goal heart rate that we want that individual patient to reach. In the clinical setting, we use a recumbent bike to determine a goal heart rate that is subthreshold to their symptoms. We then ask the patient to engage in activity up to that heart rate every day for the next couple of days. As they tolerate this, they can increase it [by] five to 10 beats per minute every three to seven days, and then we reevaluate this every one to two weeks to determine what the next step is.”

Once the exertion protocol is completed, a more sports-specific return-to-play protocol can be initiated. “During a concussion, the player can become deconditioned from their specific sport, so a sport-specific return to play protocol is important in that setting,” Dr. Starling said.

Recommending retirement from high-risk athletic activity is, of course, an individualized decision in which various components of the history come into play. According to Dr. Starling, the red flags for retirement include reduced threshold for concussion, neuroimaging abnormalities, persistent cognitive impairment, and debilitating refractory headaches.

Review the PDF of the fact sheet on adult photosensitivity disorders with board-relevant, easy-to-review material. This month's fact sheet will review important disorders in the adult population where photosensitivity is a major feature.

Practice Questions

1. A 50-year-old woman with a history of alcoholism and new-onset diarrhea developed a painful, scaly, erythematous, and hyperpigmented eruption on the photoexposed areas on the chest and hands. A similar presentation can occur in patients on which medications?

a. azathioprine

b. fluorouracil

c. pyrazinamide

d. A and C only

e. all of the above

2. A college student presents with a streaky blistering rash on the arms and legs. He is on summer vacation and recently started a side job of mowing lawns. This phototoxic eruption requires which light spectrum?

a. 200–290 nm

b. 290–315 nm

c. 315–400 nm

d. 400–700 nm

e. none of the above

3. A middle-aged man with psoriasis complains of new onset of redness of the hands and face that occurs within hours of going outside. The patient may be taking which medications?

a. doxepin

b. NSAIDS

c. tar shampoo

d. terbinafine

e. A, B, and C

f. B, C, and D

4. A patient with metastatic melanoma was just started on vemurafenib. Which side effect is most likely to occur from this medication?

a. cough

b. myalgia

c. panniculitis

d. photosensitivity

e. squamous cell carcinoma

5. A 30-year-old black woman reports an itchy, flesh-colored, bumpy rash on the extensor forearms that appears 24 hours after sun exposure. There was no prior exposure to systemic or topical photoallergens. Which of the following is false regarding this condition?

a. classified as a type IV hypersensitivity reaction

b. condition improves with subsequent exposures (hardening)

c. histology is characterized by mucin deposition

d. rash is generally nonscarring

e. similar reaction localized to the helices may occur in adolescent boys

Answers to practice questions provided on next page

Practice Question Answers

1. A 50-year-old woman with a history of alcoholism and new-onset diarrhea developed a painful, scaly, erythematous, and hyperpigmented eruption on the photoexposed areas on the chest and hands. A similar presentation can occur in patients on which medications?

a. azathioprine

b. fluorouracil

c. pyrazinamide

d. A and C only

e. all of the above

2. A college student presents with a streaky blistering rash on the arms and legs. He is on summer vacation and recently started a side job of mowing lawns. This phototoxic eruption requires which light spectrum?

a. 200–290 nm

b. 290–315 nm

c. 315–400 nm

d. 400–700 nm

e. none of the above

3. A middle-aged man with psoriasis complains of new onset of redness of the hands and face that occurs within hours of going outside. The patient may be taking which medications?

a. doxepin

b. NSAIDS

c. tar shampoo

d. terbinafine

e. A, B, and C

f. B, C, and D

4. A patient with metastatic melanoma was just started on vemurafenib. Which side effect is most likely to occur from this medication?

a. cough

b. myalgia

c. panniculitis

d. photosensitivity

e. squamous cell carcinoma

5. A 30-year-old black woman reports an itchy, flesh-colored, bumpy rash on the extensor forearms that appears 24 hours after sun exposure. There was no prior exposure to systemic or topical photoallergens. Which of the following is false regarding this condition?

a. classified as a type IV hypersensitivity reaction

b. condition improves with subsequent exposures (hardening)

c. histology is characterized by mucin deposition

d. rash is generally nonscarring

e. similar reaction localized to the helices may occur in adolescent boys

Review the PDF of the fact sheet on adult photosensitivity disorders with board-relevant, easy-to-review material. This month's fact sheet will review important disorders in the adult population where photosensitivity is a major feature.

Practice Questions

1. A 50-year-old woman with a history of alcoholism and new-onset diarrhea developed a painful, scaly, erythematous, and hyperpigmented eruption on the photoexposed areas on the chest and hands. A similar presentation can occur in patients on which medications?

a. azathioprine

b. fluorouracil

c. pyrazinamide

d. A and C only

e. all of the above

2. A college student presents with a streaky blistering rash on the arms and legs. He is on summer vacation and recently started a side job of mowing lawns. This phototoxic eruption requires which light spectrum?

a. 200–290 nm

b. 290–315 nm

c. 315–400 nm

d. 400–700 nm

e. none of the above

3. A middle-aged man with psoriasis complains of new onset of redness of the hands and face that occurs within hours of going outside. The patient may be taking which medications?

a. doxepin

b. NSAIDS

c. tar shampoo

d. terbinafine

e. A, B, and C

f. B, C, and D

4. A patient with metastatic melanoma was just started on vemurafenib. Which side effect is most likely to occur from this medication?

a. cough

b. myalgia

c. panniculitis

d. photosensitivity

e. squamous cell carcinoma

5. A 30-year-old black woman reports an itchy, flesh-colored, bumpy rash on the extensor forearms that appears 24 hours after sun exposure. There was no prior exposure to systemic or topical photoallergens. Which of the following is false regarding this condition?

a. classified as a type IV hypersensitivity reaction

b. condition improves with subsequent exposures (hardening)

c. histology is characterized by mucin deposition

d. rash is generally nonscarring

e. similar reaction localized to the helices may occur in adolescent boys

Answers to practice questions provided on next page

Practice Question Answers

1. A 50-year-old woman with a history of alcoholism and new-onset diarrhea developed a painful, scaly, erythematous, and hyperpigmented eruption on the photoexposed areas on the chest and hands. A similar presentation can occur in patients on which medications?

a. azathioprine

b. fluorouracil

c. pyrazinamide

d. A and C only

e. all of the above

2. A college student presents with a streaky blistering rash on the arms and legs. He is on summer vacation and recently started a side job of mowing lawns. This phototoxic eruption requires which light spectrum?

a. 200–290 nm

b. 290–315 nm

c. 315–400 nm

d. 400–700 nm

e. none of the above

3. A middle-aged man with psoriasis complains of new onset of redness of the hands and face that occurs within hours of going outside. The patient may be taking which medications?

a. doxepin

b. NSAIDS

c. tar shampoo

d. terbinafine

e. A, B, and C

f. B, C, and D

4. A patient with metastatic melanoma was just started on vemurafenib. Which side effect is most likely to occur from this medication?

a. cough

b. myalgia

c. panniculitis

d. photosensitivity

e. squamous cell carcinoma

5. A 30-year-old black woman reports an itchy, flesh-colored, bumpy rash on the extensor forearms that appears 24 hours after sun exposure. There was no prior exposure to systemic or topical photoallergens. Which of the following is false regarding this condition?

a. classified as a type IV hypersensitivity reaction

b. condition improves with subsequent exposures (hardening)

c. histology is characterized by mucin deposition

d. rash is generally nonscarring

e. similar reaction localized to the helices may occur in adolescent boys

Review the PDF of the fact sheet on adult photosensitivity disorders with board-relevant, easy-to-review material. This month's fact sheet will review important disorders in the adult population where photosensitivity is a major feature.

Practice Questions

1. A 50-year-old woman with a history of alcoholism and new-onset diarrhea developed a painful, scaly, erythematous, and hyperpigmented eruption on the photoexposed areas on the chest and hands. A similar presentation can occur in patients on which medications?

a. azathioprine

b. fluorouracil

c. pyrazinamide

d. A and C only

e. all of the above

2. A college student presents with a streaky blistering rash on the arms and legs. He is on summer vacation and recently started a side job of mowing lawns. This phototoxic eruption requires which light spectrum?

a. 200–290 nm

b. 290–315 nm

c. 315–400 nm

d. 400–700 nm

e. none of the above

3. A middle-aged man with psoriasis complains of new onset of redness of the hands and face that occurs within hours of going outside. The patient may be taking which medications?

a. doxepin

b. NSAIDS

c. tar shampoo

d. terbinafine

e. A, B, and C

f. B, C, and D

4. A patient with metastatic melanoma was just started on vemurafenib. Which side effect is most likely to occur from this medication?

a. cough

b. myalgia

c. panniculitis

d. photosensitivity

e. squamous cell carcinoma

5. A 30-year-old black woman reports an itchy, flesh-colored, bumpy rash on the extensor forearms that appears 24 hours after sun exposure. There was no prior exposure to systemic or topical photoallergens. Which of the following is false regarding this condition?

a. classified as a type IV hypersensitivity reaction

b. condition improves with subsequent exposures (hardening)

c. histology is characterized by mucin deposition

d. rash is generally nonscarring

e. similar reaction localized to the helices may occur in adolescent boys

Answers to practice questions provided on next page

Practice Question Answers

1. A 50-year-old woman with a history of alcoholism and new-onset diarrhea developed a painful, scaly, erythematous, and hyperpigmented eruption on the photoexposed areas on the chest and hands. A similar presentation can occur in patients on which medications?

a. azathioprine

b. fluorouracil

c. pyrazinamide

d. A and C only

e. all of the above

2. A college student presents with a streaky blistering rash on the arms and legs. He is on summer vacation and recently started a side job of mowing lawns. This phototoxic eruption requires which light spectrum?

a. 200–290 nm

b. 290–315 nm

c. 315–400 nm

d. 400–700 nm

e. none of the above

3. A middle-aged man with psoriasis complains of new onset of redness of the hands and face that occurs within hours of going outside. The patient may be taking which medications?

a. doxepin

b. NSAIDS

c. tar shampoo

d. terbinafine

e. A, B, and C

f. B, C, and D

4. A patient with metastatic melanoma was just started on vemurafenib. Which side effect is most likely to occur from this medication?

a. cough

b. myalgia

c. panniculitis

d. photosensitivity

e. squamous cell carcinoma

5. A 30-year-old black woman reports an itchy, flesh-colored, bumpy rash on the extensor forearms that appears 24 hours after sun exposure. There was no prior exposure to systemic or topical photoallergens. Which of the following is false regarding this condition?

a. classified as a type IV hypersensitivity reaction

b. condition improves with subsequent exposures (hardening)

c. histology is characterized by mucin deposition

d. rash is generally nonscarring

e. similar reaction localized to the helices may occur in adolescent boys

In the first part of this article series (“Preparation: Tips that lead to a solid, engaging presentation,” OBG Manag. 2016;28[7]:31–36.), we offered tips on preparing for a group presentation. In this article, part 2, we discuss the presentation itself and what you can do to capture and hold your audience’s attention.

Paul Zwolak for OBG Management

How to connect with the audience

Let’s assume the meeting host has just introduced you to the audience using, as we suggested in the previous article, an autobiographical profile you provided. You now have the audience’s undivided attention. What you do and say in the next 30 to 60 seconds will set the stage for your program. Following the requisite “thank you” to the host and meeting sponsor, use this time to establish your expertise as a spokesperson on the chosen topic. Or, if the introductory remarks made your expertise plain, you may choose to connect with the audience on an informal, personal level. If you are from out of town, for instance, you could remark on an interesting aspect of the city or region you are visiting that you learned on the Internet before arriving.

Underscore the topic’s importance. On the other hand, you might want to begin with an insightful statistic germane to your talk. For example, a talk on breast cancer might begin with, “According to the American Cancer Society, there are nearly 250,000 new cases of breast cancer each year, and breast cancer accounts for more than 40,000 deaths per year. That means more women die from breast cancer than die in auto accidents each year. So this emphasizes the importance of appropriately screening women for breast cancer annually after age 40.”

An opening story about a patient can be powerful. Better yet, a personal experience reflecting your topic is a great way to connect with your audience members and get their attention. For example, one of us (NHB) gives talks on practice management and practice efficiency. I might talk about when I was called from an exam room 3 times to answer “emergency” phone calls from a patient who wanted only to request her medical records. To ensure that this embarrassment would never happen again, I put in place a system that I then describe for the audience.

Alternatively, an opening that addresses the audience’s unspoken question, “What’s in this for me?” is sure to grab their attention. For instance, a talk on office productivity might begin by promising to share a way to increase annual collections by $250,000 per physician through scheduling adjustments that can increase the number of examined patients by one per hour.

Steer clear of these openings. In general, avoid “I’m delighted to be here” and other clichés. One exception would be if you can make that cliché humorous. For example, if a speaker from the deep South is visiting the northern part of the country in summer, she might say, “Most speakers say they’re delighted to be here, and you may well question their sincerity. However, I’m from New Orleans where the temperature is approaching 105 degrees with 95% humidity. You know I’m really delighted to be here!”

Importantly, avoid starting with an apology. Do not mention problems with the audiovisual equipment or why you arrived late. The audience does not care, and you will immediately lose their attention. They want to be educated and entertained. There is no better way to do this than by offering a compelling and captivating opening that begins the moment after you are introduced.

Finally, avoid use of the “royal I,” as in “I am here to talk about XYZ.” It places you in a position superior to the audience, and that is a turnoff. Instead, you could say to the audience, “The reason you are here is to learn about XYZ.” This places the audience on an equal level with you, and they know there will be something in the presentation for them.

Housekeeping notes

The audience will appreciate knowing how long you plan to speak and whether you will take questions during or after the presentation. Based on our experience, if there are fewer than 20 attendees, we often encourage questions during the program instead of waiting until the end. This makes the program more conversational and usually generates more questions. With a dinner presentation, we prefer to speak while the audience is eating. We usually start after the waiters have taken the orders and the attendees have had their appetizers. We might say we will finish the program by the time they are ready for dessert. We also mention that we will distribute a handout after the presentation so they do not have to worry about following the handout, taking notes, and watching the speaker while trying to eat.

The main body of the program

As for structuring your talk, we suggest you follow this time-honored advice often attributed to Aristotle: Tell the audience what you are going to say, say it, and tell them what you said.

So we begin a presentation by stating the objectives of our program, usually limited to 3 and no more than 4. For example, a talk on hormone therapy (HT) for treating vasomotor symptoms of menopause might mention 1) the history of HT use, 2) which women are appropriate candidates for HT, and 3) how to monitor women who receive HT.

Enhance the talk’s relevance. We like to begin a clinical program with a case scenario wherein we describe how one of our patients had the specific problem and how we used a particular drug, treatment, or device to manage the case. We try to select a patient similar to ones who would be seen by members of the audience.

Simplify as much as possible. We then present the slides exactly as they have been provided by the pharmaceutical company. Most company slides contain too many words as well as diagrams that are too complex for the audience to grasp easily. We try to find one salient point on each slide and focus attention on that single word, phrase, or sentence. We can do this in a small audience by walking over to the screen and pointing it out, or we can use the laser pointer from a distance.

Change things up to keep the message fresh. Let’s be honest, most medical talks are dry and boring. Try to inject some energy and enthusiasm in the middle of the presentation. Every few minutes we tell a story or ask the audience a question. For example, during a program on practice management, one of us (NHB) will relate a story about an unhappy patient and then ask a physician in the audience how he or she might handle the disgruntled patient. This is a nice break from the main content of the presentation, re-engaging the audience in an interactive exchange.

Should you use humor?

Although many physicians attempt to use humor during a presentation, few are talented at stand-up comedy. However, used judiciously humor, like seasoning in fine cuisine, can do great things for a presentation. It can break the ice, drive home a point, and enhance your likeability. It can, though, also backfire. One of us (NHB) once gave a talk to a large audience of pharmaceutical representatives. As part of my wrap-up I displayed a slide from the cover of Economics that showed 2 camels in the mating position. My closing line was that reps need to “hump to it” and get involved with their physicians and be value-added in their product detailing. Afterward, the meeting planner told me that he would never hire me again. He said I had a great program, great material, and a good connection with the audience. But my closing was over the top. I learned my lesson. Never use material that has the potential to offend. If you want to use humor, the self-deprecatingkind is always safest.

Try using visual aids

Our observation is that few physician speakers use visual aids other than their slides. We have learned that audience attention will stay focused on you if you make use of visual aids. For example, if we are speaking to a lay audience about urinary incontinence, we might use a balloon to demonstrate the bladder and the urethra.

Studies have shown that there are more nerve endings from the eye to the brain than from the ear to the brain. Humans purportedly receive 25 times as much stimulus from visual cues than from auditory ones. To paraphrase an old proverb, “One seeing is better than 100 times hearing about”!

A few suggestions regarding the use of visual aids:

1. Keep the visual aid out of sight until you are ready to use it. You do not want the audience staring at it when they should be focusing on you or your slide material. We usually keep our visual aids under the table that supports the computer and projector.
2. Make certain the visual aid is large enough to be seen by everyone in the audience.
3. Do not hand out the aid to the audience during your program. Doing so will divert their attention from you and your material.
4. When you have finished using the aid, put it away.

Closing out the program

After we have covered the program’s 3 objectives, we let the audience know we are approaching the end of the presentation. For a dinner program, we try to time the ending just as plates are being cleared and before dessert is served. We then restate the 3 objectives as they might pertain to the attendees’ patients and practices. At this time, we take questions from the audience, even if some were asked during the presentation. We repeat each question when it is asked so that everyone can hear it. (This also gives us a few seconds to think about it and frame our answer.) If it appears that many questions will be asked, we assure everyone that we plan to finish on time and will remain after the program is over to answer additional questions.

Tips on fielding questions. When responding to a question, direct your attention initially to the person who asked it. After that, spend about 20% of the time focused on that person and 80% of the time on the rest of the audience. If you focus only on the questioner, it becomes a one-on-one conversation. You want to end your response with your eyes on the group and not on the questioner. Looking at the group will also act as a bridge to the next question. Although we used to reply to an inquiry with, “That’s a great question,” we now suggest avoiding this comment. Why? Because it is unlikely that you’ll keep using that line, and the next questioner who does not receive the same compliment might feel slighted.

Wrap up. When you announce, “I would like to conclude my program with…,” this is the magical time when you hold the complete attention of the audience. Often, the speaker’s last words are the ones the audience remembers the longest. So this is the time to offer your take-home message. For example, a talk on how to motivate your staff might conclude, “Remember, your staff members are the people that patients encounter first and the ones they see last as they leave the office. Every patient can have a positive experience with you and your practice if you ensure that your personnel are highly motivated. This happens in part by your effort to recognize their accomplishments.” Then hold up your hands and spread out your arms as you end with “Thank you.” The audience likely will applaud and, if your speech is truly exceptional, you might receive a gratifying standing ovation!

Be seated

Renowned for his speeches, Franklin Delano Roosevelt summarized the art of effective speaking when he said, “Be sincere. Be brief. Be seated.” When your time is up, turn the program back over to the meeting host and take a seat.

In the final article in this public speaking series, we will discuss the follow-up steps to take once the program is over, including the call to action or what you want the audience to do after you have left the podium or the speaking venue.

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.

In the first part of this article series (“Preparation: Tips that lead to a solid, engaging presentation,” OBG Manag. 2016;28[7]:31–36.), we offered tips on preparing for a group presentation. In this article, part 2, we discuss the presentation itself and what you can do to capture and hold your audience’s attention.

Paul Zwolak for OBG Management

How to connect with the audience

Let’s assume the meeting host has just introduced you to the audience using, as we suggested in the previous article, an autobiographical profile you provided. You now have the audience’s undivided attention. What you do and say in the next 30 to 60 seconds will set the stage for your program. Following the requisite “thank you” to the host and meeting sponsor, use this time to establish your expertise as a spokesperson on the chosen topic. Or, if the introductory remarks made your expertise plain, you may choose to connect with the audience on an informal, personal level. If you are from out of town, for instance, you could remark on an interesting aspect of the city or region you are visiting that you learned on the Internet before arriving.

Underscore the topic’s importance. On the other hand, you might want to begin with an insightful statistic germane to your talk. For example, a talk on breast cancer might begin with, “According to the American Cancer Society, there are nearly 250,000 new cases of breast cancer each year, and breast cancer accounts for more than 40,000 deaths per year. That means more women die from breast cancer than die in auto accidents each year. So this emphasizes the importance of appropriately screening women for breast cancer annually after age 40.”

An opening story about a patient can be powerful. Better yet, a personal experience reflecting your topic is a great way to connect with your audience members and get their attention. For example, one of us (NHB) gives talks on practice management and practice efficiency. I might talk about when I was called from an exam room 3 times to answer “emergency” phone calls from a patient who wanted only to request her medical records. To ensure that this embarrassment would never happen again, I put in place a system that I then describe for the audience.

Alternatively, an opening that addresses the audience’s unspoken question, “What’s in this for me?” is sure to grab their attention. For instance, a talk on office productivity might begin by promising to share a way to increase annual collections by $250,000 per physician through scheduling adjustments that can increase the number of examined patients by one per hour.

Steer clear of these openings. In general, avoid “I’m delighted to be here” and other clichés. One exception would be if you can make that cliché humorous. For example, if a speaker from the deep South is visiting the northern part of the country in summer, she might say, “Most speakers say they’re delighted to be here, and you may well question their sincerity. However, I’m from New Orleans where the temperature is approaching 105 degrees with 95% humidity. You know I’m really delighted to be here!”

Importantly, avoid starting with an apology. Do not mention problems with the audiovisual equipment or why you arrived late. The audience does not care, and you will immediately lose their attention. They want to be educated and entertained. There is no better way to do this than by offering a compelling and captivating opening that begins the moment after you are introduced.

Finally, avoid use of the “royal I,” as in “I am here to talk about XYZ.” It places you in a position superior to the audience, and that is a turnoff. Instead, you could say to the audience, “The reason you are here is to learn about XYZ.” This places the audience on an equal level with you, and they know there will be something in the presentation for them.

Housekeeping notes

The audience will appreciate knowing how long you plan to speak and whether you will take questions during or after the presentation. Based on our experience, if there are fewer than 20 attendees, we often encourage questions during the program instead of waiting until the end. This makes the program more conversational and usually generates more questions. With a dinner presentation, we prefer to speak while the audience is eating. We usually start after the waiters have taken the orders and the attendees have had their appetizers. We might say we will finish the program by the time they are ready for dessert. We also mention that we will distribute a handout after the presentation so they do not have to worry about following the handout, taking notes, and watching the speaker while trying to eat.

The main body of the program

As for structuring your talk, we suggest you follow this time-honored advice often attributed to Aristotle: Tell the audience what you are going to say, say it, and tell them what you said.

So we begin a presentation by stating the objectives of our program, usually limited to 3 and no more than 4. For example, a talk on hormone therapy (HT) for treating vasomotor symptoms of menopause might mention 1) the history of HT use, 2) which women are appropriate candidates for HT, and 3) how to monitor women who receive HT.

Enhance the talk’s relevance. We like to begin a clinical program with a case scenario wherein we describe how one of our patients had the specific problem and how we used a particular drug, treatment, or device to manage the case. We try to select a patient similar to ones who would be seen by members of the audience.

Simplify as much as possible. We then present the slides exactly as they have been provided by the pharmaceutical company. Most company slides contain too many words as well as diagrams that are too complex for the audience to grasp easily. We try to find one salient point on each slide and focus attention on that single word, phrase, or sentence. We can do this in a small audience by walking over to the screen and pointing it out, or we can use the laser pointer from a distance.

Change things up to keep the message fresh. Let’s be honest, most medical talks are dry and boring. Try to inject some energy and enthusiasm in the middle of the presentation. Every few minutes we tell a story or ask the audience a question. For example, during a program on practice management, one of us (NHB) will relate a story about an unhappy patient and then ask a physician in the audience how he or she might handle the disgruntled patient. This is a nice break from the main content of the presentation, re-engaging the audience in an interactive exchange.

Should you use humor?

Although many physicians attempt to use humor during a presentation, few are talented at stand-up comedy. However, used judiciously humor, like seasoning in fine cuisine, can do great things for a presentation. It can break the ice, drive home a point, and enhance your likeability. It can, though, also backfire. One of us (NHB) once gave a talk to a large audience of pharmaceutical representatives. As part of my wrap-up I displayed a slide from the cover of Economics that showed 2 camels in the mating position. My closing line was that reps need to “hump to it” and get involved with their physicians and be value-added in their product detailing. Afterward, the meeting planner told me that he would never hire me again. He said I had a great program, great material, and a good connection with the audience. But my closing was over the top. I learned my lesson. Never use material that has the potential to offend. If you want to use humor, the self-deprecatingkind is always safest.

Try using visual aids

Our observation is that few physician speakers use visual aids other than their slides. We have learned that audience attention will stay focused on you if you make use of visual aids. For example, if we are speaking to a lay audience about urinary incontinence, we might use a balloon to demonstrate the bladder and the urethra.

Studies have shown that there are more nerve endings from the eye to the brain than from the ear to the brain. Humans purportedly receive 25 times as much stimulus from visual cues than from auditory ones. To paraphrase an old proverb, “One seeing is better than 100 times hearing about”!

A few suggestions regarding the use of visual aids:

1. Keep the visual aid out of sight until you are ready to use it. You do not want the audience staring at it when they should be focusing on you or your slide material. We usually keep our visual aids under the table that supports the computer and projector.
2. Make certain the visual aid is large enough to be seen by everyone in the audience.
3. Do not hand out the aid to the audience during your program. Doing so will divert their attention from you and your material.
4. When you have finished using the aid, put it away.

Closing out the program

After we have covered the program’s 3 objectives, we let the audience know we are approaching the end of the presentation. For a dinner program, we try to time the ending just as plates are being cleared and before dessert is served. We then restate the 3 objectives as they might pertain to the attendees’ patients and practices. At this time, we take questions from the audience, even if some were asked during the presentation. We repeat each question when it is asked so that everyone can hear it. (This also gives us a few seconds to think about it and frame our answer.) If it appears that many questions will be asked, we assure everyone that we plan to finish on time and will remain after the program is over to answer additional questions.

Tips on fielding questions. When responding to a question, direct your attention initially to the person who asked it. After that, spend about 20% of the time focused on that person and 80% of the time on the rest of the audience. If you focus only on the questioner, it becomes a one-on-one conversation. You want to end your response with your eyes on the group and not on the questioner. Looking at the group will also act as a bridge to the next question. Although we used to reply to an inquiry with, “That’s a great question,” we now suggest avoiding this comment. Why? Because it is unlikely that you’ll keep using that line, and the next questioner who does not receive the same compliment might feel slighted.

Wrap up. When you announce, “I would like to conclude my program with…,” this is the magical time when you hold the complete attention of the audience. Often, the speaker’s last words are the ones the audience remembers the longest. So this is the time to offer your take-home message. For example, a talk on how to motivate your staff might conclude, “Remember, your staff members are the people that patients encounter first and the ones they see last as they leave the office. Every patient can have a positive experience with you and your practice if you ensure that your personnel are highly motivated. This happens in part by your effort to recognize their accomplishments.” Then hold up your hands and spread out your arms as you end with “Thank you.” The audience likely will applaud and, if your speech is truly exceptional, you might receive a gratifying standing ovation!

Be seated

Renowned for his speeches, Franklin Delano Roosevelt summarized the art of effective speaking when he said, “Be sincere. Be brief. Be seated.” When your time is up, turn the program back over to the meeting host and take a seat.

In the final article in this public speaking series, we will discuss the follow-up steps to take once the program is over, including the call to action or what you want the audience to do after you have left the podium or the speaking venue.

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.

In the first part of this article series (“Preparation: Tips that lead to a solid, engaging presentation,” OBG Manag. 2016;28[7]:31–36.), we offered tips on preparing for a group presentation. In this article, part 2, we discuss the presentation itself and what you can do to capture and hold your audience’s attention.

Paul Zwolak for OBG Management

How to connect with the audience

Let’s assume the meeting host has just introduced you to the audience using, as we suggested in the previous article, an autobiographical profile you provided. You now have the audience’s undivided attention. What you do and say in the next 30 to 60 seconds will set the stage for your program. Following the requisite “thank you” to the host and meeting sponsor, use this time to establish your expertise as a spokesperson on the chosen topic. Or, if the introductory remarks made your expertise plain, you may choose to connect with the audience on an informal, personal level. If you are from out of town, for instance, you could remark on an interesting aspect of the city or region you are visiting that you learned on the Internet before arriving.

Underscore the topic’s importance. On the other hand, you might want to begin with an insightful statistic germane to your talk. For example, a talk on breast cancer might begin with, “According to the American Cancer Society, there are nearly 250,000 new cases of breast cancer each year, and breast cancer accounts for more than 40,000 deaths per year. That means more women die from breast cancer than die in auto accidents each year. So this emphasizes the importance of appropriately screening women for breast cancer annually after age 40.”

An opening story about a patient can be powerful. Better yet, a personal experience reflecting your topic is a great way to connect with your audience members and get their attention. For example, one of us (NHB) gives talks on practice management and practice efficiency. I might talk about when I was called from an exam room 3 times to answer “emergency” phone calls from a patient who wanted only to request her medical records. To ensure that this embarrassment would never happen again, I put in place a system that I then describe for the audience.

Alternatively, an opening that addresses the audience’s unspoken question, “What’s in this for me?” is sure to grab their attention. For instance, a talk on office productivity might begin by promising to share a way to increase annual collections by $250,000 per physician through scheduling adjustments that can increase the number of examined patients by one per hour.

Steer clear of these openings. In general, avoid “I’m delighted to be here” and other clichés. One exception would be if you can make that cliché humorous. For example, if a speaker from the deep South is visiting the northern part of the country in summer, she might say, “Most speakers say they’re delighted to be here, and you may well question their sincerity. However, I’m from New Orleans where the temperature is approaching 105 degrees with 95% humidity. You know I’m really delighted to be here!”

Importantly, avoid starting with an apology. Do not mention problems with the audiovisual equipment or why you arrived late. The audience does not care, and you will immediately lose their attention. They want to be educated and entertained. There is no better way to do this than by offering a compelling and captivating opening that begins the moment after you are introduced.

Finally, avoid use of the “royal I,” as in “I am here to talk about XYZ.” It places you in a position superior to the audience, and that is a turnoff. Instead, you could say to the audience, “The reason you are here is to learn about XYZ.” This places the audience on an equal level with you, and they know there will be something in the presentation for them.

Housekeeping notes

The audience will appreciate knowing how long you plan to speak and whether you will take questions during or after the presentation. Based on our experience, if there are fewer than 20 attendees, we often encourage questions during the program instead of waiting until the end. This makes the program more conversational and usually generates more questions. With a dinner presentation, we prefer to speak while the audience is eating. We usually start after the waiters have taken the orders and the attendees have had their appetizers. We might say we will finish the program by the time they are ready for dessert. We also mention that we will distribute a handout after the presentation so they do not have to worry about following the handout, taking notes, and watching the speaker while trying to eat.

The main body of the program

As for structuring your talk, we suggest you follow this time-honored advice often attributed to Aristotle: Tell the audience what you are going to say, say it, and tell them what you said.

So we begin a presentation by stating the objectives of our program, usually limited to 3 and no more than 4. For example, a talk on hormone therapy (HT) for treating vasomotor symptoms of menopause might mention 1) the history of HT use, 2) which women are appropriate candidates for HT, and 3) how to monitor women who receive HT.

Enhance the talk’s relevance. We like to begin a clinical program with a case scenario wherein we describe how one of our patients had the specific problem and how we used a particular drug, treatment, or device to manage the case. We try to select a patient similar to ones who would be seen by members of the audience.

Simplify as much as possible. We then present the slides exactly as they have been provided by the pharmaceutical company. Most company slides contain too many words as well as diagrams that are too complex for the audience to grasp easily. We try to find one salient point on each slide and focus attention on that single word, phrase, or sentence. We can do this in a small audience by walking over to the screen and pointing it out, or we can use the laser pointer from a distance.

Change things up to keep the message fresh. Let’s be honest, most medical talks are dry and boring. Try to inject some energy and enthusiasm in the middle of the presentation. Every few minutes we tell a story or ask the audience a question. For example, during a program on practice management, one of us (NHB) will relate a story about an unhappy patient and then ask a physician in the audience how he or she might handle the disgruntled patient. This is a nice break from the main content of the presentation, re-engaging the audience in an interactive exchange.

Should you use humor?

Although many physicians attempt to use humor during a presentation, few are talented at stand-up comedy. However, used judiciously humor, like seasoning in fine cuisine, can do great things for a presentation. It can break the ice, drive home a point, and enhance your likeability. It can, though, also backfire. One of us (NHB) once gave a talk to a large audience of pharmaceutical representatives. As part of my wrap-up I displayed a slide from the cover of Economics that showed 2 camels in the mating position. My closing line was that reps need to “hump to it” and get involved with their physicians and be value-added in their product detailing. Afterward, the meeting planner told me that he would never hire me again. He said I had a great program, great material, and a good connection with the audience. But my closing was over the top. I learned my lesson. Never use material that has the potential to offend. If you want to use humor, the self-deprecatingkind is always safest.

Try using visual aids

Our observation is that few physician speakers use visual aids other than their slides. We have learned that audience attention will stay focused on you if you make use of visual aids. For example, if we are speaking to a lay audience about urinary incontinence, we might use a balloon to demonstrate the bladder and the urethra.

Studies have shown that there are more nerve endings from the eye to the brain than from the ear to the brain. Humans purportedly receive 25 times as much stimulus from visual cues than from auditory ones. To paraphrase an old proverb, “One seeing is better than 100 times hearing about”!

A few suggestions regarding the use of visual aids:

1. Keep the visual aid out of sight until you are ready to use it. You do not want the audience staring at it when they should be focusing on you or your slide material. We usually keep our visual aids under the table that supports the computer and projector.
2. Make certain the visual aid is large enough to be seen by everyone in the audience.
3. Do not hand out the aid to the audience during your program. Doing so will divert their attention from you and your material.
4. When you have finished using the aid, put it away.

Closing out the program

After we have covered the program’s 3 objectives, we let the audience know we are approaching the end of the presentation. For a dinner program, we try to time the ending just as plates are being cleared and before dessert is served. We then restate the 3 objectives as they might pertain to the attendees’ patients and practices. At this time, we take questions from the audience, even if some were asked during the presentation. We repeat each question when it is asked so that everyone can hear it. (This also gives us a few seconds to think about it and frame our answer.) If it appears that many questions will be asked, we assure everyone that we plan to finish on time and will remain after the program is over to answer additional questions.

Tips on fielding questions. When responding to a question, direct your attention initially to the person who asked it. After that, spend about 20% of the time focused on that person and 80% of the time on the rest of the audience. If you focus only on the questioner, it becomes a one-on-one conversation. You want to end your response with your eyes on the group and not on the questioner. Looking at the group will also act as a bridge to the next question. Although we used to reply to an inquiry with, “That’s a great question,” we now suggest avoiding this comment. Why? Because it is unlikely that you’ll keep using that line, and the next questioner who does not receive the same compliment might feel slighted.

Wrap up. When you announce, “I would like to conclude my program with…,” this is the magical time when you hold the complete attention of the audience. Often, the speaker’s last words are the ones the audience remembers the longest. So this is the time to offer your take-home message. For example, a talk on how to motivate your staff might conclude, “Remember, your staff members are the people that patients encounter first and the ones they see last as they leave the office. Every patient can have a positive experience with you and your practice if you ensure that your personnel are highly motivated. This happens in part by your effort to recognize their accomplishments.” Then hold up your hands and spread out your arms as you end with “Thank you.” The audience likely will applaud and, if your speech is truly exceptional, you might receive a gratifying standing ovation!

Be seated

Renowned for his speeches, Franklin Delano Roosevelt summarized the art of effective speaking when he said, “Be sincere. Be brief. Be seated.” When your time is up, turn the program back over to the meeting host and take a seat.

In the final article in this public speaking series, we will discuss the follow-up steps to take once the program is over, including the call to action or what you want the audience to do after you have left the podium or the speaking venue.

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.

TORONTO—LMTM, an investigational tau-aggregation inhibitor, may not benefit patients with Alzheimer’s disease who are receiving standard of care, according to research presented at the Alzheimer’s Association International Conference. As monotherapy, however, the drug may stabilize cognition and reduce brain atrophy, according to Serge Gauthier, MD, Director of the Alzheimer’s Disease Research Unit at McGill University in Montreal.

The aggregation of tau protein is one of the hallmarks of Alzheimer’s disease, but most therapies to date have been designed to reduce the number of amyloid plaques. LMTM is a stabilized, reduced form of the methylthionium moiety. As the oxidized chloride salt (methylthionium chloride or MTC), it is commonly known as methylene blue. LMTM is better absorbed, better tolerated, and can be administered in a broader dose range than MTC. Phase II studies of MTC provided evidence for the treatment’s efficacy as monotherapy, but the drug was poorly absorbed at higher doses. MTC and LMTM block tau aggregation in vitro and in tau transgenic animal models.

An International Trial

Dr. Gauthier and colleagues conducted a 15-month phase III study of LMTM in patients with mild to moderate Alzheimer’s disease. Researchers in 16 countries randomized 891 patients to 8 mg/day, 150 mg/day, or 250 mg/day of LMTM. Like methylene blue, LMTM discolors the urine. Because no dye achieves the same effect, researchers administered 8 mg/day of LMTM as a control dose. This dose is enough to discolor the urine, and thus avoid breaking the blind, but is believed to be pharmacologically inactive.

The primary end point was a composite of cognition, as measured by the Alzheimer’s Disease Assessment Scale-Cognition (ADAS-Cog), and activities of daily living, as measured by the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL). The secondary end points were brain volume (ie, lateral ventricular volume) as measured by MRI, Clinical Global Impression of Change, and the Mini-Mental State Examination (MMSE).

The investigators examined the data using a standard, mixed-model, repeated-measure analysis with no imputation for missing data. They included patients’ Alzheimer’s disease treatment status as an additive term in their primary analysis. In addition, they planned a second analysis that used this treatment status as a covariate.

LMTM Failed Primary End Point

Approximately 62% of the population was female, and the population’s mean age was 70.6. About 85% of participants were taking approved treatments for Alzheimer’s disease at baseline. Baseline MMSE score was 18.6, and dementia was of moderate severity in 62% of patients. The study’s retention rate was 69%.

At 15 months, Dr. Gauthier and colleagues found no difference in ADAS-Cog score or ADCS-ADL score between the three treatment arms. Patients who took LMTM as monotherapy, however, had stable scores during the study period, compared with patients who took LMTM and standard treatments for Alzheimer’s disease. ADAS-Cog scores were 5.8 and 6.3 points higher, respectively, in patients taking the two higher doses of LMTM as monotherapy, compared with patients taking LMTM in combination with standard treatments. In addition, the rate of brain atrophy was 33% lower among patients taking LMTM as monotherapy, compared with patients taking LMTM and standard treatments.

Diarrhea was the most common side effect of the 250-mg/day dose of LMTM. This side effect may lead to a reduction of dose or treatment cessation. Dysuria was another adverse event and is explained by the drug effect in the urinary tract, according to the researchers.

What Is the Future of Tau Therapy?

The study results are disappointing, according to David Knopman, MD, Professor of Neurology at the Mayo Clinic College of Medicine in Rochester, Minnesota, who was not involved in the study. “The only thing that really counts is the primary outcome that was prespecified…. It was the group as a whole, and there weren’t any benefits.” Although the secondary results are interesting, secondary analyses are “fraught with interpretive difficulties because of hidden biases,” Dr. Knopman added. “When we’re only looking at a small subset of participants, and 15% were on no drug, I think it becomes difficult to interpret.” In addition, the results may have limited relevance for North American populations, where few people with Alzheimer’s disease are not receiving standard care.

A second, predominantly North American, study of LMTM in 800 patients with mild Alzheimer’s disease will be reported in the fall. In light of LMTM’s lack of efficacy as add-on to existing treatments, the researchers modified the primary analyses of the second study before unblinding to focus on monotherapy. “Tau therapy is a way to go. It’s just maybe more complicated than we thought,” said Dr. Gauthier, who is a member of the scientific advisory board of TauRx, the company that sponsored the study.

TORONTO—LMTM, an investigational tau-aggregation inhibitor, may not benefit patients with Alzheimer’s disease who are receiving standard of care, according to research presented at the Alzheimer’s Association International Conference. As monotherapy, however, the drug may stabilize cognition and reduce brain atrophy, according to Serge Gauthier, MD, Director of the Alzheimer’s Disease Research Unit at McGill University in Montreal.

The aggregation of tau protein is one of the hallmarks of Alzheimer’s disease, but most therapies to date have been designed to reduce the number of amyloid plaques. LMTM is a stabilized, reduced form of the methylthionium moiety. As the oxidized chloride salt (methylthionium chloride or MTC), it is commonly known as methylene blue. LMTM is better absorbed, better tolerated, and can be administered in a broader dose range than MTC. Phase II studies of MTC provided evidence for the treatment’s efficacy as monotherapy, but the drug was poorly absorbed at higher doses. MTC and LMTM block tau aggregation in vitro and in tau transgenic animal models.

An International Trial

Dr. Gauthier and colleagues conducted a 15-month phase III study of LMTM in patients with mild to moderate Alzheimer’s disease. Researchers in 16 countries randomized 891 patients to 8 mg/day, 150 mg/day, or 250 mg/day of LMTM. Like methylene blue, LMTM discolors the urine. Because no dye achieves the same effect, researchers administered 8 mg/day of LMTM as a control dose. This dose is enough to discolor the urine, and thus avoid breaking the blind, but is believed to be pharmacologically inactive.

The primary end point was a composite of cognition, as measured by the Alzheimer’s Disease Assessment Scale-Cognition (ADAS-Cog), and activities of daily living, as measured by the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL). The secondary end points were brain volume (ie, lateral ventricular volume) as measured by MRI, Clinical Global Impression of Change, and the Mini-Mental State Examination (MMSE).

The investigators examined the data using a standard, mixed-model, repeated-measure analysis with no imputation for missing data. They included patients’ Alzheimer’s disease treatment status as an additive term in their primary analysis. In addition, they planned a second analysis that used this treatment status as a covariate.

LMTM Failed Primary End Point

Approximately 62% of the population was female, and the population’s mean age was 70.6. About 85% of participants were taking approved treatments for Alzheimer’s disease at baseline. Baseline MMSE score was 18.6, and dementia was of moderate severity in 62% of patients. The study’s retention rate was 69%.

At 15 months, Dr. Gauthier and colleagues found no difference in ADAS-Cog score or ADCS-ADL score between the three treatment arms. Patients who took LMTM as monotherapy, however, had stable scores during the study period, compared with patients who took LMTM and standard treatments for Alzheimer’s disease. ADAS-Cog scores were 5.8 and 6.3 points higher, respectively, in patients taking the two higher doses of LMTM as monotherapy, compared with patients taking LMTM in combination with standard treatments. In addition, the rate of brain atrophy was 33% lower among patients taking LMTM as monotherapy, compared with patients taking LMTM and standard treatments.

Diarrhea was the most common side effect of the 250-mg/day dose of LMTM. This side effect may lead to a reduction of dose or treatment cessation. Dysuria was another adverse event and is explained by the drug effect in the urinary tract, according to the researchers.

What Is the Future of Tau Therapy?

The study results are disappointing, according to David Knopman, MD, Professor of Neurology at the Mayo Clinic College of Medicine in Rochester, Minnesota, who was not involved in the study. “The only thing that really counts is the primary outcome that was prespecified…. It was the group as a whole, and there weren’t any benefits.” Although the secondary results are interesting, secondary analyses are “fraught with interpretive difficulties because of hidden biases,” Dr. Knopman added. “When we’re only looking at a small subset of participants, and 15% were on no drug, I think it becomes difficult to interpret.” In addition, the results may have limited relevance for North American populations, where few people with Alzheimer’s disease are not receiving standard care.

A second, predominantly North American, study of LMTM in 800 patients with mild Alzheimer’s disease will be reported in the fall. In light of LMTM’s lack of efficacy as add-on to existing treatments, the researchers modified the primary analyses of the second study before unblinding to focus on monotherapy. “Tau therapy is a way to go. It’s just maybe more complicated than we thought,” said Dr. Gauthier, who is a member of the scientific advisory board of TauRx, the company that sponsored the study.

TORONTO—LMTM, an investigational tau-aggregation inhibitor, may not benefit patients with Alzheimer’s disease who are receiving standard of care, according to research presented at the Alzheimer’s Association International Conference. As monotherapy, however, the drug may stabilize cognition and reduce brain atrophy, according to Serge Gauthier, MD, Director of the Alzheimer’s Disease Research Unit at McGill University in Montreal.

The aggregation of tau protein is one of the hallmarks of Alzheimer’s disease, but most therapies to date have been designed to reduce the number of amyloid plaques. LMTM is a stabilized, reduced form of the methylthionium moiety. As the oxidized chloride salt (methylthionium chloride or MTC), it is commonly known as methylene blue. LMTM is better absorbed, better tolerated, and can be administered in a broader dose range than MTC. Phase II studies of MTC provided evidence for the treatment’s efficacy as monotherapy, but the drug was poorly absorbed at higher doses. MTC and LMTM block tau aggregation in vitro and in tau transgenic animal models.

An International Trial

Dr. Gauthier and colleagues conducted a 15-month phase III study of LMTM in patients with mild to moderate Alzheimer’s disease. Researchers in 16 countries randomized 891 patients to 8 mg/day, 150 mg/day, or 250 mg/day of LMTM. Like methylene blue, LMTM discolors the urine. Because no dye achieves the same effect, researchers administered 8 mg/day of LMTM as a control dose. This dose is enough to discolor the urine, and thus avoid breaking the blind, but is believed to be pharmacologically inactive.

The primary end point was a composite of cognition, as measured by the Alzheimer’s Disease Assessment Scale-Cognition (ADAS-Cog), and activities of daily living, as measured by the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL). The secondary end points were brain volume (ie, lateral ventricular volume) as measured by MRI, Clinical Global Impression of Change, and the Mini-Mental State Examination (MMSE).

The investigators examined the data using a standard, mixed-model, repeated-measure analysis with no imputation for missing data. They included patients’ Alzheimer’s disease treatment status as an additive term in their primary analysis. In addition, they planned a second analysis that used this treatment status as a covariate.

LMTM Failed Primary End Point

Approximately 62% of the population was female, and the population’s mean age was 70.6. About 85% of participants were taking approved treatments for Alzheimer’s disease at baseline. Baseline MMSE score was 18.6, and dementia was of moderate severity in 62% of patients. The study’s retention rate was 69%.

At 15 months, Dr. Gauthier and colleagues found no difference in ADAS-Cog score or ADCS-ADL score between the three treatment arms. Patients who took LMTM as monotherapy, however, had stable scores during the study period, compared with patients who took LMTM and standard treatments for Alzheimer’s disease. ADAS-Cog scores were 5.8 and 6.3 points higher, respectively, in patients taking the two higher doses of LMTM as monotherapy, compared with patients taking LMTM in combination with standard treatments. In addition, the rate of brain atrophy was 33% lower among patients taking LMTM as monotherapy, compared with patients taking LMTM and standard treatments.

Diarrhea was the most common side effect of the 250-mg/day dose of LMTM. This side effect may lead to a reduction of dose or treatment cessation. Dysuria was another adverse event and is explained by the drug effect in the urinary tract, according to the researchers.

What Is the Future of Tau Therapy?

The study results are disappointing, according to David Knopman, MD, Professor of Neurology at the Mayo Clinic College of Medicine in Rochester, Minnesota, who was not involved in the study. “The only thing that really counts is the primary outcome that was prespecified…. It was the group as a whole, and there weren’t any benefits.” Although the secondary results are interesting, secondary analyses are “fraught with interpretive difficulties because of hidden biases,” Dr. Knopman added. “When we’re only looking at a small subset of participants, and 15% were on no drug, I think it becomes difficult to interpret.” In addition, the results may have limited relevance for North American populations, where few people with Alzheimer’s disease are not receiving standard care.

A second, predominantly North American, study of LMTM in 800 patients with mild Alzheimer’s disease will be reported in the fall. In light of LMTM’s lack of efficacy as add-on to existing treatments, the researchers modified the primary analyses of the second study before unblinding to focus on monotherapy. “Tau therapy is a way to go. It’s just maybe more complicated than we thought,” said Dr. Gauthier, who is a member of the scientific advisory board of TauRx, the company that sponsored the study.

EXPERT COMMENTARY

After having a previous cesarean delivery (CD), women who subsequently become pregnant inevitably face the decision to undergo a repeat CD or attempt a trial of labor after cesarean (TOLAC). Currently in the United States, 83% of women with a prior uterine scar are delivered by repeat CD.¹ According to the Consortium on Safe Labor, more than half of all CD indications are attributed to having a prior uterine scar.¹ Furthermore, only 28% of women attempt a TOLAC, with a successful vaginal birth after cesarean (VBAC) rate of approximately 57%.¹

The reason for the low TOLAC rate is multifactorial, but a primary concern may be the safety risk of a TOLAC as it relates to uterine rupture, a rare but potentially catastrophic complication. In a large, multicenter prospective observational trial of more than 17,800 women attempting a TOLAC, the symptomatic uterine rupture rate was 0.7%.² As such, efforts to identify women at highest risk for uterine rupture and those with characteristics predictive of a successful VBAC have remained ongoing. Jastrow and colleagues have expanded this body of knowledge with their prospective cohort study.

Details of the study

The researchers assessed lower uterine segment thickness via vaginal and abdominal ultrasound at 34 to 38 weeks’ gestation in more than 1,850 women with a previous CD. Women enrolled in the trial were classified into 3 risk categories based on lower uterine segment thickness: high risk (<2.0 mm), intermediate risk (2.0 to 2.4 mm), and low risk (≥2.5 mm). The investigators’ objective was to estimate the occurrence of uterine rupture when this measurement was included in the decision-making process on mode of delivery.

An important aspect of this study involved how the provider discussed the mode of delivery with the patient after the lower uterine segment measurement was obtained. Both the provider and the patient were informed of the risk category, and further counseling included the following:

• average overall uterine rupture risk, 0.5% to 1%
• if <2.0 mm, uterine rupture risk likely >1%
• if ≥2.5 mm, uterine rupture risk likely <0.5%
• uterine rupture risks (including perinatal asphyxia and death)
• maternal and neonatal complications of cesarean
• estimation of likelihood for successful VBAC.

How did risk-stratified women fare?

In approximately 1,000 cases, the authors reported no symptomatic uterine ruptures. Of particular interest, however, is the rate of women attempting a TOLAC in each category:

• 194 women with high risk
  • 9% underwent a TOLAC
  • 82% had a successful vaginal birth
• 217 women with intermediate risk
  • 42% underwent a TOLAC
  • 78% had a successful vaginal birth
• 1,438 women with low risk
  • 61% underwent a TOLAC
  • 66% had a successful vaginal birth.

Considering cesarean scar defect

Finally, uterine scar defects at CD in those who underwent a TOLAC were 0/3 (0%), 5/21 (25%), and 20/276 (7%) in the high-, intermediate-, and low-risk groups, respectively. Given the observational nature of the study, the authors suggest that uterine scar dehiscence may be predictive of labor dystocia, but it remains unclear if it predicts or is a prerequisite for subsequent uterine rupture if labor occurs.
 

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.

EXPERT COMMENTARY

After having a previous cesarean delivery (CD), women who subsequently become pregnant inevitably face the decision to undergo a repeat CD or attempt a trial of labor after cesarean (TOLAC). Currently in the United States, 83% of women with a prior uterine scar are delivered by repeat CD.¹ According to the Consortium on Safe Labor, more than half of all CD indications are attributed to having a prior uterine scar.¹ Furthermore, only 28% of women attempt a TOLAC, with a successful vaginal birth after cesarean (VBAC) rate of approximately 57%.¹

The reason for the low TOLAC rate is multifactorial, but a primary concern may be the safety risk of a TOLAC as it relates to uterine rupture, a rare but potentially catastrophic complication. In a large, multicenter prospective observational trial of more than 17,800 women attempting a TOLAC, the symptomatic uterine rupture rate was 0.7%.² As such, efforts to identify women at highest risk for uterine rupture and those with characteristics predictive of a successful VBAC have remained ongoing. Jastrow and colleagues have expanded this body of knowledge with their prospective cohort study.

Details of the study

The researchers assessed lower uterine segment thickness via vaginal and abdominal ultrasound at 34 to 38 weeks’ gestation in more than 1,850 women with a previous CD. Women enrolled in the trial were classified into 3 risk categories based on lower uterine segment thickness: high risk (<2.0 mm), intermediate risk (2.0 to 2.4 mm), and low risk (≥2.5 mm). The investigators’ objective was to estimate the occurrence of uterine rupture when this measurement was included in the decision-making process on mode of delivery.

An important aspect of this study involved how the provider discussed the mode of delivery with the patient after the lower uterine segment measurement was obtained. Both the provider and the patient were informed of the risk category, and further counseling included the following:

• average overall uterine rupture risk, 0.5% to 1%
• if <2.0 mm, uterine rupture risk likely >1%
• if ≥2.5 mm, uterine rupture risk likely <0.5%
• uterine rupture risks (including perinatal asphyxia and death)
• maternal and neonatal complications of cesarean
• estimation of likelihood for successful VBAC.

How did risk-stratified women fare?

In approximately 1,000 cases, the authors reported no symptomatic uterine ruptures. Of particular interest, however, is the rate of women attempting a TOLAC in each category:

• 194 women with high risk
  • 9% underwent a TOLAC
  • 82% had a successful vaginal birth
• 217 women with intermediate risk
  • 42% underwent a TOLAC
  • 78% had a successful vaginal birth
• 1,438 women with low risk
  • 61% underwent a TOLAC
  • 66% had a successful vaginal birth.

Considering cesarean scar defect

Finally, uterine scar defects at CD in those who underwent a TOLAC were 0/3 (0%), 5/21 (25%), and 20/276 (7%) in the high-, intermediate-, and low-risk groups, respectively. Given the observational nature of the study, the authors suggest that uterine scar dehiscence may be predictive of labor dystocia, but it remains unclear if it predicts or is a prerequisite for subsequent uterine rupture if labor occurs.
 

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.

EXPERT COMMENTARY

After having a previous cesarean delivery (CD), women who subsequently become pregnant inevitably face the decision to undergo a repeat CD or attempt a trial of labor after cesarean (TOLAC). Currently in the United States, 83% of women with a prior uterine scar are delivered by repeat CD.¹ According to the Consortium on Safe Labor, more than half of all CD indications are attributed to having a prior uterine scar.¹ Furthermore, only 28% of women attempt a TOLAC, with a successful vaginal birth after cesarean (VBAC) rate of approximately 57%.¹

The reason for the low TOLAC rate is multifactorial, but a primary concern may be the safety risk of a TOLAC as it relates to uterine rupture, a rare but potentially catastrophic complication. In a large, multicenter prospective observational trial of more than 17,800 women attempting a TOLAC, the symptomatic uterine rupture rate was 0.7%.² As such, efforts to identify women at highest risk for uterine rupture and those with characteristics predictive of a successful VBAC have remained ongoing. Jastrow and colleagues have expanded this body of knowledge with their prospective cohort study.

Details of the study

The researchers assessed lower uterine segment thickness via vaginal and abdominal ultrasound at 34 to 38 weeks’ gestation in more than 1,850 women with a previous CD. Women enrolled in the trial were classified into 3 risk categories based on lower uterine segment thickness: high risk (<2.0 mm), intermediate risk (2.0 to 2.4 mm), and low risk (≥2.5 mm). The investigators’ objective was to estimate the occurrence of uterine rupture when this measurement was included in the decision-making process on mode of delivery.

An important aspect of this study involved how the provider discussed the mode of delivery with the patient after the lower uterine segment measurement was obtained. Both the provider and the patient were informed of the risk category, and further counseling included the following:

• average overall uterine rupture risk, 0.5% to 1%
• if <2.0 mm, uterine rupture risk likely >1%
• if ≥2.5 mm, uterine rupture risk likely <0.5%
• uterine rupture risks (including perinatal asphyxia and death)
• maternal and neonatal complications of cesarean
• estimation of likelihood for successful VBAC.

How did risk-stratified women fare?

In approximately 1,000 cases, the authors reported no symptomatic uterine ruptures. Of particular interest, however, is the rate of women attempting a TOLAC in each category:

• 194 women with high risk
  • 9% underwent a TOLAC
  • 82% had a successful vaginal birth
• 217 women with intermediate risk
  • 42% underwent a TOLAC
  • 78% had a successful vaginal birth
• 1,438 women with low risk
  • 61% underwent a TOLAC
  • 66% had a successful vaginal birth.

Considering cesarean scar defect

Finally, uterine scar defects at CD in those who underwent a TOLAC were 0/3 (0%), 5/21 (25%), and 20/276 (7%) in the high-, intermediate-, and low-risk groups, respectively. Given the observational nature of the study, the authors suggest that uterine scar dehiscence may be predictive of labor dystocia, but it remains unclear if it predicts or is a prerequisite for subsequent uterine rupture if labor occurs.
 

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.

ROME – Weekly lipoprotein apheresis in patients with highly refractory angina accompanied by high plasma lipoprotein(a) without elevated LDL cholesterol led to significantly improved myocardial blood flow in a randomized, blinded, sham-controlled clinical trial, Tina Khan, MD, reported at the annual congress of the European Society of Cardiology.

Participants also experienced clinically meaningful improvements in the secondary endpoints of quality of life, angina symptoms, exercise capacity, and atheroma burden, added Dr. Khan of Imperial College London.

Bruce Jancin/Frontline Medical News

Angina pectoris that is refractory to maximal pharmacologic, percutaneous, and surgical interventions is a major and growing problem. More than 100,000 new cases occur per year in the United States.

“We have a desperate need to develop new therapeutic options,” she said.

Lipoprotein(a), or Lp(a), is a potent independent cardiovascular risk factor. And it figures prominently in refractory angina. Indeed, 60% of the patients with refractory angina screened by Dr. Khan for her clinical trial had an isolated plasma Lp(a) level of 50 mg/dL or more, the threshold at which cardiovascular risk sharply increases. Statins have no effect on Lp(a) levels.

While a couple of observational cohort studies have suggested that reducing elevated Lp(a) in patients with cardiovascular disease is associated with a decrease in major adverse cardiovascular events, until now there have been no randomized controlled trials of apheresis as Lp(a)-lowering therapy in patients with refractory angina, according to Dr. Khan.

She presented a randomized, crossover design study in 20 patients with severe refractory angina and an Lp(a) in excess of 50 mg/dL but no elevation in LDL. They underwent 3 months of blinded weekly extracorporeal lipoprotein apheresis using a dextran sulfate filtration system or sham apheresis, followed by a month-long washout period. Participants were then crossed over to the other study arm to increase the statistical power of this small study.

The primary study endpoint was change in myocardial perfusion reserve as measured by cardiovascular magnetic resonance imaging at baseline and after 3 months of true or sham apheresis. The myocardial perfusion reserve index improved by a net of 0.63 after apheresis from a baseline of 1.45. This effect was strongly driven by a substantial increase in stress myocardial perfusion, with very little change in perfusion at rest.

Significant improvements were also recorded after apheresis in the secondary endpoints of change in carotid atheroma as reflected in total carotid wall volume, improvement on various domains of the Seattle Angina Questionnaire, physical limitations as scored on the SF-36, and exercise capacity as measured on the 6-minute walk test.

Discussant Peter Libby, MD, was effusive in his praise for Dr. Khan’s study.

Bruce Jancin/Frontline Medical News

“This is a wonderful example of how we may be able to offer new hope for patients and families with high Lp(a),” declared Dr. Libby, chief of cardiovascular medicine at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.

He approved of the methodology and embraced what he called “the intriguing preliminary picture of benefit for lowering Lp(a).”

Most of all, he was pleased that Dr. Khan’s well conducted albeit small study has thrown a spotlight on Lp(a), which he characterized as a greatly underappreciated causal risk factor for a range of cardiovascular diseases.

“Lp(a) stands out like a Manhattan skyscraper as the major driver of calcific aortic stenosis, an epidemic that we see in our aging population,” he observed.

He added that topics worthy of further research with regard to Lp(a)-lowering apheresis as a treatment for refractory angina include the question of whether the mechanism of benefit involves structural changes in atherosclerosis or functional changes. And if it’s the latter, is it a matter of changes in microvascular function, macrovascular function, or a combination of the two?

Apheresis is extremely costly, inconvenient, and invasive, and there are only several dozen apheresis centers in the United States. So the future of Lp(a)-lowering to treat refractory angina, calcific aortic stenosis, and other cardiovascular conditions where elevated Lp(a) is an important player may lie in pharmacotherapy with the PCSK9 inhibitors, Dr. Libby predicted.

He cited “very promising” data showing that evolocumab (Repatha) and alirocumab (Praluent) lower Lp(a) in dose-dependent fashion. Ongoing very large clinical trials with hard clinical endpoints should eventually provide key information regarding the cardiovascular benefits of lowering Lp(a).

“We may be entering an era where we may be able to offer our patients and families – because this is often a familial problem – a non-apheresis approach to controlling what we are learning is a very important causal risk factor for atherosclerosis,” Dr. Libby said.

Patrick M. Moriarty, MD, said in a video interview that he was very intrigued by the results, and “not personally surprised.” They should stimulate interest in cardiologists to start measuring Lp(a) in their patients like those in this study, in whom the disease severity doesn’t match up with the clinical risk factors, said Dr. Moriarty of the University of Kansas, Kansas City.

Dr. Khan’s study was funded by the UK National Institute for Health Research. She reported having no financial conflicts of interest.

[email protected]

ROME – Weekly lipoprotein apheresis in patients with highly refractory angina accompanied by high plasma lipoprotein(a) without elevated LDL cholesterol led to significantly improved myocardial blood flow in a randomized, blinded, sham-controlled clinical trial, Tina Khan, MD, reported at the annual congress of the European Society of Cardiology.

Participants also experienced clinically meaningful improvements in the secondary endpoints of quality of life, angina symptoms, exercise capacity, and atheroma burden, added Dr. Khan of Imperial College London.

Bruce Jancin/Frontline Medical News

Angina pectoris that is refractory to maximal pharmacologic, percutaneous, and surgical interventions is a major and growing problem. More than 100,000 new cases occur per year in the United States.

“We have a desperate need to develop new therapeutic options,” she said.

Lipoprotein(a), or Lp(a), is a potent independent cardiovascular risk factor. And it figures prominently in refractory angina. Indeed, 60% of the patients with refractory angina screened by Dr. Khan for her clinical trial had an isolated plasma Lp(a) level of 50 mg/dL or more, the threshold at which cardiovascular risk sharply increases. Statins have no effect on Lp(a) levels.

While a couple of observational cohort studies have suggested that reducing elevated Lp(a) in patients with cardiovascular disease is associated with a decrease in major adverse cardiovascular events, until now there have been no randomized controlled trials of apheresis as Lp(a)-lowering therapy in patients with refractory angina, according to Dr. Khan.

She presented a randomized, crossover design study in 20 patients with severe refractory angina and an Lp(a) in excess of 50 mg/dL but no elevation in LDL. They underwent 3 months of blinded weekly extracorporeal lipoprotein apheresis using a dextran sulfate filtration system or sham apheresis, followed by a month-long washout period. Participants were then crossed over to the other study arm to increase the statistical power of this small study.

The primary study endpoint was change in myocardial perfusion reserve as measured by cardiovascular magnetic resonance imaging at baseline and after 3 months of true or sham apheresis. The myocardial perfusion reserve index improved by a net of 0.63 after apheresis from a baseline of 1.45. This effect was strongly driven by a substantial increase in stress myocardial perfusion, with very little change in perfusion at rest.

Significant improvements were also recorded after apheresis in the secondary endpoints of change in carotid atheroma as reflected in total carotid wall volume, improvement on various domains of the Seattle Angina Questionnaire, physical limitations as scored on the SF-36, and exercise capacity as measured on the 6-minute walk test.

Discussant Peter Libby, MD, was effusive in his praise for Dr. Khan’s study.

Bruce Jancin/Frontline Medical News

“This is a wonderful example of how we may be able to offer new hope for patients and families with high Lp(a),” declared Dr. Libby, chief of cardiovascular medicine at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.

He approved of the methodology and embraced what he called “the intriguing preliminary picture of benefit for lowering Lp(a).”

Most of all, he was pleased that Dr. Khan’s well conducted albeit small study has thrown a spotlight on Lp(a), which he characterized as a greatly underappreciated causal risk factor for a range of cardiovascular diseases.

“Lp(a) stands out like a Manhattan skyscraper as the major driver of calcific aortic stenosis, an epidemic that we see in our aging population,” he observed.

He added that topics worthy of further research with regard to Lp(a)-lowering apheresis as a treatment for refractory angina include the question of whether the mechanism of benefit involves structural changes in atherosclerosis or functional changes. And if it’s the latter, is it a matter of changes in microvascular function, macrovascular function, or a combination of the two?

Apheresis is extremely costly, inconvenient, and invasive, and there are only several dozen apheresis centers in the United States. So the future of Lp(a)-lowering to treat refractory angina, calcific aortic stenosis, and other cardiovascular conditions where elevated Lp(a) is an important player may lie in pharmacotherapy with the PCSK9 inhibitors, Dr. Libby predicted.

He cited “very promising” data showing that evolocumab (Repatha) and alirocumab (Praluent) lower Lp(a) in dose-dependent fashion. Ongoing very large clinical trials with hard clinical endpoints should eventually provide key information regarding the cardiovascular benefits of lowering Lp(a).

“We may be entering an era where we may be able to offer our patients and families – because this is often a familial problem – a non-apheresis approach to controlling what we are learning is a very important causal risk factor for atherosclerosis,” Dr. Libby said.

Patrick M. Moriarty, MD, said in a video interview that he was very intrigued by the results, and “not personally surprised.” They should stimulate interest in cardiologists to start measuring Lp(a) in their patients like those in this study, in whom the disease severity doesn’t match up with the clinical risk factors, said Dr. Moriarty of the University of Kansas, Kansas City.

Dr. Khan’s study was funded by the UK National Institute for Health Research. She reported having no financial conflicts of interest.

[email protected]

ROME – Weekly lipoprotein apheresis in patients with highly refractory angina accompanied by high plasma lipoprotein(a) without elevated LDL cholesterol led to significantly improved myocardial blood flow in a randomized, blinded, sham-controlled clinical trial, Tina Khan, MD, reported at the annual congress of the European Society of Cardiology.

Participants also experienced clinically meaningful improvements in the secondary endpoints of quality of life, angina symptoms, exercise capacity, and atheroma burden, added Dr. Khan of Imperial College London.

Bruce Jancin/Frontline Medical News

Angina pectoris that is refractory to maximal pharmacologic, percutaneous, and surgical interventions is a major and growing problem. More than 100,000 new cases occur per year in the United States.

“We have a desperate need to develop new therapeutic options,” she said.

Lipoprotein(a), or Lp(a), is a potent independent cardiovascular risk factor. And it figures prominently in refractory angina. Indeed, 60% of the patients with refractory angina screened by Dr. Khan for her clinical trial had an isolated plasma Lp(a) level of 50 mg/dL or more, the threshold at which cardiovascular risk sharply increases. Statins have no effect on Lp(a) levels.

While a couple of observational cohort studies have suggested that reducing elevated Lp(a) in patients with cardiovascular disease is associated with a decrease in major adverse cardiovascular events, until now there have been no randomized controlled trials of apheresis as Lp(a)-lowering therapy in patients with refractory angina, according to Dr. Khan.

She presented a randomized, crossover design study in 20 patients with severe refractory angina and an Lp(a) in excess of 50 mg/dL but no elevation in LDL. They underwent 3 months of blinded weekly extracorporeal lipoprotein apheresis using a dextran sulfate filtration system or sham apheresis, followed by a month-long washout period. Participants were then crossed over to the other study arm to increase the statistical power of this small study.

The primary study endpoint was change in myocardial perfusion reserve as measured by cardiovascular magnetic resonance imaging at baseline and after 3 months of true or sham apheresis. The myocardial perfusion reserve index improved by a net of 0.63 after apheresis from a baseline of 1.45. This effect was strongly driven by a substantial increase in stress myocardial perfusion, with very little change in perfusion at rest.

Significant improvements were also recorded after apheresis in the secondary endpoints of change in carotid atheroma as reflected in total carotid wall volume, improvement on various domains of the Seattle Angina Questionnaire, physical limitations as scored on the SF-36, and exercise capacity as measured on the 6-minute walk test.

Discussant Peter Libby, MD, was effusive in his praise for Dr. Khan’s study.

Bruce Jancin/Frontline Medical News

“This is a wonderful example of how we may be able to offer new hope for patients and families with high Lp(a),” declared Dr. Libby, chief of cardiovascular medicine at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.

He approved of the methodology and embraced what he called “the intriguing preliminary picture of benefit for lowering Lp(a).”

Most of all, he was pleased that Dr. Khan’s well conducted albeit small study has thrown a spotlight on Lp(a), which he characterized as a greatly underappreciated causal risk factor for a range of cardiovascular diseases.

“Lp(a) stands out like a Manhattan skyscraper as the major driver of calcific aortic stenosis, an epidemic that we see in our aging population,” he observed.

He added that topics worthy of further research with regard to Lp(a)-lowering apheresis as a treatment for refractory angina include the question of whether the mechanism of benefit involves structural changes in atherosclerosis or functional changes. And if it’s the latter, is it a matter of changes in microvascular function, macrovascular function, or a combination of the two?

Apheresis is extremely costly, inconvenient, and invasive, and there are only several dozen apheresis centers in the United States. So the future of Lp(a)-lowering to treat refractory angina, calcific aortic stenosis, and other cardiovascular conditions where elevated Lp(a) is an important player may lie in pharmacotherapy with the PCSK9 inhibitors, Dr. Libby predicted.

He cited “very promising” data showing that evolocumab (Repatha) and alirocumab (Praluent) lower Lp(a) in dose-dependent fashion. Ongoing very large clinical trials with hard clinical endpoints should eventually provide key information regarding the cardiovascular benefits of lowering Lp(a).

“We may be entering an era where we may be able to offer our patients and families – because this is often a familial problem – a non-apheresis approach to controlling what we are learning is a very important causal risk factor for atherosclerosis,” Dr. Libby said.

Patrick M. Moriarty, MD, said in a video interview that he was very intrigued by the results, and “not personally surprised.” They should stimulate interest in cardiologists to start measuring Lp(a) in their patients like those in this study, in whom the disease severity doesn’t match up with the clinical risk factors, said Dr. Moriarty of the University of Kansas, Kansas City.

Dr. Khan’s study was funded by the UK National Institute for Health Research. She reported having no financial conflicts of interest.

[email protected]

Researchers have discovered a pair of tissue biomarkers that directly contribute to the joint degeneration associated with spine osteoarthritis, according to a study published in the Journal of Clinical Investigation Insight.

The study evaluated tissue biopsies from 55 patients undergoing decompression or discectomy. Investigators screened 2,100 microRNAs and found that microRNA-181a-5p and microRNA-4454 biomarkers are involved in destroying cartilage and increase inflammation, and that measuring these two biomarkers can help clinicians determine the stage to which spine osteoarthritis has progressed, and provide a tool for determining the degree of cartilage destruction.

Researchers have discovered a pair of tissue biomarkers that directly contribute to the joint degeneration associated with spine osteoarthritis, according to a study published in the Journal of Clinical Investigation Insight.

The study evaluated tissue biopsies from 55 patients undergoing decompression or discectomy. Investigators screened 2,100 microRNAs and found that microRNA-181a-5p and microRNA-4454 biomarkers are involved in destroying cartilage and increase inflammation, and that measuring these two biomarkers can help clinicians determine the stage to which spine osteoarthritis has progressed, and provide a tool for determining the degree of cartilage destruction.

Researchers have discovered a pair of tissue biomarkers that directly contribute to the joint degeneration associated with spine osteoarthritis, according to a study published in the Journal of Clinical Investigation Insight.

The study evaluated tissue biopsies from 55 patients undergoing decompression or discectomy. Investigators screened 2,100 microRNAs and found that microRNA-181a-5p and microRNA-4454 biomarkers are involved in destroying cartilage and increase inflammation, and that measuring these two biomarkers can help clinicians determine the stage to which spine osteoarthritis has progressed, and provide a tool for determining the degree of cartilage destruction.

One of the most important medical interventions to improve maternal-child health is providing effective contraception to men and women of reproductive age. The 52-mg levonorgestrel-intrauterine device (LNG-IUD; Mirena) is one of the most effective forms of reversible contraception available to women, with a failure rate of 1.1% over 5 years of use.¹ The TCu380A copper-IUD (ParaGard), another highly effective reversible contraceptive, is reported to have failure rates of approximately 1.4% and 2.2%, over 5 and 10 years of use.²

An interesting question is whether—in certain clinical situations—a single IUD can be used for longer than the currently recommended 5 and 10 years for a Mirena IUD and a ParaGard IUD, respectively.

The LNG-IUD containing 52 mg LNG may be effective up to 7 years

The US Food and Drug Administration (FDA) package insert for the Mirena 52-mg LNG-IUD states that the device is “indicated for contraception for up to 5 years. Thereafter if continued contraception is desired, the system should be replaced.”¹ The FDA package insert for the levonorgestrel-releasing intrauterine system, Liletta 52-mg LNG-IUD, states that it is “indicated for prevention of pregnancy up to 3 years.”³ The FDA guidance is based on data submitted to the agency by the manufacturers to support the approval process. Completing large-scale clinical trials that extend past 5 years or more is challenging, because of the cost and the loss of study participants to follow-up. Hence, few clinical trials of contraceptive IUDs continue for more than 5 to 10 years.

Although the FDA-approved indication for Mirena and Liletta is 5 and 3 years, respectively, evidence suggests that the 52-mg LNG-IUD is an effective contraceptive beyond 5 years. In fact, multiple studies report that this IUD is an effective contraceptive for at least 6 or 7 years (TABLE 1).^4–9 Among 895 women using the 52-mg LNG-IUD for 6 to 7 years, only 1 pregnancy was reported in the last year of use. In that case, the IUD was in the cervix and partially expelled from the uterus.⁸ These data indicate that the 52-mg LNG-IUD is likely an effective contraceptive for up to 7 years, with pregnancy rates below 1% in the last year of use.

The TCu380A copper-IUD is effective up to 12 years

The currently available TCu380A copper-IUD (ParaGard) is FDA approved for 10 years.² Studies evaluating the efficacy of this copper-IUD are limited, but those that have been published reported that it is effective for at least 12 years and possibly up to 20 years (TABLE 2).¹⁰⁻¹³

Recently I saw a patient who had a copper-IUD (ParaGard, TCu380A) inserted as a teen after a birth, and had successfully used the same device for 17 years. She presented for removal of the IUD so that she could attempt conception. After removal of the IUD, copper wire was visible on the device. Long-term studies of the TCu220 copper-IUD, which contains less copper than the ParaGard, report pregnancies with the use of the device beyond 10 years.¹² These devices, which are not available in the United States, should not be used past their recommended interval.

Plastic devices without copper or levonorgestrel are effective intrauterine contraceptives

---

In 1962, the plastic, double S-IUD (Lippes loop) was marketed for use in the United States.^1,2 Developed by the New York ObGyn Dr. Jack Lippes, the Lippes loop was thought to prevent pregnancy by inducing a local inflammatory response that disrupts endometrial, tubal, and sperm function.³ No longer marketed, the Lippes loop came in 4 sizes, with size A the smallest and size D the largest. The Lippes loop contains no copper and no progestin, demonstrating that plastic devices are highly effective intrauterine contraceptives. However, the smallest Lippes loop (size A), with less surface area, was associated with a higher pregnancy rate than the largest Lippes loop (size D), at 4.8 versus 1.0 per 100 women-years, respectively.¹ This finding suggests that the surface area of the plastic device may influence contraceptive efficacy.

The shape of the device also may be important. The double S shape of the Lippes loop maximized the area of contact between the device and the endometrium. For plastic devices that contain copper (ParaGard) or LNG (Mirena) the relative contribution of the plastic device and the active agent to contraceptive efficacy is not well characterized.

References

1. Lippes J. Contraception with intrauterine plastic loops. Am J Obstet Gynecol. 1965;93(7):1024–1030.
2. Wright EA, Aisien OA. Comparison of copper T-200 with Lippes loop as a contraceptive device. Int J Gynaecol Obstet. 1989;29(2):173–177.
3. Ortiz ME, Croxatto HB. The mode of action of IUDs. Contraception. 1987;36(1):37–53.

Patient age is important in deciding to extend use of an IUD

A woman’s age is an important determinant of fecundity. Younger women are at a higher risk of pregnancy while using a contraceptive than older women. Hence, the age of the woman may be an important factor in identifying patients who are the best candidates for extending the time interval before replacing an IUD.

For women who are younger than 35 years and have completed 5 and 10 years of use of the Mirena and ParaGard, respectively, most authorities recommend replacing the device at the FDA-recommended time.

For women who are 35 to 45 years of age and have completed 5 and 10 years of use of the Mirena and ParaGard, respectively, the woman can be offered the option of extending use of the device for 1 to 2 additional years. The patient should be made aware of the FDA recommendation to exchange the device and proceed to extended use only after being informed that such use is off-label.

For women who are older than 45 years and have completed 10 years of use of the ParaGard IUD, the device will probably remain effective throughout the perimenopause and does not need to be removed until menses cease and the postmenopause begins. For women who are older than 45 years, have completed 5 years of use of the Mirena, and had the Mirena placed to control abnormal uterine bleeding, maintenance of amenorrhea is a sign that the device continues to release sufficient quantities of LNG or that the patient has transitioned into the postmenopause. Use of the device likely can be safely extended in these women.

For women who are using the Mirena IUD to control heavy uterine bleeding, dysmenorrhea, or endometriosis-related pelvic pain, the return of bothersome symptoms between years 4 and 7 may be an indication that insufficient quantities of LNG are being released and the device should be replaced. Alternatively, the increase in symptoms may be due to a change in underlying disease activity.

 

 

Emergency contraception with immediate placement of an IUD

---

For women who need emergency contraception and would like to initiate long-term contraception with an IUD, the copper device is an optimal choice. Recently, a novel use of combined oral levonorgestrel emergency contraception (1.5-mg dose) with immediate placement of a 52-mg LNG-IUD was reported to be an effective alternative to the placement of a copper-IUD for women who need both emergency and long-term contraception.¹

References

1. Turok DK, Sanders JN, Thompson IS, Royer PA, Eggebroten J, Gawron LM. Preference for and efficacy of oral levonorgestrel for emergency contraception with concomitant placement of a levonorgestrel IUD: a prospective cohort study. Contraception. 2016;93(6):526–532.

ParaGard and Mirena: Two highly effective contraceptives

For women with contraceptive needs and gynecologic issues such as heavy menstrual bleeding, dysmenorrhea, or endometriosis-related pelvic pain, the LNG-IUD may be an optimal choice. For women who desire to have monthly uterine bleeding and for women who prefer to avoid “hormones,” the copper-IUD may be the preferred option.

The IUD is one of the most effective forms of reversible contraception available. Yet IUDs are underutilized in the United States compared with Europe and Asia. Optimizing use of these devices is an important goal for ObGyns. The FDA does recommend that a single LNG-IUD (Mirena) or copper-IUD (ParaGard) not be used beyond 5 and 10 years, respectively. However, in certain clinical situations it may be appropriate to extend device use for a greater length of time.

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.

One of the most important medical interventions to improve maternal-child health is providing effective contraception to men and women of reproductive age. The 52-mg levonorgestrel-intrauterine device (LNG-IUD; Mirena) is one of the most effective forms of reversible contraception available to women, with a failure rate of 1.1% over 5 years of use.¹ The TCu380A copper-IUD (ParaGard), another highly effective reversible contraceptive, is reported to have failure rates of approximately 1.4% and 2.2%, over 5 and 10 years of use.²

An interesting question is whether—in certain clinical situations—a single IUD can be used for longer than the currently recommended 5 and 10 years for a Mirena IUD and a ParaGard IUD, respectively.

The LNG-IUD containing 52 mg LNG may be effective up to 7 years

The US Food and Drug Administration (FDA) package insert for the Mirena 52-mg LNG-IUD states that the device is “indicated for contraception for up to 5 years. Thereafter if continued contraception is desired, the system should be replaced.”¹ The FDA package insert for the levonorgestrel-releasing intrauterine system, Liletta 52-mg LNG-IUD, states that it is “indicated for prevention of pregnancy up to 3 years.”³ The FDA guidance is based on data submitted to the agency by the manufacturers to support the approval process. Completing large-scale clinical trials that extend past 5 years or more is challenging, because of the cost and the loss of study participants to follow-up. Hence, few clinical trials of contraceptive IUDs continue for more than 5 to 10 years.

Although the FDA-approved indication for Mirena and Liletta is 5 and 3 years, respectively, evidence suggests that the 52-mg LNG-IUD is an effective contraceptive beyond 5 years. In fact, multiple studies report that this IUD is an effective contraceptive for at least 6 or 7 years (TABLE 1).^4–9 Among 895 women using the 52-mg LNG-IUD for 6 to 7 years, only 1 pregnancy was reported in the last year of use. In that case, the IUD was in the cervix and partially expelled from the uterus.⁸ These data indicate that the 52-mg LNG-IUD is likely an effective contraceptive for up to 7 years, with pregnancy rates below 1% in the last year of use.

The TCu380A copper-IUD is effective up to 12 years

The currently available TCu380A copper-IUD (ParaGard) is FDA approved for 10 years.² Studies evaluating the efficacy of this copper-IUD are limited, but those that have been published reported that it is effective for at least 12 years and possibly up to 20 years (TABLE 2).¹⁰⁻¹³

Recently I saw a patient who had a copper-IUD (ParaGard, TCu380A) inserted as a teen after a birth, and had successfully used the same device for 17 years. She presented for removal of the IUD so that she could attempt conception. After removal of the IUD, copper wire was visible on the device. Long-term studies of the TCu220 copper-IUD, which contains less copper than the ParaGard, report pregnancies with the use of the device beyond 10 years.¹² These devices, which are not available in the United States, should not be used past their recommended interval.

Plastic devices without copper or levonorgestrel are effective intrauterine contraceptives

---

In 1962, the plastic, double S-IUD (Lippes loop) was marketed for use in the United States.^1,2 Developed by the New York ObGyn Dr. Jack Lippes, the Lippes loop was thought to prevent pregnancy by inducing a local inflammatory response that disrupts endometrial, tubal, and sperm function.³ No longer marketed, the Lippes loop came in 4 sizes, with size A the smallest and size D the largest. The Lippes loop contains no copper and no progestin, demonstrating that plastic devices are highly effective intrauterine contraceptives. However, the smallest Lippes loop (size A), with less surface area, was associated with a higher pregnancy rate than the largest Lippes loop (size D), at 4.8 versus 1.0 per 100 women-years, respectively.¹ This finding suggests that the surface area of the plastic device may influence contraceptive efficacy.

The shape of the device also may be important. The double S shape of the Lippes loop maximized the area of contact between the device and the endometrium. For plastic devices that contain copper (ParaGard) or LNG (Mirena) the relative contribution of the plastic device and the active agent to contraceptive efficacy is not well characterized.

References

1. Lippes J. Contraception with intrauterine plastic loops. Am J Obstet Gynecol. 1965;93(7):1024–1030.
2. Wright EA, Aisien OA. Comparison of copper T-200 with Lippes loop as a contraceptive device. Int J Gynaecol Obstet. 1989;29(2):173–177.
3. Ortiz ME, Croxatto HB. The mode of action of IUDs. Contraception. 1987;36(1):37–53.

Patient age is important in deciding to extend use of an IUD

A woman’s age is an important determinant of fecundity. Younger women are at a higher risk of pregnancy while using a contraceptive than older women. Hence, the age of the woman may be an important factor in identifying patients who are the best candidates for extending the time interval before replacing an IUD.

For women who are younger than 35 years and have completed 5 and 10 years of use of the Mirena and ParaGard, respectively, most authorities recommend replacing the device at the FDA-recommended time.

For women who are 35 to 45 years of age and have completed 5 and 10 years of use of the Mirena and ParaGard, respectively, the woman can be offered the option of extending use of the device for 1 to 2 additional years. The patient should be made aware of the FDA recommendation to exchange the device and proceed to extended use only after being informed that such use is off-label.

For women who are older than 45 years and have completed 10 years of use of the ParaGard IUD, the device will probably remain effective throughout the perimenopause and does not need to be removed until menses cease and the postmenopause begins. For women who are older than 45 years, have completed 5 years of use of the Mirena, and had the Mirena placed to control abnormal uterine bleeding, maintenance of amenorrhea is a sign that the device continues to release sufficient quantities of LNG or that the patient has transitioned into the postmenopause. Use of the device likely can be safely extended in these women.

For women who are using the Mirena IUD to control heavy uterine bleeding, dysmenorrhea, or endometriosis-related pelvic pain, the return of bothersome symptoms between years 4 and 7 may be an indication that insufficient quantities of LNG are being released and the device should be replaced. Alternatively, the increase in symptoms may be due to a change in underlying disease activity.

 

 

Emergency contraception with immediate placement of an IUD

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For women who need emergency contraception and would like to initiate long-term contraception with an IUD, the copper device is an optimal choice. Recently, a novel use of combined oral levonorgestrel emergency contraception (1.5-mg dose) with immediate placement of a 52-mg LNG-IUD was reported to be an effective alternative to the placement of a copper-IUD for women who need both emergency and long-term contraception.¹

References

1. Turok DK, Sanders JN, Thompson IS, Royer PA, Eggebroten J, Gawron LM. Preference for and efficacy of oral levonorgestrel for emergency contraception with concomitant placement of a levonorgestrel IUD: a prospective cohort study. Contraception. 2016;93(6):526–532.

ParaGard and Mirena: Two highly effective contraceptives

For women with contraceptive needs and gynecologic issues such as heavy menstrual bleeding, dysmenorrhea, or endometriosis-related pelvic pain, the LNG-IUD may be an optimal choice. For women who desire to have monthly uterine bleeding and for women who prefer to avoid “hormones,” the copper-IUD may be the preferred option.

The IUD is one of the most effective forms of reversible contraception available. Yet IUDs are underutilized in the United States compared with Europe and Asia. Optimizing use of these devices is an important goal for ObGyns. The FDA does recommend that a single LNG-IUD (Mirena) or copper-IUD (ParaGard) not be used beyond 5 and 10 years, respectively. However, in certain clinical situations it may be appropriate to extend device use for a greater length of time.

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.

One of the most important medical interventions to improve maternal-child health is providing effective contraception to men and women of reproductive age. The 52-mg levonorgestrel-intrauterine device (LNG-IUD; Mirena) is one of the most effective forms of reversible contraception available to women, with a failure rate of 1.1% over 5 years of use.¹ The TCu380A copper-IUD (ParaGard), another highly effective reversible contraceptive, is reported to have failure rates of approximately 1.4% and 2.2%, over 5 and 10 years of use.²

An interesting question is whether—in certain clinical situations—a single IUD can be used for longer than the currently recommended 5 and 10 years for a Mirena IUD and a ParaGard IUD, respectively.

The LNG-IUD containing 52 mg LNG may be effective up to 7 years

The US Food and Drug Administration (FDA) package insert for the Mirena 52-mg LNG-IUD states that the device is “indicated for contraception for up to 5 years. Thereafter if continued contraception is desired, the system should be replaced.”¹ The FDA package insert for the levonorgestrel-releasing intrauterine system, Liletta 52-mg LNG-IUD, states that it is “indicated for prevention of pregnancy up to 3 years.”³ The FDA guidance is based on data submitted to the agency by the manufacturers to support the approval process. Completing large-scale clinical trials that extend past 5 years or more is challenging, because of the cost and the loss of study participants to follow-up. Hence, few clinical trials of contraceptive IUDs continue for more than 5 to 10 years.

Although the FDA-approved indication for Mirena and Liletta is 5 and 3 years, respectively, evidence suggests that the 52-mg LNG-IUD is an effective contraceptive beyond 5 years. In fact, multiple studies report that this IUD is an effective contraceptive for at least 6 or 7 years (TABLE 1).^4–9 Among 895 women using the 52-mg LNG-IUD for 6 to 7 years, only 1 pregnancy was reported in the last year of use. In that case, the IUD was in the cervix and partially expelled from the uterus.⁸ These data indicate that the 52-mg LNG-IUD is likely an effective contraceptive for up to 7 years, with pregnancy rates below 1% in the last year of use.

The TCu380A copper-IUD is effective up to 12 years

The currently available TCu380A copper-IUD (ParaGard) is FDA approved for 10 years.² Studies evaluating the efficacy of this copper-IUD are limited, but those that have been published reported that it is effective for at least 12 years and possibly up to 20 years (TABLE 2).¹⁰⁻¹³

Recently I saw a patient who had a copper-IUD (ParaGard, TCu380A) inserted as a teen after a birth, and had successfully used the same device for 17 years. She presented for removal of the IUD so that she could attempt conception. After removal of the IUD, copper wire was visible on the device. Long-term studies of the TCu220 copper-IUD, which contains less copper than the ParaGard, report pregnancies with the use of the device beyond 10 years.¹² These devices, which are not available in the United States, should not be used past their recommended interval.

Plastic devices without copper or levonorgestrel are effective intrauterine contraceptives

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In 1962, the plastic, double S-IUD (Lippes loop) was marketed for use in the United States.^1,2 Developed by the New York ObGyn Dr. Jack Lippes, the Lippes loop was thought to prevent pregnancy by inducing a local inflammatory response that disrupts endometrial, tubal, and sperm function.³ No longer marketed, the Lippes loop came in 4 sizes, with size A the smallest and size D the largest. The Lippes loop contains no copper and no progestin, demonstrating that plastic devices are highly effective intrauterine contraceptives. However, the smallest Lippes loop (size A), with less surface area, was associated with a higher pregnancy rate than the largest Lippes loop (size D), at 4.8 versus 1.0 per 100 women-years, respectively.¹ This finding suggests that the surface area of the plastic device may influence contraceptive efficacy.

The shape of the device also may be important. The double S shape of the Lippes loop maximized the area of contact between the device and the endometrium. For plastic devices that contain copper (ParaGard) or LNG (Mirena) the relative contribution of the plastic device and the active agent to contraceptive efficacy is not well characterized.

References

1. Lippes J. Contraception with intrauterine plastic loops. Am J Obstet Gynecol. 1965;93(7):1024–1030.
2. Wright EA, Aisien OA. Comparison of copper T-200 with Lippes loop as a contraceptive device. Int J Gynaecol Obstet. 1989;29(2):173–177.
3. Ortiz ME, Croxatto HB. The mode of action of IUDs. Contraception. 1987;36(1):37–53.

Patient age is important in deciding to extend use of an IUD

A woman’s age is an important determinant of fecundity. Younger women are at a higher risk of pregnancy while using a contraceptive than older women. Hence, the age of the woman may be an important factor in identifying patients who are the best candidates for extending the time interval before replacing an IUD.

For women who are younger than 35 years and have completed 5 and 10 years of use of the Mirena and ParaGard, respectively, most authorities recommend replacing the device at the FDA-recommended time.

For women who are 35 to 45 years of age and have completed 5 and 10 years of use of the Mirena and ParaGard, respectively, the woman can be offered the option of extending use of the device for 1 to 2 additional years. The patient should be made aware of the FDA recommendation to exchange the device and proceed to extended use only after being informed that such use is off-label.

For women who are older than 45 years and have completed 10 years of use of the ParaGard IUD, the device will probably remain effective throughout the perimenopause and does not need to be removed until menses cease and the postmenopause begins. For women who are older than 45 years, have completed 5 years of use of the Mirena, and had the Mirena placed to control abnormal uterine bleeding, maintenance of amenorrhea is a sign that the device continues to release sufficient quantities of LNG or that the patient has transitioned into the postmenopause. Use of the device likely can be safely extended in these women.

For women who are using the Mirena IUD to control heavy uterine bleeding, dysmenorrhea, or endometriosis-related pelvic pain, the return of bothersome symptoms between years 4 and 7 may be an indication that insufficient quantities of LNG are being released and the device should be replaced. Alternatively, the increase in symptoms may be due to a change in underlying disease activity.

 

 

Emergency contraception with immediate placement of an IUD

---

For women who need emergency contraception and would like to initiate long-term contraception with an IUD, the copper device is an optimal choice. Recently, a novel use of combined oral levonorgestrel emergency contraception (1.5-mg dose) with immediate placement of a 52-mg LNG-IUD was reported to be an effective alternative to the placement of a copper-IUD for women who need both emergency and long-term contraception.¹

References

1. Turok DK, Sanders JN, Thompson IS, Royer PA, Eggebroten J, Gawron LM. Preference for and efficacy of oral levonorgestrel for emergency contraception with concomitant placement of a levonorgestrel IUD: a prospective cohort study. Contraception. 2016;93(6):526–532.

ParaGard and Mirena: Two highly effective contraceptives

For women with contraceptive needs and gynecologic issues such as heavy menstrual bleeding, dysmenorrhea, or endometriosis-related pelvic pain, the LNG-IUD may be an optimal choice. For women who desire to have monthly uterine bleeding and for women who prefer to avoid “hormones,” the copper-IUD may be the preferred option.

The IUD is one of the most effective forms of reversible contraception available. Yet IUDs are underutilized in the United States compared with Europe and Asia. Optimizing use of these devices is an important goal for ObGyns. The FDA does recommend that a single LNG-IUD (Mirena) or copper-IUD (ParaGard) not be used beyond 5 and 10 years, respectively. However, in certain clinical situations it may be appropriate to extend device use for a greater length of time.

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.

Compared to white patients, minority patients have lower rates of total knee replacement (TKR), but higher rates of adverse health outcomes associated with this procedure, according to a study in the Journal of Bone and Joint Surgery.

The study analyzed data on 547,380 patients from 8 racially diverse states who underwent TKR from 2001 to 2008. Race was categorized as white, black, Hispanic, Asian, Native American, and mixed race.

In comparison to the white patients, minorities had lower rates of TKR. Minorities also were less likely to undergo TKR in a high-volume hospital. In addition, the risk for in-hospital mortality and the rate of complications following TKR were significantly higher for patients who were black, Native American, or mixed race.

Compared to white patients, minority patients have lower rates of total knee replacement (TKR), but higher rates of adverse health outcomes associated with this procedure, according to a study in the Journal of Bone and Joint Surgery.

The study analyzed data on 547,380 patients from 8 racially diverse states who underwent TKR from 2001 to 2008. Race was categorized as white, black, Hispanic, Asian, Native American, and mixed race.

In comparison to the white patients, minorities had lower rates of TKR. Minorities also were less likely to undergo TKR in a high-volume hospital. In addition, the risk for in-hospital mortality and the rate of complications following TKR were significantly higher for patients who were black, Native American, or mixed race.

Compared to white patients, minority patients have lower rates of total knee replacement (TKR), but higher rates of adverse health outcomes associated with this procedure, according to a study in the Journal of Bone and Joint Surgery.

The study analyzed data on 547,380 patients from 8 racially diverse states who underwent TKR from 2001 to 2008. Race was categorized as white, black, Hispanic, Asian, Native American, and mixed race.

In comparison to the white patients, minorities had lower rates of TKR. Minorities also were less likely to undergo TKR in a high-volume hospital. In addition, the risk for in-hospital mortality and the rate of complications following TKR were significantly higher for patients who were black, Native American, or mixed race.