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3 clear dos, and 3 specific don'ts, of vacuum extraction
A survey of liability claims against obstetric providers highlights major areas of contention
An analysis of 882 obstetric claims closed between 2007 and 2014 highlighted 3 common patient allegations:
- a delay in treatment of fetal distress (22%). The term fetal distress remains a common allegation in malpractice claims. Cases in this category most often reflected a delay or failure to act in the face of Category II or III fetal heart-rate tracings.
- improper performance of vaginal delivery (20%). Almost half of the cases in this category involved brachial plexus injuries linked to shoulder dystocia. Patients alleged that improper maneuvers were used to resolve the dystocia. The remainder of cases in this category involved forceps and vacuum extraction deliveries.
- improper management of pregnancy (17%). Among the allegations were a failure to test for fetal abnormalities, failure to recognize complications of pregnancy, and failure to address abnormal findings.
Together, these 3 allegations accounted for 59% of claims. Other allegations included diagnosis-related claims, delay in delivery, improper performance of operative delivery, retained foreign bodies, and improper choice of delivery method.1
The Obstetrics Closed Claims Study findings were released earlier this spring by the Napa, California−based Doctors Company, the nation’s largest physician-owned medical malpractice insurer.1 Susan Mann, MD, a spokesperson for the company, provided expert commentary on the study at the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco. (Listen to this accompanying audiocast featuring her comments.) Dr. Mann practices obstetrics and gynecology in Brookline, Massachusetts, and at Beth Israel Deaconess Medical Center in Boston. She is president of the QualBridge Institute, a consulting firm focused on issues of quality and safety.
Top 7 factors contributing to patient injury
The Doctors Company identified specific factors that contributed to patient injury in the closed claims:
1. Selection and management of therapy (34%). Among the issues here were decisions involving augmentation of labor, route of delivery, and the timing of interventions. This factor also related to medications—for example, a failure to order antibiotics for Group A and Group B strep, a failure to order Rho(D) immune globulin for Rh-negative mothers, and a failure to provide magnesium sulfate for women with eclampsia.
2. Patient-assessment issues (32%). The Doctors Company reviewers found that physicians frequently failed to consider information that was available, or overlooked abnormal findings.
3. Technical performance (18%). This factor involved problems associated with known risks of various procedures, such as postpartum hemorrhage and brachial plexus injuries. It also included poor technique.
4. Communication among providers (17%)
5. Patient factors (16%). These factors included a failure to comply with therapy or to show up for appointments.
6. Insufficient or lack of documentation (14%)
7. Communication between patient/family and provider (14%).
“Studying obstetrical medical malpractice claims sheds light on the wide array of problems that may arise during pregnancy and in labor and delivery,” the study authors conclude. “Many of these cases reflect unusual maternal or neonatal conditions that can be diagnosed only with vigilance. Examples include protein deficiencies, clotting abnormalities, placental abruptions, infections, and genetic abnormalities. More common conditions should be identified with close attention to vital signs, laboratory studies, changes to maternal and neonatal conditions, and patient complaints.”
“Obstetric departments must plan for clinical emergencies by developing and maintaining physician and staff competencies through mock drills and simulations that reduce the likelihood of injuries to mothers and their infants,” the study authors conclude.
Tips for reducing malpractice claims in obstetrics
The Obstetrics Closed Claim Study identified a number of “underlying vulnerabilities” that place patients at risk and increase liability for clinicians. The Doctors Company offers the following tips to help reduce these claims:
• Require periodic training and certification for physicians and nurses to maintain competency and facilitate conversations about fetal heart-rate (FHR) tracing interpretation. Both parties should use the same terminology when discussing the strips.
• Use technology that allows physicians to review FHR patterns from remote locations so that physicians and nurses are able to see the same information when discussing next steps.
• When operative vaginal delivery is attempted in the face of a Category III FHR tracing, a contingency team should be available for possible emergent cesarean delivery.
• Foster a culture in which caregivers feel comfortable speaking up if they have a concern. Ensure that the organization has a well-defined escalation guideline.
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Reference
- The Doctors Company. Obstetrics Closed Claim Study. http://www.thedoctors.com/KnowledgeCenter/PatientSafety/articles/CON_ID_011803. Published April 2015. Accessed May 6, 2015.
An analysis of 882 obstetric claims closed between 2007 and 2014 highlighted 3 common patient allegations:
- a delay in treatment of fetal distress (22%). The term fetal distress remains a common allegation in malpractice claims. Cases in this category most often reflected a delay or failure to act in the face of Category II or III fetal heart-rate tracings.
- improper performance of vaginal delivery (20%). Almost half of the cases in this category involved brachial plexus injuries linked to shoulder dystocia. Patients alleged that improper maneuvers were used to resolve the dystocia. The remainder of cases in this category involved forceps and vacuum extraction deliveries.
- improper management of pregnancy (17%). Among the allegations were a failure to test for fetal abnormalities, failure to recognize complications of pregnancy, and failure to address abnormal findings.
Together, these 3 allegations accounted for 59% of claims. Other allegations included diagnosis-related claims, delay in delivery, improper performance of operative delivery, retained foreign bodies, and improper choice of delivery method.1
The Obstetrics Closed Claims Study findings were released earlier this spring by the Napa, California−based Doctors Company, the nation’s largest physician-owned medical malpractice insurer.1 Susan Mann, MD, a spokesperson for the company, provided expert commentary on the study at the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco. (Listen to this accompanying audiocast featuring her comments.) Dr. Mann practices obstetrics and gynecology in Brookline, Massachusetts, and at Beth Israel Deaconess Medical Center in Boston. She is president of the QualBridge Institute, a consulting firm focused on issues of quality and safety.
Top 7 factors contributing to patient injury
The Doctors Company identified specific factors that contributed to patient injury in the closed claims:
1. Selection and management of therapy (34%). Among the issues here were decisions involving augmentation of labor, route of delivery, and the timing of interventions. This factor also related to medications—for example, a failure to order antibiotics for Group A and Group B strep, a failure to order Rho(D) immune globulin for Rh-negative mothers, and a failure to provide magnesium sulfate for women with eclampsia.
2. Patient-assessment issues (32%). The Doctors Company reviewers found that physicians frequently failed to consider information that was available, or overlooked abnormal findings.
3. Technical performance (18%). This factor involved problems associated with known risks of various procedures, such as postpartum hemorrhage and brachial plexus injuries. It also included poor technique.
4. Communication among providers (17%)
5. Patient factors (16%). These factors included a failure to comply with therapy or to show up for appointments.
6. Insufficient or lack of documentation (14%)
7. Communication between patient/family and provider (14%).
“Studying obstetrical medical malpractice claims sheds light on the wide array of problems that may arise during pregnancy and in labor and delivery,” the study authors conclude. “Many of these cases reflect unusual maternal or neonatal conditions that can be diagnosed only with vigilance. Examples include protein deficiencies, clotting abnormalities, placental abruptions, infections, and genetic abnormalities. More common conditions should be identified with close attention to vital signs, laboratory studies, changes to maternal and neonatal conditions, and patient complaints.”
“Obstetric departments must plan for clinical emergencies by developing and maintaining physician and staff competencies through mock drills and simulations that reduce the likelihood of injuries to mothers and their infants,” the study authors conclude.
Tips for reducing malpractice claims in obstetrics
The Obstetrics Closed Claim Study identified a number of “underlying vulnerabilities” that place patients at risk and increase liability for clinicians. The Doctors Company offers the following tips to help reduce these claims:
• Require periodic training and certification for physicians and nurses to maintain competency and facilitate conversations about fetal heart-rate (FHR) tracing interpretation. Both parties should use the same terminology when discussing the strips.
• Use technology that allows physicians to review FHR patterns from remote locations so that physicians and nurses are able to see the same information when discussing next steps.
• When operative vaginal delivery is attempted in the face of a Category III FHR tracing, a contingency team should be available for possible emergent cesarean delivery.
• Foster a culture in which caregivers feel comfortable speaking up if they have a concern. Ensure that the organization has a well-defined escalation guideline.
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
An analysis of 882 obstetric claims closed between 2007 and 2014 highlighted 3 common patient allegations:
- a delay in treatment of fetal distress (22%). The term fetal distress remains a common allegation in malpractice claims. Cases in this category most often reflected a delay or failure to act in the face of Category II or III fetal heart-rate tracings.
- improper performance of vaginal delivery (20%). Almost half of the cases in this category involved brachial plexus injuries linked to shoulder dystocia. Patients alleged that improper maneuvers were used to resolve the dystocia. The remainder of cases in this category involved forceps and vacuum extraction deliveries.
- improper management of pregnancy (17%). Among the allegations were a failure to test for fetal abnormalities, failure to recognize complications of pregnancy, and failure to address abnormal findings.
Together, these 3 allegations accounted for 59% of claims. Other allegations included diagnosis-related claims, delay in delivery, improper performance of operative delivery, retained foreign bodies, and improper choice of delivery method.1
The Obstetrics Closed Claims Study findings were released earlier this spring by the Napa, California−based Doctors Company, the nation’s largest physician-owned medical malpractice insurer.1 Susan Mann, MD, a spokesperson for the company, provided expert commentary on the study at the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco. (Listen to this accompanying audiocast featuring her comments.) Dr. Mann practices obstetrics and gynecology in Brookline, Massachusetts, and at Beth Israel Deaconess Medical Center in Boston. She is president of the QualBridge Institute, a consulting firm focused on issues of quality and safety.
Top 7 factors contributing to patient injury
The Doctors Company identified specific factors that contributed to patient injury in the closed claims:
1. Selection and management of therapy (34%). Among the issues here were decisions involving augmentation of labor, route of delivery, and the timing of interventions. This factor also related to medications—for example, a failure to order antibiotics for Group A and Group B strep, a failure to order Rho(D) immune globulin for Rh-negative mothers, and a failure to provide magnesium sulfate for women with eclampsia.
2. Patient-assessment issues (32%). The Doctors Company reviewers found that physicians frequently failed to consider information that was available, or overlooked abnormal findings.
3. Technical performance (18%). This factor involved problems associated with known risks of various procedures, such as postpartum hemorrhage and brachial plexus injuries. It also included poor technique.
4. Communication among providers (17%)
5. Patient factors (16%). These factors included a failure to comply with therapy or to show up for appointments.
6. Insufficient or lack of documentation (14%)
7. Communication between patient/family and provider (14%).
“Studying obstetrical medical malpractice claims sheds light on the wide array of problems that may arise during pregnancy and in labor and delivery,” the study authors conclude. “Many of these cases reflect unusual maternal or neonatal conditions that can be diagnosed only with vigilance. Examples include protein deficiencies, clotting abnormalities, placental abruptions, infections, and genetic abnormalities. More common conditions should be identified with close attention to vital signs, laboratory studies, changes to maternal and neonatal conditions, and patient complaints.”
“Obstetric departments must plan for clinical emergencies by developing and maintaining physician and staff competencies through mock drills and simulations that reduce the likelihood of injuries to mothers and their infants,” the study authors conclude.
Tips for reducing malpractice claims in obstetrics
The Obstetrics Closed Claim Study identified a number of “underlying vulnerabilities” that place patients at risk and increase liability for clinicians. The Doctors Company offers the following tips to help reduce these claims:
• Require periodic training and certification for physicians and nurses to maintain competency and facilitate conversations about fetal heart-rate (FHR) tracing interpretation. Both parties should use the same terminology when discussing the strips.
• Use technology that allows physicians to review FHR patterns from remote locations so that physicians and nurses are able to see the same information when discussing next steps.
• When operative vaginal delivery is attempted in the face of a Category III FHR tracing, a contingency team should be available for possible emergent cesarean delivery.
• Foster a culture in which caregivers feel comfortable speaking up if they have a concern. Ensure that the organization has a well-defined escalation guideline.
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Reference
- The Doctors Company. Obstetrics Closed Claim Study. http://www.thedoctors.com/KnowledgeCenter/PatientSafety/articles/CON_ID_011803. Published April 2015. Accessed May 6, 2015.
Reference
- The Doctors Company. Obstetrics Closed Claim Study. http://www.thedoctors.com/KnowledgeCenter/PatientSafety/articles/CON_ID_011803. Published April 2015. Accessed May 6, 2015.
Dr. Michael Krychman details new and in-the-pipeline treatment options for vulvovaginal atrophy
In an audiocast summarizing his Sunday Lunch Talk at the Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG) on May 3, 2015, Dr. Michael L. Krychman discusses new treatment options for vulvar and vaginal atrophy (VVA), including over-the-counter and prescription products and procedures. He emphasizes that a better understanding of the physical and anatomic changes in menopause has led to these improved options.
Dr. Krychman also recommends the use of "genitourinary syndrome of menopause" (GSM), new terminology for VVA suggested by the International Society for the Study of Women's Sexual Health and the North American Menopause Society.1
Among the products Dr. Krychman details are neogyn® Feminine Soothing Cream (neogyn, inc., Switzerland); RepHresh™ Vaginal Gel (Church & Dwight Co., Inc., Princeton, New Jersey); Replens™ Long-Lasting Vaginal Moisturizer (Church & Dwight); silicone- and water-based lubricants (Replens™ Silky Smooth Lubricant [Church & Dwight]; JuvaGyn® Feminine Moisturizer [neogyn, inc.]); and ospemifene (Osphena®, Shionogi Inc., Florham Park, New Jersey).
Dr. Krychman is interested in a new laser procedure for VVA/GSM, but comments that more study is needed before he can recommend its general use. He also talks about other exciting alternatives in the pipeline.
- Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women’s Sexual Health and the North American Menopause Society. Menopause. 2014;11(12):2865–2872.
In an audiocast summarizing his Sunday Lunch Talk at the Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG) on May 3, 2015, Dr. Michael L. Krychman discusses new treatment options for vulvar and vaginal atrophy (VVA), including over-the-counter and prescription products and procedures. He emphasizes that a better understanding of the physical and anatomic changes in menopause has led to these improved options.
Dr. Krychman also recommends the use of "genitourinary syndrome of menopause" (GSM), new terminology for VVA suggested by the International Society for the Study of Women's Sexual Health and the North American Menopause Society.1
Among the products Dr. Krychman details are neogyn® Feminine Soothing Cream (neogyn, inc., Switzerland); RepHresh™ Vaginal Gel (Church & Dwight Co., Inc., Princeton, New Jersey); Replens™ Long-Lasting Vaginal Moisturizer (Church & Dwight); silicone- and water-based lubricants (Replens™ Silky Smooth Lubricant [Church & Dwight]; JuvaGyn® Feminine Moisturizer [neogyn, inc.]); and ospemifene (Osphena®, Shionogi Inc., Florham Park, New Jersey).
Dr. Krychman is interested in a new laser procedure for VVA/GSM, but comments that more study is needed before he can recommend its general use. He also talks about other exciting alternatives in the pipeline.
In an audiocast summarizing his Sunday Lunch Talk at the Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG) on May 3, 2015, Dr. Michael L. Krychman discusses new treatment options for vulvar and vaginal atrophy (VVA), including over-the-counter and prescription products and procedures. He emphasizes that a better understanding of the physical and anatomic changes in menopause has led to these improved options.
Dr. Krychman also recommends the use of "genitourinary syndrome of menopause" (GSM), new terminology for VVA suggested by the International Society for the Study of Women's Sexual Health and the North American Menopause Society.1
Among the products Dr. Krychman details are neogyn® Feminine Soothing Cream (neogyn, inc., Switzerland); RepHresh™ Vaginal Gel (Church & Dwight Co., Inc., Princeton, New Jersey); Replens™ Long-Lasting Vaginal Moisturizer (Church & Dwight); silicone- and water-based lubricants (Replens™ Silky Smooth Lubricant [Church & Dwight]; JuvaGyn® Feminine Moisturizer [neogyn, inc.]); and ospemifene (Osphena®, Shionogi Inc., Florham Park, New Jersey).
Dr. Krychman is interested in a new laser procedure for VVA/GSM, but comments that more study is needed before he can recommend its general use. He also talks about other exciting alternatives in the pipeline.
- Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women’s Sexual Health and the North American Menopause Society. Menopause. 2014;11(12):2865–2872.
- Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women’s Sexual Health and the North American Menopause Society. Menopause. 2014;11(12):2865–2872.
Care of the transgender patient: What is the gynecologist's role?
Although precise data are unavailable, it was estimated in 2011 that there were nearly 700,000 transgendered persons in the United States.1 This means that gynecologists in certain locales regularly encounter transgender patients in clinical practice.
At the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG), held May 2-6 in San Francisco, California, Dr. Cecile A. Unger discussed the role of the gynecologist in the care of transgender patients.
In this interview with OBG Management, Dr. Unger discusses:
- pertinent terminology, including gender dysphoria, and important clinical aspects of examining and treating a transgender patient
- what a clinician be screening for in general, as well as specifically, in the transgender population, including considerations for when a patient is undergoing hormone therapy
- the importance of developing trust and how that can be accomplished.
Reference
- Gates GJ. How many people are lesbian, gay, bisexual, and transgender? The Williams Institute Web site. http://williamsinstitute.law.ucla.edu/wp-content/uploads/Gates-How-Many-People-LGBT-Apr-2011.pdf. Published April 2011. Accessed May 5, 2015.
Although precise data are unavailable, it was estimated in 2011 that there were nearly 700,000 transgendered persons in the United States.1 This means that gynecologists in certain locales regularly encounter transgender patients in clinical practice.
At the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG), held May 2-6 in San Francisco, California, Dr. Cecile A. Unger discussed the role of the gynecologist in the care of transgender patients.
In this interview with OBG Management, Dr. Unger discusses:
- pertinent terminology, including gender dysphoria, and important clinical aspects of examining and treating a transgender patient
- what a clinician be screening for in general, as well as specifically, in the transgender population, including considerations for when a patient is undergoing hormone therapy
- the importance of developing trust and how that can be accomplished.
Although precise data are unavailable, it was estimated in 2011 that there were nearly 700,000 transgendered persons in the United States.1 This means that gynecologists in certain locales regularly encounter transgender patients in clinical practice.
At the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG), held May 2-6 in San Francisco, California, Dr. Cecile A. Unger discussed the role of the gynecologist in the care of transgender patients.
In this interview with OBG Management, Dr. Unger discusses:
- pertinent terminology, including gender dysphoria, and important clinical aspects of examining and treating a transgender patient
- what a clinician be screening for in general, as well as specifically, in the transgender population, including considerations for when a patient is undergoing hormone therapy
- the importance of developing trust and how that can be accomplished.
Reference
- Gates GJ. How many people are lesbian, gay, bisexual, and transgender? The Williams Institute Web site. http://williamsinstitute.law.ucla.edu/wp-content/uploads/Gates-How-Many-People-LGBT-Apr-2011.pdf. Published April 2011. Accessed May 5, 2015.
Reference
- Gates GJ. How many people are lesbian, gay, bisexual, and transgender? The Williams Institute Web site. http://williamsinstitute.law.ucla.edu/wp-content/uploads/Gates-How-Many-People-LGBT-Apr-2011.pdf. Published April 2011. Accessed May 5, 2015.
AAS: Experts say suicide research needs a reboot
ATLANTA– Progress has stalled in understanding the predictors and prevention of suicide, and it’s time for researchers to step up their game, experts agreed at the annual conference of the American Association of Suicidology.
“In the past couple of decades we’ve learned a fair amount about suicidal behavior. However, I think progress has been fairly slow – some might even say a little stagnant – in our pushing things forward and improving our understanding,” Matthew K. Nock, Ph.D., said in the meeting’s opening plenary talk.
He cited a soon-to-be-published meta-analysis led by his post-doctoral fellow Joseph C. Franklin, Ph.D., which evaluated all of the studies of predictors of suicide attempts and completed suicides published during the last 5 decades. The eye opening finding: The predictive odds ratios for the standard risk factors have remained essentially the same – namely, weak – for the past 50 years.
“In general, we’re not getting better in our ability to predict suicidal behavior – and that’s a serious problem for us. We still have enormous gaps in our understanding and in our ability to predict and prevent these outcomes,” declared Dr. Nock, professor of psychology at Harvard University, Boston.
The necessity for a fresh approach to suicide and suicide risk also was emphasized by E. David Klonsky, Ph.D., in his Edwin Shneidman Award Lecture.
“Despite what seems like a very large body of knowledge, suicide rates in the U.S. have increased for numerous consecutive years, and the same is true worldwide,” observed Dr. Klonsky, a psychologist at the University of British Columbia, Vancouver.
“What’s really hard to wrap our heads around is that we’re still only at a 1960s level in our ability to predict suicide. And the main reason for that is our risk factors don’t tell us what we think they do,” he continued.
This was first demonstrated in a 1999 study by Dr. Ronald C. Kessler of Harvard Medical School and coworkers (Arch. Gen. Psychiatry 1999;56:617-26).
They showed that the widely accepted suicide risk factors -- including any mood or anxiety disorder or substance disorders -- are strong predictors of suicidal ideation, but not significant predictors of who will transition from ideation to suicidal action. This finding has subsequently been confirmed by Dr. Nock and others in both adults and adolescents in a massive World Health Organization-sponsored project. Yet to date the concept hasn’t really sunk in broadly in the mental health and medical fields, according to Dr. Klonsky.
In his plenary talk, Dr. Nock focused on four key gaps in the current understanding of how to predict and prevent suicide and outlined how he and others are addressing these needs:
The need for objective markers of suicidal risk: Historically, nearly all patient assessments have relied upon self-report and cross-sectional surveys. That has an obvious limitation, since people are often motivated to conceal their thoughts of suicide. For example, one study found that 78% of patients who died by suicide while in a psychiatric hospital denied suicidal thoughts or intent in their last assessment.
The emerging emphasis is on creating brief computerized tests of memory and reaction time to gain a window into people’s implicit cognitions. Dr. Nock and colleagues have developed one such test, the Implicit Association Test. They had patients who presented to a psychiatric emergency department take the 5-minute word association test and demonstrated that those who scored high for implicit associations between death and suicide were six-fold more likely to make a suicide attempt in the next 6 months (Psychol. Sci. 2010;21:511-7). These findings have since been confirmed by a Canadian group (Psychol. Assess. 2013;25:714-21). The test is available online (www.ImplicitMentalHealth.com) with expert feedback provided as a public education tool and as a means for Dr. Nock and coinvestigators to gather large quantities of data.
Other objective tests for suicide risk that measure physiologic and neural responses to suicide-related stimuli include the Suicide Stroop and Affect Misattribution Procedure.
The need for better predictors of the transition from ideation to attempt: There are a few early leads on such predictors from the WHO dataset and other large studies. These include disorders characterized by aggression, agitation, and/or anxiety, such as conduct disorder, bipolar disorder, and a history of physical or sexual abuse. In a large study in the U.S. Army, the number-one predictor is intermittent explosive disorder.
The need for methods of combining risk factor data: Nearly all studies of suicide risk factors have utilized bivariate analysis -- that is, they examine risk based upon the presence or absence of an individual risk factor, such as a personal history of a mental disorder. But in a study led by Guilherme Borges, Sc.D., of the National Institute of Psychiatry in Mexico City, a group including Dr. Nock showed using National Comorbidity Survey Replication data that by simply together individual risk factors to create a 0-11 scale it became possible to identify a high-risk subgroup consisting of 13.7% of survey participants. This subgroup accounted for 67% of all suicide attempts within the next 12 months (Psychol. Med. 2006;36:1747-57).
The investigators have gone on to validate this approach in more than 108,000 subjects in 21 countries participating in the World Health Organization mental health project (J. Clin. Psychiatry 2010;71:1617-28).
Simple addition of suicidality risk factors, while a big step forward in risk assessment, is still a relatively crude predictive tool. More recently, Dr. Kessler, collaborating with Dr. Nock and others, has developed a much more sophisticated actuarial risk algorithm and applied it to more than 54,000 U.S. Army soldiers hospitalized for psychiatric disorders. They found that subjects who scored in the top 5% in terms of predicted suicide risk accounted for 53% of all suicides that occurred within the next 12 months. The suicide rate in this highest-risk group was massive: 3,624 per 100,000 per year as compared to a background rate of 18.5/100,000/year in the Army overall.
Moreover, nearly one-half of soldiers with a risk score in the top 5% had a 12-month composite adverse outcome, defined as another suicide attempt, death by suicide, accidental death, or psychiatric rehospitalization (JAMA Psychiatry 2015;72:49-57).
The need for data on imminent risk: Dr. Nock called this the biggest unmet need in suicidology; it’s what clinicians and family members desperately want but don’t have. At present there is “approximately zero data” on how to predict suicidal behavior in the hours, days, or weeks before it occurs, Dr. Nock said. Indeed, Dr. Franklin’s meta-analysis showed that in the past 50 years more than three-quarters of studies examining suicide risk have looked at risk a year or more in the future. Only 2% of studies have looked at risk during the window of the next month or so.
Numerous groups are now looking at real-time patient monitoring using cell phones and smart watches as a means of developing short-term risk predictors. These tools enable investigators to monitor changes in mood, thoughts, behavior, and physiology in large populations in order to see what leads up to a suicide attempt. Dr. Nock’s group is collaborating with information scientists at Massachusetts Intitute of Technology on such projects.
This technology also shows promise for therapeutic intervention. Dr. Franklin and coworkers have developed a brief, game-like mobile app to administer what he calls Therapeutic Evaluative Conditioning. In three soon-to-be-published randomized controlled trials, he has shown that this simple intervention – essentially, playing a game on a cell phone – resulted in reductions of 42%-49% in self-cutting and other nonsuicidal self-injury, 21%-64% reductions in suicidal planning, and 20%-57% decreases in suicidal behaviors, according to Dr. Nock.
Dr. Nock’s research is funded chiefly by the National Institute of Mental Health, the World Health Organization, and the Department of Defense; he reported having no financial conflicts. Dr. Klonsky’s research is largely supported by the American Foundation for Suicide Prevention.
ATLANTA– Progress has stalled in understanding the predictors and prevention of suicide, and it’s time for researchers to step up their game, experts agreed at the annual conference of the American Association of Suicidology.
“In the past couple of decades we’ve learned a fair amount about suicidal behavior. However, I think progress has been fairly slow – some might even say a little stagnant – in our pushing things forward and improving our understanding,” Matthew K. Nock, Ph.D., said in the meeting’s opening plenary talk.
He cited a soon-to-be-published meta-analysis led by his post-doctoral fellow Joseph C. Franklin, Ph.D., which evaluated all of the studies of predictors of suicide attempts and completed suicides published during the last 5 decades. The eye opening finding: The predictive odds ratios for the standard risk factors have remained essentially the same – namely, weak – for the past 50 years.
“In general, we’re not getting better in our ability to predict suicidal behavior – and that’s a serious problem for us. We still have enormous gaps in our understanding and in our ability to predict and prevent these outcomes,” declared Dr. Nock, professor of psychology at Harvard University, Boston.
The necessity for a fresh approach to suicide and suicide risk also was emphasized by E. David Klonsky, Ph.D., in his Edwin Shneidman Award Lecture.
“Despite what seems like a very large body of knowledge, suicide rates in the U.S. have increased for numerous consecutive years, and the same is true worldwide,” observed Dr. Klonsky, a psychologist at the University of British Columbia, Vancouver.
“What’s really hard to wrap our heads around is that we’re still only at a 1960s level in our ability to predict suicide. And the main reason for that is our risk factors don’t tell us what we think they do,” he continued.
This was first demonstrated in a 1999 study by Dr. Ronald C. Kessler of Harvard Medical School and coworkers (Arch. Gen. Psychiatry 1999;56:617-26).
They showed that the widely accepted suicide risk factors -- including any mood or anxiety disorder or substance disorders -- are strong predictors of suicidal ideation, but not significant predictors of who will transition from ideation to suicidal action. This finding has subsequently been confirmed by Dr. Nock and others in both adults and adolescents in a massive World Health Organization-sponsored project. Yet to date the concept hasn’t really sunk in broadly in the mental health and medical fields, according to Dr. Klonsky.
In his plenary talk, Dr. Nock focused on four key gaps in the current understanding of how to predict and prevent suicide and outlined how he and others are addressing these needs:
The need for objective markers of suicidal risk: Historically, nearly all patient assessments have relied upon self-report and cross-sectional surveys. That has an obvious limitation, since people are often motivated to conceal their thoughts of suicide. For example, one study found that 78% of patients who died by suicide while in a psychiatric hospital denied suicidal thoughts or intent in their last assessment.
The emerging emphasis is on creating brief computerized tests of memory and reaction time to gain a window into people’s implicit cognitions. Dr. Nock and colleagues have developed one such test, the Implicit Association Test. They had patients who presented to a psychiatric emergency department take the 5-minute word association test and demonstrated that those who scored high for implicit associations between death and suicide were six-fold more likely to make a suicide attempt in the next 6 months (Psychol. Sci. 2010;21:511-7). These findings have since been confirmed by a Canadian group (Psychol. Assess. 2013;25:714-21). The test is available online (www.ImplicitMentalHealth.com) with expert feedback provided as a public education tool and as a means for Dr. Nock and coinvestigators to gather large quantities of data.
Other objective tests for suicide risk that measure physiologic and neural responses to suicide-related stimuli include the Suicide Stroop and Affect Misattribution Procedure.
The need for better predictors of the transition from ideation to attempt: There are a few early leads on such predictors from the WHO dataset and other large studies. These include disorders characterized by aggression, agitation, and/or anxiety, such as conduct disorder, bipolar disorder, and a history of physical or sexual abuse. In a large study in the U.S. Army, the number-one predictor is intermittent explosive disorder.
The need for methods of combining risk factor data: Nearly all studies of suicide risk factors have utilized bivariate analysis -- that is, they examine risk based upon the presence or absence of an individual risk factor, such as a personal history of a mental disorder. But in a study led by Guilherme Borges, Sc.D., of the National Institute of Psychiatry in Mexico City, a group including Dr. Nock showed using National Comorbidity Survey Replication data that by simply together individual risk factors to create a 0-11 scale it became possible to identify a high-risk subgroup consisting of 13.7% of survey participants. This subgroup accounted for 67% of all suicide attempts within the next 12 months (Psychol. Med. 2006;36:1747-57).
The investigators have gone on to validate this approach in more than 108,000 subjects in 21 countries participating in the World Health Organization mental health project (J. Clin. Psychiatry 2010;71:1617-28).
Simple addition of suicidality risk factors, while a big step forward in risk assessment, is still a relatively crude predictive tool. More recently, Dr. Kessler, collaborating with Dr. Nock and others, has developed a much more sophisticated actuarial risk algorithm and applied it to more than 54,000 U.S. Army soldiers hospitalized for psychiatric disorders. They found that subjects who scored in the top 5% in terms of predicted suicide risk accounted for 53% of all suicides that occurred within the next 12 months. The suicide rate in this highest-risk group was massive: 3,624 per 100,000 per year as compared to a background rate of 18.5/100,000/year in the Army overall.
Moreover, nearly one-half of soldiers with a risk score in the top 5% had a 12-month composite adverse outcome, defined as another suicide attempt, death by suicide, accidental death, or psychiatric rehospitalization (JAMA Psychiatry 2015;72:49-57).
The need for data on imminent risk: Dr. Nock called this the biggest unmet need in suicidology; it’s what clinicians and family members desperately want but don’t have. At present there is “approximately zero data” on how to predict suicidal behavior in the hours, days, or weeks before it occurs, Dr. Nock said. Indeed, Dr. Franklin’s meta-analysis showed that in the past 50 years more than three-quarters of studies examining suicide risk have looked at risk a year or more in the future. Only 2% of studies have looked at risk during the window of the next month or so.
Numerous groups are now looking at real-time patient monitoring using cell phones and smart watches as a means of developing short-term risk predictors. These tools enable investigators to monitor changes in mood, thoughts, behavior, and physiology in large populations in order to see what leads up to a suicide attempt. Dr. Nock’s group is collaborating with information scientists at Massachusetts Intitute of Technology on such projects.
This technology also shows promise for therapeutic intervention. Dr. Franklin and coworkers have developed a brief, game-like mobile app to administer what he calls Therapeutic Evaluative Conditioning. In three soon-to-be-published randomized controlled trials, he has shown that this simple intervention – essentially, playing a game on a cell phone – resulted in reductions of 42%-49% in self-cutting and other nonsuicidal self-injury, 21%-64% reductions in suicidal planning, and 20%-57% decreases in suicidal behaviors, according to Dr. Nock.
Dr. Nock’s research is funded chiefly by the National Institute of Mental Health, the World Health Organization, and the Department of Defense; he reported having no financial conflicts. Dr. Klonsky’s research is largely supported by the American Foundation for Suicide Prevention.
ATLANTA– Progress has stalled in understanding the predictors and prevention of suicide, and it’s time for researchers to step up their game, experts agreed at the annual conference of the American Association of Suicidology.
“In the past couple of decades we’ve learned a fair amount about suicidal behavior. However, I think progress has been fairly slow – some might even say a little stagnant – in our pushing things forward and improving our understanding,” Matthew K. Nock, Ph.D., said in the meeting’s opening plenary talk.
He cited a soon-to-be-published meta-analysis led by his post-doctoral fellow Joseph C. Franklin, Ph.D., which evaluated all of the studies of predictors of suicide attempts and completed suicides published during the last 5 decades. The eye opening finding: The predictive odds ratios for the standard risk factors have remained essentially the same – namely, weak – for the past 50 years.
“In general, we’re not getting better in our ability to predict suicidal behavior – and that’s a serious problem for us. We still have enormous gaps in our understanding and in our ability to predict and prevent these outcomes,” declared Dr. Nock, professor of psychology at Harvard University, Boston.
The necessity for a fresh approach to suicide and suicide risk also was emphasized by E. David Klonsky, Ph.D., in his Edwin Shneidman Award Lecture.
“Despite what seems like a very large body of knowledge, suicide rates in the U.S. have increased for numerous consecutive years, and the same is true worldwide,” observed Dr. Klonsky, a psychologist at the University of British Columbia, Vancouver.
“What’s really hard to wrap our heads around is that we’re still only at a 1960s level in our ability to predict suicide. And the main reason for that is our risk factors don’t tell us what we think they do,” he continued.
This was first demonstrated in a 1999 study by Dr. Ronald C. Kessler of Harvard Medical School and coworkers (Arch. Gen. Psychiatry 1999;56:617-26).
They showed that the widely accepted suicide risk factors -- including any mood or anxiety disorder or substance disorders -- are strong predictors of suicidal ideation, but not significant predictors of who will transition from ideation to suicidal action. This finding has subsequently been confirmed by Dr. Nock and others in both adults and adolescents in a massive World Health Organization-sponsored project. Yet to date the concept hasn’t really sunk in broadly in the mental health and medical fields, according to Dr. Klonsky.
In his plenary talk, Dr. Nock focused on four key gaps in the current understanding of how to predict and prevent suicide and outlined how he and others are addressing these needs:
The need for objective markers of suicidal risk: Historically, nearly all patient assessments have relied upon self-report and cross-sectional surveys. That has an obvious limitation, since people are often motivated to conceal their thoughts of suicide. For example, one study found that 78% of patients who died by suicide while in a psychiatric hospital denied suicidal thoughts or intent in their last assessment.
The emerging emphasis is on creating brief computerized tests of memory and reaction time to gain a window into people’s implicit cognitions. Dr. Nock and colleagues have developed one such test, the Implicit Association Test. They had patients who presented to a psychiatric emergency department take the 5-minute word association test and demonstrated that those who scored high for implicit associations between death and suicide were six-fold more likely to make a suicide attempt in the next 6 months (Psychol. Sci. 2010;21:511-7). These findings have since been confirmed by a Canadian group (Psychol. Assess. 2013;25:714-21). The test is available online (www.ImplicitMentalHealth.com) with expert feedback provided as a public education tool and as a means for Dr. Nock and coinvestigators to gather large quantities of data.
Other objective tests for suicide risk that measure physiologic and neural responses to suicide-related stimuli include the Suicide Stroop and Affect Misattribution Procedure.
The need for better predictors of the transition from ideation to attempt: There are a few early leads on such predictors from the WHO dataset and other large studies. These include disorders characterized by aggression, agitation, and/or anxiety, such as conduct disorder, bipolar disorder, and a history of physical or sexual abuse. In a large study in the U.S. Army, the number-one predictor is intermittent explosive disorder.
The need for methods of combining risk factor data: Nearly all studies of suicide risk factors have utilized bivariate analysis -- that is, they examine risk based upon the presence or absence of an individual risk factor, such as a personal history of a mental disorder. But in a study led by Guilherme Borges, Sc.D., of the National Institute of Psychiatry in Mexico City, a group including Dr. Nock showed using National Comorbidity Survey Replication data that by simply together individual risk factors to create a 0-11 scale it became possible to identify a high-risk subgroup consisting of 13.7% of survey participants. This subgroup accounted for 67% of all suicide attempts within the next 12 months (Psychol. Med. 2006;36:1747-57).
The investigators have gone on to validate this approach in more than 108,000 subjects in 21 countries participating in the World Health Organization mental health project (J. Clin. Psychiatry 2010;71:1617-28).
Simple addition of suicidality risk factors, while a big step forward in risk assessment, is still a relatively crude predictive tool. More recently, Dr. Kessler, collaborating with Dr. Nock and others, has developed a much more sophisticated actuarial risk algorithm and applied it to more than 54,000 U.S. Army soldiers hospitalized for psychiatric disorders. They found that subjects who scored in the top 5% in terms of predicted suicide risk accounted for 53% of all suicides that occurred within the next 12 months. The suicide rate in this highest-risk group was massive: 3,624 per 100,000 per year as compared to a background rate of 18.5/100,000/year in the Army overall.
Moreover, nearly one-half of soldiers with a risk score in the top 5% had a 12-month composite adverse outcome, defined as another suicide attempt, death by suicide, accidental death, or psychiatric rehospitalization (JAMA Psychiatry 2015;72:49-57).
The need for data on imminent risk: Dr. Nock called this the biggest unmet need in suicidology; it’s what clinicians and family members desperately want but don’t have. At present there is “approximately zero data” on how to predict suicidal behavior in the hours, days, or weeks before it occurs, Dr. Nock said. Indeed, Dr. Franklin’s meta-analysis showed that in the past 50 years more than three-quarters of studies examining suicide risk have looked at risk a year or more in the future. Only 2% of studies have looked at risk during the window of the next month or so.
Numerous groups are now looking at real-time patient monitoring using cell phones and smart watches as a means of developing short-term risk predictors. These tools enable investigators to monitor changes in mood, thoughts, behavior, and physiology in large populations in order to see what leads up to a suicide attempt. Dr. Nock’s group is collaborating with information scientists at Massachusetts Intitute of Technology on such projects.
This technology also shows promise for therapeutic intervention. Dr. Franklin and coworkers have developed a brief, game-like mobile app to administer what he calls Therapeutic Evaluative Conditioning. In three soon-to-be-published randomized controlled trials, he has shown that this simple intervention – essentially, playing a game on a cell phone – resulted in reductions of 42%-49% in self-cutting and other nonsuicidal self-injury, 21%-64% reductions in suicidal planning, and 20%-57% decreases in suicidal behaviors, according to Dr. Nock.
Dr. Nock’s research is funded chiefly by the National Institute of Mental Health, the World Health Organization, and the Department of Defense; he reported having no financial conflicts. Dr. Klonsky’s research is largely supported by the American Foundation for Suicide Prevention.
EXPERT ANALYSIS FROM THE ANNUAL AAS CONFERENCE
LISTEN NOW: Win Whitcomb, MD, MHM, talks about practice management in an ever-changing healthcare landscape
SHM founder Win Whitcomb, MD, MHM, chief medical officer of Remedy Partners of Darien, Conn., talks about the annual practice management pre-course in an ever-changing healthcare landscape.
SHM founder Win Whitcomb, MD, MHM, chief medical officer of Remedy Partners of Darien, Conn., talks about the annual practice management pre-course in an ever-changing healthcare landscape.
SHM founder Win Whitcomb, MD, MHM, chief medical officer of Remedy Partners of Darien, Conn., talks about the annual practice management pre-course in an ever-changing healthcare landscape.
Is it time to revive rotational forceps?
The relative safety of instrumental rotations in the second stage of labor remains controversial. Older reports suggest an unacceptable risk of fetal injury, while recent studies demonstrate more favorable outcomes without significant fetal or maternal morbidity. This study by Aiken and colleagues goes one step further by using propensity analysis to adjust for the likelihood of receiving an attempted instrumental rotation.
Details of the study
With a cohort of 833 women with second-stage positional abnormalities, Aiken and colleagues compared maternal and newborn outcomes associated with cesarean delivery (n = 534) with those of an attempted rotational procedure (n = 334). Among the attempted instrumental rotations, 299 (90%) were successful. By intention to treat, failed attempts at rotation and vaginal delivery were included in the instrumental rotation group. The authors relied on propensity analysis to adjust for selection bias.
Strengths and weaknesses
The main strengths of this study are the relatively large sample size, the inclusion of failed procedures in the forceps group based on intention to treat, the robust approach to adjusting for the likelihood of undergoing an attempted rotation, and the contemporary nature of the cohort.
However, the study has 4 important limitations:
- More than 30% of rotations were attempted with vacuum devices. Many clinicians, including me, eschew vacuum deliveries for rotation due to reported higher failure rates and more scalp lacerations or other trauma. The analysis was not stratified by whether the rotation was attempted with a vacuum or Kielland forceps.
- Information about maternal pelvic features, critical in determining the safety of any operative vaginal delivery, was not included. When the pelvis has anthropoid features, such as more room in the posterior segment, rotation is not needed and may be counterproductive. Android features raise the likelihood of dangerous outlet obstruction and generally suggest the need for cesarean delivery.
- As Aiken and colleagues note, manual rotations followed by instrumental delivery from an occiput anterior position were not included.
- The study was not stratified by whether the abnormal position was occiput posterior (OP) or occiput transverse (OT). Although the degree of rotation is greater with OP position, operative vaginal delivery from OT can be far more challenging.
What this evidence means for practice
Although this study does have limitations, it adds to the increasing number of contemporary reports suggesting that instrumental rotational procedures are safe. Though it is not without challenges, training in rotational forceps should continue.
— William H. Barth Jr, MD
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
The relative safety of instrumental rotations in the second stage of labor remains controversial. Older reports suggest an unacceptable risk of fetal injury, while recent studies demonstrate more favorable outcomes without significant fetal or maternal morbidity. This study by Aiken and colleagues goes one step further by using propensity analysis to adjust for the likelihood of receiving an attempted instrumental rotation.
Details of the study
With a cohort of 833 women with second-stage positional abnormalities, Aiken and colleagues compared maternal and newborn outcomes associated with cesarean delivery (n = 534) with those of an attempted rotational procedure (n = 334). Among the attempted instrumental rotations, 299 (90%) were successful. By intention to treat, failed attempts at rotation and vaginal delivery were included in the instrumental rotation group. The authors relied on propensity analysis to adjust for selection bias.
Strengths and weaknesses
The main strengths of this study are the relatively large sample size, the inclusion of failed procedures in the forceps group based on intention to treat, the robust approach to adjusting for the likelihood of undergoing an attempted rotation, and the contemporary nature of the cohort.
However, the study has 4 important limitations:
- More than 30% of rotations were attempted with vacuum devices. Many clinicians, including me, eschew vacuum deliveries for rotation due to reported higher failure rates and more scalp lacerations or other trauma. The analysis was not stratified by whether the rotation was attempted with a vacuum or Kielland forceps.
- Information about maternal pelvic features, critical in determining the safety of any operative vaginal delivery, was not included. When the pelvis has anthropoid features, such as more room in the posterior segment, rotation is not needed and may be counterproductive. Android features raise the likelihood of dangerous outlet obstruction and generally suggest the need for cesarean delivery.
- As Aiken and colleagues note, manual rotations followed by instrumental delivery from an occiput anterior position were not included.
- The study was not stratified by whether the abnormal position was occiput posterior (OP) or occiput transverse (OT). Although the degree of rotation is greater with OP position, operative vaginal delivery from OT can be far more challenging.
What this evidence means for practice
Although this study does have limitations, it adds to the increasing number of contemporary reports suggesting that instrumental rotational procedures are safe. Though it is not without challenges, training in rotational forceps should continue.
— William H. Barth Jr, MD
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
The relative safety of instrumental rotations in the second stage of labor remains controversial. Older reports suggest an unacceptable risk of fetal injury, while recent studies demonstrate more favorable outcomes without significant fetal or maternal morbidity. This study by Aiken and colleagues goes one step further by using propensity analysis to adjust for the likelihood of receiving an attempted instrumental rotation.
Details of the study
With a cohort of 833 women with second-stage positional abnormalities, Aiken and colleagues compared maternal and newborn outcomes associated with cesarean delivery (n = 534) with those of an attempted rotational procedure (n = 334). Among the attempted instrumental rotations, 299 (90%) were successful. By intention to treat, failed attempts at rotation and vaginal delivery were included in the instrumental rotation group. The authors relied on propensity analysis to adjust for selection bias.
Strengths and weaknesses
The main strengths of this study are the relatively large sample size, the inclusion of failed procedures in the forceps group based on intention to treat, the robust approach to adjusting for the likelihood of undergoing an attempted rotation, and the contemporary nature of the cohort.
However, the study has 4 important limitations:
- More than 30% of rotations were attempted with vacuum devices. Many clinicians, including me, eschew vacuum deliveries for rotation due to reported higher failure rates and more scalp lacerations or other trauma. The analysis was not stratified by whether the rotation was attempted with a vacuum or Kielland forceps.
- Information about maternal pelvic features, critical in determining the safety of any operative vaginal delivery, was not included. When the pelvis has anthropoid features, such as more room in the posterior segment, rotation is not needed and may be counterproductive. Android features raise the likelihood of dangerous outlet obstruction and generally suggest the need for cesarean delivery.
- As Aiken and colleagues note, manual rotations followed by instrumental delivery from an occiput anterior position were not included.
- The study was not stratified by whether the abnormal position was occiput posterior (OP) or occiput transverse (OT). Although the degree of rotation is greater with OP position, operative vaginal delivery from OT can be far more challenging.
What this evidence means for practice
Although this study does have limitations, it adds to the increasing number of contemporary reports suggesting that instrumental rotational procedures are safe. Though it is not without challenges, training in rotational forceps should continue.
— William H. Barth Jr, MD
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.
Is the levonorgestrel-releasing intrauterine system more effective than the copper IUD at preventing pregnancy?
Both the LNG-IUS and the copper IUD are highly effective at pregnancy prevention. However, large-scale comparative studies are lacking. These findings from the European Active Surveillance Study for Intrauterine Devices (EURAS IUD), an investigation of new users of the LNG-IUS (20 µg/day) and copper IUD (>30 different types) in Austria, Finland, Germany, Poland, Sweden, and the United Kingdom, confirm the low contraceptive failure rate for both devices.
The primary objective of this trial was to compare uterine perforation rates,1 but the results of a planned secondary analysis comparing contraceptive effectiveness may be of more interest to patients and providers.
Details of the study
Women who had a newly inserted IUD during the study period were eligible for recruitment. These women and their inserting health care provider then completed a follow-up questionnaire 12 months after enrollment to assess for pregnancy or any potential IUD complication.
In total, 61,448 women were enrolled, and 58,324 patients (41,001 using the LNG-IUS and 17,323 using the copper IUD) were included in the analysis. Only 1.7% of LNG-IUS users and 2.8% of copper IUD users were lost to follow-up. Women using the LNG-IUS were older than those using the copper IUD (mean age of 37.4 vs 33.3 years, respectively). About 43% and 24% of LNG-IUS and copper IUD users, respectively, were age 40 or older at the time of IUD insertion.
Strengths and limitations
The large sample size and low number of women lost to follow-up are strengths of this study. A major weakness: The indication for IUD insertion was not recorded. Nor was the risk of pregnancy assessed at enrollment.
Overall, the age of the study population was older than is typically found in a contraceptive efficacy trial, which generally covers the age range of 18 to 35 years.
Because women chose their type of IUD (as opposed to random allocation), variations in underlying fertility, age, and other confounders of efficacy cannot be accounted for fully with statistical analyses. The variation in age strongly suggests that women may have chosen the LNG-IUS for reasons other than contraception.
Furthermore, more than 30 types of copper IUDs were inserted during the study period, and small variations in contraceptive efficacy from one type to another may contribute to the overall difference in failure rates between the LNG-IUS and copper IUD. Although Heinemann and colleagues did perform an analysis of failure rates by copper content and found no differences between users of IUDs with less than 300 mm2 and those with at least 300 mm2 of copper, earlier prospective randomized trials show differences in contraceptive efficacy by device type and amount of copper.2
What this evidence means for practice
The LNG-IUS may be a more effective contraceptive than the copper IUD, but both possess excellent contraceptive efficacy. Prospective randomized trials, although much smaller than this nonrandomized cohort study, do not demonstrate differences in contraceptive efficacy between the LNG-IUS and copper IUD.3 The small difference in contraceptive failure rates (less than 1 in 200 women), if real, should not be the deciding factor for choosing one IUD over the other.
— Melissa J. Chen, MD, MPH, and Mitchell D. Creinin, MDShare your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
1. Heinemann K, Reed S, Moehner S, Do Minh T. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015;91(4):274–279.
2. Thonneau PF, Almont T. Contraceptive efficacy of intrauterine devices. Am J Obstet Gynecol. 2008;198(3):248–253.
3. Sivin I, el Mahgoub S, McCarthy T, et al. Long-term contraception with the levonorgestrel 20 mcg/day (LNg 20) and the copper T380Ag intrauterine devices: a five-year randomized study. Contraception. 1990;42(4):361–378.
Both the LNG-IUS and the copper IUD are highly effective at pregnancy prevention. However, large-scale comparative studies are lacking. These findings from the European Active Surveillance Study for Intrauterine Devices (EURAS IUD), an investigation of new users of the LNG-IUS (20 µg/day) and copper IUD (>30 different types) in Austria, Finland, Germany, Poland, Sweden, and the United Kingdom, confirm the low contraceptive failure rate for both devices.
The primary objective of this trial was to compare uterine perforation rates,1 but the results of a planned secondary analysis comparing contraceptive effectiveness may be of more interest to patients and providers.
Details of the study
Women who had a newly inserted IUD during the study period were eligible for recruitment. These women and their inserting health care provider then completed a follow-up questionnaire 12 months after enrollment to assess for pregnancy or any potential IUD complication.
In total, 61,448 women were enrolled, and 58,324 patients (41,001 using the LNG-IUS and 17,323 using the copper IUD) were included in the analysis. Only 1.7% of LNG-IUS users and 2.8% of copper IUD users were lost to follow-up. Women using the LNG-IUS were older than those using the copper IUD (mean age of 37.4 vs 33.3 years, respectively). About 43% and 24% of LNG-IUS and copper IUD users, respectively, were age 40 or older at the time of IUD insertion.
Strengths and limitations
The large sample size and low number of women lost to follow-up are strengths of this study. A major weakness: The indication for IUD insertion was not recorded. Nor was the risk of pregnancy assessed at enrollment.
Overall, the age of the study population was older than is typically found in a contraceptive efficacy trial, which generally covers the age range of 18 to 35 years.
Because women chose their type of IUD (as opposed to random allocation), variations in underlying fertility, age, and other confounders of efficacy cannot be accounted for fully with statistical analyses. The variation in age strongly suggests that women may have chosen the LNG-IUS for reasons other than contraception.
Furthermore, more than 30 types of copper IUDs were inserted during the study period, and small variations in contraceptive efficacy from one type to another may contribute to the overall difference in failure rates between the LNG-IUS and copper IUD. Although Heinemann and colleagues did perform an analysis of failure rates by copper content and found no differences between users of IUDs with less than 300 mm2 and those with at least 300 mm2 of copper, earlier prospective randomized trials show differences in contraceptive efficacy by device type and amount of copper.2
What this evidence means for practice
The LNG-IUS may be a more effective contraceptive than the copper IUD, but both possess excellent contraceptive efficacy. Prospective randomized trials, although much smaller than this nonrandomized cohort study, do not demonstrate differences in contraceptive efficacy between the LNG-IUS and copper IUD.3 The small difference in contraceptive failure rates (less than 1 in 200 women), if real, should not be the deciding factor for choosing one IUD over the other.
— Melissa J. Chen, MD, MPH, and Mitchell D. Creinin, MDShare your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Both the LNG-IUS and the copper IUD are highly effective at pregnancy prevention. However, large-scale comparative studies are lacking. These findings from the European Active Surveillance Study for Intrauterine Devices (EURAS IUD), an investigation of new users of the LNG-IUS (20 µg/day) and copper IUD (>30 different types) in Austria, Finland, Germany, Poland, Sweden, and the United Kingdom, confirm the low contraceptive failure rate for both devices.
The primary objective of this trial was to compare uterine perforation rates,1 but the results of a planned secondary analysis comparing contraceptive effectiveness may be of more interest to patients and providers.
Details of the study
Women who had a newly inserted IUD during the study period were eligible for recruitment. These women and their inserting health care provider then completed a follow-up questionnaire 12 months after enrollment to assess for pregnancy or any potential IUD complication.
In total, 61,448 women were enrolled, and 58,324 patients (41,001 using the LNG-IUS and 17,323 using the copper IUD) were included in the analysis. Only 1.7% of LNG-IUS users and 2.8% of copper IUD users were lost to follow-up. Women using the LNG-IUS were older than those using the copper IUD (mean age of 37.4 vs 33.3 years, respectively). About 43% and 24% of LNG-IUS and copper IUD users, respectively, were age 40 or older at the time of IUD insertion.
Strengths and limitations
The large sample size and low number of women lost to follow-up are strengths of this study. A major weakness: The indication for IUD insertion was not recorded. Nor was the risk of pregnancy assessed at enrollment.
Overall, the age of the study population was older than is typically found in a contraceptive efficacy trial, which generally covers the age range of 18 to 35 years.
Because women chose their type of IUD (as opposed to random allocation), variations in underlying fertility, age, and other confounders of efficacy cannot be accounted for fully with statistical analyses. The variation in age strongly suggests that women may have chosen the LNG-IUS for reasons other than contraception.
Furthermore, more than 30 types of copper IUDs were inserted during the study period, and small variations in contraceptive efficacy from one type to another may contribute to the overall difference in failure rates between the LNG-IUS and copper IUD. Although Heinemann and colleagues did perform an analysis of failure rates by copper content and found no differences between users of IUDs with less than 300 mm2 and those with at least 300 mm2 of copper, earlier prospective randomized trials show differences in contraceptive efficacy by device type and amount of copper.2
What this evidence means for practice
The LNG-IUS may be a more effective contraceptive than the copper IUD, but both possess excellent contraceptive efficacy. Prospective randomized trials, although much smaller than this nonrandomized cohort study, do not demonstrate differences in contraceptive efficacy between the LNG-IUS and copper IUD.3 The small difference in contraceptive failure rates (less than 1 in 200 women), if real, should not be the deciding factor for choosing one IUD over the other.
— Melissa J. Chen, MD, MPH, and Mitchell D. Creinin, MDShare your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
1. Heinemann K, Reed S, Moehner S, Do Minh T. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015;91(4):274–279.
2. Thonneau PF, Almont T. Contraceptive efficacy of intrauterine devices. Am J Obstet Gynecol. 2008;198(3):248–253.
3. Sivin I, el Mahgoub S, McCarthy T, et al. Long-term contraception with the levonorgestrel 20 mcg/day (LNg 20) and the copper T380Ag intrauterine devices: a five-year randomized study. Contraception. 1990;42(4):361–378.
1. Heinemann K, Reed S, Moehner S, Do Minh T. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015;91(4):274–279.
2. Thonneau PF, Almont T. Contraceptive efficacy of intrauterine devices. Am J Obstet Gynecol. 2008;198(3):248–253.
3. Sivin I, el Mahgoub S, McCarthy T, et al. Long-term contraception with the levonorgestrel 20 mcg/day (LNg 20) and the copper T380Ag intrauterine devices: a five-year randomized study. Contraception. 1990;42(4):361–378.
‘Mossy Oak sign’ suggests delayed anaphylaxis to red meat
HOUSTON– In central Virginia, where IgE-mediated delayed allergic reactions to red meat have become the most common cause of anaphylaxis in adults, physicians have taken to looking for what they call the ‘Mossy Oak sign.’
“If a patient shows up in a blaze-orange cap and hunter’s camouflage fatigues, an allergy fellow will tell me, ‘There’s a positive Mossy Oak sign in room 2,’ and I know that probably means the patient has delayed anaphylaxis to alpha-gal,” Dr. Scott P. Commins said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Alpha-gal is short for galactose-alpha-1,3,-galactose, an oligosaccharide present on thyroglobulin and other tissues in nonprimate mammals. It’s not normally present in humans, but when a lone star tick (Amblyomma americanum) that has fed on a nonprimate mammal bites a human, the alpha-gal is transferred, eliciting serum IgE antibodies.
Mossy Oak is a popular brand of hunter’s camouflage clothing. A positive Mossy Oak sign is useful in clinical practice because a patient who presents to a medical clinic dressed in hunting regalia is someone who spends a lot of time outdoors in the woods and fields where ticks lurk. He’s also typically someone who enjoys eating red meat. And whether it’s venison, beef, pork, lamb, goat, or bison, it contains alpha-gal. The result, in a patient who’s been primed via tick bite, can be a life-threatening anaphylactic or urticarial reaction arising 3-6 hours later, explained Dr. Commins, an allergist at the University of Virginia, Charlottesville.
He and his coinvestigators have played a central role in the still-unfolding story of this novel disease involving late-onset anaphylaxis to mammalian meat. Dr. Commins was the lead author of the paper that first described the syndrome (J. Allergy Clin. Immunol. 2009;123:426-33), as well as a subsequent paper that established the lone star tick as the culprit, making this syndrome the first known example of a response to an ectoparasite giving rise to a serious form of food allergy (J. Allergy Clin. Immunol. 2011;127:1286-93). More recently, the investigators have shown that alpha-gal-specific IgE does not cause or worsen asthma (Am. J. Respir. Crit. Care Med. 2012;185:723-30).
In a wide-ranging talk, Dr. Commins addressed the diagnosis and management of delayed anaphylaxis to red meat. He also touched upon some provocative emerging issues, including the possible risks posed by placing a porcine heart valve or bioprosthetic ligament in a patient with serum IgE antibodies to alpha-gal.
The investigators stumbled upon the phenomenon of tick-transmitted delayed anaphylaxis to red meat while they were trying to unravel the explanation for the markedly regional occurrence of IgE-mediated hypersensitivity reactions to the chimeric monoclonal antibody cetuximab (Erbitux) previously reported in the oncology literature (J. Clin. Oncol. 2007;25:3644-8). Dr. Commins and his colleagues realized that the same southeastern and south-central states where reactions to the initial infusion of cetuximab were concentrated were the states where the lone star tick abounds.
Incidentally, scientists at the Centers for Disease Control and Prevention follow the lone star tick closely because it is the primary vector for ehrlichiosis. CDC researchers say the tick’s range is steadily expanding and now includes 28 states, with New York’s Long Island a hot spot.
There is no public health requirement to report serum IgE-mediated delayed reactions to red meat, so the exact number of affected patients is unknown. But it’s clear that many thousands of individuals are affected, and estimates are being revised upward as the novel syndrome becomes more widely known. The disorder is common in Europe and Australia as well.
Classically, IgE-mediated anaphylactic reactions occur within 5-30 minutes after exposure to the offending agent. Thus, the 3- to 6-hour delay in symptom onset in patients with a reaction to the alpha-gal in red meat is remarkable; the explanation for the time lag remains unclear.
Dr. Commins and others have shown that individuals with serum IgE antibodies to alpha-gal also typically have serum IgE antibodies to cat, dog, beef, and pork, but not to egg, peanut, chicken, fish, or house dust mite.
Diagnosis of IgE-mediated urticarial or anaphylactic reactions to mammalian meat is made on the basis of the presence of serum IgE antibodies to alpha-gal. Dr. Commins recommended considering the diagnosis and ordering the blood test in the setting of new-onset anaphylaxis in a patient who enjoys hunting or other outdoor activities in a state where the lone star tick is found, particularly if the symptoms occur at night, hours after a big meat-heavy meal. A history of recent or persistent tick bites is an obvious clue.
“Also, it’s striking how many patients develop palmar erythema and itching during an episode. Not all report it, but when they do it’s usually a pretty good giveaway that they might have IgE to alpha-gal,” according to the allergist.
He added that it’s entirely reasonable to order a screening test for IgE to alpha-gal in patients in lone star tick–abiding states whose anaphylactic reactions seem to occur randomly without an apparent trigger.
Dr. Commins and his coinvestigators have assembled a database of roughly 500 of their patients with IgE to alpha-gal, about half of whom have a history of atopy. The investigators have found that an individual’s atopic status has no bearing on IgE antibody titer or the severity of the delayed reactions. Moreover, neither the alpha-gal IgE antibody level, the ratio of alpha-gal-specific IgE to total IgE, nor IgG antibodies correlate with reaction severity, he continued.
Based upon their study of 45 affected children, Dr. Commins and coworkers concluded that the clinical presentation and serum IgE pattern are the same as in adults (Pediatrics 2013 May [doi:10.1542/peds.2012-2585]). Since that publication, however, the investigators have realized there is a subgroup of affected teenagers who present with GI symptoms, he added.
Turning to disease management, Dr. Commins said he advocates an avoidance diet that eliminates mammalian meats, rich desserts, and super-premium ice cream.
“I also counsel patients to avoid broths, gravies, and anything that might be a mystery sauce,” he said. “You’d be surprised at how many people with alpha-gal order chicken at a Mexican restaurant thinking that they’re doing the right thing and end up reacting. I don’t know exactly why it happens, so I just say ‘avoid mystery sauces.’ Dairy and cheese are actually fairly well tolerated, although soft cheeses, like brie, can cause a reaction.”
Reactions are inconsistent, and symptoms can vary from episode to episode. Cofactors are a concern, with exercise and alcohol tending to make patients more sensitive to an alpha-gal exposure. The degree of risk posed by vaccines containing gelatin constitutes an emerging and unresolved issue.
“We’ve heard of several reactions to the shingles vaccine because of the gelatin, and the MMR vaccine is also on the radar,” Dr. Commins said.
Implantation of porcine bioprosthetic heart valves in patients with serum IgE antibodies to alpha-gal has been associated with reports of early valve failure; all bioprosthetic valves contain alpha-gal unless they’ve been decellularized. In addition, Dr. Commins is familiar with a case at another university in which three separate attempts to place a bioprosthetic ligament during repeated arthroscopic knee surgeries failed in a patient who had a “screamingly high” level of IgE to alpha-gal.
“I think this bioprosthesis issue is yet to be resolved,” he added.
One audience member, a Texas allergist, said she has a lot of trouble convincing her patients who are avid hunters to give up eating red meats. Dr. Commins said he faces the same issue.
“There is a recalcitrant group that just wants to eat a side of beef every day. I tell them if you’re not going to be on an avoidance diet, at least avoid the fattier cuts and don’t eat tremendous amounts. We believe that the antigen is possibly a glycolipid. Those cuts of meat that are high in fat are the ones patients tell us over and over again give them the worst reactions,” he said.
“The inconsistency of the allergic reactions keeps some patients from taking this disease seriously,” the allergist added. “What eventually happens for some patients is they end up having a really bad reaction. And then that convinces them.”
He monitors affected patients’ alpha-gal IgE levels over time. If and when the IgE becomes negative, he recommends a food challenge test. The patient comes in at 8 a.m., eats three pork sausage patties, and spends the day under observation at the clinic, walking the stairs periodically since exercise is a cofactor. If the challenge goes off without a hitch, the patient is free to go home at 4 or 5 p.m. In the past, that was the patient’s ticket to clearance to safely eat a big meat meal with alcohol, but Dr. Commins has pulled back of late from that recommendation.
“We believe that additional tick bites can make the allergy come back. So if someone passes a challenge in October and then the following spring gets more tick bites, you may have set them up to have a reaction because you’ve told them they can eat meat again. So the utility of a negative food challenge is unclear unless you’re pretty confident a patient is not going to have more tick bites,” he explained.
Dr. Commins reported receiving research grants from the National Institutes of Health to conduct his studies on delayed anaphylactic reactions to red meat. He serves on speakers bureaus for Genentech and Teva.
HOUSTON– In central Virginia, where IgE-mediated delayed allergic reactions to red meat have become the most common cause of anaphylaxis in adults, physicians have taken to looking for what they call the ‘Mossy Oak sign.’
“If a patient shows up in a blaze-orange cap and hunter’s camouflage fatigues, an allergy fellow will tell me, ‘There’s a positive Mossy Oak sign in room 2,’ and I know that probably means the patient has delayed anaphylaxis to alpha-gal,” Dr. Scott P. Commins said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Alpha-gal is short for galactose-alpha-1,3,-galactose, an oligosaccharide present on thyroglobulin and other tissues in nonprimate mammals. It’s not normally present in humans, but when a lone star tick (Amblyomma americanum) that has fed on a nonprimate mammal bites a human, the alpha-gal is transferred, eliciting serum IgE antibodies.
Mossy Oak is a popular brand of hunter’s camouflage clothing. A positive Mossy Oak sign is useful in clinical practice because a patient who presents to a medical clinic dressed in hunting regalia is someone who spends a lot of time outdoors in the woods and fields where ticks lurk. He’s also typically someone who enjoys eating red meat. And whether it’s venison, beef, pork, lamb, goat, or bison, it contains alpha-gal. The result, in a patient who’s been primed via tick bite, can be a life-threatening anaphylactic or urticarial reaction arising 3-6 hours later, explained Dr. Commins, an allergist at the University of Virginia, Charlottesville.
He and his coinvestigators have played a central role in the still-unfolding story of this novel disease involving late-onset anaphylaxis to mammalian meat. Dr. Commins was the lead author of the paper that first described the syndrome (J. Allergy Clin. Immunol. 2009;123:426-33), as well as a subsequent paper that established the lone star tick as the culprit, making this syndrome the first known example of a response to an ectoparasite giving rise to a serious form of food allergy (J. Allergy Clin. Immunol. 2011;127:1286-93). More recently, the investigators have shown that alpha-gal-specific IgE does not cause or worsen asthma (Am. J. Respir. Crit. Care Med. 2012;185:723-30).
In a wide-ranging talk, Dr. Commins addressed the diagnosis and management of delayed anaphylaxis to red meat. He also touched upon some provocative emerging issues, including the possible risks posed by placing a porcine heart valve or bioprosthetic ligament in a patient with serum IgE antibodies to alpha-gal.
The investigators stumbled upon the phenomenon of tick-transmitted delayed anaphylaxis to red meat while they were trying to unravel the explanation for the markedly regional occurrence of IgE-mediated hypersensitivity reactions to the chimeric monoclonal antibody cetuximab (Erbitux) previously reported in the oncology literature (J. Clin. Oncol. 2007;25:3644-8). Dr. Commins and his colleagues realized that the same southeastern and south-central states where reactions to the initial infusion of cetuximab were concentrated were the states where the lone star tick abounds.
Incidentally, scientists at the Centers for Disease Control and Prevention follow the lone star tick closely because it is the primary vector for ehrlichiosis. CDC researchers say the tick’s range is steadily expanding and now includes 28 states, with New York’s Long Island a hot spot.
There is no public health requirement to report serum IgE-mediated delayed reactions to red meat, so the exact number of affected patients is unknown. But it’s clear that many thousands of individuals are affected, and estimates are being revised upward as the novel syndrome becomes more widely known. The disorder is common in Europe and Australia as well.
Classically, IgE-mediated anaphylactic reactions occur within 5-30 minutes after exposure to the offending agent. Thus, the 3- to 6-hour delay in symptom onset in patients with a reaction to the alpha-gal in red meat is remarkable; the explanation for the time lag remains unclear.
Dr. Commins and others have shown that individuals with serum IgE antibodies to alpha-gal also typically have serum IgE antibodies to cat, dog, beef, and pork, but not to egg, peanut, chicken, fish, or house dust mite.
Diagnosis of IgE-mediated urticarial or anaphylactic reactions to mammalian meat is made on the basis of the presence of serum IgE antibodies to alpha-gal. Dr. Commins recommended considering the diagnosis and ordering the blood test in the setting of new-onset anaphylaxis in a patient who enjoys hunting or other outdoor activities in a state where the lone star tick is found, particularly if the symptoms occur at night, hours after a big meat-heavy meal. A history of recent or persistent tick bites is an obvious clue.
“Also, it’s striking how many patients develop palmar erythema and itching during an episode. Not all report it, but when they do it’s usually a pretty good giveaway that they might have IgE to alpha-gal,” according to the allergist.
He added that it’s entirely reasonable to order a screening test for IgE to alpha-gal in patients in lone star tick–abiding states whose anaphylactic reactions seem to occur randomly without an apparent trigger.
Dr. Commins and his coinvestigators have assembled a database of roughly 500 of their patients with IgE to alpha-gal, about half of whom have a history of atopy. The investigators have found that an individual’s atopic status has no bearing on IgE antibody titer or the severity of the delayed reactions. Moreover, neither the alpha-gal IgE antibody level, the ratio of alpha-gal-specific IgE to total IgE, nor IgG antibodies correlate with reaction severity, he continued.
Based upon their study of 45 affected children, Dr. Commins and coworkers concluded that the clinical presentation and serum IgE pattern are the same as in adults (Pediatrics 2013 May [doi:10.1542/peds.2012-2585]). Since that publication, however, the investigators have realized there is a subgroup of affected teenagers who present with GI symptoms, he added.
Turning to disease management, Dr. Commins said he advocates an avoidance diet that eliminates mammalian meats, rich desserts, and super-premium ice cream.
“I also counsel patients to avoid broths, gravies, and anything that might be a mystery sauce,” he said. “You’d be surprised at how many people with alpha-gal order chicken at a Mexican restaurant thinking that they’re doing the right thing and end up reacting. I don’t know exactly why it happens, so I just say ‘avoid mystery sauces.’ Dairy and cheese are actually fairly well tolerated, although soft cheeses, like brie, can cause a reaction.”
Reactions are inconsistent, and symptoms can vary from episode to episode. Cofactors are a concern, with exercise and alcohol tending to make patients more sensitive to an alpha-gal exposure. The degree of risk posed by vaccines containing gelatin constitutes an emerging and unresolved issue.
“We’ve heard of several reactions to the shingles vaccine because of the gelatin, and the MMR vaccine is also on the radar,” Dr. Commins said.
Implantation of porcine bioprosthetic heart valves in patients with serum IgE antibodies to alpha-gal has been associated with reports of early valve failure; all bioprosthetic valves contain alpha-gal unless they’ve been decellularized. In addition, Dr. Commins is familiar with a case at another university in which three separate attempts to place a bioprosthetic ligament during repeated arthroscopic knee surgeries failed in a patient who had a “screamingly high” level of IgE to alpha-gal.
“I think this bioprosthesis issue is yet to be resolved,” he added.
One audience member, a Texas allergist, said she has a lot of trouble convincing her patients who are avid hunters to give up eating red meats. Dr. Commins said he faces the same issue.
“There is a recalcitrant group that just wants to eat a side of beef every day. I tell them if you’re not going to be on an avoidance diet, at least avoid the fattier cuts and don’t eat tremendous amounts. We believe that the antigen is possibly a glycolipid. Those cuts of meat that are high in fat are the ones patients tell us over and over again give them the worst reactions,” he said.
“The inconsistency of the allergic reactions keeps some patients from taking this disease seriously,” the allergist added. “What eventually happens for some patients is they end up having a really bad reaction. And then that convinces them.”
He monitors affected patients’ alpha-gal IgE levels over time. If and when the IgE becomes negative, he recommends a food challenge test. The patient comes in at 8 a.m., eats three pork sausage patties, and spends the day under observation at the clinic, walking the stairs periodically since exercise is a cofactor. If the challenge goes off without a hitch, the patient is free to go home at 4 or 5 p.m. In the past, that was the patient’s ticket to clearance to safely eat a big meat meal with alcohol, but Dr. Commins has pulled back of late from that recommendation.
“We believe that additional tick bites can make the allergy come back. So if someone passes a challenge in October and then the following spring gets more tick bites, you may have set them up to have a reaction because you’ve told them they can eat meat again. So the utility of a negative food challenge is unclear unless you’re pretty confident a patient is not going to have more tick bites,” he explained.
Dr. Commins reported receiving research grants from the National Institutes of Health to conduct his studies on delayed anaphylactic reactions to red meat. He serves on speakers bureaus for Genentech and Teva.
HOUSTON– In central Virginia, where IgE-mediated delayed allergic reactions to red meat have become the most common cause of anaphylaxis in adults, physicians have taken to looking for what they call the ‘Mossy Oak sign.’
“If a patient shows up in a blaze-orange cap and hunter’s camouflage fatigues, an allergy fellow will tell me, ‘There’s a positive Mossy Oak sign in room 2,’ and I know that probably means the patient has delayed anaphylaxis to alpha-gal,” Dr. Scott P. Commins said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Alpha-gal is short for galactose-alpha-1,3,-galactose, an oligosaccharide present on thyroglobulin and other tissues in nonprimate mammals. It’s not normally present in humans, but when a lone star tick (Amblyomma americanum) that has fed on a nonprimate mammal bites a human, the alpha-gal is transferred, eliciting serum IgE antibodies.
Mossy Oak is a popular brand of hunter’s camouflage clothing. A positive Mossy Oak sign is useful in clinical practice because a patient who presents to a medical clinic dressed in hunting regalia is someone who spends a lot of time outdoors in the woods and fields where ticks lurk. He’s also typically someone who enjoys eating red meat. And whether it’s venison, beef, pork, lamb, goat, or bison, it contains alpha-gal. The result, in a patient who’s been primed via tick bite, can be a life-threatening anaphylactic or urticarial reaction arising 3-6 hours later, explained Dr. Commins, an allergist at the University of Virginia, Charlottesville.
He and his coinvestigators have played a central role in the still-unfolding story of this novel disease involving late-onset anaphylaxis to mammalian meat. Dr. Commins was the lead author of the paper that first described the syndrome (J. Allergy Clin. Immunol. 2009;123:426-33), as well as a subsequent paper that established the lone star tick as the culprit, making this syndrome the first known example of a response to an ectoparasite giving rise to a serious form of food allergy (J. Allergy Clin. Immunol. 2011;127:1286-93). More recently, the investigators have shown that alpha-gal-specific IgE does not cause or worsen asthma (Am. J. Respir. Crit. Care Med. 2012;185:723-30).
In a wide-ranging talk, Dr. Commins addressed the diagnosis and management of delayed anaphylaxis to red meat. He also touched upon some provocative emerging issues, including the possible risks posed by placing a porcine heart valve or bioprosthetic ligament in a patient with serum IgE antibodies to alpha-gal.
The investigators stumbled upon the phenomenon of tick-transmitted delayed anaphylaxis to red meat while they were trying to unravel the explanation for the markedly regional occurrence of IgE-mediated hypersensitivity reactions to the chimeric monoclonal antibody cetuximab (Erbitux) previously reported in the oncology literature (J. Clin. Oncol. 2007;25:3644-8). Dr. Commins and his colleagues realized that the same southeastern and south-central states where reactions to the initial infusion of cetuximab were concentrated were the states where the lone star tick abounds.
Incidentally, scientists at the Centers for Disease Control and Prevention follow the lone star tick closely because it is the primary vector for ehrlichiosis. CDC researchers say the tick’s range is steadily expanding and now includes 28 states, with New York’s Long Island a hot spot.
There is no public health requirement to report serum IgE-mediated delayed reactions to red meat, so the exact number of affected patients is unknown. But it’s clear that many thousands of individuals are affected, and estimates are being revised upward as the novel syndrome becomes more widely known. The disorder is common in Europe and Australia as well.
Classically, IgE-mediated anaphylactic reactions occur within 5-30 minutes after exposure to the offending agent. Thus, the 3- to 6-hour delay in symptom onset in patients with a reaction to the alpha-gal in red meat is remarkable; the explanation for the time lag remains unclear.
Dr. Commins and others have shown that individuals with serum IgE antibodies to alpha-gal also typically have serum IgE antibodies to cat, dog, beef, and pork, but not to egg, peanut, chicken, fish, or house dust mite.
Diagnosis of IgE-mediated urticarial or anaphylactic reactions to mammalian meat is made on the basis of the presence of serum IgE antibodies to alpha-gal. Dr. Commins recommended considering the diagnosis and ordering the blood test in the setting of new-onset anaphylaxis in a patient who enjoys hunting or other outdoor activities in a state where the lone star tick is found, particularly if the symptoms occur at night, hours after a big meat-heavy meal. A history of recent or persistent tick bites is an obvious clue.
“Also, it’s striking how many patients develop palmar erythema and itching during an episode. Not all report it, but when they do it’s usually a pretty good giveaway that they might have IgE to alpha-gal,” according to the allergist.
He added that it’s entirely reasonable to order a screening test for IgE to alpha-gal in patients in lone star tick–abiding states whose anaphylactic reactions seem to occur randomly without an apparent trigger.
Dr. Commins and his coinvestigators have assembled a database of roughly 500 of their patients with IgE to alpha-gal, about half of whom have a history of atopy. The investigators have found that an individual’s atopic status has no bearing on IgE antibody titer or the severity of the delayed reactions. Moreover, neither the alpha-gal IgE antibody level, the ratio of alpha-gal-specific IgE to total IgE, nor IgG antibodies correlate with reaction severity, he continued.
Based upon their study of 45 affected children, Dr. Commins and coworkers concluded that the clinical presentation and serum IgE pattern are the same as in adults (Pediatrics 2013 May [doi:10.1542/peds.2012-2585]). Since that publication, however, the investigators have realized there is a subgroup of affected teenagers who present with GI symptoms, he added.
Turning to disease management, Dr. Commins said he advocates an avoidance diet that eliminates mammalian meats, rich desserts, and super-premium ice cream.
“I also counsel patients to avoid broths, gravies, and anything that might be a mystery sauce,” he said. “You’d be surprised at how many people with alpha-gal order chicken at a Mexican restaurant thinking that they’re doing the right thing and end up reacting. I don’t know exactly why it happens, so I just say ‘avoid mystery sauces.’ Dairy and cheese are actually fairly well tolerated, although soft cheeses, like brie, can cause a reaction.”
Reactions are inconsistent, and symptoms can vary from episode to episode. Cofactors are a concern, with exercise and alcohol tending to make patients more sensitive to an alpha-gal exposure. The degree of risk posed by vaccines containing gelatin constitutes an emerging and unresolved issue.
“We’ve heard of several reactions to the shingles vaccine because of the gelatin, and the MMR vaccine is also on the radar,” Dr. Commins said.
Implantation of porcine bioprosthetic heart valves in patients with serum IgE antibodies to alpha-gal has been associated with reports of early valve failure; all bioprosthetic valves contain alpha-gal unless they’ve been decellularized. In addition, Dr. Commins is familiar with a case at another university in which three separate attempts to place a bioprosthetic ligament during repeated arthroscopic knee surgeries failed in a patient who had a “screamingly high” level of IgE to alpha-gal.
“I think this bioprosthesis issue is yet to be resolved,” he added.
One audience member, a Texas allergist, said she has a lot of trouble convincing her patients who are avid hunters to give up eating red meats. Dr. Commins said he faces the same issue.
“There is a recalcitrant group that just wants to eat a side of beef every day. I tell them if you’re not going to be on an avoidance diet, at least avoid the fattier cuts and don’t eat tremendous amounts. We believe that the antigen is possibly a glycolipid. Those cuts of meat that are high in fat are the ones patients tell us over and over again give them the worst reactions,” he said.
“The inconsistency of the allergic reactions keeps some patients from taking this disease seriously,” the allergist added. “What eventually happens for some patients is they end up having a really bad reaction. And then that convinces them.”
He monitors affected patients’ alpha-gal IgE levels over time. If and when the IgE becomes negative, he recommends a food challenge test. The patient comes in at 8 a.m., eats three pork sausage patties, and spends the day under observation at the clinic, walking the stairs periodically since exercise is a cofactor. If the challenge goes off without a hitch, the patient is free to go home at 4 or 5 p.m. In the past, that was the patient’s ticket to clearance to safely eat a big meat meal with alcohol, but Dr. Commins has pulled back of late from that recommendation.
“We believe that additional tick bites can make the allergy come back. So if someone passes a challenge in October and then the following spring gets more tick bites, you may have set them up to have a reaction because you’ve told them they can eat meat again. So the utility of a negative food challenge is unclear unless you’re pretty confident a patient is not going to have more tick bites,” he explained.
Dr. Commins reported receiving research grants from the National Institutes of Health to conduct his studies on delayed anaphylactic reactions to red meat. He serves on speakers bureaus for Genentech and Teva.
EXPERT ANALYSIS FROM THE 2015 AAAAI ANNUAL MEETING
Complicated concussions drive new clinics, management approaches
The Fairfax Family Practice Comprehensive Concussion Center is an example of what dedicated physicians can accomplish when they undertake to improve upon an accepted medical approach to a health problem because it falls far short of effective. The concussion center’s hall wall is adorned with a broad and colorful sign autographed by scores of patients – many of them student-athletes – who have been cleared to return to their sports and activities and to lives free of restrictions and struggle following concussion.
Dr. Garry W.K. Ho, the double-credentialed family practice and sports medicine physician who directs the 2-year-old concussion center in Fairfax, Va., takes pride in the skills his team has acquired to facilitate these recoveries.
He and his colleagues within the practice’s sports medicine division established the center, teaming up with several certified athletic trainers, to meet what they saw as a growing, urgent need: to help concussed patients who were taking longer than the oft-mentioned 7-10 days or 2 weeks to heal.
“While many of the people we’d been treating in the clinic with typical 15- to 30-minute appointments and relatively simple follow-up were able to get better, there was clearly a subset of the population that was more complicated and needed a more dedicated, multidimensional approach,” Dr. Ho said.
Findings from a growing number of studies have shown that concussions can involve a vast array of deficits – problems with the vestibular and vision systems, for example – and that a more comprehensive initial evaluation and a multipronged approach to management could shorten recovery time for any individual with the brain injury, he said.
“We’d started to realize how much patients can benefit from new and creative approaches,” said Dr. Ho. “We were also appreciating that no one person can own this disorder. You can’t say that only the neurologist can treat a concussion, or only the family physician or sports medicine physician.
‘Silent epidemic’
A small but growing number of concussion-care programs and clinics are being established across the country. Most often, the programs are incorporated into hospitals and sports medicine clinics. But some, like the program Dr. Ho leads, are embedded within larger primary care practices with a sports medicine component.
And, in other traditional family practices, some physicians are deepening their knowledge of concussions and building the networks necessary for managing prolonged impairment.
“If we have a good understanding of brain injury, we can often facilitate recovery and help [our patients] get back on track seamlessly,” said Dr. Rebecca Jaffe, a family physician in Wilmington, Del. “And when recovery is protracted, when issues don’t resolve in 2-3 weeks, there’s often more to the situation than is initially apparent, and it’s often better that we have a team of individuals who can help us.”
According to the Institute of Medicine (IOM), there are not enough data for an accurate estimate of the incidence of sports-related concussions in youth (Institute of Medicine and National Research Council. 2014. Sports-related concussions in youth: Improving the science, changing the culture. Washington, D.C.: The National Academies Press.)
But among high school athletes, an increase in concussions has been documented in several emergency department studies and other longitudinal studies published over the past 7-8 years. Most recently, the first national study to look at trends among high school athletes showed the numbers of concussions reported by certified athletic trainers increasing from 0.23/1,000 athlete-exposures in the 2005-2006 academic year to 0.51/1,000 in the 2011-2012 academic year (Am. J. Sports Med. 2014;42:1710-5).
Experts attribute such increases largely to improved awareness and new state laws. The Centers for Disease Control and Prevention’s launched its “Heads Up” educational program in 2004, for instance. And as of last year, every state and the District of Columbia had enacted at least one law to protect young athletes with concussions.
State concussion laws vary, but most require that parents, athletes, and coaches be educated about concussions, and that athletes with suspected concussions be evaluated and cleared by a health care professional with knowledge in concussions before returning to play.
It is likely, some experts say, that the upward curve is leveling off with improved awareness and diagnosis. But with such improvements there lurks a void of data on concussions in youth outside the realm of high school sports. And, according to the 2014 IOM report, the acute and long-term health threat from concussions is “not fully appreciated or acted upon” in many settings. “Kids are getting removed from play more frequently, but then it’s not really clear what anyone should do after that,” said Dr. Shireen Atabaki, an emergency medicine specialist at Children’s National Medical Center in Washington, who is leading several national initiatives to improve concussion care.
Too often, concussed children and teens receive little besides unnecessary CT scans in emergency departments and concussions go undiagnosed. And when concussions are diagnosed, discharge instructions are poor and “kids are sent out into a no-man’s land” where recovery is often poorly managed, she said.
When Dr. Ho and his colleagues opened their concussion center in March 2013, they began seeing patients who remained symptomatic after concussions that had occurred 6-12 months ago, and longer. “It was almost like a silent epidemic,” he said. “We had one young woman who’d been injured in her senior year of high school and was still symptomatic after 2 years.”
To build the program at Fairfax Family Practice, Dr. Ho and his colleagues, Dr. Thomas Howard and Dr. Marc Childress (who, like Dr. Ho, are board certified in sports medicine as well as family medicine), capitalized on what they saw as a valuable synergy with high school athletic trainers.
Dr. Ho had worked closely with athletic trainers as a volunteer medical adviser to the Fairfax County Public School System’s athletic training program, which provides care to student-athletes in 25 high schools. He drew on his relationships to recruit three athletic trainers who were at transition points in their careers and who had both experience and “passion” in the treatment of concussions.
One of them, Jon Almquist, VATL, ATC, had led the development of return-to-learn protocols and other management practices for the high schools. He had also partnered with investigators at MedStar Health Research Institute in Baltimore on research that documented a 4.2-fold increase in concussions among the school system’s high school athletes between 1997 and 2008 (Am. J. Sports Med. 2011;39:958-63).
More surprising than this increase, however, were some data collected after the study period ended. When Mr. Almquist looked at recovery times for the concussions reported between 2011 and 2013, he found that about 25% of concussions took 30 days or longer to recover – a portion greater than he’d seen anywhere in the literature.
According to the 2014 IOM report, youth athletes typically recover from a concussion within 2 weeks of the injury, but in 10-20% of cases the symptoms persist for a number of weeks, months, or even years.
“Families would come to us for advice,” Mr. Almquist recalled. Other than referring them to the University of Pittsburgh Medical Center’s (UPMC) Sports Medicine Concussion Program, there were few local providers whom they believed offered comprehensive care and had experience with prolonged impairment.
Mr. Almquist and his fellow athletic trainers, and Dr. Ho and his physician colleagues, all had been following developments at UPMC’s Sports Medicine Concussion Program since it was established in 2000. The program had evolved to assess and manage diverse facets of concussions, including vision, vestibular, exertion, and medication components—not all of which are fully addressed in clinical practice guidelines and position statements. By 2010, the program was drawing 10,000 patients a year.
Care at UPMC is guided by a clinical neuropsychologist who assesses head injuries and then refers patients on as needed to other members of the team – like a neurovestibular expert for vestibular assessment and therapy, a neuro-optometrist for vision therapy, a physical therapist for exertion training, or a sports medicine physician for medication.
In planning their own concussion center, Dr. Ho and his team visited various programs in the country but homed in on UPMC. They decided to mimic several aspects of UPMC’s approach by providing comprehensive and individualized care, and by having the certified athletic trainers serve as the “quarterbacks.”
“The athletic trainer in our center does all the symptom inventories and history taking, a concussion-focused physical exam, vestibular-ocular-motor screening, and neurocognitive tests if appropriate,” said Dr. Ho.
Dr. Ho or one of his sports medicine physician colleagues then discusses results with the athletic trainer and completes the patient visit – with the trainer – by asking any necessary follow-up questions, probing further with additional evaluation, and writing medication prescriptions when appropriate.
Throughout the course of care – visits occur weekly to monthly and often last 30-90 minutes – the athletic trainer and physician work together on clinical issues such as sleep and mental health and on subtyping headaches (cognitive fatigue, cervicogenic, or migrainelike) and “determining where the headaches lie relative to other areas of dysfunction,” said Dr. Ho.
Much of the individualized counseling, monitoring, and coordination that’s required to address sleep hygiene, rest, nutrition, and graded return to physical and cognitive activity can be led by the athletic trainer, he said.
For the first year or so, patients were referred out for such special services as vision or vestibular therapy. But there were problems with this approach: One frequent issue was poor insurance coverage for these therapies. Another was the stress involved in getting to additional appointments on Fairfax’s congested roads. “Traffic and busy environments aren’t always tolerable for a concussed patient,” Dr. Ho said.
Dr. Ho searched the Internet, worked the phone, read the neuro-optometry and vestibular therapy literature, and attended conferences to learn what kinds of therapeutic exercises they could integrate into office visits and take-home care plans. Dr. Ho said he was “surprised at how willing some of [their] colleagues were to give us some basic skills” to help patients who “don’t all need the Cadillac version” of therapy.
About the same time they integrated basic vision and vestibular therapy, they also revamped their billing strategy, moving away from the use of prolonged service billing codes, which Dr. Ho said were frequently denied on the first submission, to using separate codes for the encounter, therapeutic exercise (which encompasses vision therapy and vestibular therapy), and various physical tests.
Concussion care networks
Fairfax Family Practice is not the only practice to center its concussion program on physician-athletic trainer partnerships. Carolina Family Practice and Sports Medicine, a 12-provider practice with three offices in and around Raleigh, N.C., took a similar approach when it established its concussion clinic in 2008.
“Concussion is the ultimate example of an injury that benefits from a team approach,” said Dr. Josh Bloom, medical director of the Carolina Sports Concussion Clinic that is embedded into the practice. “And it’s the one injury – the only injury in sports medicine – where the standard of care calls for the injury to be 100% resolved prior to being cleared to return to play.”
Dr. Jaffe, the family physician in Delaware, said she is fortunate to have a neuro-optometrist practicing in the medical building where her three-physician family practice resides, and a concussion care team in the nearby Nemours/Alfred I. Dupont Hospital for Children, also in Wilmington.
Someday, she and others hope, physicians who see patients soon after injury will have tools to better predict clinical trajectories and identify who could benefit from earlier referral to a “more sophisticated team.”
For now, Dr. Jaffe said, she seeks assistance when headache and initial symptoms persist after 2-3 weeks or when their symptoms “seem out of proportion to the incident.”
Dr. Scott Ross of Novant Health Bull Run Family Medicine based in Manassas, Va., said that family physicians are well suited to guide management and should learn to evaluate each patient’s concussion-related impairments as thoroughly as possible.
About 3 years ago, he and a partner established an official “Sports Medicine and Concussion Management” service line in their practice. “We don’t have a concussion center all under one roof, but we have the knowledge, skills, and resources that we need,” he said.
This article was updated April 13, 2015.
The Fairfax Family Practice Comprehensive Concussion Center is an example of what dedicated physicians can accomplish when they undertake to improve upon an accepted medical approach to a health problem because it falls far short of effective. The concussion center’s hall wall is adorned with a broad and colorful sign autographed by scores of patients – many of them student-athletes – who have been cleared to return to their sports and activities and to lives free of restrictions and struggle following concussion.
Dr. Garry W.K. Ho, the double-credentialed family practice and sports medicine physician who directs the 2-year-old concussion center in Fairfax, Va., takes pride in the skills his team has acquired to facilitate these recoveries.
He and his colleagues within the practice’s sports medicine division established the center, teaming up with several certified athletic trainers, to meet what they saw as a growing, urgent need: to help concussed patients who were taking longer than the oft-mentioned 7-10 days or 2 weeks to heal.
“While many of the people we’d been treating in the clinic with typical 15- to 30-minute appointments and relatively simple follow-up were able to get better, there was clearly a subset of the population that was more complicated and needed a more dedicated, multidimensional approach,” Dr. Ho said.
Findings from a growing number of studies have shown that concussions can involve a vast array of deficits – problems with the vestibular and vision systems, for example – and that a more comprehensive initial evaluation and a multipronged approach to management could shorten recovery time for any individual with the brain injury, he said.
“We’d started to realize how much patients can benefit from new and creative approaches,” said Dr. Ho. “We were also appreciating that no one person can own this disorder. You can’t say that only the neurologist can treat a concussion, or only the family physician or sports medicine physician.
‘Silent epidemic’
A small but growing number of concussion-care programs and clinics are being established across the country. Most often, the programs are incorporated into hospitals and sports medicine clinics. But some, like the program Dr. Ho leads, are embedded within larger primary care practices with a sports medicine component.
And, in other traditional family practices, some physicians are deepening their knowledge of concussions and building the networks necessary for managing prolonged impairment.
“If we have a good understanding of brain injury, we can often facilitate recovery and help [our patients] get back on track seamlessly,” said Dr. Rebecca Jaffe, a family physician in Wilmington, Del. “And when recovery is protracted, when issues don’t resolve in 2-3 weeks, there’s often more to the situation than is initially apparent, and it’s often better that we have a team of individuals who can help us.”
According to the Institute of Medicine (IOM), there are not enough data for an accurate estimate of the incidence of sports-related concussions in youth (Institute of Medicine and National Research Council. 2014. Sports-related concussions in youth: Improving the science, changing the culture. Washington, D.C.: The National Academies Press.)
But among high school athletes, an increase in concussions has been documented in several emergency department studies and other longitudinal studies published over the past 7-8 years. Most recently, the first national study to look at trends among high school athletes showed the numbers of concussions reported by certified athletic trainers increasing from 0.23/1,000 athlete-exposures in the 2005-2006 academic year to 0.51/1,000 in the 2011-2012 academic year (Am. J. Sports Med. 2014;42:1710-5).
Experts attribute such increases largely to improved awareness and new state laws. The Centers for Disease Control and Prevention’s launched its “Heads Up” educational program in 2004, for instance. And as of last year, every state and the District of Columbia had enacted at least one law to protect young athletes with concussions.
State concussion laws vary, but most require that parents, athletes, and coaches be educated about concussions, and that athletes with suspected concussions be evaluated and cleared by a health care professional with knowledge in concussions before returning to play.
It is likely, some experts say, that the upward curve is leveling off with improved awareness and diagnosis. But with such improvements there lurks a void of data on concussions in youth outside the realm of high school sports. And, according to the 2014 IOM report, the acute and long-term health threat from concussions is “not fully appreciated or acted upon” in many settings. “Kids are getting removed from play more frequently, but then it’s not really clear what anyone should do after that,” said Dr. Shireen Atabaki, an emergency medicine specialist at Children’s National Medical Center in Washington, who is leading several national initiatives to improve concussion care.
Too often, concussed children and teens receive little besides unnecessary CT scans in emergency departments and concussions go undiagnosed. And when concussions are diagnosed, discharge instructions are poor and “kids are sent out into a no-man’s land” where recovery is often poorly managed, she said.
When Dr. Ho and his colleagues opened their concussion center in March 2013, they began seeing patients who remained symptomatic after concussions that had occurred 6-12 months ago, and longer. “It was almost like a silent epidemic,” he said. “We had one young woman who’d been injured in her senior year of high school and was still symptomatic after 2 years.”
To build the program at Fairfax Family Practice, Dr. Ho and his colleagues, Dr. Thomas Howard and Dr. Marc Childress (who, like Dr. Ho, are board certified in sports medicine as well as family medicine), capitalized on what they saw as a valuable synergy with high school athletic trainers.
Dr. Ho had worked closely with athletic trainers as a volunteer medical adviser to the Fairfax County Public School System’s athletic training program, which provides care to student-athletes in 25 high schools. He drew on his relationships to recruit three athletic trainers who were at transition points in their careers and who had both experience and “passion” in the treatment of concussions.
One of them, Jon Almquist, VATL, ATC, had led the development of return-to-learn protocols and other management practices for the high schools. He had also partnered with investigators at MedStar Health Research Institute in Baltimore on research that documented a 4.2-fold increase in concussions among the school system’s high school athletes between 1997 and 2008 (Am. J. Sports Med. 2011;39:958-63).
More surprising than this increase, however, were some data collected after the study period ended. When Mr. Almquist looked at recovery times for the concussions reported between 2011 and 2013, he found that about 25% of concussions took 30 days or longer to recover – a portion greater than he’d seen anywhere in the literature.
According to the 2014 IOM report, youth athletes typically recover from a concussion within 2 weeks of the injury, but in 10-20% of cases the symptoms persist for a number of weeks, months, or even years.
“Families would come to us for advice,” Mr. Almquist recalled. Other than referring them to the University of Pittsburgh Medical Center’s (UPMC) Sports Medicine Concussion Program, there were few local providers whom they believed offered comprehensive care and had experience with prolonged impairment.
Mr. Almquist and his fellow athletic trainers, and Dr. Ho and his physician colleagues, all had been following developments at UPMC’s Sports Medicine Concussion Program since it was established in 2000. The program had evolved to assess and manage diverse facets of concussions, including vision, vestibular, exertion, and medication components—not all of which are fully addressed in clinical practice guidelines and position statements. By 2010, the program was drawing 10,000 patients a year.
Care at UPMC is guided by a clinical neuropsychologist who assesses head injuries and then refers patients on as needed to other members of the team – like a neurovestibular expert for vestibular assessment and therapy, a neuro-optometrist for vision therapy, a physical therapist for exertion training, or a sports medicine physician for medication.
In planning their own concussion center, Dr. Ho and his team visited various programs in the country but homed in on UPMC. They decided to mimic several aspects of UPMC’s approach by providing comprehensive and individualized care, and by having the certified athletic trainers serve as the “quarterbacks.”
“The athletic trainer in our center does all the symptom inventories and history taking, a concussion-focused physical exam, vestibular-ocular-motor screening, and neurocognitive tests if appropriate,” said Dr. Ho.
Dr. Ho or one of his sports medicine physician colleagues then discusses results with the athletic trainer and completes the patient visit – with the trainer – by asking any necessary follow-up questions, probing further with additional evaluation, and writing medication prescriptions when appropriate.
Throughout the course of care – visits occur weekly to monthly and often last 30-90 minutes – the athletic trainer and physician work together on clinical issues such as sleep and mental health and on subtyping headaches (cognitive fatigue, cervicogenic, or migrainelike) and “determining where the headaches lie relative to other areas of dysfunction,” said Dr. Ho.
Much of the individualized counseling, monitoring, and coordination that’s required to address sleep hygiene, rest, nutrition, and graded return to physical and cognitive activity can be led by the athletic trainer, he said.
For the first year or so, patients were referred out for such special services as vision or vestibular therapy. But there were problems with this approach: One frequent issue was poor insurance coverage for these therapies. Another was the stress involved in getting to additional appointments on Fairfax’s congested roads. “Traffic and busy environments aren’t always tolerable for a concussed patient,” Dr. Ho said.
Dr. Ho searched the Internet, worked the phone, read the neuro-optometry and vestibular therapy literature, and attended conferences to learn what kinds of therapeutic exercises they could integrate into office visits and take-home care plans. Dr. Ho said he was “surprised at how willing some of [their] colleagues were to give us some basic skills” to help patients who “don’t all need the Cadillac version” of therapy.
About the same time they integrated basic vision and vestibular therapy, they also revamped their billing strategy, moving away from the use of prolonged service billing codes, which Dr. Ho said were frequently denied on the first submission, to using separate codes for the encounter, therapeutic exercise (which encompasses vision therapy and vestibular therapy), and various physical tests.
Concussion care networks
Fairfax Family Practice is not the only practice to center its concussion program on physician-athletic trainer partnerships. Carolina Family Practice and Sports Medicine, a 12-provider practice with three offices in and around Raleigh, N.C., took a similar approach when it established its concussion clinic in 2008.
“Concussion is the ultimate example of an injury that benefits from a team approach,” said Dr. Josh Bloom, medical director of the Carolina Sports Concussion Clinic that is embedded into the practice. “And it’s the one injury – the only injury in sports medicine – where the standard of care calls for the injury to be 100% resolved prior to being cleared to return to play.”
Dr. Jaffe, the family physician in Delaware, said she is fortunate to have a neuro-optometrist practicing in the medical building where her three-physician family practice resides, and a concussion care team in the nearby Nemours/Alfred I. Dupont Hospital for Children, also in Wilmington.
Someday, she and others hope, physicians who see patients soon after injury will have tools to better predict clinical trajectories and identify who could benefit from earlier referral to a “more sophisticated team.”
For now, Dr. Jaffe said, she seeks assistance when headache and initial symptoms persist after 2-3 weeks or when their symptoms “seem out of proportion to the incident.”
Dr. Scott Ross of Novant Health Bull Run Family Medicine based in Manassas, Va., said that family physicians are well suited to guide management and should learn to evaluate each patient’s concussion-related impairments as thoroughly as possible.
About 3 years ago, he and a partner established an official “Sports Medicine and Concussion Management” service line in their practice. “We don’t have a concussion center all under one roof, but we have the knowledge, skills, and resources that we need,” he said.
This article was updated April 13, 2015.
The Fairfax Family Practice Comprehensive Concussion Center is an example of what dedicated physicians can accomplish when they undertake to improve upon an accepted medical approach to a health problem because it falls far short of effective. The concussion center’s hall wall is adorned with a broad and colorful sign autographed by scores of patients – many of them student-athletes – who have been cleared to return to their sports and activities and to lives free of restrictions and struggle following concussion.
Dr. Garry W.K. Ho, the double-credentialed family practice and sports medicine physician who directs the 2-year-old concussion center in Fairfax, Va., takes pride in the skills his team has acquired to facilitate these recoveries.
He and his colleagues within the practice’s sports medicine division established the center, teaming up with several certified athletic trainers, to meet what they saw as a growing, urgent need: to help concussed patients who were taking longer than the oft-mentioned 7-10 days or 2 weeks to heal.
“While many of the people we’d been treating in the clinic with typical 15- to 30-minute appointments and relatively simple follow-up were able to get better, there was clearly a subset of the population that was more complicated and needed a more dedicated, multidimensional approach,” Dr. Ho said.
Findings from a growing number of studies have shown that concussions can involve a vast array of deficits – problems with the vestibular and vision systems, for example – and that a more comprehensive initial evaluation and a multipronged approach to management could shorten recovery time for any individual with the brain injury, he said.
“We’d started to realize how much patients can benefit from new and creative approaches,” said Dr. Ho. “We were also appreciating that no one person can own this disorder. You can’t say that only the neurologist can treat a concussion, or only the family physician or sports medicine physician.
‘Silent epidemic’
A small but growing number of concussion-care programs and clinics are being established across the country. Most often, the programs are incorporated into hospitals and sports medicine clinics. But some, like the program Dr. Ho leads, are embedded within larger primary care practices with a sports medicine component.
And, in other traditional family practices, some physicians are deepening their knowledge of concussions and building the networks necessary for managing prolonged impairment.
“If we have a good understanding of brain injury, we can often facilitate recovery and help [our patients] get back on track seamlessly,” said Dr. Rebecca Jaffe, a family physician in Wilmington, Del. “And when recovery is protracted, when issues don’t resolve in 2-3 weeks, there’s often more to the situation than is initially apparent, and it’s often better that we have a team of individuals who can help us.”
According to the Institute of Medicine (IOM), there are not enough data for an accurate estimate of the incidence of sports-related concussions in youth (Institute of Medicine and National Research Council. 2014. Sports-related concussions in youth: Improving the science, changing the culture. Washington, D.C.: The National Academies Press.)
But among high school athletes, an increase in concussions has been documented in several emergency department studies and other longitudinal studies published over the past 7-8 years. Most recently, the first national study to look at trends among high school athletes showed the numbers of concussions reported by certified athletic trainers increasing from 0.23/1,000 athlete-exposures in the 2005-2006 academic year to 0.51/1,000 in the 2011-2012 academic year (Am. J. Sports Med. 2014;42:1710-5).
Experts attribute such increases largely to improved awareness and new state laws. The Centers for Disease Control and Prevention’s launched its “Heads Up” educational program in 2004, for instance. And as of last year, every state and the District of Columbia had enacted at least one law to protect young athletes with concussions.
State concussion laws vary, but most require that parents, athletes, and coaches be educated about concussions, and that athletes with suspected concussions be evaluated and cleared by a health care professional with knowledge in concussions before returning to play.
It is likely, some experts say, that the upward curve is leveling off with improved awareness and diagnosis. But with such improvements there lurks a void of data on concussions in youth outside the realm of high school sports. And, according to the 2014 IOM report, the acute and long-term health threat from concussions is “not fully appreciated or acted upon” in many settings. “Kids are getting removed from play more frequently, but then it’s not really clear what anyone should do after that,” said Dr. Shireen Atabaki, an emergency medicine specialist at Children’s National Medical Center in Washington, who is leading several national initiatives to improve concussion care.
Too often, concussed children and teens receive little besides unnecessary CT scans in emergency departments and concussions go undiagnosed. And when concussions are diagnosed, discharge instructions are poor and “kids are sent out into a no-man’s land” where recovery is often poorly managed, she said.
When Dr. Ho and his colleagues opened their concussion center in March 2013, they began seeing patients who remained symptomatic after concussions that had occurred 6-12 months ago, and longer. “It was almost like a silent epidemic,” he said. “We had one young woman who’d been injured in her senior year of high school and was still symptomatic after 2 years.”
To build the program at Fairfax Family Practice, Dr. Ho and his colleagues, Dr. Thomas Howard and Dr. Marc Childress (who, like Dr. Ho, are board certified in sports medicine as well as family medicine), capitalized on what they saw as a valuable synergy with high school athletic trainers.
Dr. Ho had worked closely with athletic trainers as a volunteer medical adviser to the Fairfax County Public School System’s athletic training program, which provides care to student-athletes in 25 high schools. He drew on his relationships to recruit three athletic trainers who were at transition points in their careers and who had both experience and “passion” in the treatment of concussions.
One of them, Jon Almquist, VATL, ATC, had led the development of return-to-learn protocols and other management practices for the high schools. He had also partnered with investigators at MedStar Health Research Institute in Baltimore on research that documented a 4.2-fold increase in concussions among the school system’s high school athletes between 1997 and 2008 (Am. J. Sports Med. 2011;39:958-63).
More surprising than this increase, however, were some data collected after the study period ended. When Mr. Almquist looked at recovery times for the concussions reported between 2011 and 2013, he found that about 25% of concussions took 30 days or longer to recover – a portion greater than he’d seen anywhere in the literature.
According to the 2014 IOM report, youth athletes typically recover from a concussion within 2 weeks of the injury, but in 10-20% of cases the symptoms persist for a number of weeks, months, or even years.
“Families would come to us for advice,” Mr. Almquist recalled. Other than referring them to the University of Pittsburgh Medical Center’s (UPMC) Sports Medicine Concussion Program, there were few local providers whom they believed offered comprehensive care and had experience with prolonged impairment.
Mr. Almquist and his fellow athletic trainers, and Dr. Ho and his physician colleagues, all had been following developments at UPMC’s Sports Medicine Concussion Program since it was established in 2000. The program had evolved to assess and manage diverse facets of concussions, including vision, vestibular, exertion, and medication components—not all of which are fully addressed in clinical practice guidelines and position statements. By 2010, the program was drawing 10,000 patients a year.
Care at UPMC is guided by a clinical neuropsychologist who assesses head injuries and then refers patients on as needed to other members of the team – like a neurovestibular expert for vestibular assessment and therapy, a neuro-optometrist for vision therapy, a physical therapist for exertion training, or a sports medicine physician for medication.
In planning their own concussion center, Dr. Ho and his team visited various programs in the country but homed in on UPMC. They decided to mimic several aspects of UPMC’s approach by providing comprehensive and individualized care, and by having the certified athletic trainers serve as the “quarterbacks.”
“The athletic trainer in our center does all the symptom inventories and history taking, a concussion-focused physical exam, vestibular-ocular-motor screening, and neurocognitive tests if appropriate,” said Dr. Ho.
Dr. Ho or one of his sports medicine physician colleagues then discusses results with the athletic trainer and completes the patient visit – with the trainer – by asking any necessary follow-up questions, probing further with additional evaluation, and writing medication prescriptions when appropriate.
Throughout the course of care – visits occur weekly to monthly and often last 30-90 minutes – the athletic trainer and physician work together on clinical issues such as sleep and mental health and on subtyping headaches (cognitive fatigue, cervicogenic, or migrainelike) and “determining where the headaches lie relative to other areas of dysfunction,” said Dr. Ho.
Much of the individualized counseling, monitoring, and coordination that’s required to address sleep hygiene, rest, nutrition, and graded return to physical and cognitive activity can be led by the athletic trainer, he said.
For the first year or so, patients were referred out for such special services as vision or vestibular therapy. But there were problems with this approach: One frequent issue was poor insurance coverage for these therapies. Another was the stress involved in getting to additional appointments on Fairfax’s congested roads. “Traffic and busy environments aren’t always tolerable for a concussed patient,” Dr. Ho said.
Dr. Ho searched the Internet, worked the phone, read the neuro-optometry and vestibular therapy literature, and attended conferences to learn what kinds of therapeutic exercises they could integrate into office visits and take-home care plans. Dr. Ho said he was “surprised at how willing some of [their] colleagues were to give us some basic skills” to help patients who “don’t all need the Cadillac version” of therapy.
About the same time they integrated basic vision and vestibular therapy, they also revamped their billing strategy, moving away from the use of prolonged service billing codes, which Dr. Ho said were frequently denied on the first submission, to using separate codes for the encounter, therapeutic exercise (which encompasses vision therapy and vestibular therapy), and various physical tests.
Concussion care networks
Fairfax Family Practice is not the only practice to center its concussion program on physician-athletic trainer partnerships. Carolina Family Practice and Sports Medicine, a 12-provider practice with three offices in and around Raleigh, N.C., took a similar approach when it established its concussion clinic in 2008.
“Concussion is the ultimate example of an injury that benefits from a team approach,” said Dr. Josh Bloom, medical director of the Carolina Sports Concussion Clinic that is embedded into the practice. “And it’s the one injury – the only injury in sports medicine – where the standard of care calls for the injury to be 100% resolved prior to being cleared to return to play.”
Dr. Jaffe, the family physician in Delaware, said she is fortunate to have a neuro-optometrist practicing in the medical building where her three-physician family practice resides, and a concussion care team in the nearby Nemours/Alfred I. Dupont Hospital for Children, also in Wilmington.
Someday, she and others hope, physicians who see patients soon after injury will have tools to better predict clinical trajectories and identify who could benefit from earlier referral to a “more sophisticated team.”
For now, Dr. Jaffe said, she seeks assistance when headache and initial symptoms persist after 2-3 weeks or when their symptoms “seem out of proportion to the incident.”
Dr. Scott Ross of Novant Health Bull Run Family Medicine based in Manassas, Va., said that family physicians are well suited to guide management and should learn to evaluate each patient’s concussion-related impairments as thoroughly as possible.
About 3 years ago, he and a partner established an official “Sports Medicine and Concussion Management” service line in their practice. “We don’t have a concussion center all under one roof, but we have the knowledge, skills, and resources that we need,” he said.
This article was updated April 13, 2015.