CHICAGO – The stroke risk in patients with recent-onset atrial fibrillation is similar to that of patients with longer-standing atrial fibrillation, according to a new secondary analysis of the landmark ARISTOTLE trial.

“Our key message is that patients with recent-onset atrial fibrillation had a similar risk of stroke but higher mortality than patients with remotely diagnosed atrial fibrillation, suggesting that patients with recently diagnosed atrial fibrillation are not at low risk and therefore warrant stroke prevention strategies,” Dr. Patricia O. Guimaraes said in presenting the findings at the annual meeting of the American College of Cardiology.

Bruce Jancin/Frontline Medical News

“Sometimes we as physicians hesitate in beginning oral anticoagulation therapy for patients that we just diagnosed. And of course patients are often afraid of anticoagulation therapy. But once they present with atrial fibrillation they are already at risk, and that’s why we need to anticoagulate them promptly,” added Dr. Guimaraes of the Duke Clinical Research Institute in Durham, N.C.

The benefits of apixaban (Eliquis) over warfarin seen in the overall randomized ARISTOTLE trial (N Engl J Med. 2011; 365:981-92) were preserved in the recent-onset subset of the atrial fibrillation (AF) study population, she noted.

The rationale for this new post hoc analysis of ARISTOTLE is that virtually all of the evidence supporting anticoagulation for stroke prevention in AF is based on studies conducted in patients with permanent, persistent, or long-standing paroxysmal AF. Much less is known about stroke risk and the benefits of anticoagulation in patients with recent-onset AF, Dr. Guimaraes explained.

The 1,899 ARISTOTLE participants with AF onset within 30 days prior to enrollment comprised 10.5% of the total study population, all of whom had AF and at least one other stroke risk factor. The recent-onset subgroup was the same age as the 16,241 subjects in this analysis who had longer-standing AF, but the recent-onset group included a higher proportion of women, had a lower prevalence of CAD, and their cardiovascular risk factor profile differed from that of the remote-onset AF group.

The composite endpoint of stroke, systemic embolism, major bleeding, or all-cause mortality occurred at a rate of 8.69%/year in the recent-onset AF group, compared with 6.43%/year in the remote-onset group. However, in a multivariate regression analysis adjusted for potential confounders, the only significant differences in outcome between the two groups were in all-cause mortality – 5.15%/year in the recent-onset group, 3.15% in the remote-onset AF patients – and in the composite of stroke, systemic embolism, or all-cause mortality, which had an incidence of 6.46%/year in the recent-onset group, compared with 4.57%/year in remote-onset patients.

Turning to the impact of apixaban, Dr. Guimaraes noted that, as previously reported in the overall study, the primary endpoint of stroke or systemic embolism occurred in the apixaban group at a rate of 1.27%/year, compared with 1.6%/year with warfarin, for a 21% relative risk reduction in favor of the newer agent. She and her coinvestigators determined that in the remote-onset AF subgroup the relative risk reduction was 20%, while in the recent-onset subgroup the size of the effect was similar at 22%.

The composite safety endpoint of major or clinically relevant bleeding occurred in the remote-onset patients at a rate of 3.97%/year with apixaban versus 5.97%/year with warfarin, for a 33% relative risk reduction favoring the novel agent. In the recent-onset group, the rates were 5.04%/year with apixaban, compared with 6.4%/year with warfarin, for a 22% relative risk reduction.

Dr. Guimaraes observed an important limitation of this post hoc analysis is that the remote-onset AF group may have been selected for improved survival, since they didn’t die in the first 30 days after diagnosis.

Session co-chair Dr. Brian Olshansky commented that this analysis, which highlights the risks of recent-onset AF, argues for a strategy whereby a patient who presents to the ED with new-onset AF should get sent home on apixaban rather than being hospitalized for several days in order to be stabilized on warfarin.

“With recent-onset atrial fibrillation it’s going to take you several days to get anticoagulated with warfarin, whereas you’re immediately anticoagulated with apixaban,” said Dr. Olshansky, emeritus professor of internal medicine at the University of Iowa, Iowa City.

The ARISTOTLE trial was supported by Bristol-Myers Squibb and Pfizer. Dr. Guimaraes reported having no financial conflicts of interest.

[email protected]

CHICAGO – The stroke risk in patients with recent-onset atrial fibrillation is similar to that of patients with longer-standing atrial fibrillation, according to a new secondary analysis of the landmark ARISTOTLE trial.

“Our key message is that patients with recent-onset atrial fibrillation had a similar risk of stroke but higher mortality than patients with remotely diagnosed atrial fibrillation, suggesting that patients with recently diagnosed atrial fibrillation are not at low risk and therefore warrant stroke prevention strategies,” Dr. Patricia O. Guimaraes said in presenting the findings at the annual meeting of the American College of Cardiology.

Bruce Jancin/Frontline Medical News

“Sometimes we as physicians hesitate in beginning oral anticoagulation therapy for patients that we just diagnosed. And of course patients are often afraid of anticoagulation therapy. But once they present with atrial fibrillation they are already at risk, and that’s why we need to anticoagulate them promptly,” added Dr. Guimaraes of the Duke Clinical Research Institute in Durham, N.C.

The benefits of apixaban (Eliquis) over warfarin seen in the overall randomized ARISTOTLE trial (N Engl J Med. 2011; 365:981-92) were preserved in the recent-onset subset of the atrial fibrillation (AF) study population, she noted.

The rationale for this new post hoc analysis of ARISTOTLE is that virtually all of the evidence supporting anticoagulation for stroke prevention in AF is based on studies conducted in patients with permanent, persistent, or long-standing paroxysmal AF. Much less is known about stroke risk and the benefits of anticoagulation in patients with recent-onset AF, Dr. Guimaraes explained.

The 1,899 ARISTOTLE participants with AF onset within 30 days prior to enrollment comprised 10.5% of the total study population, all of whom had AF and at least one other stroke risk factor. The recent-onset subgroup was the same age as the 16,241 subjects in this analysis who had longer-standing AF, but the recent-onset group included a higher proportion of women, had a lower prevalence of CAD, and their cardiovascular risk factor profile differed from that of the remote-onset AF group.

The composite endpoint of stroke, systemic embolism, major bleeding, or all-cause mortality occurred at a rate of 8.69%/year in the recent-onset AF group, compared with 6.43%/year in the remote-onset group. However, in a multivariate regression analysis adjusted for potential confounders, the only significant differences in outcome between the two groups were in all-cause mortality – 5.15%/year in the recent-onset group, 3.15% in the remote-onset AF patients – and in the composite of stroke, systemic embolism, or all-cause mortality, which had an incidence of 6.46%/year in the recent-onset group, compared with 4.57%/year in remote-onset patients.

Turning to the impact of apixaban, Dr. Guimaraes noted that, as previously reported in the overall study, the primary endpoint of stroke or systemic embolism occurred in the apixaban group at a rate of 1.27%/year, compared with 1.6%/year with warfarin, for a 21% relative risk reduction in favor of the newer agent. She and her coinvestigators determined that in the remote-onset AF subgroup the relative risk reduction was 20%, while in the recent-onset subgroup the size of the effect was similar at 22%.

The composite safety endpoint of major or clinically relevant bleeding occurred in the remote-onset patients at a rate of 3.97%/year with apixaban versus 5.97%/year with warfarin, for a 33% relative risk reduction favoring the novel agent. In the recent-onset group, the rates were 5.04%/year with apixaban, compared with 6.4%/year with warfarin, for a 22% relative risk reduction.

Dr. Guimaraes observed an important limitation of this post hoc analysis is that the remote-onset AF group may have been selected for improved survival, since they didn’t die in the first 30 days after diagnosis.

Session co-chair Dr. Brian Olshansky commented that this analysis, which highlights the risks of recent-onset AF, argues for a strategy whereby a patient who presents to the ED with new-onset AF should get sent home on apixaban rather than being hospitalized for several days in order to be stabilized on warfarin.

“With recent-onset atrial fibrillation it’s going to take you several days to get anticoagulated with warfarin, whereas you’re immediately anticoagulated with apixaban,” said Dr. Olshansky, emeritus professor of internal medicine at the University of Iowa, Iowa City.

The ARISTOTLE trial was supported by Bristol-Myers Squibb and Pfizer. Dr. Guimaraes reported having no financial conflicts of interest.

[email protected]

CHICAGO – The stroke risk in patients with recent-onset atrial fibrillation is similar to that of patients with longer-standing atrial fibrillation, according to a new secondary analysis of the landmark ARISTOTLE trial.

“Our key message is that patients with recent-onset atrial fibrillation had a similar risk of stroke but higher mortality than patients with remotely diagnosed atrial fibrillation, suggesting that patients with recently diagnosed atrial fibrillation are not at low risk and therefore warrant stroke prevention strategies,” Dr. Patricia O. Guimaraes said in presenting the findings at the annual meeting of the American College of Cardiology.

Bruce Jancin/Frontline Medical News

“Sometimes we as physicians hesitate in beginning oral anticoagulation therapy for patients that we just diagnosed. And of course patients are often afraid of anticoagulation therapy. But once they present with atrial fibrillation they are already at risk, and that’s why we need to anticoagulate them promptly,” added Dr. Guimaraes of the Duke Clinical Research Institute in Durham, N.C.

The benefits of apixaban (Eliquis) over warfarin seen in the overall randomized ARISTOTLE trial (N Engl J Med. 2011; 365:981-92) were preserved in the recent-onset subset of the atrial fibrillation (AF) study population, she noted.

The rationale for this new post hoc analysis of ARISTOTLE is that virtually all of the evidence supporting anticoagulation for stroke prevention in AF is based on studies conducted in patients with permanent, persistent, or long-standing paroxysmal AF. Much less is known about stroke risk and the benefits of anticoagulation in patients with recent-onset AF, Dr. Guimaraes explained.

The 1,899 ARISTOTLE participants with AF onset within 30 days prior to enrollment comprised 10.5% of the total study population, all of whom had AF and at least one other stroke risk factor. The recent-onset subgroup was the same age as the 16,241 subjects in this analysis who had longer-standing AF, but the recent-onset group included a higher proportion of women, had a lower prevalence of CAD, and their cardiovascular risk factor profile differed from that of the remote-onset AF group.

The composite endpoint of stroke, systemic embolism, major bleeding, or all-cause mortality occurred at a rate of 8.69%/year in the recent-onset AF group, compared with 6.43%/year in the remote-onset group. However, in a multivariate regression analysis adjusted for potential confounders, the only significant differences in outcome between the two groups were in all-cause mortality – 5.15%/year in the recent-onset group, 3.15% in the remote-onset AF patients – and in the composite of stroke, systemic embolism, or all-cause mortality, which had an incidence of 6.46%/year in the recent-onset group, compared with 4.57%/year in remote-onset patients.

Turning to the impact of apixaban, Dr. Guimaraes noted that, as previously reported in the overall study, the primary endpoint of stroke or systemic embolism occurred in the apixaban group at a rate of 1.27%/year, compared with 1.6%/year with warfarin, for a 21% relative risk reduction in favor of the newer agent. She and her coinvestigators determined that in the remote-onset AF subgroup the relative risk reduction was 20%, while in the recent-onset subgroup the size of the effect was similar at 22%.

The composite safety endpoint of major or clinically relevant bleeding occurred in the remote-onset patients at a rate of 3.97%/year with apixaban versus 5.97%/year with warfarin, for a 33% relative risk reduction favoring the novel agent. In the recent-onset group, the rates were 5.04%/year with apixaban, compared with 6.4%/year with warfarin, for a 22% relative risk reduction.

Dr. Guimaraes observed an important limitation of this post hoc analysis is that the remote-onset AF group may have been selected for improved survival, since they didn’t die in the first 30 days after diagnosis.

Session co-chair Dr. Brian Olshansky commented that this analysis, which highlights the risks of recent-onset AF, argues for a strategy whereby a patient who presents to the ED with new-onset AF should get sent home on apixaban rather than being hospitalized for several days in order to be stabilized on warfarin.

“With recent-onset atrial fibrillation it’s going to take you several days to get anticoagulated with warfarin, whereas you’re immediately anticoagulated with apixaban,” said Dr. Olshansky, emeritus professor of internal medicine at the University of Iowa, Iowa City.

The ARISTOTLE trial was supported by Bristol-Myers Squibb and Pfizer. Dr. Guimaraes reported having no financial conflicts of interest.

[email protected]

ATLANTA – Nearly half of 2,100 multiple sclerosis (MS) patients enrolled at baseline in the Sonya Slifka Longitudinal Multiple Sclerosis Study reported experiencing emotional distress, and 9% of those patients reported difficulties with accessing mental health services.

Younger patients, those with more recently diagnosed illness, and those with more frequent MS relapses were more likely to experience emotional distress, Dr. Laura Safar of Brigham and Women’s Hospital, Boston, said at the annual meeting of the American Psychiatric Association.

HUNG KUO CHUN/Thinkstock

The Sonya Slifka study was an 8-year population-based cohort study that, at last report, included more than 4,000 MS patients from across the United States, with varying disease duration. Dr. Safar reported on baseline mental health data from the study.

Patients with MS may experience symptoms involving any part of the central nervous system, including psychiatric symptoms such as depression, anxiety, and cognitive disorders, she said, noting that these are highly prevalent, but often go unrecognized and untreated by primary care doctors and neurologists.

Prior studies have suggested that depression occurs in 25%-80% of patients, depending on the study setting. The rates are higher in those with MS than in the general population or in those with other neurologic and chronic medical conditions, she said.

In the Sonya Slifka study, 77% of patients were women with an average age of 50 years and disease duration ranging from 1 week to 64 years. Most were white. The disease distribution was representative of that seen in the general MS population, with most (57%) having relapsing-remitting disease, 25% having secondary progressive disease, and the remaining patients having primary progressive disease or progressing-relapsing disease (Mult Scler. 2006 Feb;12[1]:24-38).

Reported disability levels varied from none/very mild to severe and requiring a wheelchair or scooter or being bedridden.

Of the 48% of patients reporting emotional distress, most reported having mild to moderate distress, but 40% reported severe distress.

Nearly half (46%) of patients reported accomplishing less than normal because of emotional difficulties, and 31% said they worked less carefully than usual.

Emotional distress was more common in patients who were younger, divorced or never married, unemployed, and in those with lower education and income levels. Emotional distress was associated with shorter duration of illness, with having multiple relapses in the prior year (highest rates were among those with five or more relapses), and with moderate disability level.

Emotional distress was also associated with poorer perceived general health, and those with higher levels of emotional distress tended to experience all or many of the symptoms on the baseline questionnaire.

Further, those with emotional distress tended to lack health insurance and to have problems accessing health care and necessary prescription medications. About one-fourth of the patients had seen a mental health professional in the prior year and nearly 8% wanted to; 2% said they had been referred to a mental health professional, and 93% of these patients had emotional distress, including 6% with severe distress.

Reasons given by these patients for not seeing a mental health professional were cost, difficulty getting an appointment, and too long of a wait.

The findings suggest that in clinical settings it is important to screen MS patients for emotional distress and depression and to treat or refer accordingly, Dr. Safar said.

“As we know from other medical illnesses, this will improve adherence to MS treatment and will improve the prognosis,” she added.

Dr. Safar reported having no disclosures.

[email protected]

ATLANTA – Nearly half of 2,100 multiple sclerosis (MS) patients enrolled at baseline in the Sonya Slifka Longitudinal Multiple Sclerosis Study reported experiencing emotional distress, and 9% of those patients reported difficulties with accessing mental health services.

Younger patients, those with more recently diagnosed illness, and those with more frequent MS relapses were more likely to experience emotional distress, Dr. Laura Safar of Brigham and Women’s Hospital, Boston, said at the annual meeting of the American Psychiatric Association.

HUNG KUO CHUN/Thinkstock

The Sonya Slifka study was an 8-year population-based cohort study that, at last report, included more than 4,000 MS patients from across the United States, with varying disease duration. Dr. Safar reported on baseline mental health data from the study.

Patients with MS may experience symptoms involving any part of the central nervous system, including psychiatric symptoms such as depression, anxiety, and cognitive disorders, she said, noting that these are highly prevalent, but often go unrecognized and untreated by primary care doctors and neurologists.

Prior studies have suggested that depression occurs in 25%-80% of patients, depending on the study setting. The rates are higher in those with MS than in the general population or in those with other neurologic and chronic medical conditions, she said.

In the Sonya Slifka study, 77% of patients were women with an average age of 50 years and disease duration ranging from 1 week to 64 years. Most were white. The disease distribution was representative of that seen in the general MS population, with most (57%) having relapsing-remitting disease, 25% having secondary progressive disease, and the remaining patients having primary progressive disease or progressing-relapsing disease (Mult Scler. 2006 Feb;12[1]:24-38).

Reported disability levels varied from none/very mild to severe and requiring a wheelchair or scooter or being bedridden.

Of the 48% of patients reporting emotional distress, most reported having mild to moderate distress, but 40% reported severe distress.

Nearly half (46%) of patients reported accomplishing less than normal because of emotional difficulties, and 31% said they worked less carefully than usual.

Emotional distress was more common in patients who were younger, divorced or never married, unemployed, and in those with lower education and income levels. Emotional distress was associated with shorter duration of illness, with having multiple relapses in the prior year (highest rates were among those with five or more relapses), and with moderate disability level.

Emotional distress was also associated with poorer perceived general health, and those with higher levels of emotional distress tended to experience all or many of the symptoms on the baseline questionnaire.

Further, those with emotional distress tended to lack health insurance and to have problems accessing health care and necessary prescription medications. About one-fourth of the patients had seen a mental health professional in the prior year and nearly 8% wanted to; 2% said they had been referred to a mental health professional, and 93% of these patients had emotional distress, including 6% with severe distress.

Reasons given by these patients for not seeing a mental health professional were cost, difficulty getting an appointment, and too long of a wait.

The findings suggest that in clinical settings it is important to screen MS patients for emotional distress and depression and to treat or refer accordingly, Dr. Safar said.

“As we know from other medical illnesses, this will improve adherence to MS treatment and will improve the prognosis,” she added.

Dr. Safar reported having no disclosures.

[email protected]

ATLANTA – Nearly half of 2,100 multiple sclerosis (MS) patients enrolled at baseline in the Sonya Slifka Longitudinal Multiple Sclerosis Study reported experiencing emotional distress, and 9% of those patients reported difficulties with accessing mental health services.

Younger patients, those with more recently diagnosed illness, and those with more frequent MS relapses were more likely to experience emotional distress, Dr. Laura Safar of Brigham and Women’s Hospital, Boston, said at the annual meeting of the American Psychiatric Association.

HUNG KUO CHUN/Thinkstock

The Sonya Slifka study was an 8-year population-based cohort study that, at last report, included more than 4,000 MS patients from across the United States, with varying disease duration. Dr. Safar reported on baseline mental health data from the study.

Patients with MS may experience symptoms involving any part of the central nervous system, including psychiatric symptoms such as depression, anxiety, and cognitive disorders, she said, noting that these are highly prevalent, but often go unrecognized and untreated by primary care doctors and neurologists.

Prior studies have suggested that depression occurs in 25%-80% of patients, depending on the study setting. The rates are higher in those with MS than in the general population or in those with other neurologic and chronic medical conditions, she said.

In the Sonya Slifka study, 77% of patients were women with an average age of 50 years and disease duration ranging from 1 week to 64 years. Most were white. The disease distribution was representative of that seen in the general MS population, with most (57%) having relapsing-remitting disease, 25% having secondary progressive disease, and the remaining patients having primary progressive disease or progressing-relapsing disease (Mult Scler. 2006 Feb;12[1]:24-38).

Reported disability levels varied from none/very mild to severe and requiring a wheelchair or scooter or being bedridden.

Of the 48% of patients reporting emotional distress, most reported having mild to moderate distress, but 40% reported severe distress.

Nearly half (46%) of patients reported accomplishing less than normal because of emotional difficulties, and 31% said they worked less carefully than usual.

Emotional distress was more common in patients who were younger, divorced or never married, unemployed, and in those with lower education and income levels. Emotional distress was associated with shorter duration of illness, with having multiple relapses in the prior year (highest rates were among those with five or more relapses), and with moderate disability level.

Emotional distress was also associated with poorer perceived general health, and those with higher levels of emotional distress tended to experience all or many of the symptoms on the baseline questionnaire.

Further, those with emotional distress tended to lack health insurance and to have problems accessing health care and necessary prescription medications. About one-fourth of the patients had seen a mental health professional in the prior year and nearly 8% wanted to; 2% said they had been referred to a mental health professional, and 93% of these patients had emotional distress, including 6% with severe distress.

Reasons given by these patients for not seeing a mental health professional were cost, difficulty getting an appointment, and too long of a wait.

The findings suggest that in clinical settings it is important to screen MS patients for emotional distress and depression and to treat or refer accordingly, Dr. Safar said.

“As we know from other medical illnesses, this will improve adherence to MS treatment and will improve the prognosis,” she added.

Dr. Safar reported having no disclosures.

[email protected]

Doctors can detect evidence of a concussion up to one week after a patient is injured by using a simple blood test, according to a report published online ahead of print March 28 in JAMA Neurology. Researchers tested two blood biomarkers—glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1)—separately and together in patients with mild and moderate traumatic brain injury (TBI) within seven days of the injury. They examined the blood biomarkers with respect to diagnostic precision of TBI, presence of traumatic intracranial lesions detectable by CT, and need for neurosurgical intervention. Linda Papa, MDCM, MSc, and colleagues reported that GFAP performed consistently in detecting mild to moderate TBI, CT lesions, and the need for neurosurgical interventions across seven days. UCH-L1, they said, performed best in the early postinjury period.

Linda Papa, MDCM, MSc

“We have so many diagnostic blood tests for different parts of the body, like the heart, liver and kidneys, but there’s never been a reliable blood test to identify trauma in the brain,” said Dr. Papa, an emergency medicine physician at Orlando Health in Florid and lead author of the study. “We think this particular test could change that.”

Dr. Papa and colleagues designed a prospective cohort study that enrolled adults with trauma seen at a level 1 trauma center from March 1, 2010, to March 5, 2014. All patients underwent screening to determine whether they had experienced mild or moderate TBI, which was defined as blunt head trauma with loss of consciousness, amnesia, or disorientation and a Glasgow Coma Scale score of 9 to 15. Of 3,025 patients assessed, 1,030 met eligibility criteria for enrollment; 446 declined participation. Initial blood samples were obtained in 584 patients enrolled within four hours of injury. Repeated blood sampling was conducted every four hours up to 24 hours postinjury, and then every 12 hours thereafter until 180 hours postinjury.

A total of 1,831 blood samples were drawn from 584 patients (mean age, 40; 62% male) over seven days. Both GFAP and UCH-L1 were detectible within one hour of injury. GFAP peaked at 20 hours postinjury and slowly declined over 72 hours. UCH-L1 rose rapidly and peaked at eight hours postinjury, then declined rapidly over 48 hours.

Over the course of one week, GFAP demonstrated a diagnostic range of areas under the curve for detecting mild to moderate TBI of 0.73 to 0.94, and UCH-L1 demonstrated a diagnostic range of 0.30 to 0.67. For detecting intracranial lesions on CT, the diagnostic ranges of areas under the curve were 0.80 to 0.97 for GFAP and 0.31 to 0.77 for UCH-L1. For distinguishing patients with and without the need for a neurosurgical intervention, the range for GFAP was 0.91 to 100 and the range for UCH-L1 was 0.50 to 0.92.

“In the context of developing a point-of-care test, the early and rapid rise of UCH-L1 could be used to detect TBI immediately at the scene of injury in settings such as in the ambulance, on the playing field, or at the battlefield,” the researchers wrote. “The longer half-life of GFAP makes it a favorable biomarker to use in both the acute and subacute phases of injury because it is able to detect CT lesions for up to seven days after injury. Although its rise is not as rapid as [that of] UCH-L1, it performs well for detecting mild TBI and CT lesions within one hour of injury.”

—Glenn S. Williams

Doctors can detect evidence of a concussion up to one week after a patient is injured by using a simple blood test, according to a report published online ahead of print March 28 in JAMA Neurology. Researchers tested two blood biomarkers—glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1)—separately and together in patients with mild and moderate traumatic brain injury (TBI) within seven days of the injury. They examined the blood biomarkers with respect to diagnostic precision of TBI, presence of traumatic intracranial lesions detectable by CT, and need for neurosurgical intervention. Linda Papa, MDCM, MSc, and colleagues reported that GFAP performed consistently in detecting mild to moderate TBI, CT lesions, and the need for neurosurgical interventions across seven days. UCH-L1, they said, performed best in the early postinjury period.

Linda Papa, MDCM, MSc

“We have so many diagnostic blood tests for different parts of the body, like the heart, liver and kidneys, but there’s never been a reliable blood test to identify trauma in the brain,” said Dr. Papa, an emergency medicine physician at Orlando Health in Florid and lead author of the study. “We think this particular test could change that.”

Dr. Papa and colleagues designed a prospective cohort study that enrolled adults with trauma seen at a level 1 trauma center from March 1, 2010, to March 5, 2014. All patients underwent screening to determine whether they had experienced mild or moderate TBI, which was defined as blunt head trauma with loss of consciousness, amnesia, or disorientation and a Glasgow Coma Scale score of 9 to 15. Of 3,025 patients assessed, 1,030 met eligibility criteria for enrollment; 446 declined participation. Initial blood samples were obtained in 584 patients enrolled within four hours of injury. Repeated blood sampling was conducted every four hours up to 24 hours postinjury, and then every 12 hours thereafter until 180 hours postinjury.

A total of 1,831 blood samples were drawn from 584 patients (mean age, 40; 62% male) over seven days. Both GFAP and UCH-L1 were detectible within one hour of injury. GFAP peaked at 20 hours postinjury and slowly declined over 72 hours. UCH-L1 rose rapidly and peaked at eight hours postinjury, then declined rapidly over 48 hours.

Over the course of one week, GFAP demonstrated a diagnostic range of areas under the curve for detecting mild to moderate TBI of 0.73 to 0.94, and UCH-L1 demonstrated a diagnostic range of 0.30 to 0.67. For detecting intracranial lesions on CT, the diagnostic ranges of areas under the curve were 0.80 to 0.97 for GFAP and 0.31 to 0.77 for UCH-L1. For distinguishing patients with and without the need for a neurosurgical intervention, the range for GFAP was 0.91 to 100 and the range for UCH-L1 was 0.50 to 0.92.

“In the context of developing a point-of-care test, the early and rapid rise of UCH-L1 could be used to detect TBI immediately at the scene of injury in settings such as in the ambulance, on the playing field, or at the battlefield,” the researchers wrote. “The longer half-life of GFAP makes it a favorable biomarker to use in both the acute and subacute phases of injury because it is able to detect CT lesions for up to seven days after injury. Although its rise is not as rapid as [that of] UCH-L1, it performs well for detecting mild TBI and CT lesions within one hour of injury.”

—Glenn S. Williams

Doctors can detect evidence of a concussion up to one week after a patient is injured by using a simple blood test, according to a report published online ahead of print March 28 in JAMA Neurology. Researchers tested two blood biomarkers—glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1)—separately and together in patients with mild and moderate traumatic brain injury (TBI) within seven days of the injury. They examined the blood biomarkers with respect to diagnostic precision of TBI, presence of traumatic intracranial lesions detectable by CT, and need for neurosurgical intervention. Linda Papa, MDCM, MSc, and colleagues reported that GFAP performed consistently in detecting mild to moderate TBI, CT lesions, and the need for neurosurgical interventions across seven days. UCH-L1, they said, performed best in the early postinjury period.

Linda Papa, MDCM, MSc

“We have so many diagnostic blood tests for different parts of the body, like the heart, liver and kidneys, but there’s never been a reliable blood test to identify trauma in the brain,” said Dr. Papa, an emergency medicine physician at Orlando Health in Florid and lead author of the study. “We think this particular test could change that.”

Dr. Papa and colleagues designed a prospective cohort study that enrolled adults with trauma seen at a level 1 trauma center from March 1, 2010, to March 5, 2014. All patients underwent screening to determine whether they had experienced mild or moderate TBI, which was defined as blunt head trauma with loss of consciousness, amnesia, or disorientation and a Glasgow Coma Scale score of 9 to 15. Of 3,025 patients assessed, 1,030 met eligibility criteria for enrollment; 446 declined participation. Initial blood samples were obtained in 584 patients enrolled within four hours of injury. Repeated blood sampling was conducted every four hours up to 24 hours postinjury, and then every 12 hours thereafter until 180 hours postinjury.

A total of 1,831 blood samples were drawn from 584 patients (mean age, 40; 62% male) over seven days. Both GFAP and UCH-L1 were detectible within one hour of injury. GFAP peaked at 20 hours postinjury and slowly declined over 72 hours. UCH-L1 rose rapidly and peaked at eight hours postinjury, then declined rapidly over 48 hours.

Over the course of one week, GFAP demonstrated a diagnostic range of areas under the curve for detecting mild to moderate TBI of 0.73 to 0.94, and UCH-L1 demonstrated a diagnostic range of 0.30 to 0.67. For detecting intracranial lesions on CT, the diagnostic ranges of areas under the curve were 0.80 to 0.97 for GFAP and 0.31 to 0.77 for UCH-L1. For distinguishing patients with and without the need for a neurosurgical intervention, the range for GFAP was 0.91 to 100 and the range for UCH-L1 was 0.50 to 0.92.

“In the context of developing a point-of-care test, the early and rapid rise of UCH-L1 could be used to detect TBI immediately at the scene of injury in settings such as in the ambulance, on the playing field, or at the battlefield,” the researchers wrote. “The longer half-life of GFAP makes it a favorable biomarker to use in both the acute and subacute phases of injury because it is able to detect CT lesions for up to seven days after injury. Although its rise is not as rapid as [that of] UCH-L1, it performs well for detecting mild TBI and CT lesions within one hour of injury.”

—Glenn S. Williams

The Food and Drug Administration has granted accelerated approval to nivolumab for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and posttransplantation brentuximab vedotin.

Approval was based on a 65% objective response rate in 95 patients treated with nivolumab following autologous HSCT and posttransplantation brentuximab vedotin. All patients in the single-arm, multicenter trial had relapsed or refractory cHL and were enrolled regardless of PD-L1 expression status. Patients received a median of 17 doses of nivolumab, the FDA said in a written statement.

The median time to response was 2.1 months (range, 0.7-5.7 months). The estimated median duration of response was 8.7 months.

The FDA also issued a warning for complications of allogeneic HSCT after nivolumab, reporting that transplant-related deaths have occurred. Health care professionals should follow patients closely for early evidence of transplant-related complications, such as hyperacute graft-versus-host disease (GVHD), severe acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions, they said.

The most common adverse reactions in a second single-arm study used to evaluate safety (n = 263) were upper respiratory tract infection, cough, pyrexia, and diarrhea. Other immune-mediated adverse reactions, occurring in 1%-5% of patients, included rash, pneumonitis, hepatitis, hyperthyroidism, and colitis. The most common serious adverse reactions, which were reported in 1%-3% of patients, were pneumonia, pleural effusion, pneumonitis, pyrexia, infusion-related reaction, and rash.

Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and has been previously approved to treat advanced renal cell carcinoma, lung cancer, and melanoma.

[email protected]

On Twitter @NikolaidesLaura

The Food and Drug Administration has granted accelerated approval to nivolumab for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and posttransplantation brentuximab vedotin.

Approval was based on a 65% objective response rate in 95 patients treated with nivolumab following autologous HSCT and posttransplantation brentuximab vedotin. All patients in the single-arm, multicenter trial had relapsed or refractory cHL and were enrolled regardless of PD-L1 expression status. Patients received a median of 17 doses of nivolumab, the FDA said in a written statement.

The median time to response was 2.1 months (range, 0.7-5.7 months). The estimated median duration of response was 8.7 months.

The FDA also issued a warning for complications of allogeneic HSCT after nivolumab, reporting that transplant-related deaths have occurred. Health care professionals should follow patients closely for early evidence of transplant-related complications, such as hyperacute graft-versus-host disease (GVHD), severe acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions, they said.

The most common adverse reactions in a second single-arm study used to evaluate safety (n = 263) were upper respiratory tract infection, cough, pyrexia, and diarrhea. Other immune-mediated adverse reactions, occurring in 1%-5% of patients, included rash, pneumonitis, hepatitis, hyperthyroidism, and colitis. The most common serious adverse reactions, which were reported in 1%-3% of patients, were pneumonia, pleural effusion, pneumonitis, pyrexia, infusion-related reaction, and rash.

Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and has been previously approved to treat advanced renal cell carcinoma, lung cancer, and melanoma.

[email protected]

On Twitter @NikolaidesLaura

The Food and Drug Administration has granted accelerated approval to nivolumab for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and posttransplantation brentuximab vedotin.

Approval was based on a 65% objective response rate in 95 patients treated with nivolumab following autologous HSCT and posttransplantation brentuximab vedotin. All patients in the single-arm, multicenter trial had relapsed or refractory cHL and were enrolled regardless of PD-L1 expression status. Patients received a median of 17 doses of nivolumab, the FDA said in a written statement.

The median time to response was 2.1 months (range, 0.7-5.7 months). The estimated median duration of response was 8.7 months.

The FDA also issued a warning for complications of allogeneic HSCT after nivolumab, reporting that transplant-related deaths have occurred. Health care professionals should follow patients closely for early evidence of transplant-related complications, such as hyperacute graft-versus-host disease (GVHD), severe acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions, they said.

The most common adverse reactions in a second single-arm study used to evaluate safety (n = 263) were upper respiratory tract infection, cough, pyrexia, and diarrhea. Other immune-mediated adverse reactions, occurring in 1%-5% of patients, included rash, pneumonitis, hepatitis, hyperthyroidism, and colitis. The most common serious adverse reactions, which were reported in 1%-3% of patients, were pneumonia, pleural effusion, pneumonitis, pyrexia, infusion-related reaction, and rash.

Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and has been previously approved to treat advanced renal cell carcinoma, lung cancer, and melanoma.

[email protected]

On Twitter @NikolaidesLaura

One of the most valuable things I learned in business school was how to be a better negotiator. Negotiation skills are helpful not only for job contracts, but also for many areas of life. Negotiating with your vendors, employees, health plans, and even spouse or children can be a fruitful experience. Indeed, using good negotiation techniques with your patients can help you optimize the best care with the best service whether in person or virtually.

The three principles I want you to understand are:

1. Negotiate on interests, not positions.

2. Frame or be framed.

3. Win/Win is not only possible; it is the most likely outcome of good negotiating.

Let’s use an example to illustrate each of these: If a patient comes to you asking for Vicodin (hydrocodone and acetaminophen) because you froze actinic keratoses, your first instinct might be to think this patient is a drug seeker and that he is not going to be satisfied unless you give in to his demand. You are a conscientious doctor and never prescribe narcotics for liquid nitrogen treatments. Here, you’ve just locked into a position, and there is no opportunity for negotiation. Instead, take a different approach – consider interests, not positions.

Positions are what you’ve decided. Interests, in contrast, are the reasons why you came to that decision. Think about both your interests and your patient’s interests. The patient wants something to block pain. You want to provide appropriate, safe care. In this instance, ask him why he wants Vicodin; probe about issues that might underlie his request. Keep asking until you feel you understand his interests. This is critical to good negotiation. Then think about your interests. You don’t want your patient to be in pain, and you don’t want to feed a patient’s dependency problem or risk your license for inappropriate drug dispensing.

Second, frame the problem (as you see it) or risk being framed by your patient. Your patient might see you as uncaring and unwilling to help him. You can change this by reframing yourself as the doctor who actually does care. For example, you might say, “I’m concerned about you. Taking Vicodin for this is not normal, and this drug is notorious for leading people into drug dependency. I don’t want to expose you to that risk.” Here, you have taken control of the frame and presented yourself as concerned rather than uncaring.

Third, in almost every negotiation there is an opportunity to expand the pie. That is, each party can offer something that was not in the original discussion but would benefit both. In this instance, you might offer to give the patient samples of a topical treatment for actinic keratoses. The patient, sensing your genuine concern, might offer to bring his mother to you for skin cancer treatment as she, too, is particularly sensitive to pain.

Of course, not all negotiations end in agreement. Sometimes your best option is to reject the request. If your patient is unwilling to compromise, then your best course of action might be to not treat him at all. Before doing so, remember that you will often have a better outcome if you try to reach agreement and that using sound negotiating practice will be a significant advantage. (Please, just don’t tell my wife about this column.)

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter. Write to him at [email protected].

One of the most valuable things I learned in business school was how to be a better negotiator. Negotiation skills are helpful not only for job contracts, but also for many areas of life. Negotiating with your vendors, employees, health plans, and even spouse or children can be a fruitful experience. Indeed, using good negotiation techniques with your patients can help you optimize the best care with the best service whether in person or virtually.

The three principles I want you to understand are:

1. Negotiate on interests, not positions.

2. Frame or be framed.

3. Win/Win is not only possible; it is the most likely outcome of good negotiating.

Let’s use an example to illustrate each of these: If a patient comes to you asking for Vicodin (hydrocodone and acetaminophen) because you froze actinic keratoses, your first instinct might be to think this patient is a drug seeker and that he is not going to be satisfied unless you give in to his demand. You are a conscientious doctor and never prescribe narcotics for liquid nitrogen treatments. Here, you’ve just locked into a position, and there is no opportunity for negotiation. Instead, take a different approach – consider interests, not positions.

Positions are what you’ve decided. Interests, in contrast, are the reasons why you came to that decision. Think about both your interests and your patient’s interests. The patient wants something to block pain. You want to provide appropriate, safe care. In this instance, ask him why he wants Vicodin; probe about issues that might underlie his request. Keep asking until you feel you understand his interests. This is critical to good negotiation. Then think about your interests. You don’t want your patient to be in pain, and you don’t want to feed a patient’s dependency problem or risk your license for inappropriate drug dispensing.

Second, frame the problem (as you see it) or risk being framed by your patient. Your patient might see you as uncaring and unwilling to help him. You can change this by reframing yourself as the doctor who actually does care. For example, you might say, “I’m concerned about you. Taking Vicodin for this is not normal, and this drug is notorious for leading people into drug dependency. I don’t want to expose you to that risk.” Here, you have taken control of the frame and presented yourself as concerned rather than uncaring.

Third, in almost every negotiation there is an opportunity to expand the pie. That is, each party can offer something that was not in the original discussion but would benefit both. In this instance, you might offer to give the patient samples of a topical treatment for actinic keratoses. The patient, sensing your genuine concern, might offer to bring his mother to you for skin cancer treatment as she, too, is particularly sensitive to pain.

Of course, not all negotiations end in agreement. Sometimes your best option is to reject the request. If your patient is unwilling to compromise, then your best course of action might be to not treat him at all. Before doing so, remember that you will often have a better outcome if you try to reach agreement and that using sound negotiating practice will be a significant advantage. (Please, just don’t tell my wife about this column.)

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter. Write to him at [email protected].

One of the most valuable things I learned in business school was how to be a better negotiator. Negotiation skills are helpful not only for job contracts, but also for many areas of life. Negotiating with your vendors, employees, health plans, and even spouse or children can be a fruitful experience. Indeed, using good negotiation techniques with your patients can help you optimize the best care with the best service whether in person or virtually.

The three principles I want you to understand are:

1. Negotiate on interests, not positions.

2. Frame or be framed.

3. Win/Win is not only possible; it is the most likely outcome of good negotiating.

Let’s use an example to illustrate each of these: If a patient comes to you asking for Vicodin (hydrocodone and acetaminophen) because you froze actinic keratoses, your first instinct might be to think this patient is a drug seeker and that he is not going to be satisfied unless you give in to his demand. You are a conscientious doctor and never prescribe narcotics for liquid nitrogen treatments. Here, you’ve just locked into a position, and there is no opportunity for negotiation. Instead, take a different approach – consider interests, not positions.

Positions are what you’ve decided. Interests, in contrast, are the reasons why you came to that decision. Think about both your interests and your patient’s interests. The patient wants something to block pain. You want to provide appropriate, safe care. In this instance, ask him why he wants Vicodin; probe about issues that might underlie his request. Keep asking until you feel you understand his interests. This is critical to good negotiation. Then think about your interests. You don’t want your patient to be in pain, and you don’t want to feed a patient’s dependency problem or risk your license for inappropriate drug dispensing.

Second, frame the problem (as you see it) or risk being framed by your patient. Your patient might see you as uncaring and unwilling to help him. You can change this by reframing yourself as the doctor who actually does care. For example, you might say, “I’m concerned about you. Taking Vicodin for this is not normal, and this drug is notorious for leading people into drug dependency. I don’t want to expose you to that risk.” Here, you have taken control of the frame and presented yourself as concerned rather than uncaring.

Third, in almost every negotiation there is an opportunity to expand the pie. That is, each party can offer something that was not in the original discussion but would benefit both. In this instance, you might offer to give the patient samples of a topical treatment for actinic keratoses. The patient, sensing your genuine concern, might offer to bring his mother to you for skin cancer treatment as she, too, is particularly sensitive to pain.

Of course, not all negotiations end in agreement. Sometimes your best option is to reject the request. If your patient is unwilling to compromise, then your best course of action might be to not treat him at all. Before doing so, remember that you will often have a better outcome if you try to reach agreement and that using sound negotiating practice will be a significant advantage. (Please, just don’t tell my wife about this column.)

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter. Write to him at [email protected].

WASHINGTON – A 1-week course of tamoxifen significantly reduced unscheduled bleeding in women using an etonogestrel contraceptive implant, compared with placebo.

The selective estrogen reuptake modifier cut bleeding days by half, compared with placebo, and in some women induced at least 1 month of amenorrhea, Dr. Katharine Simmons said at the annual meeting of the American College of Obstetricians and Gynecologists.

There were no real downsides to using the drug, added Dr. Simmons, an ob.gyn. in Atlanta. There were no significant differences in adverse events between the two treatment groups.

The 6-month study randomized 56 women to 10 mg tamoxifen twice daily or placebo for 7 days. Women were instructed to begin treatment on the third day of any period of unscheduled bleeding. They could use the drug once each month, for up to three cycles during the study period. Every day, the women had to complete a short bleeding diary. This was administered by a daily text message, which asked them to rate the strength of any bleeding over the last 24 hours, and whether or not they had taken the study drug on that day.

The women were young (mean age 25 years), and most were white (about 80%). More than 60% were nulliparous. They had been using the implant for a mean of 275 days. Upon randomization, those in the tamoxifen group reported more unscheduled bleeding days than did those in the placebo group (mean 23 vs. 20 per 30 days). Ten women in the tamoxifen group reported bleeding almost every day of the prior month.

Thirty days after taking the study drug, bleeding days were significantly reduced in the tamoxifen group, compared with the placebo group. Four of 28 women taking the drug experienced complete amenorrhea; 9 reported 5 days of bleeding. The tamoxifen group reported a median of 6 bleeding days after treatment, compared with 12 days in the placebo group.

The effect was sustained, Dr. Simmons said, with a median of 30 days before bleeding resumed in the tamoxifen group, compared with 8 days in the placebo group. Women taking the drug reported significantly greater levels of satisfaction than did those taking placebo. They also were less likely to discontinue the treatment (18% vs. 36%).

There were no significant differences in side effects. Headache was the most common, with 12 women in each group reporting it. Mood changes occurred in 7 taking tamoxifen and in 12 women taking placebo. Hot flashes were slightly more common in the tamoxifen group (6 vs. 4). Reports of nausea, weight gain, and fluid retention were similar.

Dr. Simmons conducted the study during her time at Oregon Health & Science University in Portland. She had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

WASHINGTON – A 1-week course of tamoxifen significantly reduced unscheduled bleeding in women using an etonogestrel contraceptive implant, compared with placebo.

The selective estrogen reuptake modifier cut bleeding days by half, compared with placebo, and in some women induced at least 1 month of amenorrhea, Dr. Katharine Simmons said at the annual meeting of the American College of Obstetricians and Gynecologists.

There were no real downsides to using the drug, added Dr. Simmons, an ob.gyn. in Atlanta. There were no significant differences in adverse events between the two treatment groups.

The 6-month study randomized 56 women to 10 mg tamoxifen twice daily or placebo for 7 days. Women were instructed to begin treatment on the third day of any period of unscheduled bleeding. They could use the drug once each month, for up to three cycles during the study period. Every day, the women had to complete a short bleeding diary. This was administered by a daily text message, which asked them to rate the strength of any bleeding over the last 24 hours, and whether or not they had taken the study drug on that day.

The women were young (mean age 25 years), and most were white (about 80%). More than 60% were nulliparous. They had been using the implant for a mean of 275 days. Upon randomization, those in the tamoxifen group reported more unscheduled bleeding days than did those in the placebo group (mean 23 vs. 20 per 30 days). Ten women in the tamoxifen group reported bleeding almost every day of the prior month.

Thirty days after taking the study drug, bleeding days were significantly reduced in the tamoxifen group, compared with the placebo group. Four of 28 women taking the drug experienced complete amenorrhea; 9 reported 5 days of bleeding. The tamoxifen group reported a median of 6 bleeding days after treatment, compared with 12 days in the placebo group.

The effect was sustained, Dr. Simmons said, with a median of 30 days before bleeding resumed in the tamoxifen group, compared with 8 days in the placebo group. Women taking the drug reported significantly greater levels of satisfaction than did those taking placebo. They also were less likely to discontinue the treatment (18% vs. 36%).

There were no significant differences in side effects. Headache was the most common, with 12 women in each group reporting it. Mood changes occurred in 7 taking tamoxifen and in 12 women taking placebo. Hot flashes were slightly more common in the tamoxifen group (6 vs. 4). Reports of nausea, weight gain, and fluid retention were similar.

Dr. Simmons conducted the study during her time at Oregon Health & Science University in Portland. She had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

WASHINGTON – A 1-week course of tamoxifen significantly reduced unscheduled bleeding in women using an etonogestrel contraceptive implant, compared with placebo.

The selective estrogen reuptake modifier cut bleeding days by half, compared with placebo, and in some women induced at least 1 month of amenorrhea, Dr. Katharine Simmons said at the annual meeting of the American College of Obstetricians and Gynecologists.

There were no real downsides to using the drug, added Dr. Simmons, an ob.gyn. in Atlanta. There were no significant differences in adverse events between the two treatment groups.

The 6-month study randomized 56 women to 10 mg tamoxifen twice daily or placebo for 7 days. Women were instructed to begin treatment on the third day of any period of unscheduled bleeding. They could use the drug once each month, for up to three cycles during the study period. Every day, the women had to complete a short bleeding diary. This was administered by a daily text message, which asked them to rate the strength of any bleeding over the last 24 hours, and whether or not they had taken the study drug on that day.

The women were young (mean age 25 years), and most were white (about 80%). More than 60% were nulliparous. They had been using the implant for a mean of 275 days. Upon randomization, those in the tamoxifen group reported more unscheduled bleeding days than did those in the placebo group (mean 23 vs. 20 per 30 days). Ten women in the tamoxifen group reported bleeding almost every day of the prior month.

Thirty days after taking the study drug, bleeding days were significantly reduced in the tamoxifen group, compared with the placebo group. Four of 28 women taking the drug experienced complete amenorrhea; 9 reported 5 days of bleeding. The tamoxifen group reported a median of 6 bleeding days after treatment, compared with 12 days in the placebo group.

The effect was sustained, Dr. Simmons said, with a median of 30 days before bleeding resumed in the tamoxifen group, compared with 8 days in the placebo group. Women taking the drug reported significantly greater levels of satisfaction than did those taking placebo. They also were less likely to discontinue the treatment (18% vs. 36%).

There were no significant differences in side effects. Headache was the most common, with 12 women in each group reporting it. Mood changes occurred in 7 taking tamoxifen and in 12 women taking placebo. Hot flashes were slightly more common in the tamoxifen group (6 vs. 4). Reports of nausea, weight gain, and fluid retention were similar.

Dr. Simmons conducted the study during her time at Oregon Health & Science University in Portland. She had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

George Smith (DOB 2/12/51) is a 65-year-old male patient with a history of hypertension and hyperlipidemia who presents to his local emergency department complaining of worsening dyspnea. He has been suffering with a “chest cold” for the past week, and has also noticed a gradual increase in chest discomfort. The patient is unsure if this is related to exertion or due to his nonproductive cough, but describes the sensation as a “tightness that seems to be getting worse.” The emergency physician is appropriately concerned about a cardiac cause for his symptoms, but is reassured after a check of his electronic health record reveals a recent nuclear treadmill stress test showing normal myocardial perfusion and excellent exercise tolerance, with a low probability of coronary disease.

The only problem is that George Smith never had a stress test. In fact, it’s his twin brother James Smith – also with a birth date of 2/12/51 and a home in the same city – who just had the study done in preparation for surgery. The mix-up in the records began 3 weeks ago, when a tech in the cardiac testing department made an error registering James for his stress test, and now the results of his study have filed into the chart of his twin brother. Fortunately for George, the primary care physician who cares for both brothers happens to be in the emergency department seeing a different patient. He is “curbsided” by the ED doc and recognizes the identification error before the patient is to be discharged home.

This alarming situation – a fictionalized version of a story that happens regularly in hospitals all across the United States – highlights several serious problems with electronic health records. With all of their claimed advantages, EHRs have created a tremendous number of new complications. Some are obvious, such as increased documentation time, connectivity issues, hardware failures, and superfluous “overdocumentation.” But the more troubling issues with electronic records are the ones that are much subtler. Specifically, as the case above highlights, there is the tendency to “lose the forest in the trees” of the EHR, and actually make mistakes that can have devastating consequences. This month we want to cast a light on how electronic tools designed to improve quality and safety actually can compromise them, beginning with the unfortunate reality that …

Modern conveniences can make errors more convenient as well

One of the great advantages of a well-designed electronic record is the ease of locating information when you need it; by entering a few pieces of information such as a last name and date of birth, we can find the needed data in seconds. Unfortunately, this simple and elegant system has exposed a weakness in the people using it: confirmation bias – the idea that we all tend to see what we want to see. This is an adaptive behavior that we all develop to improve efficiency and successfully navigate all of the conscious and subconscious decisions we make throughout the day. Typically, confirmation bias serves to make our lives easier, but in the case above, it didn’t help Mr. Smith; on the contrary, it almost led to disastrous consequences. The error was fortunately recognized by his astute primary care physician, but this case could have ended much differently. The experience should serve as a reminder to us that …

We can easily lose the big picture

The days of hunting for missing patient charts are thankfully long gone, but there are a few critical aspects of paper records that have been lost in the translation to electronic form. One such missing piece was noted by a colleague when first transitioning to an EHR. After a day or two of struggling with the new software, he lamented “I’m missing the big picture!” He had lost the advantage of glancing at a paper chart and instantly recalling the details about his patients that he had compiled over many years of care. For many physicians like him, this may mean reviewing handwritten notes or jottings in the margin of the chart, but sometimes just the appearance of the chart itself is enough to trigger an intellectual or emotional response.

This notion simply doesn’t exist in the world of electronic “charts,” which are all uniform by design. In the quest to simplify workflow and encourage muscle memory, EHR designers have eschewed the intangible experience of holding a yellowing, dog-eared, overflowing patient folder. Instead, physicians now find themselves holding the same PC or tablet as they walk into every patient encounter, left with only a name and date of birth to distinguish one patient from the next. Even worse, the mere definition of a patient chart has moved from a physical construct to a metaphysical one. Charts can be anywhere and everywhere, and can be edited by any end user at virtually any point of care. This opens up almost limitless opportunities for error, and unfortunately …

Errors can last a lifetime

With each episode of care, the charts of the two Mr. Smiths could become more enmeshed, and the histories harder to untangle. (In this case, a passing reference to the stress test results in the ED intern’s history and physical of George Smith may perpetuate the mistake, even though the error has been caught this time.) When mistakes like this are identified, hundreds of collective staff hours can be required to unweave comingled medical records, even when they don’t result in patient harm. It is therefore critical to develop safeguards to prevent them from occurring in the first place, with efforts that include training programs, workflow process improvement, and technology enhancement.

Ultimately, it may be impossible to prevent all documentation errors. However, by focusing on the big picture and considering patient safety first, we can raise awareness of these and other critical issues and develop the tools and training necessary to make mistakes possible to avoid.

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is also a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital and professor of family and community medicine at Temple University, Philadelphia.

George Smith (DOB 2/12/51) is a 65-year-old male patient with a history of hypertension and hyperlipidemia who presents to his local emergency department complaining of worsening dyspnea. He has been suffering with a “chest cold” for the past week, and has also noticed a gradual increase in chest discomfort. The patient is unsure if this is related to exertion or due to his nonproductive cough, but describes the sensation as a “tightness that seems to be getting worse.” The emergency physician is appropriately concerned about a cardiac cause for his symptoms, but is reassured after a check of his electronic health record reveals a recent nuclear treadmill stress test showing normal myocardial perfusion and excellent exercise tolerance, with a low probability of coronary disease.

The only problem is that George Smith never had a stress test. In fact, it’s his twin brother James Smith – also with a birth date of 2/12/51 and a home in the same city – who just had the study done in preparation for surgery. The mix-up in the records began 3 weeks ago, when a tech in the cardiac testing department made an error registering James for his stress test, and now the results of his study have filed into the chart of his twin brother. Fortunately for George, the primary care physician who cares for both brothers happens to be in the emergency department seeing a different patient. He is “curbsided” by the ED doc and recognizes the identification error before the patient is to be discharged home.

This alarming situation – a fictionalized version of a story that happens regularly in hospitals all across the United States – highlights several serious problems with electronic health records. With all of their claimed advantages, EHRs have created a tremendous number of new complications. Some are obvious, such as increased documentation time, connectivity issues, hardware failures, and superfluous “overdocumentation.” But the more troubling issues with electronic records are the ones that are much subtler. Specifically, as the case above highlights, there is the tendency to “lose the forest in the trees” of the EHR, and actually make mistakes that can have devastating consequences. This month we want to cast a light on how electronic tools designed to improve quality and safety actually can compromise them, beginning with the unfortunate reality that …

Modern conveniences can make errors more convenient as well

One of the great advantages of a well-designed electronic record is the ease of locating information when you need it; by entering a few pieces of information such as a last name and date of birth, we can find the needed data in seconds. Unfortunately, this simple and elegant system has exposed a weakness in the people using it: confirmation bias – the idea that we all tend to see what we want to see. This is an adaptive behavior that we all develop to improve efficiency and successfully navigate all of the conscious and subconscious decisions we make throughout the day. Typically, confirmation bias serves to make our lives easier, but in the case above, it didn’t help Mr. Smith; on the contrary, it almost led to disastrous consequences. The error was fortunately recognized by his astute primary care physician, but this case could have ended much differently. The experience should serve as a reminder to us that …

We can easily lose the big picture

The days of hunting for missing patient charts are thankfully long gone, but there are a few critical aspects of paper records that have been lost in the translation to electronic form. One such missing piece was noted by a colleague when first transitioning to an EHR. After a day or two of struggling with the new software, he lamented “I’m missing the big picture!” He had lost the advantage of glancing at a paper chart and instantly recalling the details about his patients that he had compiled over many years of care. For many physicians like him, this may mean reviewing handwritten notes or jottings in the margin of the chart, but sometimes just the appearance of the chart itself is enough to trigger an intellectual or emotional response.

This notion simply doesn’t exist in the world of electronic “charts,” which are all uniform by design. In the quest to simplify workflow and encourage muscle memory, EHR designers have eschewed the intangible experience of holding a yellowing, dog-eared, overflowing patient folder. Instead, physicians now find themselves holding the same PC or tablet as they walk into every patient encounter, left with only a name and date of birth to distinguish one patient from the next. Even worse, the mere definition of a patient chart has moved from a physical construct to a metaphysical one. Charts can be anywhere and everywhere, and can be edited by any end user at virtually any point of care. This opens up almost limitless opportunities for error, and unfortunately …

Errors can last a lifetime

With each episode of care, the charts of the two Mr. Smiths could become more enmeshed, and the histories harder to untangle. (In this case, a passing reference to the stress test results in the ED intern’s history and physical of George Smith may perpetuate the mistake, even though the error has been caught this time.) When mistakes like this are identified, hundreds of collective staff hours can be required to unweave comingled medical records, even when they don’t result in patient harm. It is therefore critical to develop safeguards to prevent them from occurring in the first place, with efforts that include training programs, workflow process improvement, and technology enhancement.

Ultimately, it may be impossible to prevent all documentation errors. However, by focusing on the big picture and considering patient safety first, we can raise awareness of these and other critical issues and develop the tools and training necessary to make mistakes possible to avoid.

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is also a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital and professor of family and community medicine at Temple University, Philadelphia.

George Smith (DOB 2/12/51) is a 65-year-old male patient with a history of hypertension and hyperlipidemia who presents to his local emergency department complaining of worsening dyspnea. He has been suffering with a “chest cold” for the past week, and has also noticed a gradual increase in chest discomfort. The patient is unsure if this is related to exertion or due to his nonproductive cough, but describes the sensation as a “tightness that seems to be getting worse.” The emergency physician is appropriately concerned about a cardiac cause for his symptoms, but is reassured after a check of his electronic health record reveals a recent nuclear treadmill stress test showing normal myocardial perfusion and excellent exercise tolerance, with a low probability of coronary disease.

The only problem is that George Smith never had a stress test. In fact, it’s his twin brother James Smith – also with a birth date of 2/12/51 and a home in the same city – who just had the study done in preparation for surgery. The mix-up in the records began 3 weeks ago, when a tech in the cardiac testing department made an error registering James for his stress test, and now the results of his study have filed into the chart of his twin brother. Fortunately for George, the primary care physician who cares for both brothers happens to be in the emergency department seeing a different patient. He is “curbsided” by the ED doc and recognizes the identification error before the patient is to be discharged home.

This alarming situation – a fictionalized version of a story that happens regularly in hospitals all across the United States – highlights several serious problems with electronic health records. With all of their claimed advantages, EHRs have created a tremendous number of new complications. Some are obvious, such as increased documentation time, connectivity issues, hardware failures, and superfluous “overdocumentation.” But the more troubling issues with electronic records are the ones that are much subtler. Specifically, as the case above highlights, there is the tendency to “lose the forest in the trees” of the EHR, and actually make mistakes that can have devastating consequences. This month we want to cast a light on how electronic tools designed to improve quality and safety actually can compromise them, beginning with the unfortunate reality that …

Modern conveniences can make errors more convenient as well

One of the great advantages of a well-designed electronic record is the ease of locating information when you need it; by entering a few pieces of information such as a last name and date of birth, we can find the needed data in seconds. Unfortunately, this simple and elegant system has exposed a weakness in the people using it: confirmation bias – the idea that we all tend to see what we want to see. This is an adaptive behavior that we all develop to improve efficiency and successfully navigate all of the conscious and subconscious decisions we make throughout the day. Typically, confirmation bias serves to make our lives easier, but in the case above, it didn’t help Mr. Smith; on the contrary, it almost led to disastrous consequences. The error was fortunately recognized by his astute primary care physician, but this case could have ended much differently. The experience should serve as a reminder to us that …

We can easily lose the big picture

The days of hunting for missing patient charts are thankfully long gone, but there are a few critical aspects of paper records that have been lost in the translation to electronic form. One such missing piece was noted by a colleague when first transitioning to an EHR. After a day or two of struggling with the new software, he lamented “I’m missing the big picture!” He had lost the advantage of glancing at a paper chart and instantly recalling the details about his patients that he had compiled over many years of care. For many physicians like him, this may mean reviewing handwritten notes or jottings in the margin of the chart, but sometimes just the appearance of the chart itself is enough to trigger an intellectual or emotional response.

This notion simply doesn’t exist in the world of electronic “charts,” which are all uniform by design. In the quest to simplify workflow and encourage muscle memory, EHR designers have eschewed the intangible experience of holding a yellowing, dog-eared, overflowing patient folder. Instead, physicians now find themselves holding the same PC or tablet as they walk into every patient encounter, left with only a name and date of birth to distinguish one patient from the next. Even worse, the mere definition of a patient chart has moved from a physical construct to a metaphysical one. Charts can be anywhere and everywhere, and can be edited by any end user at virtually any point of care. This opens up almost limitless opportunities for error, and unfortunately …

Errors can last a lifetime

With each episode of care, the charts of the two Mr. Smiths could become more enmeshed, and the histories harder to untangle. (In this case, a passing reference to the stress test results in the ED intern’s history and physical of George Smith may perpetuate the mistake, even though the error has been caught this time.) When mistakes like this are identified, hundreds of collective staff hours can be required to unweave comingled medical records, even when they don’t result in patient harm. It is therefore critical to develop safeguards to prevent them from occurring in the first place, with efforts that include training programs, workflow process improvement, and technology enhancement.

Ultimately, it may be impossible to prevent all documentation errors. However, by focusing on the big picture and considering patient safety first, we can raise awareness of these and other critical issues and develop the tools and training necessary to make mistakes possible to avoid.

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is also a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital and professor of family and community medicine at Temple University, Philadelphia.

The recent reclassification of encapsulated follicular variant of papillary thyroid carcinoma (EFVPTC) as noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) – an action taken to better reflect the very low risk of adverse events associated with these tumors – has important clinical and psychological implications for patients.

“Even though physicians know that most thyroid cancers have an excellent prognosis, the impact on a patient of being given a diagnosis of cancer should not be underestimated,” Dr. Peter Angelos, professor of surgery and chief of endocrine surgery at the University of Chicago, said in an interview. “It is, however, critical for doctors and patients to understand that this change from ‘thyroid cancer’ to a ‘benign thyroid nodule,’ is not something that can be determined prior to surgery. Patients will still need thyroid operations to determine if their indeterminate nodules have cancer in them or not.”

The change in nomenclature followed an international, multidisciplinary, retrospective study of patients with thyroid nodules diagnosed as EFVPTC. Such patients are usually treated as having conventional thyroid cancer. The study included 109 patients with noninvasive EFVPTC who were followed for 10-26 years, and 101 with invasive EFVPTC who were followed for 1-18 years. At median follow-up of 13 years, all of the 109 patients with noninvasive EFVPTC were alive, and based on consensus diagnostic criteria developed by an Endocrine Pathology Society working group – a multinational panel of 24 thyroid pathologists – they had no evidence of disease, reported Dr. Yuri E. Nikiforov of the University of Pittsburgh and colleagues (JAMA Oncol. 2016 April 14. doi: 10.1001/jamaoncol.2016.0386).

Most of those patients (67%) were treated only with lobectomy, and none received radioiodine (RAI) treatment.

Of the 101 with invasive EFVPTC, 12 experienced an adverse event, including 5 who developed distant (lung and/or bone) metastases. Two died from the disease, one had a lymph node recurrence, one had persistent disease, and five had detectable serum thyroglobulin and were considered to have indeterminate or biochemically incomplete response to therapy, the investigators said.

Based on the findings in the noninvasive EFVPTC patients, the recommended nomenclature change was adopted to reflect the main morphological features of, and lack of invasion of, the benign tumors as well as their very low risk of adverse outcome. To assist in the diagnosis of NIFTP in routine pathology practice, a simplified three-point diagnostic nuclear scoring scheme based on the six main consensus nuclear features of the tumors was developed and validated; the scoring scheme yielded sensitivity of 98.6%, specificity of 90.1%, and overall classification accuracy of 94.3% for NIFTP.

The study involved a review of digitized histologic slides collected at 13 sites in 5 countries. The pathologists who composed the working group conducted the review and consulted in a series of teleconferences and face-to-face meetings to establish the consensus criteria. They measured the frequency of adverse outcomes, including death from disease, distant or locoregional metastases, and structural or biochemical recurrence.

The findings suggest that “clinical management of patients with NIFTP can be deescalated because they are unlikely to benefit from immediate completion thyroidectomy and RAI therapy,” the investigators said.

“Staging would be unnecessary. In addition to eliminating the psychological impact of the diagnosis of cancer, this would reduce complications of total thyroidectomy, risk of secondary tumors following RAI therapy, and the overall cost of health care. Avoidance of RAI treatment alone would save between $5,000 and $8,500 per patient (based on U.S. cost),” they wrote, adding that an estimated 45,000 patients worldwide each year will be affected by this reclassification, resulting in significant reduction in “psychological burden, medical overtreatment and expense, and other clinical consequences associated with a cancer diagnosis.”

Dr. Martha A. Zeiger, professor of surgery at Johns Hopkins University, Baltimore, agreed that the change has important implications for patients.

“With the advent of new nomenclature for encapsulated follicular variant of papillary thyroid cancer, namely that it is now considered a benign tumor, thousands of patients who have carried this original diagnosis of cancer can breathe a sigh of relief. Our new understanding will also decrease the number of patients undergoing more extensive surgery and many can now be treated with a thyroid lobectomy only,” she said in an interview.

One thing the new nomenclature doesn’t do, however, is solve the problem of the suspicious or indeterminate thyroid fine needle aspiration diagnosis, she noted.

“Clouding the landscape even further is the fact that many of our commonly used molecular diagnostics were based on studies in which encapsulated follicular variant of papillary thyroid cancer was considered malignant, and were included in the analysis. Because of this, diagnostic molecular tools will likely now require a renewed scrutiny as to their true efficacy in differentiating benign from malignant tumors,” she said.

Dr. Nikiforov is a consultant for Quest Diagnostics. A coauthor, Dr. Sylvia Asa, is a member of the medical advisory board of Leica Aperio, and another coauthor, Dr. Virginia LiVolsi, is a consultant for Veracyte Inc. The project used a facility supported by the National Cancer Institute, and molecular analysis was supported in part by funds from the University of Pittsburgh Cancer Institute and the University of Pittsburgh Medical Center. The Endocrine Pathology Society working group conference was supported by a grant from CBLPath Inc. Dr. Angelos and Dr. Zeiger reported having no disclosures.

[email protected]

The recent reclassification of encapsulated follicular variant of papillary thyroid carcinoma (EFVPTC) as noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) – an action taken to better reflect the very low risk of adverse events associated with these tumors – has important clinical and psychological implications for patients.

“Even though physicians know that most thyroid cancers have an excellent prognosis, the impact on a patient of being given a diagnosis of cancer should not be underestimated,” Dr. Peter Angelos, professor of surgery and chief of endocrine surgery at the University of Chicago, said in an interview. “It is, however, critical for doctors and patients to understand that this change from ‘thyroid cancer’ to a ‘benign thyroid nodule,’ is not something that can be determined prior to surgery. Patients will still need thyroid operations to determine if their indeterminate nodules have cancer in them or not.”

The change in nomenclature followed an international, multidisciplinary, retrospective study of patients with thyroid nodules diagnosed as EFVPTC. Such patients are usually treated as having conventional thyroid cancer. The study included 109 patients with noninvasive EFVPTC who were followed for 10-26 years, and 101 with invasive EFVPTC who were followed for 1-18 years. At median follow-up of 13 years, all of the 109 patients with noninvasive EFVPTC were alive, and based on consensus diagnostic criteria developed by an Endocrine Pathology Society working group – a multinational panel of 24 thyroid pathologists – they had no evidence of disease, reported Dr. Yuri E. Nikiforov of the University of Pittsburgh and colleagues (JAMA Oncol. 2016 April 14. doi: 10.1001/jamaoncol.2016.0386).

Most of those patients (67%) were treated only with lobectomy, and none received radioiodine (RAI) treatment.

Of the 101 with invasive EFVPTC, 12 experienced an adverse event, including 5 who developed distant (lung and/or bone) metastases. Two died from the disease, one had a lymph node recurrence, one had persistent disease, and five had detectable serum thyroglobulin and were considered to have indeterminate or biochemically incomplete response to therapy, the investigators said.

Based on the findings in the noninvasive EFVPTC patients, the recommended nomenclature change was adopted to reflect the main morphological features of, and lack of invasion of, the benign tumors as well as their very low risk of adverse outcome. To assist in the diagnosis of NIFTP in routine pathology practice, a simplified three-point diagnostic nuclear scoring scheme based on the six main consensus nuclear features of the tumors was developed and validated; the scoring scheme yielded sensitivity of 98.6%, specificity of 90.1%, and overall classification accuracy of 94.3% for NIFTP.

The study involved a review of digitized histologic slides collected at 13 sites in 5 countries. The pathologists who composed the working group conducted the review and consulted in a series of teleconferences and face-to-face meetings to establish the consensus criteria. They measured the frequency of adverse outcomes, including death from disease, distant or locoregional metastases, and structural or biochemical recurrence.

The findings suggest that “clinical management of patients with NIFTP can be deescalated because they are unlikely to benefit from immediate completion thyroidectomy and RAI therapy,” the investigators said.

“Staging would be unnecessary. In addition to eliminating the psychological impact of the diagnosis of cancer, this would reduce complications of total thyroidectomy, risk of secondary tumors following RAI therapy, and the overall cost of health care. Avoidance of RAI treatment alone would save between $5,000 and $8,500 per patient (based on U.S. cost),” they wrote, adding that an estimated 45,000 patients worldwide each year will be affected by this reclassification, resulting in significant reduction in “psychological burden, medical overtreatment and expense, and other clinical consequences associated with a cancer diagnosis.”

Dr. Martha A. Zeiger, professor of surgery at Johns Hopkins University, Baltimore, agreed that the change has important implications for patients.

“With the advent of new nomenclature for encapsulated follicular variant of papillary thyroid cancer, namely that it is now considered a benign tumor, thousands of patients who have carried this original diagnosis of cancer can breathe a sigh of relief. Our new understanding will also decrease the number of patients undergoing more extensive surgery and many can now be treated with a thyroid lobectomy only,” she said in an interview.

One thing the new nomenclature doesn’t do, however, is solve the problem of the suspicious or indeterminate thyroid fine needle aspiration diagnosis, she noted.

“Clouding the landscape even further is the fact that many of our commonly used molecular diagnostics were based on studies in which encapsulated follicular variant of papillary thyroid cancer was considered malignant, and were included in the analysis. Because of this, diagnostic molecular tools will likely now require a renewed scrutiny as to their true efficacy in differentiating benign from malignant tumors,” she said.

Dr. Nikiforov is a consultant for Quest Diagnostics. A coauthor, Dr. Sylvia Asa, is a member of the medical advisory board of Leica Aperio, and another coauthor, Dr. Virginia LiVolsi, is a consultant for Veracyte Inc. The project used a facility supported by the National Cancer Institute, and molecular analysis was supported in part by funds from the University of Pittsburgh Cancer Institute and the University of Pittsburgh Medical Center. The Endocrine Pathology Society working group conference was supported by a grant from CBLPath Inc. Dr. Angelos and Dr. Zeiger reported having no disclosures.

[email protected]

The recent reclassification of encapsulated follicular variant of papillary thyroid carcinoma (EFVPTC) as noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) – an action taken to better reflect the very low risk of adverse events associated with these tumors – has important clinical and psychological implications for patients.

“Even though physicians know that most thyroid cancers have an excellent prognosis, the impact on a patient of being given a diagnosis of cancer should not be underestimated,” Dr. Peter Angelos, professor of surgery and chief of endocrine surgery at the University of Chicago, said in an interview. “It is, however, critical for doctors and patients to understand that this change from ‘thyroid cancer’ to a ‘benign thyroid nodule,’ is not something that can be determined prior to surgery. Patients will still need thyroid operations to determine if their indeterminate nodules have cancer in them or not.”

The change in nomenclature followed an international, multidisciplinary, retrospective study of patients with thyroid nodules diagnosed as EFVPTC. Such patients are usually treated as having conventional thyroid cancer. The study included 109 patients with noninvasive EFVPTC who were followed for 10-26 years, and 101 with invasive EFVPTC who were followed for 1-18 years. At median follow-up of 13 years, all of the 109 patients with noninvasive EFVPTC were alive, and based on consensus diagnostic criteria developed by an Endocrine Pathology Society working group – a multinational panel of 24 thyroid pathologists – they had no evidence of disease, reported Dr. Yuri E. Nikiforov of the University of Pittsburgh and colleagues (JAMA Oncol. 2016 April 14. doi: 10.1001/jamaoncol.2016.0386).

Most of those patients (67%) were treated only with lobectomy, and none received radioiodine (RAI) treatment.

Of the 101 with invasive EFVPTC, 12 experienced an adverse event, including 5 who developed distant (lung and/or bone) metastases. Two died from the disease, one had a lymph node recurrence, one had persistent disease, and five had detectable serum thyroglobulin and were considered to have indeterminate or biochemically incomplete response to therapy, the investigators said.

Based on the findings in the noninvasive EFVPTC patients, the recommended nomenclature change was adopted to reflect the main morphological features of, and lack of invasion of, the benign tumors as well as their very low risk of adverse outcome. To assist in the diagnosis of NIFTP in routine pathology practice, a simplified three-point diagnostic nuclear scoring scheme based on the six main consensus nuclear features of the tumors was developed and validated; the scoring scheme yielded sensitivity of 98.6%, specificity of 90.1%, and overall classification accuracy of 94.3% for NIFTP.

The study involved a review of digitized histologic slides collected at 13 sites in 5 countries. The pathologists who composed the working group conducted the review and consulted in a series of teleconferences and face-to-face meetings to establish the consensus criteria. They measured the frequency of adverse outcomes, including death from disease, distant or locoregional metastases, and structural or biochemical recurrence.

The findings suggest that “clinical management of patients with NIFTP can be deescalated because they are unlikely to benefit from immediate completion thyroidectomy and RAI therapy,” the investigators said.

“Staging would be unnecessary. In addition to eliminating the psychological impact of the diagnosis of cancer, this would reduce complications of total thyroidectomy, risk of secondary tumors following RAI therapy, and the overall cost of health care. Avoidance of RAI treatment alone would save between $5,000 and $8,500 per patient (based on U.S. cost),” they wrote, adding that an estimated 45,000 patients worldwide each year will be affected by this reclassification, resulting in significant reduction in “psychological burden, medical overtreatment and expense, and other clinical consequences associated with a cancer diagnosis.”

Dr. Martha A. Zeiger, professor of surgery at Johns Hopkins University, Baltimore, agreed that the change has important implications for patients.

“With the advent of new nomenclature for encapsulated follicular variant of papillary thyroid cancer, namely that it is now considered a benign tumor, thousands of patients who have carried this original diagnosis of cancer can breathe a sigh of relief. Our new understanding will also decrease the number of patients undergoing more extensive surgery and many can now be treated with a thyroid lobectomy only,” she said in an interview.

One thing the new nomenclature doesn’t do, however, is solve the problem of the suspicious or indeterminate thyroid fine needle aspiration diagnosis, she noted.

“Clouding the landscape even further is the fact that many of our commonly used molecular diagnostics were based on studies in which encapsulated follicular variant of papillary thyroid cancer was considered malignant, and were included in the analysis. Because of this, diagnostic molecular tools will likely now require a renewed scrutiny as to their true efficacy in differentiating benign from malignant tumors,” she said.

Dr. Nikiforov is a consultant for Quest Diagnostics. A coauthor, Dr. Sylvia Asa, is a member of the medical advisory board of Leica Aperio, and another coauthor, Dr. Virginia LiVolsi, is a consultant for Veracyte Inc. The project used a facility supported by the National Cancer Institute, and molecular analysis was supported in part by funds from the University of Pittsburgh Cancer Institute and the University of Pittsburgh Medical Center. The Endocrine Pathology Society working group conference was supported by a grant from CBLPath Inc. Dr. Angelos and Dr. Zeiger reported having no disclosures.

[email protected]

The measure of a country’s greatness, Mahatma Gandhi said, should be based on how well it cares for its most vulnerable. Recently, I had the opportunity to work with members of a vulnerable population: men and women who have a mental illness and languish in jails and prisons around the country. My experience was eye-opening and heartbreaking.

Widespread incarceration of the mentally ill in a developed country such as the United States should be a national embarrassment. But this tragedy, which has reached an epidemic level, has been effectively shut out of the national conversation.

The problem has grown, and is enormous
By the estimate of the U.S. Department of Justice, more than one-half of people incarcerated in the United States are mentally ill and approximately 20% suffer from a serious mental illness.^1,2 In fact, there are now 3 times as many mentally ill people in jail and prison as there are occupying psychiatric beds in hospitals.³ These numbers represent a considerable increase over the past 6 decades, and can be attributed to 2 major factors:

• A program of deinstitutionalization set in motion by the federal government in the 1950s called for shuttering of state psychiatric facilities around the country. This was a period of renewed national discourse on civil rights; for many people, the practice of institutionalization was considered a violation of civil rights. (Coincidentally, chlorpromazine was introduced about this time, and many experts believed that the drug would revolutionize outpatient management of psychiatric disorders.)
• More recently, heavy criminal penalties have been attached to convictions for possession and distribution of illegal substances—part of the government’s “war on drugs.”

As a consequence of these programs and policies, the United States has come full circle—routinely incarcerating the mentally ill as it did in the early 19th century, before reforms were initiated in response to the lobbying efforts of activist Dorothea Dix and her contemporaries.

My distressing, eye-opening experience
The time I spent with the incarcerated mentally ill was limited to a 6-month period at a county jail during residency. Yet the contrast between services provided to this population and those that are available to people in the community was immediately evident—and stark. The sheer number of adults in jails and prisons who require mental health care is such that the ratio of patients to psychiatrists, psychologists, and other mental health clinicians is shockingly skewed.

It does not take years of experience to figure out that a brief interview with an 18-year-old who is being jailed for the first time, has never seen a psychiatrist, and suffers panic attacks (or hallucinations, or suicidal thoughts) is a less-than-ideal clinical situation. Making that situation even more hazardous is that inmates have a high risk of suicide, particularly in the first 24 to 48 hours of incarceration.⁴

Other ethical issues arose during my stint in the correctional system: My patients frequently would be charged with prison-rule violations (there is evidence that mentally ill inmates are more likely to be charged with such violations²); on many such occasions, they would be placed in solitary confinement (“the hole”), a practice the United Nations has called “cruel, inhuman, and degrading: for the mentally ill⁵ and that, in turn, exacerbates the inmate’s psychiatric illness.^6-11

Last, there are restrictions on the types of formulations of medications that can be prescribed, involuntary treatment, and other critical aspects of care that make the experience of providing care in this system frustrating for mental health providers.

Are there solutions?
One way to tackle this crisis might be to insert more psychiatrists and psychologists into the correctional system. A more sensible approach, however, would be to tackle the root cause and divert the mentally ill away from incarceration and into treatment—moving from a model of retribution and incapacitation to one of rehabilitation. For example:

• Several counties nationwide have adopted diversion programs that include so-called mental health courts and drug courts, with encouraging results¹²
• Police departments are establishing Crisis Intervention Teams
• Assisted outpatient treatment programs are growing in popularity.

Far more needs to be done, however. In the absence of a national debate on the problem of the incarcerated mentally ill, there is real risk that this population will continue to be ignored and that our mental health care infrastructure will remain inadequate for meeting their need for services.

The measure of a country’s greatness, Mahatma Gandhi said, should be based on how well it cares for its most vulnerable. Recently, I had the opportunity to work with members of a vulnerable population: men and women who have a mental illness and languish in jails and prisons around the country. My experience was eye-opening and heartbreaking.

Widespread incarceration of the mentally ill in a developed country such as the United States should be a national embarrassment. But this tragedy, which has reached an epidemic level, has been effectively shut out of the national conversation.

The problem has grown, and is enormous
By the estimate of the U.S. Department of Justice, more than one-half of people incarcerated in the United States are mentally ill and approximately 20% suffer from a serious mental illness.^1,2 In fact, there are now 3 times as many mentally ill people in jail and prison as there are occupying psychiatric beds in hospitals.³ These numbers represent a considerable increase over the past 6 decades, and can be attributed to 2 major factors:

• A program of deinstitutionalization set in motion by the federal government in the 1950s called for shuttering of state psychiatric facilities around the country. This was a period of renewed national discourse on civil rights; for many people, the practice of institutionalization was considered a violation of civil rights. (Coincidentally, chlorpromazine was introduced about this time, and many experts believed that the drug would revolutionize outpatient management of psychiatric disorders.)
• More recently, heavy criminal penalties have been attached to convictions for possession and distribution of illegal substances—part of the government’s “war on drugs.”

As a consequence of these programs and policies, the United States has come full circle—routinely incarcerating the mentally ill as it did in the early 19th century, before reforms were initiated in response to the lobbying efforts of activist Dorothea Dix and her contemporaries.

My distressing, eye-opening experience
The time I spent with the incarcerated mentally ill was limited to a 6-month period at a county jail during residency. Yet the contrast between services provided to this population and those that are available to people in the community was immediately evident—and stark. The sheer number of adults in jails and prisons who require mental health care is such that the ratio of patients to psychiatrists, psychologists, and other mental health clinicians is shockingly skewed.

It does not take years of experience to figure out that a brief interview with an 18-year-old who is being jailed for the first time, has never seen a psychiatrist, and suffers panic attacks (or hallucinations, or suicidal thoughts) is a less-than-ideal clinical situation. Making that situation even more hazardous is that inmates have a high risk of suicide, particularly in the first 24 to 48 hours of incarceration.⁴

Other ethical issues arose during my stint in the correctional system: My patients frequently would be charged with prison-rule violations (there is evidence that mentally ill inmates are more likely to be charged with such violations²); on many such occasions, they would be placed in solitary confinement (“the hole”), a practice the United Nations has called “cruel, inhuman, and degrading: for the mentally ill⁵ and that, in turn, exacerbates the inmate’s psychiatric illness.^6-11

Last, there are restrictions on the types of formulations of medications that can be prescribed, involuntary treatment, and other critical aspects of care that make the experience of providing care in this system frustrating for mental health providers.

Are there solutions?
One way to tackle this crisis might be to insert more psychiatrists and psychologists into the correctional system. A more sensible approach, however, would be to tackle the root cause and divert the mentally ill away from incarceration and into treatment—moving from a model of retribution and incapacitation to one of rehabilitation. For example:

• Several counties nationwide have adopted diversion programs that include so-called mental health courts and drug courts, with encouraging results¹²
• Police departments are establishing Crisis Intervention Teams
• Assisted outpatient treatment programs are growing in popularity.

Far more needs to be done, however. In the absence of a national debate on the problem of the incarcerated mentally ill, there is real risk that this population will continue to be ignored and that our mental health care infrastructure will remain inadequate for meeting their need for services.

The measure of a country’s greatness, Mahatma Gandhi said, should be based on how well it cares for its most vulnerable. Recently, I had the opportunity to work with members of a vulnerable population: men and women who have a mental illness and languish in jails and prisons around the country. My experience was eye-opening and heartbreaking.

Widespread incarceration of the mentally ill in a developed country such as the United States should be a national embarrassment. But this tragedy, which has reached an epidemic level, has been effectively shut out of the national conversation.

The problem has grown, and is enormous
By the estimate of the U.S. Department of Justice, more than one-half of people incarcerated in the United States are mentally ill and approximately 20% suffer from a serious mental illness.^1,2 In fact, there are now 3 times as many mentally ill people in jail and prison as there are occupying psychiatric beds in hospitals.³ These numbers represent a considerable increase over the past 6 decades, and can be attributed to 2 major factors:

• A program of deinstitutionalization set in motion by the federal government in the 1950s called for shuttering of state psychiatric facilities around the country. This was a period of renewed national discourse on civil rights; for many people, the practice of institutionalization was considered a violation of civil rights. (Coincidentally, chlorpromazine was introduced about this time, and many experts believed that the drug would revolutionize outpatient management of psychiatric disorders.)
• More recently, heavy criminal penalties have been attached to convictions for possession and distribution of illegal substances—part of the government’s “war on drugs.”

As a consequence of these programs and policies, the United States has come full circle—routinely incarcerating the mentally ill as it did in the early 19th century, before reforms were initiated in response to the lobbying efforts of activist Dorothea Dix and her contemporaries.

My distressing, eye-opening experience
The time I spent with the incarcerated mentally ill was limited to a 6-month period at a county jail during residency. Yet the contrast between services provided to this population and those that are available to people in the community was immediately evident—and stark. The sheer number of adults in jails and prisons who require mental health care is such that the ratio of patients to psychiatrists, psychologists, and other mental health clinicians is shockingly skewed.

It does not take years of experience to figure out that a brief interview with an 18-year-old who is being jailed for the first time, has never seen a psychiatrist, and suffers panic attacks (or hallucinations, or suicidal thoughts) is a less-than-ideal clinical situation. Making that situation even more hazardous is that inmates have a high risk of suicide, particularly in the first 24 to 48 hours of incarceration.⁴

Other ethical issues arose during my stint in the correctional system: My patients frequently would be charged with prison-rule violations (there is evidence that mentally ill inmates are more likely to be charged with such violations²); on many such occasions, they would be placed in solitary confinement (“the hole”), a practice the United Nations has called “cruel, inhuman, and degrading: for the mentally ill⁵ and that, in turn, exacerbates the inmate’s psychiatric illness.^6-11

Last, there are restrictions on the types of formulations of medications that can be prescribed, involuntary treatment, and other critical aspects of care that make the experience of providing care in this system frustrating for mental health providers.

Are there solutions?
One way to tackle this crisis might be to insert more psychiatrists and psychologists into the correctional system. A more sensible approach, however, would be to tackle the root cause and divert the mentally ill away from incarceration and into treatment—moving from a model of retribution and incapacitation to one of rehabilitation. For example:

• Several counties nationwide have adopted diversion programs that include so-called mental health courts and drug courts, with encouraging results¹²
• Police departments are establishing Crisis Intervention Teams
• Assisted outpatient treatment programs are growing in popularity.

Far more needs to be done, however. In the absence of a national debate on the problem of the incarcerated mentally ill, there is real risk that this population will continue to be ignored and that our mental health care infrastructure will remain inadequate for meeting their need for services.

Men do not know as much about skin cancer prevention and detection techniques as women, according to a recent survey conducted by the American Academy of Dermatology (AAD). This lack of knowledge may delay or prevent early diagnosis and treatment of melanoma and other nonmelanoma skin cancers in this patient population.

The survey results showed that only 56% of men versus 76% of women know there is no such thing as a healthy tan, and only 54% of men versus 70% of women know that getting a base tan is not a healthy way to protect skin from the sun. Furthermore, only 56% of men surveyed were aware that skin cancer could occur on areas of the skin not typically exposed to the sun compared to 65% of women.

“While our survey results indicate that men don’t know as much about skin cancer prevention and detection as women, men over 50 have a higher risk of developing melanoma, so it’s especially important for them to be vigilant about protecting and monitoring their skin,” said AAD President Abel Torres, MD, JD.

More resources on the diagnosis and treatment of melanoma.

May is skin cancer awareness month and the AAD is encouraging patients to make sure their skin is “Looking Good in 2016” by using sun protection and regularly examining skin for signs of skin cancer. The campaign features a public service announcement encouraging men to check their skin for signs of skin cancer and find a partner to help. The AAD also released a new infographic with tips on performing a skin cancer self-examination that dermatologists can share with patients to promote early detection of skin cancer.

More resources on nonmelanoma skin cancers. 

Dermatologist intervention in catching skin cancers when they are easier to treat also is key. At the 74th Annual Meeting of the American Academy of Dermatology in Washington, DC, Dr. Orit Markowitz discussed noninvasive imaging tools that can help dermatologists diagnose skin cancers earlier. She noted that even when a lesion looks very small, tools such as dermoscopy can reveal features that indicate it already has depth and therefore may progress to a more serious malignancy. Early detection is particularly crucial in cases of rare aggressive tumors such as amelanotic melanoma. “If something is very pink clinically and then suddenly has pigmentation dermoscopically, you really have to be considering biopsying that lesion because you may be looking at an early amelanotic melanoma,” Dr. Markowitz explained. By the time the lesion develops more obvious clinical features suggesting malignancy, the tumor progression may be far more advanced.

Men do not know as much about skin cancer prevention and detection techniques as women, according to a recent survey conducted by the American Academy of Dermatology (AAD). This lack of knowledge may delay or prevent early diagnosis and treatment of melanoma and other nonmelanoma skin cancers in this patient population.

The survey results showed that only 56% of men versus 76% of women know there is no such thing as a healthy tan, and only 54% of men versus 70% of women know that getting a base tan is not a healthy way to protect skin from the sun. Furthermore, only 56% of men surveyed were aware that skin cancer could occur on areas of the skin not typically exposed to the sun compared to 65% of women.

“While our survey results indicate that men don’t know as much about skin cancer prevention and detection as women, men over 50 have a higher risk of developing melanoma, so it’s especially important for them to be vigilant about protecting and monitoring their skin,” said AAD President Abel Torres, MD, JD.

More resources on the diagnosis and treatment of melanoma.

May is skin cancer awareness month and the AAD is encouraging patients to make sure their skin is “Looking Good in 2016” by using sun protection and regularly examining skin for signs of skin cancer. The campaign features a public service announcement encouraging men to check their skin for signs of skin cancer and find a partner to help. The AAD also released a new infographic with tips on performing a skin cancer self-examination that dermatologists can share with patients to promote early detection of skin cancer.

More resources on nonmelanoma skin cancers. 

Dermatologist intervention in catching skin cancers when they are easier to treat also is key. At the 74th Annual Meeting of the American Academy of Dermatology in Washington, DC, Dr. Orit Markowitz discussed noninvasive imaging tools that can help dermatologists diagnose skin cancers earlier. She noted that even when a lesion looks very small, tools such as dermoscopy can reveal features that indicate it already has depth and therefore may progress to a more serious malignancy. Early detection is particularly crucial in cases of rare aggressive tumors such as amelanotic melanoma. “If something is very pink clinically and then suddenly has pigmentation dermoscopically, you really have to be considering biopsying that lesion because you may be looking at an early amelanotic melanoma,” Dr. Markowitz explained. By the time the lesion develops more obvious clinical features suggesting malignancy, the tumor progression may be far more advanced.

Men do not know as much about skin cancer prevention and detection techniques as women, according to a recent survey conducted by the American Academy of Dermatology (AAD). This lack of knowledge may delay or prevent early diagnosis and treatment of melanoma and other nonmelanoma skin cancers in this patient population.

The survey results showed that only 56% of men versus 76% of women know there is no such thing as a healthy tan, and only 54% of men versus 70% of women know that getting a base tan is not a healthy way to protect skin from the sun. Furthermore, only 56% of men surveyed were aware that skin cancer could occur on areas of the skin not typically exposed to the sun compared to 65% of women.

“While our survey results indicate that men don’t know as much about skin cancer prevention and detection as women, men over 50 have a higher risk of developing melanoma, so it’s especially important for them to be vigilant about protecting and monitoring their skin,” said AAD President Abel Torres, MD, JD.

More resources on the diagnosis and treatment of melanoma.

May is skin cancer awareness month and the AAD is encouraging patients to make sure their skin is “Looking Good in 2016” by using sun protection and regularly examining skin for signs of skin cancer. The campaign features a public service announcement encouraging men to check their skin for signs of skin cancer and find a partner to help. The AAD also released a new infographic with tips on performing a skin cancer self-examination that dermatologists can share with patients to promote early detection of skin cancer.

More resources on nonmelanoma skin cancers. 

Dermatologist intervention in catching skin cancers when they are easier to treat also is key. At the 74th Annual Meeting of the American Academy of Dermatology in Washington, DC, Dr. Orit Markowitz discussed noninvasive imaging tools that can help dermatologists diagnose skin cancers earlier. She noted that even when a lesion looks very small, tools such as dermoscopy can reveal features that indicate it already has depth and therefore may progress to a more serious malignancy. Early detection is particularly crucial in cases of rare aggressive tumors such as amelanotic melanoma. “If something is very pink clinically and then suddenly has pigmentation dermoscopically, you really have to be considering biopsying that lesion because you may be looking at an early amelanotic melanoma,” Dr. Markowitz explained. By the time the lesion develops more obvious clinical features suggesting malignancy, the tumor progression may be far more advanced.