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FDA approves new treatment for Dravet syndrome
Dravet syndrome is a rare childhood-onset epilepsy characterized by frequent, drug-resistant convulsive seizures that may contribute to intellectual disability and impairments in motor control, behavior, and cognition, as well as an increased risk of sudden unexpected death in epilepsy (SUDEP).
Dravet syndrome takes a “tremendous toll on both patients and their families. Fintepla offers an additional effective treatment option for the treatment of seizures associated with Dravet syndrome,” Billy Dunn, MD, director, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a news release.
The FDA approved fenfluramine for Dravet syndrome based on the results of two randomized, double-blind, placebo-controlled phase 3 trials involving children ages 2 to 18 years with Dravet syndrome.
In both studies, children treated with fenfluramine experienced significantly greater reductions in the frequency of convulsive seizures than did their peers who received placebo. These reductions occurred within 3 to 4 weeks, and remained generally consistent over the 14- to 15-week treatment periods, the FDA said.
“There remains a huge unmet need for the many Dravet syndrome patients who continue to experience frequent severe seizures even while taking one or more of the currently available antiseizure medications,” Joseph Sullivan, MD, who worked on the fenfluramine for Dravet syndrome studies, said in a news release.
Given the “profound reductions” in convulsive seizure frequency seen in the clinical trials, combined with the “ongoing, robust safety monitoring,” fenfluramine offers “an extremely important treatment option for Dravet syndrome patients,” said Dr. Sullivan, director of the Pediatric Epilepsy Center of Excellence at the University of California San Francisco (UCSF) Benioff Children’s Hospital.
Fenfluramine is an anorectic agent that was used to treat obesity until it was removed from the market in 1997 over reports of increased risk of valvular heart disease when prescribed in higher doses and most often when prescribed with phentermine. The combination of the two drugs was known as fen-phen.
In the clinical trials of Dravet syndrome, the most common adverse reactions were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; increased blood pressure; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; and status epilepticus.
The Fintepla label has a boxed warning stating that the drug is associated with valvular heart disease (VHD) and pulmonary arterial hypertension (PAH). Due to these risks, patients must undergo echocardiography before treatment, every 6 months during treatment, and once 3 to 6 months after treatment is stopped.
If signs of VHD, PAH, or other cardiac abnormalities are present, clinicians should weigh the benefits and risks of continuing treatment with Fintepla, the FDA said.
Fintepla is available only through a risk evaluation and mitigation strategy (REMS) program, which requires physicians who prescribe the drug and pharmacies that dispense it to be certified in the Fintepla REMS and that patients be enrolled in the program.
As part of the REMS requirements, prescribers and patients must adhere to the required cardiac monitoring to receive the drug.
Fintepla will be available to certified prescribers in the United States in July. Zogenix is launching Zogenix Central, a comprehensive support service that will provide ongoing product assistance to patients, caregivers, and their medical teams. Further information is available online.
This article first appeared on Medscape.com.
Dravet syndrome is a rare childhood-onset epilepsy characterized by frequent, drug-resistant convulsive seizures that may contribute to intellectual disability and impairments in motor control, behavior, and cognition, as well as an increased risk of sudden unexpected death in epilepsy (SUDEP).
Dravet syndrome takes a “tremendous toll on both patients and their families. Fintepla offers an additional effective treatment option for the treatment of seizures associated with Dravet syndrome,” Billy Dunn, MD, director, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a news release.
The FDA approved fenfluramine for Dravet syndrome based on the results of two randomized, double-blind, placebo-controlled phase 3 trials involving children ages 2 to 18 years with Dravet syndrome.
In both studies, children treated with fenfluramine experienced significantly greater reductions in the frequency of convulsive seizures than did their peers who received placebo. These reductions occurred within 3 to 4 weeks, and remained generally consistent over the 14- to 15-week treatment periods, the FDA said.
“There remains a huge unmet need for the many Dravet syndrome patients who continue to experience frequent severe seizures even while taking one or more of the currently available antiseizure medications,” Joseph Sullivan, MD, who worked on the fenfluramine for Dravet syndrome studies, said in a news release.
Given the “profound reductions” in convulsive seizure frequency seen in the clinical trials, combined with the “ongoing, robust safety monitoring,” fenfluramine offers “an extremely important treatment option for Dravet syndrome patients,” said Dr. Sullivan, director of the Pediatric Epilepsy Center of Excellence at the University of California San Francisco (UCSF) Benioff Children’s Hospital.
Fenfluramine is an anorectic agent that was used to treat obesity until it was removed from the market in 1997 over reports of increased risk of valvular heart disease when prescribed in higher doses and most often when prescribed with phentermine. The combination of the two drugs was known as fen-phen.
In the clinical trials of Dravet syndrome, the most common adverse reactions were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; increased blood pressure; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; and status epilepticus.
The Fintepla label has a boxed warning stating that the drug is associated with valvular heart disease (VHD) and pulmonary arterial hypertension (PAH). Due to these risks, patients must undergo echocardiography before treatment, every 6 months during treatment, and once 3 to 6 months after treatment is stopped.
If signs of VHD, PAH, or other cardiac abnormalities are present, clinicians should weigh the benefits and risks of continuing treatment with Fintepla, the FDA said.
Fintepla is available only through a risk evaluation and mitigation strategy (REMS) program, which requires physicians who prescribe the drug and pharmacies that dispense it to be certified in the Fintepla REMS and that patients be enrolled in the program.
As part of the REMS requirements, prescribers and patients must adhere to the required cardiac monitoring to receive the drug.
Fintepla will be available to certified prescribers in the United States in July. Zogenix is launching Zogenix Central, a comprehensive support service that will provide ongoing product assistance to patients, caregivers, and their medical teams. Further information is available online.
This article first appeared on Medscape.com.
Dravet syndrome is a rare childhood-onset epilepsy characterized by frequent, drug-resistant convulsive seizures that may contribute to intellectual disability and impairments in motor control, behavior, and cognition, as well as an increased risk of sudden unexpected death in epilepsy (SUDEP).
Dravet syndrome takes a “tremendous toll on both patients and their families. Fintepla offers an additional effective treatment option for the treatment of seizures associated with Dravet syndrome,” Billy Dunn, MD, director, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a news release.
The FDA approved fenfluramine for Dravet syndrome based on the results of two randomized, double-blind, placebo-controlled phase 3 trials involving children ages 2 to 18 years with Dravet syndrome.
In both studies, children treated with fenfluramine experienced significantly greater reductions in the frequency of convulsive seizures than did their peers who received placebo. These reductions occurred within 3 to 4 weeks, and remained generally consistent over the 14- to 15-week treatment periods, the FDA said.
“There remains a huge unmet need for the many Dravet syndrome patients who continue to experience frequent severe seizures even while taking one or more of the currently available antiseizure medications,” Joseph Sullivan, MD, who worked on the fenfluramine for Dravet syndrome studies, said in a news release.
Given the “profound reductions” in convulsive seizure frequency seen in the clinical trials, combined with the “ongoing, robust safety monitoring,” fenfluramine offers “an extremely important treatment option for Dravet syndrome patients,” said Dr. Sullivan, director of the Pediatric Epilepsy Center of Excellence at the University of California San Francisco (UCSF) Benioff Children’s Hospital.
Fenfluramine is an anorectic agent that was used to treat obesity until it was removed from the market in 1997 over reports of increased risk of valvular heart disease when prescribed in higher doses and most often when prescribed with phentermine. The combination of the two drugs was known as fen-phen.
In the clinical trials of Dravet syndrome, the most common adverse reactions were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; increased blood pressure; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; and status epilepticus.
The Fintepla label has a boxed warning stating that the drug is associated with valvular heart disease (VHD) and pulmonary arterial hypertension (PAH). Due to these risks, patients must undergo echocardiography before treatment, every 6 months during treatment, and once 3 to 6 months after treatment is stopped.
If signs of VHD, PAH, or other cardiac abnormalities are present, clinicians should weigh the benefits and risks of continuing treatment with Fintepla, the FDA said.
Fintepla is available only through a risk evaluation and mitigation strategy (REMS) program, which requires physicians who prescribe the drug and pharmacies that dispense it to be certified in the Fintepla REMS and that patients be enrolled in the program.
As part of the REMS requirements, prescribers and patients must adhere to the required cardiac monitoring to receive the drug.
Fintepla will be available to certified prescribers in the United States in July. Zogenix is launching Zogenix Central, a comprehensive support service that will provide ongoing product assistance to patients, caregivers, and their medical teams. Further information is available online.
This article first appeared on Medscape.com.
COVID-19: ‘dramatic’ surge in out-of-hospital cardiac arrests in NYC
The COVID-19 pandemic in New York City led to a surge in out-of-hospital cardiac arrests (OHCAs) that placed a huge burden on first responders, a new analysis shows.
During the height of the pandemic in New York, there was a “dramatic increase in cardiopulmonary arrests, nearly all presented in non-shockable cardiac rhythms (> 90% fatality rate) and vulnerable patient populations were most affected,” David J. Prezant, MD, chief medical officer, Fire Department of New York (FDNY), said in an interview.
In a news release, Dr. Prezant noted that “relatively few, if any, patients were tested to confirm the presence of COVID-19,” making it impossible to distinguish between cardiac arrests as a result of COVID-19 and those that may have resulted from other health conditions.
“We also can’t rule out the possibility that some people may have died from delays in seeking or receiving treatment for non–COVID-19-related conditions. However, the dramatic increase in cardiac arrests compared to the same period in 2019 strongly indicates that the pandemic was directly or indirectly responsible for that surge in cardiac arrests and deaths,” said Dr. Prezant.
The study was published online June 19 in JAMA Cardiology.
New York City has the largest and busiest EMS system in the United States, serving a population of more than 8.4 million people and responding to more than 1.5 million calls every year.
To gauge the impact of COVID-19 on first responders, Dr. Prezant and colleagues analyzed data for adults with OHCA who received EMS resuscitation from March 1, when the first case of COVID-19 was diagnosed in the city, through April 25, when EMS call volume had receded to pre-COVID-19 levels.
Compared with the same period in 2019, the COVID-19 period had an excess of 2,653 patients with OHCA who underwent EMS resuscitation attempts (3,989 in 2020 vs. 1,336 in 2019, P < .001), an incidence rate triple that of 2019 (47.5 vs. 15.9 per 100,000).
On the worst day – Monday, April 6 – OHCAs peaked at 305 cases, an increase of nearly 10-fold compared with the same day in 2019.
Despite the surge in cases, the median response time of available EMS units to OHCAs increased by about 1 minute over 2019, a nonsignificant difference. Although the average time varied, median response time during the COVID-19 period was less than 3 minutes.
A more vulnerable group
Compared with 2019, patients suffering OHCA during the pandemic period were older (mean age 72 vs. 68 years), less likely to be white (20% white vs. 33%) and more likely to have hypertension (54% vs. 46%), diabetes (36% vs. 26%), physical limitations (57% vs. 48%) and cardiac rhythms that don’t respond to defibrillator shocks (92% vs. 81%).
Compared with 2019, the COVID-19 period had substantial reductions in return of spontaneous circulation (ROSC) (18% vs. 35%; P < .001) and sustained ROSC (11% vs. 25%; P < .001). The case fatality rate was 90% in the COVID-19 period vs. 75% a year earlier.
“The tragedy of the COVID-19 pandemic is not just the number of patients infected, but the large increase in OHCAs and deaths,” Dr. Prezant and colleagues said.
Identifying patients with the greatest risk for OHCA and death during the COVID-19 pandemic “should allow for early, targeted interventions in the outpatient setting that could lead to reductions in out-of-hospital deaths,” they noted.
“Vulnerable patient populations need outreach, telephonic medicine, televideo medicine, home visits, not just temperature monitoring but home O2 saturation monitoring,” Dr. Prezant said in an interview. “Barriers need to be removed, not just for this pandemic but for the future – no matter what the trigger is.”
Unsung heroes
In an Editor’s Note in JAMA Cardiology, Robert O. Bonow, MD, Northwestern University, Chicago, and colleagues said the American people owe a debt of gratitude to first responders for their “heroic work” triaging, resuscitating, and transporting thousands of people affected by COVID-19.
“Although the typically bustling NYC streets remained eerily deserted, the characteristic cacophony of sounds of the ‘City that Never Sleeps’ was replaced by sirens wailing all hours of the night,” they wrote.
First responders to OHCAs in the COVID-19 era place themselves at extremely high risk, in some cases without optimal personal protective equipment, they pointed out. “Sadly,” many first responders have fallen ill to COVID-19 infection, they added.
As of June 1, 29 EMS workers and volunteers across the United States had died of COVID-19.
They are James Villecco, Gregory Hodge, Tony Thomas, Mike Field, John Redd, Idris Bey, Richard Seaberry, and Sal Mancuso of New York; Israel Tolentino, Reuven Maroth, Liana Sá, Kevin Leiva, Frank Molinari, Robert Weber, Robert Tarrant, Solomon Donald, Scott Geiger, John Farrarella, John Careccia, Bill Nauta, and David Pinto of New Jersey; Kevin Bundy, Robert Zerman, and Jeremy Emerich of Pennsylvania; Paul Cary of Colorado; Paul Novicki of Michigan; David Martin of Mississippi; Billy Birmingham of Missouri; and John “JP” Granger of South Carolina.
“We offer their families, friends, and colleagues our sincerest condolences and honor their memory with our highest respect and gratitude,” Dr. Bonow and colleagues wrote.
This study was supported by the City of New York and the Fire Department of the City of New York. The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The COVID-19 pandemic in New York City led to a surge in out-of-hospital cardiac arrests (OHCAs) that placed a huge burden on first responders, a new analysis shows.
During the height of the pandemic in New York, there was a “dramatic increase in cardiopulmonary arrests, nearly all presented in non-shockable cardiac rhythms (> 90% fatality rate) and vulnerable patient populations were most affected,” David J. Prezant, MD, chief medical officer, Fire Department of New York (FDNY), said in an interview.
In a news release, Dr. Prezant noted that “relatively few, if any, patients were tested to confirm the presence of COVID-19,” making it impossible to distinguish between cardiac arrests as a result of COVID-19 and those that may have resulted from other health conditions.
“We also can’t rule out the possibility that some people may have died from delays in seeking or receiving treatment for non–COVID-19-related conditions. However, the dramatic increase in cardiac arrests compared to the same period in 2019 strongly indicates that the pandemic was directly or indirectly responsible for that surge in cardiac arrests and deaths,” said Dr. Prezant.
The study was published online June 19 in JAMA Cardiology.
New York City has the largest and busiest EMS system in the United States, serving a population of more than 8.4 million people and responding to more than 1.5 million calls every year.
To gauge the impact of COVID-19 on first responders, Dr. Prezant and colleagues analyzed data for adults with OHCA who received EMS resuscitation from March 1, when the first case of COVID-19 was diagnosed in the city, through April 25, when EMS call volume had receded to pre-COVID-19 levels.
Compared with the same period in 2019, the COVID-19 period had an excess of 2,653 patients with OHCA who underwent EMS resuscitation attempts (3,989 in 2020 vs. 1,336 in 2019, P < .001), an incidence rate triple that of 2019 (47.5 vs. 15.9 per 100,000).
On the worst day – Monday, April 6 – OHCAs peaked at 305 cases, an increase of nearly 10-fold compared with the same day in 2019.
Despite the surge in cases, the median response time of available EMS units to OHCAs increased by about 1 minute over 2019, a nonsignificant difference. Although the average time varied, median response time during the COVID-19 period was less than 3 minutes.
A more vulnerable group
Compared with 2019, patients suffering OHCA during the pandemic period were older (mean age 72 vs. 68 years), less likely to be white (20% white vs. 33%) and more likely to have hypertension (54% vs. 46%), diabetes (36% vs. 26%), physical limitations (57% vs. 48%) and cardiac rhythms that don’t respond to defibrillator shocks (92% vs. 81%).
Compared with 2019, the COVID-19 period had substantial reductions in return of spontaneous circulation (ROSC) (18% vs. 35%; P < .001) and sustained ROSC (11% vs. 25%; P < .001). The case fatality rate was 90% in the COVID-19 period vs. 75% a year earlier.
“The tragedy of the COVID-19 pandemic is not just the number of patients infected, but the large increase in OHCAs and deaths,” Dr. Prezant and colleagues said.
Identifying patients with the greatest risk for OHCA and death during the COVID-19 pandemic “should allow for early, targeted interventions in the outpatient setting that could lead to reductions in out-of-hospital deaths,” they noted.
“Vulnerable patient populations need outreach, telephonic medicine, televideo medicine, home visits, not just temperature monitoring but home O2 saturation monitoring,” Dr. Prezant said in an interview. “Barriers need to be removed, not just for this pandemic but for the future – no matter what the trigger is.”
Unsung heroes
In an Editor’s Note in JAMA Cardiology, Robert O. Bonow, MD, Northwestern University, Chicago, and colleagues said the American people owe a debt of gratitude to first responders for their “heroic work” triaging, resuscitating, and transporting thousands of people affected by COVID-19.
“Although the typically bustling NYC streets remained eerily deserted, the characteristic cacophony of sounds of the ‘City that Never Sleeps’ was replaced by sirens wailing all hours of the night,” they wrote.
First responders to OHCAs in the COVID-19 era place themselves at extremely high risk, in some cases without optimal personal protective equipment, they pointed out. “Sadly,” many first responders have fallen ill to COVID-19 infection, they added.
As of June 1, 29 EMS workers and volunteers across the United States had died of COVID-19.
They are James Villecco, Gregory Hodge, Tony Thomas, Mike Field, John Redd, Idris Bey, Richard Seaberry, and Sal Mancuso of New York; Israel Tolentino, Reuven Maroth, Liana Sá, Kevin Leiva, Frank Molinari, Robert Weber, Robert Tarrant, Solomon Donald, Scott Geiger, John Farrarella, John Careccia, Bill Nauta, and David Pinto of New Jersey; Kevin Bundy, Robert Zerman, and Jeremy Emerich of Pennsylvania; Paul Cary of Colorado; Paul Novicki of Michigan; David Martin of Mississippi; Billy Birmingham of Missouri; and John “JP” Granger of South Carolina.
“We offer their families, friends, and colleagues our sincerest condolences and honor their memory with our highest respect and gratitude,” Dr. Bonow and colleagues wrote.
This study was supported by the City of New York and the Fire Department of the City of New York. The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The COVID-19 pandemic in New York City led to a surge in out-of-hospital cardiac arrests (OHCAs) that placed a huge burden on first responders, a new analysis shows.
During the height of the pandemic in New York, there was a “dramatic increase in cardiopulmonary arrests, nearly all presented in non-shockable cardiac rhythms (> 90% fatality rate) and vulnerable patient populations were most affected,” David J. Prezant, MD, chief medical officer, Fire Department of New York (FDNY), said in an interview.
In a news release, Dr. Prezant noted that “relatively few, if any, patients were tested to confirm the presence of COVID-19,” making it impossible to distinguish between cardiac arrests as a result of COVID-19 and those that may have resulted from other health conditions.
“We also can’t rule out the possibility that some people may have died from delays in seeking or receiving treatment for non–COVID-19-related conditions. However, the dramatic increase in cardiac arrests compared to the same period in 2019 strongly indicates that the pandemic was directly or indirectly responsible for that surge in cardiac arrests and deaths,” said Dr. Prezant.
The study was published online June 19 in JAMA Cardiology.
New York City has the largest and busiest EMS system in the United States, serving a population of more than 8.4 million people and responding to more than 1.5 million calls every year.
To gauge the impact of COVID-19 on first responders, Dr. Prezant and colleagues analyzed data for adults with OHCA who received EMS resuscitation from March 1, when the first case of COVID-19 was diagnosed in the city, through April 25, when EMS call volume had receded to pre-COVID-19 levels.
Compared with the same period in 2019, the COVID-19 period had an excess of 2,653 patients with OHCA who underwent EMS resuscitation attempts (3,989 in 2020 vs. 1,336 in 2019, P < .001), an incidence rate triple that of 2019 (47.5 vs. 15.9 per 100,000).
On the worst day – Monday, April 6 – OHCAs peaked at 305 cases, an increase of nearly 10-fold compared with the same day in 2019.
Despite the surge in cases, the median response time of available EMS units to OHCAs increased by about 1 minute over 2019, a nonsignificant difference. Although the average time varied, median response time during the COVID-19 period was less than 3 minutes.
A more vulnerable group
Compared with 2019, patients suffering OHCA during the pandemic period were older (mean age 72 vs. 68 years), less likely to be white (20% white vs. 33%) and more likely to have hypertension (54% vs. 46%), diabetes (36% vs. 26%), physical limitations (57% vs. 48%) and cardiac rhythms that don’t respond to defibrillator shocks (92% vs. 81%).
Compared with 2019, the COVID-19 period had substantial reductions in return of spontaneous circulation (ROSC) (18% vs. 35%; P < .001) and sustained ROSC (11% vs. 25%; P < .001). The case fatality rate was 90% in the COVID-19 period vs. 75% a year earlier.
“The tragedy of the COVID-19 pandemic is not just the number of patients infected, but the large increase in OHCAs and deaths,” Dr. Prezant and colleagues said.
Identifying patients with the greatest risk for OHCA and death during the COVID-19 pandemic “should allow for early, targeted interventions in the outpatient setting that could lead to reductions in out-of-hospital deaths,” they noted.
“Vulnerable patient populations need outreach, telephonic medicine, televideo medicine, home visits, not just temperature monitoring but home O2 saturation monitoring,” Dr. Prezant said in an interview. “Barriers need to be removed, not just for this pandemic but for the future – no matter what the trigger is.”
Unsung heroes
In an Editor’s Note in JAMA Cardiology, Robert O. Bonow, MD, Northwestern University, Chicago, and colleagues said the American people owe a debt of gratitude to first responders for their “heroic work” triaging, resuscitating, and transporting thousands of people affected by COVID-19.
“Although the typically bustling NYC streets remained eerily deserted, the characteristic cacophony of sounds of the ‘City that Never Sleeps’ was replaced by sirens wailing all hours of the night,” they wrote.
First responders to OHCAs in the COVID-19 era place themselves at extremely high risk, in some cases without optimal personal protective equipment, they pointed out. “Sadly,” many first responders have fallen ill to COVID-19 infection, they added.
As of June 1, 29 EMS workers and volunteers across the United States had died of COVID-19.
They are James Villecco, Gregory Hodge, Tony Thomas, Mike Field, John Redd, Idris Bey, Richard Seaberry, and Sal Mancuso of New York; Israel Tolentino, Reuven Maroth, Liana Sá, Kevin Leiva, Frank Molinari, Robert Weber, Robert Tarrant, Solomon Donald, Scott Geiger, John Farrarella, John Careccia, Bill Nauta, and David Pinto of New Jersey; Kevin Bundy, Robert Zerman, and Jeremy Emerich of Pennsylvania; Paul Cary of Colorado; Paul Novicki of Michigan; David Martin of Mississippi; Billy Birmingham of Missouri; and John “JP” Granger of South Carolina.
“We offer their families, friends, and colleagues our sincerest condolences and honor their memory with our highest respect and gratitude,” Dr. Bonow and colleagues wrote.
This study was supported by the City of New York and the Fire Department of the City of New York. The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Consistent effects for galcanezumab in cluster headache
new research suggests. A post hoc analysis of patients from the phase 3 CGAL study who also entered the open-label CGAR extension study was conducted. Results showed that the majority of participants whose scores on the Patient Global Impression of Improvement (PGI-I) showed improvement 1 month after the initial dose of galcanezumab in the CGAL study also showed improvement after treatment for subsequent cluster bouts during the CGAR study.
“There was good agreement between PGI-I between the two [cluster headache] periods,” noted the investigators, led by Brian Plato, DO, a neurologist at Norton Neuroscience Institute in Louisville, Ky.
The findings were presented at the virtual annual meeting of the American Headache Society.
Two cluster periods
Galcanezumab was approved by the Food and Drug Administration in 2019 for the treatment of episodic cluster headache in adults.
In cluster headache, attacks of recurrent, unilateral headaches with cranial autonomic symptoms last for weeks or months and are followed by periods of remission. Most studies of therapies for cluster headache examine only one cluster period. Few data about the consistency of treatment response throughout consecutive cluster periods are available, the investigators noted.
The current analysis was undertaken to examine the consistency of galcanezumab’s effect in episodic cluster headache during two cluster periods. Patients eligible for inclusion in the analysis had completed the double-blind phase of the CGAL study and had entered the open-label CGAR study.
CGAL was a phase 3, multicenter, randomized, double-blind study in which patients with episodic cluster headache were assigned to receive galcanezumab 300 mg per month or placebo. Patients who completed the double-blind and washout phases of this study were eligible for enrollment into CGAR, a phase 3b, single-arm safety study. The investigators determined the dose of galcanezumab in accordance with each patient’s symptoms and clinical response.
Response agreement
In both studies, the PGI-I was administered 1 month after the initial dose of galcanezumab. Only patients who were in an active cluster bout on entry into CGAR and who had valid PGI-I results 1 month after the first dose in CGAL and CGAR were included in the analysis.
PGI-I responses ranged from 1, signifying very much better, to 7, signifying very much worse. The investigators summarized the proportions of patients who reported each level of PGI-I score in CGAR and analyzed the results by dichotomizing PGI-I scores at both time points in two ways.
Fifty patients entered CGAR (78% men; mean age, 46.8 years). Of this group, Dr. Plato and colleagues included 39 in their analysis. Of the 17 patients who had a PGI-I score of 1 or 2 in CGAL, 12 (70.6%) had a score in the same range in CGAR. All four participants who had a score of 3 or higher in CGAL had a score in the same range in CGAR. Eighteen participants had a PGI-I score of 1, 2, or 3 in CGAL. Of this group, 15 patients (83.3%) had a score in the same range in CGAR. Of the three patients who had a score above 3 in CGAL, two (66.7%) had a score in the same range in CGAR.
The results indicate that most patients whose PGI-I score improved in one cluster bout, such as in CGAL, also improved in a subsequent bout, such as in CGAR, the investigators noted.
‘Encouraging’ results
Commenting on the study, Brian E. McGeeney, MD, a neurologist at the John R. Graham Headache Center, Brigham and Women’s Faulkner Hospital, Boston, noted that the PGI-I is an “easy-to-understand” outcome that has been widely used in headache medicine.
“Patient-assessed outcomes have become increasingly important and are an important complement to other outcomes,” said Dr. McGeeney, who was not involved in the research. However, a disadvantage is that “it is entirely subjective and may or may not reflect a change on other outcome measures that reflect the disorder itself,” he said.
“It can be difficult to demonstrate how much usefulness a treatment has with the helpful but simple outcome measures that are seen in CGAL and CGAR,” Dr. McGeeney added. “This is due to the nature of cluster headache and not to any methodological shortcomings of those studies.”
He said this is a core problem in general with cluster headache studies, “of which there are very few.”
In addition, CGAR only included episodic cluster headache, and the study period was relatively short; and CGAL only explored one cluster period per patient, Dr. McGeeney noted.
The current research attempts to provide insight that was previously unavailable, he said. “Many headache medicine clinical trial results reflect only one episode, and in general, we infer repeated usefulness – although it is not demonstrated in clinical trials,” said Dr. McGeeney.
“In this recent presentation, the authors attempt to go further and demonstrate some consistency across multiple cluster periods. The results are encouraging and what one might expect,” he said. However, “the small numbers and ad hoc nature preclude much inference from this study alone.”
Dr. Plato has received honoraria for speaking from Allergan, Amgen/Novartis, and Eli Lilly. He has also received research grants and support from Electrocore and Teva. Dr. McGeeney has consulted for Upsher-Smith and Theranica.
A version of this article originally appeared on Medscape.com.
new research suggests. A post hoc analysis of patients from the phase 3 CGAL study who also entered the open-label CGAR extension study was conducted. Results showed that the majority of participants whose scores on the Patient Global Impression of Improvement (PGI-I) showed improvement 1 month after the initial dose of galcanezumab in the CGAL study also showed improvement after treatment for subsequent cluster bouts during the CGAR study.
“There was good agreement between PGI-I between the two [cluster headache] periods,” noted the investigators, led by Brian Plato, DO, a neurologist at Norton Neuroscience Institute in Louisville, Ky.
The findings were presented at the virtual annual meeting of the American Headache Society.
Two cluster periods
Galcanezumab was approved by the Food and Drug Administration in 2019 for the treatment of episodic cluster headache in adults.
In cluster headache, attacks of recurrent, unilateral headaches with cranial autonomic symptoms last for weeks or months and are followed by periods of remission. Most studies of therapies for cluster headache examine only one cluster period. Few data about the consistency of treatment response throughout consecutive cluster periods are available, the investigators noted.
The current analysis was undertaken to examine the consistency of galcanezumab’s effect in episodic cluster headache during two cluster periods. Patients eligible for inclusion in the analysis had completed the double-blind phase of the CGAL study and had entered the open-label CGAR study.
CGAL was a phase 3, multicenter, randomized, double-blind study in which patients with episodic cluster headache were assigned to receive galcanezumab 300 mg per month or placebo. Patients who completed the double-blind and washout phases of this study were eligible for enrollment into CGAR, a phase 3b, single-arm safety study. The investigators determined the dose of galcanezumab in accordance with each patient’s symptoms and clinical response.
Response agreement
In both studies, the PGI-I was administered 1 month after the initial dose of galcanezumab. Only patients who were in an active cluster bout on entry into CGAR and who had valid PGI-I results 1 month after the first dose in CGAL and CGAR were included in the analysis.
PGI-I responses ranged from 1, signifying very much better, to 7, signifying very much worse. The investigators summarized the proportions of patients who reported each level of PGI-I score in CGAR and analyzed the results by dichotomizing PGI-I scores at both time points in two ways.
Fifty patients entered CGAR (78% men; mean age, 46.8 years). Of this group, Dr. Plato and colleagues included 39 in their analysis. Of the 17 patients who had a PGI-I score of 1 or 2 in CGAL, 12 (70.6%) had a score in the same range in CGAR. All four participants who had a score of 3 or higher in CGAL had a score in the same range in CGAR. Eighteen participants had a PGI-I score of 1, 2, or 3 in CGAL. Of this group, 15 patients (83.3%) had a score in the same range in CGAR. Of the three patients who had a score above 3 in CGAL, two (66.7%) had a score in the same range in CGAR.
The results indicate that most patients whose PGI-I score improved in one cluster bout, such as in CGAL, also improved in a subsequent bout, such as in CGAR, the investigators noted.
‘Encouraging’ results
Commenting on the study, Brian E. McGeeney, MD, a neurologist at the John R. Graham Headache Center, Brigham and Women’s Faulkner Hospital, Boston, noted that the PGI-I is an “easy-to-understand” outcome that has been widely used in headache medicine.
“Patient-assessed outcomes have become increasingly important and are an important complement to other outcomes,” said Dr. McGeeney, who was not involved in the research. However, a disadvantage is that “it is entirely subjective and may or may not reflect a change on other outcome measures that reflect the disorder itself,” he said.
“It can be difficult to demonstrate how much usefulness a treatment has with the helpful but simple outcome measures that are seen in CGAL and CGAR,” Dr. McGeeney added. “This is due to the nature of cluster headache and not to any methodological shortcomings of those studies.”
He said this is a core problem in general with cluster headache studies, “of which there are very few.”
In addition, CGAR only included episodic cluster headache, and the study period was relatively short; and CGAL only explored one cluster period per patient, Dr. McGeeney noted.
The current research attempts to provide insight that was previously unavailable, he said. “Many headache medicine clinical trial results reflect only one episode, and in general, we infer repeated usefulness – although it is not demonstrated in clinical trials,” said Dr. McGeeney.
“In this recent presentation, the authors attempt to go further and demonstrate some consistency across multiple cluster periods. The results are encouraging and what one might expect,” he said. However, “the small numbers and ad hoc nature preclude much inference from this study alone.”
Dr. Plato has received honoraria for speaking from Allergan, Amgen/Novartis, and Eli Lilly. He has also received research grants and support from Electrocore and Teva. Dr. McGeeney has consulted for Upsher-Smith and Theranica.
A version of this article originally appeared on Medscape.com.
new research suggests. A post hoc analysis of patients from the phase 3 CGAL study who also entered the open-label CGAR extension study was conducted. Results showed that the majority of participants whose scores on the Patient Global Impression of Improvement (PGI-I) showed improvement 1 month after the initial dose of galcanezumab in the CGAL study also showed improvement after treatment for subsequent cluster bouts during the CGAR study.
“There was good agreement between PGI-I between the two [cluster headache] periods,” noted the investigators, led by Brian Plato, DO, a neurologist at Norton Neuroscience Institute in Louisville, Ky.
The findings were presented at the virtual annual meeting of the American Headache Society.
Two cluster periods
Galcanezumab was approved by the Food and Drug Administration in 2019 for the treatment of episodic cluster headache in adults.
In cluster headache, attacks of recurrent, unilateral headaches with cranial autonomic symptoms last for weeks or months and are followed by periods of remission. Most studies of therapies for cluster headache examine only one cluster period. Few data about the consistency of treatment response throughout consecutive cluster periods are available, the investigators noted.
The current analysis was undertaken to examine the consistency of galcanezumab’s effect in episodic cluster headache during two cluster periods. Patients eligible for inclusion in the analysis had completed the double-blind phase of the CGAL study and had entered the open-label CGAR study.
CGAL was a phase 3, multicenter, randomized, double-blind study in which patients with episodic cluster headache were assigned to receive galcanezumab 300 mg per month or placebo. Patients who completed the double-blind and washout phases of this study were eligible for enrollment into CGAR, a phase 3b, single-arm safety study. The investigators determined the dose of galcanezumab in accordance with each patient’s symptoms and clinical response.
Response agreement
In both studies, the PGI-I was administered 1 month after the initial dose of galcanezumab. Only patients who were in an active cluster bout on entry into CGAR and who had valid PGI-I results 1 month after the first dose in CGAL and CGAR were included in the analysis.
PGI-I responses ranged from 1, signifying very much better, to 7, signifying very much worse. The investigators summarized the proportions of patients who reported each level of PGI-I score in CGAR and analyzed the results by dichotomizing PGI-I scores at both time points in two ways.
Fifty patients entered CGAR (78% men; mean age, 46.8 years). Of this group, Dr. Plato and colleagues included 39 in their analysis. Of the 17 patients who had a PGI-I score of 1 or 2 in CGAL, 12 (70.6%) had a score in the same range in CGAR. All four participants who had a score of 3 or higher in CGAL had a score in the same range in CGAR. Eighteen participants had a PGI-I score of 1, 2, or 3 in CGAL. Of this group, 15 patients (83.3%) had a score in the same range in CGAR. Of the three patients who had a score above 3 in CGAL, two (66.7%) had a score in the same range in CGAR.
The results indicate that most patients whose PGI-I score improved in one cluster bout, such as in CGAL, also improved in a subsequent bout, such as in CGAR, the investigators noted.
‘Encouraging’ results
Commenting on the study, Brian E. McGeeney, MD, a neurologist at the John R. Graham Headache Center, Brigham and Women’s Faulkner Hospital, Boston, noted that the PGI-I is an “easy-to-understand” outcome that has been widely used in headache medicine.
“Patient-assessed outcomes have become increasingly important and are an important complement to other outcomes,” said Dr. McGeeney, who was not involved in the research. However, a disadvantage is that “it is entirely subjective and may or may not reflect a change on other outcome measures that reflect the disorder itself,” he said.
“It can be difficult to demonstrate how much usefulness a treatment has with the helpful but simple outcome measures that are seen in CGAL and CGAR,” Dr. McGeeney added. “This is due to the nature of cluster headache and not to any methodological shortcomings of those studies.”
He said this is a core problem in general with cluster headache studies, “of which there are very few.”
In addition, CGAR only included episodic cluster headache, and the study period was relatively short; and CGAL only explored one cluster period per patient, Dr. McGeeney noted.
The current research attempts to provide insight that was previously unavailable, he said. “Many headache medicine clinical trial results reflect only one episode, and in general, we infer repeated usefulness – although it is not demonstrated in clinical trials,” said Dr. McGeeney.
“In this recent presentation, the authors attempt to go further and demonstrate some consistency across multiple cluster periods. The results are encouraging and what one might expect,” he said. However, “the small numbers and ad hoc nature preclude much inference from this study alone.”
Dr. Plato has received honoraria for speaking from Allergan, Amgen/Novartis, and Eli Lilly. He has also received research grants and support from Electrocore and Teva. Dr. McGeeney has consulted for Upsher-Smith and Theranica.
A version of this article originally appeared on Medscape.com.
FROM AHS 2020
Daily Recap: Healthy lifestyle may stave off dementia; Tentative evidence on marijuana for migraine
Here are the stories our MDedge editors across specialties think you need to know about today:
First reported U.S. case of COVID-19 linked to Guillain-Barré syndrome
The first official U.S. case of Guillain-Barré syndrome (GBS) associated with COVID-19 has been reported by neurologists from Allegheny General Hospital in Pittsburgh, further supporting a link between the virus and neurologic complications, including GBS.
Physicians in China reported the first case that initially presented as acute GBS. Subsequently, physicians in Italy reported five cases of GBS in association with COVID-19.
“This onset is similar to a case report of acute Zika virus infection with concurrent GBS suggesting a parainfectious complication,” first author Sandeep Rana, MD, and colleagues noted. Read more.
Five healthy lifestyle choices tied to dramatic cut in dementia risk
Combining four of five healthy lifestyle choices has been linked to up to a 60% reduced risk for Alzheimer’s dementia in new research that strengthens ties between healthy behaviors and lower dementia risk. “I hope this study will motivate people to engage in a healthy lifestyle by not smoking, being physically and cognitively active, and having a high-quality diet,” lead investigator Klodian Dhana, MD, PhD, said in an interview.
They defined a healthy lifestyle score on the basis of the following factors: not smoking; engaging in 150 min/wk or more of physical exercise; light to moderate alcohol consumption; consuming a high-quality Mediterranean-DASH Diet Intervention for Neurodegenerative Delay diet (upper 40%); and engaging in late-life cognitive activities.
“What needs to be determined is how early should we start ‘behaving.’ We should all aim to score four to five factors across our entire lifespan, but this is not always feasible. So, when is the time to behave? Also, what is the relative weight of each of these factors?” said Luca Giliberto, MD, PhD. Read more.
Marijuana for migraine? Some tentative evidence
Medical marijuana may have promise for managing headache pain, according to results from a small study conducted at the Jefferson Headache Center at Thomas Jefferson University. The researchers found general satisfaction with medical marijuana, more frequent use as an abortive medication rather than a preventative, and more than two-thirds using the inhaled form rather than oral.
“A lot of patients are interested in medical marijuana but don’t know how to integrate it into the therapy plan they already have – whether it should be just to treat bad headaches when they happen, or is it meant to be a preventive medicine they use every day? We have some data out there that it can be helpful, but not a lot of specific information to guide your recommendations,” said Jefferson headache fellow Claire Ceriani, MD, in an interview. Read more.
Inside Mercy’s mission to care for non-COVID patients in Los Angeles
When the hospital ship USNS Mercy departed San Diego’s Naval Station North Island on March 23, 2020, to support the Department of Defense efforts in Los Angeles during the coronavirus outbreak, Commander Erin Blevins remembers the crew’s excitement was palpable. “We normally do partnerships abroad and respond to tsunamis and earthquakes,” said Cdr. Blevins, MD, a pediatric hematologist-oncologist who served as director of medical services for the mission.
Between March 29 and May 15, about 1,071 medical personnel aboard the Mercy cared for 77 patients with an average age of 53 years who were referred from 11 Los Angeles area hospitals.
Care aboard the ship ranged from basic medical and surgical care to critical care and trauma. The most common procedures were cholecystectomies and orthopedic procedures, and the average length of stay was 4-5 days, according to Cdr. Blevins. Over the course of the mission, the medical professionals conducted 36 surgeries, 77 x-ray exams, 26 CT scans, and administered hundreds of ancillary studies ranging from routine labs to high-end x-rays and blood transfusion support. Special Feature.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
First reported U.S. case of COVID-19 linked to Guillain-Barré syndrome
The first official U.S. case of Guillain-Barré syndrome (GBS) associated with COVID-19 has been reported by neurologists from Allegheny General Hospital in Pittsburgh, further supporting a link between the virus and neurologic complications, including GBS.
Physicians in China reported the first case that initially presented as acute GBS. Subsequently, physicians in Italy reported five cases of GBS in association with COVID-19.
“This onset is similar to a case report of acute Zika virus infection with concurrent GBS suggesting a parainfectious complication,” first author Sandeep Rana, MD, and colleagues noted. Read more.
Five healthy lifestyle choices tied to dramatic cut in dementia risk
Combining four of five healthy lifestyle choices has been linked to up to a 60% reduced risk for Alzheimer’s dementia in new research that strengthens ties between healthy behaviors and lower dementia risk. “I hope this study will motivate people to engage in a healthy lifestyle by not smoking, being physically and cognitively active, and having a high-quality diet,” lead investigator Klodian Dhana, MD, PhD, said in an interview.
They defined a healthy lifestyle score on the basis of the following factors: not smoking; engaging in 150 min/wk or more of physical exercise; light to moderate alcohol consumption; consuming a high-quality Mediterranean-DASH Diet Intervention for Neurodegenerative Delay diet (upper 40%); and engaging in late-life cognitive activities.
“What needs to be determined is how early should we start ‘behaving.’ We should all aim to score four to five factors across our entire lifespan, but this is not always feasible. So, when is the time to behave? Also, what is the relative weight of each of these factors?” said Luca Giliberto, MD, PhD. Read more.
Marijuana for migraine? Some tentative evidence
Medical marijuana may have promise for managing headache pain, according to results from a small study conducted at the Jefferson Headache Center at Thomas Jefferson University. The researchers found general satisfaction with medical marijuana, more frequent use as an abortive medication rather than a preventative, and more than two-thirds using the inhaled form rather than oral.
“A lot of patients are interested in medical marijuana but don’t know how to integrate it into the therapy plan they already have – whether it should be just to treat bad headaches when they happen, or is it meant to be a preventive medicine they use every day? We have some data out there that it can be helpful, but not a lot of specific information to guide your recommendations,” said Jefferson headache fellow Claire Ceriani, MD, in an interview. Read more.
Inside Mercy’s mission to care for non-COVID patients in Los Angeles
When the hospital ship USNS Mercy departed San Diego’s Naval Station North Island on March 23, 2020, to support the Department of Defense efforts in Los Angeles during the coronavirus outbreak, Commander Erin Blevins remembers the crew’s excitement was palpable. “We normally do partnerships abroad and respond to tsunamis and earthquakes,” said Cdr. Blevins, MD, a pediatric hematologist-oncologist who served as director of medical services for the mission.
Between March 29 and May 15, about 1,071 medical personnel aboard the Mercy cared for 77 patients with an average age of 53 years who were referred from 11 Los Angeles area hospitals.
Care aboard the ship ranged from basic medical and surgical care to critical care and trauma. The most common procedures were cholecystectomies and orthopedic procedures, and the average length of stay was 4-5 days, according to Cdr. Blevins. Over the course of the mission, the medical professionals conducted 36 surgeries, 77 x-ray exams, 26 CT scans, and administered hundreds of ancillary studies ranging from routine labs to high-end x-rays and blood transfusion support. Special Feature.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
First reported U.S. case of COVID-19 linked to Guillain-Barré syndrome
The first official U.S. case of Guillain-Barré syndrome (GBS) associated with COVID-19 has been reported by neurologists from Allegheny General Hospital in Pittsburgh, further supporting a link between the virus and neurologic complications, including GBS.
Physicians in China reported the first case that initially presented as acute GBS. Subsequently, physicians in Italy reported five cases of GBS in association with COVID-19.
“This onset is similar to a case report of acute Zika virus infection with concurrent GBS suggesting a parainfectious complication,” first author Sandeep Rana, MD, and colleagues noted. Read more.
Five healthy lifestyle choices tied to dramatic cut in dementia risk
Combining four of five healthy lifestyle choices has been linked to up to a 60% reduced risk for Alzheimer’s dementia in new research that strengthens ties between healthy behaviors and lower dementia risk. “I hope this study will motivate people to engage in a healthy lifestyle by not smoking, being physically and cognitively active, and having a high-quality diet,” lead investigator Klodian Dhana, MD, PhD, said in an interview.
They defined a healthy lifestyle score on the basis of the following factors: not smoking; engaging in 150 min/wk or more of physical exercise; light to moderate alcohol consumption; consuming a high-quality Mediterranean-DASH Diet Intervention for Neurodegenerative Delay diet (upper 40%); and engaging in late-life cognitive activities.
“What needs to be determined is how early should we start ‘behaving.’ We should all aim to score four to five factors across our entire lifespan, but this is not always feasible. So, when is the time to behave? Also, what is the relative weight of each of these factors?” said Luca Giliberto, MD, PhD. Read more.
Marijuana for migraine? Some tentative evidence
Medical marijuana may have promise for managing headache pain, according to results from a small study conducted at the Jefferson Headache Center at Thomas Jefferson University. The researchers found general satisfaction with medical marijuana, more frequent use as an abortive medication rather than a preventative, and more than two-thirds using the inhaled form rather than oral.
“A lot of patients are interested in medical marijuana but don’t know how to integrate it into the therapy plan they already have – whether it should be just to treat bad headaches when they happen, or is it meant to be a preventive medicine they use every day? We have some data out there that it can be helpful, but not a lot of specific information to guide your recommendations,” said Jefferson headache fellow Claire Ceriani, MD, in an interview. Read more.
Inside Mercy’s mission to care for non-COVID patients in Los Angeles
When the hospital ship USNS Mercy departed San Diego’s Naval Station North Island on March 23, 2020, to support the Department of Defense efforts in Los Angeles during the coronavirus outbreak, Commander Erin Blevins remembers the crew’s excitement was palpable. “We normally do partnerships abroad and respond to tsunamis and earthquakes,” said Cdr. Blevins, MD, a pediatric hematologist-oncologist who served as director of medical services for the mission.
Between March 29 and May 15, about 1,071 medical personnel aboard the Mercy cared for 77 patients with an average age of 53 years who were referred from 11 Los Angeles area hospitals.
Care aboard the ship ranged from basic medical and surgical care to critical care and trauma. The most common procedures were cholecystectomies and orthopedic procedures, and the average length of stay was 4-5 days, according to Cdr. Blevins. Over the course of the mission, the medical professionals conducted 36 surgeries, 77 x-ray exams, 26 CT scans, and administered hundreds of ancillary studies ranging from routine labs to high-end x-rays and blood transfusion support. Special Feature.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
First reported U.S. case of COVID-19 linked to Guillain-Barré syndrome
further supporting a link between the virus and neurologic complications, including GBS.
Physicians in China reported the first case of COVID-19 that initially presented as acute GBS. The patient was a 61-year-old woman returning home from Wuhan during the pandemic.
Subsequently, physicians in Italy reported five cases of GBS in association with COVID-19.
The first U.S. case is described in the June issue of the Journal of Clinical Neuromuscular Disease.
Like cases from China and Italy, the U.S. patient’s symptoms of GBS reportedly occurred within days of being infected with SARS-CoV-2. “This onset is similar to a case report of acute Zika virus infection with concurrent GBS suggesting a parainfectious complication,” first author Sandeep Rana, MD, and colleagues noted.
The 54-year-old man was transferred to Allegheny General Hospital after developing ascending limb weakness and numbness that followed symptoms of a respiratory infection. Two weeks earlier, he initially developed rhinorrhea, odynophagia, fevers, chills, and night sweats. The man reported that his wife had tested positive for COVID-19 and that his symptoms started soon after her illness. The man also tested positive for COVID-19.
His deficits were characterized by quadriparesis and areflexia, burning dysesthesias, mild ophthalmoparesis, and dysautonomia. He did not have the loss of smell and taste documented in other COVID-19 patients. He briefly required mechanical ventilation and was successfully weaned after receiving a course of intravenous immunoglobulin.
Compared with other cases reported in the literature, the unique clinical features in the U.S. case are urinary retention secondary to dysautonomia and ocular symptoms of diplopia. These highlight the variability in the clinical presentation of GBS associated with COVID-19, the researchers noted.
They added that, with the Pittsburgh patient, electrophysiological findings were typical of demyelinating polyneuropathy seen in patients with GBS. The case series from Italy suggests that axonal variants could be as common in COVID-19–associated GBS.
“Although the number of documented cases internationally is notably small to date, it’s not completely surprising that a COVID-19 diagnosis may lead to a patient developing GBS. The increase of inflammation and inflammatory cells caused by the infection may trigger an irregular immune response that leads to the hallmark symptoms of this neurological disorder,” Dr. Rana said in a news release.
“Since GBS can significantly affect the respiratory system and other vital organs being pushed into overdrive during a COVID-19 immune response, it will be critically important to further investigate and understand this potential connection,” he added.
A version of this article originally appeared on Medscape.com.
further supporting a link between the virus and neurologic complications, including GBS.
Physicians in China reported the first case of COVID-19 that initially presented as acute GBS. The patient was a 61-year-old woman returning home from Wuhan during the pandemic.
Subsequently, physicians in Italy reported five cases of GBS in association with COVID-19.
The first U.S. case is described in the June issue of the Journal of Clinical Neuromuscular Disease.
Like cases from China and Italy, the U.S. patient’s symptoms of GBS reportedly occurred within days of being infected with SARS-CoV-2. “This onset is similar to a case report of acute Zika virus infection with concurrent GBS suggesting a parainfectious complication,” first author Sandeep Rana, MD, and colleagues noted.
The 54-year-old man was transferred to Allegheny General Hospital after developing ascending limb weakness and numbness that followed symptoms of a respiratory infection. Two weeks earlier, he initially developed rhinorrhea, odynophagia, fevers, chills, and night sweats. The man reported that his wife had tested positive for COVID-19 and that his symptoms started soon after her illness. The man also tested positive for COVID-19.
His deficits were characterized by quadriparesis and areflexia, burning dysesthesias, mild ophthalmoparesis, and dysautonomia. He did not have the loss of smell and taste documented in other COVID-19 patients. He briefly required mechanical ventilation and was successfully weaned after receiving a course of intravenous immunoglobulin.
Compared with other cases reported in the literature, the unique clinical features in the U.S. case are urinary retention secondary to dysautonomia and ocular symptoms of diplopia. These highlight the variability in the clinical presentation of GBS associated with COVID-19, the researchers noted.
They added that, with the Pittsburgh patient, electrophysiological findings were typical of demyelinating polyneuropathy seen in patients with GBS. The case series from Italy suggests that axonal variants could be as common in COVID-19–associated GBS.
“Although the number of documented cases internationally is notably small to date, it’s not completely surprising that a COVID-19 diagnosis may lead to a patient developing GBS. The increase of inflammation and inflammatory cells caused by the infection may trigger an irregular immune response that leads to the hallmark symptoms of this neurological disorder,” Dr. Rana said in a news release.
“Since GBS can significantly affect the respiratory system and other vital organs being pushed into overdrive during a COVID-19 immune response, it will be critically important to further investigate and understand this potential connection,” he added.
A version of this article originally appeared on Medscape.com.
further supporting a link between the virus and neurologic complications, including GBS.
Physicians in China reported the first case of COVID-19 that initially presented as acute GBS. The patient was a 61-year-old woman returning home from Wuhan during the pandemic.
Subsequently, physicians in Italy reported five cases of GBS in association with COVID-19.
The first U.S. case is described in the June issue of the Journal of Clinical Neuromuscular Disease.
Like cases from China and Italy, the U.S. patient’s symptoms of GBS reportedly occurred within days of being infected with SARS-CoV-2. “This onset is similar to a case report of acute Zika virus infection with concurrent GBS suggesting a parainfectious complication,” first author Sandeep Rana, MD, and colleagues noted.
The 54-year-old man was transferred to Allegheny General Hospital after developing ascending limb weakness and numbness that followed symptoms of a respiratory infection. Two weeks earlier, he initially developed rhinorrhea, odynophagia, fevers, chills, and night sweats. The man reported that his wife had tested positive for COVID-19 and that his symptoms started soon after her illness. The man also tested positive for COVID-19.
His deficits were characterized by quadriparesis and areflexia, burning dysesthesias, mild ophthalmoparesis, and dysautonomia. He did not have the loss of smell and taste documented in other COVID-19 patients. He briefly required mechanical ventilation and was successfully weaned after receiving a course of intravenous immunoglobulin.
Compared with other cases reported in the literature, the unique clinical features in the U.S. case are urinary retention secondary to dysautonomia and ocular symptoms of diplopia. These highlight the variability in the clinical presentation of GBS associated with COVID-19, the researchers noted.
They added that, with the Pittsburgh patient, electrophysiological findings were typical of demyelinating polyneuropathy seen in patients with GBS. The case series from Italy suggests that axonal variants could be as common in COVID-19–associated GBS.
“Although the number of documented cases internationally is notably small to date, it’s not completely surprising that a COVID-19 diagnosis may lead to a patient developing GBS. The increase of inflammation and inflammatory cells caused by the infection may trigger an irregular immune response that leads to the hallmark symptoms of this neurological disorder,” Dr. Rana said in a news release.
“Since GBS can significantly affect the respiratory system and other vital organs being pushed into overdrive during a COVID-19 immune response, it will be critically important to further investigate and understand this potential connection,” he added.
A version of this article originally appeared on Medscape.com.
What COVID-19 has taught us about senior care
Across the globe, there are marked differences in how countries responded to the COVID-19 outbreak, with varying degrees of success in limiting the spread of the virus. Some countries learned important lessons from previous outbreaks, including SARS and MERS, and put policies in place that contributed to lower infection and death rates from COVID-19 in these countries. Others struggled to respond appropriately to the outbreak.
The United States and most of the world was not affected significantly by SARS and MERS. Hence there is a need for different perspectives and observations on lessons that can be learned from this outbreak to help develop effective strategies and policies for the future. It also makes sense to focus intently on the demographic most affected by COVID-19 – the elderly.
Medical care, for the most part, is governed by protocols that clearly detail processes to be followed for the prevention and treatment of disease. Caring for older patients requires going above and beyond the protocols. That is one of the lessons learned from the COVID-19 pandemic – a wake-up call for a more proactive approach for at-risk patients, in this case everyone over the age of 60 years.
In this context, it is important for medical outreach to continue with the senior population long after the pandemic has run its course. Many seniors, particularly those susceptible to other illnesses or exhibiting ongoing issues, would benefit from a consistent and preplanned pattern of contacts by medical professionals and agencies that work with the aging population. These proactive follow-ups can facilitate prevention and treatment and, at the same time, reduce costs that would otherwise increase when health care is reactive.
Lessons in infectious disease containment
As COVID-19 spread globally, there were contrasting responses from individual countries in their efforts to contain the disease. Unfortunately, Italy suffered from its decision to lock down only specific regions of the country initially. The leadership in Italy may have ignored the advice of medical experts and been caught off guard by the intensity of the spread of COVID-19. In fact, they might not have taken strict actions right away because they did not want their responses to be viewed as an overreaction to the disease.
The government decided to shut down areas where the infection rates were high (“red zones”) rather than implement restrictions nationally. This may have inadvertently increased the spread as Italians vacated those “red zones” for other areas of the country not yet affected by COVID-19. Italy’s decentralized health care system also played a part in the effects of the disease, with some regions demonstrating more success in slowing the reach of the disease. According to an article in the Harvard Business Review, the neighboring regions of Lombardy and Veneto applied similar approaches to social distancing and retail closures. Veneto was more proactive, and its response to the outbreak was multipronged, including putting a “strong emphasis on home diagnosis and care” and “specific efforts to monitor and protect health care and other essential workers.” These measures most likely contributed to a slowdown of the spread of the disease in Veneto’s health care facilities, which lessened the load on medical providers.1
Conversely, Taiwan implemented proactive measures swiftly after learning about COVID-19. Taiwan was impacted adversely by the SARS outbreak in 2003 and, afterward, revised their medical policies and procedures to respond quickly to future infectious disease crises. In the beginning, little was known about COVID-19 or how it spread. However, Taiwan’s swift public health response to COVID-19 included early travel restrictions, patient screening, and quarantining of symptomatic patients. The government emphasized education and created real-time digital updates and alerts sent to their citizens, as well as partnering with media to broadcast crucial proactive health information and quickly disproving false information related to COVID-19. They coordinated with organizations throughout the country to increase supplies of personal protective equipment (PPE).2
Although countries and even cities within a country differ in terms of population demographics, health resources, government policies, and cultural practices, initial success stories have some similarities, including the following:
- Early travel restrictions from countries with positive cases, with some circumstances requiring compulsory quarantine periods and testing before entry.
- Extensive testing and proactive tracing of symptomatic cases early. Contacts of people testing positive were also tested, irrespective of being symptomatic or asymptomatic. If testing kits were unavailable, the contacts were self-quarantined.
- Emphasis on avoiding overburdening hospitals by having the public health infrastructure to divert people exhibiting symptoms, including using public health hotlines to send patients to dedicated testing sites and drive-through testing, rather than have patients presenting to emergency rooms and hospitals. This approach protected medical staff from exposure and allowed the focus to remain on treating severe symptomatic patients.
The vastly different response to the COVID-19 outbreak in these two countries illuminates the need for better preparation in the United States. At the onset of this outbreak, emergency room medical professionals, hospitalists, and outpatient primary care providers did not know how to screen for or treat this virus. Additionally, there was limited information on the most effective contact protocols for medical professionals, patients, and visitors. Finally, the lack of PPE and COVID-19 test kits hindered the U.S. response. Once the country is on the road to recovery from COVID-19, it is imperative to set the groundwork to prepare for future outbreaks and create mechanisms to quickly identify vulnerable populations when outbreaks occur.
Senior care in future infectious disease outbreaks
How can medical providers translate lessons learned from this outbreak into improving the quality of care for seniors? The National Institute on Aging (NIA) maintains a website with information about healthy aging. Seniors and their caregivers can use this website to learn more about chronic diseases, lifestyle modifications, disease prevention, and mental health.
In times of a pandemic, this website provides consistent and accurate information and education. One recommendation for reaching the elderly population during future outbreaks is for NIA to develop and implement strategies to increase the use of the website, including adding more audio and visual interfaces and developing a mobile app. Other recommendations for improving the quality of care for seniors include the following:
1. Identify which populations may be most affected when future outbreaks occur.
2. Consider nontraditional platforms, including social media, for communicating with the general population and for medical providers worldwide to learn from each other about new diseases, including the signs, symptoms, and treatment plans. Some medical professionals created specific WhatsApp groups to communicate, and the World Health Organization sent updated information about COVID-19 to anyone who texted them via WhatsApp.3
3. Create a checklist of signs and symptoms related to current infectious diseases and assess every vulnerable patient.
4. Share these guidelines with medical facilities that treat these populations, such as senior care, assisted living and rehabilitation facilities, hospitals, and outpatient treatment centers. Teach the staff at these medical facilities how to screen patients for signs and symptoms of the disease.
5. Implement social isolation strategies, travel and visitor restrictions, and testing and screening as soon as possible at these medical facilities.
6. Recognize that these strategies may affect the psychological and emotional well-being of seniors, increasing their risk for depression and anxiety and negatively affecting their immunity and mental health. Additionally, the use of PPE, either by the medical providers or the patient, may cause anxiety in seniors and those with mild cognitive impairment.
7. Encourage these medical facilities to improve coping strategies with older patients, such as incorporating communication technology that helps seniors stay connected with their families, and participating in physical and mental exercise, as well as religious activities.
8. Ask these medical facilities to create isolation or quarantine rooms for infected seniors.
9. Work with family members to proactively report to medical professionals any symptoms noticed in their senior relatives. Educate seniors to report symptoms earlier.
10. Offer incentives for medical professionals to conduct on-site testing in primary care offices or senior care facilities instead of sending patients to hospital emergency rooms for evaluation. This will only be effective if there are enough test kits available.
11. Urge insurance companies and Medicare to allow additional medical visits for screening vulnerable populations. Encourage the use of telemedicine in place of in-office visits (preferably billed at the same rate as an in-office visit) where appropriate, especially with nonambulatory patients or those with transportation issues. Many insurance companies, including Medicare, approved COVID-19–related coverage of telemedicine in place of office visits to limit the spread of the disease.
12. Provide community health care and integration and better coordination of local, state, and national health care.
13. Hold regular epidemic and pandemic preparedness exercises in every hospital, nursing home, and assisted living facility.
Proactive health care outreach
It is easier to identify the signs and symptoms of already identified infectious diseases as opposed to a novel one like COVID-19. The United States faced a steep learning curve with COVID-19. Hospitalists and other medical professionals were not able to learn about COVID-19 in a journal. At first, they did not know how to screen patients coming into the ER, how to protect staff, or what the treatment plan was for this new disease. As a result, the medical system experienced disorder and confusion. Investing in community health care and better coordination of local, state, and national health care resources is a priority.
The senior citizen population appears to be most vulnerable to this virus and may be just as vulnerable in future outbreaks. Yet the insights gained from this pandemic can lead to a more comprehensive outreach to senior patients and increased screenings for comorbidities and future contagious diseases. An emphasis on proactive health care and outreach for seniors, with a focus on identifying and treating comorbid conditions, improves the medical care system overall and may prevent or slow future community outbreaks.
Dr. Kasarla is a hospitalist with APOGEE Physicians at Wise Surgical at Parkway in Fort Worth, Tex. He did his internal medicine residency at Mercy Hospital & Medical Center, Chicago. Readers can contact him at madhukarreddy.kasarla@apogeephysicians.com. Dr. Devireddy is a family physician at Positive Health Medical Center, Kingston, Jamaica. Contact him at drjaisheel@gmail.com.
References
1. Pisano GP et al. Lessons from Italy’s response to coronavirus. Harvard Business Review. 2020 Mar 27. https://hbr.org/2020/03/lessons-from-italys-response-to-coronavirus.
2. Tu C. Lessons from Taiwan’s experience with COVID-19. New Atlanticist. 2020 Apr 7. https://atlanticcouncil.org/blogs/new-atlanticist/lessons-from-taiwans-experience-with-covid-19/.
3. Newman LH. WhatsApp is at the center of coronavirus response. WIRED. 2020 Mar 20. https://www.wired.com/story/whatsapp-coronavirus-who-information-app/.
Across the globe, there are marked differences in how countries responded to the COVID-19 outbreak, with varying degrees of success in limiting the spread of the virus. Some countries learned important lessons from previous outbreaks, including SARS and MERS, and put policies in place that contributed to lower infection and death rates from COVID-19 in these countries. Others struggled to respond appropriately to the outbreak.
The United States and most of the world was not affected significantly by SARS and MERS. Hence there is a need for different perspectives and observations on lessons that can be learned from this outbreak to help develop effective strategies and policies for the future. It also makes sense to focus intently on the demographic most affected by COVID-19 – the elderly.
Medical care, for the most part, is governed by protocols that clearly detail processes to be followed for the prevention and treatment of disease. Caring for older patients requires going above and beyond the protocols. That is one of the lessons learned from the COVID-19 pandemic – a wake-up call for a more proactive approach for at-risk patients, in this case everyone over the age of 60 years.
In this context, it is important for medical outreach to continue with the senior population long after the pandemic has run its course. Many seniors, particularly those susceptible to other illnesses or exhibiting ongoing issues, would benefit from a consistent and preplanned pattern of contacts by medical professionals and agencies that work with the aging population. These proactive follow-ups can facilitate prevention and treatment and, at the same time, reduce costs that would otherwise increase when health care is reactive.
Lessons in infectious disease containment
As COVID-19 spread globally, there were contrasting responses from individual countries in their efforts to contain the disease. Unfortunately, Italy suffered from its decision to lock down only specific regions of the country initially. The leadership in Italy may have ignored the advice of medical experts and been caught off guard by the intensity of the spread of COVID-19. In fact, they might not have taken strict actions right away because they did not want their responses to be viewed as an overreaction to the disease.
The government decided to shut down areas where the infection rates were high (“red zones”) rather than implement restrictions nationally. This may have inadvertently increased the spread as Italians vacated those “red zones” for other areas of the country not yet affected by COVID-19. Italy’s decentralized health care system also played a part in the effects of the disease, with some regions demonstrating more success in slowing the reach of the disease. According to an article in the Harvard Business Review, the neighboring regions of Lombardy and Veneto applied similar approaches to social distancing and retail closures. Veneto was more proactive, and its response to the outbreak was multipronged, including putting a “strong emphasis on home diagnosis and care” and “specific efforts to monitor and protect health care and other essential workers.” These measures most likely contributed to a slowdown of the spread of the disease in Veneto’s health care facilities, which lessened the load on medical providers.1
Conversely, Taiwan implemented proactive measures swiftly after learning about COVID-19. Taiwan was impacted adversely by the SARS outbreak in 2003 and, afterward, revised their medical policies and procedures to respond quickly to future infectious disease crises. In the beginning, little was known about COVID-19 or how it spread. However, Taiwan’s swift public health response to COVID-19 included early travel restrictions, patient screening, and quarantining of symptomatic patients. The government emphasized education and created real-time digital updates and alerts sent to their citizens, as well as partnering with media to broadcast crucial proactive health information and quickly disproving false information related to COVID-19. They coordinated with organizations throughout the country to increase supplies of personal protective equipment (PPE).2
Although countries and even cities within a country differ in terms of population demographics, health resources, government policies, and cultural practices, initial success stories have some similarities, including the following:
- Early travel restrictions from countries with positive cases, with some circumstances requiring compulsory quarantine periods and testing before entry.
- Extensive testing and proactive tracing of symptomatic cases early. Contacts of people testing positive were also tested, irrespective of being symptomatic or asymptomatic. If testing kits were unavailable, the contacts were self-quarantined.
- Emphasis on avoiding overburdening hospitals by having the public health infrastructure to divert people exhibiting symptoms, including using public health hotlines to send patients to dedicated testing sites and drive-through testing, rather than have patients presenting to emergency rooms and hospitals. This approach protected medical staff from exposure and allowed the focus to remain on treating severe symptomatic patients.
The vastly different response to the COVID-19 outbreak in these two countries illuminates the need for better preparation in the United States. At the onset of this outbreak, emergency room medical professionals, hospitalists, and outpatient primary care providers did not know how to screen for or treat this virus. Additionally, there was limited information on the most effective contact protocols for medical professionals, patients, and visitors. Finally, the lack of PPE and COVID-19 test kits hindered the U.S. response. Once the country is on the road to recovery from COVID-19, it is imperative to set the groundwork to prepare for future outbreaks and create mechanisms to quickly identify vulnerable populations when outbreaks occur.
Senior care in future infectious disease outbreaks
How can medical providers translate lessons learned from this outbreak into improving the quality of care for seniors? The National Institute on Aging (NIA) maintains a website with information about healthy aging. Seniors and their caregivers can use this website to learn more about chronic diseases, lifestyle modifications, disease prevention, and mental health.
In times of a pandemic, this website provides consistent and accurate information and education. One recommendation for reaching the elderly population during future outbreaks is for NIA to develop and implement strategies to increase the use of the website, including adding more audio and visual interfaces and developing a mobile app. Other recommendations for improving the quality of care for seniors include the following:
1. Identify which populations may be most affected when future outbreaks occur.
2. Consider nontraditional platforms, including social media, for communicating with the general population and for medical providers worldwide to learn from each other about new diseases, including the signs, symptoms, and treatment plans. Some medical professionals created specific WhatsApp groups to communicate, and the World Health Organization sent updated information about COVID-19 to anyone who texted them via WhatsApp.3
3. Create a checklist of signs and symptoms related to current infectious diseases and assess every vulnerable patient.
4. Share these guidelines with medical facilities that treat these populations, such as senior care, assisted living and rehabilitation facilities, hospitals, and outpatient treatment centers. Teach the staff at these medical facilities how to screen patients for signs and symptoms of the disease.
5. Implement social isolation strategies, travel and visitor restrictions, and testing and screening as soon as possible at these medical facilities.
6. Recognize that these strategies may affect the psychological and emotional well-being of seniors, increasing their risk for depression and anxiety and negatively affecting their immunity and mental health. Additionally, the use of PPE, either by the medical providers or the patient, may cause anxiety in seniors and those with mild cognitive impairment.
7. Encourage these medical facilities to improve coping strategies with older patients, such as incorporating communication technology that helps seniors stay connected with their families, and participating in physical and mental exercise, as well as religious activities.
8. Ask these medical facilities to create isolation or quarantine rooms for infected seniors.
9. Work with family members to proactively report to medical professionals any symptoms noticed in their senior relatives. Educate seniors to report symptoms earlier.
10. Offer incentives for medical professionals to conduct on-site testing in primary care offices or senior care facilities instead of sending patients to hospital emergency rooms for evaluation. This will only be effective if there are enough test kits available.
11. Urge insurance companies and Medicare to allow additional medical visits for screening vulnerable populations. Encourage the use of telemedicine in place of in-office visits (preferably billed at the same rate as an in-office visit) where appropriate, especially with nonambulatory patients or those with transportation issues. Many insurance companies, including Medicare, approved COVID-19–related coverage of telemedicine in place of office visits to limit the spread of the disease.
12. Provide community health care and integration and better coordination of local, state, and national health care.
13. Hold regular epidemic and pandemic preparedness exercises in every hospital, nursing home, and assisted living facility.
Proactive health care outreach
It is easier to identify the signs and symptoms of already identified infectious diseases as opposed to a novel one like COVID-19. The United States faced a steep learning curve with COVID-19. Hospitalists and other medical professionals were not able to learn about COVID-19 in a journal. At first, they did not know how to screen patients coming into the ER, how to protect staff, or what the treatment plan was for this new disease. As a result, the medical system experienced disorder and confusion. Investing in community health care and better coordination of local, state, and national health care resources is a priority.
The senior citizen population appears to be most vulnerable to this virus and may be just as vulnerable in future outbreaks. Yet the insights gained from this pandemic can lead to a more comprehensive outreach to senior patients and increased screenings for comorbidities and future contagious diseases. An emphasis on proactive health care and outreach for seniors, with a focus on identifying and treating comorbid conditions, improves the medical care system overall and may prevent or slow future community outbreaks.
Dr. Kasarla is a hospitalist with APOGEE Physicians at Wise Surgical at Parkway in Fort Worth, Tex. He did his internal medicine residency at Mercy Hospital & Medical Center, Chicago. Readers can contact him at madhukarreddy.kasarla@apogeephysicians.com. Dr. Devireddy is a family physician at Positive Health Medical Center, Kingston, Jamaica. Contact him at drjaisheel@gmail.com.
References
1. Pisano GP et al. Lessons from Italy’s response to coronavirus. Harvard Business Review. 2020 Mar 27. https://hbr.org/2020/03/lessons-from-italys-response-to-coronavirus.
2. Tu C. Lessons from Taiwan’s experience with COVID-19. New Atlanticist. 2020 Apr 7. https://atlanticcouncil.org/blogs/new-atlanticist/lessons-from-taiwans-experience-with-covid-19/.
3. Newman LH. WhatsApp is at the center of coronavirus response. WIRED. 2020 Mar 20. https://www.wired.com/story/whatsapp-coronavirus-who-information-app/.
Across the globe, there are marked differences in how countries responded to the COVID-19 outbreak, with varying degrees of success in limiting the spread of the virus. Some countries learned important lessons from previous outbreaks, including SARS and MERS, and put policies in place that contributed to lower infection and death rates from COVID-19 in these countries. Others struggled to respond appropriately to the outbreak.
The United States and most of the world was not affected significantly by SARS and MERS. Hence there is a need for different perspectives and observations on lessons that can be learned from this outbreak to help develop effective strategies and policies for the future. It also makes sense to focus intently on the demographic most affected by COVID-19 – the elderly.
Medical care, for the most part, is governed by protocols that clearly detail processes to be followed for the prevention and treatment of disease. Caring for older patients requires going above and beyond the protocols. That is one of the lessons learned from the COVID-19 pandemic – a wake-up call for a more proactive approach for at-risk patients, in this case everyone over the age of 60 years.
In this context, it is important for medical outreach to continue with the senior population long after the pandemic has run its course. Many seniors, particularly those susceptible to other illnesses or exhibiting ongoing issues, would benefit from a consistent and preplanned pattern of contacts by medical professionals and agencies that work with the aging population. These proactive follow-ups can facilitate prevention and treatment and, at the same time, reduce costs that would otherwise increase when health care is reactive.
Lessons in infectious disease containment
As COVID-19 spread globally, there were contrasting responses from individual countries in their efforts to contain the disease. Unfortunately, Italy suffered from its decision to lock down only specific regions of the country initially. The leadership in Italy may have ignored the advice of medical experts and been caught off guard by the intensity of the spread of COVID-19. In fact, they might not have taken strict actions right away because they did not want their responses to be viewed as an overreaction to the disease.
The government decided to shut down areas where the infection rates were high (“red zones”) rather than implement restrictions nationally. This may have inadvertently increased the spread as Italians vacated those “red zones” for other areas of the country not yet affected by COVID-19. Italy’s decentralized health care system also played a part in the effects of the disease, with some regions demonstrating more success in slowing the reach of the disease. According to an article in the Harvard Business Review, the neighboring regions of Lombardy and Veneto applied similar approaches to social distancing and retail closures. Veneto was more proactive, and its response to the outbreak was multipronged, including putting a “strong emphasis on home diagnosis and care” and “specific efforts to monitor and protect health care and other essential workers.” These measures most likely contributed to a slowdown of the spread of the disease in Veneto’s health care facilities, which lessened the load on medical providers.1
Conversely, Taiwan implemented proactive measures swiftly after learning about COVID-19. Taiwan was impacted adversely by the SARS outbreak in 2003 and, afterward, revised their medical policies and procedures to respond quickly to future infectious disease crises. In the beginning, little was known about COVID-19 or how it spread. However, Taiwan’s swift public health response to COVID-19 included early travel restrictions, patient screening, and quarantining of symptomatic patients. The government emphasized education and created real-time digital updates and alerts sent to their citizens, as well as partnering with media to broadcast crucial proactive health information and quickly disproving false information related to COVID-19. They coordinated with organizations throughout the country to increase supplies of personal protective equipment (PPE).2
Although countries and even cities within a country differ in terms of population demographics, health resources, government policies, and cultural practices, initial success stories have some similarities, including the following:
- Early travel restrictions from countries with positive cases, with some circumstances requiring compulsory quarantine periods and testing before entry.
- Extensive testing and proactive tracing of symptomatic cases early. Contacts of people testing positive were also tested, irrespective of being symptomatic or asymptomatic. If testing kits were unavailable, the contacts were self-quarantined.
- Emphasis on avoiding overburdening hospitals by having the public health infrastructure to divert people exhibiting symptoms, including using public health hotlines to send patients to dedicated testing sites and drive-through testing, rather than have patients presenting to emergency rooms and hospitals. This approach protected medical staff from exposure and allowed the focus to remain on treating severe symptomatic patients.
The vastly different response to the COVID-19 outbreak in these two countries illuminates the need for better preparation in the United States. At the onset of this outbreak, emergency room medical professionals, hospitalists, and outpatient primary care providers did not know how to screen for or treat this virus. Additionally, there was limited information on the most effective contact protocols for medical professionals, patients, and visitors. Finally, the lack of PPE and COVID-19 test kits hindered the U.S. response. Once the country is on the road to recovery from COVID-19, it is imperative to set the groundwork to prepare for future outbreaks and create mechanisms to quickly identify vulnerable populations when outbreaks occur.
Senior care in future infectious disease outbreaks
How can medical providers translate lessons learned from this outbreak into improving the quality of care for seniors? The National Institute on Aging (NIA) maintains a website with information about healthy aging. Seniors and their caregivers can use this website to learn more about chronic diseases, lifestyle modifications, disease prevention, and mental health.
In times of a pandemic, this website provides consistent and accurate information and education. One recommendation for reaching the elderly population during future outbreaks is for NIA to develop and implement strategies to increase the use of the website, including adding more audio and visual interfaces and developing a mobile app. Other recommendations for improving the quality of care for seniors include the following:
1. Identify which populations may be most affected when future outbreaks occur.
2. Consider nontraditional platforms, including social media, for communicating with the general population and for medical providers worldwide to learn from each other about new diseases, including the signs, symptoms, and treatment plans. Some medical professionals created specific WhatsApp groups to communicate, and the World Health Organization sent updated information about COVID-19 to anyone who texted them via WhatsApp.3
3. Create a checklist of signs and symptoms related to current infectious diseases and assess every vulnerable patient.
4. Share these guidelines with medical facilities that treat these populations, such as senior care, assisted living and rehabilitation facilities, hospitals, and outpatient treatment centers. Teach the staff at these medical facilities how to screen patients for signs and symptoms of the disease.
5. Implement social isolation strategies, travel and visitor restrictions, and testing and screening as soon as possible at these medical facilities.
6. Recognize that these strategies may affect the psychological and emotional well-being of seniors, increasing their risk for depression and anxiety and negatively affecting their immunity and mental health. Additionally, the use of PPE, either by the medical providers or the patient, may cause anxiety in seniors and those with mild cognitive impairment.
7. Encourage these medical facilities to improve coping strategies with older patients, such as incorporating communication technology that helps seniors stay connected with their families, and participating in physical and mental exercise, as well as religious activities.
8. Ask these medical facilities to create isolation or quarantine rooms for infected seniors.
9. Work with family members to proactively report to medical professionals any symptoms noticed in their senior relatives. Educate seniors to report symptoms earlier.
10. Offer incentives for medical professionals to conduct on-site testing in primary care offices or senior care facilities instead of sending patients to hospital emergency rooms for evaluation. This will only be effective if there are enough test kits available.
11. Urge insurance companies and Medicare to allow additional medical visits for screening vulnerable populations. Encourage the use of telemedicine in place of in-office visits (preferably billed at the same rate as an in-office visit) where appropriate, especially with nonambulatory patients or those with transportation issues. Many insurance companies, including Medicare, approved COVID-19–related coverage of telemedicine in place of office visits to limit the spread of the disease.
12. Provide community health care and integration and better coordination of local, state, and national health care.
13. Hold regular epidemic and pandemic preparedness exercises in every hospital, nursing home, and assisted living facility.
Proactive health care outreach
It is easier to identify the signs and symptoms of already identified infectious diseases as opposed to a novel one like COVID-19. The United States faced a steep learning curve with COVID-19. Hospitalists and other medical professionals were not able to learn about COVID-19 in a journal. At first, they did not know how to screen patients coming into the ER, how to protect staff, or what the treatment plan was for this new disease. As a result, the medical system experienced disorder and confusion. Investing in community health care and better coordination of local, state, and national health care resources is a priority.
The senior citizen population appears to be most vulnerable to this virus and may be just as vulnerable in future outbreaks. Yet the insights gained from this pandemic can lead to a more comprehensive outreach to senior patients and increased screenings for comorbidities and future contagious diseases. An emphasis on proactive health care and outreach for seniors, with a focus on identifying and treating comorbid conditions, improves the medical care system overall and may prevent or slow future community outbreaks.
Dr. Kasarla is a hospitalist with APOGEE Physicians at Wise Surgical at Parkway in Fort Worth, Tex. He did his internal medicine residency at Mercy Hospital & Medical Center, Chicago. Readers can contact him at madhukarreddy.kasarla@apogeephysicians.com. Dr. Devireddy is a family physician at Positive Health Medical Center, Kingston, Jamaica. Contact him at drjaisheel@gmail.com.
References
1. Pisano GP et al. Lessons from Italy’s response to coronavirus. Harvard Business Review. 2020 Mar 27. https://hbr.org/2020/03/lessons-from-italys-response-to-coronavirus.
2. Tu C. Lessons from Taiwan’s experience with COVID-19. New Atlanticist. 2020 Apr 7. https://atlanticcouncil.org/blogs/new-atlanticist/lessons-from-taiwans-experience-with-covid-19/.
3. Newman LH. WhatsApp is at the center of coronavirus response. WIRED. 2020 Mar 20. https://www.wired.com/story/whatsapp-coronavirus-who-information-app/.
Marijuana for migraine? Some tentative evidence
according to results from a small study conducted at the Jefferson Headache Center at Thomas Jefferson University. The researchers found general satisfaction with medical marijuana, more frequent use as an abortive medication rather than a preventative, and more than two-thirds using the inhaled form rather than oral.
Many patients ask about medical marijuana, but there is relatively little data on its effects on headache. Studies are generally retrospective, and often focus on marijuana use for general pain, with subset analyses looking at headache, according to coauthor Claire Ceriani, MD, who is a headache fellow at Jefferson. “A lot of patients are interested in medical marijuana but don’t know how to integrate it into the therapy plan they already have – whether it should be just to treat bad headaches when they happen, or is it meant to be a preventive medicine they use every day? We have some data out there that it can be helpful, but not a lot of specific information to guide your recommendations,” said Dr. Ceriani in an interview.
Although the research is far from a final word on the subject, it did have some take-home messages, said Dr. Ceriani. “Most people seem to find it effective as an abortive medication that might be able to take the place of some of the prescription medications that they were previously using,” she said.
The study was part of the virtual annual meeting of the American Headache Society.
An effective abortive therapy?
The study began shortly after the Jefferson Headache Center became certified to offer medical marijuana around the beginning of 2019. “We wanted to start keeping track of these patients from the get-go so we’d be able to learn as much as possible from them and help guide the recommendations we give to patients in the future,” said Dr. Ceriani.
The study included 48 patients with migraine or other types of chronic headache who received medical marijuana treatment between January and September 2019. After collecting baseline information from medical records and questionnaires filled out at marijuana treatment initiation, the researchers followed up periodically with telephone questionnaires to assess treatment response and side effects. About half of the participants (56.3%) reported daily headache. 14.6% had posttraumatic headache, 10.4% new daily persistent headache, and 4.2% tension-type headache. Additional symptoms were common, including anxiety (72.9%) and insomnia (62.5%).
A total of 28 subjects completed a follow-up questionnaire over the phone. Out of the 28 participants , 3 had stopped using marijuana. Of 25 subjects who continued use, 71.4% used it two or more times per week, and 25.0% used it every day. Among participants, 50% used a THC-dominant strain of marijuana. Overall, 71.4% used an inhaled form.
Side effects included dry mouth/throat (46.4%), dry/red eyes (35.7%), fatigue/lethargy (35.7%), and increased appetite (35.7%).
Before starting on marijuana, 46.4% of the subjects used abortive medications at least 10 days per month. After starting marijuana treatment, the rate dropped to 25.0%. Marijuana use was associated with improvements in anxiety: 57.1% who had anxiety reported improvement with marijuana use, as did 78.6% with insomnia. On a scale of 10, the average rating of marijuana’s usefulness was 5.9, and 17.9% rated it as 10.
Several concerns
The study has numerous limitations. It has a small sample size, it is from a single center, and the patient population had relatively severe symptoms. Such studies are “fraught with possible bias,” said Andrew Charles, MD, professor of neurology and director of the UCLA Goldberg Migraine Program, when asked to comment.
He pointed out that one key concern for marijuana is concerns over worsening of the condition or refractoriness caused by medication overuse. The cannabinoid receptors it acts on bear some similarity to opioid receptors, and opioid overuse headache is well known. The recent changes in marijuana laws makes it an important issue, one that patients often asked about. But prospective clinical trials face a range of roadblocks: Marijuana remains a controlled substance, it would be difficult to create a placebo control, and no large companies are likely to sponsor such a trial.
“But I think it’s important to keep talking about and developing evidence as much as we can and addressing not just the benefits but also being keenly aware of the possible adverse effects, especially medication overuse,” said Dr. Charles.
The authors also acknowledged the study’s limitations, “but I think there is value, because there are definitely specific patterns we were able to find in terms of what’s helpful for patients, and we also found that a lot of patients also have other disorders in addition to headache, like anxiety and insomnia. And we found that those patients in particular seemed to have more benefit than most with medical marijuana,” said coauthor Angela Hou, MD, who is also a headache fellow at Jefferson.
Dr. Hou and Dr. Ceriani cautioned against use of marijuana in any patient with a substance use disorder, as well as the inhaled form in patients with chronic lung conditions.
The study received no funding. Dr. Ceriani and Dr. Hou had no relevant financial disclosures. Dr. Charles has consulted for Amgen, Biohaven, Eli Lilly, Novartis, and Lundbeck.
SOURCE: Marmura MJ et al. AHS 2020, Abstract 842679.
according to results from a small study conducted at the Jefferson Headache Center at Thomas Jefferson University. The researchers found general satisfaction with medical marijuana, more frequent use as an abortive medication rather than a preventative, and more than two-thirds using the inhaled form rather than oral.
Many patients ask about medical marijuana, but there is relatively little data on its effects on headache. Studies are generally retrospective, and often focus on marijuana use for general pain, with subset analyses looking at headache, according to coauthor Claire Ceriani, MD, who is a headache fellow at Jefferson. “A lot of patients are interested in medical marijuana but don’t know how to integrate it into the therapy plan they already have – whether it should be just to treat bad headaches when they happen, or is it meant to be a preventive medicine they use every day? We have some data out there that it can be helpful, but not a lot of specific information to guide your recommendations,” said Dr. Ceriani in an interview.
Although the research is far from a final word on the subject, it did have some take-home messages, said Dr. Ceriani. “Most people seem to find it effective as an abortive medication that might be able to take the place of some of the prescription medications that they were previously using,” she said.
The study was part of the virtual annual meeting of the American Headache Society.
An effective abortive therapy?
The study began shortly after the Jefferson Headache Center became certified to offer medical marijuana around the beginning of 2019. “We wanted to start keeping track of these patients from the get-go so we’d be able to learn as much as possible from them and help guide the recommendations we give to patients in the future,” said Dr. Ceriani.
The study included 48 patients with migraine or other types of chronic headache who received medical marijuana treatment between January and September 2019. After collecting baseline information from medical records and questionnaires filled out at marijuana treatment initiation, the researchers followed up periodically with telephone questionnaires to assess treatment response and side effects. About half of the participants (56.3%) reported daily headache. 14.6% had posttraumatic headache, 10.4% new daily persistent headache, and 4.2% tension-type headache. Additional symptoms were common, including anxiety (72.9%) and insomnia (62.5%).
A total of 28 subjects completed a follow-up questionnaire over the phone. Out of the 28 participants , 3 had stopped using marijuana. Of 25 subjects who continued use, 71.4% used it two or more times per week, and 25.0% used it every day. Among participants, 50% used a THC-dominant strain of marijuana. Overall, 71.4% used an inhaled form.
Side effects included dry mouth/throat (46.4%), dry/red eyes (35.7%), fatigue/lethargy (35.7%), and increased appetite (35.7%).
Before starting on marijuana, 46.4% of the subjects used abortive medications at least 10 days per month. After starting marijuana treatment, the rate dropped to 25.0%. Marijuana use was associated with improvements in anxiety: 57.1% who had anxiety reported improvement with marijuana use, as did 78.6% with insomnia. On a scale of 10, the average rating of marijuana’s usefulness was 5.9, and 17.9% rated it as 10.
Several concerns
The study has numerous limitations. It has a small sample size, it is from a single center, and the patient population had relatively severe symptoms. Such studies are “fraught with possible bias,” said Andrew Charles, MD, professor of neurology and director of the UCLA Goldberg Migraine Program, when asked to comment.
He pointed out that one key concern for marijuana is concerns over worsening of the condition or refractoriness caused by medication overuse. The cannabinoid receptors it acts on bear some similarity to opioid receptors, and opioid overuse headache is well known. The recent changes in marijuana laws makes it an important issue, one that patients often asked about. But prospective clinical trials face a range of roadblocks: Marijuana remains a controlled substance, it would be difficult to create a placebo control, and no large companies are likely to sponsor such a trial.
“But I think it’s important to keep talking about and developing evidence as much as we can and addressing not just the benefits but also being keenly aware of the possible adverse effects, especially medication overuse,” said Dr. Charles.
The authors also acknowledged the study’s limitations, “but I think there is value, because there are definitely specific patterns we were able to find in terms of what’s helpful for patients, and we also found that a lot of patients also have other disorders in addition to headache, like anxiety and insomnia. And we found that those patients in particular seemed to have more benefit than most with medical marijuana,” said coauthor Angela Hou, MD, who is also a headache fellow at Jefferson.
Dr. Hou and Dr. Ceriani cautioned against use of marijuana in any patient with a substance use disorder, as well as the inhaled form in patients with chronic lung conditions.
The study received no funding. Dr. Ceriani and Dr. Hou had no relevant financial disclosures. Dr. Charles has consulted for Amgen, Biohaven, Eli Lilly, Novartis, and Lundbeck.
SOURCE: Marmura MJ et al. AHS 2020, Abstract 842679.
according to results from a small study conducted at the Jefferson Headache Center at Thomas Jefferson University. The researchers found general satisfaction with medical marijuana, more frequent use as an abortive medication rather than a preventative, and more than two-thirds using the inhaled form rather than oral.
Many patients ask about medical marijuana, but there is relatively little data on its effects on headache. Studies are generally retrospective, and often focus on marijuana use for general pain, with subset analyses looking at headache, according to coauthor Claire Ceriani, MD, who is a headache fellow at Jefferson. “A lot of patients are interested in medical marijuana but don’t know how to integrate it into the therapy plan they already have – whether it should be just to treat bad headaches when they happen, or is it meant to be a preventive medicine they use every day? We have some data out there that it can be helpful, but not a lot of specific information to guide your recommendations,” said Dr. Ceriani in an interview.
Although the research is far from a final word on the subject, it did have some take-home messages, said Dr. Ceriani. “Most people seem to find it effective as an abortive medication that might be able to take the place of some of the prescription medications that they were previously using,” she said.
The study was part of the virtual annual meeting of the American Headache Society.
An effective abortive therapy?
The study began shortly after the Jefferson Headache Center became certified to offer medical marijuana around the beginning of 2019. “We wanted to start keeping track of these patients from the get-go so we’d be able to learn as much as possible from them and help guide the recommendations we give to patients in the future,” said Dr. Ceriani.
The study included 48 patients with migraine or other types of chronic headache who received medical marijuana treatment between January and September 2019. After collecting baseline information from medical records and questionnaires filled out at marijuana treatment initiation, the researchers followed up periodically with telephone questionnaires to assess treatment response and side effects. About half of the participants (56.3%) reported daily headache. 14.6% had posttraumatic headache, 10.4% new daily persistent headache, and 4.2% tension-type headache. Additional symptoms were common, including anxiety (72.9%) and insomnia (62.5%).
A total of 28 subjects completed a follow-up questionnaire over the phone. Out of the 28 participants , 3 had stopped using marijuana. Of 25 subjects who continued use, 71.4% used it two or more times per week, and 25.0% used it every day. Among participants, 50% used a THC-dominant strain of marijuana. Overall, 71.4% used an inhaled form.
Side effects included dry mouth/throat (46.4%), dry/red eyes (35.7%), fatigue/lethargy (35.7%), and increased appetite (35.7%).
Before starting on marijuana, 46.4% of the subjects used abortive medications at least 10 days per month. After starting marijuana treatment, the rate dropped to 25.0%. Marijuana use was associated with improvements in anxiety: 57.1% who had anxiety reported improvement with marijuana use, as did 78.6% with insomnia. On a scale of 10, the average rating of marijuana’s usefulness was 5.9, and 17.9% rated it as 10.
Several concerns
The study has numerous limitations. It has a small sample size, it is from a single center, and the patient population had relatively severe symptoms. Such studies are “fraught with possible bias,” said Andrew Charles, MD, professor of neurology and director of the UCLA Goldberg Migraine Program, when asked to comment.
He pointed out that one key concern for marijuana is concerns over worsening of the condition or refractoriness caused by medication overuse. The cannabinoid receptors it acts on bear some similarity to opioid receptors, and opioid overuse headache is well known. The recent changes in marijuana laws makes it an important issue, one that patients often asked about. But prospective clinical trials face a range of roadblocks: Marijuana remains a controlled substance, it would be difficult to create a placebo control, and no large companies are likely to sponsor such a trial.
“But I think it’s important to keep talking about and developing evidence as much as we can and addressing not just the benefits but also being keenly aware of the possible adverse effects, especially medication overuse,” said Dr. Charles.
The authors also acknowledged the study’s limitations, “but I think there is value, because there are definitely specific patterns we were able to find in terms of what’s helpful for patients, and we also found that a lot of patients also have other disorders in addition to headache, like anxiety and insomnia. And we found that those patients in particular seemed to have more benefit than most with medical marijuana,” said coauthor Angela Hou, MD, who is also a headache fellow at Jefferson.
Dr. Hou and Dr. Ceriani cautioned against use of marijuana in any patient with a substance use disorder, as well as the inhaled form in patients with chronic lung conditions.
The study received no funding. Dr. Ceriani and Dr. Hou had no relevant financial disclosures. Dr. Charles has consulted for Amgen, Biohaven, Eli Lilly, Novartis, and Lundbeck.
SOURCE: Marmura MJ et al. AHS 2020, Abstract 842679.
FROM AHS 2020
A tribute to Edward Ross Ritvo, MD, 1930-2020
Reflections on loss amid COVID-19
I sit here on Father’s Day during a global pandemic and can’t help but think of Mark Twain’s quote, “Truth is stranger than fiction.” Isn’t that what calls us to our profession? When friends ask if I have watched a particular movie or TV show, I almost always say no. Why would I? Day after day at “work” I am hearing the most remarkable stories – many unfolding right before my eyes.
My Dad’s story is no less remarkable. As he was a pioneer in our field, I hope you will allow me to share a few recollections.
June 10, just 10 days after turning 90, Dad died peacefully in his home. His obituary, written by James McCracken, MD, says: “He was an internationally known child psychiatrist who, with colleagues, formed the vanguard of UCLA researchers establishing the biomedical basis of autism in the 1960s despite the prevailing psychological theories of the day ... who would later break new ground in identifying the role of genetics, sleep, and neurophysiological differences, perinatal risk factors, and biomarkers relating to autism and autism risk.”
Dad had extensive training in psychoanalysis and worked hard to maintain expertise in both the psychological and biological arenas. While he helped established autism as a neurologic disease and advocated for DSM criteria changes, he continued teaching Psychodynamic Theory of Personality to the UCLA medical students and maintained a clinical practice based in psychotherapeutic techniques. He was practicing biopsychosocial medicine long before the concept was articulated.
He conducted the first epidemiologic survey of autism in the state of Utah. He chose Utah because the Mormons keep perfect genealogical records. He identified multiple families with more than one child affected as well as examining, pre-, peri-, and postnatal factors affecting these families. Being a maverick has its challenges. One paper about parents with mild autism was rejected from publication seven times before a watered-down version of clinical vignettes finally got accepted. In collaboration with his wife, Riva Ariella Ritvo, he developed the Ritvo Autism Asperger Diagnostic Scale–Revised, (RAADS-R) still in use today.
Dad’s career was complicated by medical issues beginning in his 40s when he had a near-fatal heart attack at the top of Mammoth Mountain while skiing. After struggling for 20 years, he ultimately had a heart transplant at Cedars-Sinai Medical Center at 69 years old. Months after the transplant, he was back at work. He was unstoppable and maintained his optimism and great sense of humor throughout this complicated ordeal. He always remembered his commitment to his donor and his new heart, and worked out every day. Living to 90 was against all the odds.
Dad also persevered throughout his youngest son’s 10-year battle with Ewing’s sarcoma. Despite losing Max in 2016, Dad was active in research and clinical practice until the very end. He was doing telepsychiatry with patients in prisons and rehabilitation hospitals the last few years because he was too weak to travel to an office. He continued his research, and his last paper on eye movement responses as a possible biological marker of autism was published in February 2020.
Although Dad did not have COVID-19, the social isolation and stress of the last few months hastened his decline. The last week in the hospital with no visitors was too much for such a social man, and he died days after he was discharged. Always a trailblazer, Dad’s Zoom funeral was watched across the country by his children, grandchildren, extended family, and friends. Choosing to honor his wish to be cautious in this pandemic, we remained sheltering in place.
As Dad was the ultimate professor, I know he would want us to learn from his life and his passing. We are in an accelerated growth phase now as our lives and the lives of our patients are radically altered.
I hope, like Dad, we can choose to feel nourished by our meaningful work as we travel through life’s ups and downs. We must learn new ways to care for ourselves, our families, and our patients during these challenging times. We must find ways to mourn and celebrate those lost during the pandemic.
I know Dad would love synchronicity that I spent Father’s Day writing about him for Clinical Psychiatry News! Thank you for giving me this gift of reflection on this special day.
Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018) and is the founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world. Dr. Ritvo also is the cofounder of the Bold Beauty Project, a nonprofit group that pairs women with disabilities with photographers who create art exhibitions to raise awareness.
Reflections on loss amid COVID-19
Reflections on loss amid COVID-19
I sit here on Father’s Day during a global pandemic and can’t help but think of Mark Twain’s quote, “Truth is stranger than fiction.” Isn’t that what calls us to our profession? When friends ask if I have watched a particular movie or TV show, I almost always say no. Why would I? Day after day at “work” I am hearing the most remarkable stories – many unfolding right before my eyes.
My Dad’s story is no less remarkable. As he was a pioneer in our field, I hope you will allow me to share a few recollections.
June 10, just 10 days after turning 90, Dad died peacefully in his home. His obituary, written by James McCracken, MD, says: “He was an internationally known child psychiatrist who, with colleagues, formed the vanguard of UCLA researchers establishing the biomedical basis of autism in the 1960s despite the prevailing psychological theories of the day ... who would later break new ground in identifying the role of genetics, sleep, and neurophysiological differences, perinatal risk factors, and biomarkers relating to autism and autism risk.”
Dad had extensive training in psychoanalysis and worked hard to maintain expertise in both the psychological and biological arenas. While he helped established autism as a neurologic disease and advocated for DSM criteria changes, he continued teaching Psychodynamic Theory of Personality to the UCLA medical students and maintained a clinical practice based in psychotherapeutic techniques. He was practicing biopsychosocial medicine long before the concept was articulated.
He conducted the first epidemiologic survey of autism in the state of Utah. He chose Utah because the Mormons keep perfect genealogical records. He identified multiple families with more than one child affected as well as examining, pre-, peri-, and postnatal factors affecting these families. Being a maverick has its challenges. One paper about parents with mild autism was rejected from publication seven times before a watered-down version of clinical vignettes finally got accepted. In collaboration with his wife, Riva Ariella Ritvo, he developed the Ritvo Autism Asperger Diagnostic Scale–Revised, (RAADS-R) still in use today.
Dad’s career was complicated by medical issues beginning in his 40s when he had a near-fatal heart attack at the top of Mammoth Mountain while skiing. After struggling for 20 years, he ultimately had a heart transplant at Cedars-Sinai Medical Center at 69 years old. Months after the transplant, he was back at work. He was unstoppable and maintained his optimism and great sense of humor throughout this complicated ordeal. He always remembered his commitment to his donor and his new heart, and worked out every day. Living to 90 was against all the odds.
Dad also persevered throughout his youngest son’s 10-year battle with Ewing’s sarcoma. Despite losing Max in 2016, Dad was active in research and clinical practice until the very end. He was doing telepsychiatry with patients in prisons and rehabilitation hospitals the last few years because he was too weak to travel to an office. He continued his research, and his last paper on eye movement responses as a possible biological marker of autism was published in February 2020.
Although Dad did not have COVID-19, the social isolation and stress of the last few months hastened his decline. The last week in the hospital with no visitors was too much for such a social man, and he died days after he was discharged. Always a trailblazer, Dad’s Zoom funeral was watched across the country by his children, grandchildren, extended family, and friends. Choosing to honor his wish to be cautious in this pandemic, we remained sheltering in place.
As Dad was the ultimate professor, I know he would want us to learn from his life and his passing. We are in an accelerated growth phase now as our lives and the lives of our patients are radically altered.
I hope, like Dad, we can choose to feel nourished by our meaningful work as we travel through life’s ups and downs. We must learn new ways to care for ourselves, our families, and our patients during these challenging times. We must find ways to mourn and celebrate those lost during the pandemic.
I know Dad would love synchronicity that I spent Father’s Day writing about him for Clinical Psychiatry News! Thank you for giving me this gift of reflection on this special day.
Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018) and is the founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world. Dr. Ritvo also is the cofounder of the Bold Beauty Project, a nonprofit group that pairs women with disabilities with photographers who create art exhibitions to raise awareness.
I sit here on Father’s Day during a global pandemic and can’t help but think of Mark Twain’s quote, “Truth is stranger than fiction.” Isn’t that what calls us to our profession? When friends ask if I have watched a particular movie or TV show, I almost always say no. Why would I? Day after day at “work” I am hearing the most remarkable stories – many unfolding right before my eyes.
My Dad’s story is no less remarkable. As he was a pioneer in our field, I hope you will allow me to share a few recollections.
June 10, just 10 days after turning 90, Dad died peacefully in his home. His obituary, written by James McCracken, MD, says: “He was an internationally known child psychiatrist who, with colleagues, formed the vanguard of UCLA researchers establishing the biomedical basis of autism in the 1960s despite the prevailing psychological theories of the day ... who would later break new ground in identifying the role of genetics, sleep, and neurophysiological differences, perinatal risk factors, and biomarkers relating to autism and autism risk.”
Dad had extensive training in psychoanalysis and worked hard to maintain expertise in both the psychological and biological arenas. While he helped established autism as a neurologic disease and advocated for DSM criteria changes, he continued teaching Psychodynamic Theory of Personality to the UCLA medical students and maintained a clinical practice based in psychotherapeutic techniques. He was practicing biopsychosocial medicine long before the concept was articulated.
He conducted the first epidemiologic survey of autism in the state of Utah. He chose Utah because the Mormons keep perfect genealogical records. He identified multiple families with more than one child affected as well as examining, pre-, peri-, and postnatal factors affecting these families. Being a maverick has its challenges. One paper about parents with mild autism was rejected from publication seven times before a watered-down version of clinical vignettes finally got accepted. In collaboration with his wife, Riva Ariella Ritvo, he developed the Ritvo Autism Asperger Diagnostic Scale–Revised, (RAADS-R) still in use today.
Dad’s career was complicated by medical issues beginning in his 40s when he had a near-fatal heart attack at the top of Mammoth Mountain while skiing. After struggling for 20 years, he ultimately had a heart transplant at Cedars-Sinai Medical Center at 69 years old. Months after the transplant, he was back at work. He was unstoppable and maintained his optimism and great sense of humor throughout this complicated ordeal. He always remembered his commitment to his donor and his new heart, and worked out every day. Living to 90 was against all the odds.
Dad also persevered throughout his youngest son’s 10-year battle with Ewing’s sarcoma. Despite losing Max in 2016, Dad was active in research and clinical practice until the very end. He was doing telepsychiatry with patients in prisons and rehabilitation hospitals the last few years because he was too weak to travel to an office. He continued his research, and his last paper on eye movement responses as a possible biological marker of autism was published in February 2020.
Although Dad did not have COVID-19, the social isolation and stress of the last few months hastened his decline. The last week in the hospital with no visitors was too much for such a social man, and he died days after he was discharged. Always a trailblazer, Dad’s Zoom funeral was watched across the country by his children, grandchildren, extended family, and friends. Choosing to honor his wish to be cautious in this pandemic, we remained sheltering in place.
As Dad was the ultimate professor, I know he would want us to learn from his life and his passing. We are in an accelerated growth phase now as our lives and the lives of our patients are radically altered.
I hope, like Dad, we can choose to feel nourished by our meaningful work as we travel through life’s ups and downs. We must learn new ways to care for ourselves, our families, and our patients during these challenging times. We must find ways to mourn and celebrate those lost during the pandemic.
I know Dad would love synchronicity that I spent Father’s Day writing about him for Clinical Psychiatry News! Thank you for giving me this gift of reflection on this special day.
Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018) and is the founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world. Dr. Ritvo also is the cofounder of the Bold Beauty Project, a nonprofit group that pairs women with disabilities with photographers who create art exhibitions to raise awareness.
Women thrive on baroreflex activation for heart failure
The striking gains in functional capacity and quality of life conferred by baroreflex activation therapy in patients with heart failure, as shown in the pivotal phase 3 clinical trial for this novel intervention, were at least as great in women as in men, JoAnn Lindenfeld, MD, said at the European Society of Cardiology Heart Failure Discoveries virtual meeting.
The results of the multicenter, prospective, randomized BeAT-HF trial led to marketing approval of the BaroStim Neo system for improvement in symptoms of heart failure with reduced ejection fraction (HFrEF) by the Food and Drug Administration in August 2019. Dr. Lindenfeld presented a fresh breakdown of the results by gender which showed, intriguingly, that the improvement in all study endpoints was consistently numerically greater in the women – sometimes startlingly so – although these gender differences in response didn’t achieve statistical significance. The 6-month randomized trial was underpowered for drawing definitive conclusions on that score, with a study population of only 53 women and 211 men. So the investigator remained circumspect.
“We think that what this study shows us is that women have at least equivalent improvement as men in this population. I don’t think we can conclude from this study yet that it’s better, but it’s certainly in all these parameters as least as good. And I think this is a population in which we’ve seen that improving symptoms and functional capacity is very important,” said Dr. Lindenfeld, professor of medicine and director of advanced heart failure/cardiac transplantation at Vanderbilt University, Nashville, Tenn.
The FDA approval was restricted to patients like those enrolled in BeAT-HF: that is, individuals with New York Heart Association functional class III heart failure, a left ventricular ejection fraction of 35% or less while on stable optimal medical therapy, and ineligibility for cardiac resynchronization therapy according to current guidelines. Seventy-eight percent of BeAT-HF participants had an implantable cardioverter-defibrillator.
Participants were randomized to baroreflex activation therapy (BAT) plus optimal medical therapy or to optimal medical therapy alone. The three coprimary endpoints were change from baseline to 6 months in 6-minute hall walk distance (6MHW), scores on the Minnesota Living with Heart Failure Questionnaire (MLHF), and N-terminal pro-B-type natriuretic peptide (NT-proBNP).
In the overall study population, 6MHW increased by 60 m in the BAT group and decreased by 8 m in controls; MLHF scores dropped by 14 and 6 points, respectively; and NT-proBNP fell by an average of 25% with BAT while rising by 3% in controls.
Very often, just a 5-point reduction in MLHF score is considered a clinically meaningful improvement in quality of life, the cardiologist noted.
The gender-based analysis is where things got particularly interesting.
The investigators defined a clinically relevant response as a greater than 10% increase from baseline on the 6MHW, at least a one-class improvement in NYHA class, or a reduction of 5 points or more on the MLHF. Among subjects in the BAT group, 70% of women and 60% of men met the clinically relevant response standard in terms of 6MHW, as did 70% of women and 64% of men for improvement in NYHA class, and 78% of women and 66% of men for MLHF score.
Eighty-seven percent of women and 68% of men on BAT had a clinically relevant response on at least one of these endpoints, as did about 28% of controls. Moreover, 31% of women in the BAT group were clinically relevant responders on at least two endpoints, compared with 19% of BAT men and 4% and 9% of controls.
Women dominate super-responder category
In order to be classified as a super responder, a patient had to demonstrate a greater than 20% increase in 6MHW, improvement in NYHA class I status, or at least a 10-point improvement in MLHF score. Ninety-one percent of women on BAT achieved super-responder status for at least one of these endpoints, compared with 76% of men. Forty-three percent of women and 24% of men in the BAT group were super responders in at least two domains, as were 8% and 11% of female and male controls, Dr. Lindenfeld continued.
Discussant Ewa Anita Jankowska, MD, PhD, deemed the BeAT-HF results on the therapeutic benefits of this autonomic modulation strategy “quite convincing.”
“We need to acknowledge that in recent years we have been spoiled a bit by the huge trials in heart failure where the ultimate goal was a reduction in mortality. But I think this is the time when we should think about the patients who want to live – here, now – with a better life. Patients expect symptomatic benefits. There is a substantial group of patients who are symptomatic even though they receive quite extensive neurohormonal blockage and who are not suitable for CRT. This study demonstrates that, for this group of patients, BAT can bring really significant symptomatic benefits,” she said.
“If you think about a treatment that provides patients who are NYHA class III an increase in 6MHW of 60 meters, that’s really something. And 20% of patients went from NYHA class III to class I – that’s really something, too,” added Dr. Jankowska, professor of medicine and head of the laboratory of applied research on the cardiovascular system at Wroclaw (Poland) University.
How baroreflex activation therapy works
The BaroStim system consists of a 2-mm unipolar electrode on a 7-mm backer that is placed over the carotid sinus. It is supported by a small generator with a 4- to 5-year battery life implanted under the collarbone, along with radiofrequency telemetry capability and programming flexibility.
Stimulation of the carotid baroreceptor promotes an integrated autonomic nervous system response which enhances parasympathetic activity and inhibits sympathetic nervous system activity. The result, as shown in numerous earlier proof-of-concept studies, is a reduced heart rate, decreased ventricular remodeling, enhanced diuresis, increased vasodilation, a drop in elevated blood pressure, and decreased renin secretion – all achieved nonpharmacologically.
The study was sponsored by CVRx. Dr. Lindenfeld reported serving as a consultant to CVRx, Abbott, AstraZeneca, Boehringer Ingelheim, Edwards Lifesciences, Impulse Dynamics, and VWave.
The striking gains in functional capacity and quality of life conferred by baroreflex activation therapy in patients with heart failure, as shown in the pivotal phase 3 clinical trial for this novel intervention, were at least as great in women as in men, JoAnn Lindenfeld, MD, said at the European Society of Cardiology Heart Failure Discoveries virtual meeting.
The results of the multicenter, prospective, randomized BeAT-HF trial led to marketing approval of the BaroStim Neo system for improvement in symptoms of heart failure with reduced ejection fraction (HFrEF) by the Food and Drug Administration in August 2019. Dr. Lindenfeld presented a fresh breakdown of the results by gender which showed, intriguingly, that the improvement in all study endpoints was consistently numerically greater in the women – sometimes startlingly so – although these gender differences in response didn’t achieve statistical significance. The 6-month randomized trial was underpowered for drawing definitive conclusions on that score, with a study population of only 53 women and 211 men. So the investigator remained circumspect.
“We think that what this study shows us is that women have at least equivalent improvement as men in this population. I don’t think we can conclude from this study yet that it’s better, but it’s certainly in all these parameters as least as good. And I think this is a population in which we’ve seen that improving symptoms and functional capacity is very important,” said Dr. Lindenfeld, professor of medicine and director of advanced heart failure/cardiac transplantation at Vanderbilt University, Nashville, Tenn.
The FDA approval was restricted to patients like those enrolled in BeAT-HF: that is, individuals with New York Heart Association functional class III heart failure, a left ventricular ejection fraction of 35% or less while on stable optimal medical therapy, and ineligibility for cardiac resynchronization therapy according to current guidelines. Seventy-eight percent of BeAT-HF participants had an implantable cardioverter-defibrillator.
Participants were randomized to baroreflex activation therapy (BAT) plus optimal medical therapy or to optimal medical therapy alone. The three coprimary endpoints were change from baseline to 6 months in 6-minute hall walk distance (6MHW), scores on the Minnesota Living with Heart Failure Questionnaire (MLHF), and N-terminal pro-B-type natriuretic peptide (NT-proBNP).
In the overall study population, 6MHW increased by 60 m in the BAT group and decreased by 8 m in controls; MLHF scores dropped by 14 and 6 points, respectively; and NT-proBNP fell by an average of 25% with BAT while rising by 3% in controls.
Very often, just a 5-point reduction in MLHF score is considered a clinically meaningful improvement in quality of life, the cardiologist noted.
The gender-based analysis is where things got particularly interesting.
The investigators defined a clinically relevant response as a greater than 10% increase from baseline on the 6MHW, at least a one-class improvement in NYHA class, or a reduction of 5 points or more on the MLHF. Among subjects in the BAT group, 70% of women and 60% of men met the clinically relevant response standard in terms of 6MHW, as did 70% of women and 64% of men for improvement in NYHA class, and 78% of women and 66% of men for MLHF score.
Eighty-seven percent of women and 68% of men on BAT had a clinically relevant response on at least one of these endpoints, as did about 28% of controls. Moreover, 31% of women in the BAT group were clinically relevant responders on at least two endpoints, compared with 19% of BAT men and 4% and 9% of controls.
Women dominate super-responder category
In order to be classified as a super responder, a patient had to demonstrate a greater than 20% increase in 6MHW, improvement in NYHA class I status, or at least a 10-point improvement in MLHF score. Ninety-one percent of women on BAT achieved super-responder status for at least one of these endpoints, compared with 76% of men. Forty-three percent of women and 24% of men in the BAT group were super responders in at least two domains, as were 8% and 11% of female and male controls, Dr. Lindenfeld continued.
Discussant Ewa Anita Jankowska, MD, PhD, deemed the BeAT-HF results on the therapeutic benefits of this autonomic modulation strategy “quite convincing.”
“We need to acknowledge that in recent years we have been spoiled a bit by the huge trials in heart failure where the ultimate goal was a reduction in mortality. But I think this is the time when we should think about the patients who want to live – here, now – with a better life. Patients expect symptomatic benefits. There is a substantial group of patients who are symptomatic even though they receive quite extensive neurohormonal blockage and who are not suitable for CRT. This study demonstrates that, for this group of patients, BAT can bring really significant symptomatic benefits,” she said.
“If you think about a treatment that provides patients who are NYHA class III an increase in 6MHW of 60 meters, that’s really something. And 20% of patients went from NYHA class III to class I – that’s really something, too,” added Dr. Jankowska, professor of medicine and head of the laboratory of applied research on the cardiovascular system at Wroclaw (Poland) University.
How baroreflex activation therapy works
The BaroStim system consists of a 2-mm unipolar electrode on a 7-mm backer that is placed over the carotid sinus. It is supported by a small generator with a 4- to 5-year battery life implanted under the collarbone, along with radiofrequency telemetry capability and programming flexibility.
Stimulation of the carotid baroreceptor promotes an integrated autonomic nervous system response which enhances parasympathetic activity and inhibits sympathetic nervous system activity. The result, as shown in numerous earlier proof-of-concept studies, is a reduced heart rate, decreased ventricular remodeling, enhanced diuresis, increased vasodilation, a drop in elevated blood pressure, and decreased renin secretion – all achieved nonpharmacologically.
The study was sponsored by CVRx. Dr. Lindenfeld reported serving as a consultant to CVRx, Abbott, AstraZeneca, Boehringer Ingelheim, Edwards Lifesciences, Impulse Dynamics, and VWave.
The striking gains in functional capacity and quality of life conferred by baroreflex activation therapy in patients with heart failure, as shown in the pivotal phase 3 clinical trial for this novel intervention, were at least as great in women as in men, JoAnn Lindenfeld, MD, said at the European Society of Cardiology Heart Failure Discoveries virtual meeting.
The results of the multicenter, prospective, randomized BeAT-HF trial led to marketing approval of the BaroStim Neo system for improvement in symptoms of heart failure with reduced ejection fraction (HFrEF) by the Food and Drug Administration in August 2019. Dr. Lindenfeld presented a fresh breakdown of the results by gender which showed, intriguingly, that the improvement in all study endpoints was consistently numerically greater in the women – sometimes startlingly so – although these gender differences in response didn’t achieve statistical significance. The 6-month randomized trial was underpowered for drawing definitive conclusions on that score, with a study population of only 53 women and 211 men. So the investigator remained circumspect.
“We think that what this study shows us is that women have at least equivalent improvement as men in this population. I don’t think we can conclude from this study yet that it’s better, but it’s certainly in all these parameters as least as good. And I think this is a population in which we’ve seen that improving symptoms and functional capacity is very important,” said Dr. Lindenfeld, professor of medicine and director of advanced heart failure/cardiac transplantation at Vanderbilt University, Nashville, Tenn.
The FDA approval was restricted to patients like those enrolled in BeAT-HF: that is, individuals with New York Heart Association functional class III heart failure, a left ventricular ejection fraction of 35% or less while on stable optimal medical therapy, and ineligibility for cardiac resynchronization therapy according to current guidelines. Seventy-eight percent of BeAT-HF participants had an implantable cardioverter-defibrillator.
Participants were randomized to baroreflex activation therapy (BAT) plus optimal medical therapy or to optimal medical therapy alone. The three coprimary endpoints were change from baseline to 6 months in 6-minute hall walk distance (6MHW), scores on the Minnesota Living with Heart Failure Questionnaire (MLHF), and N-terminal pro-B-type natriuretic peptide (NT-proBNP).
In the overall study population, 6MHW increased by 60 m in the BAT group and decreased by 8 m in controls; MLHF scores dropped by 14 and 6 points, respectively; and NT-proBNP fell by an average of 25% with BAT while rising by 3% in controls.
Very often, just a 5-point reduction in MLHF score is considered a clinically meaningful improvement in quality of life, the cardiologist noted.
The gender-based analysis is where things got particularly interesting.
The investigators defined a clinically relevant response as a greater than 10% increase from baseline on the 6MHW, at least a one-class improvement in NYHA class, or a reduction of 5 points or more on the MLHF. Among subjects in the BAT group, 70% of women and 60% of men met the clinically relevant response standard in terms of 6MHW, as did 70% of women and 64% of men for improvement in NYHA class, and 78% of women and 66% of men for MLHF score.
Eighty-seven percent of women and 68% of men on BAT had a clinically relevant response on at least one of these endpoints, as did about 28% of controls. Moreover, 31% of women in the BAT group were clinically relevant responders on at least two endpoints, compared with 19% of BAT men and 4% and 9% of controls.
Women dominate super-responder category
In order to be classified as a super responder, a patient had to demonstrate a greater than 20% increase in 6MHW, improvement in NYHA class I status, or at least a 10-point improvement in MLHF score. Ninety-one percent of women on BAT achieved super-responder status for at least one of these endpoints, compared with 76% of men. Forty-three percent of women and 24% of men in the BAT group were super responders in at least two domains, as were 8% and 11% of female and male controls, Dr. Lindenfeld continued.
Discussant Ewa Anita Jankowska, MD, PhD, deemed the BeAT-HF results on the therapeutic benefits of this autonomic modulation strategy “quite convincing.”
“We need to acknowledge that in recent years we have been spoiled a bit by the huge trials in heart failure where the ultimate goal was a reduction in mortality. But I think this is the time when we should think about the patients who want to live – here, now – with a better life. Patients expect symptomatic benefits. There is a substantial group of patients who are symptomatic even though they receive quite extensive neurohormonal blockage and who are not suitable for CRT. This study demonstrates that, for this group of patients, BAT can bring really significant symptomatic benefits,” she said.
“If you think about a treatment that provides patients who are NYHA class III an increase in 6MHW of 60 meters, that’s really something. And 20% of patients went from NYHA class III to class I – that’s really something, too,” added Dr. Jankowska, professor of medicine and head of the laboratory of applied research on the cardiovascular system at Wroclaw (Poland) University.
How baroreflex activation therapy works
The BaroStim system consists of a 2-mm unipolar electrode on a 7-mm backer that is placed over the carotid sinus. It is supported by a small generator with a 4- to 5-year battery life implanted under the collarbone, along with radiofrequency telemetry capability and programming flexibility.
Stimulation of the carotid baroreceptor promotes an integrated autonomic nervous system response which enhances parasympathetic activity and inhibits sympathetic nervous system activity. The result, as shown in numerous earlier proof-of-concept studies, is a reduced heart rate, decreased ventricular remodeling, enhanced diuresis, increased vasodilation, a drop in elevated blood pressure, and decreased renin secretion – all achieved nonpharmacologically.
The study was sponsored by CVRx. Dr. Lindenfeld reported serving as a consultant to CVRx, Abbott, AstraZeneca, Boehringer Ingelheim, Edwards Lifesciences, Impulse Dynamics, and VWave.
FROM ESC HEART FAILURE 2020
Inside Mercy’s mission to care for non-COVID patients in Los Angeles
When the hospital ship USNS Mercy departed San Diego’s Naval Station North Island on March 23, 2020, to support the Department of Defense efforts in Los Angeles during the coronavirus outbreak, Commander Erin Blevins remembers the crew’s excitement was palpable.
“We normally do partnerships abroad and respond to tsunamis and earthquakes,” said Cdr. Blevins, MD, a pediatric hematologist-oncologist who served as director of medical services for the mission. “This was a slight change in situation, but still disaster relief in the form of a pandemic. We switched our mindset to putting together the best experts for an infectious disease pandemic versus an earthquake disaster relief.”
A new mission
The 1,000-bed Mercy ship – a converted San Clemente–class oil tanker that was delivered in 1986 – spent nearly 50 days pier side in Los Angeles as a referral hospital for non–COVID-19 patients, so that clinicians at Los Angeles area hospitals could care for an anticipated surge of COVID-19 patients. “We went into it with expectations of, ‘We’ll treat as many patients as you need us to take,” Cdr. Blevins recalled. “I don’t even think Los Angeles [health officials] knew exactly where they were going to peak and what the need was going to be.”
Between March 29 and May 15, about 1,071 medical personnel aboard the Mercy cared for 77 patients with an average age of 53 years who were referred from 11 Los Angeles area hospitals. The physicians, nurses, and other medical support personnel were drawn from military treatment facilities across the country. “We had additional people join us as we scoped the mission to be more medically heavy and surgically light,” said Captain John Rotruck, MD, an anesthesiologist who is commanding officer of Mercy’s medical treatment facility. “We did adjust to make sure that we had the right staffing mix to meet the parameters that we were assigned. That was the crux of the change: a change in flavors of staffing to ensure that we focused on ICU and ward medical care as opposed to very heavy surgical care in support of a combat operation.”
About 10% of the team consisted of reservists who volunteered for the mission. “There’s no way you could have walked around the ship and known who was active duty and who was reservist,” said Capt. Rotruck, who was formerly chief of staff at Walter Reed National Military Medical Center, Bethesda, Md. “They worked together so well, and I think that marriage of active duty who are used to working in a military medical treatment facility – in our case, a Navy medical treatment facility – together with our reservist physician colleagues who work in civilian facilities around the country, was beneficial. It was a synergistic relationship. I think both sides walked away learning quite a bit from each other.”
Start with screening
All crew members underwent a temperature check and completed a health screening questionnaire: once before departing their home of record and again before boarding Mercy. Based on those results, crew members and medical staff were screened for COVID-19 and tested as needed in order to minimize the risk of an outbreak aboard the ship.
Fewer than 1% of crew members developed COVID-19 or tested positive for the virus during the mission, according to Capt. Rotruck. Affected individuals were isolated and quarantined. “All staff have recovered and are doing well,” he said.
Mercy personnel worked with local health officials to ensure that all patients transferred to the ship tested negative for COVID-19. Physicians aboard the Mercy then worked directly with the patients’ civilian physician to ensure a safe and thorough turnover process before the patients were transferred.
From basic medical to trauma care
Care aboard the ship, which consists of open-bay medical wards, ranged from basic medical and surgical care to critical care and trauma. The most common procedures were cholecystectomies and orthopedic procedures, and the average length of stay was 4-5 days, according to Cdr. Blevins. Over the course of the mission, the medical professionals conducted 36 surgeries, 77 x-ray exams, 26 CT scans, and administered hundreds of ancillary studies ranging from routine labs to high-end x-rays and blood transfusion support.
“Within our ICU, we did have some end-of-life patients who ended up dying on our ship in comfort care,” Cdr. Blevins said. “Fortunately, we had a wonderful ICU team who had a great deal of experience with end-of-life care and were able to take care of these patients very comfortably and ensure good communication with family and loved ones during that time. In most instances we tried to make sure that people got to FaceTime or video chat with their loved one before they passed away.”
The Mercy, which includes 12 operating rooms, four x-ray units, and one CAT-scan unit, was not equipped to deliver pediatric or obstetrical care. Other unavailable services included psychiatry, oncology, cardiac and thoracic surgery, nuclear medicine, MRI, mammography, electrophysiology, cardiac catheterization, negative-pressure isolation, speech therapy, and occupational therapy.
Not your typical hospital experience
But for patients who did receive medical care aboard the Mercy – which made three 150-day deployments in recent years for the military-led humanitarian response known as Pacific Partnership in 2015, 2016, and 2018 – it was an experience that they are unlikely to forget.
“Every time a patient left the ship, our team on the ground surveyed them to see how their experience was and see what we could do to improve,” Cdr. Blevins said. “Across the board, they were all very appreciative of the medical care. We had a couple of veterans on board. They got [USNS Mercy] hats on their way out and seemed to very much enjoy a slightly different experience than they would get at a regular hospital.”
Capt. Rotruck added that the enthusiasm crew members had for supporting fellow Americans “really energized our team and really saturated that caring aspect of the people who interacted directly with patients,” he said. “It wasn’t just the physicians and nurses, but it was the staff delivering the food and coming to take blood samples and every other interaction that the patients had with our team. I think they really felt that enthusiasm for being there and supporting our neighbors in LA [Los Angeles].”
Crew life aboard the Mercy
Just as with any hospital on shore, personnel aboard the Mercy practiced preventive hygiene measures recommended by the Centers for Disease Control and Prevention to help prevent the spread of COVID-19, such as wearing cloth face masks, spacing out tables in the dining hall, closing indoor gyms, and devising creative ways to stay physically fit. Popular options included jogging around the perimeter of the ship and practicing yoga and calisthenics on the deck, “making sure you were physically distanced appropriately, and when you were done, putting your mask back on,” Cdr. Blevins said. Others supplemented their workouts with a pull-up bar on the deck. “In addition, we have a series of ramps that run on the starboard side of the ship that we can use for patient movement with litters on wheels or patient beds,” Capt. Rotruck said. “The uphill portion of those ramps represents a good workout opportunity as well.”
Downtime in an era of physical distancing also afforded crew members the opportunity to call or FaceTime with loved ones, watch streamed TV shows and movies, and work on their own professional development. Some continued with coursework for online degree programs offered by colleges and universities they were enrolled in, while some enlisted personnel used the time to complete the Navy Enlisted Warfare Qualification Programs Instruction, which issues the basic overarching requirements for the qualification and designation of all enlisted warfare programs.
“As you can imagine, people spend a lot of time learning how the ship works and how it integrates into larger naval forces and so forth,” Capt. Rotruck said. “Not just our ship but also other ships: their weapons systems and defense mechanisms and navigation systems. We had people spending a significant amount of time working on that. We had people complete their Enlisted Surface Warfare qualification while we were on the mission.”
End of the mission
Mercy returned to its home base in San Diego on May 15, but about 60 medical personnel stayed behind in Los Angeles to support Federal Emergency Management Agency (FEMA), state, and local health care professionals. Some worked at a site where clinicians provided care for COVID-19–positive patients who had been transferred from area skilled nursing facilities.
In addition, a team consisting of one nurse and five corpsmen “would go out to individual skilled nursing facilities and mainly conduct assessments and training, such as training in donning proper PPE [personal protective equipment] and determining what needs they had,” Capt. Rotruck said. “They met those needs if possible or [communicated with California officials] and let them know what the requirements were and what the needs were in that facility.” The assignment for those who stayed behind ended on May 31.
On the opposite coast, Mercy’s sister ship, USNS Comfort, arrived in New York Harbor from Norfolk, Va., on March 30 and spent 3½ weeks assisting area hospitals in the COVID-19 pandemic fight. A few days into the mission, Comfort’s internal spaces were reconfigured to create separate COVID-negative and COVID-positive sections. Medical teams aboard the ship cared for a total of 182 patients during the assignment.
Looking back on Mercy’s mission, Cdr. Blevins marveled at the sense of teamwork that unfolded. “We have quarterly training exercises with a core set of personnel, [and] we train getting ready for activation in 5 days,” she said. “All of that training kicks in and it comes to fruition in a mission like this. It was terrific to see a group of very disparate subject matter experts from all over the country come together with one purpose: which was to serve our own country during the pandemic.”
Capt. Rotruck pointed out that the experience enabled enlisted and nonenlisted physicians to maintain their skill sets during a time when military and civilian hospitals had stopped doing elective procedures and routine appointments. “The fact that those people were able to come on board the ship and continue to conduct their medical practice and maintain their skills and competencies in an environment that they weren’t quite used to is great,” he said. “Otherwise, some of those medical personnel would have been sitting idle, wherever they were from. This is the power of Navy medicine on behalf of our country.”
When the hospital ship USNS Mercy departed San Diego’s Naval Station North Island on March 23, 2020, to support the Department of Defense efforts in Los Angeles during the coronavirus outbreak, Commander Erin Blevins remembers the crew’s excitement was palpable.
“We normally do partnerships abroad and respond to tsunamis and earthquakes,” said Cdr. Blevins, MD, a pediatric hematologist-oncologist who served as director of medical services for the mission. “This was a slight change in situation, but still disaster relief in the form of a pandemic. We switched our mindset to putting together the best experts for an infectious disease pandemic versus an earthquake disaster relief.”
A new mission
The 1,000-bed Mercy ship – a converted San Clemente–class oil tanker that was delivered in 1986 – spent nearly 50 days pier side in Los Angeles as a referral hospital for non–COVID-19 patients, so that clinicians at Los Angeles area hospitals could care for an anticipated surge of COVID-19 patients. “We went into it with expectations of, ‘We’ll treat as many patients as you need us to take,” Cdr. Blevins recalled. “I don’t even think Los Angeles [health officials] knew exactly where they were going to peak and what the need was going to be.”
Between March 29 and May 15, about 1,071 medical personnel aboard the Mercy cared for 77 patients with an average age of 53 years who were referred from 11 Los Angeles area hospitals. The physicians, nurses, and other medical support personnel were drawn from military treatment facilities across the country. “We had additional people join us as we scoped the mission to be more medically heavy and surgically light,” said Captain John Rotruck, MD, an anesthesiologist who is commanding officer of Mercy’s medical treatment facility. “We did adjust to make sure that we had the right staffing mix to meet the parameters that we were assigned. That was the crux of the change: a change in flavors of staffing to ensure that we focused on ICU and ward medical care as opposed to very heavy surgical care in support of a combat operation.”
About 10% of the team consisted of reservists who volunteered for the mission. “There’s no way you could have walked around the ship and known who was active duty and who was reservist,” said Capt. Rotruck, who was formerly chief of staff at Walter Reed National Military Medical Center, Bethesda, Md. “They worked together so well, and I think that marriage of active duty who are used to working in a military medical treatment facility – in our case, a Navy medical treatment facility – together with our reservist physician colleagues who work in civilian facilities around the country, was beneficial. It was a synergistic relationship. I think both sides walked away learning quite a bit from each other.”
Start with screening
All crew members underwent a temperature check and completed a health screening questionnaire: once before departing their home of record and again before boarding Mercy. Based on those results, crew members and medical staff were screened for COVID-19 and tested as needed in order to minimize the risk of an outbreak aboard the ship.
Fewer than 1% of crew members developed COVID-19 or tested positive for the virus during the mission, according to Capt. Rotruck. Affected individuals were isolated and quarantined. “All staff have recovered and are doing well,” he said.
Mercy personnel worked with local health officials to ensure that all patients transferred to the ship tested negative for COVID-19. Physicians aboard the Mercy then worked directly with the patients’ civilian physician to ensure a safe and thorough turnover process before the patients were transferred.
From basic medical to trauma care
Care aboard the ship, which consists of open-bay medical wards, ranged from basic medical and surgical care to critical care and trauma. The most common procedures were cholecystectomies and orthopedic procedures, and the average length of stay was 4-5 days, according to Cdr. Blevins. Over the course of the mission, the medical professionals conducted 36 surgeries, 77 x-ray exams, 26 CT scans, and administered hundreds of ancillary studies ranging from routine labs to high-end x-rays and blood transfusion support.
“Within our ICU, we did have some end-of-life patients who ended up dying on our ship in comfort care,” Cdr. Blevins said. “Fortunately, we had a wonderful ICU team who had a great deal of experience with end-of-life care and were able to take care of these patients very comfortably and ensure good communication with family and loved ones during that time. In most instances we tried to make sure that people got to FaceTime or video chat with their loved one before they passed away.”
The Mercy, which includes 12 operating rooms, four x-ray units, and one CAT-scan unit, was not equipped to deliver pediatric or obstetrical care. Other unavailable services included psychiatry, oncology, cardiac and thoracic surgery, nuclear medicine, MRI, mammography, electrophysiology, cardiac catheterization, negative-pressure isolation, speech therapy, and occupational therapy.
Not your typical hospital experience
But for patients who did receive medical care aboard the Mercy – which made three 150-day deployments in recent years for the military-led humanitarian response known as Pacific Partnership in 2015, 2016, and 2018 – it was an experience that they are unlikely to forget.
“Every time a patient left the ship, our team on the ground surveyed them to see how their experience was and see what we could do to improve,” Cdr. Blevins said. “Across the board, they were all very appreciative of the medical care. We had a couple of veterans on board. They got [USNS Mercy] hats on their way out and seemed to very much enjoy a slightly different experience than they would get at a regular hospital.”
Capt. Rotruck added that the enthusiasm crew members had for supporting fellow Americans “really energized our team and really saturated that caring aspect of the people who interacted directly with patients,” he said. “It wasn’t just the physicians and nurses, but it was the staff delivering the food and coming to take blood samples and every other interaction that the patients had with our team. I think they really felt that enthusiasm for being there and supporting our neighbors in LA [Los Angeles].”
Crew life aboard the Mercy
Just as with any hospital on shore, personnel aboard the Mercy practiced preventive hygiene measures recommended by the Centers for Disease Control and Prevention to help prevent the spread of COVID-19, such as wearing cloth face masks, spacing out tables in the dining hall, closing indoor gyms, and devising creative ways to stay physically fit. Popular options included jogging around the perimeter of the ship and practicing yoga and calisthenics on the deck, “making sure you were physically distanced appropriately, and when you were done, putting your mask back on,” Cdr. Blevins said. Others supplemented their workouts with a pull-up bar on the deck. “In addition, we have a series of ramps that run on the starboard side of the ship that we can use for patient movement with litters on wheels or patient beds,” Capt. Rotruck said. “The uphill portion of those ramps represents a good workout opportunity as well.”
Downtime in an era of physical distancing also afforded crew members the opportunity to call or FaceTime with loved ones, watch streamed TV shows and movies, and work on their own professional development. Some continued with coursework for online degree programs offered by colleges and universities they were enrolled in, while some enlisted personnel used the time to complete the Navy Enlisted Warfare Qualification Programs Instruction, which issues the basic overarching requirements for the qualification and designation of all enlisted warfare programs.
“As you can imagine, people spend a lot of time learning how the ship works and how it integrates into larger naval forces and so forth,” Capt. Rotruck said. “Not just our ship but also other ships: their weapons systems and defense mechanisms and navigation systems. We had people spending a significant amount of time working on that. We had people complete their Enlisted Surface Warfare qualification while we were on the mission.”
End of the mission
Mercy returned to its home base in San Diego on May 15, but about 60 medical personnel stayed behind in Los Angeles to support Federal Emergency Management Agency (FEMA), state, and local health care professionals. Some worked at a site where clinicians provided care for COVID-19–positive patients who had been transferred from area skilled nursing facilities.
In addition, a team consisting of one nurse and five corpsmen “would go out to individual skilled nursing facilities and mainly conduct assessments and training, such as training in donning proper PPE [personal protective equipment] and determining what needs they had,” Capt. Rotruck said. “They met those needs if possible or [communicated with California officials] and let them know what the requirements were and what the needs were in that facility.” The assignment for those who stayed behind ended on May 31.
On the opposite coast, Mercy’s sister ship, USNS Comfort, arrived in New York Harbor from Norfolk, Va., on March 30 and spent 3½ weeks assisting area hospitals in the COVID-19 pandemic fight. A few days into the mission, Comfort’s internal spaces were reconfigured to create separate COVID-negative and COVID-positive sections. Medical teams aboard the ship cared for a total of 182 patients during the assignment.
Looking back on Mercy’s mission, Cdr. Blevins marveled at the sense of teamwork that unfolded. “We have quarterly training exercises with a core set of personnel, [and] we train getting ready for activation in 5 days,” she said. “All of that training kicks in and it comes to fruition in a mission like this. It was terrific to see a group of very disparate subject matter experts from all over the country come together with one purpose: which was to serve our own country during the pandemic.”
Capt. Rotruck pointed out that the experience enabled enlisted and nonenlisted physicians to maintain their skill sets during a time when military and civilian hospitals had stopped doing elective procedures and routine appointments. “The fact that those people were able to come on board the ship and continue to conduct their medical practice and maintain their skills and competencies in an environment that they weren’t quite used to is great,” he said. “Otherwise, some of those medical personnel would have been sitting idle, wherever they were from. This is the power of Navy medicine on behalf of our country.”
When the hospital ship USNS Mercy departed San Diego’s Naval Station North Island on March 23, 2020, to support the Department of Defense efforts in Los Angeles during the coronavirus outbreak, Commander Erin Blevins remembers the crew’s excitement was palpable.
“We normally do partnerships abroad and respond to tsunamis and earthquakes,” said Cdr. Blevins, MD, a pediatric hematologist-oncologist who served as director of medical services for the mission. “This was a slight change in situation, but still disaster relief in the form of a pandemic. We switched our mindset to putting together the best experts for an infectious disease pandemic versus an earthquake disaster relief.”
A new mission
The 1,000-bed Mercy ship – a converted San Clemente–class oil tanker that was delivered in 1986 – spent nearly 50 days pier side in Los Angeles as a referral hospital for non–COVID-19 patients, so that clinicians at Los Angeles area hospitals could care for an anticipated surge of COVID-19 patients. “We went into it with expectations of, ‘We’ll treat as many patients as you need us to take,” Cdr. Blevins recalled. “I don’t even think Los Angeles [health officials] knew exactly where they were going to peak and what the need was going to be.”
Between March 29 and May 15, about 1,071 medical personnel aboard the Mercy cared for 77 patients with an average age of 53 years who were referred from 11 Los Angeles area hospitals. The physicians, nurses, and other medical support personnel were drawn from military treatment facilities across the country. “We had additional people join us as we scoped the mission to be more medically heavy and surgically light,” said Captain John Rotruck, MD, an anesthesiologist who is commanding officer of Mercy’s medical treatment facility. “We did adjust to make sure that we had the right staffing mix to meet the parameters that we were assigned. That was the crux of the change: a change in flavors of staffing to ensure that we focused on ICU and ward medical care as opposed to very heavy surgical care in support of a combat operation.”
About 10% of the team consisted of reservists who volunteered for the mission. “There’s no way you could have walked around the ship and known who was active duty and who was reservist,” said Capt. Rotruck, who was formerly chief of staff at Walter Reed National Military Medical Center, Bethesda, Md. “They worked together so well, and I think that marriage of active duty who are used to working in a military medical treatment facility – in our case, a Navy medical treatment facility – together with our reservist physician colleagues who work in civilian facilities around the country, was beneficial. It was a synergistic relationship. I think both sides walked away learning quite a bit from each other.”
Start with screening
All crew members underwent a temperature check and completed a health screening questionnaire: once before departing their home of record and again before boarding Mercy. Based on those results, crew members and medical staff were screened for COVID-19 and tested as needed in order to minimize the risk of an outbreak aboard the ship.
Fewer than 1% of crew members developed COVID-19 or tested positive for the virus during the mission, according to Capt. Rotruck. Affected individuals were isolated and quarantined. “All staff have recovered and are doing well,” he said.
Mercy personnel worked with local health officials to ensure that all patients transferred to the ship tested negative for COVID-19. Physicians aboard the Mercy then worked directly with the patients’ civilian physician to ensure a safe and thorough turnover process before the patients were transferred.
From basic medical to trauma care
Care aboard the ship, which consists of open-bay medical wards, ranged from basic medical and surgical care to critical care and trauma. The most common procedures were cholecystectomies and orthopedic procedures, and the average length of stay was 4-5 days, according to Cdr. Blevins. Over the course of the mission, the medical professionals conducted 36 surgeries, 77 x-ray exams, 26 CT scans, and administered hundreds of ancillary studies ranging from routine labs to high-end x-rays and blood transfusion support.
“Within our ICU, we did have some end-of-life patients who ended up dying on our ship in comfort care,” Cdr. Blevins said. “Fortunately, we had a wonderful ICU team who had a great deal of experience with end-of-life care and were able to take care of these patients very comfortably and ensure good communication with family and loved ones during that time. In most instances we tried to make sure that people got to FaceTime or video chat with their loved one before they passed away.”
The Mercy, which includes 12 operating rooms, four x-ray units, and one CAT-scan unit, was not equipped to deliver pediatric or obstetrical care. Other unavailable services included psychiatry, oncology, cardiac and thoracic surgery, nuclear medicine, MRI, mammography, electrophysiology, cardiac catheterization, negative-pressure isolation, speech therapy, and occupational therapy.
Not your typical hospital experience
But for patients who did receive medical care aboard the Mercy – which made three 150-day deployments in recent years for the military-led humanitarian response known as Pacific Partnership in 2015, 2016, and 2018 – it was an experience that they are unlikely to forget.
“Every time a patient left the ship, our team on the ground surveyed them to see how their experience was and see what we could do to improve,” Cdr. Blevins said. “Across the board, they were all very appreciative of the medical care. We had a couple of veterans on board. They got [USNS Mercy] hats on their way out and seemed to very much enjoy a slightly different experience than they would get at a regular hospital.”
Capt. Rotruck added that the enthusiasm crew members had for supporting fellow Americans “really energized our team and really saturated that caring aspect of the people who interacted directly with patients,” he said. “It wasn’t just the physicians and nurses, but it was the staff delivering the food and coming to take blood samples and every other interaction that the patients had with our team. I think they really felt that enthusiasm for being there and supporting our neighbors in LA [Los Angeles].”
Crew life aboard the Mercy
Just as with any hospital on shore, personnel aboard the Mercy practiced preventive hygiene measures recommended by the Centers for Disease Control and Prevention to help prevent the spread of COVID-19, such as wearing cloth face masks, spacing out tables in the dining hall, closing indoor gyms, and devising creative ways to stay physically fit. Popular options included jogging around the perimeter of the ship and practicing yoga and calisthenics on the deck, “making sure you were physically distanced appropriately, and when you were done, putting your mask back on,” Cdr. Blevins said. Others supplemented their workouts with a pull-up bar on the deck. “In addition, we have a series of ramps that run on the starboard side of the ship that we can use for patient movement with litters on wheels or patient beds,” Capt. Rotruck said. “The uphill portion of those ramps represents a good workout opportunity as well.”
Downtime in an era of physical distancing also afforded crew members the opportunity to call or FaceTime with loved ones, watch streamed TV shows and movies, and work on their own professional development. Some continued with coursework for online degree programs offered by colleges and universities they were enrolled in, while some enlisted personnel used the time to complete the Navy Enlisted Warfare Qualification Programs Instruction, which issues the basic overarching requirements for the qualification and designation of all enlisted warfare programs.
“As you can imagine, people spend a lot of time learning how the ship works and how it integrates into larger naval forces and so forth,” Capt. Rotruck said. “Not just our ship but also other ships: their weapons systems and defense mechanisms and navigation systems. We had people spending a significant amount of time working on that. We had people complete their Enlisted Surface Warfare qualification while we were on the mission.”
End of the mission
Mercy returned to its home base in San Diego on May 15, but about 60 medical personnel stayed behind in Los Angeles to support Federal Emergency Management Agency (FEMA), state, and local health care professionals. Some worked at a site where clinicians provided care for COVID-19–positive patients who had been transferred from area skilled nursing facilities.
In addition, a team consisting of one nurse and five corpsmen “would go out to individual skilled nursing facilities and mainly conduct assessments and training, such as training in donning proper PPE [personal protective equipment] and determining what needs they had,” Capt. Rotruck said. “They met those needs if possible or [communicated with California officials] and let them know what the requirements were and what the needs were in that facility.” The assignment for those who stayed behind ended on May 31.
On the opposite coast, Mercy’s sister ship, USNS Comfort, arrived in New York Harbor from Norfolk, Va., on March 30 and spent 3½ weeks assisting area hospitals in the COVID-19 pandemic fight. A few days into the mission, Comfort’s internal spaces were reconfigured to create separate COVID-negative and COVID-positive sections. Medical teams aboard the ship cared for a total of 182 patients during the assignment.
Looking back on Mercy’s mission, Cdr. Blevins marveled at the sense of teamwork that unfolded. “We have quarterly training exercises with a core set of personnel, [and] we train getting ready for activation in 5 days,” she said. “All of that training kicks in and it comes to fruition in a mission like this. It was terrific to see a group of very disparate subject matter experts from all over the country come together with one purpose: which was to serve our own country during the pandemic.”
Capt. Rotruck pointed out that the experience enabled enlisted and nonenlisted physicians to maintain their skill sets during a time when military and civilian hospitals had stopped doing elective procedures and routine appointments. “The fact that those people were able to come on board the ship and continue to conduct their medical practice and maintain their skills and competencies in an environment that they weren’t quite used to is great,” he said. “Otherwise, some of those medical personnel would have been sitting idle, wherever they were from. This is the power of Navy medicine on behalf of our country.”