Journal of Clinical Outcomes Management

A consensus statement on the role of imaging during the acute work-up of COVID-19 patients called for liberal use in patients with moderate to severe clinical features indicative of infection, regardless of their COVID-19 test results, but limited use in patients who present with mild symptoms or are asymptomatic.

The consensus statement on The Role of Imaging in Patient Management during the COVID-19 Pandemic released by the Fleischner Society on April 7 was designed to highlight the “key decision points around imaging” in COVID-19 patients.

“We developed the statement to be applicable across settings” so that each clinic or hospital managing COVID-19 patients could decide the situations where chest radiography (CXR) or CT would work best, said Geoffrey D. Rubin, MD, professor of cardiovascular research, radiology, and bioengineering at Duke University in Durham, N.C., and lead author of the statement.

Written by 15 thoracic radiologists and 10 pulmonologists/intensivists including an anesthesiologist, a pathologist, and additional experts in emergency medicine, infection control, and laboratory medicine, and with members from any of 10 countries on three continents, the panel arrived at agreement by more than 70% for each of the 14 questions.

“I was impressed and a little surprised that consensus was achieved for every question” posed to the panel by the Fleischner Society for Thoracic Imaging and Diagnosis, Dr. Rubin said in an interview. The panel also placed their 14 decisions about imaging within the context of three distinct clinical scenarios chosen to mirror common real-world situations: mild COVID-19 features, moderate to severe features with no critical-resource constraints, and moderate to severe features with constrained resources. The statement also summarized its conclusions as five main recommendations and three additional recommendations.
 

Main recommendations

• Imaging is not routinely indicated for COVID-19 screening in asymptomatic people.
• Imaging is not indicated for patients with mild features of COVID-19 unless they are at risk for disease progression.
• Imaging is indicated for patients with features of moderate to severe COVID-19 regardless of COVID-19 test results.
• Imaging is indicated for patients with COVID-19 and evidence of worsening respiratory status.
• When access to CT is limited, chest radiography may be preferred for COVID-19 patients unless features of respiratory worsening warrant using CT.

Additional recommendations

• Daily chest radiographs are not indicated in stable, intubated patients with COVID-19.
• CT is indicated in patients with functional impairment, hypoxemia, or both, after COVID-19 recovery.
• COVID-19 testing is warranted in patients incidentally found to have findings suggestive of COVID-19 on a CT scan.

The statement particularly called out one of its recommendations – that a COVID-19 diagnosis “may be presumed when imaging findings are strongly suggestive of COVID-19 despite negative COVID-19 testing” in a patient who has moderate to severe clinical features of COVID-19 and whose pretest probability is high. The panel voted unanimously in favor of this concept, that imaging is “indicated” in hospitalized patients with moderate to severe symptoms consistent with COVID-19 despite a negative COVID-19 test result. “This guidance represents variance from other published recommendations which advise against the use of imaging for the initial diagnosis of COVID-19,” the statement acknowledged and specifically cited the recommendations issued in March 2020 by the American College of Radiology. Despite that, the ACR and Fleischner recommendations “are not at odds with one another,” maintained Dr. Rubin. The panel based its take on this question on the “direct experience” of its members caring for COVID-19 patients, according to the statement.

“I wholeheartedly agree with the suggested uses of imaging outlined by the panel,” commented Sachin Gupta, MD, FCCP, a pulmonologist and critical care physician in San Francisco. “The consensus statement brings a practical way to consider obtaining imaging. It leaves the door open to local standards and best judgment for using CXR or CT. Many physicians are unclear whether to image low-risk and mildly symptomatic patients. This statement gives support to a watchful waiting approach.” Another recommendation advises against daily CXR in stable, intubated COVID-19 patients. This “now gives backing from an important society and thought leaders while giving an explanation” for why daily imaging is problematic, he noted in an interview. The daily CXR in these patients adds no value, and skipping unneeded imaging minimizes SARS-CoV-2 exposure to radiology personnel, and conserves personal protection equipment, said the statement.

“The Fleischner Society is known worldwide for its recommendations. Having the society lend its weight on triage with imaging for COVID-19 patients is important. I suspect it will help standardize practice.”

Dr. Gupta also highlighted that lung imaging with a portable ultrasound unit has quickly become recognized as a very useful imaging tool with increasing use as the pandemic has unfolded, an option not covered by the Fleischner statement. Study results have “confirmed excellent sensitivity, specificity, and reproducibility” with lung ultrasound, and it’s also “easy to use,” Dr. Gupta said.

Ultrasound chest imaging of COVID-19 patients did not get included in the statement despite the reliance some U.S. sites have already placed on it largely because few on the panel had direct experience using it. “We didn’t feel we could contribute” to a discussion of ultrasound, Dr. Rubin said.

The statement’s recommendations appear to have already begun influencing practice. “The feedback I’ve gotten is that people are relying on them,” said Dr. Rubin, and some programs have sent him screen shots of the recommendations embedded in their local electronic health record.

The Radiological Society of North America is hosting a webinar on the statement on April 17.

[email protected]

A consensus statement on the role of imaging during the acute work-up of COVID-19 patients called for liberal use in patients with moderate to severe clinical features indicative of infection, regardless of their COVID-19 test results, but limited use in patients who present with mild symptoms or are asymptomatic.

The consensus statement on The Role of Imaging in Patient Management during the COVID-19 Pandemic released by the Fleischner Society on April 7 was designed to highlight the “key decision points around imaging” in COVID-19 patients.

“We developed the statement to be applicable across settings” so that each clinic or hospital managing COVID-19 patients could decide the situations where chest radiography (CXR) or CT would work best, said Geoffrey D. Rubin, MD, professor of cardiovascular research, radiology, and bioengineering at Duke University in Durham, N.C., and lead author of the statement.

Written by 15 thoracic radiologists and 10 pulmonologists/intensivists including an anesthesiologist, a pathologist, and additional experts in emergency medicine, infection control, and laboratory medicine, and with members from any of 10 countries on three continents, the panel arrived at agreement by more than 70% for each of the 14 questions.

“I was impressed and a little surprised that consensus was achieved for every question” posed to the panel by the Fleischner Society for Thoracic Imaging and Diagnosis, Dr. Rubin said in an interview. The panel also placed their 14 decisions about imaging within the context of three distinct clinical scenarios chosen to mirror common real-world situations: mild COVID-19 features, moderate to severe features with no critical-resource constraints, and moderate to severe features with constrained resources. The statement also summarized its conclusions as five main recommendations and three additional recommendations.
 

Main recommendations

• Imaging is not routinely indicated for COVID-19 screening in asymptomatic people.
• Imaging is not indicated for patients with mild features of COVID-19 unless they are at risk for disease progression.
• Imaging is indicated for patients with features of moderate to severe COVID-19 regardless of COVID-19 test results.
• Imaging is indicated for patients with COVID-19 and evidence of worsening respiratory status.
• When access to CT is limited, chest radiography may be preferred for COVID-19 patients unless features of respiratory worsening warrant using CT.

Additional recommendations

• Daily chest radiographs are not indicated in stable, intubated patients with COVID-19.
• CT is indicated in patients with functional impairment, hypoxemia, or both, after COVID-19 recovery.
• COVID-19 testing is warranted in patients incidentally found to have findings suggestive of COVID-19 on a CT scan.

The statement particularly called out one of its recommendations – that a COVID-19 diagnosis “may be presumed when imaging findings are strongly suggestive of COVID-19 despite negative COVID-19 testing” in a patient who has moderate to severe clinical features of COVID-19 and whose pretest probability is high. The panel voted unanimously in favor of this concept, that imaging is “indicated” in hospitalized patients with moderate to severe symptoms consistent with COVID-19 despite a negative COVID-19 test result. “This guidance represents variance from other published recommendations which advise against the use of imaging for the initial diagnosis of COVID-19,” the statement acknowledged and specifically cited the recommendations issued in March 2020 by the American College of Radiology. Despite that, the ACR and Fleischner recommendations “are not at odds with one another,” maintained Dr. Rubin. The panel based its take on this question on the “direct experience” of its members caring for COVID-19 patients, according to the statement.

“I wholeheartedly agree with the suggested uses of imaging outlined by the panel,” commented Sachin Gupta, MD, FCCP, a pulmonologist and critical care physician in San Francisco. “The consensus statement brings a practical way to consider obtaining imaging. It leaves the door open to local standards and best judgment for using CXR or CT. Many physicians are unclear whether to image low-risk and mildly symptomatic patients. This statement gives support to a watchful waiting approach.” Another recommendation advises against daily CXR in stable, intubated COVID-19 patients. This “now gives backing from an important society and thought leaders while giving an explanation” for why daily imaging is problematic, he noted in an interview. The daily CXR in these patients adds no value, and skipping unneeded imaging minimizes SARS-CoV-2 exposure to radiology personnel, and conserves personal protection equipment, said the statement.

“The Fleischner Society is known worldwide for its recommendations. Having the society lend its weight on triage with imaging for COVID-19 patients is important. I suspect it will help standardize practice.”

Dr. Gupta also highlighted that lung imaging with a portable ultrasound unit has quickly become recognized as a very useful imaging tool with increasing use as the pandemic has unfolded, an option not covered by the Fleischner statement. Study results have “confirmed excellent sensitivity, specificity, and reproducibility” with lung ultrasound, and it’s also “easy to use,” Dr. Gupta said.

Ultrasound chest imaging of COVID-19 patients did not get included in the statement despite the reliance some U.S. sites have already placed on it largely because few on the panel had direct experience using it. “We didn’t feel we could contribute” to a discussion of ultrasound, Dr. Rubin said.

The statement’s recommendations appear to have already begun influencing practice. “The feedback I’ve gotten is that people are relying on them,” said Dr. Rubin, and some programs have sent him screen shots of the recommendations embedded in their local electronic health record.

The Radiological Society of North America is hosting a webinar on the statement on April 17.

[email protected]

A consensus statement on the role of imaging during the acute work-up of COVID-19 patients called for liberal use in patients with moderate to severe clinical features indicative of infection, regardless of their COVID-19 test results, but limited use in patients who present with mild symptoms or are asymptomatic.

The consensus statement on The Role of Imaging in Patient Management during the COVID-19 Pandemic released by the Fleischner Society on April 7 was designed to highlight the “key decision points around imaging” in COVID-19 patients.

“We developed the statement to be applicable across settings” so that each clinic or hospital managing COVID-19 patients could decide the situations where chest radiography (CXR) or CT would work best, said Geoffrey D. Rubin, MD, professor of cardiovascular research, radiology, and bioengineering at Duke University in Durham, N.C., and lead author of the statement.

Written by 15 thoracic radiologists and 10 pulmonologists/intensivists including an anesthesiologist, a pathologist, and additional experts in emergency medicine, infection control, and laboratory medicine, and with members from any of 10 countries on three continents, the panel arrived at agreement by more than 70% for each of the 14 questions.

“I was impressed and a little surprised that consensus was achieved for every question” posed to the panel by the Fleischner Society for Thoracic Imaging and Diagnosis, Dr. Rubin said in an interview. The panel also placed their 14 decisions about imaging within the context of three distinct clinical scenarios chosen to mirror common real-world situations: mild COVID-19 features, moderate to severe features with no critical-resource constraints, and moderate to severe features with constrained resources. The statement also summarized its conclusions as five main recommendations and three additional recommendations.
 

Main recommendations

• Imaging is not routinely indicated for COVID-19 screening in asymptomatic people.
• Imaging is not indicated for patients with mild features of COVID-19 unless they are at risk for disease progression.
• Imaging is indicated for patients with features of moderate to severe COVID-19 regardless of COVID-19 test results.
• Imaging is indicated for patients with COVID-19 and evidence of worsening respiratory status.
• When access to CT is limited, chest radiography may be preferred for COVID-19 patients unless features of respiratory worsening warrant using CT.

Additional recommendations

• Daily chest radiographs are not indicated in stable, intubated patients with COVID-19.
• CT is indicated in patients with functional impairment, hypoxemia, or both, after COVID-19 recovery.
• COVID-19 testing is warranted in patients incidentally found to have findings suggestive of COVID-19 on a CT scan.

The statement particularly called out one of its recommendations – that a COVID-19 diagnosis “may be presumed when imaging findings are strongly suggestive of COVID-19 despite negative COVID-19 testing” in a patient who has moderate to severe clinical features of COVID-19 and whose pretest probability is high. The panel voted unanimously in favor of this concept, that imaging is “indicated” in hospitalized patients with moderate to severe symptoms consistent with COVID-19 despite a negative COVID-19 test result. “This guidance represents variance from other published recommendations which advise against the use of imaging for the initial diagnosis of COVID-19,” the statement acknowledged and specifically cited the recommendations issued in March 2020 by the American College of Radiology. Despite that, the ACR and Fleischner recommendations “are not at odds with one another,” maintained Dr. Rubin. The panel based its take on this question on the “direct experience” of its members caring for COVID-19 patients, according to the statement.

“I wholeheartedly agree with the suggested uses of imaging outlined by the panel,” commented Sachin Gupta, MD, FCCP, a pulmonologist and critical care physician in San Francisco. “The consensus statement brings a practical way to consider obtaining imaging. It leaves the door open to local standards and best judgment for using CXR or CT. Many physicians are unclear whether to image low-risk and mildly symptomatic patients. This statement gives support to a watchful waiting approach.” Another recommendation advises against daily CXR in stable, intubated COVID-19 patients. This “now gives backing from an important society and thought leaders while giving an explanation” for why daily imaging is problematic, he noted in an interview. The daily CXR in these patients adds no value, and skipping unneeded imaging minimizes SARS-CoV-2 exposure to radiology personnel, and conserves personal protection equipment, said the statement.

“The Fleischner Society is known worldwide for its recommendations. Having the society lend its weight on triage with imaging for COVID-19 patients is important. I suspect it will help standardize practice.”

Dr. Gupta also highlighted that lung imaging with a portable ultrasound unit has quickly become recognized as a very useful imaging tool with increasing use as the pandemic has unfolded, an option not covered by the Fleischner statement. Study results have “confirmed excellent sensitivity, specificity, and reproducibility” with lung ultrasound, and it’s also “easy to use,” Dr. Gupta said.

Ultrasound chest imaging of COVID-19 patients did not get included in the statement despite the reliance some U.S. sites have already placed on it largely because few on the panel had direct experience using it. “We didn’t feel we could contribute” to a discussion of ultrasound, Dr. Rubin said.

The statement’s recommendations appear to have already begun influencing practice. “The feedback I’ve gotten is that people are relying on them,” said Dr. Rubin, and some programs have sent him screen shots of the recommendations embedded in their local electronic health record.

The Radiological Society of North America is hosting a webinar on the statement on April 17.

[email protected]

Patients infected by the COVID-19 virus may benefit from treatments that dampen the renin-angiotensin system, according to a review of several animal studies. These preclinical findings generally support the positions taken in recent week by several cardiology societies that recommended patients taking drugs that moderate the renin-angiotensin system stay on these treatments.

“In patients with cardiovascular disease and SARS-CoV2, the use of ACE inhibitors, ARBs [angiotensin receptor blockers], or MRAs [mineralocorticoid-receptor antagonists] may be favorable as a method to endogenously upregulate ACE2 as a compensatory mechanism that provides anti-inflammatory, antifibrotic, and antithrombotic support as well as reduction in progression of vascular/cardiac remodeling and heart failure,” wrote Jeffrey Bander, MD, and his associates in a report published online (J Am Coll Cardiol. 2020 Apr 15. doi: 10.1016/j.jacc.2020.04.028).

“Based on our review, we hypothesize cardiovascular patients with COVID-19 should remain on RAS [renin-angiotensin system] inhibitors given the protective effects of the ACE2 pathway until RAS blockade is proven to increase the risk to COVID-19,” said the researchers, who are affiliated with the Icahn School of Medicine at Mount Sinai in New York.

The ACE2 protein, found both in human blood as well as in cell membranes, especially cells of the lungs, heart, kidneys, and gastrointestinal tissues, functions as both a key enzyme in RAS regulation as well as the primary cell receptor for entry of SARS-CoV2.

Their conclusion jibed with both a joint statement in March from the American College of Cardiology, American Heart Association, and the Heart Failure Society of America; and with the conclusions of a review organized by the European Society of Hypertension’s COVID-19 Task Force (Cardiovasc Res. 2020 Apr 15. doi: 10.1093/cvr/cvaa097).

In their review, the Mount Sinai authors described results from several animal studies suggesting that ACE2 and its associated signaling proteins could potentially be a “valuable therapeutic target.” They also highlighted several clinical intervention studies recently launched to target ACE2, related proteins, and regulation of this arm of the RAS.

Currently, “no data support any conclusive effects of the use of RAS inhibitors in patients with COVID-19,” they concluded. They acknowledged that “the question remains whether the use of ACE inhibitors, ARBs, and MRAs should be avoided in the setting of SARS-CoV infection,” but emphasized that “adequate data on the effects of RAS inhibition in COVID-19 patients is not available,” with more data becoming available soon from ongoing clinical studies.

None of the authors had any disclosures.

[email protected]

Patients infected by the COVID-19 virus may benefit from treatments that dampen the renin-angiotensin system, according to a review of several animal studies. These preclinical findings generally support the positions taken in recent week by several cardiology societies that recommended patients taking drugs that moderate the renin-angiotensin system stay on these treatments.

“In patients with cardiovascular disease and SARS-CoV2, the use of ACE inhibitors, ARBs [angiotensin receptor blockers], or MRAs [mineralocorticoid-receptor antagonists] may be favorable as a method to endogenously upregulate ACE2 as a compensatory mechanism that provides anti-inflammatory, antifibrotic, and antithrombotic support as well as reduction in progression of vascular/cardiac remodeling and heart failure,” wrote Jeffrey Bander, MD, and his associates in a report published online (J Am Coll Cardiol. 2020 Apr 15. doi: 10.1016/j.jacc.2020.04.028).

“Based on our review, we hypothesize cardiovascular patients with COVID-19 should remain on RAS [renin-angiotensin system] inhibitors given the protective effects of the ACE2 pathway until RAS blockade is proven to increase the risk to COVID-19,” said the researchers, who are affiliated with the Icahn School of Medicine at Mount Sinai in New York.

The ACE2 protein, found both in human blood as well as in cell membranes, especially cells of the lungs, heart, kidneys, and gastrointestinal tissues, functions as both a key enzyme in RAS regulation as well as the primary cell receptor for entry of SARS-CoV2.

Their conclusion jibed with both a joint statement in March from the American College of Cardiology, American Heart Association, and the Heart Failure Society of America; and with the conclusions of a review organized by the European Society of Hypertension’s COVID-19 Task Force (Cardiovasc Res. 2020 Apr 15. doi: 10.1093/cvr/cvaa097).

In their review, the Mount Sinai authors described results from several animal studies suggesting that ACE2 and its associated signaling proteins could potentially be a “valuable therapeutic target.” They also highlighted several clinical intervention studies recently launched to target ACE2, related proteins, and regulation of this arm of the RAS.

Currently, “no data support any conclusive effects of the use of RAS inhibitors in patients with COVID-19,” they concluded. They acknowledged that “the question remains whether the use of ACE inhibitors, ARBs, and MRAs should be avoided in the setting of SARS-CoV infection,” but emphasized that “adequate data on the effects of RAS inhibition in COVID-19 patients is not available,” with more data becoming available soon from ongoing clinical studies.

None of the authors had any disclosures.

[email protected]

Patients infected by the COVID-19 virus may benefit from treatments that dampen the renin-angiotensin system, according to a review of several animal studies. These preclinical findings generally support the positions taken in recent week by several cardiology societies that recommended patients taking drugs that moderate the renin-angiotensin system stay on these treatments.

“In patients with cardiovascular disease and SARS-CoV2, the use of ACE inhibitors, ARBs [angiotensin receptor blockers], or MRAs [mineralocorticoid-receptor antagonists] may be favorable as a method to endogenously upregulate ACE2 as a compensatory mechanism that provides anti-inflammatory, antifibrotic, and antithrombotic support as well as reduction in progression of vascular/cardiac remodeling and heart failure,” wrote Jeffrey Bander, MD, and his associates in a report published online (J Am Coll Cardiol. 2020 Apr 15. doi: 10.1016/j.jacc.2020.04.028).

“Based on our review, we hypothesize cardiovascular patients with COVID-19 should remain on RAS [renin-angiotensin system] inhibitors given the protective effects of the ACE2 pathway until RAS blockade is proven to increase the risk to COVID-19,” said the researchers, who are affiliated with the Icahn School of Medicine at Mount Sinai in New York.

The ACE2 protein, found both in human blood as well as in cell membranes, especially cells of the lungs, heart, kidneys, and gastrointestinal tissues, functions as both a key enzyme in RAS regulation as well as the primary cell receptor for entry of SARS-CoV2.

Their conclusion jibed with both a joint statement in March from the American College of Cardiology, American Heart Association, and the Heart Failure Society of America; and with the conclusions of a review organized by the European Society of Hypertension’s COVID-19 Task Force (Cardiovasc Res. 2020 Apr 15. doi: 10.1093/cvr/cvaa097).

In their review, the Mount Sinai authors described results from several animal studies suggesting that ACE2 and its associated signaling proteins could potentially be a “valuable therapeutic target.” They also highlighted several clinical intervention studies recently launched to target ACE2, related proteins, and regulation of this arm of the RAS.

Currently, “no data support any conclusive effects of the use of RAS inhibitors in patients with COVID-19,” they concluded. They acknowledged that “the question remains whether the use of ACE inhibitors, ARBs, and MRAs should be avoided in the setting of SARS-CoV infection,” but emphasized that “adequate data on the effects of RAS inhibition in COVID-19 patients is not available,” with more data becoming available soon from ongoing clinical studies.

None of the authors had any disclosures.

[email protected]

Mass social distancing and social isolation to prevent the spread of a deadly disease, along with technological tools that allow social communication and continued work and school, is an unprecedented situation.

Stockbyte/Thinkstock.com

The current reality of most people’s lives during the COVID-19 pandemic has the potential to induce or exacerbate sleep problems, though it may also present some with an opportunity to improve sleep, wrote Ellemarije Altena, PhD, of the University of Bordeaux (France), and her colleagues in a recent research review in the Journal of Sleep Research.

The review was conducted by a task force of the European Academy for Cognitive Behavioural Therapy for Insomnia. The European CBT-I Academy is an initiative of the European Insomnia Network to promote implementation and dissemination of treatment.

After discussing the known effects of stress, confinement, and altered schedules on sleep, the authors present recommendations on ways to manage sleep problems such as insomnia in the general public and potentially encourage people to take advantage of the opportunity to align their schedules with their natural circadian rhythms. Physicians may find the recommendations helpful in advising patients with sleep problems related to the COVID-19 emergency.

“Being forced to stay at home, work from home, do homeschooling with children, drastically minimize outings, reduce social interaction or work many more hours under stressful circumstances, and in parallel manage the attendant health risks, can have a major impact on daily functioning and nighttime sleep,” Dr. Altena and colleagues wrote.

There may also be a lag time in physicians hearing about changes in sleep or sleeping problems from patients, said Krishna M. Sundar, MD, FCCP, medical director of the Sleep-Wake Center at the University of Utah in Salt Lake City. “There may actually be some improvement in sleep durations given that most folks are working from home with more time with family and less work-related stress,” he said in an interview. “In terms of sleep or other effects on worsening of psychiatric problems, it is still not clear what the overall effects are going to be.”

Although daylight has the biggest impact on regulating circadian rhythms, artificial light, meal times, diet, and amount of physical activity can also have an influence. Negative effects on sleep can result from both excessively high activity levels, such as stress and work overload, or excessively low levels, such as from depression or confinement, the authors note.

The current situation also opens the door to interactions between stress, sleep, anxiety, and risk of PTSD. “Those sensitive to stress-related sleep disruption are more likely to develop chronic insomnia,” which, in combination with a major stressor, is a risk factor for PTSD, the authors write. They note that 7% of Wuhan residents, the city in China where the virus appears to have originated, particularly women, reported PTSD symptoms after the COVID-19 outbreak, and anxiety was highest in those under age 35 years and those who followed news about the disease for more than 3 hours a day.

Better sleep quality and fewer early morning awakenings, however, appeared to be protective against PTSD symptoms. The authors note the value of physical exercise, cognitive interventions, and relaxation techniques, including meditation, for reducing stress and milder symptoms of PTSD.

“Some patients are sleeping a bit better because of the pace of things has slowed down a bit,” said Anne C. Trainor, a nurse practitioner and instructor in the neurology department’s sleep disorders program at Oregon Health & Science University in Portland, who was not involved in the study. “Keeping a regular schedule for sleeping and eating, getting exercise daily – preferably in sunlight and not just before bedtime – and using relaxation or mindfulness practice and cognitive interventions to help manage anxiety” were the key takeaways from this review, Ms. Trainor said in an interview.


 

Home confinement, stressors and sleep

A wide range of stressors could affect sleep during COVID-19 social distancing interventions, including “major changes in routines, living with uncertainty,” and anxiety about health, the economic situation, and how long this situation will last, the authors write.

Parents must juggle work, homeschooling, and ordinary household errands and management. Meanwhile, entrepreneurs, small business owners ,and workers in entertainment, hospitality and food service must contend with anxiety about job uncertainty and financial security. For anyone working from home, disruptions to work and home routines can make it difficult to associate being home with relaxation – and sleep.

“The more regular our sleep schedule is the better quality our sleep tends to be, but it is a struggle when we don’t have separate spaces to work and parent in,” Ms. Trainor said.

At the same time, “confinement-related stress may be caused by an inability to engage in rewarding activities, such as visiting friends and family, shopping, attending cultural and sports events, and visiting bars or restaurants,” the authors write. “Spending more time with family in a limited space can also induce stress, particularly in situations where there are preexisting family difficulties.”

Being stuck at home may lead to less daylight exposure than usual, reduced physical activity, and increased eating, which can contribute to weight gain and other health risks. However, “the effect of stress from confinement, loss of work, and health concerns needs to be individualized and may be difficult to generalize,” Dr. Sundar said.

The authors of the review note the established associations between too little social interaction, increased stress, and poor sleep quality, though loneliness mediates this relationship. Loneliness is also a risk during this time, with or without online social interaction.

Children and teens may also have difficulty sleeping, which can affect their behavioral and emotional regulation, and primary caregivers experience more stress while juggling childcare, household duties, and work.

“While many parents share childcare and household responsibilities, in most families these tasks are still predominantly managed by mothers,” the authors added.

“Sharing responsibilities between parents and not overworking just one parent is key,” said Brandon M. Seay MD, a pediatric pulmonologist and sleep specialist at Children’s Healthcare of Atlanta. He also recommended trying to incorporate work into the day while kids are doing online learning.

Ms. Trainor agreed that trading off responsibilities between parents is ideal, though the challenge is greater for single parents. It may be possible for some to take family leave, but not all families have that option, she said.

The study authors also point out a Catch-22 for many people: The blurred boundary between home life and work life can undermine work productivity and efficiency, thereby increasing stress. “Healthy sleep may be a key protective factor to cope positively with these challenges, although adequate opportunity to sleep may be affected by increased time pressure of work, childcare, and household requirements.”

Dr. Seay advises adults to try to get at least 6-8 hours of sleep each night, even taking advantage of a later waking time – if the kids also sleep in – to help. “If anything, the ability to sleep later and wake up later is of benefit for a lot of my teenage patients,” he said in an interview.

In fact, the study authors also address possible positive effects on sleep for some people during the current situation. Since social support can improve sleep quality, social media interaction might provide some social support, though it’s not the same as meeting people in person and “screen exposure may hamper sleep quality when used close to bedtime.”

Some people may actually have an opportunity to get more daylight exposure or exercise, which can improve sleep, and some, especially night owls and teenagers, may be able to align their daily schedules more closely to their natural circadian rhythms.

“Given that we are not bound by usual work or social schedules, there may be a tendency to drift to our sleep chronotypes,” especially for teenagers, Dr. Sundar said.

For some, this may be their first opportunity to learn what their chronotype is, Dr. Seay said.

“It is always advantageous to ‘obey’ your natural sleep timing, [although] it simply isn’t always the most efficient outside of our current situation,” he said. “Use this as a time to figure out your natural sleep timing if you constantly have issues being able to wake up in the morning. Now that you don’t have to be up for work or school, you can figure out what time works for you.”

At the same time, if you have an extreme circadian rhythm disorder, especially an irregular one, it may still be best to try to keep a regular sleep schedule to avoid feeling isolated if others are socializing while you’re asleep, Ms. Trainor said.

The authors similarly note the limits of potential benefits during this time, noting that they “may not be enough to counteract the negative effects of the increased work and family requirements, as well as the overwhelming levels of stress and anxiety about the well-being of oneself and others, and the negative effects of confinement for family social reactions.”
 

Treating stress, anxiety, and insomnia

The first-line treatment for chronic insomnia is cognitive-behavioral therapy for insomnia, but “recent evidence shows that cognitive-behavioral therapy can also serve to treat sudden-onset (acute) insomnia due to rapid stress-causing situation changes,” the authors noted. They also reviewed the key elements of CBT-I: stimulus control, sleep hygiene, relaxation interventions, cognitive reappraisal, paradoxical intention, and sleep restriction.

CBT-I lends very naturally to telemedicine, Dr. Seay, Dr. Sundar, and Ms. Trainor all agreed.

“I actually see this current situation as an opportunity for health care practices and providers to expand the reach of telemedicine – due to necessity – which will hopefully continue after confinement has been lifted worldwide,” Dr. Seay said.  

Dr. Sundar pointed to research supporting CBT-I online and several apps that can be used for it, such as SHUTi and Sleepio. Ms. Trainor noted that the Cleveland Clinic offers a basic CBT-I online class for $40.

The authors note that prescribing medication is generally discouraged because it lacks evidence for long-term effectiveness of chronic insomnia, but it might be worth considering as a second-line therapy for acute insomnia from outside stressors, such as home confinement, if CBT-I doesn’t work or isn’t possible. Pharmacologic treatment can include benzodiazepines, hypnotic benzodiazepine receptor agonists, or sedating antidepressants, particularly if used for a comorbid mood disorder.

The authors then offer general recommendations for improving sleep that doctors can pass on to their patients:

• Get up and go to bed at approximately the same times daily.
• Schedule 15-minute breaks during the day to manage stress and reflect on worries and the situation.
• Reserve the bed for sleep and sex only; not for working, watching TV, using the computer, or doing other activities.
• Try to follow your natural sleep rhythm as much as possible.
• Use social media as stress relief, an opportunity to communicate with friends and family, and distraction, especially with uplifting stories or humor.
• Leave devices out of the bedroom.
• Limit your exposure to news about the COVID-19 pandemic.
• Exercise regularly, ideally in daylight.
• Look for ways to stay busy and distracted, including making your home or bedroom more comfortable if possible.
• Get as much daylight during the day as possible, and keep lights dim or dark at night.
• Engage in familiar, comfortable, relaxing activities before bedtime.
• If your daily activity level is lower, eat less as well, ideally at least 2 hours before going to bed.

The authors also offered recommendations specifically for families:

• Divide child care, home maintenance, and chores between adults, being sure not to let the lion’s share fall on women.
• Maintain regular sleep times for children and spend the 30 minutes before their bedtime doing a calming, familiar activity that both the children and parents enjoy.
• “While using computer, smartphones, and watching TV more than usual may be inevitable in confinement, avoid technological devices after dinner or too close to bedtime.”
• Ensure your child has daily physical activity, keep a relatively consistent schedule or routine, expose them to as much daylight or bright light as possible during the day, and try to limit their bed use only to sleeping if possible. “Parents need to be involved in setting schedules for sleep and meal times so that kids do not get into sleep patterns that are difficult to change when school starts back,” Dr. Sundar said. “Limiting screen time is also important especially during nighttime.”
• Reassure children if they wake up anxious at night.

SOURCE: Altena E et al. J Sleep Res. 2020 Apr 4. doi: 10.1111/jsr.13052.

Mass social distancing and social isolation to prevent the spread of a deadly disease, along with technological tools that allow social communication and continued work and school, is an unprecedented situation.

Stockbyte/Thinkstock.com

The current reality of most people’s lives during the COVID-19 pandemic has the potential to induce or exacerbate sleep problems, though it may also present some with an opportunity to improve sleep, wrote Ellemarije Altena, PhD, of the University of Bordeaux (France), and her colleagues in a recent research review in the Journal of Sleep Research.

The review was conducted by a task force of the European Academy for Cognitive Behavioural Therapy for Insomnia. The European CBT-I Academy is an initiative of the European Insomnia Network to promote implementation and dissemination of treatment.

After discussing the known effects of stress, confinement, and altered schedules on sleep, the authors present recommendations on ways to manage sleep problems such as insomnia in the general public and potentially encourage people to take advantage of the opportunity to align their schedules with their natural circadian rhythms. Physicians may find the recommendations helpful in advising patients with sleep problems related to the COVID-19 emergency.

“Being forced to stay at home, work from home, do homeschooling with children, drastically minimize outings, reduce social interaction or work many more hours under stressful circumstances, and in parallel manage the attendant health risks, can have a major impact on daily functioning and nighttime sleep,” Dr. Altena and colleagues wrote.

There may also be a lag time in physicians hearing about changes in sleep or sleeping problems from patients, said Krishna M. Sundar, MD, FCCP, medical director of the Sleep-Wake Center at the University of Utah in Salt Lake City. “There may actually be some improvement in sleep durations given that most folks are working from home with more time with family and less work-related stress,” he said in an interview. “In terms of sleep or other effects on worsening of psychiatric problems, it is still not clear what the overall effects are going to be.”

Although daylight has the biggest impact on regulating circadian rhythms, artificial light, meal times, diet, and amount of physical activity can also have an influence. Negative effects on sleep can result from both excessively high activity levels, such as stress and work overload, or excessively low levels, such as from depression or confinement, the authors note.

The current situation also opens the door to interactions between stress, sleep, anxiety, and risk of PTSD. “Those sensitive to stress-related sleep disruption are more likely to develop chronic insomnia,” which, in combination with a major stressor, is a risk factor for PTSD, the authors write. They note that 7% of Wuhan residents, the city in China where the virus appears to have originated, particularly women, reported PTSD symptoms after the COVID-19 outbreak, and anxiety was highest in those under age 35 years and those who followed news about the disease for more than 3 hours a day.

Better sleep quality and fewer early morning awakenings, however, appeared to be protective against PTSD symptoms. The authors note the value of physical exercise, cognitive interventions, and relaxation techniques, including meditation, for reducing stress and milder symptoms of PTSD.

“Some patients are sleeping a bit better because of the pace of things has slowed down a bit,” said Anne C. Trainor, a nurse practitioner and instructor in the neurology department’s sleep disorders program at Oregon Health & Science University in Portland, who was not involved in the study. “Keeping a regular schedule for sleeping and eating, getting exercise daily – preferably in sunlight and not just before bedtime – and using relaxation or mindfulness practice and cognitive interventions to help manage anxiety” were the key takeaways from this review, Ms. Trainor said in an interview.


 

Home confinement, stressors and sleep

A wide range of stressors could affect sleep during COVID-19 social distancing interventions, including “major changes in routines, living with uncertainty,” and anxiety about health, the economic situation, and how long this situation will last, the authors write.

Parents must juggle work, homeschooling, and ordinary household errands and management. Meanwhile, entrepreneurs, small business owners ,and workers in entertainment, hospitality and food service must contend with anxiety about job uncertainty and financial security. For anyone working from home, disruptions to work and home routines can make it difficult to associate being home with relaxation – and sleep.

“The more regular our sleep schedule is the better quality our sleep tends to be, but it is a struggle when we don’t have separate spaces to work and parent in,” Ms. Trainor said.

At the same time, “confinement-related stress may be caused by an inability to engage in rewarding activities, such as visiting friends and family, shopping, attending cultural and sports events, and visiting bars or restaurants,” the authors write. “Spending more time with family in a limited space can also induce stress, particularly in situations where there are preexisting family difficulties.”

Being stuck at home may lead to less daylight exposure than usual, reduced physical activity, and increased eating, which can contribute to weight gain and other health risks. However, “the effect of stress from confinement, loss of work, and health concerns needs to be individualized and may be difficult to generalize,” Dr. Sundar said.

The authors of the review note the established associations between too little social interaction, increased stress, and poor sleep quality, though loneliness mediates this relationship. Loneliness is also a risk during this time, with or without online social interaction.

Children and teens may also have difficulty sleeping, which can affect their behavioral and emotional regulation, and primary caregivers experience more stress while juggling childcare, household duties, and work.

“While many parents share childcare and household responsibilities, in most families these tasks are still predominantly managed by mothers,” the authors added.

“Sharing responsibilities between parents and not overworking just one parent is key,” said Brandon M. Seay MD, a pediatric pulmonologist and sleep specialist at Children’s Healthcare of Atlanta. He also recommended trying to incorporate work into the day while kids are doing online learning.

Ms. Trainor agreed that trading off responsibilities between parents is ideal, though the challenge is greater for single parents. It may be possible for some to take family leave, but not all families have that option, she said.

The study authors also point out a Catch-22 for many people: The blurred boundary between home life and work life can undermine work productivity and efficiency, thereby increasing stress. “Healthy sleep may be a key protective factor to cope positively with these challenges, although adequate opportunity to sleep may be affected by increased time pressure of work, childcare, and household requirements.”

Dr. Seay advises adults to try to get at least 6-8 hours of sleep each night, even taking advantage of a later waking time – if the kids also sleep in – to help. “If anything, the ability to sleep later and wake up later is of benefit for a lot of my teenage patients,” he said in an interview.

In fact, the study authors also address possible positive effects on sleep for some people during the current situation. Since social support can improve sleep quality, social media interaction might provide some social support, though it’s not the same as meeting people in person and “screen exposure may hamper sleep quality when used close to bedtime.”

Some people may actually have an opportunity to get more daylight exposure or exercise, which can improve sleep, and some, especially night owls and teenagers, may be able to align their daily schedules more closely to their natural circadian rhythms.

“Given that we are not bound by usual work or social schedules, there may be a tendency to drift to our sleep chronotypes,” especially for teenagers, Dr. Sundar said.

For some, this may be their first opportunity to learn what their chronotype is, Dr. Seay said.

“It is always advantageous to ‘obey’ your natural sleep timing, [although] it simply isn’t always the most efficient outside of our current situation,” he said. “Use this as a time to figure out your natural sleep timing if you constantly have issues being able to wake up in the morning. Now that you don’t have to be up for work or school, you can figure out what time works for you.”

At the same time, if you have an extreme circadian rhythm disorder, especially an irregular one, it may still be best to try to keep a regular sleep schedule to avoid feeling isolated if others are socializing while you’re asleep, Ms. Trainor said.

The authors similarly note the limits of potential benefits during this time, noting that they “may not be enough to counteract the negative effects of the increased work and family requirements, as well as the overwhelming levels of stress and anxiety about the well-being of oneself and others, and the negative effects of confinement for family social reactions.”
 

Treating stress, anxiety, and insomnia

The first-line treatment for chronic insomnia is cognitive-behavioral therapy for insomnia, but “recent evidence shows that cognitive-behavioral therapy can also serve to treat sudden-onset (acute) insomnia due to rapid stress-causing situation changes,” the authors noted. They also reviewed the key elements of CBT-I: stimulus control, sleep hygiene, relaxation interventions, cognitive reappraisal, paradoxical intention, and sleep restriction.

CBT-I lends very naturally to telemedicine, Dr. Seay, Dr. Sundar, and Ms. Trainor all agreed.

“I actually see this current situation as an opportunity for health care practices and providers to expand the reach of telemedicine – due to necessity – which will hopefully continue after confinement has been lifted worldwide,” Dr. Seay said.  

Dr. Sundar pointed to research supporting CBT-I online and several apps that can be used for it, such as SHUTi and Sleepio. Ms. Trainor noted that the Cleveland Clinic offers a basic CBT-I online class for $40.

The authors note that prescribing medication is generally discouraged because it lacks evidence for long-term effectiveness of chronic insomnia, but it might be worth considering as a second-line therapy for acute insomnia from outside stressors, such as home confinement, if CBT-I doesn’t work or isn’t possible. Pharmacologic treatment can include benzodiazepines, hypnotic benzodiazepine receptor agonists, or sedating antidepressants, particularly if used for a comorbid mood disorder.

The authors then offer general recommendations for improving sleep that doctors can pass on to their patients:

• Get up and go to bed at approximately the same times daily.
• Schedule 15-minute breaks during the day to manage stress and reflect on worries and the situation.
• Reserve the bed for sleep and sex only; not for working, watching TV, using the computer, or doing other activities.
• Try to follow your natural sleep rhythm as much as possible.
• Use social media as stress relief, an opportunity to communicate with friends and family, and distraction, especially with uplifting stories or humor.
• Leave devices out of the bedroom.
• Limit your exposure to news about the COVID-19 pandemic.
• Exercise regularly, ideally in daylight.
• Look for ways to stay busy and distracted, including making your home or bedroom more comfortable if possible.
• Get as much daylight during the day as possible, and keep lights dim or dark at night.
• Engage in familiar, comfortable, relaxing activities before bedtime.
• If your daily activity level is lower, eat less as well, ideally at least 2 hours before going to bed.

The authors also offered recommendations specifically for families:

• Divide child care, home maintenance, and chores between adults, being sure not to let the lion’s share fall on women.
• Maintain regular sleep times for children and spend the 30 minutes before their bedtime doing a calming, familiar activity that both the children and parents enjoy.
• “While using computer, smartphones, and watching TV more than usual may be inevitable in confinement, avoid technological devices after dinner or too close to bedtime.”
• Ensure your child has daily physical activity, keep a relatively consistent schedule or routine, expose them to as much daylight or bright light as possible during the day, and try to limit their bed use only to sleeping if possible. “Parents need to be involved in setting schedules for sleep and meal times so that kids do not get into sleep patterns that are difficult to change when school starts back,” Dr. Sundar said. “Limiting screen time is also important especially during nighttime.”
• Reassure children if they wake up anxious at night.

SOURCE: Altena E et al. J Sleep Res. 2020 Apr 4. doi: 10.1111/jsr.13052.

Mass social distancing and social isolation to prevent the spread of a deadly disease, along with technological tools that allow social communication and continued work and school, is an unprecedented situation.

Stockbyte/Thinkstock.com

The current reality of most people’s lives during the COVID-19 pandemic has the potential to induce or exacerbate sleep problems, though it may also present some with an opportunity to improve sleep, wrote Ellemarije Altena, PhD, of the University of Bordeaux (France), and her colleagues in a recent research review in the Journal of Sleep Research.

The review was conducted by a task force of the European Academy for Cognitive Behavioural Therapy for Insomnia. The European CBT-I Academy is an initiative of the European Insomnia Network to promote implementation and dissemination of treatment.

After discussing the known effects of stress, confinement, and altered schedules on sleep, the authors present recommendations on ways to manage sleep problems such as insomnia in the general public and potentially encourage people to take advantage of the opportunity to align their schedules with their natural circadian rhythms. Physicians may find the recommendations helpful in advising patients with sleep problems related to the COVID-19 emergency.

“Being forced to stay at home, work from home, do homeschooling with children, drastically minimize outings, reduce social interaction or work many more hours under stressful circumstances, and in parallel manage the attendant health risks, can have a major impact on daily functioning and nighttime sleep,” Dr. Altena and colleagues wrote.

There may also be a lag time in physicians hearing about changes in sleep or sleeping problems from patients, said Krishna M. Sundar, MD, FCCP, medical director of the Sleep-Wake Center at the University of Utah in Salt Lake City. “There may actually be some improvement in sleep durations given that most folks are working from home with more time with family and less work-related stress,” he said in an interview. “In terms of sleep or other effects on worsening of psychiatric problems, it is still not clear what the overall effects are going to be.”

Although daylight has the biggest impact on regulating circadian rhythms, artificial light, meal times, diet, and amount of physical activity can also have an influence. Negative effects on sleep can result from both excessively high activity levels, such as stress and work overload, or excessively low levels, such as from depression or confinement, the authors note.

The current situation also opens the door to interactions between stress, sleep, anxiety, and risk of PTSD. “Those sensitive to stress-related sleep disruption are more likely to develop chronic insomnia,” which, in combination with a major stressor, is a risk factor for PTSD, the authors write. They note that 7% of Wuhan residents, the city in China where the virus appears to have originated, particularly women, reported PTSD symptoms after the COVID-19 outbreak, and anxiety was highest in those under age 35 years and those who followed news about the disease for more than 3 hours a day.

Better sleep quality and fewer early morning awakenings, however, appeared to be protective against PTSD symptoms. The authors note the value of physical exercise, cognitive interventions, and relaxation techniques, including meditation, for reducing stress and milder symptoms of PTSD.

“Some patients are sleeping a bit better because of the pace of things has slowed down a bit,” said Anne C. Trainor, a nurse practitioner and instructor in the neurology department’s sleep disorders program at Oregon Health & Science University in Portland, who was not involved in the study. “Keeping a regular schedule for sleeping and eating, getting exercise daily – preferably in sunlight and not just before bedtime – and using relaxation or mindfulness practice and cognitive interventions to help manage anxiety” were the key takeaways from this review, Ms. Trainor said in an interview.


 

Home confinement, stressors and sleep

A wide range of stressors could affect sleep during COVID-19 social distancing interventions, including “major changes in routines, living with uncertainty,” and anxiety about health, the economic situation, and how long this situation will last, the authors write.

Parents must juggle work, homeschooling, and ordinary household errands and management. Meanwhile, entrepreneurs, small business owners ,and workers in entertainment, hospitality and food service must contend with anxiety about job uncertainty and financial security. For anyone working from home, disruptions to work and home routines can make it difficult to associate being home with relaxation – and sleep.

“The more regular our sleep schedule is the better quality our sleep tends to be, but it is a struggle when we don’t have separate spaces to work and parent in,” Ms. Trainor said.

At the same time, “confinement-related stress may be caused by an inability to engage in rewarding activities, such as visiting friends and family, shopping, attending cultural and sports events, and visiting bars or restaurants,” the authors write. “Spending more time with family in a limited space can also induce stress, particularly in situations where there are preexisting family difficulties.”

Being stuck at home may lead to less daylight exposure than usual, reduced physical activity, and increased eating, which can contribute to weight gain and other health risks. However, “the effect of stress from confinement, loss of work, and health concerns needs to be individualized and may be difficult to generalize,” Dr. Sundar said.

The authors of the review note the established associations between too little social interaction, increased stress, and poor sleep quality, though loneliness mediates this relationship. Loneliness is also a risk during this time, with or without online social interaction.

Children and teens may also have difficulty sleeping, which can affect their behavioral and emotional regulation, and primary caregivers experience more stress while juggling childcare, household duties, and work.

“While many parents share childcare and household responsibilities, in most families these tasks are still predominantly managed by mothers,” the authors added.

“Sharing responsibilities between parents and not overworking just one parent is key,” said Brandon M. Seay MD, a pediatric pulmonologist and sleep specialist at Children’s Healthcare of Atlanta. He also recommended trying to incorporate work into the day while kids are doing online learning.

Ms. Trainor agreed that trading off responsibilities between parents is ideal, though the challenge is greater for single parents. It may be possible for some to take family leave, but not all families have that option, she said.

The study authors also point out a Catch-22 for many people: The blurred boundary between home life and work life can undermine work productivity and efficiency, thereby increasing stress. “Healthy sleep may be a key protective factor to cope positively with these challenges, although adequate opportunity to sleep may be affected by increased time pressure of work, childcare, and household requirements.”

Dr. Seay advises adults to try to get at least 6-8 hours of sleep each night, even taking advantage of a later waking time – if the kids also sleep in – to help. “If anything, the ability to sleep later and wake up later is of benefit for a lot of my teenage patients,” he said in an interview.

In fact, the study authors also address possible positive effects on sleep for some people during the current situation. Since social support can improve sleep quality, social media interaction might provide some social support, though it’s not the same as meeting people in person and “screen exposure may hamper sleep quality when used close to bedtime.”

Some people may actually have an opportunity to get more daylight exposure or exercise, which can improve sleep, and some, especially night owls and teenagers, may be able to align their daily schedules more closely to their natural circadian rhythms.

“Given that we are not bound by usual work or social schedules, there may be a tendency to drift to our sleep chronotypes,” especially for teenagers, Dr. Sundar said.

For some, this may be their first opportunity to learn what their chronotype is, Dr. Seay said.

“It is always advantageous to ‘obey’ your natural sleep timing, [although] it simply isn’t always the most efficient outside of our current situation,” he said. “Use this as a time to figure out your natural sleep timing if you constantly have issues being able to wake up in the morning. Now that you don’t have to be up for work or school, you can figure out what time works for you.”

At the same time, if you have an extreme circadian rhythm disorder, especially an irregular one, it may still be best to try to keep a regular sleep schedule to avoid feeling isolated if others are socializing while you’re asleep, Ms. Trainor said.

The authors similarly note the limits of potential benefits during this time, noting that they “may not be enough to counteract the negative effects of the increased work and family requirements, as well as the overwhelming levels of stress and anxiety about the well-being of oneself and others, and the negative effects of confinement for family social reactions.”
 

Treating stress, anxiety, and insomnia

The first-line treatment for chronic insomnia is cognitive-behavioral therapy for insomnia, but “recent evidence shows that cognitive-behavioral therapy can also serve to treat sudden-onset (acute) insomnia due to rapid stress-causing situation changes,” the authors noted. They also reviewed the key elements of CBT-I: stimulus control, sleep hygiene, relaxation interventions, cognitive reappraisal, paradoxical intention, and sleep restriction.

CBT-I lends very naturally to telemedicine, Dr. Seay, Dr. Sundar, and Ms. Trainor all agreed.

“I actually see this current situation as an opportunity for health care practices and providers to expand the reach of telemedicine – due to necessity – which will hopefully continue after confinement has been lifted worldwide,” Dr. Seay said.  

Dr. Sundar pointed to research supporting CBT-I online and several apps that can be used for it, such as SHUTi and Sleepio. Ms. Trainor noted that the Cleveland Clinic offers a basic CBT-I online class for $40.

The authors note that prescribing medication is generally discouraged because it lacks evidence for long-term effectiveness of chronic insomnia, but it might be worth considering as a second-line therapy for acute insomnia from outside stressors, such as home confinement, if CBT-I doesn’t work or isn’t possible. Pharmacologic treatment can include benzodiazepines, hypnotic benzodiazepine receptor agonists, or sedating antidepressants, particularly if used for a comorbid mood disorder.

The authors then offer general recommendations for improving sleep that doctors can pass on to their patients:

• Get up and go to bed at approximately the same times daily.
• Schedule 15-minute breaks during the day to manage stress and reflect on worries and the situation.
• Reserve the bed for sleep and sex only; not for working, watching TV, using the computer, or doing other activities.
• Try to follow your natural sleep rhythm as much as possible.
• Use social media as stress relief, an opportunity to communicate with friends and family, and distraction, especially with uplifting stories or humor.
• Leave devices out of the bedroom.
• Limit your exposure to news about the COVID-19 pandemic.
• Exercise regularly, ideally in daylight.
• Look for ways to stay busy and distracted, including making your home or bedroom more comfortable if possible.
• Get as much daylight during the day as possible, and keep lights dim or dark at night.
• Engage in familiar, comfortable, relaxing activities before bedtime.
• If your daily activity level is lower, eat less as well, ideally at least 2 hours before going to bed.

The authors also offered recommendations specifically for families:

• Divide child care, home maintenance, and chores between adults, being sure not to let the lion’s share fall on women.
• Maintain regular sleep times for children and spend the 30 minutes before their bedtime doing a calming, familiar activity that both the children and parents enjoy.
• “While using computer, smartphones, and watching TV more than usual may be inevitable in confinement, avoid technological devices after dinner or too close to bedtime.”
• Ensure your child has daily physical activity, keep a relatively consistent schedule or routine, expose them to as much daylight or bright light as possible during the day, and try to limit their bed use only to sleeping if possible. “Parents need to be involved in setting schedules for sleep and meal times so that kids do not get into sleep patterns that are difficult to change when school starts back,” Dr. Sundar said. “Limiting screen time is also important especially during nighttime.”
• Reassure children if they wake up anxious at night.

SOURCE: Altena E et al. J Sleep Res. 2020 Apr 4. doi: 10.1111/jsr.13052.

Hydroxychloroquine (HCQ) does not help clear the SARS-CoV-2 virus or relieve symptoms for COVID-19 patients more than standard care alone and has more side effects, a randomized controlled trial of 150 hospitalized adults in China suggests.

However, two experts caution that, because of confounding, the trial is unable to answer convincingly the question of whether HCQ can benefit COVID-19 patients.

Wei Tang, with the Departments of Pulmonology and Critical Care Medicine at Ruijin Hospital, in Shanghai, China, and colleagues enrolled patients with COVID-19 from 16 treatment centers in China in February. They posted their findings on the medRxiv preprint server, but their paper has not been peer reviewed. A coauthor told Medscape Medical News the work has been submitted to a journal.

The overall 28-day negative conversion rate of SARS-CoV-2, which was the primary endpoint, was similar in the two 75-patient treatment groups. The Kaplan-Meier estimate for negative conversion rate was 85.4% in the HCQ plus standard of care (SOC) arm, vs 81.3% in the SOC-only group (P = .341). Negative conversion rates for the two groups were similar at days 4, 7, 10, 14, and 21.

Adverse events were reported in 8.8% of patients in the control group compared with 30% in the HCQ group. Diarrhea was the most common side effect, occurring in 10% of patients in the HCQ group vs none in the control group. Two patients in the HCQ arm had serious adverse events; one experienced disease progression, and the other experienced upper respiratory tract infection.

Patients in the HCQ group received a high loading dose of 1200 mg daily for 3 days followed by a maintenance dose of 800 mg daily for the remaining days. Total duration was 2 weeks for patients with mild or moderate disease and 3 weeks for those with severe disease.

No Difference in Relief of Symptoms

The two arms were similar in alleviation of symptoms by day 28: 59.9% with HCQ plus SOC vs 66.6% with SOC alone.

However, the researchers said that in a post hoc analysis, they found a significant reduction of symptoms after adjusting for the confounding effects of antiviral agents (hazard ratio, 8.83; 95% confidence interval, 1.09 – 71.3).

In addition, Tang and colleagues report a significantly greater reduction of C-reactive protein (CRP), a biomarker for inflammation, from baseline to day 28 in the HCQ group in comparison with the control group (6.986 vs 2.723 mg/L).

The authors suggest the alleviation of symptoms may come from HCQ’s anti-inflammatory effects.

The mean age of the patients was 46 years, and 55% were male. Almost all patients had mild or moderate disease; two had severe disease.

Experts Say Study Arms May Not Have Been Comparable

J. Michelle Kahlenberg, MD, PhD, research professor of rheumatology at the University of Michigan in Ann Arbor, told Medscape Medical News that it’s important to note that in the post hoc analysis, 89% of the patients in this trial were receiving other therapy in addition to HCQ.

“When [the researchers] say they saw improvement in symptoms when they removed the confounders, what they actually did was remove the patients from the analysis that got antivirals, and that left 14 patients in each arm,” Kahlenberg said.

Moreover, Kahlenberg noted, 20% of patients who received HCQ had mild symptoms, whereas only 9% of those in the SOC group did.

“We don’t know how those patients played out in the post hoc analysis — whether it was the patients who were really mild that didn’t get the antivirals that were left in the hydroxychloroquine group and that’s why they had a slightly faster resolution of symptoms,” she said.

She said that in this study, the researchers calculated CRP in milligrams per liter, whereas in the United States, it is measured in milligrams per deciliter. The conversion highlights the fact that the reduction in CRP was not terribly noteworthy, she said.

“The patients with COVID who tend to tank and have cytokine storms ― their CRP is much higher,” she said. “So the small improvement in CRP wasn’t that exciting.

“I don’t think this gets us anywhere closer to an answer. It’s another muddy study,” she said.

Similarly, Christopher V. Plowe, MD, MPH, director of the Global Health Institute at Duke University in Durham, North Carolina, told Medscape Medical News he sees no convincing answers in this study.

Plowe, professor of medicine, molecular genetics, microbiology, and global health at Duke, also noted differences between the two groups at enrollment.

For example, the HCQ group had more than three times the number of patients with shortness of breath (22.1% vs 5.9%); more with sputum production (16.2 vs 5.9%); and more with cough (51.5% vs 38.2%). In addition, the average age was 4 years higher in the HCQ group.

“It makes me wonder whether the randomization was truly random,” Plowe said.

Plowe also questioned the authors’ statement that they didn’t see cardiac arrhythmia events, such as prolonged QT intervals. “I can’t see any evidence that they did an EKG on anybody,” he said.

“This study leaves the door open to the possibility that hydroxychloroquine may have a clinical benefit. If there is a benefit, it seems to be related to the drug’s anti-inflammatory properties. If that’s the case, I’m not sure this particular drug, as opposed to others, would be the way to go,” Plowe said.

Mixed Results in Other Studies

“Our negative results on the anti-viral efficacy of HCQ obtained in this trial are on the contrary to the encouraging in-vitro results and to the recently reported promising results from a non-randomized trial with 36 COVID-19 patients,” the authors write.

However, the 36-patient trial to which they refer has since been called into question, as previously reported by Retraction Watch.

Despite lack of clear evidence of benefit, HCQ is recommended off label for the treatment of COVID-19 by the Chinese National guideline, and the US Food and Drug Administration has issued an emergency-use authorization for the treatment of adult patients with COVID-19.

By contrast, the Infectious Diseases Society of America recently concluded that because of insufficient data, they could not recommend any particular treatment for patients with COVID-19.

The work was supported by the Emergent Projects of National Science and Technology; the National Natural Science Foundation of China; the National Key Research and Development Program of China; the Shanghai Municipal Key Clinical Specialty; the National Innovative Research Team of High-Level Local Universities in Shanghai; the Shanghai Key Discipline for Respiratory Diseases; the National Major Scientific and Technological Special Project for Significant New Drugs Development; and Key Projects in the National Science and Technology Pillar Program. The authors, Kahlenberg, and Plowe have disclosed no relevant financial relationships.

This story first appeared on Medscape.com.
 

Hydroxychloroquine (HCQ) does not help clear the SARS-CoV-2 virus or relieve symptoms for COVID-19 patients more than standard care alone and has more side effects, a randomized controlled trial of 150 hospitalized adults in China suggests.

However, two experts caution that, because of confounding, the trial is unable to answer convincingly the question of whether HCQ can benefit COVID-19 patients.

Wei Tang, with the Departments of Pulmonology and Critical Care Medicine at Ruijin Hospital, in Shanghai, China, and colleagues enrolled patients with COVID-19 from 16 treatment centers in China in February. They posted their findings on the medRxiv preprint server, but their paper has not been peer reviewed. A coauthor told Medscape Medical News the work has been submitted to a journal.

The overall 28-day negative conversion rate of SARS-CoV-2, which was the primary endpoint, was similar in the two 75-patient treatment groups. The Kaplan-Meier estimate for negative conversion rate was 85.4% in the HCQ plus standard of care (SOC) arm, vs 81.3% in the SOC-only group (P = .341). Negative conversion rates for the two groups were similar at days 4, 7, 10, 14, and 21.

Adverse events were reported in 8.8% of patients in the control group compared with 30% in the HCQ group. Diarrhea was the most common side effect, occurring in 10% of patients in the HCQ group vs none in the control group. Two patients in the HCQ arm had serious adverse events; one experienced disease progression, and the other experienced upper respiratory tract infection.

Patients in the HCQ group received a high loading dose of 1200 mg daily for 3 days followed by a maintenance dose of 800 mg daily for the remaining days. Total duration was 2 weeks for patients with mild or moderate disease and 3 weeks for those with severe disease.

No Difference in Relief of Symptoms

The two arms were similar in alleviation of symptoms by day 28: 59.9% with HCQ plus SOC vs 66.6% with SOC alone.

However, the researchers said that in a post hoc analysis, they found a significant reduction of symptoms after adjusting for the confounding effects of antiviral agents (hazard ratio, 8.83; 95% confidence interval, 1.09 – 71.3).

In addition, Tang and colleagues report a significantly greater reduction of C-reactive protein (CRP), a biomarker for inflammation, from baseline to day 28 in the HCQ group in comparison with the control group (6.986 vs 2.723 mg/L).

The authors suggest the alleviation of symptoms may come from HCQ’s anti-inflammatory effects.

The mean age of the patients was 46 years, and 55% were male. Almost all patients had mild or moderate disease; two had severe disease.

Experts Say Study Arms May Not Have Been Comparable

J. Michelle Kahlenberg, MD, PhD, research professor of rheumatology at the University of Michigan in Ann Arbor, told Medscape Medical News that it’s important to note that in the post hoc analysis, 89% of the patients in this trial were receiving other therapy in addition to HCQ.

“When [the researchers] say they saw improvement in symptoms when they removed the confounders, what they actually did was remove the patients from the analysis that got antivirals, and that left 14 patients in each arm,” Kahlenberg said.

Moreover, Kahlenberg noted, 20% of patients who received HCQ had mild symptoms, whereas only 9% of those in the SOC group did.

“We don’t know how those patients played out in the post hoc analysis — whether it was the patients who were really mild that didn’t get the antivirals that were left in the hydroxychloroquine group and that’s why they had a slightly faster resolution of symptoms,” she said.

She said that in this study, the researchers calculated CRP in milligrams per liter, whereas in the United States, it is measured in milligrams per deciliter. The conversion highlights the fact that the reduction in CRP was not terribly noteworthy, she said.

“The patients with COVID who tend to tank and have cytokine storms ― their CRP is much higher,” she said. “So the small improvement in CRP wasn’t that exciting.

“I don’t think this gets us anywhere closer to an answer. It’s another muddy study,” she said.

Similarly, Christopher V. Plowe, MD, MPH, director of the Global Health Institute at Duke University in Durham, North Carolina, told Medscape Medical News he sees no convincing answers in this study.

Plowe, professor of medicine, molecular genetics, microbiology, and global health at Duke, also noted differences between the two groups at enrollment.

For example, the HCQ group had more than three times the number of patients with shortness of breath (22.1% vs 5.9%); more with sputum production (16.2 vs 5.9%); and more with cough (51.5% vs 38.2%). In addition, the average age was 4 years higher in the HCQ group.

“It makes me wonder whether the randomization was truly random,” Plowe said.

Plowe also questioned the authors’ statement that they didn’t see cardiac arrhythmia events, such as prolonged QT intervals. “I can’t see any evidence that they did an EKG on anybody,” he said.

“This study leaves the door open to the possibility that hydroxychloroquine may have a clinical benefit. If there is a benefit, it seems to be related to the drug’s anti-inflammatory properties. If that’s the case, I’m not sure this particular drug, as opposed to others, would be the way to go,” Plowe said.

Mixed Results in Other Studies

“Our negative results on the anti-viral efficacy of HCQ obtained in this trial are on the contrary to the encouraging in-vitro results and to the recently reported promising results from a non-randomized trial with 36 COVID-19 patients,” the authors write.

However, the 36-patient trial to which they refer has since been called into question, as previously reported by Retraction Watch.

Despite lack of clear evidence of benefit, HCQ is recommended off label for the treatment of COVID-19 by the Chinese National guideline, and the US Food and Drug Administration has issued an emergency-use authorization for the treatment of adult patients with COVID-19.

By contrast, the Infectious Diseases Society of America recently concluded that because of insufficient data, they could not recommend any particular treatment for patients with COVID-19.

The work was supported by the Emergent Projects of National Science and Technology; the National Natural Science Foundation of China; the National Key Research and Development Program of China; the Shanghai Municipal Key Clinical Specialty; the National Innovative Research Team of High-Level Local Universities in Shanghai; the Shanghai Key Discipline for Respiratory Diseases; the National Major Scientific and Technological Special Project for Significant New Drugs Development; and Key Projects in the National Science and Technology Pillar Program. The authors, Kahlenberg, and Plowe have disclosed no relevant financial relationships.

This story first appeared on Medscape.com.
 

Hydroxychloroquine (HCQ) does not help clear the SARS-CoV-2 virus or relieve symptoms for COVID-19 patients more than standard care alone and has more side effects, a randomized controlled trial of 150 hospitalized adults in China suggests.

However, two experts caution that, because of confounding, the trial is unable to answer convincingly the question of whether HCQ can benefit COVID-19 patients.

Wei Tang, with the Departments of Pulmonology and Critical Care Medicine at Ruijin Hospital, in Shanghai, China, and colleagues enrolled patients with COVID-19 from 16 treatment centers in China in February. They posted their findings on the medRxiv preprint server, but their paper has not been peer reviewed. A coauthor told Medscape Medical News the work has been submitted to a journal.

The overall 28-day negative conversion rate of SARS-CoV-2, which was the primary endpoint, was similar in the two 75-patient treatment groups. The Kaplan-Meier estimate for negative conversion rate was 85.4% in the HCQ plus standard of care (SOC) arm, vs 81.3% in the SOC-only group (P = .341). Negative conversion rates for the two groups were similar at days 4, 7, 10, 14, and 21.

Adverse events were reported in 8.8% of patients in the control group compared with 30% in the HCQ group. Diarrhea was the most common side effect, occurring in 10% of patients in the HCQ group vs none in the control group. Two patients in the HCQ arm had serious adverse events; one experienced disease progression, and the other experienced upper respiratory tract infection.

Patients in the HCQ group received a high loading dose of 1200 mg daily for 3 days followed by a maintenance dose of 800 mg daily for the remaining days. Total duration was 2 weeks for patients with mild or moderate disease and 3 weeks for those with severe disease.

No Difference in Relief of Symptoms

The two arms were similar in alleviation of symptoms by day 28: 59.9% with HCQ plus SOC vs 66.6% with SOC alone.

However, the researchers said that in a post hoc analysis, they found a significant reduction of symptoms after adjusting for the confounding effects of antiviral agents (hazard ratio, 8.83; 95% confidence interval, 1.09 – 71.3).

In addition, Tang and colleagues report a significantly greater reduction of C-reactive protein (CRP), a biomarker for inflammation, from baseline to day 28 in the HCQ group in comparison with the control group (6.986 vs 2.723 mg/L).

The authors suggest the alleviation of symptoms may come from HCQ’s anti-inflammatory effects.

The mean age of the patients was 46 years, and 55% were male. Almost all patients had mild or moderate disease; two had severe disease.

Experts Say Study Arms May Not Have Been Comparable

J. Michelle Kahlenberg, MD, PhD, research professor of rheumatology at the University of Michigan in Ann Arbor, told Medscape Medical News that it’s important to note that in the post hoc analysis, 89% of the patients in this trial were receiving other therapy in addition to HCQ.

“When [the researchers] say they saw improvement in symptoms when they removed the confounders, what they actually did was remove the patients from the analysis that got antivirals, and that left 14 patients in each arm,” Kahlenberg said.

Moreover, Kahlenberg noted, 20% of patients who received HCQ had mild symptoms, whereas only 9% of those in the SOC group did.

“We don’t know how those patients played out in the post hoc analysis — whether it was the patients who were really mild that didn’t get the antivirals that were left in the hydroxychloroquine group and that’s why they had a slightly faster resolution of symptoms,” she said.

She said that in this study, the researchers calculated CRP in milligrams per liter, whereas in the United States, it is measured in milligrams per deciliter. The conversion highlights the fact that the reduction in CRP was not terribly noteworthy, she said.

“The patients with COVID who tend to tank and have cytokine storms ― their CRP is much higher,” she said. “So the small improvement in CRP wasn’t that exciting.

“I don’t think this gets us anywhere closer to an answer. It’s another muddy study,” she said.

Similarly, Christopher V. Plowe, MD, MPH, director of the Global Health Institute at Duke University in Durham, North Carolina, told Medscape Medical News he sees no convincing answers in this study.

Plowe, professor of medicine, molecular genetics, microbiology, and global health at Duke, also noted differences between the two groups at enrollment.

For example, the HCQ group had more than three times the number of patients with shortness of breath (22.1% vs 5.9%); more with sputum production (16.2 vs 5.9%); and more with cough (51.5% vs 38.2%). In addition, the average age was 4 years higher in the HCQ group.

“It makes me wonder whether the randomization was truly random,” Plowe said.

Plowe also questioned the authors’ statement that they didn’t see cardiac arrhythmia events, such as prolonged QT intervals. “I can’t see any evidence that they did an EKG on anybody,” he said.

“This study leaves the door open to the possibility that hydroxychloroquine may have a clinical benefit. If there is a benefit, it seems to be related to the drug’s anti-inflammatory properties. If that’s the case, I’m not sure this particular drug, as opposed to others, would be the way to go,” Plowe said.

Mixed Results in Other Studies

“Our negative results on the anti-viral efficacy of HCQ obtained in this trial are on the contrary to the encouraging in-vitro results and to the recently reported promising results from a non-randomized trial with 36 COVID-19 patients,” the authors write.

However, the 36-patient trial to which they refer has since been called into question, as previously reported by Retraction Watch.

Despite lack of clear evidence of benefit, HCQ is recommended off label for the treatment of COVID-19 by the Chinese National guideline, and the US Food and Drug Administration has issued an emergency-use authorization for the treatment of adult patients with COVID-19.

By contrast, the Infectious Diseases Society of America recently concluded that because of insufficient data, they could not recommend any particular treatment for patients with COVID-19.

The work was supported by the Emergent Projects of National Science and Technology; the National Natural Science Foundation of China; the National Key Research and Development Program of China; the Shanghai Municipal Key Clinical Specialty; the National Innovative Research Team of High-Level Local Universities in Shanghai; the Shanghai Key Discipline for Respiratory Diseases; the National Major Scientific and Technological Special Project for Significant New Drugs Development; and Key Projects in the National Science and Technology Pillar Program. The authors, Kahlenberg, and Plowe have disclosed no relevant financial relationships.

This story first appeared on Medscape.com.
 

The adoption of the infused biosimilar infliximab therapies Inflectra and Renflexis was slower at an academic medical center than at a neighboring Veterans Affairs Medical Center (VAMC) during the same time period in 2015-2019, according to an analysis published in Arthritis and Rheumatology.

The use of the biosimilars also was associated with cost savings at the VAMC, but not at the academic medical center, which illustrates that insufficient financial incentives can delay the adoption of biosimilars and the health care system’s realization of cost savings, according to the authors.

Medicare, which is not allowed to negotiate drug prices, is one of the largest payers for infused therapies. Medicare reimbursement for infused therapies is based on the latter’s average selling price (ASP) during the previous quarter. Institutions may negotiate purchase prices with drug manufacturers and receive Medicare reimbursement. Biosimilars generally have lower ASPs than their corresponding reference therapies, and biosimilar manufacturers may have less room to negotiate prices than reference therapy manufacturers. Consequently, a given institution might have a greater incentive to use reference products than to use biosimilars.
 

An examination of pharmacy data

The VA negotiates drug prices for all of its medical centers and has mandated that clinicians prefer biosimilars to their corresponding reference therapies, so Joshua F. Baker, MD, of the University of Pennsylvania and the Corporal Michael J. Crescenz VAMC, both in Philadelphia, and his colleagues hypothesized that the adoption of biosimilars had proceeded more quickly at a VAMC than at a nearby academic medical center.

The investigators examined pharmacy data from the University of Pennsylvania Health System (UPHS) electronic medical record and the Corporal Michael J. Crescenz VAMC to compare the frequency of prescribing biosimilars at these sites between Jan. 1, 2015, and May 31, 2019. Dr. Baker and his associates focused specifically on reference infliximab (Remicade) and the reference noninfusion therapies filgrastim (Neupogen) and pegfilgrastim (Neulasta) and on biosimilars of these therapies (infliximab-dyyb [Inflectra], infliximab-abda [Renflexis], filgrastim-sndz [Zarxio], and pegfilgrastim-jmdb [Fulphila]).

Because Medicare was the predominant payer, the researchers estimated reimbursement for reference and biosimilar infliximabs according to the Medicare Part B reimbursement policy. They defined an institution’s incentive to use a given therapy as the difference between the reimbursement and acquisition cost for that therapy. Dr. Baker and colleagues compared the incentives for UPHS with those for the VAMC.
 

VAMC saved 81% of reference product cost

The researchers identified 15,761 infusions of infliximab at UPHS and 446 at the VAMC during the study period. The proportion of infusions that used the reference product was 99% at UPHS and 62% at the VAMC. ASPs for biosimilar infliximab have been consistently lower than those for the reference product since July 2017. In December 2017, the VAMC switched to the biosimilar infliximab.

Institutional incentives based on Medicare Part B reimbursement and acquisitions costs for reference and biosimilar infliximab have been similar since 2018. In 2019, the institutional incentive favored the reference product by $49-$64 per 100-mg vial. But at the VAMC, the cost per 100-mg vial was $623.48 for the reference product and $115.58 for the biosimilar Renflexis. Purchasing the biosimilar thus yielded a savings of 81%. The current costs for the therapies are $546 and $116, respectively.

In addition, Dr. Baker and colleagues identified 46,683 orders for filgrastim or pegfilgrastim at UPHS. Approximately 90% of the orders were for either of the two reference products despite the ASP of biosimilar filgrastim being approximately 40% lower than that of its reference product. At the VAMC, about 88% of orders were for the reference products. Biosimilars became available in 2016. UPHS began using them at a modest rate, but their adoption was greater at the VAMC, which designated them as preferred products.

Tendering and a nationwide policy mandating use of biosimilars have resulted in financial savings for the VAMC, wrote Dr. Baker and colleagues. “These data suggest that, with current Medicare Part B reimbursement policy, the absence of financial incentives to encourage use of infliximab biosimilars has resulted in slower uptake of biosimilar use at institutions outside of the VA system. The implications of this are a slower reduction in costs to the health care system, since decreases in ASP over time are predicated on negotiations at the institutional level, which have been gradual and stepwise. ...

“Although some of our results may not be applicable to other geographical regions of the U.S., the comparison of two affiliated institutions in geographical proximity and with shared health care providers is a strength,” they continued. “Our findings should be replicated using national VAMC data or data from other health care systems.”

The researchers said that their findings may not apply to noninfused therapies, which are not covered under Medicare Part B, and they did not directly study the impact of pharmacy benefit managers. However, they noted that their data on filgrastim and pegfilgrastim support the hypothesis that pharmacy benefit managers receive “incentives that continue to promote the use of reference products that have higher manufacturer’s list prices, which likely will limit the uptake of both infused and injectable biosimilar therapies over time.” They said that “this finding has important implications for when noninfused biosimilars (e.g. etanercept and adalimumab) are eventually introduced to the U.S. market.”

European governments incentivize use of biosimilars

Government and institutional incentives have increased the adoption of biosimilars in Europe, wrote Guro Lovik Goll, MD, and Tore Kristian Kvien, MD, of the department of rheumatology at Diakonhjemmet Hospital in Oslo, in an accompanying editorial. Norway and Denmark have annual national tender systems in which biosimilars and reference products compete. The price of infliximab biosimilar was 39% lower than the reference product in 2014 and 69% lower in 2015. “Competition has caused dramatically lower prices both for biosimilars and also for the originator drugs competing with them,” wrote the authors.

In 2015, the government of Denmark mandated that patients on infliximab be switched to a biosimilar, and patients in Norway also have been switched to biosimilars. The use of etanercept in Norway increased by 40% from 2016 to 2019, and the use of infliximab has increased by more than threefold since 2015. “In Norway, the consequence of competition, national tenders, and availability of biosimilars have led to better access to therapy for more people in need of biologic drugs, while at the same time showing a total cost reduction of biologics for use in rheumatology, gastroenterology, and dermatology,” wrote the authors.

Health care costs $10,000 per capita in the United States, compared with $5,300 for other wealthy countries in the Organization for Economic Cooperation and Development. Low life expectancy and high infant mortality in the U.S. indicate that high costs are not associated with better outcomes. “As Americans seem to lose out on the cost-cutting potential of biosimilars, this missed opportunity is set to get even more expensive,” the authors concluded.

The U.S. Department of Veterans Affairs, the National Institutes of Health, and the American Diabetes Association contributed funding for the study. Dr. Baker reported receiving consulting fees from Bristol-Myers Squibb and Gilead, and another author reported receiving research support paid to his institution by Pfizer and UCB, as well as receiving consulting fees from nine pharmaceutical companies. Dr. Goll and Dr. Kvien both reported receiving fees for speaking and/or consulting from numerous pharmaceutical companies, including Pfizer.

[email protected]

SOURCES: Baker JF et al. Arthritis Rheumatol. 2020 Apr 6. doi: 10.1002/art.41277.

The adoption of the infused biosimilar infliximab therapies Inflectra and Renflexis was slower at an academic medical center than at a neighboring Veterans Affairs Medical Center (VAMC) during the same time period in 2015-2019, according to an analysis published in Arthritis and Rheumatology.

The use of the biosimilars also was associated with cost savings at the VAMC, but not at the academic medical center, which illustrates that insufficient financial incentives can delay the adoption of biosimilars and the health care system’s realization of cost savings, according to the authors.

Medicare, which is not allowed to negotiate drug prices, is one of the largest payers for infused therapies. Medicare reimbursement for infused therapies is based on the latter’s average selling price (ASP) during the previous quarter. Institutions may negotiate purchase prices with drug manufacturers and receive Medicare reimbursement. Biosimilars generally have lower ASPs than their corresponding reference therapies, and biosimilar manufacturers may have less room to negotiate prices than reference therapy manufacturers. Consequently, a given institution might have a greater incentive to use reference products than to use biosimilars.
 

An examination of pharmacy data

The VA negotiates drug prices for all of its medical centers and has mandated that clinicians prefer biosimilars to their corresponding reference therapies, so Joshua F. Baker, MD, of the University of Pennsylvania and the Corporal Michael J. Crescenz VAMC, both in Philadelphia, and his colleagues hypothesized that the adoption of biosimilars had proceeded more quickly at a VAMC than at a nearby academic medical center.

The investigators examined pharmacy data from the University of Pennsylvania Health System (UPHS) electronic medical record and the Corporal Michael J. Crescenz VAMC to compare the frequency of prescribing biosimilars at these sites between Jan. 1, 2015, and May 31, 2019. Dr. Baker and his associates focused specifically on reference infliximab (Remicade) and the reference noninfusion therapies filgrastim (Neupogen) and pegfilgrastim (Neulasta) and on biosimilars of these therapies (infliximab-dyyb [Inflectra], infliximab-abda [Renflexis], filgrastim-sndz [Zarxio], and pegfilgrastim-jmdb [Fulphila]).

Because Medicare was the predominant payer, the researchers estimated reimbursement for reference and biosimilar infliximabs according to the Medicare Part B reimbursement policy. They defined an institution’s incentive to use a given therapy as the difference between the reimbursement and acquisition cost for that therapy. Dr. Baker and colleagues compared the incentives for UPHS with those for the VAMC.
 

VAMC saved 81% of reference product cost

The researchers identified 15,761 infusions of infliximab at UPHS and 446 at the VAMC during the study period. The proportion of infusions that used the reference product was 99% at UPHS and 62% at the VAMC. ASPs for biosimilar infliximab have been consistently lower than those for the reference product since July 2017. In December 2017, the VAMC switched to the biosimilar infliximab.

Institutional incentives based on Medicare Part B reimbursement and acquisitions costs for reference and biosimilar infliximab have been similar since 2018. In 2019, the institutional incentive favored the reference product by $49-$64 per 100-mg vial. But at the VAMC, the cost per 100-mg vial was $623.48 for the reference product and $115.58 for the biosimilar Renflexis. Purchasing the biosimilar thus yielded a savings of 81%. The current costs for the therapies are $546 and $116, respectively.

In addition, Dr. Baker and colleagues identified 46,683 orders for filgrastim or pegfilgrastim at UPHS. Approximately 90% of the orders were for either of the two reference products despite the ASP of biosimilar filgrastim being approximately 40% lower than that of its reference product. At the VAMC, about 88% of orders were for the reference products. Biosimilars became available in 2016. UPHS began using them at a modest rate, but their adoption was greater at the VAMC, which designated them as preferred products.

Tendering and a nationwide policy mandating use of biosimilars have resulted in financial savings for the VAMC, wrote Dr. Baker and colleagues. “These data suggest that, with current Medicare Part B reimbursement policy, the absence of financial incentives to encourage use of infliximab biosimilars has resulted in slower uptake of biosimilar use at institutions outside of the VA system. The implications of this are a slower reduction in costs to the health care system, since decreases in ASP over time are predicated on negotiations at the institutional level, which have been gradual and stepwise. ...

“Although some of our results may not be applicable to other geographical regions of the U.S., the comparison of two affiliated institutions in geographical proximity and with shared health care providers is a strength,” they continued. “Our findings should be replicated using national VAMC data or data from other health care systems.”

The researchers said that their findings may not apply to noninfused therapies, which are not covered under Medicare Part B, and they did not directly study the impact of pharmacy benefit managers. However, they noted that their data on filgrastim and pegfilgrastim support the hypothesis that pharmacy benefit managers receive “incentives that continue to promote the use of reference products that have higher manufacturer’s list prices, which likely will limit the uptake of both infused and injectable biosimilar therapies over time.” They said that “this finding has important implications for when noninfused biosimilars (e.g. etanercept and adalimumab) are eventually introduced to the U.S. market.”

European governments incentivize use of biosimilars

Government and institutional incentives have increased the adoption of biosimilars in Europe, wrote Guro Lovik Goll, MD, and Tore Kristian Kvien, MD, of the department of rheumatology at Diakonhjemmet Hospital in Oslo, in an accompanying editorial. Norway and Denmark have annual national tender systems in which biosimilars and reference products compete. The price of infliximab biosimilar was 39% lower than the reference product in 2014 and 69% lower in 2015. “Competition has caused dramatically lower prices both for biosimilars and also for the originator drugs competing with them,” wrote the authors.

In 2015, the government of Denmark mandated that patients on infliximab be switched to a biosimilar, and patients in Norway also have been switched to biosimilars. The use of etanercept in Norway increased by 40% from 2016 to 2019, and the use of infliximab has increased by more than threefold since 2015. “In Norway, the consequence of competition, national tenders, and availability of biosimilars have led to better access to therapy for more people in need of biologic drugs, while at the same time showing a total cost reduction of biologics for use in rheumatology, gastroenterology, and dermatology,” wrote the authors.

Health care costs $10,000 per capita in the United States, compared with $5,300 for other wealthy countries in the Organization for Economic Cooperation and Development. Low life expectancy and high infant mortality in the U.S. indicate that high costs are not associated with better outcomes. “As Americans seem to lose out on the cost-cutting potential of biosimilars, this missed opportunity is set to get even more expensive,” the authors concluded.

The U.S. Department of Veterans Affairs, the National Institutes of Health, and the American Diabetes Association contributed funding for the study. Dr. Baker reported receiving consulting fees from Bristol-Myers Squibb and Gilead, and another author reported receiving research support paid to his institution by Pfizer and UCB, as well as receiving consulting fees from nine pharmaceutical companies. Dr. Goll and Dr. Kvien both reported receiving fees for speaking and/or consulting from numerous pharmaceutical companies, including Pfizer.

[email protected]

SOURCES: Baker JF et al. Arthritis Rheumatol. 2020 Apr 6. doi: 10.1002/art.41277.

The adoption of the infused biosimilar infliximab therapies Inflectra and Renflexis was slower at an academic medical center than at a neighboring Veterans Affairs Medical Center (VAMC) during the same time period in 2015-2019, according to an analysis published in Arthritis and Rheumatology.

The use of the biosimilars also was associated with cost savings at the VAMC, but not at the academic medical center, which illustrates that insufficient financial incentives can delay the adoption of biosimilars and the health care system’s realization of cost savings, according to the authors.

Medicare, which is not allowed to negotiate drug prices, is one of the largest payers for infused therapies. Medicare reimbursement for infused therapies is based on the latter’s average selling price (ASP) during the previous quarter. Institutions may negotiate purchase prices with drug manufacturers and receive Medicare reimbursement. Biosimilars generally have lower ASPs than their corresponding reference therapies, and biosimilar manufacturers may have less room to negotiate prices than reference therapy manufacturers. Consequently, a given institution might have a greater incentive to use reference products than to use biosimilars.
 

An examination of pharmacy data

The VA negotiates drug prices for all of its medical centers and has mandated that clinicians prefer biosimilars to their corresponding reference therapies, so Joshua F. Baker, MD, of the University of Pennsylvania and the Corporal Michael J. Crescenz VAMC, both in Philadelphia, and his colleagues hypothesized that the adoption of biosimilars had proceeded more quickly at a VAMC than at a nearby academic medical center.

The investigators examined pharmacy data from the University of Pennsylvania Health System (UPHS) electronic medical record and the Corporal Michael J. Crescenz VAMC to compare the frequency of prescribing biosimilars at these sites between Jan. 1, 2015, and May 31, 2019. Dr. Baker and his associates focused specifically on reference infliximab (Remicade) and the reference noninfusion therapies filgrastim (Neupogen) and pegfilgrastim (Neulasta) and on biosimilars of these therapies (infliximab-dyyb [Inflectra], infliximab-abda [Renflexis], filgrastim-sndz [Zarxio], and pegfilgrastim-jmdb [Fulphila]).

Because Medicare was the predominant payer, the researchers estimated reimbursement for reference and biosimilar infliximabs according to the Medicare Part B reimbursement policy. They defined an institution’s incentive to use a given therapy as the difference between the reimbursement and acquisition cost for that therapy. Dr. Baker and colleagues compared the incentives for UPHS with those for the VAMC.
 

VAMC saved 81% of reference product cost

The researchers identified 15,761 infusions of infliximab at UPHS and 446 at the VAMC during the study period. The proportion of infusions that used the reference product was 99% at UPHS and 62% at the VAMC. ASPs for biosimilar infliximab have been consistently lower than those for the reference product since July 2017. In December 2017, the VAMC switched to the biosimilar infliximab.

Institutional incentives based on Medicare Part B reimbursement and acquisitions costs for reference and biosimilar infliximab have been similar since 2018. In 2019, the institutional incentive favored the reference product by $49-$64 per 100-mg vial. But at the VAMC, the cost per 100-mg vial was $623.48 for the reference product and $115.58 for the biosimilar Renflexis. Purchasing the biosimilar thus yielded a savings of 81%. The current costs for the therapies are $546 and $116, respectively.

In addition, Dr. Baker and colleagues identified 46,683 orders for filgrastim or pegfilgrastim at UPHS. Approximately 90% of the orders were for either of the two reference products despite the ASP of biosimilar filgrastim being approximately 40% lower than that of its reference product. At the VAMC, about 88% of orders were for the reference products. Biosimilars became available in 2016. UPHS began using them at a modest rate, but their adoption was greater at the VAMC, which designated them as preferred products.

Tendering and a nationwide policy mandating use of biosimilars have resulted in financial savings for the VAMC, wrote Dr. Baker and colleagues. “These data suggest that, with current Medicare Part B reimbursement policy, the absence of financial incentives to encourage use of infliximab biosimilars has resulted in slower uptake of biosimilar use at institutions outside of the VA system. The implications of this are a slower reduction in costs to the health care system, since decreases in ASP over time are predicated on negotiations at the institutional level, which have been gradual and stepwise. ...

“Although some of our results may not be applicable to other geographical regions of the U.S., the comparison of two affiliated institutions in geographical proximity and with shared health care providers is a strength,” they continued. “Our findings should be replicated using national VAMC data or data from other health care systems.”

The researchers said that their findings may not apply to noninfused therapies, which are not covered under Medicare Part B, and they did not directly study the impact of pharmacy benefit managers. However, they noted that their data on filgrastim and pegfilgrastim support the hypothesis that pharmacy benefit managers receive “incentives that continue to promote the use of reference products that have higher manufacturer’s list prices, which likely will limit the uptake of both infused and injectable biosimilar therapies over time.” They said that “this finding has important implications for when noninfused biosimilars (e.g. etanercept and adalimumab) are eventually introduced to the U.S. market.”

European governments incentivize use of biosimilars

Government and institutional incentives have increased the adoption of biosimilars in Europe, wrote Guro Lovik Goll, MD, and Tore Kristian Kvien, MD, of the department of rheumatology at Diakonhjemmet Hospital in Oslo, in an accompanying editorial. Norway and Denmark have annual national tender systems in which biosimilars and reference products compete. The price of infliximab biosimilar was 39% lower than the reference product in 2014 and 69% lower in 2015. “Competition has caused dramatically lower prices both for biosimilars and also for the originator drugs competing with them,” wrote the authors.

In 2015, the government of Denmark mandated that patients on infliximab be switched to a biosimilar, and patients in Norway also have been switched to biosimilars. The use of etanercept in Norway increased by 40% from 2016 to 2019, and the use of infliximab has increased by more than threefold since 2015. “In Norway, the consequence of competition, national tenders, and availability of biosimilars have led to better access to therapy for more people in need of biologic drugs, while at the same time showing a total cost reduction of biologics for use in rheumatology, gastroenterology, and dermatology,” wrote the authors.

Health care costs $10,000 per capita in the United States, compared with $5,300 for other wealthy countries in the Organization for Economic Cooperation and Development. Low life expectancy and high infant mortality in the U.S. indicate that high costs are not associated with better outcomes. “As Americans seem to lose out on the cost-cutting potential of biosimilars, this missed opportunity is set to get even more expensive,” the authors concluded.

The U.S. Department of Veterans Affairs, the National Institutes of Health, and the American Diabetes Association contributed funding for the study. Dr. Baker reported receiving consulting fees from Bristol-Myers Squibb and Gilead, and another author reported receiving research support paid to his institution by Pfizer and UCB, as well as receiving consulting fees from nine pharmaceutical companies. Dr. Goll and Dr. Kvien both reported receiving fees for speaking and/or consulting from numerous pharmaceutical companies, including Pfizer.

[email protected]

SOURCES: Baker JF et al. Arthritis Rheumatol. 2020 Apr 6. doi: 10.1002/art.41277.

STOWE, VT. – A large and growing number of medications is available for the acute treatment of migraine. Effective acute treatment enables patients to re-engage in their work and other daily activities, as well as reducing the likelihood that their disease will progress from episodic to chronic migraine. Considering appropriate routes of delivery, assessing efficacy and tolerability, and communicating well with the patient are essential components in the acute treatment of migraine, according to Barbara L. Nye, MD, assistant professor of neurology at the Geisel School of Medicine at Dartmouth, Hanover, N.H.. Dr. Nye discussed the acute treatment of migraine at the annual meeting of the Headache Cooperative of New England.

Choosing an initial treatment

Nonspecific medications are perhaps the first treatments to consider for a patient with acute migraine. This class includes NSAIDs such as naproxen sodium, piroxicam, diclofenac, celecoxib, and indomethacin. Emerging data indicate that some NSAIDs are associated with an increased risk of stroke, which is an important consideration as the population ages, said Dr. Nye. Other nonspecific options are neuroleptics such as prochlorperazine, metoclopramide, promethazine, and chlorpromazine. Many neuroleptics have sedative effects, however, so they do not necessarily help a patient return to function. Nevertheless, these drugs can be good rescue medications, said Dr. Nye.

Triptans are effective in the acute treatment of migraine, and seven drugs in this class are available. Most, such as rizatriptan, almotriptan, eletriptan, naratriptan, and frovatriptan, are available only as tablets. Other routes of delivery are available, however. Sumatriptan, for example, is available in injectable and intranasal formulations, and zolmitriptan is available as an orally dissolving tablet.

Another option to consider is dihydroergotamine (DHE), which has long been used for migraine. The injectable formulation of DHE can be cumbersome because it requires the patients with a headache to open a vial, draw the medication into a filter needle, and inject themselves, said Dr. Nye. “The nasal sprays that are available right now aren’t as effective as we’d like them to be,” she added. But overall, DHE is effective. Associated adverse events include flushing, nausea, and diarrhea.

Lasmiditan received approval from the Food and Drug Administration for the acute treatment of migraine in October 2019. Compared with placebo, the drug increases the likelihood of pain freedom and freedom from the most bothersome symptom at 2 hours. Driving tests indicated that patients were impaired for about 8 hours after treatment, and lasmiditan is a Schedule V drug. It is available in doses of 50 mg/day, 100 mg/day, and 200 mg/day.

The class of drugs known as the “gepants” provides further options. The most recently approved therapy in this class, which targets calcitonin gene–related peptide, is ubrogepant. Because the drug is metabolized through the CYP3A4 system, they are not appropriate for patients who use strong CYP3A4 inhibitors. The most common side effects are nausea, hypersensitivity reaction, and somnolence.

Neuromodulation can provide effective treatment without provoking side effects, said Dr. Nye. Options include transcutaneous supraorbital stimulation, single-pulse transcutaneous magnetic stimulation, noninvasive vagal nerve stimulation, and remote nonpainful stimulation.

If a patient presents during an acute attack, neurologists could consider using a nerve block. The latter may administer occipital nerve blocks, trigger point injections, auriculotemporal nerve blocks, and supraorbital and supratrochlear nerve blocks. This treatment can bring immediate relief, which is gratifying for patients and neurologists. But no consensus about which medications to use or how to administer them has been established. Neurologists most often use a combination of bupivacaine and lidocaine. Another possibility is a sphenopalatine ganglion nerve block, which requires treatment to be inserted through the nose. This treatment can be delivered in the office using the Sphenocath device or the Allevio device. Another device, the Tx360, is intended to enable patient self-administration.
 

Addressing treatment failure

If a patient returns and reports that the current treatment is ineffective, the neurologist must reevaluate the therapy. A helpful way to conduct this reassessment is to administer the Migraine Treatment Optimization Questionnaire (MTOQ), which was developed by Lipton et al., to the patient. Neurologists ask whether the patient can function normally 2 hours after treatment or whether the medication is, for example, causing a side effect that makes this outcome less likely. Other questions for the patient are whether the headache pain disappears within 2 hours and whether the medication provides consistent relief. Finally, the neurologist can ask whether the patient is comfortable taking the medication. A score lower than 2 on the MTOQ indicates that the acute treatment should be changed, said Dr. Nye.

Gastroparesis is common during migraine attacks. It is inadvisable to give an oral medication to a patient who vomits within 20 minutes of attack onset, said Dr. Nye. “It’s a little less intuitive for those people who are nauseous immediately to think that that oral tablet is probably going to sit in their stomach and not get absorbed in the intestines as intended.” Nasal sprays, injectable medicines, and oral dissolving tablets are appropriate options for patients with gastroparesis.
 

Treating migraine during pregnancy

Special consideration must be given to treatment when the patient is pregnant. Decreased headache frequency is common in pregnancy, but not universal. Occipital nerve blocks are a good option for prevention and acute management in pregnant patients. They may be administered every 2 weeks. Sphenopalatine ganglion nerve block is another option, and it can be administered several times per week. Data “suggest that stacking the injections 2 or 3 days per week for up to 6 weeks can eliminate headaches for up to 6 months,” said Dr. Nye.

Tylenol is appropriate for acute headache in pregnant patients, “but we do warn about medication overuse headache and limiting its use.” Ondansetron and promethazine are acceptable treatments for nausea. Although ondansetron has less central activity than promethazine, and thus does not reduce the headache, it lessens nausea, said Dr. Nye.

Triptan exposure during the first trimester is not significantly associated with major congenital malformations, which is reassuring, given that many patients take triptans before they realize that they are pregnant. During the second and third trimesters, triptan exposure is significantly associated with atonic uterus and increased blood loss during labor. In a 16-year registry, sumatriptan, naratriptan, and treximet were not associated with teratogenicity.

Nonpharmacological treatments, too, may help pregnant patients. Lifestyle management, including a regular sleep schedule, exercise routine, and diet, can be beneficial. Massage therapy may reduce stress, and cognitive-behavioral therapy and biofeedback are additional options. Behavioral therapy, however, should be initiated before the patient plans the pregnancy, said Dr. Nye. These therapies require training that a patient having an exacerbation of migraine is less likely to have the motivation to begin.

Many medications are transferred to infants through breast milk. The American Pediatric Association considers a relative infant dosing of less than 10% to be safe. A clinician or patient can look up a medication on websites such as LactMed to understand the relative infant dose and possible effects. Another helpful reference is Medications and Mothers’ Milk, said Dr. Nye. Acetaminophen, steroids, ibuprofen, riboflavin, indomethacin, ketorolac, and naproxen are generally safe during lactation. “Eletriptan is the triptan that’s least likely to be in the breast milk,” said Dr. Nye. Aspirin, atenolol, ergotamine, and lithium, however, should be given with caution. The safety of amitriptyline, nortriptyline, and SSRIs during lactation is unknown.

Dr. Nye is on advisory boards for Alder, Allergan, Biohaven, electroCore, Pernix, and Xoc.

[email protected]

STOWE, VT. – A large and growing number of medications is available for the acute treatment of migraine. Effective acute treatment enables patients to re-engage in their work and other daily activities, as well as reducing the likelihood that their disease will progress from episodic to chronic migraine. Considering appropriate routes of delivery, assessing efficacy and tolerability, and communicating well with the patient are essential components in the acute treatment of migraine, according to Barbara L. Nye, MD, assistant professor of neurology at the Geisel School of Medicine at Dartmouth, Hanover, N.H.. Dr. Nye discussed the acute treatment of migraine at the annual meeting of the Headache Cooperative of New England.

Choosing an initial treatment

Nonspecific medications are perhaps the first treatments to consider for a patient with acute migraine. This class includes NSAIDs such as naproxen sodium, piroxicam, diclofenac, celecoxib, and indomethacin. Emerging data indicate that some NSAIDs are associated with an increased risk of stroke, which is an important consideration as the population ages, said Dr. Nye. Other nonspecific options are neuroleptics such as prochlorperazine, metoclopramide, promethazine, and chlorpromazine. Many neuroleptics have sedative effects, however, so they do not necessarily help a patient return to function. Nevertheless, these drugs can be good rescue medications, said Dr. Nye.

Triptans are effective in the acute treatment of migraine, and seven drugs in this class are available. Most, such as rizatriptan, almotriptan, eletriptan, naratriptan, and frovatriptan, are available only as tablets. Other routes of delivery are available, however. Sumatriptan, for example, is available in injectable and intranasal formulations, and zolmitriptan is available as an orally dissolving tablet.

Another option to consider is dihydroergotamine (DHE), which has long been used for migraine. The injectable formulation of DHE can be cumbersome because it requires the patients with a headache to open a vial, draw the medication into a filter needle, and inject themselves, said Dr. Nye. “The nasal sprays that are available right now aren’t as effective as we’d like them to be,” she added. But overall, DHE is effective. Associated adverse events include flushing, nausea, and diarrhea.

Lasmiditan received approval from the Food and Drug Administration for the acute treatment of migraine in October 2019. Compared with placebo, the drug increases the likelihood of pain freedom and freedom from the most bothersome symptom at 2 hours. Driving tests indicated that patients were impaired for about 8 hours after treatment, and lasmiditan is a Schedule V drug. It is available in doses of 50 mg/day, 100 mg/day, and 200 mg/day.

The class of drugs known as the “gepants” provides further options. The most recently approved therapy in this class, which targets calcitonin gene–related peptide, is ubrogepant. Because the drug is metabolized through the CYP3A4 system, they are not appropriate for patients who use strong CYP3A4 inhibitors. The most common side effects are nausea, hypersensitivity reaction, and somnolence.

Neuromodulation can provide effective treatment without provoking side effects, said Dr. Nye. Options include transcutaneous supraorbital stimulation, single-pulse transcutaneous magnetic stimulation, noninvasive vagal nerve stimulation, and remote nonpainful stimulation.

If a patient presents during an acute attack, neurologists could consider using a nerve block. The latter may administer occipital nerve blocks, trigger point injections, auriculotemporal nerve blocks, and supraorbital and supratrochlear nerve blocks. This treatment can bring immediate relief, which is gratifying for patients and neurologists. But no consensus about which medications to use or how to administer them has been established. Neurologists most often use a combination of bupivacaine and lidocaine. Another possibility is a sphenopalatine ganglion nerve block, which requires treatment to be inserted through the nose. This treatment can be delivered in the office using the Sphenocath device or the Allevio device. Another device, the Tx360, is intended to enable patient self-administration.
 

Addressing treatment failure

If a patient returns and reports that the current treatment is ineffective, the neurologist must reevaluate the therapy. A helpful way to conduct this reassessment is to administer the Migraine Treatment Optimization Questionnaire (MTOQ), which was developed by Lipton et al., to the patient. Neurologists ask whether the patient can function normally 2 hours after treatment or whether the medication is, for example, causing a side effect that makes this outcome less likely. Other questions for the patient are whether the headache pain disappears within 2 hours and whether the medication provides consistent relief. Finally, the neurologist can ask whether the patient is comfortable taking the medication. A score lower than 2 on the MTOQ indicates that the acute treatment should be changed, said Dr. Nye.

Gastroparesis is common during migraine attacks. It is inadvisable to give an oral medication to a patient who vomits within 20 minutes of attack onset, said Dr. Nye. “It’s a little less intuitive for those people who are nauseous immediately to think that that oral tablet is probably going to sit in their stomach and not get absorbed in the intestines as intended.” Nasal sprays, injectable medicines, and oral dissolving tablets are appropriate options for patients with gastroparesis.
 

Treating migraine during pregnancy

Special consideration must be given to treatment when the patient is pregnant. Decreased headache frequency is common in pregnancy, but not universal. Occipital nerve blocks are a good option for prevention and acute management in pregnant patients. They may be administered every 2 weeks. Sphenopalatine ganglion nerve block is another option, and it can be administered several times per week. Data “suggest that stacking the injections 2 or 3 days per week for up to 6 weeks can eliminate headaches for up to 6 months,” said Dr. Nye.

Tylenol is appropriate for acute headache in pregnant patients, “but we do warn about medication overuse headache and limiting its use.” Ondansetron and promethazine are acceptable treatments for nausea. Although ondansetron has less central activity than promethazine, and thus does not reduce the headache, it lessens nausea, said Dr. Nye.

Triptan exposure during the first trimester is not significantly associated with major congenital malformations, which is reassuring, given that many patients take triptans before they realize that they are pregnant. During the second and third trimesters, triptan exposure is significantly associated with atonic uterus and increased blood loss during labor. In a 16-year registry, sumatriptan, naratriptan, and treximet were not associated with teratogenicity.

Nonpharmacological treatments, too, may help pregnant patients. Lifestyle management, including a regular sleep schedule, exercise routine, and diet, can be beneficial. Massage therapy may reduce stress, and cognitive-behavioral therapy and biofeedback are additional options. Behavioral therapy, however, should be initiated before the patient plans the pregnancy, said Dr. Nye. These therapies require training that a patient having an exacerbation of migraine is less likely to have the motivation to begin.

Many medications are transferred to infants through breast milk. The American Pediatric Association considers a relative infant dosing of less than 10% to be safe. A clinician or patient can look up a medication on websites such as LactMed to understand the relative infant dose and possible effects. Another helpful reference is Medications and Mothers’ Milk, said Dr. Nye. Acetaminophen, steroids, ibuprofen, riboflavin, indomethacin, ketorolac, and naproxen are generally safe during lactation. “Eletriptan is the triptan that’s least likely to be in the breast milk,” said Dr. Nye. Aspirin, atenolol, ergotamine, and lithium, however, should be given with caution. The safety of amitriptyline, nortriptyline, and SSRIs during lactation is unknown.

Dr. Nye is on advisory boards for Alder, Allergan, Biohaven, electroCore, Pernix, and Xoc.

[email protected]

STOWE, VT. – A large and growing number of medications is available for the acute treatment of migraine. Effective acute treatment enables patients to re-engage in their work and other daily activities, as well as reducing the likelihood that their disease will progress from episodic to chronic migraine. Considering appropriate routes of delivery, assessing efficacy and tolerability, and communicating well with the patient are essential components in the acute treatment of migraine, according to Barbara L. Nye, MD, assistant professor of neurology at the Geisel School of Medicine at Dartmouth, Hanover, N.H.. Dr. Nye discussed the acute treatment of migraine at the annual meeting of the Headache Cooperative of New England.

Choosing an initial treatment

Nonspecific medications are perhaps the first treatments to consider for a patient with acute migraine. This class includes NSAIDs such as naproxen sodium, piroxicam, diclofenac, celecoxib, and indomethacin. Emerging data indicate that some NSAIDs are associated with an increased risk of stroke, which is an important consideration as the population ages, said Dr. Nye. Other nonspecific options are neuroleptics such as prochlorperazine, metoclopramide, promethazine, and chlorpromazine. Many neuroleptics have sedative effects, however, so they do not necessarily help a patient return to function. Nevertheless, these drugs can be good rescue medications, said Dr. Nye.

Triptans are effective in the acute treatment of migraine, and seven drugs in this class are available. Most, such as rizatriptan, almotriptan, eletriptan, naratriptan, and frovatriptan, are available only as tablets. Other routes of delivery are available, however. Sumatriptan, for example, is available in injectable and intranasal formulations, and zolmitriptan is available as an orally dissolving tablet.

Another option to consider is dihydroergotamine (DHE), which has long been used for migraine. The injectable formulation of DHE can be cumbersome because it requires the patients with a headache to open a vial, draw the medication into a filter needle, and inject themselves, said Dr. Nye. “The nasal sprays that are available right now aren’t as effective as we’d like them to be,” she added. But overall, DHE is effective. Associated adverse events include flushing, nausea, and diarrhea.

Lasmiditan received approval from the Food and Drug Administration for the acute treatment of migraine in October 2019. Compared with placebo, the drug increases the likelihood of pain freedom and freedom from the most bothersome symptom at 2 hours. Driving tests indicated that patients were impaired for about 8 hours after treatment, and lasmiditan is a Schedule V drug. It is available in doses of 50 mg/day, 100 mg/day, and 200 mg/day.

The class of drugs known as the “gepants” provides further options. The most recently approved therapy in this class, which targets calcitonin gene–related peptide, is ubrogepant. Because the drug is metabolized through the CYP3A4 system, they are not appropriate for patients who use strong CYP3A4 inhibitors. The most common side effects are nausea, hypersensitivity reaction, and somnolence.

Neuromodulation can provide effective treatment without provoking side effects, said Dr. Nye. Options include transcutaneous supraorbital stimulation, single-pulse transcutaneous magnetic stimulation, noninvasive vagal nerve stimulation, and remote nonpainful stimulation.

If a patient presents during an acute attack, neurologists could consider using a nerve block. The latter may administer occipital nerve blocks, trigger point injections, auriculotemporal nerve blocks, and supraorbital and supratrochlear nerve blocks. This treatment can bring immediate relief, which is gratifying for patients and neurologists. But no consensus about which medications to use or how to administer them has been established. Neurologists most often use a combination of bupivacaine and lidocaine. Another possibility is a sphenopalatine ganglion nerve block, which requires treatment to be inserted through the nose. This treatment can be delivered in the office using the Sphenocath device or the Allevio device. Another device, the Tx360, is intended to enable patient self-administration.
 

Addressing treatment failure

If a patient returns and reports that the current treatment is ineffective, the neurologist must reevaluate the therapy. A helpful way to conduct this reassessment is to administer the Migraine Treatment Optimization Questionnaire (MTOQ), which was developed by Lipton et al., to the patient. Neurologists ask whether the patient can function normally 2 hours after treatment or whether the medication is, for example, causing a side effect that makes this outcome less likely. Other questions for the patient are whether the headache pain disappears within 2 hours and whether the medication provides consistent relief. Finally, the neurologist can ask whether the patient is comfortable taking the medication. A score lower than 2 on the MTOQ indicates that the acute treatment should be changed, said Dr. Nye.

Gastroparesis is common during migraine attacks. It is inadvisable to give an oral medication to a patient who vomits within 20 minutes of attack onset, said Dr. Nye. “It’s a little less intuitive for those people who are nauseous immediately to think that that oral tablet is probably going to sit in their stomach and not get absorbed in the intestines as intended.” Nasal sprays, injectable medicines, and oral dissolving tablets are appropriate options for patients with gastroparesis.
 

Treating migraine during pregnancy

Special consideration must be given to treatment when the patient is pregnant. Decreased headache frequency is common in pregnancy, but not universal. Occipital nerve blocks are a good option for prevention and acute management in pregnant patients. They may be administered every 2 weeks. Sphenopalatine ganglion nerve block is another option, and it can be administered several times per week. Data “suggest that stacking the injections 2 or 3 days per week for up to 6 weeks can eliminate headaches for up to 6 months,” said Dr. Nye.

Tylenol is appropriate for acute headache in pregnant patients, “but we do warn about medication overuse headache and limiting its use.” Ondansetron and promethazine are acceptable treatments for nausea. Although ondansetron has less central activity than promethazine, and thus does not reduce the headache, it lessens nausea, said Dr. Nye.

Triptan exposure during the first trimester is not significantly associated with major congenital malformations, which is reassuring, given that many patients take triptans before they realize that they are pregnant. During the second and third trimesters, triptan exposure is significantly associated with atonic uterus and increased blood loss during labor. In a 16-year registry, sumatriptan, naratriptan, and treximet were not associated with teratogenicity.

Nonpharmacological treatments, too, may help pregnant patients. Lifestyle management, including a regular sleep schedule, exercise routine, and diet, can be beneficial. Massage therapy may reduce stress, and cognitive-behavioral therapy and biofeedback are additional options. Behavioral therapy, however, should be initiated before the patient plans the pregnancy, said Dr. Nye. These therapies require training that a patient having an exacerbation of migraine is less likely to have the motivation to begin.

Many medications are transferred to infants through breast milk. The American Pediatric Association considers a relative infant dosing of less than 10% to be safe. A clinician or patient can look up a medication on websites such as LactMed to understand the relative infant dose and possible effects. Another helpful reference is Medications and Mothers’ Milk, said Dr. Nye. Acetaminophen, steroids, ibuprofen, riboflavin, indomethacin, ketorolac, and naproxen are generally safe during lactation. “Eletriptan is the triptan that’s least likely to be in the breast milk,” said Dr. Nye. Aspirin, atenolol, ergotamine, and lithium, however, should be given with caution. The safety of amitriptyline, nortriptyline, and SSRIs during lactation is unknown.

Dr. Nye is on advisory boards for Alder, Allergan, Biohaven, electroCore, Pernix, and Xoc.

[email protected]

The Consortium of Multiple Sclerosis Centers (CMSC) and the National Multiple Sclerosis Society (NMSS) have created a database to collect information on COVID-19 infections and outcomes in North American patients with multiple sclerosis (MS) and related diseases. The COViMS (COVID-19 Infections in Multiple Sclerosis and Related Diseases) database is gathering information from patients throughout the United States and will soon gain access to Canadian data. Data from patients with CNS demyelinating diseases such as neuromyelitis optica and myelin oligodendrocyte glycoprotein antibody diseases also will be included in COViMS. Amber Salter, PhD, MPH, the director of the North American Research Committee on MS (NARCOMS) is supervising the data collection and analyses.

“COViMS will provide valuable insight on how COVID-19 affects people with MS, including if certain disease-modifying treatments incur special risks,” said June Halper, CEO of CMSC, in a press release.

The project began when CMSC and NMSS established independent registries of epidemiologic data related to MS and COVID-19. The two groups soon began communicating and included other researchers, who also were considering establishing registries, in their discussions. In addition, representatives of the Cleveland Clinic verbally agreed to share data that they have been collecting with the COViMS registry. “The fast-moving, almost parallel, efforts led to this collaboration,” said Gary Cutter, PhD, professor of biostatistics at the University of Alabama at Birmingham. “This in itself is noteworthy because all of this took place within an incredibly short time from inception to the initiation of data collection.”

The effects of SARS-CoV-2 infection on the health of patients with MS is little understood. In North America, no reporting system had been organized to gather information on these patients and track outcomes. Such a system could influence the treatment of people with MS who become infected with the novel coronavirus or other similar future viruses. The COViMS registry is intended to define the impact of COVID-19 on patients with MS and ascertain how factors such as age, comorbidities, and MS treatments affect outcomes of COVID-19. “The estimated median age of MS patients in the U.S. is about 52 years, thus putting many at increased risk just due to age,” said Dr. Cutter.

“People with MS and their health care providers need evidence-based guidance to provide optimal MS care during the COVID-19 pandemic, and the COViMS database will help answer the many pressing questions,” said Bruce Bebo, executive vice president of research for the NMSS, in a press release.

The two organizations encourage neurologists and other health care providers who treat patients with MS and documented COVID-19 infection to complete a Case Report Form on the COViMS website, which includes answers to frequently asked questions, a sample CRF, and other resources. The website will provide real-time data once registry participation is underway.

[email protected]

The Consortium of Multiple Sclerosis Centers (CMSC) and the National Multiple Sclerosis Society (NMSS) have created a database to collect information on COVID-19 infections and outcomes in North American patients with multiple sclerosis (MS) and related diseases. The COViMS (COVID-19 Infections in Multiple Sclerosis and Related Diseases) database is gathering information from patients throughout the United States and will soon gain access to Canadian data. Data from patients with CNS demyelinating diseases such as neuromyelitis optica and myelin oligodendrocyte glycoprotein antibody diseases also will be included in COViMS. Amber Salter, PhD, MPH, the director of the North American Research Committee on MS (NARCOMS) is supervising the data collection and analyses.

“COViMS will provide valuable insight on how COVID-19 affects people with MS, including if certain disease-modifying treatments incur special risks,” said June Halper, CEO of CMSC, in a press release.

The project began when CMSC and NMSS established independent registries of epidemiologic data related to MS and COVID-19. The two groups soon began communicating and included other researchers, who also were considering establishing registries, in their discussions. In addition, representatives of the Cleveland Clinic verbally agreed to share data that they have been collecting with the COViMS registry. “The fast-moving, almost parallel, efforts led to this collaboration,” said Gary Cutter, PhD, professor of biostatistics at the University of Alabama at Birmingham. “This in itself is noteworthy because all of this took place within an incredibly short time from inception to the initiation of data collection.”

The effects of SARS-CoV-2 infection on the health of patients with MS is little understood. In North America, no reporting system had been organized to gather information on these patients and track outcomes. Such a system could influence the treatment of people with MS who become infected with the novel coronavirus or other similar future viruses. The COViMS registry is intended to define the impact of COVID-19 on patients with MS and ascertain how factors such as age, comorbidities, and MS treatments affect outcomes of COVID-19. “The estimated median age of MS patients in the U.S. is about 52 years, thus putting many at increased risk just due to age,” said Dr. Cutter.

“People with MS and their health care providers need evidence-based guidance to provide optimal MS care during the COVID-19 pandemic, and the COViMS database will help answer the many pressing questions,” said Bruce Bebo, executive vice president of research for the NMSS, in a press release.

The two organizations encourage neurologists and other health care providers who treat patients with MS and documented COVID-19 infection to complete a Case Report Form on the COViMS website, which includes answers to frequently asked questions, a sample CRF, and other resources. The website will provide real-time data once registry participation is underway.

[email protected]

The Consortium of Multiple Sclerosis Centers (CMSC) and the National Multiple Sclerosis Society (NMSS) have created a database to collect information on COVID-19 infections and outcomes in North American patients with multiple sclerosis (MS) and related diseases. The COViMS (COVID-19 Infections in Multiple Sclerosis and Related Diseases) database is gathering information from patients throughout the United States and will soon gain access to Canadian data. Data from patients with CNS demyelinating diseases such as neuromyelitis optica and myelin oligodendrocyte glycoprotein antibody diseases also will be included in COViMS. Amber Salter, PhD, MPH, the director of the North American Research Committee on MS (NARCOMS) is supervising the data collection and analyses.

“COViMS will provide valuable insight on how COVID-19 affects people with MS, including if certain disease-modifying treatments incur special risks,” said June Halper, CEO of CMSC, in a press release.

The project began when CMSC and NMSS established independent registries of epidemiologic data related to MS and COVID-19. The two groups soon began communicating and included other researchers, who also were considering establishing registries, in their discussions. In addition, representatives of the Cleveland Clinic verbally agreed to share data that they have been collecting with the COViMS registry. “The fast-moving, almost parallel, efforts led to this collaboration,” said Gary Cutter, PhD, professor of biostatistics at the University of Alabama at Birmingham. “This in itself is noteworthy because all of this took place within an incredibly short time from inception to the initiation of data collection.”

The effects of SARS-CoV-2 infection on the health of patients with MS is little understood. In North America, no reporting system had been organized to gather information on these patients and track outcomes. Such a system could influence the treatment of people with MS who become infected with the novel coronavirus or other similar future viruses. The COViMS registry is intended to define the impact of COVID-19 on patients with MS and ascertain how factors such as age, comorbidities, and MS treatments affect outcomes of COVID-19. “The estimated median age of MS patients in the U.S. is about 52 years, thus putting many at increased risk just due to age,” said Dr. Cutter.

“People with MS and their health care providers need evidence-based guidance to provide optimal MS care during the COVID-19 pandemic, and the COViMS database will help answer the many pressing questions,” said Bruce Bebo, executive vice president of research for the NMSS, in a press release.

The two organizations encourage neurologists and other health care providers who treat patients with MS and documented COVID-19 infection to complete a Case Report Form on the COViMS website, which includes answers to frequently asked questions, a sample CRF, and other resources. The website will provide real-time data once registry participation is underway.

[email protected]

Senate Democrats are calling on the Trump Administration to develop a comprehensive strategy for nationwide COVID-19 testing.

Lawmakers released a “roadmap” document with the goal of including its provisions in the next legislative aid package for COVID-19. Sen. Patty Murray (D-Wash.), the ranking member of the Health, Education, Labor & Pensions committee, noted during an April 15 press conference call that testing in the United States is actually slowing because of shortages and glitches.

“At our current pace, getting 100 million tests done would already take far too long,” she said. “We absolutely cannot afford any backsliding.”

The components of the roadmap include requiring the federal government to develop and communicate a detailed strategic plan to rapidly scale and optimize COVID-19 testing, Sen. Murray said. “This is a national crisis. We need a federally coordinated, whole-of-society response, not one that leaves each state to fend for itself.”

The strategic plan called for in the roadmap would need to establish a high-functioning supply chain with a sufficient amount of available testing materials and supplies; assess potential bottlenecks in the supply chain and communicate them to all stakeholders; and develop and validate accurate and reliable tests for COVID-19, with an emphasis on tests that can deliver rapid results.

Legislation would be used to bolster the supply chain enhancements, according to the roadmap, and would include incentives for domestic manufacturing of testing supplies and compel the sharing of intellectual property and guarantees on the purchase of testing materials.

Testing would be available to patients at no cost sharing under this proposal. The plan also calls for strengthening the price gouging policy in the CARES (Coronavirus Aid, Relief, and Economic Security) Act to ensure that health care professionals are fairly reimbursed by insurers.

The roadmap calls for $30 billion in new emergency funding to enable faster scaling of testing and development of different types of test, with an emphasis on rapid response tests. The funding would also be used to address supply chain issues, according to the roadmap document.

Sen. Lamar Alexander (R.-Tenn.), who chairs the Senate Health, Education, Labor & Pensions committee, echoed the need for more testing to be done, but suggested that the funding that has already been approved by Congress should be exhausted before more is allocated.

“In the last month, Congress has given federal agencies up to $38 billion to develop tests, treatments, and vaccines. Nothing is more important than finding a new diagnostic technology that will make it possible to test tens of millions of Americans, something our country has never tried to do before,” he said in a statement issued after the roadmap’s release. “We should start by using the money Congress has already provided, put politics aside, and work together on more tests with quick results.”

[email protected]

Senate Democrats are calling on the Trump Administration to develop a comprehensive strategy for nationwide COVID-19 testing.

Lawmakers released a “roadmap” document with the goal of including its provisions in the next legislative aid package for COVID-19. Sen. Patty Murray (D-Wash.), the ranking member of the Health, Education, Labor & Pensions committee, noted during an April 15 press conference call that testing in the United States is actually slowing because of shortages and glitches.

“At our current pace, getting 100 million tests done would already take far too long,” she said. “We absolutely cannot afford any backsliding.”

The components of the roadmap include requiring the federal government to develop and communicate a detailed strategic plan to rapidly scale and optimize COVID-19 testing, Sen. Murray said. “This is a national crisis. We need a federally coordinated, whole-of-society response, not one that leaves each state to fend for itself.”

The strategic plan called for in the roadmap would need to establish a high-functioning supply chain with a sufficient amount of available testing materials and supplies; assess potential bottlenecks in the supply chain and communicate them to all stakeholders; and develop and validate accurate and reliable tests for COVID-19, with an emphasis on tests that can deliver rapid results.

Legislation would be used to bolster the supply chain enhancements, according to the roadmap, and would include incentives for domestic manufacturing of testing supplies and compel the sharing of intellectual property and guarantees on the purchase of testing materials.

Testing would be available to patients at no cost sharing under this proposal. The plan also calls for strengthening the price gouging policy in the CARES (Coronavirus Aid, Relief, and Economic Security) Act to ensure that health care professionals are fairly reimbursed by insurers.

The roadmap calls for $30 billion in new emergency funding to enable faster scaling of testing and development of different types of test, with an emphasis on rapid response tests. The funding would also be used to address supply chain issues, according to the roadmap document.

Sen. Lamar Alexander (R.-Tenn.), who chairs the Senate Health, Education, Labor & Pensions committee, echoed the need for more testing to be done, but suggested that the funding that has already been approved by Congress should be exhausted before more is allocated.

“In the last month, Congress has given federal agencies up to $38 billion to develop tests, treatments, and vaccines. Nothing is more important than finding a new diagnostic technology that will make it possible to test tens of millions of Americans, something our country has never tried to do before,” he said in a statement issued after the roadmap’s release. “We should start by using the money Congress has already provided, put politics aside, and work together on more tests with quick results.”

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Senate Democrats are calling on the Trump Administration to develop a comprehensive strategy for nationwide COVID-19 testing.

Lawmakers released a “roadmap” document with the goal of including its provisions in the next legislative aid package for COVID-19. Sen. Patty Murray (D-Wash.), the ranking member of the Health, Education, Labor & Pensions committee, noted during an April 15 press conference call that testing in the United States is actually slowing because of shortages and glitches.

“At our current pace, getting 100 million tests done would already take far too long,” she said. “We absolutely cannot afford any backsliding.”

The components of the roadmap include requiring the federal government to develop and communicate a detailed strategic plan to rapidly scale and optimize COVID-19 testing, Sen. Murray said. “This is a national crisis. We need a federally coordinated, whole-of-society response, not one that leaves each state to fend for itself.”

The strategic plan called for in the roadmap would need to establish a high-functioning supply chain with a sufficient amount of available testing materials and supplies; assess potential bottlenecks in the supply chain and communicate them to all stakeholders; and develop and validate accurate and reliable tests for COVID-19, with an emphasis on tests that can deliver rapid results.

Legislation would be used to bolster the supply chain enhancements, according to the roadmap, and would include incentives for domestic manufacturing of testing supplies and compel the sharing of intellectual property and guarantees on the purchase of testing materials.

Testing would be available to patients at no cost sharing under this proposal. The plan also calls for strengthening the price gouging policy in the CARES (Coronavirus Aid, Relief, and Economic Security) Act to ensure that health care professionals are fairly reimbursed by insurers.

The roadmap calls for $30 billion in new emergency funding to enable faster scaling of testing and development of different types of test, with an emphasis on rapid response tests. The funding would also be used to address supply chain issues, according to the roadmap document.

Sen. Lamar Alexander (R.-Tenn.), who chairs the Senate Health, Education, Labor & Pensions committee, echoed the need for more testing to be done, but suggested that the funding that has already been approved by Congress should be exhausted before more is allocated.

“In the last month, Congress has given federal agencies up to $38 billion to develop tests, treatments, and vaccines. Nothing is more important than finding a new diagnostic technology that will make it possible to test tens of millions of Americans, something our country has never tried to do before,” he said in a statement issued after the roadmap’s release. “We should start by using the money Congress has already provided, put politics aside, and work together on more tests with quick results.”

[email protected]

African Americans are overrepresented among patients who have died as a result of the COVID-19 pandemic, but the current crisis puts a spotlight on long-standing racial disparities in health care and health access in the United States, according to David R. Williams, PhD, a professor of public health at the Harvard T.H. Chan School of Public Health in Boston.

Dr. Williams, a social scientist specializing in the link between race and health, is a professor of African and African American Studies and of Sociology at Harvard. He spoke on the topic of racial disparities amid the COVID-19 pandemic in a teleconference sponsored by the Robert Wood Johnson Foundation.

“Many Americans are shocked” by the higher mortality rates among African American COVID-19 patients, said Dr. Williams. However, data from decades of research show that “black people in America live sicker and shorter lives,” he said.

Keys to the increased mortality among African Americans include an increased prevalence of risk factors, increased risk for exposure to the virus because of socioeconomic factors, and less access to health care if they do become ill, he said.

Many minority individuals work outside the home in areas deemed essential during the pandemic, such as transit, delivery, maintenance, cleaning, and in businesses such as grocery stores, although in general “race continues to matter for health at every level of income and education,” Dr. Williams said.

In addition, social distance guidelines are not realistic for many people in high-density, low-income areas, who often live in shared, multigenerational housing, he said.

Data show that individuals with chronic conditions such as diabetes and cardiovascular disease are more likely to die as a result of COVID-19, and minority populations are more likely to develop these conditions at younger ages, Dr. Williams noted. Access to health care also plays a role. Many minority individuals of lower socioeconomic status are less likely to have health insurance, or if they do, may have Medicaid, which is not consistently accepted, he said. Also, some low-income neighborhoods lack convenient access to primary care and thus to screening services, he noted.

A recent study from the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report cited COVID-NET (the COVID-19 Associated Hospitalization Surveillance Network) as showing that, in their catchment population, “approximately 59% of residents are white, 18% are black, and 14% are Hispanic; however, among 580 hospitalized COVID-19 patients with race/ethnicity data, approximately 45% were white, 33% were black, and 8% were Hispanic, suggesting that black populations might be disproportionately affected by COVID-19,” the researchers said.

“These findings, including the potential impact of both sex and race on COVID-19–associated hospitalization rates, need to be confirmed with additional data,” according to the report.

Collecting racial/ethnic information is not always feasible on the front lines, and many areas still face shortages of ventilators and protective equipment, said Dr. Williams.

“I want to salute the providers on the front lines of this pandemic, many putting their own lives at risk, I want to acknowledge the good that they are doing,” Dr. Williams emphasized. He noted that all of us, himself included, may have conscious or unconscious stereotypes, but the key is to acknowledge the potential for these thoughts and feelings and continue to provide the best care.

“Why is this uniquely important to me? I am an academic cardiologist; I study health care disparities; and I am a black man,” he wrote.

“Even though these data are preliminary and further study is warranted, the pattern is irrefutable: Underrepresented minorities are developing COVID-19 infection more frequently and dying disproportionately,” said Dr. Yancy.

Dr. Williams’ and Dr. Yancy’s comments were supported by an analysis of COVID-19 patient data from several areas of the country conducted by the Washington Post. In that analysis, data showed that several counties with a majority black population showed three times the rate of COVID-19 infections and approximately six times as many deaths compared with counties with a majority of white residents.

“The U.S. has needed a trigger to fully address health care disparities; COVID-19 may be that bellwether event,” said Dr. Yancy. “Certainly, within the broad and powerful economic and legislative engines of the US, there is room to definitively address a scourge even worse than COVID-19: health care disparities. It only takes will. It is time to end the refrain,” he said.

Dr. Williams had no financial conflicts to disclose. Dr. Yancy had no financial conflicts to disclose.

SOURCES: Yancy CW. JAMA 2020 Apr 15. doi: 10.1001/jama.2020.6548Garg S et al. MMWR Morb Mortal Wkly Rep 2020 Apr 8;69:458-64.

Thebault R et al. The coronavirus is infecting and killing black Americans at an alarmingly high rate. Washington Post. 2020 Apr 7.

African Americans are overrepresented among patients who have died as a result of the COVID-19 pandemic, but the current crisis puts a spotlight on long-standing racial disparities in health care and health access in the United States, according to David R. Williams, PhD, a professor of public health at the Harvard T.H. Chan School of Public Health in Boston.

Dr. Williams, a social scientist specializing in the link between race and health, is a professor of African and African American Studies and of Sociology at Harvard. He spoke on the topic of racial disparities amid the COVID-19 pandemic in a teleconference sponsored by the Robert Wood Johnson Foundation.

“Many Americans are shocked” by the higher mortality rates among African American COVID-19 patients, said Dr. Williams. However, data from decades of research show that “black people in America live sicker and shorter lives,” he said.

Keys to the increased mortality among African Americans include an increased prevalence of risk factors, increased risk for exposure to the virus because of socioeconomic factors, and less access to health care if they do become ill, he said.

Many minority individuals work outside the home in areas deemed essential during the pandemic, such as transit, delivery, maintenance, cleaning, and in businesses such as grocery stores, although in general “race continues to matter for health at every level of income and education,” Dr. Williams said.

In addition, social distance guidelines are not realistic for many people in high-density, low-income areas, who often live in shared, multigenerational housing, he said.

Data show that individuals with chronic conditions such as diabetes and cardiovascular disease are more likely to die as a result of COVID-19, and minority populations are more likely to develop these conditions at younger ages, Dr. Williams noted. Access to health care also plays a role. Many minority individuals of lower socioeconomic status are less likely to have health insurance, or if they do, may have Medicaid, which is not consistently accepted, he said. Also, some low-income neighborhoods lack convenient access to primary care and thus to screening services, he noted.

A recent study from the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report cited COVID-NET (the COVID-19 Associated Hospitalization Surveillance Network) as showing that, in their catchment population, “approximately 59% of residents are white, 18% are black, and 14% are Hispanic; however, among 580 hospitalized COVID-19 patients with race/ethnicity data, approximately 45% were white, 33% were black, and 8% were Hispanic, suggesting that black populations might be disproportionately affected by COVID-19,” the researchers said.

“These findings, including the potential impact of both sex and race on COVID-19–associated hospitalization rates, need to be confirmed with additional data,” according to the report.

Collecting racial/ethnic information is not always feasible on the front lines, and many areas still face shortages of ventilators and protective equipment, said Dr. Williams.

“I want to salute the providers on the front lines of this pandemic, many putting their own lives at risk, I want to acknowledge the good that they are doing,” Dr. Williams emphasized. He noted that all of us, himself included, may have conscious or unconscious stereotypes, but the key is to acknowledge the potential for these thoughts and feelings and continue to provide the best care.

“Why is this uniquely important to me? I am an academic cardiologist; I study health care disparities; and I am a black man,” he wrote.

“Even though these data are preliminary and further study is warranted, the pattern is irrefutable: Underrepresented minorities are developing COVID-19 infection more frequently and dying disproportionately,” said Dr. Yancy.

Dr. Williams’ and Dr. Yancy’s comments were supported by an analysis of COVID-19 patient data from several areas of the country conducted by the Washington Post. In that analysis, data showed that several counties with a majority black population showed three times the rate of COVID-19 infections and approximately six times as many deaths compared with counties with a majority of white residents.

“The U.S. has needed a trigger to fully address health care disparities; COVID-19 may be that bellwether event,” said Dr. Yancy. “Certainly, within the broad and powerful economic and legislative engines of the US, there is room to definitively address a scourge even worse than COVID-19: health care disparities. It only takes will. It is time to end the refrain,” he said.

Dr. Williams had no financial conflicts to disclose. Dr. Yancy had no financial conflicts to disclose.

SOURCES: Yancy CW. JAMA 2020 Apr 15. doi: 10.1001/jama.2020.6548Garg S et al. MMWR Morb Mortal Wkly Rep 2020 Apr 8;69:458-64.

Thebault R et al. The coronavirus is infecting and killing black Americans at an alarmingly high rate. Washington Post. 2020 Apr 7.

African Americans are overrepresented among patients who have died as a result of the COVID-19 pandemic, but the current crisis puts a spotlight on long-standing racial disparities in health care and health access in the United States, according to David R. Williams, PhD, a professor of public health at the Harvard T.H. Chan School of Public Health in Boston.

Dr. Williams, a social scientist specializing in the link between race and health, is a professor of African and African American Studies and of Sociology at Harvard. He spoke on the topic of racial disparities amid the COVID-19 pandemic in a teleconference sponsored by the Robert Wood Johnson Foundation.

“Many Americans are shocked” by the higher mortality rates among African American COVID-19 patients, said Dr. Williams. However, data from decades of research show that “black people in America live sicker and shorter lives,” he said.

Keys to the increased mortality among African Americans include an increased prevalence of risk factors, increased risk for exposure to the virus because of socioeconomic factors, and less access to health care if they do become ill, he said.

Many minority individuals work outside the home in areas deemed essential during the pandemic, such as transit, delivery, maintenance, cleaning, and in businesses such as grocery stores, although in general “race continues to matter for health at every level of income and education,” Dr. Williams said.

In addition, social distance guidelines are not realistic for many people in high-density, low-income areas, who often live in shared, multigenerational housing, he said.

Data show that individuals with chronic conditions such as diabetes and cardiovascular disease are more likely to die as a result of COVID-19, and minority populations are more likely to develop these conditions at younger ages, Dr. Williams noted. Access to health care also plays a role. Many minority individuals of lower socioeconomic status are less likely to have health insurance, or if they do, may have Medicaid, which is not consistently accepted, he said. Also, some low-income neighborhoods lack convenient access to primary care and thus to screening services, he noted.

A recent study from the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report cited COVID-NET (the COVID-19 Associated Hospitalization Surveillance Network) as showing that, in their catchment population, “approximately 59% of residents are white, 18% are black, and 14% are Hispanic; however, among 580 hospitalized COVID-19 patients with race/ethnicity data, approximately 45% were white, 33% were black, and 8% were Hispanic, suggesting that black populations might be disproportionately affected by COVID-19,” the researchers said.

“These findings, including the potential impact of both sex and race on COVID-19–associated hospitalization rates, need to be confirmed with additional data,” according to the report.

Collecting racial/ethnic information is not always feasible on the front lines, and many areas still face shortages of ventilators and protective equipment, said Dr. Williams.

“I want to salute the providers on the front lines of this pandemic, many putting their own lives at risk, I want to acknowledge the good that they are doing,” Dr. Williams emphasized. He noted that all of us, himself included, may have conscious or unconscious stereotypes, but the key is to acknowledge the potential for these thoughts and feelings and continue to provide the best care.

“Why is this uniquely important to me? I am an academic cardiologist; I study health care disparities; and I am a black man,” he wrote.

“Even though these data are preliminary and further study is warranted, the pattern is irrefutable: Underrepresented minorities are developing COVID-19 infection more frequently and dying disproportionately,” said Dr. Yancy.

Dr. Williams’ and Dr. Yancy’s comments were supported by an analysis of COVID-19 patient data from several areas of the country conducted by the Washington Post. In that analysis, data showed that several counties with a majority black population showed three times the rate of COVID-19 infections and approximately six times as many deaths compared with counties with a majority of white residents.

“The U.S. has needed a trigger to fully address health care disparities; COVID-19 may be that bellwether event,” said Dr. Yancy. “Certainly, within the broad and powerful economic and legislative engines of the US, there is room to definitively address a scourge even worse than COVID-19: health care disparities. It only takes will. It is time to end the refrain,” he said.

Dr. Williams had no financial conflicts to disclose. Dr. Yancy had no financial conflicts to disclose.

SOURCES: Yancy CW. JAMA 2020 Apr 15. doi: 10.1001/jama.2020.6548Garg S et al. MMWR Morb Mortal Wkly Rep 2020 Apr 8;69:458-64.

Thebault R et al. The coronavirus is infecting and killing black Americans at an alarmingly high rate. Washington Post. 2020 Apr 7.