Neurology

People with migraines appeared to have a higher likelihood of COVID-19 infection and subsequent symptoms of the disease, but they were less likely to receive health care, according to a study presented at the American Headache Society’s 2021 annual meeting.

“These data suggest that people with migraine are either more susceptible to contracting COVID-19, or that they may be more sensitive to the development of symptoms once COVID-19 has been contracted, or both,” Robert Shapiro, MD, PhD, professor of neurological science at the University of Vermont, Burlington. “Further, once COVID-19 has been contracted, people with migraine may be less likely to develop serious COVID-19 outcomes, or they may be less likely to seek health care for COVID-19, or both.”

In providing background information, Dr. Shapiro noted previous research showing that headache is associated with a positive prognosis in COVID-19 inpatients, including lower IL-6 levels throughout the disease course, a 1-week shorter disease course, and a 2.2 times greater relative risk of survival.

Yet in a study across 171 countries, a higher population prevalence of migraine is associated with higher COVID-19 mortality rates. It’s unclear what conclusions can be drawn from that association, however, said Deborah I. Friedman, MD, MPH, professor of neurology and ophthalmology at University of Texas, Dallas, who was not involved in the research.

Dr. Shapiro suggested a theoretical possibility, noting that two genes linked to migraine susceptibility – SCN1A and IFNAR2 – are among 15 host loci also associated with COVID-19 outcomes. Further, Dr. Shapiro noted in his background information, COVID-19 is linked to lower serum calcitonin gene-related peptide levels.

For the study, Dr. Shapiro and colleagues analyzed data from U.S. adults who responded to the National Health and Wellness Survey from April to July 2020. The researchers limited their analysis to the 41,155 participants who had not received the flu vaccine in 2020 since previous research has suggested reduced morbidity among those with COVID-19 who had been vaccinated against the flu. In this group, 4,550 participants had ever been diagnosed by a doctor with migraine (11%) and 36,605 participants had not (89%).

The majority of those with a history of migraine were female (78%), compared with the overall sample (50% female), and tended to be younger, with an average age of 39 compared with 45 for those without migraine (P < .001).

Among those with a previous migraine diagnosis, 3.8% self-reported having had a COVID-19 infection, compared with infection in 2.4% of those without a history of migraine (P < .001). That translated to a 58% increased risk of COVID-19 infection in those with migraine history, with a similar rate of test positivity in both groups (33.7% with migraine history vs. 34.5% without). Test negativity was also similar in both groups (15.9% vs. 17.8%).

Of 360 respondents who had tested positive for COVID-19, the 60 with a history of migraine reported more frequent symptoms than those without migraine. The increased frequency was statistically significant (P < .001 unless otherwise indicated) for the following symptoms:

• Difficulty breathing or shortness of breath (P = .005).
• Fever.
• Headache, sore throat, and/or congestion.
• Fatigue.
• Loss of smell and taste.
• Chills and body aches.
• Persistent pain or pressure in the chest.
• Confusion or inability to arouse.
• Digestive issues (P = .005).
• Bluish lips or face.

For several of these symptoms – such as headache/sore throat/congestion, persistent pain or pressure in the chest, confusion/inability to arouse, and digestive issues – more than twice as many respondents with migraine reported the symptom, vs. those without migraine.
 

Changes in health care utilization

“I think that people with migraine are aware of their bodies and aware of their symptoms more than the average person,” Dr. Friedman said. Yet those with migraine were less likely to use health care while diagnosed with COVID-19 than were those without migraine. Migraine sufferers with a COVID-19 infection were 1.2 times more likely to visit a health care provider than were those without an infection, but the similar relative risk was 1.35 greater for those with COVID-19 infections and no migraines.

Similarly, those with a migraine history were more than twice as likely to visit the emergency department when they had a COVID-19 vaccine infection than were those without an infection (RR = 2.6), but among those without a history of migraine, respondents were nearly five times more likely to visit the emergency department when they had a COVID-19 infection than when they didn’t (RR = 4.9).

Dr. Friedman suggested that the lower utilization rate may have to do with the nature of migraine itself. “There are people with migraine who go to the emergency room all the time, but then there’s most of the people with migraine, who would rather die than go to the emergency room because with the light and the noise, it’s just a horrible place to be if you have migraine,” Dr. Friedman said. “I think the majority of people would prefer not to go to the emergency room if given the choice.”

Increased likelihood of hospitalization among those with migraine and a COVID-19 infection was 4.6 compared with those with a migraine and no infection; the corresponding hospitalization risk for COVID-19 among those without migraine was 7.6 times greater than for those with no infection. All these risk ratios were statistically significant.

Dr. Shapiro then speculated on what it might mean that headache is a positive prognostic indicator for COVID-19 inpatients and that migraine population prevalence is linked to higher COVID-19 mortality.

“A hypothesis emerges that headache as a symptom, and migraine as a disease, may reflect adaptive processes associated with host defenses against viruses,” Dr. Shapiro said. “For example, migraine-driven behaviors, such as social distancing due to photophobia, in the setting of viral illness may play adaptive roles in reducing viral spread.”

The researchers did not receive external funding. Dr. Shapiro has consulted for Eli Lilly and Lundbeck. Dr. Friedman reports grant support and/or advisory board participation for Allergan, Biohaven Pharmaceuticals, Eli Lilly, Impel NeuroPharma, Invex, Lundbeck, Merck, Revance Therapeutics, Satsuma Pharmaceuticals, Teva Pharmaceuticals, Theranica, and Zosano Pharma.

People with migraines appeared to have a higher likelihood of COVID-19 infection and subsequent symptoms of the disease, but they were less likely to receive health care, according to a study presented at the American Headache Society’s 2021 annual meeting.

“These data suggest that people with migraine are either more susceptible to contracting COVID-19, or that they may be more sensitive to the development of symptoms once COVID-19 has been contracted, or both,” Robert Shapiro, MD, PhD, professor of neurological science at the University of Vermont, Burlington. “Further, once COVID-19 has been contracted, people with migraine may be less likely to develop serious COVID-19 outcomes, or they may be less likely to seek health care for COVID-19, or both.”

In providing background information, Dr. Shapiro noted previous research showing that headache is associated with a positive prognosis in COVID-19 inpatients, including lower IL-6 levels throughout the disease course, a 1-week shorter disease course, and a 2.2 times greater relative risk of survival.

Yet in a study across 171 countries, a higher population prevalence of migraine is associated with higher COVID-19 mortality rates. It’s unclear what conclusions can be drawn from that association, however, said Deborah I. Friedman, MD, MPH, professor of neurology and ophthalmology at University of Texas, Dallas, who was not involved in the research.

Dr. Shapiro suggested a theoretical possibility, noting that two genes linked to migraine susceptibility – SCN1A and IFNAR2 – are among 15 host loci also associated with COVID-19 outcomes. Further, Dr. Shapiro noted in his background information, COVID-19 is linked to lower serum calcitonin gene-related peptide levels.

For the study, Dr. Shapiro and colleagues analyzed data from U.S. adults who responded to the National Health and Wellness Survey from April to July 2020. The researchers limited their analysis to the 41,155 participants who had not received the flu vaccine in 2020 since previous research has suggested reduced morbidity among those with COVID-19 who had been vaccinated against the flu. In this group, 4,550 participants had ever been diagnosed by a doctor with migraine (11%) and 36,605 participants had not (89%).

The majority of those with a history of migraine were female (78%), compared with the overall sample (50% female), and tended to be younger, with an average age of 39 compared with 45 for those without migraine (P < .001).

Among those with a previous migraine diagnosis, 3.8% self-reported having had a COVID-19 infection, compared with infection in 2.4% of those without a history of migraine (P < .001). That translated to a 58% increased risk of COVID-19 infection in those with migraine history, with a similar rate of test positivity in both groups (33.7% with migraine history vs. 34.5% without). Test negativity was also similar in both groups (15.9% vs. 17.8%).

Of 360 respondents who had tested positive for COVID-19, the 60 with a history of migraine reported more frequent symptoms than those without migraine. The increased frequency was statistically significant (P < .001 unless otherwise indicated) for the following symptoms:

• Difficulty breathing or shortness of breath (P = .005).
• Fever.
• Headache, sore throat, and/or congestion.
• Fatigue.
• Loss of smell and taste.
• Chills and body aches.
• Persistent pain or pressure in the chest.
• Confusion or inability to arouse.
• Digestive issues (P = .005).
• Bluish lips or face.

For several of these symptoms – such as headache/sore throat/congestion, persistent pain or pressure in the chest, confusion/inability to arouse, and digestive issues – more than twice as many respondents with migraine reported the symptom, vs. those without migraine.
 

Changes in health care utilization

“I think that people with migraine are aware of their bodies and aware of their symptoms more than the average person,” Dr. Friedman said. Yet those with migraine were less likely to use health care while diagnosed with COVID-19 than were those without migraine. Migraine sufferers with a COVID-19 infection were 1.2 times more likely to visit a health care provider than were those without an infection, but the similar relative risk was 1.35 greater for those with COVID-19 infections and no migraines.

Similarly, those with a migraine history were more than twice as likely to visit the emergency department when they had a COVID-19 vaccine infection than were those without an infection (RR = 2.6), but among those without a history of migraine, respondents were nearly five times more likely to visit the emergency department when they had a COVID-19 infection than when they didn’t (RR = 4.9).

Dr. Friedman suggested that the lower utilization rate may have to do with the nature of migraine itself. “There are people with migraine who go to the emergency room all the time, but then there’s most of the people with migraine, who would rather die than go to the emergency room because with the light and the noise, it’s just a horrible place to be if you have migraine,” Dr. Friedman said. “I think the majority of people would prefer not to go to the emergency room if given the choice.”

Increased likelihood of hospitalization among those with migraine and a COVID-19 infection was 4.6 compared with those with a migraine and no infection; the corresponding hospitalization risk for COVID-19 among those without migraine was 7.6 times greater than for those with no infection. All these risk ratios were statistically significant.

Dr. Shapiro then speculated on what it might mean that headache is a positive prognostic indicator for COVID-19 inpatients and that migraine population prevalence is linked to higher COVID-19 mortality.

“A hypothesis emerges that headache as a symptom, and migraine as a disease, may reflect adaptive processes associated with host defenses against viruses,” Dr. Shapiro said. “For example, migraine-driven behaviors, such as social distancing due to photophobia, in the setting of viral illness may play adaptive roles in reducing viral spread.”

The researchers did not receive external funding. Dr. Shapiro has consulted for Eli Lilly and Lundbeck. Dr. Friedman reports grant support and/or advisory board participation for Allergan, Biohaven Pharmaceuticals, Eli Lilly, Impel NeuroPharma, Invex, Lundbeck, Merck, Revance Therapeutics, Satsuma Pharmaceuticals, Teva Pharmaceuticals, Theranica, and Zosano Pharma.

People with migraines appeared to have a higher likelihood of COVID-19 infection and subsequent symptoms of the disease, but they were less likely to receive health care, according to a study presented at the American Headache Society’s 2021 annual meeting.

“These data suggest that people with migraine are either more susceptible to contracting COVID-19, or that they may be more sensitive to the development of symptoms once COVID-19 has been contracted, or both,” Robert Shapiro, MD, PhD, professor of neurological science at the University of Vermont, Burlington. “Further, once COVID-19 has been contracted, people with migraine may be less likely to develop serious COVID-19 outcomes, or they may be less likely to seek health care for COVID-19, or both.”

In providing background information, Dr. Shapiro noted previous research showing that headache is associated with a positive prognosis in COVID-19 inpatients, including lower IL-6 levels throughout the disease course, a 1-week shorter disease course, and a 2.2 times greater relative risk of survival.

Yet in a study across 171 countries, a higher population prevalence of migraine is associated with higher COVID-19 mortality rates. It’s unclear what conclusions can be drawn from that association, however, said Deborah I. Friedman, MD, MPH, professor of neurology and ophthalmology at University of Texas, Dallas, who was not involved in the research.

Dr. Shapiro suggested a theoretical possibility, noting that two genes linked to migraine susceptibility – SCN1A and IFNAR2 – are among 15 host loci also associated with COVID-19 outcomes. Further, Dr. Shapiro noted in his background information, COVID-19 is linked to lower serum calcitonin gene-related peptide levels.

For the study, Dr. Shapiro and colleagues analyzed data from U.S. adults who responded to the National Health and Wellness Survey from April to July 2020. The researchers limited their analysis to the 41,155 participants who had not received the flu vaccine in 2020 since previous research has suggested reduced morbidity among those with COVID-19 who had been vaccinated against the flu. In this group, 4,550 participants had ever been diagnosed by a doctor with migraine (11%) and 36,605 participants had not (89%).

The majority of those with a history of migraine were female (78%), compared with the overall sample (50% female), and tended to be younger, with an average age of 39 compared with 45 for those without migraine (P < .001).

Among those with a previous migraine diagnosis, 3.8% self-reported having had a COVID-19 infection, compared with infection in 2.4% of those without a history of migraine (P < .001). That translated to a 58% increased risk of COVID-19 infection in those with migraine history, with a similar rate of test positivity in both groups (33.7% with migraine history vs. 34.5% without). Test negativity was also similar in both groups (15.9% vs. 17.8%).

Of 360 respondents who had tested positive for COVID-19, the 60 with a history of migraine reported more frequent symptoms than those without migraine. The increased frequency was statistically significant (P < .001 unless otherwise indicated) for the following symptoms:

• Difficulty breathing or shortness of breath (P = .005).
• Fever.
• Headache, sore throat, and/or congestion.
• Fatigue.
• Loss of smell and taste.
• Chills and body aches.
• Persistent pain or pressure in the chest.
• Confusion or inability to arouse.
• Digestive issues (P = .005).
• Bluish lips or face.

For several of these symptoms – such as headache/sore throat/congestion, persistent pain or pressure in the chest, confusion/inability to arouse, and digestive issues – more than twice as many respondents with migraine reported the symptom, vs. those without migraine.
 

Changes in health care utilization

“I think that people with migraine are aware of their bodies and aware of their symptoms more than the average person,” Dr. Friedman said. Yet those with migraine were less likely to use health care while diagnosed with COVID-19 than were those without migraine. Migraine sufferers with a COVID-19 infection were 1.2 times more likely to visit a health care provider than were those without an infection, but the similar relative risk was 1.35 greater for those with COVID-19 infections and no migraines.

Similarly, those with a migraine history were more than twice as likely to visit the emergency department when they had a COVID-19 vaccine infection than were those without an infection (RR = 2.6), but among those without a history of migraine, respondents were nearly five times more likely to visit the emergency department when they had a COVID-19 infection than when they didn’t (RR = 4.9).

Dr. Friedman suggested that the lower utilization rate may have to do with the nature of migraine itself. “There are people with migraine who go to the emergency room all the time, but then there’s most of the people with migraine, who would rather die than go to the emergency room because with the light and the noise, it’s just a horrible place to be if you have migraine,” Dr. Friedman said. “I think the majority of people would prefer not to go to the emergency room if given the choice.”

Increased likelihood of hospitalization among those with migraine and a COVID-19 infection was 4.6 compared with those with a migraine and no infection; the corresponding hospitalization risk for COVID-19 among those without migraine was 7.6 times greater than for those with no infection. All these risk ratios were statistically significant.

Dr. Shapiro then speculated on what it might mean that headache is a positive prognostic indicator for COVID-19 inpatients and that migraine population prevalence is linked to higher COVID-19 mortality.

“A hypothesis emerges that headache as a symptom, and migraine as a disease, may reflect adaptive processes associated with host defenses against viruses,” Dr. Shapiro said. “For example, migraine-driven behaviors, such as social distancing due to photophobia, in the setting of viral illness may play adaptive roles in reducing viral spread.”

The researchers did not receive external funding. Dr. Shapiro has consulted for Eli Lilly and Lundbeck. Dr. Friedman reports grant support and/or advisory board participation for Allergan, Biohaven Pharmaceuticals, Eli Lilly, Impel NeuroPharma, Invex, Lundbeck, Merck, Revance Therapeutics, Satsuma Pharmaceuticals, Teva Pharmaceuticals, Theranica, and Zosano Pharma.

Veterans with chronic headaches had a greater risk of a suicide attempt than that of veterans suffering from chronic neck or back pain, according to findings presented at the American Headache Society’s 2021 annual meeting. Risk rose even more in those with chronic headache pain and a comorbid traumatic brain injury (TBI).

“In addition, as expected, veterans with psychiatric conditions have increased risk of suicide attempt with the exception of anxiety in men and dependent personality in women,” said X. Michelle Androulakis, MD, associate professor of neurology at the University of South Carolina, Columbia.
 

‘Surprising’ findings

“These findings are eye-opening but not surprising since we know that veterans in general and people with chronic pain are at higher risk for suicidal behaviors compared with their civilian counterparts,” said Amy. S Grinberg, PhD, a clinical health psychologist who practices in New Rochelle, N.Y. Dr. Grinberg, who also works at VA Connecticut Healthcare System, was not involved in the study.

“It is, however, very interesting that suicidal attempts are higher in veterans with chronic headache compared with other chronic pain disorders, such as chronic neck and back pain,” Dr Grinberg said. “This really highlights the impact of living with a chronic headache disorder, and emphasizes the continued efforts that should be put into place to support veterans with chronic headache, including improved access to a range of treatment options and continued funding for future research.”
 

Veterans with chronic pain

The researchers retrospectively analyzed Veterans Health Administration electronic health records of 3,252,704 veterans, predominantly male and White, who had been diagnosed with any type of chronic pain from 2000 to 2010.

The researchers looked at overall headache diagnoses instead of specific diagnoses, such as migraine, cluster headache, or posttraumatic headache, since specific headache disorders are frequently underdiagnosed.

The population included 14.7% of patients with chronic headache, 14.9% with chronic neck pain, 59.2% with chronic back pain, and 60.2% with other types of chronic pain, including arthritis, fibromyalgia, joint pain, and reflex sympathetic dystrophy.

Traumatic brain injury occurred in 11.2% of those with chronic headaches, compared with 6.8% of those with chronic back pain, 8.5% of those with chronic neck pain, and 5.9% of those with other chronic pain.

More than half (56.4%) of those with chronic headache had depression, the most common comorbidity in the group, followed by 31.5% who had posttraumatic stress disorder (PTSD), and 21.8% who had adjustment disorder. Other rates of psychiatric disorders were all below 10%. Prevalence of depression occurred in 44.5% of those with back pain, 52.4% of those with neck pain, and 39% of those with other chronic pain. PTSD rates were also lower in those with back (22%), neck (27.2%), or other chronic pain (18.6%).

“Interestingly, this study found that those veterans with a history of traumatic brain injury and psychiatric comorbidities, such as depression, are at greater risk for suicide attempts,” said Dr. Grinberg. “The good news is that these are modifiable risk factors, and evidence-based treatments for depression, PTSD, and headache, for example, are widely disseminated within the VA.”

The majority of headache diagnoses were not otherwise specified (80.1%). Half (50.2%) were migraine headaches while rates were much lower for tension-type headache (8.8%), trigeminal neuralgia (5%), cluster headache (0.8%), and posttraumatic headache (0.7%).

The highest incidence of suicide attempts occurred among those with chronic headaches, ranging from 329 to 396 per 100,000, aside from a peak of 482 per 100,000 in 2005. Suicide attempts peaked among all patients with chronic pain in 2005, “likely related to the deployment and policy changes in the Veterans Health Administration,” Dr. Androulakis said.

Those with neck pain had the next highest rate of suicide attempts, ranging from 263 to 314 per 100,000, excluding the peak of 398 per 100,000 in 2005.

Male veterans with chronic headaches had a 1.5 times greater likelihood of a suicide attempt than did those with back or neck pain (relative risk [RR] = 1.5), which increased to a relative risk of 2.8 greater for those with concurrent TBI. Among female veterans, chronic headache was associated with a 1.6 times greater risk of a suicide attempt, which rose to 2.15 times greater with concurrent TBI.

“Knowing that veterans with chronic headache disorders have an elevated rate of suicide, it is imperative that doctors and other clinical providers continue to conduct in-depth risk assessments and implement strategies to support those veterans who are at risk,” said Dr. Grinberg. “Clinical providers should continue in their efforts to reduce stigma associated with headache disorders and mental health treatment in order to effectively engage veterans in evidence-based treatments that are likely a step towards reducing symptoms and suicidal attempts.”

No external funding was noted. Dr. Androulakis and Dr. Grinberg had no disclosures.

Veterans with chronic headaches had a greater risk of a suicide attempt than that of veterans suffering from chronic neck or back pain, according to findings presented at the American Headache Society’s 2021 annual meeting. Risk rose even more in those with chronic headache pain and a comorbid traumatic brain injury (TBI).

“In addition, as expected, veterans with psychiatric conditions have increased risk of suicide attempt with the exception of anxiety in men and dependent personality in women,” said X. Michelle Androulakis, MD, associate professor of neurology at the University of South Carolina, Columbia.
 

‘Surprising’ findings

“These findings are eye-opening but not surprising since we know that veterans in general and people with chronic pain are at higher risk for suicidal behaviors compared with their civilian counterparts,” said Amy. S Grinberg, PhD, a clinical health psychologist who practices in New Rochelle, N.Y. Dr. Grinberg, who also works at VA Connecticut Healthcare System, was not involved in the study.

“It is, however, very interesting that suicidal attempts are higher in veterans with chronic headache compared with other chronic pain disorders, such as chronic neck and back pain,” Dr Grinberg said. “This really highlights the impact of living with a chronic headache disorder, and emphasizes the continued efforts that should be put into place to support veterans with chronic headache, including improved access to a range of treatment options and continued funding for future research.”
 

Veterans with chronic pain

The researchers retrospectively analyzed Veterans Health Administration electronic health records of 3,252,704 veterans, predominantly male and White, who had been diagnosed with any type of chronic pain from 2000 to 2010.

The researchers looked at overall headache diagnoses instead of specific diagnoses, such as migraine, cluster headache, or posttraumatic headache, since specific headache disorders are frequently underdiagnosed.

The population included 14.7% of patients with chronic headache, 14.9% with chronic neck pain, 59.2% with chronic back pain, and 60.2% with other types of chronic pain, including arthritis, fibromyalgia, joint pain, and reflex sympathetic dystrophy.

Traumatic brain injury occurred in 11.2% of those with chronic headaches, compared with 6.8% of those with chronic back pain, 8.5% of those with chronic neck pain, and 5.9% of those with other chronic pain.

More than half (56.4%) of those with chronic headache had depression, the most common comorbidity in the group, followed by 31.5% who had posttraumatic stress disorder (PTSD), and 21.8% who had adjustment disorder. Other rates of psychiatric disorders were all below 10%. Prevalence of depression occurred in 44.5% of those with back pain, 52.4% of those with neck pain, and 39% of those with other chronic pain. PTSD rates were also lower in those with back (22%), neck (27.2%), or other chronic pain (18.6%).

“Interestingly, this study found that those veterans with a history of traumatic brain injury and psychiatric comorbidities, such as depression, are at greater risk for suicide attempts,” said Dr. Grinberg. “The good news is that these are modifiable risk factors, and evidence-based treatments for depression, PTSD, and headache, for example, are widely disseminated within the VA.”

The majority of headache diagnoses were not otherwise specified (80.1%). Half (50.2%) were migraine headaches while rates were much lower for tension-type headache (8.8%), trigeminal neuralgia (5%), cluster headache (0.8%), and posttraumatic headache (0.7%).

The highest incidence of suicide attempts occurred among those with chronic headaches, ranging from 329 to 396 per 100,000, aside from a peak of 482 per 100,000 in 2005. Suicide attempts peaked among all patients with chronic pain in 2005, “likely related to the deployment and policy changes in the Veterans Health Administration,” Dr. Androulakis said.

Those with neck pain had the next highest rate of suicide attempts, ranging from 263 to 314 per 100,000, excluding the peak of 398 per 100,000 in 2005.

Male veterans with chronic headaches had a 1.5 times greater likelihood of a suicide attempt than did those with back or neck pain (relative risk [RR] = 1.5), which increased to a relative risk of 2.8 greater for those with concurrent TBI. Among female veterans, chronic headache was associated with a 1.6 times greater risk of a suicide attempt, which rose to 2.15 times greater with concurrent TBI.

“Knowing that veterans with chronic headache disorders have an elevated rate of suicide, it is imperative that doctors and other clinical providers continue to conduct in-depth risk assessments and implement strategies to support those veterans who are at risk,” said Dr. Grinberg. “Clinical providers should continue in their efforts to reduce stigma associated with headache disorders and mental health treatment in order to effectively engage veterans in evidence-based treatments that are likely a step towards reducing symptoms and suicidal attempts.”

No external funding was noted. Dr. Androulakis and Dr. Grinberg had no disclosures.

Veterans with chronic headaches had a greater risk of a suicide attempt than that of veterans suffering from chronic neck or back pain, according to findings presented at the American Headache Society’s 2021 annual meeting. Risk rose even more in those with chronic headache pain and a comorbid traumatic brain injury (TBI).

“In addition, as expected, veterans with psychiatric conditions have increased risk of suicide attempt with the exception of anxiety in men and dependent personality in women,” said X. Michelle Androulakis, MD, associate professor of neurology at the University of South Carolina, Columbia.
 

‘Surprising’ findings

“These findings are eye-opening but not surprising since we know that veterans in general and people with chronic pain are at higher risk for suicidal behaviors compared with their civilian counterparts,” said Amy. S Grinberg, PhD, a clinical health psychologist who practices in New Rochelle, N.Y. Dr. Grinberg, who also works at VA Connecticut Healthcare System, was not involved in the study.

“It is, however, very interesting that suicidal attempts are higher in veterans with chronic headache compared with other chronic pain disorders, such as chronic neck and back pain,” Dr Grinberg said. “This really highlights the impact of living with a chronic headache disorder, and emphasizes the continued efforts that should be put into place to support veterans with chronic headache, including improved access to a range of treatment options and continued funding for future research.”
 

Veterans with chronic pain

The researchers retrospectively analyzed Veterans Health Administration electronic health records of 3,252,704 veterans, predominantly male and White, who had been diagnosed with any type of chronic pain from 2000 to 2010.

The researchers looked at overall headache diagnoses instead of specific diagnoses, such as migraine, cluster headache, or posttraumatic headache, since specific headache disorders are frequently underdiagnosed.

The population included 14.7% of patients with chronic headache, 14.9% with chronic neck pain, 59.2% with chronic back pain, and 60.2% with other types of chronic pain, including arthritis, fibromyalgia, joint pain, and reflex sympathetic dystrophy.

Traumatic brain injury occurred in 11.2% of those with chronic headaches, compared with 6.8% of those with chronic back pain, 8.5% of those with chronic neck pain, and 5.9% of those with other chronic pain.

More than half (56.4%) of those with chronic headache had depression, the most common comorbidity in the group, followed by 31.5% who had posttraumatic stress disorder (PTSD), and 21.8% who had adjustment disorder. Other rates of psychiatric disorders were all below 10%. Prevalence of depression occurred in 44.5% of those with back pain, 52.4% of those with neck pain, and 39% of those with other chronic pain. PTSD rates were also lower in those with back (22%), neck (27.2%), or other chronic pain (18.6%).

“Interestingly, this study found that those veterans with a history of traumatic brain injury and psychiatric comorbidities, such as depression, are at greater risk for suicide attempts,” said Dr. Grinberg. “The good news is that these are modifiable risk factors, and evidence-based treatments for depression, PTSD, and headache, for example, are widely disseminated within the VA.”

The majority of headache diagnoses were not otherwise specified (80.1%). Half (50.2%) were migraine headaches while rates were much lower for tension-type headache (8.8%), trigeminal neuralgia (5%), cluster headache (0.8%), and posttraumatic headache (0.7%).

The highest incidence of suicide attempts occurred among those with chronic headaches, ranging from 329 to 396 per 100,000, aside from a peak of 482 per 100,000 in 2005. Suicide attempts peaked among all patients with chronic pain in 2005, “likely related to the deployment and policy changes in the Veterans Health Administration,” Dr. Androulakis said.

Those with neck pain had the next highest rate of suicide attempts, ranging from 263 to 314 per 100,000, excluding the peak of 398 per 100,000 in 2005.

Male veterans with chronic headaches had a 1.5 times greater likelihood of a suicide attempt than did those with back or neck pain (relative risk [RR] = 1.5), which increased to a relative risk of 2.8 greater for those with concurrent TBI. Among female veterans, chronic headache was associated with a 1.6 times greater risk of a suicide attempt, which rose to 2.15 times greater with concurrent TBI.

“Knowing that veterans with chronic headache disorders have an elevated rate of suicide, it is imperative that doctors and other clinical providers continue to conduct in-depth risk assessments and implement strategies to support those veterans who are at risk,” said Dr. Grinberg. “Clinical providers should continue in their efforts to reduce stigma associated with headache disorders and mental health treatment in order to effectively engage veterans in evidence-based treatments that are likely a step towards reducing symptoms and suicidal attempts.”

No external funding was noted. Dr. Androulakis and Dr. Grinberg had no disclosures.

A phase 3, sham-controlled clinical trial of an external trigeminal nerve stimulation (e-TNS) device showed confirmed superiority over a sham device and eliminated the most bothersome migraine symptoms after 2 hours of use. The study also demonstrated that the device, manufactured by Cefaly and cleared in 2020 by the Food and Drug Administration for over-the-counter use, can be safely and effectively used at home.

The study also explored the benefits of 2 hours of use, rather than the 1 hour of use tested in a previous study. “The programming on the device is currently [set to] turn off at 1 hour. As a result of this study, I tell patients if they don’t have adequate relief, and they’re tolerating it, that they can activate it again for a second hour,” Stewart Tepper, MD, said in an interview. Dr. Tepper is a professor of neurology at Geisel School of Medicine at Dartmouth, Hanover, N.H., and a coauthor of the study that was presented by Deena Kuruvilla, MD, at the American Headache Society’s 2021 annual meeting. Dr. Kuruvilla is a neurologist and director of the Westport (Conn.) Headache Institute.

The improvements seen over the sham were significant but not overwhelming, according to Deborah Friedman, MD, MPH, professor of neurology and ophthalmology at the University of Texas, Dallas.

“The numbers are not super impressive when you compare them with other devices. I thought it was interesting that the most bothersome symptom went away in a much higher percentage of people than the headache. That was actually pretty impressive,” said Dr. Friedman, who was asked to comment on the study. She also wondered if the sham device may have inadvertently provided a small amount of stimulation, which could explain the smaller than expected efficacy difference. “It just kind of makes me wonder because I would expect to see a larger separation, even though it was statistically significant.”

The study was an overall success according to Dr. Tepper, who noted that the efficacy of pain freedom was comparable with what has been seen with calcitonin gene-related peptide receptor antagonists (gepants), as well as relieving the most bothersome symptom at 2 hours. The device failed to reduce the usage of rescue medication, suggesting that it might be a candidate to combine with rescue medications. “I think the main thing is it works. It works in a sham-controlled trial, it works at home, and it works comparably to acute medication. And it is further evidence that the lack of access is something that needs to be addressed,” said Dr. Tepper.

Access will depend on insurance companies, who have so far been reluctant to pay for the device. Dr. Tepper is not optimistic they will come around on their own. “My feeling about it is that the only way that payers will finally start to cover this is with a concerted, organized advocacy campaign by patients. The analogy is that when the disease-modifying therapies became available for multiple sclerosis, the National MS Society organized the MS patients and they demanded that the payers cover the disease modifying therapies. That’s the kind of intense focus of advocacy that needs to be done for these noninvasive neuromodulation devices,” said Dr. Tepper.

The TEAM study was a double blind, randomized, sham-controlled trial of 538 patients who were asked to use neurostimulation for a 2-hour, continuous session within 4 hours of a moderate to severe migraine accompanied by at least one migraine-associated symptom. At 2 hours, 25.5% of those using the device achieved pain freedom, compared with 18.3% of those using the sham (P < .05). Among those using the device, 56.4% had freedom from most bothersome symptom, compared with 42.3% of those using the sham (P < .01).

Pain relief at 2 hours was more common in the device group (69.5% vs. 55.2%; P < .01), as was absence of all migraine-associated symptoms at 2 hours (42.5% vs. 34.1%; P < .05), sustained pain freedom at 24 hours (22.8% vs. 15.8%; P < .05), and sustained pain relief at 24 hours (45.9% vs. 34.4%; P < .01). There was no statistically significant between-group difference in use of rescue medications.

In the device group, 8.5% of patients experienced an adverse event, versus 2.9% in the sham group (P = .004). The only adverse reaction that occurred more frequently in the device group was forehead paresthesia, discomfort, and burning (3.5% vs. 0.4%; P = .009).

The study was funded by Cefaly. Dr. Tepper and Dr. Friedman have no relevant financial disclosures.

A phase 3, sham-controlled clinical trial of an external trigeminal nerve stimulation (e-TNS) device showed confirmed superiority over a sham device and eliminated the most bothersome migraine symptoms after 2 hours of use. The study also demonstrated that the device, manufactured by Cefaly and cleared in 2020 by the Food and Drug Administration for over-the-counter use, can be safely and effectively used at home.

The study also explored the benefits of 2 hours of use, rather than the 1 hour of use tested in a previous study. “The programming on the device is currently [set to] turn off at 1 hour. As a result of this study, I tell patients if they don’t have adequate relief, and they’re tolerating it, that they can activate it again for a second hour,” Stewart Tepper, MD, said in an interview. Dr. Tepper is a professor of neurology at Geisel School of Medicine at Dartmouth, Hanover, N.H., and a coauthor of the study that was presented by Deena Kuruvilla, MD, at the American Headache Society’s 2021 annual meeting. Dr. Kuruvilla is a neurologist and director of the Westport (Conn.) Headache Institute.

The improvements seen over the sham were significant but not overwhelming, according to Deborah Friedman, MD, MPH, professor of neurology and ophthalmology at the University of Texas, Dallas.

“The numbers are not super impressive when you compare them with other devices. I thought it was interesting that the most bothersome symptom went away in a much higher percentage of people than the headache. That was actually pretty impressive,” said Dr. Friedman, who was asked to comment on the study. She also wondered if the sham device may have inadvertently provided a small amount of stimulation, which could explain the smaller than expected efficacy difference. “It just kind of makes me wonder because I would expect to see a larger separation, even though it was statistically significant.”

The study was an overall success according to Dr. Tepper, who noted that the efficacy of pain freedom was comparable with what has been seen with calcitonin gene-related peptide receptor antagonists (gepants), as well as relieving the most bothersome symptom at 2 hours. The device failed to reduce the usage of rescue medication, suggesting that it might be a candidate to combine with rescue medications. “I think the main thing is it works. It works in a sham-controlled trial, it works at home, and it works comparably to acute medication. And it is further evidence that the lack of access is something that needs to be addressed,” said Dr. Tepper.

Access will depend on insurance companies, who have so far been reluctant to pay for the device. Dr. Tepper is not optimistic they will come around on their own. “My feeling about it is that the only way that payers will finally start to cover this is with a concerted, organized advocacy campaign by patients. The analogy is that when the disease-modifying therapies became available for multiple sclerosis, the National MS Society organized the MS patients and they demanded that the payers cover the disease modifying therapies. That’s the kind of intense focus of advocacy that needs to be done for these noninvasive neuromodulation devices,” said Dr. Tepper.

The TEAM study was a double blind, randomized, sham-controlled trial of 538 patients who were asked to use neurostimulation for a 2-hour, continuous session within 4 hours of a moderate to severe migraine accompanied by at least one migraine-associated symptom. At 2 hours, 25.5% of those using the device achieved pain freedom, compared with 18.3% of those using the sham (P < .05). Among those using the device, 56.4% had freedom from most bothersome symptom, compared with 42.3% of those using the sham (P < .01).

Pain relief at 2 hours was more common in the device group (69.5% vs. 55.2%; P < .01), as was absence of all migraine-associated symptoms at 2 hours (42.5% vs. 34.1%; P < .05), sustained pain freedom at 24 hours (22.8% vs. 15.8%; P < .05), and sustained pain relief at 24 hours (45.9% vs. 34.4%; P < .01). There was no statistically significant between-group difference in use of rescue medications.

In the device group, 8.5% of patients experienced an adverse event, versus 2.9% in the sham group (P = .004). The only adverse reaction that occurred more frequently in the device group was forehead paresthesia, discomfort, and burning (3.5% vs. 0.4%; P = .009).

The study was funded by Cefaly. Dr. Tepper and Dr. Friedman have no relevant financial disclosures.

A phase 3, sham-controlled clinical trial of an external trigeminal nerve stimulation (e-TNS) device showed confirmed superiority over a sham device and eliminated the most bothersome migraine symptoms after 2 hours of use. The study also demonstrated that the device, manufactured by Cefaly and cleared in 2020 by the Food and Drug Administration for over-the-counter use, can be safely and effectively used at home.

The study also explored the benefits of 2 hours of use, rather than the 1 hour of use tested in a previous study. “The programming on the device is currently [set to] turn off at 1 hour. As a result of this study, I tell patients if they don’t have adequate relief, and they’re tolerating it, that they can activate it again for a second hour,” Stewart Tepper, MD, said in an interview. Dr. Tepper is a professor of neurology at Geisel School of Medicine at Dartmouth, Hanover, N.H., and a coauthor of the study that was presented by Deena Kuruvilla, MD, at the American Headache Society’s 2021 annual meeting. Dr. Kuruvilla is a neurologist and director of the Westport (Conn.) Headache Institute.

The improvements seen over the sham were significant but not overwhelming, according to Deborah Friedman, MD, MPH, professor of neurology and ophthalmology at the University of Texas, Dallas.

“The numbers are not super impressive when you compare them with other devices. I thought it was interesting that the most bothersome symptom went away in a much higher percentage of people than the headache. That was actually pretty impressive,” said Dr. Friedman, who was asked to comment on the study. She also wondered if the sham device may have inadvertently provided a small amount of stimulation, which could explain the smaller than expected efficacy difference. “It just kind of makes me wonder because I would expect to see a larger separation, even though it was statistically significant.”

The study was an overall success according to Dr. Tepper, who noted that the efficacy of pain freedom was comparable with what has been seen with calcitonin gene-related peptide receptor antagonists (gepants), as well as relieving the most bothersome symptom at 2 hours. The device failed to reduce the usage of rescue medication, suggesting that it might be a candidate to combine with rescue medications. “I think the main thing is it works. It works in a sham-controlled trial, it works at home, and it works comparably to acute medication. And it is further evidence that the lack of access is something that needs to be addressed,” said Dr. Tepper.

Access will depend on insurance companies, who have so far been reluctant to pay for the device. Dr. Tepper is not optimistic they will come around on their own. “My feeling about it is that the only way that payers will finally start to cover this is with a concerted, organized advocacy campaign by patients. The analogy is that when the disease-modifying therapies became available for multiple sclerosis, the National MS Society organized the MS patients and they demanded that the payers cover the disease modifying therapies. That’s the kind of intense focus of advocacy that needs to be done for these noninvasive neuromodulation devices,” said Dr. Tepper.

The TEAM study was a double blind, randomized, sham-controlled trial of 538 patients who were asked to use neurostimulation for a 2-hour, continuous session within 4 hours of a moderate to severe migraine accompanied by at least one migraine-associated symptom. At 2 hours, 25.5% of those using the device achieved pain freedom, compared with 18.3% of those using the sham (P < .05). Among those using the device, 56.4% had freedom from most bothersome symptom, compared with 42.3% of those using the sham (P < .01).

Pain relief at 2 hours was more common in the device group (69.5% vs. 55.2%; P < .01), as was absence of all migraine-associated symptoms at 2 hours (42.5% vs. 34.1%; P < .05), sustained pain freedom at 24 hours (22.8% vs. 15.8%; P < .05), and sustained pain relief at 24 hours (45.9% vs. 34.4%; P < .01). There was no statistically significant between-group difference in use of rescue medications.

In the device group, 8.5% of patients experienced an adverse event, versus 2.9% in the sham group (P = .004). The only adverse reaction that occurred more frequently in the device group was forehead paresthesia, discomfort, and burning (3.5% vs. 0.4%; P = .009).

The study was funded by Cefaly. Dr. Tepper and Dr. Friedman have no relevant financial disclosures.

Applications of 3-dimensional (3D) printing in medical imaging and health care are expanding. 3D printing may serve a variety of roles and is used increasingly in the context of presurgical planning, as specific medical models may be created using individual patient imaging data.¹ These patient-specific models may assist in medical trainee education, decrease operating room time, improve patient education for potential planned surgery, and guide clinicians for optimizing therapy.^1,2 This article discusses the utility of 3D printing at a single institution to serve in enhancing specifically neuroradiology education.

Background

As digital imaging and 3D printing have increased in popularity, the potential application of using imaging data to guide patient therapy has shown significant promise. Computed tomography (CT) is a commonly used modality that can be used to create 3D anatomical models, as it is frequently used in the medical setting, demonstrates excellent resolution to the millimeter scale, and can readily pinpoint pathology on imaging.

Image Acquisition

CT scans can be rapidly obtained, which adds significant value, particularly in the context of point-of-care 3D printing. Another modality commonly used for 3D printing is magnetic resonance imaging (MRI), which unlike CT, does not expose the patient to ionizing radiation. The 3D printing process is initiated with patient-specific CT or MRI data stored in the digital imaging and communications in medicine (DICOM) format, which is the international standard for communication and management of medical imaging information and related data. DICOM allows for faster and robust collaboration among imaging professionals.³

Image Processing 

To print 3D anatomical models, patient-specific data must be converted from DICOM into standard tessellation language (STL) format, which can be created and edited with a variety of softwares.³ At James A. Haley Veterans’ Hospital in Tampa, Florida, we use an image processing package that includes the Materialise 3-matic and interactive medical image control system. Image quality is essential; therefore, careful attention to details such as pixel dimensions, slice thickness, and slice increments must be considered.^3,4

An STL file creates a 3D image from triangle approximations. The entire 3D shape will be made of numerous large or small triangles, depending on the slice thickness, therefore, quality of the original radiologic image. The size and position of the triangles used to make the model can be varied to approximate the object’s shape. The smaller the triangles, the better the image quality and vice versa. This concept is analogous to approximating a circle using straight lines of equal length—more, smaller lines will result in better approximation of a circle (Figure 1).^5,6 Similarly, using smaller triangles allows for better approximation of the image. As the human body is a complex structure, mimicking the body requires a system able to create nongeometrical shapes, which is made possible via these triangle approximations in a 3D STL file.

The creation of an STL file from DICOM data starts with a threshold-based segmentation process followed by additional fine-tuning and edits, and ends in the creation of a 3D part. The initial segmentation can be created with the threshold tool, using a Hounsfield unit range based on the area of interest desired (eg, bone, blood, fat). This is used to create an initial mask, which can be further optimized. The region grow tool allows the user to focus the segmentation by discarding areas that are not directly connected to the region of interest. In contrast, the split mask tool divides areas that are connected. Next, fine-tuning the segmentation using tools such as multiple slice edit helps to optimize the model. After all edits are made, the calculate part tool converts the mask into a 3D component that can be used in downstream applications. For the purposes of demonstration and proof of concept, the models provided in this article were created via open-source hardware designs under free or open licenses.^7-9

3D Printing in Neuroradiology Education

Neuroradiologists focus on diagnosing pathology related to the brain, head and neck, and spine. CT and MRI scans are the primary modalities used to diagnose these conditions. 3D printing is a useful tool for the trainee who wishes to fully understand neuroanatomy and obtain further appreciation of imaging pathology as it relates to 3D anatomy. Head and neck imaging are a complex subdiscipline of neuroradiology that often require further training beyond radiology residency. A neuroradiology fellowship that focuses on head and neck imaging extends the training.

3D printing has the potential to improve the understanding of various imaging pathologies by providing the trainee with a more in-depth appreciation of the anterior, middle, and posterior cranial fossa, the skull base foramina (ie, foramen ovale, spinosum, rotundum), and complex 3D areas, such as the pterygopalatine fossa, which are all critical areas to investigate on imaging. Figure 2 highlights how a complex anatomical structure, such as the sphenoid bone when printed in 3D, can be correlated with CT cross-sectional images to supplement the educational experience.

Future Directions

Artificial Intelligence (AI) offers the ability to teach computers to perform tasks that ordinarily require human intelligence. In the context of 3D printing, the ability to use AI to readily convert and process DICOM data into printable STL models holds significant promise. Currently, the manual conversion of a DICOM file into a segmented 3D model may take several days, necessitating a number of productive hours even from the imaging and engineering champion. If machines could aid in this process, the ability to readily scale clinical 3D printing and promote widespread adoption would be feasible. Several studies already are looking into this concept to determine how deep learning networks may automatically recognize lesions on medical imaging to assist a human operator, potentially cutting hours from the clinical 3D printing workflow.^12,13

Furthermore, there are several applications for AI in the context of 3D printing upstream or before the creation of a 3D model. A number of AI tools are already in use at the CT and MRI scanner. Current strategies leverage deep learning and advances in neural networks to improve image quality and create thin section DICOM data, which can be converted into printable 3D files. Additionally, the ability to automate tasks using AI can improve production capacity by assessing material costs and ensuring cost efficiency, which will be critical as point-of-care 3D printing develops widespread adoption. AI also can reduce printing errors by using automated adaptive feedback, using machine learning to search for possible print errors, and sending feedback to the computer to ensure appropriate settings (eg, temperature settings/environmental conditions).

Conclusions

Based on this single-institution experience, 3D-printed complex neuroanatomical structures seems feasible and may enhance resident education and patient safety. Interested trainees may have the opportunity to learn and be involved in the printing process of new and innovative ideas. Further studies may involve printing various pathologic processes and applying these same steps and principles to other subspecialties of radiology. Finally, AI has the potential to advance the 3D printing process in the future.

Applications of 3-dimensional (3D) printing in medical imaging and health care are expanding. 3D printing may serve a variety of roles and is used increasingly in the context of presurgical planning, as specific medical models may be created using individual patient imaging data.¹ These patient-specific models may assist in medical trainee education, decrease operating room time, improve patient education for potential planned surgery, and guide clinicians for optimizing therapy.^1,2 This article discusses the utility of 3D printing at a single institution to serve in enhancing specifically neuroradiology education.

Background

As digital imaging and 3D printing have increased in popularity, the potential application of using imaging data to guide patient therapy has shown significant promise. Computed tomography (CT) is a commonly used modality that can be used to create 3D anatomical models, as it is frequently used in the medical setting, demonstrates excellent resolution to the millimeter scale, and can readily pinpoint pathology on imaging.

Image Acquisition

CT scans can be rapidly obtained, which adds significant value, particularly in the context of point-of-care 3D printing. Another modality commonly used for 3D printing is magnetic resonance imaging (MRI), which unlike CT, does not expose the patient to ionizing radiation. The 3D printing process is initiated with patient-specific CT or MRI data stored in the digital imaging and communications in medicine (DICOM) format, which is the international standard for communication and management of medical imaging information and related data. DICOM allows for faster and robust collaboration among imaging professionals.³

Image Processing 

To print 3D anatomical models, patient-specific data must be converted from DICOM into standard tessellation language (STL) format, which can be created and edited with a variety of softwares.³ At James A. Haley Veterans’ Hospital in Tampa, Florida, we use an image processing package that includes the Materialise 3-matic and interactive medical image control system. Image quality is essential; therefore, careful attention to details such as pixel dimensions, slice thickness, and slice increments must be considered.^3,4

An STL file creates a 3D image from triangle approximations. The entire 3D shape will be made of numerous large or small triangles, depending on the slice thickness, therefore, quality of the original radiologic image. The size and position of the triangles used to make the model can be varied to approximate the object’s shape. The smaller the triangles, the better the image quality and vice versa. This concept is analogous to approximating a circle using straight lines of equal length—more, smaller lines will result in better approximation of a circle (Figure 1).^5,6 Similarly, using smaller triangles allows for better approximation of the image. As the human body is a complex structure, mimicking the body requires a system able to create nongeometrical shapes, which is made possible via these triangle approximations in a 3D STL file.

The creation of an STL file from DICOM data starts with a threshold-based segmentation process followed by additional fine-tuning and edits, and ends in the creation of a 3D part. The initial segmentation can be created with the threshold tool, using a Hounsfield unit range based on the area of interest desired (eg, bone, blood, fat). This is used to create an initial mask, which can be further optimized. The region grow tool allows the user to focus the segmentation by discarding areas that are not directly connected to the region of interest. In contrast, the split mask tool divides areas that are connected. Next, fine-tuning the segmentation using tools such as multiple slice edit helps to optimize the model. After all edits are made, the calculate part tool converts the mask into a 3D component that can be used in downstream applications. For the purposes of demonstration and proof of concept, the models provided in this article were created via open-source hardware designs under free or open licenses.^7-9

3D Printing in Neuroradiology Education

Neuroradiologists focus on diagnosing pathology related to the brain, head and neck, and spine. CT and MRI scans are the primary modalities used to diagnose these conditions. 3D printing is a useful tool for the trainee who wishes to fully understand neuroanatomy and obtain further appreciation of imaging pathology as it relates to 3D anatomy. Head and neck imaging are a complex subdiscipline of neuroradiology that often require further training beyond radiology residency. A neuroradiology fellowship that focuses on head and neck imaging extends the training.

3D printing has the potential to improve the understanding of various imaging pathologies by providing the trainee with a more in-depth appreciation of the anterior, middle, and posterior cranial fossa, the skull base foramina (ie, foramen ovale, spinosum, rotundum), and complex 3D areas, such as the pterygopalatine fossa, which are all critical areas to investigate on imaging. Figure 2 highlights how a complex anatomical structure, such as the sphenoid bone when printed in 3D, can be correlated with CT cross-sectional images to supplement the educational experience.

Future Directions

Artificial Intelligence (AI) offers the ability to teach computers to perform tasks that ordinarily require human intelligence. In the context of 3D printing, the ability to use AI to readily convert and process DICOM data into printable STL models holds significant promise. Currently, the manual conversion of a DICOM file into a segmented 3D model may take several days, necessitating a number of productive hours even from the imaging and engineering champion. If machines could aid in this process, the ability to readily scale clinical 3D printing and promote widespread adoption would be feasible. Several studies already are looking into this concept to determine how deep learning networks may automatically recognize lesions on medical imaging to assist a human operator, potentially cutting hours from the clinical 3D printing workflow.^12,13

Furthermore, there are several applications for AI in the context of 3D printing upstream or before the creation of a 3D model. A number of AI tools are already in use at the CT and MRI scanner. Current strategies leverage deep learning and advances in neural networks to improve image quality and create thin section DICOM data, which can be converted into printable 3D files. Additionally, the ability to automate tasks using AI can improve production capacity by assessing material costs and ensuring cost efficiency, which will be critical as point-of-care 3D printing develops widespread adoption. AI also can reduce printing errors by using automated adaptive feedback, using machine learning to search for possible print errors, and sending feedback to the computer to ensure appropriate settings (eg, temperature settings/environmental conditions).

Conclusions

Based on this single-institution experience, 3D-printed complex neuroanatomical structures seems feasible and may enhance resident education and patient safety. Interested trainees may have the opportunity to learn and be involved in the printing process of new and innovative ideas. Further studies may involve printing various pathologic processes and applying these same steps and principles to other subspecialties of radiology. Finally, AI has the potential to advance the 3D printing process in the future.

Applications of 3-dimensional (3D) printing in medical imaging and health care are expanding. 3D printing may serve a variety of roles and is used increasingly in the context of presurgical planning, as specific medical models may be created using individual patient imaging data.¹ These patient-specific models may assist in medical trainee education, decrease operating room time, improve patient education for potential planned surgery, and guide clinicians for optimizing therapy.^1,2 This article discusses the utility of 3D printing at a single institution to serve in enhancing specifically neuroradiology education.

Background

As digital imaging and 3D printing have increased in popularity, the potential application of using imaging data to guide patient therapy has shown significant promise. Computed tomography (CT) is a commonly used modality that can be used to create 3D anatomical models, as it is frequently used in the medical setting, demonstrates excellent resolution to the millimeter scale, and can readily pinpoint pathology on imaging.

Image Acquisition

CT scans can be rapidly obtained, which adds significant value, particularly in the context of point-of-care 3D printing. Another modality commonly used for 3D printing is magnetic resonance imaging (MRI), which unlike CT, does not expose the patient to ionizing radiation. The 3D printing process is initiated with patient-specific CT or MRI data stored in the digital imaging and communications in medicine (DICOM) format, which is the international standard for communication and management of medical imaging information and related data. DICOM allows for faster and robust collaboration among imaging professionals.³

Image Processing 

To print 3D anatomical models, patient-specific data must be converted from DICOM into standard tessellation language (STL) format, which can be created and edited with a variety of softwares.³ At James A. Haley Veterans’ Hospital in Tampa, Florida, we use an image processing package that includes the Materialise 3-matic and interactive medical image control system. Image quality is essential; therefore, careful attention to details such as pixel dimensions, slice thickness, and slice increments must be considered.^3,4

An STL file creates a 3D image from triangle approximations. The entire 3D shape will be made of numerous large or small triangles, depending on the slice thickness, therefore, quality of the original radiologic image. The size and position of the triangles used to make the model can be varied to approximate the object’s shape. The smaller the triangles, the better the image quality and vice versa. This concept is analogous to approximating a circle using straight lines of equal length—more, smaller lines will result in better approximation of a circle (Figure 1).^5,6 Similarly, using smaller triangles allows for better approximation of the image. As the human body is a complex structure, mimicking the body requires a system able to create nongeometrical shapes, which is made possible via these triangle approximations in a 3D STL file.

The creation of an STL file from DICOM data starts with a threshold-based segmentation process followed by additional fine-tuning and edits, and ends in the creation of a 3D part. The initial segmentation can be created with the threshold tool, using a Hounsfield unit range based on the area of interest desired (eg, bone, blood, fat). This is used to create an initial mask, which can be further optimized. The region grow tool allows the user to focus the segmentation by discarding areas that are not directly connected to the region of interest. In contrast, the split mask tool divides areas that are connected. Next, fine-tuning the segmentation using tools such as multiple slice edit helps to optimize the model. After all edits are made, the calculate part tool converts the mask into a 3D component that can be used in downstream applications. For the purposes of demonstration and proof of concept, the models provided in this article were created via open-source hardware designs under free or open licenses.^7-9

3D Printing in Neuroradiology Education

Neuroradiologists focus on diagnosing pathology related to the brain, head and neck, and spine. CT and MRI scans are the primary modalities used to diagnose these conditions. 3D printing is a useful tool for the trainee who wishes to fully understand neuroanatomy and obtain further appreciation of imaging pathology as it relates to 3D anatomy. Head and neck imaging are a complex subdiscipline of neuroradiology that often require further training beyond radiology residency. A neuroradiology fellowship that focuses on head and neck imaging extends the training.

3D printing has the potential to improve the understanding of various imaging pathologies by providing the trainee with a more in-depth appreciation of the anterior, middle, and posterior cranial fossa, the skull base foramina (ie, foramen ovale, spinosum, rotundum), and complex 3D areas, such as the pterygopalatine fossa, which are all critical areas to investigate on imaging. Figure 2 highlights how a complex anatomical structure, such as the sphenoid bone when printed in 3D, can be correlated with CT cross-sectional images to supplement the educational experience.

Future Directions

Artificial Intelligence (AI) offers the ability to teach computers to perform tasks that ordinarily require human intelligence. In the context of 3D printing, the ability to use AI to readily convert and process DICOM data into printable STL models holds significant promise. Currently, the manual conversion of a DICOM file into a segmented 3D model may take several days, necessitating a number of productive hours even from the imaging and engineering champion. If machines could aid in this process, the ability to readily scale clinical 3D printing and promote widespread adoption would be feasible. Several studies already are looking into this concept to determine how deep learning networks may automatically recognize lesions on medical imaging to assist a human operator, potentially cutting hours from the clinical 3D printing workflow.^12,13

Furthermore, there are several applications for AI in the context of 3D printing upstream or before the creation of a 3D model. A number of AI tools are already in use at the CT and MRI scanner. Current strategies leverage deep learning and advances in neural networks to improve image quality and create thin section DICOM data, which can be converted into printable 3D files. Additionally, the ability to automate tasks using AI can improve production capacity by assessing material costs and ensuring cost efficiency, which will be critical as point-of-care 3D printing develops widespread adoption. AI also can reduce printing errors by using automated adaptive feedback, using machine learning to search for possible print errors, and sending feedback to the computer to ensure appropriate settings (eg, temperature settings/environmental conditions).

Conclusions

Based on this single-institution experience, 3D-printed complex neuroanatomical structures seems feasible and may enhance resident education and patient safety. Interested trainees may have the opportunity to learn and be involved in the printing process of new and innovative ideas. Further studies may involve printing various pathologic processes and applying these same steps and principles to other subspecialties of radiology. Finally, AI has the potential to advance the 3D printing process in the future.

Few patients with migraine receive or are offered preventive therapy, leaving a significant treatment gap in this patient population, new research suggests. Investigators found that among patients with migraine who are eligible for preventive therapy, more than a third were not offered this option. In addition, fewer than 10% were currently taking preventive medication, and an additional 10% had discontinued preventive therapy.

“We confirmed that as of 2012 to 2013 – the years these data were collected from a large, comprehensive survey – gaps in care remained,” said study investigator Stephanie J. Nahas, MD, director of the headache medicine fellowship program, Thomas Jefferson University, Philadelphia. “In this preventive-eligible population, 35% reported never even being offered preventive medication.”

Furthermore, only 28% of patients taking preventive medication experienced a reduction in headache frequency to less than 4 days per month, which is a primary goal of treatment, said Dr. Nahas. Disease burden, as measured with scales of disability and affective comorbidities, remained substantial.

The findings were presented at the American Headache Society’s 2021 annual meeting.


 

Lack of efficacy?

In 2019, the American Headache Society published a position statement recommending that preventive treatment be considered for patients who have migraine and four or more monthly headache days (MHDs), regardless of their level of associated disability. However, previous data suggest few patients who are eligible for preventive treatment receive it. In addition, many who have used preventive medications do not adhere to their regimens because of problems with tolerability, efficacy, or both.

To identify treatment gaps and characterize self-reported use of preventive medications for migraine, the investigators examined data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) study, a web-based survey conducted in a representative U.S. sample from September 2012 through November 2013.

The survey identified and characterized patients who met modified criteria for migraine consistent with those in ICHD-3. The researchers classified respondents who had migraine and four or more MHDs as potentially eligible for migraine preventive treatment.

The investigators assessed the study population’s use of oral preventive medications, migraine-related disability and burden, willingness to take preventive treatment, and reasons for discontinuation.

Assessments included the Migraine Disability Assessment Questionnaire, the Patient Health Questionnaire–9 for depression, the Generalized Anxiety Disorder 7-Item Scale, the Migraine Specific Quality of Life questionnaire, and the Migraine Symptom Severity Scale.

In all, 16,789 respondents met criteria for migraine, and 6,579 (39.2%) reported having at least four MHDs. The median age of this subgroup that was eligible for preventive treatment was 40.3 years, and approximately 79% were women.

Only 9.8% of respondents who were eligible for preventive medications were currently using an oral preventive medication. Among those who had ever tried an oral preventive medication, 53.6% discontinued it. Efficacy for patients who used medications appeared to be inadequate. Among all current users of preventive treatment, 68.4% continued to have at least four MHDs.

The researchers assessed treatment eligibility among patients not taking preventive medication. Among respondents who had never used a preventive treatment, 35.7% were eligible to receive it. Among all users who had discontinued preventive medication, 61.0% were still eligible to receive it.
 

Attitudes toward injectables

Among respondents who had never used a preventive treatment, 64.3% had zero to three MHDs. The remaining 35.7% had 4-7, 8-14, or 15 or more MHDs. Among current users of preventive treatments, 68.4% had four or more MHDs. Among those who had discontinued preventive treatment, 61.0% had four or more MHDs.

Patients who have never used preventive medication “have substantial management gaps,” said Dr. Nahas. High proportions of these patients have moderate or severe disability (64.7%), depression (43%), and anxiety (39%). The rates of these outcomes are higher in users who discontinued treatment, likely because of confounding by indication, she added.

The prevalence of anxiety was similar between those who currently used, formerly used, or never used preventive medications. However, there were differences between never-users and current or former users with respect to moderate to severe depression (never-users, 43%; current users, 49.4%; discontinued users, 46.5%) and moderate to severe disability (never-users, 64.7%; current users, 80.4%; discontinued users, 78.9%).

In all, 44.6% of those who discontinued preventive therapy reported safety and tolerability problems as reasons for stopping treatment. In addition, 39.7% reported that these medications did not prevent enough headaches. Some patients reported partial or temporary efficacy as a reason for discontinuation. Other reasons were related to health care costs and access and personal preferences. Only 9.2% of patients who discontinued treatment said that their headaches improved enough to stop medication.

The investigators also analyzed respondents’ interest in preventive therapies. Among respondents who had never used preventive therapies, 61.8% of those who were eligible to use them were somewhat or very interested in trying an oral prescription medication for migraine prevention. However, 59.1% of never-users who were eligible for preventive medications were not at all interested, not sure, or needed more information about trying an injectable preventive medication. About 40% were not at all interested in injectables. In general, current users and those who had discontinued medication were more interested in preventive medication, including injectables.
 

‘Disheartening’ discontinuation rates

There are likely multiple reasons for the low rate of migraine prevention treatment, said Dr. Nahas. Many people with migraine never consult a clinician, owing to factors such as stigma, cost, lack of access, and lack of awareness. In addition, patients with migraine are frequently misdiagnosed, she added.

“Other data suggest that only about a quarter of people with episodic migraine and under 5% of people with chronic migraine consult a clinician, receive an accurate diagnosis, and are prescribed appropriate therapy,” said Dr. Nahas.

When the data in this analysis were gathered, public awareness of migraine was much lower than it is today, and injectable migraine therapies had not gained broad acceptance, she noted. Dr. Nahas added it is possible that attitudes toward injectable preventive medications have changed.

“Would people still prefer daily oral medications? We can’t know for sure until we start asking,” she said. In addition, scientific advances and educational outreach have increased clinicians’ awareness, interest, and skill regarding injectable medications, she said.

“I would certainly hope to see that a much greater proportion of preventive-eligible persons with migraine were at least offered, if not currently taking, preventive medication,” said Dr. Nahas. “But there’s no pleasing everyone, so I think we would still see somewhat disheartening discontinuation rates. The reasons for discontinuation, however, might be less typified by concerns about safety and tolerability.”
 

Still relevant

Commenting on the study, Mia Tova Minen, MD, chief of headache research and associate professor of neurology and population health at NYU Langone Health, New York, noted that although CaMEO is an older study, its results are still highly relevant.

“Unfortunately, primary care providers are still uncomfortable prescribing migraine preventive medications, and this accounts for the large percentage [of patients] with migraine who, while eligible for migraine preventive therapy, are not offered it,” she said.

Although the public and primary care physicians are now more aware of preventive treatments for migraine, “the number of people offered migraine preventive medication still needs to increase dramatically,” said Dr. Minen.

The American Academy of Neurology’s guidelines for migraine prevention were published in 2012 and are currently being updated. The updated guidelines may include new evidence for candesartan and emerging treatments, such as melatonin and aerobic exercise.

“It is my hope that primary care providers will become more comfortable prescribing migraine preventive medications sooner,” said Dr. Minen.

The current findings suggest a need for additional ways of educating patients with migraine who are eligible for preventive therapies so that they can advocate for themselves, she added. They also suggest the idea of demanding more insurance coverage of behavioral therapies for migraine, because data indicate that these treatments have long-term efficacy and good safety profiles, said Dr. Minen.
 

An ‘invisible’ disorder

Also commenting on the study, Barbara L. Nye, MD, director of the headache fellowship and codirector of the headache clinic at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., said the CaMEO cohort likely is representative of the general population of patients with migraine.

She noted that a significant weakness of the current study is that it examined data collected before the Food and Drug Administration approved monoclonal antibodies and therefore does not reflect patients’ current experience with medications.

“I believe that the attitudes and fears surrounding the use of injectable medication are now likely far less than previously reported, given the positive track record the new generation of once-a-month injectable medications has,” said Dr. Nye.

The findings reinforce the idea that either patients are not talking to their primary care physicians about their headaches and disability or that clinicians are not asking about them, she added. “Both issues are likely linked to the stigma that this disease state has surrounding it. This is an invisible neurological disorder to most,” Dr. Nye said.

The study was sponsored by Allergan before it was acquired by AbbVie. Dr. Nahas has served as a consultant, advisory board member, or speaker for AbbVie/Allergan, Alder/Lundbeck, Amgen/Novartis, Biohaven, Eli Lilly, Impel, Nesos Corp, Supernus, Teva, Theranica, and Zosano. She has not received and will not receive monetary compensation for this research. Dr. Minen has disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Few patients with migraine receive or are offered preventive therapy, leaving a significant treatment gap in this patient population, new research suggests. Investigators found that among patients with migraine who are eligible for preventive therapy, more than a third were not offered this option. In addition, fewer than 10% were currently taking preventive medication, and an additional 10% had discontinued preventive therapy.

“We confirmed that as of 2012 to 2013 – the years these data were collected from a large, comprehensive survey – gaps in care remained,” said study investigator Stephanie J. Nahas, MD, director of the headache medicine fellowship program, Thomas Jefferson University, Philadelphia. “In this preventive-eligible population, 35% reported never even being offered preventive medication.”

Furthermore, only 28% of patients taking preventive medication experienced a reduction in headache frequency to less than 4 days per month, which is a primary goal of treatment, said Dr. Nahas. Disease burden, as measured with scales of disability and affective comorbidities, remained substantial.

The findings were presented at the American Headache Society’s 2021 annual meeting.


 

Lack of efficacy?

In 2019, the American Headache Society published a position statement recommending that preventive treatment be considered for patients who have migraine and four or more monthly headache days (MHDs), regardless of their level of associated disability. However, previous data suggest few patients who are eligible for preventive treatment receive it. In addition, many who have used preventive medications do not adhere to their regimens because of problems with tolerability, efficacy, or both.

To identify treatment gaps and characterize self-reported use of preventive medications for migraine, the investigators examined data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) study, a web-based survey conducted in a representative U.S. sample from September 2012 through November 2013.

The survey identified and characterized patients who met modified criteria for migraine consistent with those in ICHD-3. The researchers classified respondents who had migraine and four or more MHDs as potentially eligible for migraine preventive treatment.

The investigators assessed the study population’s use of oral preventive medications, migraine-related disability and burden, willingness to take preventive treatment, and reasons for discontinuation.

Assessments included the Migraine Disability Assessment Questionnaire, the Patient Health Questionnaire–9 for depression, the Generalized Anxiety Disorder 7-Item Scale, the Migraine Specific Quality of Life questionnaire, and the Migraine Symptom Severity Scale.

In all, 16,789 respondents met criteria for migraine, and 6,579 (39.2%) reported having at least four MHDs. The median age of this subgroup that was eligible for preventive treatment was 40.3 years, and approximately 79% were women.

Only 9.8% of respondents who were eligible for preventive medications were currently using an oral preventive medication. Among those who had ever tried an oral preventive medication, 53.6% discontinued it. Efficacy for patients who used medications appeared to be inadequate. Among all current users of preventive treatment, 68.4% continued to have at least four MHDs.

The researchers assessed treatment eligibility among patients not taking preventive medication. Among respondents who had never used a preventive treatment, 35.7% were eligible to receive it. Among all users who had discontinued preventive medication, 61.0% were still eligible to receive it.
 

Attitudes toward injectables

Among respondents who had never used a preventive treatment, 64.3% had zero to three MHDs. The remaining 35.7% had 4-7, 8-14, or 15 or more MHDs. Among current users of preventive treatments, 68.4% had four or more MHDs. Among those who had discontinued preventive treatment, 61.0% had four or more MHDs.

Patients who have never used preventive medication “have substantial management gaps,” said Dr. Nahas. High proportions of these patients have moderate or severe disability (64.7%), depression (43%), and anxiety (39%). The rates of these outcomes are higher in users who discontinued treatment, likely because of confounding by indication, she added.

The prevalence of anxiety was similar between those who currently used, formerly used, or never used preventive medications. However, there were differences between never-users and current or former users with respect to moderate to severe depression (never-users, 43%; current users, 49.4%; discontinued users, 46.5%) and moderate to severe disability (never-users, 64.7%; current users, 80.4%; discontinued users, 78.9%).

In all, 44.6% of those who discontinued preventive therapy reported safety and tolerability problems as reasons for stopping treatment. In addition, 39.7% reported that these medications did not prevent enough headaches. Some patients reported partial or temporary efficacy as a reason for discontinuation. Other reasons were related to health care costs and access and personal preferences. Only 9.2% of patients who discontinued treatment said that their headaches improved enough to stop medication.

The investigators also analyzed respondents’ interest in preventive therapies. Among respondents who had never used preventive therapies, 61.8% of those who were eligible to use them were somewhat or very interested in trying an oral prescription medication for migraine prevention. However, 59.1% of never-users who were eligible for preventive medications were not at all interested, not sure, or needed more information about trying an injectable preventive medication. About 40% were not at all interested in injectables. In general, current users and those who had discontinued medication were more interested in preventive medication, including injectables.
 

‘Disheartening’ discontinuation rates

There are likely multiple reasons for the low rate of migraine prevention treatment, said Dr. Nahas. Many people with migraine never consult a clinician, owing to factors such as stigma, cost, lack of access, and lack of awareness. In addition, patients with migraine are frequently misdiagnosed, she added.

“Other data suggest that only about a quarter of people with episodic migraine and under 5% of people with chronic migraine consult a clinician, receive an accurate diagnosis, and are prescribed appropriate therapy,” said Dr. Nahas.

When the data in this analysis were gathered, public awareness of migraine was much lower than it is today, and injectable migraine therapies had not gained broad acceptance, she noted. Dr. Nahas added it is possible that attitudes toward injectable preventive medications have changed.

“Would people still prefer daily oral medications? We can’t know for sure until we start asking,” she said. In addition, scientific advances and educational outreach have increased clinicians’ awareness, interest, and skill regarding injectable medications, she said.

“I would certainly hope to see that a much greater proportion of preventive-eligible persons with migraine were at least offered, if not currently taking, preventive medication,” said Dr. Nahas. “But there’s no pleasing everyone, so I think we would still see somewhat disheartening discontinuation rates. The reasons for discontinuation, however, might be less typified by concerns about safety and tolerability.”
 

Still relevant

Commenting on the study, Mia Tova Minen, MD, chief of headache research and associate professor of neurology and population health at NYU Langone Health, New York, noted that although CaMEO is an older study, its results are still highly relevant.

“Unfortunately, primary care providers are still uncomfortable prescribing migraine preventive medications, and this accounts for the large percentage [of patients] with migraine who, while eligible for migraine preventive therapy, are not offered it,” she said.

Although the public and primary care physicians are now more aware of preventive treatments for migraine, “the number of people offered migraine preventive medication still needs to increase dramatically,” said Dr. Minen.

The American Academy of Neurology’s guidelines for migraine prevention were published in 2012 and are currently being updated. The updated guidelines may include new evidence for candesartan and emerging treatments, such as melatonin and aerobic exercise.

“It is my hope that primary care providers will become more comfortable prescribing migraine preventive medications sooner,” said Dr. Minen.

The current findings suggest a need for additional ways of educating patients with migraine who are eligible for preventive therapies so that they can advocate for themselves, she added. They also suggest the idea of demanding more insurance coverage of behavioral therapies for migraine, because data indicate that these treatments have long-term efficacy and good safety profiles, said Dr. Minen.
 

An ‘invisible’ disorder

Also commenting on the study, Barbara L. Nye, MD, director of the headache fellowship and codirector of the headache clinic at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., said the CaMEO cohort likely is representative of the general population of patients with migraine.

She noted that a significant weakness of the current study is that it examined data collected before the Food and Drug Administration approved monoclonal antibodies and therefore does not reflect patients’ current experience with medications.

“I believe that the attitudes and fears surrounding the use of injectable medication are now likely far less than previously reported, given the positive track record the new generation of once-a-month injectable medications has,” said Dr. Nye.

The findings reinforce the idea that either patients are not talking to their primary care physicians about their headaches and disability or that clinicians are not asking about them, she added. “Both issues are likely linked to the stigma that this disease state has surrounding it. This is an invisible neurological disorder to most,” Dr. Nye said.

The study was sponsored by Allergan before it was acquired by AbbVie. Dr. Nahas has served as a consultant, advisory board member, or speaker for AbbVie/Allergan, Alder/Lundbeck, Amgen/Novartis, Biohaven, Eli Lilly, Impel, Nesos Corp, Supernus, Teva, Theranica, and Zosano. She has not received and will not receive monetary compensation for this research. Dr. Minen has disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Few patients with migraine receive or are offered preventive therapy, leaving a significant treatment gap in this patient population, new research suggests. Investigators found that among patients with migraine who are eligible for preventive therapy, more than a third were not offered this option. In addition, fewer than 10% were currently taking preventive medication, and an additional 10% had discontinued preventive therapy.

“We confirmed that as of 2012 to 2013 – the years these data were collected from a large, comprehensive survey – gaps in care remained,” said study investigator Stephanie J. Nahas, MD, director of the headache medicine fellowship program, Thomas Jefferson University, Philadelphia. “In this preventive-eligible population, 35% reported never even being offered preventive medication.”

Furthermore, only 28% of patients taking preventive medication experienced a reduction in headache frequency to less than 4 days per month, which is a primary goal of treatment, said Dr. Nahas. Disease burden, as measured with scales of disability and affective comorbidities, remained substantial.

The findings were presented at the American Headache Society’s 2021 annual meeting.


 

Lack of efficacy?

In 2019, the American Headache Society published a position statement recommending that preventive treatment be considered for patients who have migraine and four or more monthly headache days (MHDs), regardless of their level of associated disability. However, previous data suggest few patients who are eligible for preventive treatment receive it. In addition, many who have used preventive medications do not adhere to their regimens because of problems with tolerability, efficacy, or both.

To identify treatment gaps and characterize self-reported use of preventive medications for migraine, the investigators examined data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) study, a web-based survey conducted in a representative U.S. sample from September 2012 through November 2013.

The survey identified and characterized patients who met modified criteria for migraine consistent with those in ICHD-3. The researchers classified respondents who had migraine and four or more MHDs as potentially eligible for migraine preventive treatment.

The investigators assessed the study population’s use of oral preventive medications, migraine-related disability and burden, willingness to take preventive treatment, and reasons for discontinuation.

Assessments included the Migraine Disability Assessment Questionnaire, the Patient Health Questionnaire–9 for depression, the Generalized Anxiety Disorder 7-Item Scale, the Migraine Specific Quality of Life questionnaire, and the Migraine Symptom Severity Scale.

In all, 16,789 respondents met criteria for migraine, and 6,579 (39.2%) reported having at least four MHDs. The median age of this subgroup that was eligible for preventive treatment was 40.3 years, and approximately 79% were women.

Only 9.8% of respondents who were eligible for preventive medications were currently using an oral preventive medication. Among those who had ever tried an oral preventive medication, 53.6% discontinued it. Efficacy for patients who used medications appeared to be inadequate. Among all current users of preventive treatment, 68.4% continued to have at least four MHDs.

The researchers assessed treatment eligibility among patients not taking preventive medication. Among respondents who had never used a preventive treatment, 35.7% were eligible to receive it. Among all users who had discontinued preventive medication, 61.0% were still eligible to receive it.
 

Attitudes toward injectables

Among respondents who had never used a preventive treatment, 64.3% had zero to three MHDs. The remaining 35.7% had 4-7, 8-14, or 15 or more MHDs. Among current users of preventive treatments, 68.4% had four or more MHDs. Among those who had discontinued preventive treatment, 61.0% had four or more MHDs.

Patients who have never used preventive medication “have substantial management gaps,” said Dr. Nahas. High proportions of these patients have moderate or severe disability (64.7%), depression (43%), and anxiety (39%). The rates of these outcomes are higher in users who discontinued treatment, likely because of confounding by indication, she added.

The prevalence of anxiety was similar between those who currently used, formerly used, or never used preventive medications. However, there were differences between never-users and current or former users with respect to moderate to severe depression (never-users, 43%; current users, 49.4%; discontinued users, 46.5%) and moderate to severe disability (never-users, 64.7%; current users, 80.4%; discontinued users, 78.9%).

In all, 44.6% of those who discontinued preventive therapy reported safety and tolerability problems as reasons for stopping treatment. In addition, 39.7% reported that these medications did not prevent enough headaches. Some patients reported partial or temporary efficacy as a reason for discontinuation. Other reasons were related to health care costs and access and personal preferences. Only 9.2% of patients who discontinued treatment said that their headaches improved enough to stop medication.

The investigators also analyzed respondents’ interest in preventive therapies. Among respondents who had never used preventive therapies, 61.8% of those who were eligible to use them were somewhat or very interested in trying an oral prescription medication for migraine prevention. However, 59.1% of never-users who were eligible for preventive medications were not at all interested, not sure, or needed more information about trying an injectable preventive medication. About 40% were not at all interested in injectables. In general, current users and those who had discontinued medication were more interested in preventive medication, including injectables.
 

‘Disheartening’ discontinuation rates

There are likely multiple reasons for the low rate of migraine prevention treatment, said Dr. Nahas. Many people with migraine never consult a clinician, owing to factors such as stigma, cost, lack of access, and lack of awareness. In addition, patients with migraine are frequently misdiagnosed, she added.

“Other data suggest that only about a quarter of people with episodic migraine and under 5% of people with chronic migraine consult a clinician, receive an accurate diagnosis, and are prescribed appropriate therapy,” said Dr. Nahas.

When the data in this analysis were gathered, public awareness of migraine was much lower than it is today, and injectable migraine therapies had not gained broad acceptance, she noted. Dr. Nahas added it is possible that attitudes toward injectable preventive medications have changed.

“Would people still prefer daily oral medications? We can’t know for sure until we start asking,” she said. In addition, scientific advances and educational outreach have increased clinicians’ awareness, interest, and skill regarding injectable medications, she said.

“I would certainly hope to see that a much greater proportion of preventive-eligible persons with migraine were at least offered, if not currently taking, preventive medication,” said Dr. Nahas. “But there’s no pleasing everyone, so I think we would still see somewhat disheartening discontinuation rates. The reasons for discontinuation, however, might be less typified by concerns about safety and tolerability.”
 

Still relevant

Commenting on the study, Mia Tova Minen, MD, chief of headache research and associate professor of neurology and population health at NYU Langone Health, New York, noted that although CaMEO is an older study, its results are still highly relevant.

“Unfortunately, primary care providers are still uncomfortable prescribing migraine preventive medications, and this accounts for the large percentage [of patients] with migraine who, while eligible for migraine preventive therapy, are not offered it,” she said.

Although the public and primary care physicians are now more aware of preventive treatments for migraine, “the number of people offered migraine preventive medication still needs to increase dramatically,” said Dr. Minen.

The American Academy of Neurology’s guidelines for migraine prevention were published in 2012 and are currently being updated. The updated guidelines may include new evidence for candesartan and emerging treatments, such as melatonin and aerobic exercise.

“It is my hope that primary care providers will become more comfortable prescribing migraine preventive medications sooner,” said Dr. Minen.

The current findings suggest a need for additional ways of educating patients with migraine who are eligible for preventive therapies so that they can advocate for themselves, she added. They also suggest the idea of demanding more insurance coverage of behavioral therapies for migraine, because data indicate that these treatments have long-term efficacy and good safety profiles, said Dr. Minen.
 

An ‘invisible’ disorder

Also commenting on the study, Barbara L. Nye, MD, director of the headache fellowship and codirector of the headache clinic at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., said the CaMEO cohort likely is representative of the general population of patients with migraine.

She noted that a significant weakness of the current study is that it examined data collected before the Food and Drug Administration approved monoclonal antibodies and therefore does not reflect patients’ current experience with medications.

“I believe that the attitudes and fears surrounding the use of injectable medication are now likely far less than previously reported, given the positive track record the new generation of once-a-month injectable medications has,” said Dr. Nye.

The findings reinforce the idea that either patients are not talking to their primary care physicians about their headaches and disability or that clinicians are not asking about them, she added. “Both issues are likely linked to the stigma that this disease state has surrounding it. This is an invisible neurological disorder to most,” Dr. Nye said.

The study was sponsored by Allergan before it was acquired by AbbVie. Dr. Nahas has served as a consultant, advisory board member, or speaker for AbbVie/Allergan, Alder/Lundbeck, Amgen/Novartis, Biohaven, Eli Lilly, Impel, Nesos Corp, Supernus, Teva, Theranica, and Zosano. She has not received and will not receive monetary compensation for this research. Dr. Minen has disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved Medtronic’s technologically advanced deep brain stimulation (DBS) system designed to more precisely target motor symptoms in Parkinson’s disease, dystonia, or essential tremor.

The SenSight Directional Lead System for DBS therapy combines two recent advancements: sensing capability that allows real-time monitoring of brain signals to optimize settings for stimulation, and a “directional lead” that enables steering of electric current for more precise targeting of stimulation through the electrode.

“Until now, sensing capability and directional leads have not been available in the same DBS system, so we have had to choose one technology or the other, based on the predicted needs of each patient,” neurosurgeon Kelly Foote, MD, who performed the first implant of the SenSight System at University of Florida (UF) Health, said in a news release.

“Now, by coupling this new directional lead with a pulse generator capable of brain sensing, we are excited to be able to offer our patients the synergistic benefits of both technologies,” added Dr. Foote, codirector of the Norman Fixel Institute for Neurological Diseases at UF Health.

Dr. Foote said DBS systems capable of adjusting therapeutic stimulation in response to continuously recorded brain signals may lead to better DBS outcomes with fewer adverse effects.

“Adding a directional lead to such a system will improve our ability to localize abnormal signals and enable us to steer current more effectively to areas in the brain where it is most beneficial,” Dr. Foote said.

“We are excited to see the clinical benefits that the new SenSight directional lead system will provide to patients and physicians in the U.S.,” added Mike Daly, vice president and general manager of brain modulation at Medtronic.

Medtronic’s SenSight directional lead DBS system received CE Mark approval in Europe in March.
 

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved Medtronic’s technologically advanced deep brain stimulation (DBS) system designed to more precisely target motor symptoms in Parkinson’s disease, dystonia, or essential tremor.

The SenSight Directional Lead System for DBS therapy combines two recent advancements: sensing capability that allows real-time monitoring of brain signals to optimize settings for stimulation, and a “directional lead” that enables steering of electric current for more precise targeting of stimulation through the electrode.

“Until now, sensing capability and directional leads have not been available in the same DBS system, so we have had to choose one technology or the other, based on the predicted needs of each patient,” neurosurgeon Kelly Foote, MD, who performed the first implant of the SenSight System at University of Florida (UF) Health, said in a news release.

“Now, by coupling this new directional lead with a pulse generator capable of brain sensing, we are excited to be able to offer our patients the synergistic benefits of both technologies,” added Dr. Foote, codirector of the Norman Fixel Institute for Neurological Diseases at UF Health.

Dr. Foote said DBS systems capable of adjusting therapeutic stimulation in response to continuously recorded brain signals may lead to better DBS outcomes with fewer adverse effects.

“Adding a directional lead to such a system will improve our ability to localize abnormal signals and enable us to steer current more effectively to areas in the brain where it is most beneficial,” Dr. Foote said.

“We are excited to see the clinical benefits that the new SenSight directional lead system will provide to patients and physicians in the U.S.,” added Mike Daly, vice president and general manager of brain modulation at Medtronic.

Medtronic’s SenSight directional lead DBS system received CE Mark approval in Europe in March.
 

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved Medtronic’s technologically advanced deep brain stimulation (DBS) system designed to more precisely target motor symptoms in Parkinson’s disease, dystonia, or essential tremor.

The SenSight Directional Lead System for DBS therapy combines two recent advancements: sensing capability that allows real-time monitoring of brain signals to optimize settings for stimulation, and a “directional lead” that enables steering of electric current for more precise targeting of stimulation through the electrode.

“Until now, sensing capability and directional leads have not been available in the same DBS system, so we have had to choose one technology or the other, based on the predicted needs of each patient,” neurosurgeon Kelly Foote, MD, who performed the first implant of the SenSight System at University of Florida (UF) Health, said in a news release.

“Now, by coupling this new directional lead with a pulse generator capable of brain sensing, we are excited to be able to offer our patients the synergistic benefits of both technologies,” added Dr. Foote, codirector of the Norman Fixel Institute for Neurological Diseases at UF Health.

Dr. Foote said DBS systems capable of adjusting therapeutic stimulation in response to continuously recorded brain signals may lead to better DBS outcomes with fewer adverse effects.

“Adding a directional lead to such a system will improve our ability to localize abnormal signals and enable us to steer current more effectively to areas in the brain where it is most beneficial,” Dr. Foote said.

“We are excited to see the clinical benefits that the new SenSight directional lead system will provide to patients and physicians in the U.S.,” added Mike Daly, vice president and general manager of brain modulation at Medtronic.

Medtronic’s SenSight directional lead DBS system received CE Mark approval in Europe in March.
 

A version of this article first appeared on Medscape.com.

OnabotulinumtoxinA alone provides relief from chronic migraine, and addition of anti-calcitonin gene-related peptide (CGRP) antibodies may boost the benefit, according to a large retrospective analysis. The results lend hope that the combination may be synergistic, according to Andrew Blumenfeld, MD, director of the Headache Center of Southern California in Carlsbad. Dr. Blumenfeld presented at the American Headache Society’s 2021 annual meeting. The study was published online April 21 in Pain Therapy.

The retrospective analysis showed a 4-day reduction in headache days per month. In contrast, in the pivotal study for erenumab, the most commonly used anti-CGRP antibody among subjects in the study, showed a 2-day benefit in a subanalysis of patients who had failed at least two oral preventives.

There is mechanistic evidence to suggest the two therapies could be synergistic. OnabotulinumtoxinA is believed to inhibit the release of CGRP, and antibodies reduce CGRP levels. OnabotulinumtoxinA prevents activation of C-fibers in the trigeminal sensory afferents, but does not affect A-delta fibers.

On the other hand, most data indicate that the anti-CGRP antibody fremanezumab prevents activation of A-delta but not C-fibers, and a recent review argues that CGRP antibody nonresponders may have migraines driven by C-fibers or other pathways. “Thus, concomitant use of medications blocking the activation of meningeal C-fibers may provide a synergistic effect on the trigeminal nociceptive pathway,” the authors wrote.
 

Study finding match clinical practice

The results of the new study strengthen the case that the combination is effective, though proof would require prospective, randomized trials. “I think that it really gives credibility to what we are seeing in practice, which is that combined therapy often is much better than therapy with onabotulinumtoxinA alone, said Deborah Friedman, MD, MPH, who was asked to comment on the findings. Dr. Friedman is professor of neurology and ophthalmology at the University of Texas, Dallas.

The extra 4 migraine-free days per month is a significant benefit, said Stewart Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth, Hanover, N.H. “It’s an extra month and a half of no disability per year, and that’s on top of what onabotulinumtoxinA does. So it’s really a very important clinical finding,” Dr. Tepper said in an interview.

Improvements with combination therapy

The study was a chart review of 257 patients who started on onabotulinumtoxinA and later initiated anti-CGRP antibody therapy. A total of 104 completed four visits after initiation of anti-CGRP antibody therapy (completers). Before starting any therapy, patients reported an average of 21 headache days per month in the overall group, and 22 among completers. That frequency dropped to 12 in both groups after onabotulinumtoxinA therapy (overall group difference, –9 days; 95% confidence interval, –8 to –11 days; completers group difference, –10; 95% CI, –7 to –12 days).

A total of 77.8% of subjects in the overall cohort took erenumab, 16.3% took galcanezumab, and 5.8% took fremanezumab. In the completers cohort, the percentages were 84.5%, 10.7%, and 4.9%, respectively.

Compared with baseline, both completers and noncompleters had clinically significant improvements in disability, as measured by at least a 5-point improvement in Migraine Disability Assessment (MIDAS) score at the 3-month visit (–5.8 for completers and –6.3 for the overall cohort group), the 6-month visit (–6.6 and –11.1), the 9-month visit (–8.3 and –6.1), and 1 year (–12.7 and –8.4).

At the first visit, 33.0% of completers had at least a 5-point reduction in MIDAS, as did 36.0% of the overall cohort group, and the trend continued at 6 months (39.8% and 45.1%), 9 months (43.7% and 43.7%), and at 1 year (45.3% and 44.8%).

The study was funded by Allergan. Dr. Blumenfeld has served on advisory boards for Aeon, AbbVie, Amgen, Alder, Biohaven, Teva, Supernus, Promius, Eaglet, and Lilly, and has received funding for speaking from AbbVie, Amgen, Pernix, Supernus, Depomed, Avanir, Promius, Teva, Eli Lilly, Lundbeck, Novartis, and Theranica. Dr. Tepper has consulted for Teva. Dr. Friedman has been on the advisory board for Allergan, Amgen, Lundbeck, Eli Lilly, and Teva Pharmaceuticals, and has received grant support from Allergan and Eli Lilly.

OnabotulinumtoxinA alone provides relief from chronic migraine, and addition of anti-calcitonin gene-related peptide (CGRP) antibodies may boost the benefit, according to a large retrospective analysis. The results lend hope that the combination may be synergistic, according to Andrew Blumenfeld, MD, director of the Headache Center of Southern California in Carlsbad. Dr. Blumenfeld presented at the American Headache Society’s 2021 annual meeting. The study was published online April 21 in Pain Therapy.

The retrospective analysis showed a 4-day reduction in headache days per month. In contrast, in the pivotal study for erenumab, the most commonly used anti-CGRP antibody among subjects in the study, showed a 2-day benefit in a subanalysis of patients who had failed at least two oral preventives.

There is mechanistic evidence to suggest the two therapies could be synergistic. OnabotulinumtoxinA is believed to inhibit the release of CGRP, and antibodies reduce CGRP levels. OnabotulinumtoxinA prevents activation of C-fibers in the trigeminal sensory afferents, but does not affect A-delta fibers.

On the other hand, most data indicate that the anti-CGRP antibody fremanezumab prevents activation of A-delta but not C-fibers, and a recent review argues that CGRP antibody nonresponders may have migraines driven by C-fibers or other pathways. “Thus, concomitant use of medications blocking the activation of meningeal C-fibers may provide a synergistic effect on the trigeminal nociceptive pathway,” the authors wrote.
 

Study finding match clinical practice

The results of the new study strengthen the case that the combination is effective, though proof would require prospective, randomized trials. “I think that it really gives credibility to what we are seeing in practice, which is that combined therapy often is much better than therapy with onabotulinumtoxinA alone, said Deborah Friedman, MD, MPH, who was asked to comment on the findings. Dr. Friedman is professor of neurology and ophthalmology at the University of Texas, Dallas.

The extra 4 migraine-free days per month is a significant benefit, said Stewart Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth, Hanover, N.H. “It’s an extra month and a half of no disability per year, and that’s on top of what onabotulinumtoxinA does. So it’s really a very important clinical finding,” Dr. Tepper said in an interview.

Improvements with combination therapy

The study was a chart review of 257 patients who started on onabotulinumtoxinA and later initiated anti-CGRP antibody therapy. A total of 104 completed four visits after initiation of anti-CGRP antibody therapy (completers). Before starting any therapy, patients reported an average of 21 headache days per month in the overall group, and 22 among completers. That frequency dropped to 12 in both groups after onabotulinumtoxinA therapy (overall group difference, –9 days; 95% confidence interval, –8 to –11 days; completers group difference, –10; 95% CI, –7 to –12 days).

A total of 77.8% of subjects in the overall cohort took erenumab, 16.3% took galcanezumab, and 5.8% took fremanezumab. In the completers cohort, the percentages were 84.5%, 10.7%, and 4.9%, respectively.

Compared with baseline, both completers and noncompleters had clinically significant improvements in disability, as measured by at least a 5-point improvement in Migraine Disability Assessment (MIDAS) score at the 3-month visit (–5.8 for completers and –6.3 for the overall cohort group), the 6-month visit (–6.6 and –11.1), the 9-month visit (–8.3 and –6.1), and 1 year (–12.7 and –8.4).

At the first visit, 33.0% of completers had at least a 5-point reduction in MIDAS, as did 36.0% of the overall cohort group, and the trend continued at 6 months (39.8% and 45.1%), 9 months (43.7% and 43.7%), and at 1 year (45.3% and 44.8%).

The study was funded by Allergan. Dr. Blumenfeld has served on advisory boards for Aeon, AbbVie, Amgen, Alder, Biohaven, Teva, Supernus, Promius, Eaglet, and Lilly, and has received funding for speaking from AbbVie, Amgen, Pernix, Supernus, Depomed, Avanir, Promius, Teva, Eli Lilly, Lundbeck, Novartis, and Theranica. Dr. Tepper has consulted for Teva. Dr. Friedman has been on the advisory board for Allergan, Amgen, Lundbeck, Eli Lilly, and Teva Pharmaceuticals, and has received grant support from Allergan and Eli Lilly.

OnabotulinumtoxinA alone provides relief from chronic migraine, and addition of anti-calcitonin gene-related peptide (CGRP) antibodies may boost the benefit, according to a large retrospective analysis. The results lend hope that the combination may be synergistic, according to Andrew Blumenfeld, MD, director of the Headache Center of Southern California in Carlsbad. Dr. Blumenfeld presented at the American Headache Society’s 2021 annual meeting. The study was published online April 21 in Pain Therapy.

The retrospective analysis showed a 4-day reduction in headache days per month. In contrast, in the pivotal study for erenumab, the most commonly used anti-CGRP antibody among subjects in the study, showed a 2-day benefit in a subanalysis of patients who had failed at least two oral preventives.

There is mechanistic evidence to suggest the two therapies could be synergistic. OnabotulinumtoxinA is believed to inhibit the release of CGRP, and antibodies reduce CGRP levels. OnabotulinumtoxinA prevents activation of C-fibers in the trigeminal sensory afferents, but does not affect A-delta fibers.

On the other hand, most data indicate that the anti-CGRP antibody fremanezumab prevents activation of A-delta but not C-fibers, and a recent review argues that CGRP antibody nonresponders may have migraines driven by C-fibers or other pathways. “Thus, concomitant use of medications blocking the activation of meningeal C-fibers may provide a synergistic effect on the trigeminal nociceptive pathway,” the authors wrote.
 

Study finding match clinical practice

The results of the new study strengthen the case that the combination is effective, though proof would require prospective, randomized trials. “I think that it really gives credibility to what we are seeing in practice, which is that combined therapy often is much better than therapy with onabotulinumtoxinA alone, said Deborah Friedman, MD, MPH, who was asked to comment on the findings. Dr. Friedman is professor of neurology and ophthalmology at the University of Texas, Dallas.

The extra 4 migraine-free days per month is a significant benefit, said Stewart Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth, Hanover, N.H. “It’s an extra month and a half of no disability per year, and that’s on top of what onabotulinumtoxinA does. So it’s really a very important clinical finding,” Dr. Tepper said in an interview.

Improvements with combination therapy

The study was a chart review of 257 patients who started on onabotulinumtoxinA and later initiated anti-CGRP antibody therapy. A total of 104 completed four visits after initiation of anti-CGRP antibody therapy (completers). Before starting any therapy, patients reported an average of 21 headache days per month in the overall group, and 22 among completers. That frequency dropped to 12 in both groups after onabotulinumtoxinA therapy (overall group difference, –9 days; 95% confidence interval, –8 to –11 days; completers group difference, –10; 95% CI, –7 to –12 days).

A total of 77.8% of subjects in the overall cohort took erenumab, 16.3% took galcanezumab, and 5.8% took fremanezumab. In the completers cohort, the percentages were 84.5%, 10.7%, and 4.9%, respectively.

Compared with baseline, both completers and noncompleters had clinically significant improvements in disability, as measured by at least a 5-point improvement in Migraine Disability Assessment (MIDAS) score at the 3-month visit (–5.8 for completers and –6.3 for the overall cohort group), the 6-month visit (–6.6 and –11.1), the 9-month visit (–8.3 and –6.1), and 1 year (–12.7 and –8.4).

At the first visit, 33.0% of completers had at least a 5-point reduction in MIDAS, as did 36.0% of the overall cohort group, and the trend continued at 6 months (39.8% and 45.1%), 9 months (43.7% and 43.7%), and at 1 year (45.3% and 44.8%).

The study was funded by Allergan. Dr. Blumenfeld has served on advisory boards for Aeon, AbbVie, Amgen, Alder, Biohaven, Teva, Supernus, Promius, Eaglet, and Lilly, and has received funding for speaking from AbbVie, Amgen, Pernix, Supernus, Depomed, Avanir, Promius, Teva, Eli Lilly, Lundbeck, Novartis, and Theranica. Dr. Tepper has consulted for Teva. Dr. Friedman has been on the advisory board for Allergan, Amgen, Lundbeck, Eli Lilly, and Teva Pharmaceuticals, and has received grant support from Allergan and Eli Lilly.

Almost 50% of patients with migraine hesitate to seek appropriate care, new research shows. A survey of nearly 18,000 participants with migraine showed that 46% were reluctant to consult a physician about their condition. Among those who hesitated, 58% ultimately consulted a physician, but 42% did not.

Common reasons for failure to seek treatment included believing that migraine was not severe enough to warrant a consultation, worries about cost and health insurance, and concern that the health care professional would not take the disorder seriously.

This is the first study to query patients with migraine regarding whether and why they have hesitated to seek care, said coinvestigator Robert E. Shapiro, MD, PhD, professor of neurologic sciences and director of the division of headache medicine at the University of Vermont, Burlington. “Previous studies have noted differences in care seeking by demographic or other distinguishing characteristics but have not asked people with migraine whether they actually intended to seek or not seek such care,” he said.

Dr. Shapiro presented the findings at the American Headache Society’s 2021 annual meeting.
 

Delays prevent diagnosis and care

For patients with migraine, hesitating to consult a physician causes delays in, and sometimes prevents, receiving a diagnosis and appropriate care.

To assess the proportion of patients who hesitate to seek a consultation for migraine care, as well as reasons for doing so, the investigators examined data from the Observational Survey of the Epidemiology, Treatment, and Care of Migraine (OVERCOME) study. OVERCOME incorporated a prospective web-based survey that was administered to a representative sample of 41,925 individuals in the United States.

Eligible participants who completed the study’s baseline assessment had had at least one migraine attack in the previous year and either met criteria for migraine on the basis of a validated diagnostic screen or provided a self-report of a migraine diagnosis by a health care practitioner. In all, 39,494 participants reported whether they had hesitated to seek a consultation from a physician for migraine care. Of these, 17,951 were included in the analysis.

Among the 46% who hesitated to seek care, 58% ultimately sought migraine care, and 42% did not.

The investigators also examined sociodemographic characteristics and migraine-related data, including the number of monthly headache days and information regarding nausea, photophobia, and phonophobia.

Patient-reported outcomes included days with migraine-related disability during the past 3 months, treatment optimization, and the degree to which migraine limited regular activities. Investigators also examined participants’ health care use in the previous 12 months and reasons for hesitating to seek migraine care.
 

Reasons for hesitancy

A total of 17,920 participants provided reasons for hesitating to seek a migraine consultation. These included a desire to take care of migraine attacks on one’s own (45%), the belief that migraine would not be taken seriously (35%), the belief that the migraine attacks were not serious or painful enough (29%), inability to afford or unwillingness to spend money on care (29%), lack of or inadequate health insurance (21%), and fear of receiving a serious diagnosis (19%).

Reasons for hesitation differed between participants who ultimately sought a consultation with a physician and those who did not. Those who did not receive a consultation (n = 7,495) were more likely to want to take care of the migraine attacks on their own (48% vs. 43%) and to believe the attacks were not serious or painful enough (36% vs. 25%).

Participants who hesitated but later sought a consultation were more likely to report concerns that migraine would not be taken seriously (38% vs. 31%) and fear of receiving a serious diagnosis (22% vs. 15%).

Among those who did not seek a consultation versus those who did, a significantly higher proportion were women (76% vs. 73%; P < .001).

“This is an interesting finding, since prior studies have indicated that, overall, women with migraine are more likely to have consulted a doctor for it – and also more likely to have been diagnosed with it,” Dr. Shapiro said.

On the other hand, women were 30% more likely to visit emergency departments or urgent care clinics for migraine care than men, he noted.

“These findings suggest some women may be experiencing particular barriers to receiving successful consultation care and that they may persistently hesitate to seek it,” said Dr. Shapiro. He noted that these barriers might be financial or attitudinal.

“Women are reported to be less likely to receive treatment for pain conditions, and furthermore, stigma toward migraine in particular may limit its perceived seriousness,” he said.
 

‘Equitable access’ needed

Those with full-time employment were significantly more likely to seek a migraine consultation than were those who were not employed full time (46% vs. 42%; P < .001). Patients who sought care were more likely to have health insurance (87% vs. 78%; P < .001).

Having health insurance (odds ratio [OR], 1.99), having previously received a migraine diagnosis (OR, 2.71), and degree of disability (severe vs. none: OR, 2.76; moderate vs. none: OR, 2.04) were associated with increased likelihood of seeking a migraine consultation among those who initially hesitated. Other factors included being male (OR, 1.49), having nausea (OR, 1.15), or being employed full time (OR, 1.24).

“Taken together, our findings suggest consultation rates may be limited by financial barriers and pervasive attitudes that migraine is either not serious or is untreatable,” said Dr. Shapiro. Consistent with this hypothesis is the finding that individuals with migraine who had received an appropriate diagnosis and were therefore better informed about the condition were more likely to continue to seek care for it, he noted.

Because most outpatient medical encounters for migraine are with primary care practitioners, it may make sense to ensure that such clinicians are “well trained in diagnosing and treating common presentations of migraine,” Dr. Shapiro said. It is equally important to ensure “equitable access to health insurance to pay for these consultations,” he added.
 

‘Take migraine more seriously’

Commenting on the findings, Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, said the study was well designed.

Potential weaknesses include the fact that patients were required only to have one migraine attack per year and that not all were diagnosed by a headache specialist using ICHD-3 criteria.

Still, “online, validated, patient-reported data is quite acceptable,” said Dr. Rapoport, who was not involved in the research.

He noted that there is a clear message from the findings for all physicians who see patients with headache disorders: “You will increase the chance of patients consulting and continuing to consult when you make an accurate migraine diagnosis, take migraine more seriously, and understand the stigmas attached to it – and when there are reduced institutional barriers and costs of health care.”

The findings suggest that neurologists should strive to provide patients with ongoing care and medication, he added. In addition, there is a need for further education about the stigma associated with migraine and about how others view this disabling disease, Dr. Rapoport concluded.

The study was funded by Eli Lilly. Dr. Shapiro has consulted for Eli Lilly and Lundbeck. Dr. Rapoport has reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Almost 50% of patients with migraine hesitate to seek appropriate care, new research shows. A survey of nearly 18,000 participants with migraine showed that 46% were reluctant to consult a physician about their condition. Among those who hesitated, 58% ultimately consulted a physician, but 42% did not.

Common reasons for failure to seek treatment included believing that migraine was not severe enough to warrant a consultation, worries about cost and health insurance, and concern that the health care professional would not take the disorder seriously.

This is the first study to query patients with migraine regarding whether and why they have hesitated to seek care, said coinvestigator Robert E. Shapiro, MD, PhD, professor of neurologic sciences and director of the division of headache medicine at the University of Vermont, Burlington. “Previous studies have noted differences in care seeking by demographic or other distinguishing characteristics but have not asked people with migraine whether they actually intended to seek or not seek such care,” he said.

Dr. Shapiro presented the findings at the American Headache Society’s 2021 annual meeting.
 

Delays prevent diagnosis and care

For patients with migraine, hesitating to consult a physician causes delays in, and sometimes prevents, receiving a diagnosis and appropriate care.

To assess the proportion of patients who hesitate to seek a consultation for migraine care, as well as reasons for doing so, the investigators examined data from the Observational Survey of the Epidemiology, Treatment, and Care of Migraine (OVERCOME) study. OVERCOME incorporated a prospective web-based survey that was administered to a representative sample of 41,925 individuals in the United States.

Eligible participants who completed the study’s baseline assessment had had at least one migraine attack in the previous year and either met criteria for migraine on the basis of a validated diagnostic screen or provided a self-report of a migraine diagnosis by a health care practitioner. In all, 39,494 participants reported whether they had hesitated to seek a consultation from a physician for migraine care. Of these, 17,951 were included in the analysis.

Among the 46% who hesitated to seek care, 58% ultimately sought migraine care, and 42% did not.

The investigators also examined sociodemographic characteristics and migraine-related data, including the number of monthly headache days and information regarding nausea, photophobia, and phonophobia.

Patient-reported outcomes included days with migraine-related disability during the past 3 months, treatment optimization, and the degree to which migraine limited regular activities. Investigators also examined participants’ health care use in the previous 12 months and reasons for hesitating to seek migraine care.
 

Reasons for hesitancy

A total of 17,920 participants provided reasons for hesitating to seek a migraine consultation. These included a desire to take care of migraine attacks on one’s own (45%), the belief that migraine would not be taken seriously (35%), the belief that the migraine attacks were not serious or painful enough (29%), inability to afford or unwillingness to spend money on care (29%), lack of or inadequate health insurance (21%), and fear of receiving a serious diagnosis (19%).

Reasons for hesitation differed between participants who ultimately sought a consultation with a physician and those who did not. Those who did not receive a consultation (n = 7,495) were more likely to want to take care of the migraine attacks on their own (48% vs. 43%) and to believe the attacks were not serious or painful enough (36% vs. 25%).

Participants who hesitated but later sought a consultation were more likely to report concerns that migraine would not be taken seriously (38% vs. 31%) and fear of receiving a serious diagnosis (22% vs. 15%).

Among those who did not seek a consultation versus those who did, a significantly higher proportion were women (76% vs. 73%; P < .001).

“This is an interesting finding, since prior studies have indicated that, overall, women with migraine are more likely to have consulted a doctor for it – and also more likely to have been diagnosed with it,” Dr. Shapiro said.

On the other hand, women were 30% more likely to visit emergency departments or urgent care clinics for migraine care than men, he noted.

“These findings suggest some women may be experiencing particular barriers to receiving successful consultation care and that they may persistently hesitate to seek it,” said Dr. Shapiro. He noted that these barriers might be financial or attitudinal.

“Women are reported to be less likely to receive treatment for pain conditions, and furthermore, stigma toward migraine in particular may limit its perceived seriousness,” he said.
 

‘Equitable access’ needed

Those with full-time employment were significantly more likely to seek a migraine consultation than were those who were not employed full time (46% vs. 42%; P < .001). Patients who sought care were more likely to have health insurance (87% vs. 78%; P < .001).

Having health insurance (odds ratio [OR], 1.99), having previously received a migraine diagnosis (OR, 2.71), and degree of disability (severe vs. none: OR, 2.76; moderate vs. none: OR, 2.04) were associated with increased likelihood of seeking a migraine consultation among those who initially hesitated. Other factors included being male (OR, 1.49), having nausea (OR, 1.15), or being employed full time (OR, 1.24).

“Taken together, our findings suggest consultation rates may be limited by financial barriers and pervasive attitudes that migraine is either not serious or is untreatable,” said Dr. Shapiro. Consistent with this hypothesis is the finding that individuals with migraine who had received an appropriate diagnosis and were therefore better informed about the condition were more likely to continue to seek care for it, he noted.

Because most outpatient medical encounters for migraine are with primary care practitioners, it may make sense to ensure that such clinicians are “well trained in diagnosing and treating common presentations of migraine,” Dr. Shapiro said. It is equally important to ensure “equitable access to health insurance to pay for these consultations,” he added.
 

‘Take migraine more seriously’

Commenting on the findings, Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, said the study was well designed.

Potential weaknesses include the fact that patients were required only to have one migraine attack per year and that not all were diagnosed by a headache specialist using ICHD-3 criteria.

Still, “online, validated, patient-reported data is quite acceptable,” said Dr. Rapoport, who was not involved in the research.

He noted that there is a clear message from the findings for all physicians who see patients with headache disorders: “You will increase the chance of patients consulting and continuing to consult when you make an accurate migraine diagnosis, take migraine more seriously, and understand the stigmas attached to it – and when there are reduced institutional barriers and costs of health care.”

The findings suggest that neurologists should strive to provide patients with ongoing care and medication, he added. In addition, there is a need for further education about the stigma associated with migraine and about how others view this disabling disease, Dr. Rapoport concluded.

The study was funded by Eli Lilly. Dr. Shapiro has consulted for Eli Lilly and Lundbeck. Dr. Rapoport has reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Almost 50% of patients with migraine hesitate to seek appropriate care, new research shows. A survey of nearly 18,000 participants with migraine showed that 46% were reluctant to consult a physician about their condition. Among those who hesitated, 58% ultimately consulted a physician, but 42% did not.

Common reasons for failure to seek treatment included believing that migraine was not severe enough to warrant a consultation, worries about cost and health insurance, and concern that the health care professional would not take the disorder seriously.

This is the first study to query patients with migraine regarding whether and why they have hesitated to seek care, said coinvestigator Robert E. Shapiro, MD, PhD, professor of neurologic sciences and director of the division of headache medicine at the University of Vermont, Burlington. “Previous studies have noted differences in care seeking by demographic or other distinguishing characteristics but have not asked people with migraine whether they actually intended to seek or not seek such care,” he said.

Dr. Shapiro presented the findings at the American Headache Society’s 2021 annual meeting.
 

Delays prevent diagnosis and care

For patients with migraine, hesitating to consult a physician causes delays in, and sometimes prevents, receiving a diagnosis and appropriate care.

To assess the proportion of patients who hesitate to seek a consultation for migraine care, as well as reasons for doing so, the investigators examined data from the Observational Survey of the Epidemiology, Treatment, and Care of Migraine (OVERCOME) study. OVERCOME incorporated a prospective web-based survey that was administered to a representative sample of 41,925 individuals in the United States.

Eligible participants who completed the study’s baseline assessment had had at least one migraine attack in the previous year and either met criteria for migraine on the basis of a validated diagnostic screen or provided a self-report of a migraine diagnosis by a health care practitioner. In all, 39,494 participants reported whether they had hesitated to seek a consultation from a physician for migraine care. Of these, 17,951 were included in the analysis.

Among the 46% who hesitated to seek care, 58% ultimately sought migraine care, and 42% did not.

The investigators also examined sociodemographic characteristics and migraine-related data, including the number of monthly headache days and information regarding nausea, photophobia, and phonophobia.

Patient-reported outcomes included days with migraine-related disability during the past 3 months, treatment optimization, and the degree to which migraine limited regular activities. Investigators also examined participants’ health care use in the previous 12 months and reasons for hesitating to seek migraine care.
 

Reasons for hesitancy

A total of 17,920 participants provided reasons for hesitating to seek a migraine consultation. These included a desire to take care of migraine attacks on one’s own (45%), the belief that migraine would not be taken seriously (35%), the belief that the migraine attacks were not serious or painful enough (29%), inability to afford or unwillingness to spend money on care (29%), lack of or inadequate health insurance (21%), and fear of receiving a serious diagnosis (19%).

Reasons for hesitation differed between participants who ultimately sought a consultation with a physician and those who did not. Those who did not receive a consultation (n = 7,495) were more likely to want to take care of the migraine attacks on their own (48% vs. 43%) and to believe the attacks were not serious or painful enough (36% vs. 25%).

Participants who hesitated but later sought a consultation were more likely to report concerns that migraine would not be taken seriously (38% vs. 31%) and fear of receiving a serious diagnosis (22% vs. 15%).

Among those who did not seek a consultation versus those who did, a significantly higher proportion were women (76% vs. 73%; P < .001).

“This is an interesting finding, since prior studies have indicated that, overall, women with migraine are more likely to have consulted a doctor for it – and also more likely to have been diagnosed with it,” Dr. Shapiro said.

On the other hand, women were 30% more likely to visit emergency departments or urgent care clinics for migraine care than men, he noted.

“These findings suggest some women may be experiencing particular barriers to receiving successful consultation care and that they may persistently hesitate to seek it,” said Dr. Shapiro. He noted that these barriers might be financial or attitudinal.

“Women are reported to be less likely to receive treatment for pain conditions, and furthermore, stigma toward migraine in particular may limit its perceived seriousness,” he said.
 

‘Equitable access’ needed

Those with full-time employment were significantly more likely to seek a migraine consultation than were those who were not employed full time (46% vs. 42%; P < .001). Patients who sought care were more likely to have health insurance (87% vs. 78%; P < .001).

Having health insurance (odds ratio [OR], 1.99), having previously received a migraine diagnosis (OR, 2.71), and degree of disability (severe vs. none: OR, 2.76; moderate vs. none: OR, 2.04) were associated with increased likelihood of seeking a migraine consultation among those who initially hesitated. Other factors included being male (OR, 1.49), having nausea (OR, 1.15), or being employed full time (OR, 1.24).

“Taken together, our findings suggest consultation rates may be limited by financial barriers and pervasive attitudes that migraine is either not serious or is untreatable,” said Dr. Shapiro. Consistent with this hypothesis is the finding that individuals with migraine who had received an appropriate diagnosis and were therefore better informed about the condition were more likely to continue to seek care for it, he noted.

Because most outpatient medical encounters for migraine are with primary care practitioners, it may make sense to ensure that such clinicians are “well trained in diagnosing and treating common presentations of migraine,” Dr. Shapiro said. It is equally important to ensure “equitable access to health insurance to pay for these consultations,” he added.
 

‘Take migraine more seriously’

Commenting on the findings, Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, said the study was well designed.

Potential weaknesses include the fact that patients were required only to have one migraine attack per year and that not all were diagnosed by a headache specialist using ICHD-3 criteria.

Still, “online, validated, patient-reported data is quite acceptable,” said Dr. Rapoport, who was not involved in the research.

He noted that there is a clear message from the findings for all physicians who see patients with headache disorders: “You will increase the chance of patients consulting and continuing to consult when you make an accurate migraine diagnosis, take migraine more seriously, and understand the stigmas attached to it – and when there are reduced institutional barriers and costs of health care.”

The findings suggest that neurologists should strive to provide patients with ongoing care and medication, he added. In addition, there is a need for further education about the stigma associated with migraine and about how others view this disabling disease, Dr. Rapoport concluded.

The study was funded by Eli Lilly. Dr. Shapiro has consulted for Eli Lilly and Lundbeck. Dr. Rapoport has reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Patients overwhelmingly found telemedicine care for headache a satisfactory and beneficial experience during the COVID-19 pandemic, according to a study presented at the American Headache Society’s 2021 annual meeting. Most patients who used telemedicine said they would like to continue using it after the pandemic, though the study also revealed barriers to care for a small percentage of respondents.

“Telemedicine minimizes the physical and geographic barriers to health care, preserves personal protective equipment, and prevents the spread of COVID-19 by allowing encounters to happen in a socially distanced way,” said Chia-Chun Chiang, MD, assistant professor of neurology at Mayo Clinic in Rochester, Minn. “Telemedicine provides patients with opportunities to gain better control of their headache disorders while not having to commit to the time to travel and risk of exposure to COVID-19.” If insurance coverage for virtual care were rolled back, “patients and multiple levels of health care providers would be significantly affected,” she said.

The research relied on findings from a 15-question survey distributed by the nonprofit American Migraine Foundation through email and social media to more than 100,000 people. Among the 1,172 patients who responded to the survey, 1,098 had complete responses, and 86.6% were female.

The vast majority of these patients (93.8%) had had a previous diagnosis of a headache. Just over half (57.5%) said they used telemedicine during the study period, with most of those visits (85.5%) being follow-up care and 14.5% involving a new patient visit.

Among those who did not use telemedicine, most (56.1%) said they didn’t need a visit. However, a quarter of these respondents (25.2%) said they didn’t know telemedicine was an option, and 12.9% said they would have preferred telemedicine but it wasn’t offered by their doctors. A smaller proportion (3.5%) said they wanted to use virtual care but that their insurance did not cover it, and nearly as many (2.2%) said they wanted telemedicine but didn’t have the technology needed to use it.

“The COVID-19 pandemic has highlighted that reliable Internet service has contributed to disparities in access in many ways, including health care via telemedicine,” Dr. Chiang said. “Those who are not able to afford Internet, lack proficiency in the use of technology, or have cognitive impairment might not be able to utilize telemedicine.”

Among those who did receive telemedicine care for headache, about a third (34.4%) received care from a general neurologist while 43.7% saw a headache specialist and nearly a third (30.7%) saw a primary care provider. The remaining visits included 11.3% who saw headache nurse practitioners and 3.2% who saw headache nurses.

Most patients did not have a new or changed diagnosis at their visit; only 7.4% received a new headache diagnosis during their telemedicine appointment. Though 43.7% had no change to their therapy, a little more than half of patients (52.4%) received a new treatment, a finding that caught the interest of Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, and past president of the International Headache Society.

“The techniques used [in virtual visits] were good enough for the caregiver to make critical decisions about how the patient was doing and what new treatment might be better for them,” said Dr. Rapoport, who was not involved in the research. “I believe that most headache specialists will gradually resume in office visits,” he said, but “this study shows it would be okay for some or most of the revisits to continue to be done virtually.”

The vast majority of patients rated their care as “very good” (62.1%) or “good” (20.7%). Less satisfied responses included 10.5% who felt their experience was “fair,” 3.6% who said it was “poor,” and 3.1% who gave other responses.

These results fit with the experience of Dr. Rapoport and of Paul B. Rizzoli, MD, associate professor of neurology at Harvard Medical School and clinical director of the John R. Graham Headache Center at Brigham and Women’s Faulkner Hospital, both in Boston.

“Telemedicine worked better than we anticipated,” said Dr. Rizzoli when asked for comment. “I was especially surprised how comfortable I became with its use for many, but not all, new patients. While I don’t expect it to replace in-person visits, I do expect that it will and should be a permanent part of our care going forward, especially for follow-up visits.”

The findings supported that expectation as well: An overwhelming majority of those who responded to the survey (89.8%) also said they would like to keep receiving telemedicine care for their headache care and treatment. This percentage was split evenly between those who said they would like to always receive care virtually and those who would only want to use it for some appointments. A smaller proportion said they did not want to keep using virtual care (7.1%) or weren’t sure (3.1%).

“Telemedicine has become an essential tool for patients and a wide variety of clinicians,” Dr. Chiang reported during her presentation. “Telemedicine facilitated headache care for many patients during the COVID-19 pandemic, resulting in high patient satisfaction rates and a desire to continue to utilize telemedicine for future headache care for those who responded to the online survey.”

Dr. Rapoport noted that a particular benefit of telemedicine in his practice is avoiding transportation issues.

“In Santa Monica and Los Angeles, my patients coming from 10 or more miles away usually have to contend with difficult traffic, which created stress and often made them late and upset the office schedule,” Dr. Rapoport said. “I found that virtual visits were almost always shorter, on time, and were as effective for the patient as an in-person visit.”

Dr. Chiang drew attention, however, to the barriers to care found in the study, including not having or knowing of telemedicine as an option, and not having access to the technology or insurance coverage needed to take advantage of it. She listed three ways to address those challenges and increase health care accessibility to patients:
 

• Expand insurance coverage to reimburse telemedicine even after the pandemic.
• Widely promote and broadcast the use of virtual care.
• Make Internet access a priority as a necessity in society and expand access.

Dr. Rizzoli also noted some ways to improve telemedicine. “We could easily develop improved means of delivering vital signs and other bio-information over telemedicine to improve decision-making,” he said. “A difficult task going forward will be to fix legal questions associated with virtual visits across state lines which, especially in the small New England states, come up frequently and are currently illegal.”

Dr. Rapoport noted ways that patients can facilitate effective telemedicine visits. “Doctors should insist that patients keep careful records of their headaches, triggers, medicines, etc., either on paper or preferably via an app on their smartphones, which is usually always accessible,” Dr. Rapoport said. “With good data and a good electronic connection, the visit should go well.”

Among the study’s limitations were a comparatively small response rate (1.11% of those invited to participate) and ascertainment bias.

“The take-home message from the experience is that this turns out to be an effective, efficient and accepted means of delivering care that should be developed further,” Dr. Rizzoli said.

No external funding was noted. Dr. Chiang and Dr. Rizzoli had no disclosures. Dr. Rapoport has advised AbbVie, Amgen, Biohaven, Cala Health, Satsuma, Teva Pharmaceutical Industries, Theranica, Xoc and Zosano, and is on the speakers bureau of AbbVie, Amgen, Biohaven, Lundbeck and Teva Pharmaceutical Industries.

Patients overwhelmingly found telemedicine care for headache a satisfactory and beneficial experience during the COVID-19 pandemic, according to a study presented at the American Headache Society’s 2021 annual meeting. Most patients who used telemedicine said they would like to continue using it after the pandemic, though the study also revealed barriers to care for a small percentage of respondents.

“Telemedicine minimizes the physical and geographic barriers to health care, preserves personal protective equipment, and prevents the spread of COVID-19 by allowing encounters to happen in a socially distanced way,” said Chia-Chun Chiang, MD, assistant professor of neurology at Mayo Clinic in Rochester, Minn. “Telemedicine provides patients with opportunities to gain better control of their headache disorders while not having to commit to the time to travel and risk of exposure to COVID-19.” If insurance coverage for virtual care were rolled back, “patients and multiple levels of health care providers would be significantly affected,” she said.

The research relied on findings from a 15-question survey distributed by the nonprofit American Migraine Foundation through email and social media to more than 100,000 people. Among the 1,172 patients who responded to the survey, 1,098 had complete responses, and 86.6% were female.

The vast majority of these patients (93.8%) had had a previous diagnosis of a headache. Just over half (57.5%) said they used telemedicine during the study period, with most of those visits (85.5%) being follow-up care and 14.5% involving a new patient visit.

Among those who did not use telemedicine, most (56.1%) said they didn’t need a visit. However, a quarter of these respondents (25.2%) said they didn’t know telemedicine was an option, and 12.9% said they would have preferred telemedicine but it wasn’t offered by their doctors. A smaller proportion (3.5%) said they wanted to use virtual care but that their insurance did not cover it, and nearly as many (2.2%) said they wanted telemedicine but didn’t have the technology needed to use it.

“The COVID-19 pandemic has highlighted that reliable Internet service has contributed to disparities in access in many ways, including health care via telemedicine,” Dr. Chiang said. “Those who are not able to afford Internet, lack proficiency in the use of technology, or have cognitive impairment might not be able to utilize telemedicine.”

Among those who did receive telemedicine care for headache, about a third (34.4%) received care from a general neurologist while 43.7% saw a headache specialist and nearly a third (30.7%) saw a primary care provider. The remaining visits included 11.3% who saw headache nurse practitioners and 3.2% who saw headache nurses.

Most patients did not have a new or changed diagnosis at their visit; only 7.4% received a new headache diagnosis during their telemedicine appointment. Though 43.7% had no change to their therapy, a little more than half of patients (52.4%) received a new treatment, a finding that caught the interest of Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, and past president of the International Headache Society.

“The techniques used [in virtual visits] were good enough for the caregiver to make critical decisions about how the patient was doing and what new treatment might be better for them,” said Dr. Rapoport, who was not involved in the research. “I believe that most headache specialists will gradually resume in office visits,” he said, but “this study shows it would be okay for some or most of the revisits to continue to be done virtually.”

The vast majority of patients rated their care as “very good” (62.1%) or “good” (20.7%). Less satisfied responses included 10.5% who felt their experience was “fair,” 3.6% who said it was “poor,” and 3.1% who gave other responses.

These results fit with the experience of Dr. Rapoport and of Paul B. Rizzoli, MD, associate professor of neurology at Harvard Medical School and clinical director of the John R. Graham Headache Center at Brigham and Women’s Faulkner Hospital, both in Boston.

“Telemedicine worked better than we anticipated,” said Dr. Rizzoli when asked for comment. “I was especially surprised how comfortable I became with its use for many, but not all, new patients. While I don’t expect it to replace in-person visits, I do expect that it will and should be a permanent part of our care going forward, especially for follow-up visits.”

The findings supported that expectation as well: An overwhelming majority of those who responded to the survey (89.8%) also said they would like to keep receiving telemedicine care for their headache care and treatment. This percentage was split evenly between those who said they would like to always receive care virtually and those who would only want to use it for some appointments. A smaller proportion said they did not want to keep using virtual care (7.1%) or weren’t sure (3.1%).

“Telemedicine has become an essential tool for patients and a wide variety of clinicians,” Dr. Chiang reported during her presentation. “Telemedicine facilitated headache care for many patients during the COVID-19 pandemic, resulting in high patient satisfaction rates and a desire to continue to utilize telemedicine for future headache care for those who responded to the online survey.”

Dr. Rapoport noted that a particular benefit of telemedicine in his practice is avoiding transportation issues.

“In Santa Monica and Los Angeles, my patients coming from 10 or more miles away usually have to contend with difficult traffic, which created stress and often made them late and upset the office schedule,” Dr. Rapoport said. “I found that virtual visits were almost always shorter, on time, and were as effective for the patient as an in-person visit.”

Dr. Chiang drew attention, however, to the barriers to care found in the study, including not having or knowing of telemedicine as an option, and not having access to the technology or insurance coverage needed to take advantage of it. She listed three ways to address those challenges and increase health care accessibility to patients:
 

• Expand insurance coverage to reimburse telemedicine even after the pandemic.
• Widely promote and broadcast the use of virtual care.
• Make Internet access a priority as a necessity in society and expand access.

Dr. Rizzoli also noted some ways to improve telemedicine. “We could easily develop improved means of delivering vital signs and other bio-information over telemedicine to improve decision-making,” he said. “A difficult task going forward will be to fix legal questions associated with virtual visits across state lines which, especially in the small New England states, come up frequently and are currently illegal.”

Dr. Rapoport noted ways that patients can facilitate effective telemedicine visits. “Doctors should insist that patients keep careful records of their headaches, triggers, medicines, etc., either on paper or preferably via an app on their smartphones, which is usually always accessible,” Dr. Rapoport said. “With good data and a good electronic connection, the visit should go well.”

Among the study’s limitations were a comparatively small response rate (1.11% of those invited to participate) and ascertainment bias.

“The take-home message from the experience is that this turns out to be an effective, efficient and accepted means of delivering care that should be developed further,” Dr. Rizzoli said.

No external funding was noted. Dr. Chiang and Dr. Rizzoli had no disclosures. Dr. Rapoport has advised AbbVie, Amgen, Biohaven, Cala Health, Satsuma, Teva Pharmaceutical Industries, Theranica, Xoc and Zosano, and is on the speakers bureau of AbbVie, Amgen, Biohaven, Lundbeck and Teva Pharmaceutical Industries.

Patients overwhelmingly found telemedicine care for headache a satisfactory and beneficial experience during the COVID-19 pandemic, according to a study presented at the American Headache Society’s 2021 annual meeting. Most patients who used telemedicine said they would like to continue using it after the pandemic, though the study also revealed barriers to care for a small percentage of respondents.

“Telemedicine minimizes the physical and geographic barriers to health care, preserves personal protective equipment, and prevents the spread of COVID-19 by allowing encounters to happen in a socially distanced way,” said Chia-Chun Chiang, MD, assistant professor of neurology at Mayo Clinic in Rochester, Minn. “Telemedicine provides patients with opportunities to gain better control of their headache disorders while not having to commit to the time to travel and risk of exposure to COVID-19.” If insurance coverage for virtual care were rolled back, “patients and multiple levels of health care providers would be significantly affected,” she said.

The research relied on findings from a 15-question survey distributed by the nonprofit American Migraine Foundation through email and social media to more than 100,000 people. Among the 1,172 patients who responded to the survey, 1,098 had complete responses, and 86.6% were female.

The vast majority of these patients (93.8%) had had a previous diagnosis of a headache. Just over half (57.5%) said they used telemedicine during the study period, with most of those visits (85.5%) being follow-up care and 14.5% involving a new patient visit.

Among those who did not use telemedicine, most (56.1%) said they didn’t need a visit. However, a quarter of these respondents (25.2%) said they didn’t know telemedicine was an option, and 12.9% said they would have preferred telemedicine but it wasn’t offered by their doctors. A smaller proportion (3.5%) said they wanted to use virtual care but that their insurance did not cover it, and nearly as many (2.2%) said they wanted telemedicine but didn’t have the technology needed to use it.

“The COVID-19 pandemic has highlighted that reliable Internet service has contributed to disparities in access in many ways, including health care via telemedicine,” Dr. Chiang said. “Those who are not able to afford Internet, lack proficiency in the use of technology, or have cognitive impairment might not be able to utilize telemedicine.”

Among those who did receive telemedicine care for headache, about a third (34.4%) received care from a general neurologist while 43.7% saw a headache specialist and nearly a third (30.7%) saw a primary care provider. The remaining visits included 11.3% who saw headache nurse practitioners and 3.2% who saw headache nurses.

Most patients did not have a new or changed diagnosis at their visit; only 7.4% received a new headache diagnosis during their telemedicine appointment. Though 43.7% had no change to their therapy, a little more than half of patients (52.4%) received a new treatment, a finding that caught the interest of Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, and past president of the International Headache Society.

“The techniques used [in virtual visits] were good enough for the caregiver to make critical decisions about how the patient was doing and what new treatment might be better for them,” said Dr. Rapoport, who was not involved in the research. “I believe that most headache specialists will gradually resume in office visits,” he said, but “this study shows it would be okay for some or most of the revisits to continue to be done virtually.”

The vast majority of patients rated their care as “very good” (62.1%) or “good” (20.7%). Less satisfied responses included 10.5% who felt their experience was “fair,” 3.6% who said it was “poor,” and 3.1% who gave other responses.

These results fit with the experience of Dr. Rapoport and of Paul B. Rizzoli, MD, associate professor of neurology at Harvard Medical School and clinical director of the John R. Graham Headache Center at Brigham and Women’s Faulkner Hospital, both in Boston.

“Telemedicine worked better than we anticipated,” said Dr. Rizzoli when asked for comment. “I was especially surprised how comfortable I became with its use for many, but not all, new patients. While I don’t expect it to replace in-person visits, I do expect that it will and should be a permanent part of our care going forward, especially for follow-up visits.”

The findings supported that expectation as well: An overwhelming majority of those who responded to the survey (89.8%) also said they would like to keep receiving telemedicine care for their headache care and treatment. This percentage was split evenly between those who said they would like to always receive care virtually and those who would only want to use it for some appointments. A smaller proportion said they did not want to keep using virtual care (7.1%) or weren’t sure (3.1%).

“Telemedicine has become an essential tool for patients and a wide variety of clinicians,” Dr. Chiang reported during her presentation. “Telemedicine facilitated headache care for many patients during the COVID-19 pandemic, resulting in high patient satisfaction rates and a desire to continue to utilize telemedicine for future headache care for those who responded to the online survey.”

Dr. Rapoport noted that a particular benefit of telemedicine in his practice is avoiding transportation issues.

“In Santa Monica and Los Angeles, my patients coming from 10 or more miles away usually have to contend with difficult traffic, which created stress and often made them late and upset the office schedule,” Dr. Rapoport said. “I found that virtual visits were almost always shorter, on time, and were as effective for the patient as an in-person visit.”

Dr. Chiang drew attention, however, to the barriers to care found in the study, including not having or knowing of telemedicine as an option, and not having access to the technology or insurance coverage needed to take advantage of it. She listed three ways to address those challenges and increase health care accessibility to patients:
 

• Expand insurance coverage to reimburse telemedicine even after the pandemic.
• Widely promote and broadcast the use of virtual care.
• Make Internet access a priority as a necessity in society and expand access.

Dr. Rizzoli also noted some ways to improve telemedicine. “We could easily develop improved means of delivering vital signs and other bio-information over telemedicine to improve decision-making,” he said. “A difficult task going forward will be to fix legal questions associated with virtual visits across state lines which, especially in the small New England states, come up frequently and are currently illegal.”

Dr. Rapoport noted ways that patients can facilitate effective telemedicine visits. “Doctors should insist that patients keep careful records of their headaches, triggers, medicines, etc., either on paper or preferably via an app on their smartphones, which is usually always accessible,” Dr. Rapoport said. “With good data and a good electronic connection, the visit should go well.”

Among the study’s limitations were a comparatively small response rate (1.11% of those invited to participate) and ascertainment bias.

“The take-home message from the experience is that this turns out to be an effective, efficient and accepted means of delivering care that should be developed further,” Dr. Rizzoli said.

No external funding was noted. Dr. Chiang and Dr. Rizzoli had no disclosures. Dr. Rapoport has advised AbbVie, Amgen, Biohaven, Cala Health, Satsuma, Teva Pharmaceutical Industries, Theranica, Xoc and Zosano, and is on the speakers bureau of AbbVie, Amgen, Biohaven, Lundbeck and Teva Pharmaceutical Industries.

Amid significant controversy, the U.S. Food and Drug Administration (FDA) has approved the anti-amyloid agent aducanumab (Biogen, Eisai) for the treatment of Alzheimer’s disease, disregarding the recommendation by its own advisory panel not to approve the drug.

In November, the Peripheral and Central Nervous System Drugs Advisory Committee voted eight to one against approving the drug because, based on clinical trial results, evidence of efficacy was not strong enough. Two other members said they were uncertain on the issue of efficacy.

In a company release Michel Vounatsos, Biogen’s Chief Executive Officer, said, “this historic moment is the culmination of more than a decade of groundbreaking research in the complex field of Alzheimer’s disease. We believe this first-in-class medicine will transform the treatment of people living with Alzheimer’s disease and spark continuous innovation in the years to come.
 

Rocky road

The road to approval has been extremely rocky for aducanumab, an anti-amyloid-beta human monoclonal antibody, previously known as BIIB037.

As reported by this news organization, two phase 3 trials evaluating the drug were initially scrapped in March 2019 because of interim futility analysis. At the time, Biogen released a statement saying that aducanumab was unlikely to meet primary endpoints in the ENGAGE and EMERGE randomized controlled trials.

However, in an about-face 7 months later, Biogen and Eisai announced that a  new analysis showed the drug met its primary endpoint of reduction in clinical decline, including cognition and function, in the EMERGE trial.

Although ENGAGE still didn’t meet its primary endpoint, data from its new analysis “supported” the EMERGE findings, the drug companies said at the time.

However, 1 year later, a majority of the members of the FDA’s advisory panel were against the drug’s approval. Details of that decision were published online March 30 in the Journal of the American Medical Association.

As reported by this news organization, a Viewpoint written by three of the committee members notes that results from the drug’s only large positive clinical trial fell short.

“There is no persuasive evidence to support approval of aducanumab at this time,” they write.

Groups such as Public Citizen’s Health Research Group not only agree with the Viewpoint’s authors, they also criticized the FDA for its collaboration with the drug’s manufacturers on briefing documents and more.

On April 1, Health Research Group members sent a letter to the U.S. Secretary of Health and Human Services requesting the temporary suspension of the FDA’s neuroscience chief, Bill Dunn, MD, because of his role in supervising the collaboration.
 

Alzheimer association weighs in

The Alzheimer’s Association has been a proponent of the drug throughout its development.

Ahead of today’s news, the organization noted in a statement that a decision to approve “would be historic” because it would make aducanumab “the first drug to slow Alzheimer’s disease” and would mark the beginning of a new future for AD treatments.

“The Alzheimer’s Association urgently supports FDA approval of the treatment based on clinical trial results that showed a 22% reduction in cognitive and function decline — something that could make a meaningful difference” for patients with AD, it said.

Kristen Clifford, chief program officer for the Alzheimer’s Association, said in an interview at the time that approval would be considered a “victory” for patients with AD and for the field overall.

“For individuals who would potentially be eligible for the treatment, this drug could mean more quality time. Slowing decline, particularly in early diagnosis, could add weeks or months or maybe even years of active life,” Clifford said.

“If approved, this would really be a landmark moment. And it could provide hope for those living with Alzheimer’s and their families,” she added.

Clifford noted that approval of this type of drug would also underscore the importance of early detection for AD. “This treatment would encourage earlier diagnosis of the disease,” she said.

In a new statement released just after approval for aducanumab was announced, the organization said that today’s news is a win-win for all patients with AD and their families.

A version of this article first appeared on Medscape.com.

Amid significant controversy, the U.S. Food and Drug Administration (FDA) has approved the anti-amyloid agent aducanumab (Biogen, Eisai) for the treatment of Alzheimer’s disease, disregarding the recommendation by its own advisory panel not to approve the drug.

In November, the Peripheral and Central Nervous System Drugs Advisory Committee voted eight to one against approving the drug because, based on clinical trial results, evidence of efficacy was not strong enough. Two other members said they were uncertain on the issue of efficacy.

In a company release Michel Vounatsos, Biogen’s Chief Executive Officer, said, “this historic moment is the culmination of more than a decade of groundbreaking research in the complex field of Alzheimer’s disease. We believe this first-in-class medicine will transform the treatment of people living with Alzheimer’s disease and spark continuous innovation in the years to come.
 

Rocky road

The road to approval has been extremely rocky for aducanumab, an anti-amyloid-beta human monoclonal antibody, previously known as BIIB037.

As reported by this news organization, two phase 3 trials evaluating the drug were initially scrapped in March 2019 because of interim futility analysis. At the time, Biogen released a statement saying that aducanumab was unlikely to meet primary endpoints in the ENGAGE and EMERGE randomized controlled trials.

However, in an about-face 7 months later, Biogen and Eisai announced that a  new analysis showed the drug met its primary endpoint of reduction in clinical decline, including cognition and function, in the EMERGE trial.

Although ENGAGE still didn’t meet its primary endpoint, data from its new analysis “supported” the EMERGE findings, the drug companies said at the time.

However, 1 year later, a majority of the members of the FDA’s advisory panel were against the drug’s approval. Details of that decision were published online March 30 in the Journal of the American Medical Association.

As reported by this news organization, a Viewpoint written by three of the committee members notes that results from the drug’s only large positive clinical trial fell short.

“There is no persuasive evidence to support approval of aducanumab at this time,” they write.

Groups such as Public Citizen’s Health Research Group not only agree with the Viewpoint’s authors, they also criticized the FDA for its collaboration with the drug’s manufacturers on briefing documents and more.

On April 1, Health Research Group members sent a letter to the U.S. Secretary of Health and Human Services requesting the temporary suspension of the FDA’s neuroscience chief, Bill Dunn, MD, because of his role in supervising the collaboration.
 

Alzheimer association weighs in

The Alzheimer’s Association has been a proponent of the drug throughout its development.

Ahead of today’s news, the organization noted in a statement that a decision to approve “would be historic” because it would make aducanumab “the first drug to slow Alzheimer’s disease” and would mark the beginning of a new future for AD treatments.

“The Alzheimer’s Association urgently supports FDA approval of the treatment based on clinical trial results that showed a 22% reduction in cognitive and function decline — something that could make a meaningful difference” for patients with AD, it said.

Kristen Clifford, chief program officer for the Alzheimer’s Association, said in an interview at the time that approval would be considered a “victory” for patients with AD and for the field overall.

“For individuals who would potentially be eligible for the treatment, this drug could mean more quality time. Slowing decline, particularly in early diagnosis, could add weeks or months or maybe even years of active life,” Clifford said.

“If approved, this would really be a landmark moment. And it could provide hope for those living with Alzheimer’s and their families,” she added.

Clifford noted that approval of this type of drug would also underscore the importance of early detection for AD. “This treatment would encourage earlier diagnosis of the disease,” she said.

In a new statement released just after approval for aducanumab was announced, the organization said that today’s news is a win-win for all patients with AD and their families.

A version of this article first appeared on Medscape.com.

Amid significant controversy, the U.S. Food and Drug Administration (FDA) has approved the anti-amyloid agent aducanumab (Biogen, Eisai) for the treatment of Alzheimer’s disease, disregarding the recommendation by its own advisory panel not to approve the drug.

In November, the Peripheral and Central Nervous System Drugs Advisory Committee voted eight to one against approving the drug because, based on clinical trial results, evidence of efficacy was not strong enough. Two other members said they were uncertain on the issue of efficacy.

In a company release Michel Vounatsos, Biogen’s Chief Executive Officer, said, “this historic moment is the culmination of more than a decade of groundbreaking research in the complex field of Alzheimer’s disease. We believe this first-in-class medicine will transform the treatment of people living with Alzheimer’s disease and spark continuous innovation in the years to come.
 

Rocky road

The road to approval has been extremely rocky for aducanumab, an anti-amyloid-beta human monoclonal antibody, previously known as BIIB037.

As reported by this news organization, two phase 3 trials evaluating the drug were initially scrapped in March 2019 because of interim futility analysis. At the time, Biogen released a statement saying that aducanumab was unlikely to meet primary endpoints in the ENGAGE and EMERGE randomized controlled trials.

However, in an about-face 7 months later, Biogen and Eisai announced that a  new analysis showed the drug met its primary endpoint of reduction in clinical decline, including cognition and function, in the EMERGE trial.

Although ENGAGE still didn’t meet its primary endpoint, data from its new analysis “supported” the EMERGE findings, the drug companies said at the time.

However, 1 year later, a majority of the members of the FDA’s advisory panel were against the drug’s approval. Details of that decision were published online March 30 in the Journal of the American Medical Association.

As reported by this news organization, a Viewpoint written by three of the committee members notes that results from the drug’s only large positive clinical trial fell short.

“There is no persuasive evidence to support approval of aducanumab at this time,” they write.

Groups such as Public Citizen’s Health Research Group not only agree with the Viewpoint’s authors, they also criticized the FDA for its collaboration with the drug’s manufacturers on briefing documents and more.

On April 1, Health Research Group members sent a letter to the U.S. Secretary of Health and Human Services requesting the temporary suspension of the FDA’s neuroscience chief, Bill Dunn, MD, because of his role in supervising the collaboration.
 

Alzheimer association weighs in

The Alzheimer’s Association has been a proponent of the drug throughout its development.

Ahead of today’s news, the organization noted in a statement that a decision to approve “would be historic” because it would make aducanumab “the first drug to slow Alzheimer’s disease” and would mark the beginning of a new future for AD treatments.

“The Alzheimer’s Association urgently supports FDA approval of the treatment based on clinical trial results that showed a 22% reduction in cognitive and function decline — something that could make a meaningful difference” for patients with AD, it said.

Kristen Clifford, chief program officer for the Alzheimer’s Association, said in an interview at the time that approval would be considered a “victory” for patients with AD and for the field overall.

“For individuals who would potentially be eligible for the treatment, this drug could mean more quality time. Slowing decline, particularly in early diagnosis, could add weeks or months or maybe even years of active life,” Clifford said.

“If approved, this would really be a landmark moment. And it could provide hope for those living with Alzheimer’s and their families,” she added.

Clifford noted that approval of this type of drug would also underscore the importance of early detection for AD. “This treatment would encourage earlier diagnosis of the disease,” she said.

In a new statement released just after approval for aducanumab was announced, the organization said that today’s news is a win-win for all patients with AD and their families.

A version of this article first appeared on Medscape.com.