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Galcanezumab looks promising for treatment-resistant migraine
“The patients included in our study had previously tried multiple migraine preventive treatments that didn’t work for them. These patients are left with limited treatment options to help with the debilitating pain of migraine,” said lead author Holland C. Detke, PhD, senior clinical research advisor at Eli Lilly and Company Biomedicines.
Participants who took the drug experienced “a rapid reduction in migraine days starting as early as month 1, and continuing through the 6 months of the study,” Dr. Detke said.
The treatment group reported an average 4.0 fewer monthly migraine days at 3 months, for example, compared with a baseline of 13.4 days, whereas the placebo group decreased an average 1.29 days from a similar baseline of 13.0 migraine days.
Dr. Detke presented these and other results of the open-label phase of the CONQUER phase 3 trial online as part of the 2020 American Academy of Neurology Science Highlights.
The investigators enrolled 462 adults with episodic or chronic migraine. All participants previously failed two to four migraine treatments because of insufficient efficacy or issues around tolerability or safety. At month 0, 232 people were randomly assigned to galcanezumab and another 230 to placebo injections. At 3 months, 449 participants received a galcanezumab injection as part of the open-label treatment phase.
Participants were an average 48 years old, approximately 86% were women, and 82% were white. At baseline, mean Migraine Specific Quality of Life Role Function Restrictive (MSQ RFR) domain score was 45, “indicating significant impairment in functioning,” Dr. Detke said. At the same time, mean Migraine Disability Assessment Test (MIDAS) total score was 51, “indicating quite severe disability.”
Significant outcomes
The decrease in migraine days at 3 months – 4.0 days with treatment versus 1.29 with placebo – was statistically significant (P < .0001). During the open-label phase, participants who switched from placebo “essentially catch up to where the previously treated people were,” Dr. Detke said. At 6 months, the decrease in average monthly headache days was 5.60 in the initial galcanezumab group versus 5.24 in the initial placebo group.
Significant differences at 3 months versus baseline were observed in participants who received galcanezumab when investigators assessed reduction in 50% or more, 75% or more, or 100% of mean monthly migraine days. No such significant decreases were seen in the placebo group.
Treatment-emergent adverse events reported in the open-label phase included nasopharyngitis in 4.2%, injection site pain in 3.8%, and injection site erythema in 2.7%. Five participants discontinued during the open-label phase because of adverse events.
The results of the study suggest galcanezumab “should be considered as a treatment option for patients who have not had success with previous treatments,” Dr. Detke said.
Multiple strengths of study
“It is encouraging that galcanezumab works in patients who have failed prior reduction strategies,” A. Laine Green, MD, a neurologist at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., said when asked to comment.
This study did not look at patients who have failed more than four previous reduction strategies, he added. “Clinically we see many of these patients. To be fair, no one has studied this group using the monoclonal antibodies.”
Dr. Green noted several strengths of the study. The groups were similar, there were few dropouts during the open-label extension, and there were no unexpected side effects or adverse events. “Those who got placebo caught up to those who received active treatment in the double-blind phase,” he said. “It is also nice to see patient reported outcomes improved as headaches improve. This adds consistency to the results.”
One caveat, Dr. Green noted, is “with open-label extensions, there is always the potential for bias because patients know what treatment they are receiving.”
Overall [the study] gives hope that patients who have failed previous reduction strategies may respond to the newer monoclonal antibodies.”
Aligns with previous findings
The results are “the same as any other long-term extension study of a drug for migraine,” Stephen Silberstein, MD, said when asked to comment. “The longer one takes it, the better you get.”
The research also confirms that if you switch patients taking placebo to an active treatment, they get better, added Dr. Silberstein, director of the Headache Center at Jefferson Health in Philadelphia.
Because they are injections, agents such as galcanezumab, other monoclonal antibodies, and botulinum toxin offer better compliance for headache compared with small molecule medications that require daily oral dosing, he added.
Eli Lilly and Company funded the study. Dr. Holland Detke is a Lilly employee. Dr. Green collaborated with Lilly on a poster for the AHS scientific meeting on a similar topic but did not receive compensation. Up until August 2019, he served as a consultant for Lilly, Novartis, Teva and Allergan. Dr. Green is also a member of the Medscape and American Headache Society Migraine Steering Committee. Dr. Silberstein is a member of the advisory board and consultant for Lilly.
Source: Detke HC et al. AAN 2020. Abstract 43625.
“The patients included in our study had previously tried multiple migraine preventive treatments that didn’t work for them. These patients are left with limited treatment options to help with the debilitating pain of migraine,” said lead author Holland C. Detke, PhD, senior clinical research advisor at Eli Lilly and Company Biomedicines.
Participants who took the drug experienced “a rapid reduction in migraine days starting as early as month 1, and continuing through the 6 months of the study,” Dr. Detke said.
The treatment group reported an average 4.0 fewer monthly migraine days at 3 months, for example, compared with a baseline of 13.4 days, whereas the placebo group decreased an average 1.29 days from a similar baseline of 13.0 migraine days.
Dr. Detke presented these and other results of the open-label phase of the CONQUER phase 3 trial online as part of the 2020 American Academy of Neurology Science Highlights.
The investigators enrolled 462 adults with episodic or chronic migraine. All participants previously failed two to four migraine treatments because of insufficient efficacy or issues around tolerability or safety. At month 0, 232 people were randomly assigned to galcanezumab and another 230 to placebo injections. At 3 months, 449 participants received a galcanezumab injection as part of the open-label treatment phase.
Participants were an average 48 years old, approximately 86% were women, and 82% were white. At baseline, mean Migraine Specific Quality of Life Role Function Restrictive (MSQ RFR) domain score was 45, “indicating significant impairment in functioning,” Dr. Detke said. At the same time, mean Migraine Disability Assessment Test (MIDAS) total score was 51, “indicating quite severe disability.”
Significant outcomes
The decrease in migraine days at 3 months – 4.0 days with treatment versus 1.29 with placebo – was statistically significant (P < .0001). During the open-label phase, participants who switched from placebo “essentially catch up to where the previously treated people were,” Dr. Detke said. At 6 months, the decrease in average monthly headache days was 5.60 in the initial galcanezumab group versus 5.24 in the initial placebo group.
Significant differences at 3 months versus baseline were observed in participants who received galcanezumab when investigators assessed reduction in 50% or more, 75% or more, or 100% of mean monthly migraine days. No such significant decreases were seen in the placebo group.
Treatment-emergent adverse events reported in the open-label phase included nasopharyngitis in 4.2%, injection site pain in 3.8%, and injection site erythema in 2.7%. Five participants discontinued during the open-label phase because of adverse events.
The results of the study suggest galcanezumab “should be considered as a treatment option for patients who have not had success with previous treatments,” Dr. Detke said.
Multiple strengths of study
“It is encouraging that galcanezumab works in patients who have failed prior reduction strategies,” A. Laine Green, MD, a neurologist at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., said when asked to comment.
This study did not look at patients who have failed more than four previous reduction strategies, he added. “Clinically we see many of these patients. To be fair, no one has studied this group using the monoclonal antibodies.”
Dr. Green noted several strengths of the study. The groups were similar, there were few dropouts during the open-label extension, and there were no unexpected side effects or adverse events. “Those who got placebo caught up to those who received active treatment in the double-blind phase,” he said. “It is also nice to see patient reported outcomes improved as headaches improve. This adds consistency to the results.”
One caveat, Dr. Green noted, is “with open-label extensions, there is always the potential for bias because patients know what treatment they are receiving.”
Overall [the study] gives hope that patients who have failed previous reduction strategies may respond to the newer monoclonal antibodies.”
Aligns with previous findings
The results are “the same as any other long-term extension study of a drug for migraine,” Stephen Silberstein, MD, said when asked to comment. “The longer one takes it, the better you get.”
The research also confirms that if you switch patients taking placebo to an active treatment, they get better, added Dr. Silberstein, director of the Headache Center at Jefferson Health in Philadelphia.
Because they are injections, agents such as galcanezumab, other monoclonal antibodies, and botulinum toxin offer better compliance for headache compared with small molecule medications that require daily oral dosing, he added.
Eli Lilly and Company funded the study. Dr. Holland Detke is a Lilly employee. Dr. Green collaborated with Lilly on a poster for the AHS scientific meeting on a similar topic but did not receive compensation. Up until August 2019, he served as a consultant for Lilly, Novartis, Teva and Allergan. Dr. Green is also a member of the Medscape and American Headache Society Migraine Steering Committee. Dr. Silberstein is a member of the advisory board and consultant for Lilly.
Source: Detke HC et al. AAN 2020. Abstract 43625.
“The patients included in our study had previously tried multiple migraine preventive treatments that didn’t work for them. These patients are left with limited treatment options to help with the debilitating pain of migraine,” said lead author Holland C. Detke, PhD, senior clinical research advisor at Eli Lilly and Company Biomedicines.
Participants who took the drug experienced “a rapid reduction in migraine days starting as early as month 1, and continuing through the 6 months of the study,” Dr. Detke said.
The treatment group reported an average 4.0 fewer monthly migraine days at 3 months, for example, compared with a baseline of 13.4 days, whereas the placebo group decreased an average 1.29 days from a similar baseline of 13.0 migraine days.
Dr. Detke presented these and other results of the open-label phase of the CONQUER phase 3 trial online as part of the 2020 American Academy of Neurology Science Highlights.
The investigators enrolled 462 adults with episodic or chronic migraine. All participants previously failed two to four migraine treatments because of insufficient efficacy or issues around tolerability or safety. At month 0, 232 people were randomly assigned to galcanezumab and another 230 to placebo injections. At 3 months, 449 participants received a galcanezumab injection as part of the open-label treatment phase.
Participants were an average 48 years old, approximately 86% were women, and 82% were white. At baseline, mean Migraine Specific Quality of Life Role Function Restrictive (MSQ RFR) domain score was 45, “indicating significant impairment in functioning,” Dr. Detke said. At the same time, mean Migraine Disability Assessment Test (MIDAS) total score was 51, “indicating quite severe disability.”
Significant outcomes
The decrease in migraine days at 3 months – 4.0 days with treatment versus 1.29 with placebo – was statistically significant (P < .0001). During the open-label phase, participants who switched from placebo “essentially catch up to where the previously treated people were,” Dr. Detke said. At 6 months, the decrease in average monthly headache days was 5.60 in the initial galcanezumab group versus 5.24 in the initial placebo group.
Significant differences at 3 months versus baseline were observed in participants who received galcanezumab when investigators assessed reduction in 50% or more, 75% or more, or 100% of mean monthly migraine days. No such significant decreases were seen in the placebo group.
Treatment-emergent adverse events reported in the open-label phase included nasopharyngitis in 4.2%, injection site pain in 3.8%, and injection site erythema in 2.7%. Five participants discontinued during the open-label phase because of adverse events.
The results of the study suggest galcanezumab “should be considered as a treatment option for patients who have not had success with previous treatments,” Dr. Detke said.
Multiple strengths of study
“It is encouraging that galcanezumab works in patients who have failed prior reduction strategies,” A. Laine Green, MD, a neurologist at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., said when asked to comment.
This study did not look at patients who have failed more than four previous reduction strategies, he added. “Clinically we see many of these patients. To be fair, no one has studied this group using the monoclonal antibodies.”
Dr. Green noted several strengths of the study. The groups were similar, there were few dropouts during the open-label extension, and there were no unexpected side effects or adverse events. “Those who got placebo caught up to those who received active treatment in the double-blind phase,” he said. “It is also nice to see patient reported outcomes improved as headaches improve. This adds consistency to the results.”
One caveat, Dr. Green noted, is “with open-label extensions, there is always the potential for bias because patients know what treatment they are receiving.”
Overall [the study] gives hope that patients who have failed previous reduction strategies may respond to the newer monoclonal antibodies.”
Aligns with previous findings
The results are “the same as any other long-term extension study of a drug for migraine,” Stephen Silberstein, MD, said when asked to comment. “The longer one takes it, the better you get.”
The research also confirms that if you switch patients taking placebo to an active treatment, they get better, added Dr. Silberstein, director of the Headache Center at Jefferson Health in Philadelphia.
Because they are injections, agents such as galcanezumab, other monoclonal antibodies, and botulinum toxin offer better compliance for headache compared with small molecule medications that require daily oral dosing, he added.
Eli Lilly and Company funded the study. Dr. Holland Detke is a Lilly employee. Dr. Green collaborated with Lilly on a poster for the AHS scientific meeting on a similar topic but did not receive compensation. Up until August 2019, he served as a consultant for Lilly, Novartis, Teva and Allergan. Dr. Green is also a member of the Medscape and American Headache Society Migraine Steering Committee. Dr. Silberstein is a member of the advisory board and consultant for Lilly.
Source: Detke HC et al. AAN 2020. Abstract 43625.
FROM AAN 2020
COVID-19 complicates prescribing for children with inflammatory skin disease
designed to offer guidance to specialists and nonspecialists faced with tough choices about risks.
Some 87% reported that they were reducing the frequency of lab monitoring for some medications, while more than half said they had reached out to patients and their families to discuss the implications of continuing or stopping a drug.
Virtually all – 97% – said that the COVID-19 crisis had affected their decision to initiate immunosuppressive medications, with 84% saying the decision depended on a patient’s risk factors for contracting COVID-19 infection, and also the potential consequences of infection while treated, compared with the risks of not optimally treating the skin condition.
To develop a consensus-based guidance for clinicians, published online April 22 in Pediatric Dermatology, Kelly Cordoro, MD, professor of dermatology at the University of California, San Francisco, assembled a task force of pediatric dermatologists at academic institutions (the Pediatric Dermatology COVID-19 Response Task Force). Together with Sean Reynolds, MD, a pediatric dermatology fellow at UCSF and colleagues, they issued a survey to the 37 members of the task force with questions on how the pandemic has affected their prescribing decisions and certain therapies specifically. All the recipients responded.
The dermatologists were asked about conventional systemic and biologic medications. Most felt confident in continuing biologics, with 78% saying they would keep patients with no signs of COVID-19 exposure or infection on tumor necrosis factor (TNF) inhibitors. More than 90% of respondents said they would continue patients on dupilumab, as well as anti–interleukin (IL)–17, anti–IL-12/23, and anti–IL-23 therapies.
Responses varied more on approaches to the nonbiologic treatments. Fewer than half (46%) said they would continue patients without apparent COVID-19 exposure on systemic steroids, with another 46% saying it depended on the clinical context.
For other systemic therapies, respondents were more likely to want to continue their patients with no signs or symptoms of COVID-19 on methotrexate and apremilast (78% and 83%, respectively) than others (mycophenolate mofetil, azathioprine, cyclosporine, and JAK inhibitors), which saw between 50% and 60% support in the survey.
Patients on any immunosuppressive medications with likely exposure to COVID-19 or who test positive for the virus should be temporarily taken off their medications, the majority concurred. Exceptions were for systemic steroids, which must be tapered. And a significant minority of the dermatologists said that they would continue apremilast or dupilumab (24% and 16%, respectively) in the event of a confirmed COVID-19 infection.
In an interview, Dr. Cordoro commented that, even in normal times, most systemic or biological immunosuppressive treatments are used off-label by pediatric dermatologists. “There’s no way this could have been an evidence-based document, as we didn’t have the data to drive this. Many of the medications have been tested in children but not necessarily for dermatologic indications; some are chemotherapy agents or drugs used in rheumatologic diseases.”
The COVID-19 pandemic complicated an already difficult decision-making process, she said.
The researchers cautioned against attempting to make decisions about medications based on data on other infections from clinical trials. “Infection data from standard infections that were identified and watched for in clinical trials really still has no bearing on COVID-19 because it’s such a different virus,” Dr. Cordoro said.
And while some immunosuppressive medications could potentially attenuate a SARS-CoV-2–induced cytokine storm, “we certainly don’t assume this is necessarily going to help.”
The authors advised that physicians anxious about initiating an immunosuppressive treatment should take into consideration whether early intervention could “prevent permanent physical impairment or disfigurement” in diseases such as erythrodermic pustular psoriasis or rapidly progressive linear morphea.
Other diseases, such as atopic dermatitis, “may be acceptably, though not optimally, managed with topical and other home-based therapeutic options” during the pandemic, they wrote.
Dr. Cordoro commented that, given how fast new findings are emerging from the pandemic, the guidance on medications could change. “We will know so much more 3 months from now,” she said. And while there are no formal plans to reissue the survey, “we’re maintaining communication and will have some kind of follow up” with the academic dermatologists.
“If we recognize any signals that are counter to what we say in this work we will immediately let people know,” she said.
The researchers received no outside funding for their study. Of the study’s 24 coauthors, nine disclosed financial relationships with industry.
SOURCE: Add the first auSOURCE: Reynolds et al. Pediatr Dermatol. 2020. doi: 10.1111/pde.14202.
designed to offer guidance to specialists and nonspecialists faced with tough choices about risks.
Some 87% reported that they were reducing the frequency of lab monitoring for some medications, while more than half said they had reached out to patients and their families to discuss the implications of continuing or stopping a drug.
Virtually all – 97% – said that the COVID-19 crisis had affected their decision to initiate immunosuppressive medications, with 84% saying the decision depended on a patient’s risk factors for contracting COVID-19 infection, and also the potential consequences of infection while treated, compared with the risks of not optimally treating the skin condition.
To develop a consensus-based guidance for clinicians, published online April 22 in Pediatric Dermatology, Kelly Cordoro, MD, professor of dermatology at the University of California, San Francisco, assembled a task force of pediatric dermatologists at academic institutions (the Pediatric Dermatology COVID-19 Response Task Force). Together with Sean Reynolds, MD, a pediatric dermatology fellow at UCSF and colleagues, they issued a survey to the 37 members of the task force with questions on how the pandemic has affected their prescribing decisions and certain therapies specifically. All the recipients responded.
The dermatologists were asked about conventional systemic and biologic medications. Most felt confident in continuing biologics, with 78% saying they would keep patients with no signs of COVID-19 exposure or infection on tumor necrosis factor (TNF) inhibitors. More than 90% of respondents said they would continue patients on dupilumab, as well as anti–interleukin (IL)–17, anti–IL-12/23, and anti–IL-23 therapies.
Responses varied more on approaches to the nonbiologic treatments. Fewer than half (46%) said they would continue patients without apparent COVID-19 exposure on systemic steroids, with another 46% saying it depended on the clinical context.
For other systemic therapies, respondents were more likely to want to continue their patients with no signs or symptoms of COVID-19 on methotrexate and apremilast (78% and 83%, respectively) than others (mycophenolate mofetil, azathioprine, cyclosporine, and JAK inhibitors), which saw between 50% and 60% support in the survey.
Patients on any immunosuppressive medications with likely exposure to COVID-19 or who test positive for the virus should be temporarily taken off their medications, the majority concurred. Exceptions were for systemic steroids, which must be tapered. And a significant minority of the dermatologists said that they would continue apremilast or dupilumab (24% and 16%, respectively) in the event of a confirmed COVID-19 infection.
In an interview, Dr. Cordoro commented that, even in normal times, most systemic or biological immunosuppressive treatments are used off-label by pediatric dermatologists. “There’s no way this could have been an evidence-based document, as we didn’t have the data to drive this. Many of the medications have been tested in children but not necessarily for dermatologic indications; some are chemotherapy agents or drugs used in rheumatologic diseases.”
The COVID-19 pandemic complicated an already difficult decision-making process, she said.
The researchers cautioned against attempting to make decisions about medications based on data on other infections from clinical trials. “Infection data from standard infections that were identified and watched for in clinical trials really still has no bearing on COVID-19 because it’s such a different virus,” Dr. Cordoro said.
And while some immunosuppressive medications could potentially attenuate a SARS-CoV-2–induced cytokine storm, “we certainly don’t assume this is necessarily going to help.”
The authors advised that physicians anxious about initiating an immunosuppressive treatment should take into consideration whether early intervention could “prevent permanent physical impairment or disfigurement” in diseases such as erythrodermic pustular psoriasis or rapidly progressive linear morphea.
Other diseases, such as atopic dermatitis, “may be acceptably, though not optimally, managed with topical and other home-based therapeutic options” during the pandemic, they wrote.
Dr. Cordoro commented that, given how fast new findings are emerging from the pandemic, the guidance on medications could change. “We will know so much more 3 months from now,” she said. And while there are no formal plans to reissue the survey, “we’re maintaining communication and will have some kind of follow up” with the academic dermatologists.
“If we recognize any signals that are counter to what we say in this work we will immediately let people know,” she said.
The researchers received no outside funding for their study. Of the study’s 24 coauthors, nine disclosed financial relationships with industry.
SOURCE: Add the first auSOURCE: Reynolds et al. Pediatr Dermatol. 2020. doi: 10.1111/pde.14202.
designed to offer guidance to specialists and nonspecialists faced with tough choices about risks.
Some 87% reported that they were reducing the frequency of lab monitoring for some medications, while more than half said they had reached out to patients and their families to discuss the implications of continuing or stopping a drug.
Virtually all – 97% – said that the COVID-19 crisis had affected their decision to initiate immunosuppressive medications, with 84% saying the decision depended on a patient’s risk factors for contracting COVID-19 infection, and also the potential consequences of infection while treated, compared with the risks of not optimally treating the skin condition.
To develop a consensus-based guidance for clinicians, published online April 22 in Pediatric Dermatology, Kelly Cordoro, MD, professor of dermatology at the University of California, San Francisco, assembled a task force of pediatric dermatologists at academic institutions (the Pediatric Dermatology COVID-19 Response Task Force). Together with Sean Reynolds, MD, a pediatric dermatology fellow at UCSF and colleagues, they issued a survey to the 37 members of the task force with questions on how the pandemic has affected their prescribing decisions and certain therapies specifically. All the recipients responded.
The dermatologists were asked about conventional systemic and biologic medications. Most felt confident in continuing biologics, with 78% saying they would keep patients with no signs of COVID-19 exposure or infection on tumor necrosis factor (TNF) inhibitors. More than 90% of respondents said they would continue patients on dupilumab, as well as anti–interleukin (IL)–17, anti–IL-12/23, and anti–IL-23 therapies.
Responses varied more on approaches to the nonbiologic treatments. Fewer than half (46%) said they would continue patients without apparent COVID-19 exposure on systemic steroids, with another 46% saying it depended on the clinical context.
For other systemic therapies, respondents were more likely to want to continue their patients with no signs or symptoms of COVID-19 on methotrexate and apremilast (78% and 83%, respectively) than others (mycophenolate mofetil, azathioprine, cyclosporine, and JAK inhibitors), which saw between 50% and 60% support in the survey.
Patients on any immunosuppressive medications with likely exposure to COVID-19 or who test positive for the virus should be temporarily taken off their medications, the majority concurred. Exceptions were for systemic steroids, which must be tapered. And a significant minority of the dermatologists said that they would continue apremilast or dupilumab (24% and 16%, respectively) in the event of a confirmed COVID-19 infection.
In an interview, Dr. Cordoro commented that, even in normal times, most systemic or biological immunosuppressive treatments are used off-label by pediatric dermatologists. “There’s no way this could have been an evidence-based document, as we didn’t have the data to drive this. Many of the medications have been tested in children but not necessarily for dermatologic indications; some are chemotherapy agents or drugs used in rheumatologic diseases.”
The COVID-19 pandemic complicated an already difficult decision-making process, she said.
The researchers cautioned against attempting to make decisions about medications based on data on other infections from clinical trials. “Infection data from standard infections that were identified and watched for in clinical trials really still has no bearing on COVID-19 because it’s such a different virus,” Dr. Cordoro said.
And while some immunosuppressive medications could potentially attenuate a SARS-CoV-2–induced cytokine storm, “we certainly don’t assume this is necessarily going to help.”
The authors advised that physicians anxious about initiating an immunosuppressive treatment should take into consideration whether early intervention could “prevent permanent physical impairment or disfigurement” in diseases such as erythrodermic pustular psoriasis or rapidly progressive linear morphea.
Other diseases, such as atopic dermatitis, “may be acceptably, though not optimally, managed with topical and other home-based therapeutic options” during the pandemic, they wrote.
Dr. Cordoro commented that, given how fast new findings are emerging from the pandemic, the guidance on medications could change. “We will know so much more 3 months from now,” she said. And while there are no formal plans to reissue the survey, “we’re maintaining communication and will have some kind of follow up” with the academic dermatologists.
“If we recognize any signals that are counter to what we say in this work we will immediately let people know,” she said.
The researchers received no outside funding for their study. Of the study’s 24 coauthors, nine disclosed financial relationships with industry.
SOURCE: Add the first auSOURCE: Reynolds et al. Pediatr Dermatol. 2020. doi: 10.1111/pde.14202.
FROM PEDIATRIC DERMATOLOGY
Half of Americans would get COVID-19 vaccine, poll shows
About half of Americans say they would get a COVID-19 vaccine if one is available, according to the Associated Press.
The poll was conducted May 14-18 and released May 27.
A massive national and international effort is underway to develop a vaccine for the coronavirus. According to the poll, 20% of Americans believe a vaccine will be available before the end of 2020. Another 61% think it will arrive in 2021, and 17% say it will take longer.
“It’s always better to under-promise and over-deliver,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, told the AP.
Americans over age 60 were more likely to say they’ll get a coronavirus vaccine when it’s available. Those who worry that they or someone in their household could become infected with the virus were also more likely to say they’ll get a vaccine. However, Black Americans were more likely than were Hispanic or white responders to say that they don’t plan to get a vaccine.
Among those who plan to get a vaccine, 93% said they want to protect themselves, and 88% said they want to protect their family. About 72% said “life won’t go back to normal until most people are vaccinated,” and 33% said they have a chronic health condition such as asthma or diabetes and believe it’s important to receive a vaccine.
Among those who don’t plan to get a vaccine, 70% said they’re concerned about side effects. Another 42% are worried about getting the coronavirus from the vaccine. Others say they’re not concerned about getting seriously ill from the coronavirus, they don’t think vaccines work well, the COVID-19 outbreak isn’t serious, or they don’t like needles.
The National Institutes of Health says that safety is the top priority and is creating a plan to test the vaccine in thousands of people for safety and efficacy in coming months, according to the AP.
“I would not want people to think that we’re cutting corners because that would be a big mistake,” NIH director Francis Collins, MD, told AP earlier this month. “I think this is an effort to try to achieve efficiencies but not to sacrifice rigor.”
This article first appeared on WebMD.com.
About half of Americans say they would get a COVID-19 vaccine if one is available, according to the Associated Press.
The poll was conducted May 14-18 and released May 27.
A massive national and international effort is underway to develop a vaccine for the coronavirus. According to the poll, 20% of Americans believe a vaccine will be available before the end of 2020. Another 61% think it will arrive in 2021, and 17% say it will take longer.
“It’s always better to under-promise and over-deliver,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, told the AP.
Americans over age 60 were more likely to say they’ll get a coronavirus vaccine when it’s available. Those who worry that they or someone in their household could become infected with the virus were also more likely to say they’ll get a vaccine. However, Black Americans were more likely than were Hispanic or white responders to say that they don’t plan to get a vaccine.
Among those who plan to get a vaccine, 93% said they want to protect themselves, and 88% said they want to protect their family. About 72% said “life won’t go back to normal until most people are vaccinated,” and 33% said they have a chronic health condition such as asthma or diabetes and believe it’s important to receive a vaccine.
Among those who don’t plan to get a vaccine, 70% said they’re concerned about side effects. Another 42% are worried about getting the coronavirus from the vaccine. Others say they’re not concerned about getting seriously ill from the coronavirus, they don’t think vaccines work well, the COVID-19 outbreak isn’t serious, or they don’t like needles.
The National Institutes of Health says that safety is the top priority and is creating a plan to test the vaccine in thousands of people for safety and efficacy in coming months, according to the AP.
“I would not want people to think that we’re cutting corners because that would be a big mistake,” NIH director Francis Collins, MD, told AP earlier this month. “I think this is an effort to try to achieve efficiencies but not to sacrifice rigor.”
This article first appeared on WebMD.com.
About half of Americans say they would get a COVID-19 vaccine if one is available, according to the Associated Press.
The poll was conducted May 14-18 and released May 27.
A massive national and international effort is underway to develop a vaccine for the coronavirus. According to the poll, 20% of Americans believe a vaccine will be available before the end of 2020. Another 61% think it will arrive in 2021, and 17% say it will take longer.
“It’s always better to under-promise and over-deliver,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, told the AP.
Americans over age 60 were more likely to say they’ll get a coronavirus vaccine when it’s available. Those who worry that they or someone in their household could become infected with the virus were also more likely to say they’ll get a vaccine. However, Black Americans were more likely than were Hispanic or white responders to say that they don’t plan to get a vaccine.
Among those who plan to get a vaccine, 93% said they want to protect themselves, and 88% said they want to protect their family. About 72% said “life won’t go back to normal until most people are vaccinated,” and 33% said they have a chronic health condition such as asthma or diabetes and believe it’s important to receive a vaccine.
Among those who don’t plan to get a vaccine, 70% said they’re concerned about side effects. Another 42% are worried about getting the coronavirus from the vaccine. Others say they’re not concerned about getting seriously ill from the coronavirus, they don’t think vaccines work well, the COVID-19 outbreak isn’t serious, or they don’t like needles.
The National Institutes of Health says that safety is the top priority and is creating a plan to test the vaccine in thousands of people for safety and efficacy in coming months, according to the AP.
“I would not want people to think that we’re cutting corners because that would be a big mistake,” NIH director Francis Collins, MD, told AP earlier this month. “I think this is an effort to try to achieve efficiencies but not to sacrifice rigor.”
This article first appeared on WebMD.com.
Domestic violence amid COVID-19: Helping your patients from afar
Roger R., MD, a primary care physician from Philadelphia, set up a telemedicine appointment with a 24-year-old female patient who was experiencing headaches and was worried she might have COVID-19.
During the televisit, Dr. R. noticed that “Tonya” (not her real name) had a purplish bruise under her right eye. When asked how she got the bruise, Tonya said she had bumped into a dresser. The physician suspected abuse. He then heard a man’s voice in the background and thought it might belong to the abuser. “Is this a good time for you to talk?” he asked Tonya.
Tonya hesitated.
“When might be a better time?”
Tonya suggested an alternate time, and the physician called her then. During the visit, she shared that her fiancé, a car salesman who was also sheltering at home, was punching her.
“He always had a bad temper. Once he shoved me, but he’s never hit me before. And when he was upset, we used to go out to eat and he calmed down. Now, we’re stuck inside, we can’t even get away from each other to go to work, and he’s getting scary,” she told the doctor.
The physician asked if she would like to be connected with a domestic violence counselor. When Tonya agreed, he called Jessica DuBois Palardy, a licensed social worker and the program supervisor at STOP Intimate Partner Violence, a Philadelphia-based collaborative project of the Children’s Hospital of Philadelphia and the Lutheran Settlement House’s Bilingual Domestic Violence Program.
A ‘horrifying’ trend
Tonya’s story is not unique. A United Nations report shows that there has been a “horrifying global surge in domestic violence” linked to “lockdowns imposed by the governments responding to the COVID-19 pandemic.” The United States is no exception – 2,345 calls were placed to the National Domestic Violence Hotline during March 16–April 6, 2020.
Carole Warshaw, MD, director of the National Center on Domestic Violence, Trauma, and Mental Health in Chicago, said, “We know that intimate partner violence is increasing among people sheltering at home, and that abuse has become more severe.”
Even in nonabusive situations, being confined together at close quarters, often amid family stress and financial hardship, can be wearing, and tempers can flare. In an abusive relationship, “the main contributor to violence during shelter-in-place restrictions is that the isolation gives abusers more opportunities for controlling their partners, who have fewer options for accessing safety and support,” Dr. Warshaw said.
It is critical to “approach every clinical encounter knowing that domestic violence may be at play,” she emphasized.
Physicians might be the most important lifeline
Physicians are already facing myriad COVID-19–related challenges, and having another concern to keep in mind may be daunting.
“We’re in uncharted territory and we’re all trying to figure out how to navigate this time, how to practice medicine via phone and video conferences, and how to deal with the financial repercussions of the pandemic – not to mention concern for the health of our families,” said Peter F. Cronholm, MD, associate professor of family medicine and community health at the Hospital of the University of Pennsylvania, Philadelphia. “So maintaining vigilance is often difficult. Nevertheless, it’s important not to let this critical issue fall to the wayside.”
Marcella Nyachogo, MSW, a licensed social worker and assistant director of the Bilingual Domestic Violence Program, noted that physicians and other health care providers “may be the only people the patient interacts with, since the abuser may cut the survivor off from family and friends. And because the survivor isn’t leaving the house, he or she doesn’t have an opportunity to interact with coworkers or others – which makes health care providers the most important lifeline.”
COVID-19 as a weapon of abuse
Carey Watson, MD, regional medical director of the Family Violence Prevention Program at Kaiser Permanente in northern California, points to a disturbing trend in COVID-19–related abuse.
“Unfortunately, I’m hearing more and more accounts of how the illness itself can be one more weapon in the abuser’s arsenal,” she said.
Experts say that increasingly, abusers are claiming that their partner, who is employed in an “essential” job outside the home, is carrying the virus, and they are using this as a means of control and manipulation.
This is especially true of abusive partners of health care providers, Dr. Watson noted. She recounted the story of a divorced nurse whose husband did not allow her to have contact with their children, allegedly out of concern that she might have COVID-19, and would threaten her with a gun when she protested.
“It is important to keep this abusive tactic in mind, not only when dealing with patients but also with fellow physicians and health care professionals, and check in to see if everything is okay – especially if they seem particularly stressed out or distant,” Dr. Watson recommended.
Trust your clinical gut
How can you tell if your patients might be experiencing abuse when you’re not seeing them in person?
Pay attention to subtle signals and “trust your clinical gut when something doesn’t feel right,” Ms. Nyachogo advised.
If a patient’s demeanor is jittery or anxious or if someone next to him or her is answering all the questions or interrupting the visit, these could be red flags.
Dr. Cronholm added that telemedicine visits offer a “rare window into a patient’s home life that would not be available in an office visit.” For example, a house in disarray, the presence of broken objects, or the presence of another person hovering in the background suggests the need for further exploration.
“The main thing for all providers to keep in mind is ‘first, do no harm,’ ” Ms. Nyachogo emphasized.
“Our agency has been working for years with medical professionals in how to screen and connect folks with help most effectively and safely, and – although the specific situations posed by COVID are new – the overall approach is the same, which is to proceed with caution in how you approach the subject and how you make referrals,” she said.
Begin by asking if it is a convenient time to talk.
“This question takes the onus off the patient, who may not know how to communicate that she has no privacy or is in the middle of an argument,” explained Elsa Swenson, program manager of Home Free community program, which serves individuals experiencing domestic violence. The program is part of Minnesota-based Missions Inc. Programs, which serves those experiencing domestic abuse and chemical dependency.
If the patient indicates that it isn’t a convenient time to talk, find out when would be a better time. “This might be difficult for busy physicians and may not be what they’re accustomed to when calling a patient at home, but the patient’s circumstances are unknown to you, so it’s essential to organize around their ability to talk,” Ms. Swenson noted.
‘Are you alone?’
Another important piece of information is whether the patient has privacy – which can be tricky if the abuser is standing right there.
“You don’t want to tip the abuser off to your concerns, so you need to frame the question in a neutral way,” Dr. Watson advised.
For example, you might say that HIPAA laws require that you conduct the consultation with no one else present, and find out if there is a location in the house where the patient can have privacy.
It might be easier to talk on the phone than via video, suggests Florence Remes, a New Jersey–based licensed social worker who specializes in domestic violence. Going into another room and playing music or turning on the television might make it less obvious that a call is taking place, and the abuser would be less likely to overhear the caller’s conversation.
Dr. Watson suggested that questions about abuse might be included with other questions and asked in a simple yes/no format. “I’d like to ask you some standard questions I’m asking everyone during the pandemic. Do you have a cough or fever? Do you have any other physical symptoms? Do you have access to hand sanitizer? How is your sleep? Are you experiencing stress? Do you feel safe at home?”
The abuser, if present, will only hear the patient’s “yes” or “no” without knowing the question. If the patient indicates that she is being abused but is unable to talk, a later time can be arranged to further explore the issue.
Technology is a double-edged sword
Modern technologies have been a great boon to patients and physicians during this time of social distancing, allowing ongoing contact and health care when it would not otherwise have been possible. On the other hand, technology is fraught with potential dangers that can jeopardize the patient’s safety and compromise privacy.
Ms. Remes recounted the story of “Susan,” a client with whom she had been conducting teletherapy visits using an approved HIPAA-compliant telemedicine forum. Susan was working from home because of shelter-in-place restrictions. Her husband had been abusive, and Susan was concerned he might be “sabotaging” the household’s WiFi to isolate her from outside sources of support.
At the recommendation of Ms. Remes, Susan continued sessions either via phone calls or by using the WhatsApp program on her cellphone. Many of the requirements governing HIPAA privacy regulations have been temporarily relaxed, and clinicians can use non–encrypted forms of transmission, such as FaceTime, WhatsApp, or Skype, if no other platform is available.
But even cellphones have risks, Dr. Warshaw noted. The patient’s abuser might track texts or look at call logs – especially on unsecured platforms. It’s advisable to ask patients about who has access to their phone and computer and discuss ways to increase security.
Follow the patient’s lead
Proceed slowly and start with nonthreatening questions, Ms. Palardy advised. “I notice you have some injuries; can you tell me how you got them? Did someone hurt you? What does your relationship look like when you argue? Is there anything that makes you feel uncomfortable or unsafe?”
Emphasizing that you are asking these questions because of care and concern is reassuring and helps patients to feel they are not alone, Ms. Nyachogo pointed out.
“As your doctor, I’m worried about your health and (if relevant) your children’s safety. I can help connect you with counseling and support, legal resources, and a shelter, and everything is free and confidential. Would you be interested?” she said.
If the client acknowledges abuse, “follow their lead, but don’t push too hard,” Ms. Nyachogo warned.
“It is the client’s choice whether or not to take action,” she noted. “I’ve met survivors who said that it wasn’t until a doctor or nurse expressed concern about bruises that it even occurred to them that they were being abused. Some lied to the doctor about how they got hurt – but the question planted a seed, even though it might have taken years to follow up on the referral,” she said.
What if the patient doesn’t want to get help?
If a patient is not ready to seek help, you can create a home-safety plan. This might include setting follow-up times. If you don’t hear from him or her, you should then call the police. Or you might create a “code word,” such as “apple pie.” If the patient uses that word during a session, you know her life is in danger, Ms. Remes suggested.
Providing written information about how to get help is important but can be problematic if the abuser finds it.
Ms. Nyachogo recommends e-mailing follow-up materials that cover a variety of topics, such as keeping safe during the COVID-19 pandemic, relaxation, healthy eating, getting exercise while homebound, activities for children, and suggestions for hotlines and other resources if one is feeling suicidal or unsafe.
“If you present these as your ‘standard’ follow-up materials, the abuser is less likely to become suspicious,” Ms. Nyachogo noted.
Resources are available during COVID-19
All of the experts emphasize that resources for victims of domestic violence remain available during the COVID-19 pandemic, although some shelters may be operating at reduced capacity. Some agencies are finding alternatives to group shelters, such as hotels or Airbnb, which carry less risk of catching COVID-19.
Referring a patient to domestic violence resources is a delicate process. “You don’t want referring the patient for help to further endanger their life,” Ms. Nyachogo said.
The more you can take the burden off the patient, the better. If she is interested in getting help, you can call a domestic violence counselor or advocate while she is on the phone.
“This type of ‘warm handoff’ is what Tonya’s physician did,” Ms. Palardy recounted.
A warm handoff requires that physicians be familiar with domestic violence resources, Dr. Warshaw emphasized.
“Don’t wait until you are working with someone who needs help to find out where to refer them. Take the time to proactively research local agencies specializing in domestic violence and have their phone numbers on hand, so you can offer resources immediately if the person is interested,” she advised. The National Domestic Violence Hotline can also assist with safety planning and access to local resources.
‘Thinking on your feet’ critical for physicians
Addressing domestic violence during this unprecedented time requires “thinking on your feet” about novel forms of detection and intervention, Dr. Watson said. This involves a combination of clinical acumen, creativity, and finely honed intuition.
Ms. Nyachogo added, “Keeping an eye on domestic violence can feel like an extra burden, but don’t forget that it is lifesaving work.”
Resources
National Domestic Violence Hotline
- 800-799-SAFE (7233)
- The patient can also text LOVEIS to 22522.
National Center on Domestic Violence, Trauma, and Mental Health
- Provides resources for health care, mental health, and substance use treatment and recovery support providers on responding to domestic violence and other trauma.
- Provides resources for professionals and patients regarding access to substance use and mental health care during the COVID-1 pandemic.
- Provides support for parents, caregivers, and children during the pandemic.
- Provides resources for advocates serving families affected by domestic violence.
- A state-by-state guide to local resources
Children’s Hospital of Philadelphia Research Institute
STOP Intimate Partner Violence (IPV)
New Jersey Coalition for Domestic Violence
American Bar Association COVID-19 resources for communities
- Text HOME to 741741.
National Network to End Domestic Violence (NNEDV) COVID-19 Technology Safety
A version of this article originally appeared on Medscape.com.
Roger R., MD, a primary care physician from Philadelphia, set up a telemedicine appointment with a 24-year-old female patient who was experiencing headaches and was worried she might have COVID-19.
During the televisit, Dr. R. noticed that “Tonya” (not her real name) had a purplish bruise under her right eye. When asked how she got the bruise, Tonya said she had bumped into a dresser. The physician suspected abuse. He then heard a man’s voice in the background and thought it might belong to the abuser. “Is this a good time for you to talk?” he asked Tonya.
Tonya hesitated.
“When might be a better time?”
Tonya suggested an alternate time, and the physician called her then. During the visit, she shared that her fiancé, a car salesman who was also sheltering at home, was punching her.
“He always had a bad temper. Once he shoved me, but he’s never hit me before. And when he was upset, we used to go out to eat and he calmed down. Now, we’re stuck inside, we can’t even get away from each other to go to work, and he’s getting scary,” she told the doctor.
The physician asked if she would like to be connected with a domestic violence counselor. When Tonya agreed, he called Jessica DuBois Palardy, a licensed social worker and the program supervisor at STOP Intimate Partner Violence, a Philadelphia-based collaborative project of the Children’s Hospital of Philadelphia and the Lutheran Settlement House’s Bilingual Domestic Violence Program.
A ‘horrifying’ trend
Tonya’s story is not unique. A United Nations report shows that there has been a “horrifying global surge in domestic violence” linked to “lockdowns imposed by the governments responding to the COVID-19 pandemic.” The United States is no exception – 2,345 calls were placed to the National Domestic Violence Hotline during March 16–April 6, 2020.
Carole Warshaw, MD, director of the National Center on Domestic Violence, Trauma, and Mental Health in Chicago, said, “We know that intimate partner violence is increasing among people sheltering at home, and that abuse has become more severe.”
Even in nonabusive situations, being confined together at close quarters, often amid family stress and financial hardship, can be wearing, and tempers can flare. In an abusive relationship, “the main contributor to violence during shelter-in-place restrictions is that the isolation gives abusers more opportunities for controlling their partners, who have fewer options for accessing safety and support,” Dr. Warshaw said.
It is critical to “approach every clinical encounter knowing that domestic violence may be at play,” she emphasized.
Physicians might be the most important lifeline
Physicians are already facing myriad COVID-19–related challenges, and having another concern to keep in mind may be daunting.
“We’re in uncharted territory and we’re all trying to figure out how to navigate this time, how to practice medicine via phone and video conferences, and how to deal with the financial repercussions of the pandemic – not to mention concern for the health of our families,” said Peter F. Cronholm, MD, associate professor of family medicine and community health at the Hospital of the University of Pennsylvania, Philadelphia. “So maintaining vigilance is often difficult. Nevertheless, it’s important not to let this critical issue fall to the wayside.”
Marcella Nyachogo, MSW, a licensed social worker and assistant director of the Bilingual Domestic Violence Program, noted that physicians and other health care providers “may be the only people the patient interacts with, since the abuser may cut the survivor off from family and friends. And because the survivor isn’t leaving the house, he or she doesn’t have an opportunity to interact with coworkers or others – which makes health care providers the most important lifeline.”
COVID-19 as a weapon of abuse
Carey Watson, MD, regional medical director of the Family Violence Prevention Program at Kaiser Permanente in northern California, points to a disturbing trend in COVID-19–related abuse.
“Unfortunately, I’m hearing more and more accounts of how the illness itself can be one more weapon in the abuser’s arsenal,” she said.
Experts say that increasingly, abusers are claiming that their partner, who is employed in an “essential” job outside the home, is carrying the virus, and they are using this as a means of control and manipulation.
This is especially true of abusive partners of health care providers, Dr. Watson noted. She recounted the story of a divorced nurse whose husband did not allow her to have contact with their children, allegedly out of concern that she might have COVID-19, and would threaten her with a gun when she protested.
“It is important to keep this abusive tactic in mind, not only when dealing with patients but also with fellow physicians and health care professionals, and check in to see if everything is okay – especially if they seem particularly stressed out or distant,” Dr. Watson recommended.
Trust your clinical gut
How can you tell if your patients might be experiencing abuse when you’re not seeing them in person?
Pay attention to subtle signals and “trust your clinical gut when something doesn’t feel right,” Ms. Nyachogo advised.
If a patient’s demeanor is jittery or anxious or if someone next to him or her is answering all the questions or interrupting the visit, these could be red flags.
Dr. Cronholm added that telemedicine visits offer a “rare window into a patient’s home life that would not be available in an office visit.” For example, a house in disarray, the presence of broken objects, or the presence of another person hovering in the background suggests the need for further exploration.
“The main thing for all providers to keep in mind is ‘first, do no harm,’ ” Ms. Nyachogo emphasized.
“Our agency has been working for years with medical professionals in how to screen and connect folks with help most effectively and safely, and – although the specific situations posed by COVID are new – the overall approach is the same, which is to proceed with caution in how you approach the subject and how you make referrals,” she said.
Begin by asking if it is a convenient time to talk.
“This question takes the onus off the patient, who may not know how to communicate that she has no privacy or is in the middle of an argument,” explained Elsa Swenson, program manager of Home Free community program, which serves individuals experiencing domestic violence. The program is part of Minnesota-based Missions Inc. Programs, which serves those experiencing domestic abuse and chemical dependency.
If the patient indicates that it isn’t a convenient time to talk, find out when would be a better time. “This might be difficult for busy physicians and may not be what they’re accustomed to when calling a patient at home, but the patient’s circumstances are unknown to you, so it’s essential to organize around their ability to talk,” Ms. Swenson noted.
‘Are you alone?’
Another important piece of information is whether the patient has privacy – which can be tricky if the abuser is standing right there.
“You don’t want to tip the abuser off to your concerns, so you need to frame the question in a neutral way,” Dr. Watson advised.
For example, you might say that HIPAA laws require that you conduct the consultation with no one else present, and find out if there is a location in the house where the patient can have privacy.
It might be easier to talk on the phone than via video, suggests Florence Remes, a New Jersey–based licensed social worker who specializes in domestic violence. Going into another room and playing music or turning on the television might make it less obvious that a call is taking place, and the abuser would be less likely to overhear the caller’s conversation.
Dr. Watson suggested that questions about abuse might be included with other questions and asked in a simple yes/no format. “I’d like to ask you some standard questions I’m asking everyone during the pandemic. Do you have a cough or fever? Do you have any other physical symptoms? Do you have access to hand sanitizer? How is your sleep? Are you experiencing stress? Do you feel safe at home?”
The abuser, if present, will only hear the patient’s “yes” or “no” without knowing the question. If the patient indicates that she is being abused but is unable to talk, a later time can be arranged to further explore the issue.
Technology is a double-edged sword
Modern technologies have been a great boon to patients and physicians during this time of social distancing, allowing ongoing contact and health care when it would not otherwise have been possible. On the other hand, technology is fraught with potential dangers that can jeopardize the patient’s safety and compromise privacy.
Ms. Remes recounted the story of “Susan,” a client with whom she had been conducting teletherapy visits using an approved HIPAA-compliant telemedicine forum. Susan was working from home because of shelter-in-place restrictions. Her husband had been abusive, and Susan was concerned he might be “sabotaging” the household’s WiFi to isolate her from outside sources of support.
At the recommendation of Ms. Remes, Susan continued sessions either via phone calls or by using the WhatsApp program on her cellphone. Many of the requirements governing HIPAA privacy regulations have been temporarily relaxed, and clinicians can use non–encrypted forms of transmission, such as FaceTime, WhatsApp, or Skype, if no other platform is available.
But even cellphones have risks, Dr. Warshaw noted. The patient’s abuser might track texts or look at call logs – especially on unsecured platforms. It’s advisable to ask patients about who has access to their phone and computer and discuss ways to increase security.
Follow the patient’s lead
Proceed slowly and start with nonthreatening questions, Ms. Palardy advised. “I notice you have some injuries; can you tell me how you got them? Did someone hurt you? What does your relationship look like when you argue? Is there anything that makes you feel uncomfortable or unsafe?”
Emphasizing that you are asking these questions because of care and concern is reassuring and helps patients to feel they are not alone, Ms. Nyachogo pointed out.
“As your doctor, I’m worried about your health and (if relevant) your children’s safety. I can help connect you with counseling and support, legal resources, and a shelter, and everything is free and confidential. Would you be interested?” she said.
If the client acknowledges abuse, “follow their lead, but don’t push too hard,” Ms. Nyachogo warned.
“It is the client’s choice whether or not to take action,” she noted. “I’ve met survivors who said that it wasn’t until a doctor or nurse expressed concern about bruises that it even occurred to them that they were being abused. Some lied to the doctor about how they got hurt – but the question planted a seed, even though it might have taken years to follow up on the referral,” she said.
What if the patient doesn’t want to get help?
If a patient is not ready to seek help, you can create a home-safety plan. This might include setting follow-up times. If you don’t hear from him or her, you should then call the police. Or you might create a “code word,” such as “apple pie.” If the patient uses that word during a session, you know her life is in danger, Ms. Remes suggested.
Providing written information about how to get help is important but can be problematic if the abuser finds it.
Ms. Nyachogo recommends e-mailing follow-up materials that cover a variety of topics, such as keeping safe during the COVID-19 pandemic, relaxation, healthy eating, getting exercise while homebound, activities for children, and suggestions for hotlines and other resources if one is feeling suicidal or unsafe.
“If you present these as your ‘standard’ follow-up materials, the abuser is less likely to become suspicious,” Ms. Nyachogo noted.
Resources are available during COVID-19
All of the experts emphasize that resources for victims of domestic violence remain available during the COVID-19 pandemic, although some shelters may be operating at reduced capacity. Some agencies are finding alternatives to group shelters, such as hotels or Airbnb, which carry less risk of catching COVID-19.
Referring a patient to domestic violence resources is a delicate process. “You don’t want referring the patient for help to further endanger their life,” Ms. Nyachogo said.
The more you can take the burden off the patient, the better. If she is interested in getting help, you can call a domestic violence counselor or advocate while she is on the phone.
“This type of ‘warm handoff’ is what Tonya’s physician did,” Ms. Palardy recounted.
A warm handoff requires that physicians be familiar with domestic violence resources, Dr. Warshaw emphasized.
“Don’t wait until you are working with someone who needs help to find out where to refer them. Take the time to proactively research local agencies specializing in domestic violence and have their phone numbers on hand, so you can offer resources immediately if the person is interested,” she advised. The National Domestic Violence Hotline can also assist with safety planning and access to local resources.
‘Thinking on your feet’ critical for physicians
Addressing domestic violence during this unprecedented time requires “thinking on your feet” about novel forms of detection and intervention, Dr. Watson said. This involves a combination of clinical acumen, creativity, and finely honed intuition.
Ms. Nyachogo added, “Keeping an eye on domestic violence can feel like an extra burden, but don’t forget that it is lifesaving work.”
Resources
National Domestic Violence Hotline
- 800-799-SAFE (7233)
- The patient can also text LOVEIS to 22522.
National Center on Domestic Violence, Trauma, and Mental Health
- Provides resources for health care, mental health, and substance use treatment and recovery support providers on responding to domestic violence and other trauma.
- Provides resources for professionals and patients regarding access to substance use and mental health care during the COVID-1 pandemic.
- Provides support for parents, caregivers, and children during the pandemic.
- Provides resources for advocates serving families affected by domestic violence.
- A state-by-state guide to local resources
Children’s Hospital of Philadelphia Research Institute
STOP Intimate Partner Violence (IPV)
New Jersey Coalition for Domestic Violence
American Bar Association COVID-19 resources for communities
- Text HOME to 741741.
National Network to End Domestic Violence (NNEDV) COVID-19 Technology Safety
A version of this article originally appeared on Medscape.com.
Roger R., MD, a primary care physician from Philadelphia, set up a telemedicine appointment with a 24-year-old female patient who was experiencing headaches and was worried she might have COVID-19.
During the televisit, Dr. R. noticed that “Tonya” (not her real name) had a purplish bruise under her right eye. When asked how she got the bruise, Tonya said she had bumped into a dresser. The physician suspected abuse. He then heard a man’s voice in the background and thought it might belong to the abuser. “Is this a good time for you to talk?” he asked Tonya.
Tonya hesitated.
“When might be a better time?”
Tonya suggested an alternate time, and the physician called her then. During the visit, she shared that her fiancé, a car salesman who was also sheltering at home, was punching her.
“He always had a bad temper. Once he shoved me, but he’s never hit me before. And when he was upset, we used to go out to eat and he calmed down. Now, we’re stuck inside, we can’t even get away from each other to go to work, and he’s getting scary,” she told the doctor.
The physician asked if she would like to be connected with a domestic violence counselor. When Tonya agreed, he called Jessica DuBois Palardy, a licensed social worker and the program supervisor at STOP Intimate Partner Violence, a Philadelphia-based collaborative project of the Children’s Hospital of Philadelphia and the Lutheran Settlement House’s Bilingual Domestic Violence Program.
A ‘horrifying’ trend
Tonya’s story is not unique. A United Nations report shows that there has been a “horrifying global surge in domestic violence” linked to “lockdowns imposed by the governments responding to the COVID-19 pandemic.” The United States is no exception – 2,345 calls were placed to the National Domestic Violence Hotline during March 16–April 6, 2020.
Carole Warshaw, MD, director of the National Center on Domestic Violence, Trauma, and Mental Health in Chicago, said, “We know that intimate partner violence is increasing among people sheltering at home, and that abuse has become more severe.”
Even in nonabusive situations, being confined together at close quarters, often amid family stress and financial hardship, can be wearing, and tempers can flare. In an abusive relationship, “the main contributor to violence during shelter-in-place restrictions is that the isolation gives abusers more opportunities for controlling their partners, who have fewer options for accessing safety and support,” Dr. Warshaw said.
It is critical to “approach every clinical encounter knowing that domestic violence may be at play,” she emphasized.
Physicians might be the most important lifeline
Physicians are already facing myriad COVID-19–related challenges, and having another concern to keep in mind may be daunting.
“We’re in uncharted territory and we’re all trying to figure out how to navigate this time, how to practice medicine via phone and video conferences, and how to deal with the financial repercussions of the pandemic – not to mention concern for the health of our families,” said Peter F. Cronholm, MD, associate professor of family medicine and community health at the Hospital of the University of Pennsylvania, Philadelphia. “So maintaining vigilance is often difficult. Nevertheless, it’s important not to let this critical issue fall to the wayside.”
Marcella Nyachogo, MSW, a licensed social worker and assistant director of the Bilingual Domestic Violence Program, noted that physicians and other health care providers “may be the only people the patient interacts with, since the abuser may cut the survivor off from family and friends. And because the survivor isn’t leaving the house, he or she doesn’t have an opportunity to interact with coworkers or others – which makes health care providers the most important lifeline.”
COVID-19 as a weapon of abuse
Carey Watson, MD, regional medical director of the Family Violence Prevention Program at Kaiser Permanente in northern California, points to a disturbing trend in COVID-19–related abuse.
“Unfortunately, I’m hearing more and more accounts of how the illness itself can be one more weapon in the abuser’s arsenal,” she said.
Experts say that increasingly, abusers are claiming that their partner, who is employed in an “essential” job outside the home, is carrying the virus, and they are using this as a means of control and manipulation.
This is especially true of abusive partners of health care providers, Dr. Watson noted. She recounted the story of a divorced nurse whose husband did not allow her to have contact with their children, allegedly out of concern that she might have COVID-19, and would threaten her with a gun when she protested.
“It is important to keep this abusive tactic in mind, not only when dealing with patients but also with fellow physicians and health care professionals, and check in to see if everything is okay – especially if they seem particularly stressed out or distant,” Dr. Watson recommended.
Trust your clinical gut
How can you tell if your patients might be experiencing abuse when you’re not seeing them in person?
Pay attention to subtle signals and “trust your clinical gut when something doesn’t feel right,” Ms. Nyachogo advised.
If a patient’s demeanor is jittery or anxious or if someone next to him or her is answering all the questions or interrupting the visit, these could be red flags.
Dr. Cronholm added that telemedicine visits offer a “rare window into a patient’s home life that would not be available in an office visit.” For example, a house in disarray, the presence of broken objects, or the presence of another person hovering in the background suggests the need for further exploration.
“The main thing for all providers to keep in mind is ‘first, do no harm,’ ” Ms. Nyachogo emphasized.
“Our agency has been working for years with medical professionals in how to screen and connect folks with help most effectively and safely, and – although the specific situations posed by COVID are new – the overall approach is the same, which is to proceed with caution in how you approach the subject and how you make referrals,” she said.
Begin by asking if it is a convenient time to talk.
“This question takes the onus off the patient, who may not know how to communicate that she has no privacy or is in the middle of an argument,” explained Elsa Swenson, program manager of Home Free community program, which serves individuals experiencing domestic violence. The program is part of Minnesota-based Missions Inc. Programs, which serves those experiencing domestic abuse and chemical dependency.
If the patient indicates that it isn’t a convenient time to talk, find out when would be a better time. “This might be difficult for busy physicians and may not be what they’re accustomed to when calling a patient at home, but the patient’s circumstances are unknown to you, so it’s essential to organize around their ability to talk,” Ms. Swenson noted.
‘Are you alone?’
Another important piece of information is whether the patient has privacy – which can be tricky if the abuser is standing right there.
“You don’t want to tip the abuser off to your concerns, so you need to frame the question in a neutral way,” Dr. Watson advised.
For example, you might say that HIPAA laws require that you conduct the consultation with no one else present, and find out if there is a location in the house where the patient can have privacy.
It might be easier to talk on the phone than via video, suggests Florence Remes, a New Jersey–based licensed social worker who specializes in domestic violence. Going into another room and playing music or turning on the television might make it less obvious that a call is taking place, and the abuser would be less likely to overhear the caller’s conversation.
Dr. Watson suggested that questions about abuse might be included with other questions and asked in a simple yes/no format. “I’d like to ask you some standard questions I’m asking everyone during the pandemic. Do you have a cough or fever? Do you have any other physical symptoms? Do you have access to hand sanitizer? How is your sleep? Are you experiencing stress? Do you feel safe at home?”
The abuser, if present, will only hear the patient’s “yes” or “no” without knowing the question. If the patient indicates that she is being abused but is unable to talk, a later time can be arranged to further explore the issue.
Technology is a double-edged sword
Modern technologies have been a great boon to patients and physicians during this time of social distancing, allowing ongoing contact and health care when it would not otherwise have been possible. On the other hand, technology is fraught with potential dangers that can jeopardize the patient’s safety and compromise privacy.
Ms. Remes recounted the story of “Susan,” a client with whom she had been conducting teletherapy visits using an approved HIPAA-compliant telemedicine forum. Susan was working from home because of shelter-in-place restrictions. Her husband had been abusive, and Susan was concerned he might be “sabotaging” the household’s WiFi to isolate her from outside sources of support.
At the recommendation of Ms. Remes, Susan continued sessions either via phone calls or by using the WhatsApp program on her cellphone. Many of the requirements governing HIPAA privacy regulations have been temporarily relaxed, and clinicians can use non–encrypted forms of transmission, such as FaceTime, WhatsApp, or Skype, if no other platform is available.
But even cellphones have risks, Dr. Warshaw noted. The patient’s abuser might track texts or look at call logs – especially on unsecured platforms. It’s advisable to ask patients about who has access to their phone and computer and discuss ways to increase security.
Follow the patient’s lead
Proceed slowly and start with nonthreatening questions, Ms. Palardy advised. “I notice you have some injuries; can you tell me how you got them? Did someone hurt you? What does your relationship look like when you argue? Is there anything that makes you feel uncomfortable or unsafe?”
Emphasizing that you are asking these questions because of care and concern is reassuring and helps patients to feel they are not alone, Ms. Nyachogo pointed out.
“As your doctor, I’m worried about your health and (if relevant) your children’s safety. I can help connect you with counseling and support, legal resources, and a shelter, and everything is free and confidential. Would you be interested?” she said.
If the client acknowledges abuse, “follow their lead, but don’t push too hard,” Ms. Nyachogo warned.
“It is the client’s choice whether or not to take action,” she noted. “I’ve met survivors who said that it wasn’t until a doctor or nurse expressed concern about bruises that it even occurred to them that they were being abused. Some lied to the doctor about how they got hurt – but the question planted a seed, even though it might have taken years to follow up on the referral,” she said.
What if the patient doesn’t want to get help?
If a patient is not ready to seek help, you can create a home-safety plan. This might include setting follow-up times. If you don’t hear from him or her, you should then call the police. Or you might create a “code word,” such as “apple pie.” If the patient uses that word during a session, you know her life is in danger, Ms. Remes suggested.
Providing written information about how to get help is important but can be problematic if the abuser finds it.
Ms. Nyachogo recommends e-mailing follow-up materials that cover a variety of topics, such as keeping safe during the COVID-19 pandemic, relaxation, healthy eating, getting exercise while homebound, activities for children, and suggestions for hotlines and other resources if one is feeling suicidal or unsafe.
“If you present these as your ‘standard’ follow-up materials, the abuser is less likely to become suspicious,” Ms. Nyachogo noted.
Resources are available during COVID-19
All of the experts emphasize that resources for victims of domestic violence remain available during the COVID-19 pandemic, although some shelters may be operating at reduced capacity. Some agencies are finding alternatives to group shelters, such as hotels or Airbnb, which carry less risk of catching COVID-19.
Referring a patient to domestic violence resources is a delicate process. “You don’t want referring the patient for help to further endanger their life,” Ms. Nyachogo said.
The more you can take the burden off the patient, the better. If she is interested in getting help, you can call a domestic violence counselor or advocate while she is on the phone.
“This type of ‘warm handoff’ is what Tonya’s physician did,” Ms. Palardy recounted.
A warm handoff requires that physicians be familiar with domestic violence resources, Dr. Warshaw emphasized.
“Don’t wait until you are working with someone who needs help to find out where to refer them. Take the time to proactively research local agencies specializing in domestic violence and have their phone numbers on hand, so you can offer resources immediately if the person is interested,” she advised. The National Domestic Violence Hotline can also assist with safety planning and access to local resources.
‘Thinking on your feet’ critical for physicians
Addressing domestic violence during this unprecedented time requires “thinking on your feet” about novel forms of detection and intervention, Dr. Watson said. This involves a combination of clinical acumen, creativity, and finely honed intuition.
Ms. Nyachogo added, “Keeping an eye on domestic violence can feel like an extra burden, but don’t forget that it is lifesaving work.”
Resources
National Domestic Violence Hotline
- 800-799-SAFE (7233)
- The patient can also text LOVEIS to 22522.
National Center on Domestic Violence, Trauma, and Mental Health
- Provides resources for health care, mental health, and substance use treatment and recovery support providers on responding to domestic violence and other trauma.
- Provides resources for professionals and patients regarding access to substance use and mental health care during the COVID-1 pandemic.
- Provides support for parents, caregivers, and children during the pandemic.
- Provides resources for advocates serving families affected by domestic violence.
- A state-by-state guide to local resources
Children’s Hospital of Philadelphia Research Institute
STOP Intimate Partner Violence (IPV)
New Jersey Coalition for Domestic Violence
American Bar Association COVID-19 resources for communities
- Text HOME to 741741.
National Network to End Domestic Violence (NNEDV) COVID-19 Technology Safety
A version of this article originally appeared on Medscape.com.
Seek safe strategies to diagnose gestational diabetes during pandemic
Clinicians and pregnant women are less likely to prescribe and undergo the oral glucose tolerance test (OGTT) to diagnose gestational diabetes in the context of the COVID-19 pandemic, according to a review by H. David McIntyre, MD, of the University of Queensland, Brisbane, Australia, and Robert G. Moses, MD, of Wollongong (Australia) Hospital.
National and international discussions of whether a one- or two-step test for gestational diabetes mellitus (GDM) is optimal, and which women should be tested are ongoing, but the potential for exposure risks to COVID-19 are impacting the test process, they wrote in a commentary published in Diabetes Care.
“Any national or local guidelines should be developed with the primary aim of being protective for pregnant women and workable in the current health crisis,” they wrote.
Key concerns expressed by women and health care providers include the need for travel to be tested, the possible need for two visits, and the several hours spent in a potentially high-risk specimen collection center.
“Further, a GDM diagnosis generally involves additional health service visits for diabetes education, glucose monitoring review, and fetal ultrasonography, all of which carry exposure risks during a pandemic,” Dr. McIntyre and Dr. Moses noted.
Professional societies in the United Kingdom, Canada, and Australia have issued guidance to clinicians for modifying GDM diagnoses criteria during the pandemic that aim to reduce the need for the oral glucose tolerance test both during and after pregnancy.
Pandemic guidelines for all three of these countries support the identification of GDM using early pregnancy hemoglobin A1c (HbA1c) of at least 41 mmol/mol (5.9%).
Then, professionals in the United Kingdom recommend testing based on risk factors and diagnosing GDM based on any of these criteria: HbA1c of at least 39 mmol/mol (5.7%), fasting venous plasma glucose of at least 5.6 mmol/L (preferred), or random VPG of at least 9.0 mmol/L.
The revised testing pathway for Canada accepts an HbA1c of at least 39 mmol/mol (5.7%) and/or random VPG of at least 11.1 mmol/L.
“The revised Australian pathway does not include HbA1c but recommends a fasting VPG with progression to OGTT only if this result is 4.7-5.0 mmol/L,” Dr. McIntyre and Dr. Moses explained.
Overall, the revised guidelines for GDM testing will likely miss some women and only identify those with higher levels of hyperglycemia, the authors wrote. In addition, “the evidence base for these revised pathways is limited and that each alternative strategy should be evaluated over the course of the current pandemic.”
Validation of new testing strategies are needed, and the pandemic may provide and opportunity to adopt an alternative to the OGTT. The World Health Organization has not issued revised guidance for other methods of testing, but fasting VPG alone may be the simplest and most cost effective, at least for the short term, they noted.
“In this ‘new COVID world,’ GDM should not be ignored but pragmatically merits a lower priority than the avoidance of exposure to the COVID-19 virus,” although no single alternative strategy applies in all countries and situations, the authors concluded. Pragmatic measures and documentation of outcomes at the local level will offer the “least worst” solution while the pandemic continues.
The authors had no relevant financial disclosures.
SOURCE: McIntyre HD, Moses RG. Diabetes Care. 2020 May. doi: 10.2337/dci20-0026.
A major concern against the backdrop of COVID-19 is ensuring long-term health while urgent care is – understandably so – being prioritized over preventive care. We can already see the impact that the decrease in primary care has had: Rates of childhood vaccination appear to have dropped; the cancellation or indefinite delay of elective medical procedures has meant a reduction in preventive cancer screenings, such as colonoscopies and mammograms; and concerns about COVID-19 may be keeping those experiencing cardiac events from seeking emergency care.
However, an outcropping of the coronavirus pandemic is an ingenuity to adapt to our new “normal.” Medical licenses have been recognized across state lines to allow much-needed professionals to practice in the hardest-hit areas. Doctors retrofitted a sleep apnea machine to be used as a makeshift ventilator. Those in the wearable device market now have a greater onus to deliver on quality, utility, security, and accuracy.
Obstetricians have had to dramatically change delivery of ante-, intra- and postpartum care. The recent commentary by Dr. McIntyre and Dr. Moses focuses on one particular area of concern: screening, diagnosis, and management of gestational diabetes mellitus (GDM).
Screening and diagnosis are mainstays to reduce the adverse maternal and neonatal outcomes of diabetes in pregnancy. Although there is no universally accepted approach to evaluating GDM, all current methods utilize an oral glucose tolerance test (OGTT), which requires significant time spent in a clinical office setting, thus increasing risk for COVID-19 exposure.
Several countries have adopted modified GDM criteria within the last months. At the time of this writing, the United States has not. Although not testing women for GDM, which is what Dr. McIntyre and Dr. Moses point out may be happening in countries with modified guidelines, seems questionable, perhaps we should think differently about our approach.
More than 20 years ago, it was reported that jelly beans could be used as an alternative to the 50-g GDM screening test (Am J Obstet Gynecol. 1999 Nov;181[5 Pt 1]:1154‐7; Am J Obstet Gynecol. 1995 Dec;173[6]:1889‐92); more recently, candy twists were used with similar results (Am J Obstet Gynecol. 2015 Apr;212[4]:522.e1-5). In addition, a number of articles have reported on the utility of capillary whole blood glucose measurements to screen for GDM in developing and resource-limited countries (Diabetes Technol Ther. 2011;13[5]:586‐91; Acta Diabetol. 2016 Feb;53[1]:91‐7; Diabetes Technol Ther. 2012 Feb;14[2]:131-4). Therefore, rather than forgo GDM screening, women could self-administer a jelly bean test at home, measure blood sugar with a glucometer, and depending on the results, have an OGTT. Importantly, this would allow ob.gyns. to maintain medical standards while managing patients via telemedicine.
We have evidence that GDM can establish poor health for generations. We know that people with underlying conditions have greater morbidity and mortality from infectious diseases. We recognize that accurate screening and diagnosis is the key to prevention and management. Rather than accept a “least worst” scenario, as Dr. McIntyre and Dr. Moses state, we must find ways to provide the best possible care under the current circumstances.
E. Albert Reece, MD, PhD, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the University of Maryland School of Medicine. He said he had no relevant financial disclosures. He is a member of the Ob.Gyn. News editorial advisory board.
A major concern against the backdrop of COVID-19 is ensuring long-term health while urgent care is – understandably so – being prioritized over preventive care. We can already see the impact that the decrease in primary care has had: Rates of childhood vaccination appear to have dropped; the cancellation or indefinite delay of elective medical procedures has meant a reduction in preventive cancer screenings, such as colonoscopies and mammograms; and concerns about COVID-19 may be keeping those experiencing cardiac events from seeking emergency care.
However, an outcropping of the coronavirus pandemic is an ingenuity to adapt to our new “normal.” Medical licenses have been recognized across state lines to allow much-needed professionals to practice in the hardest-hit areas. Doctors retrofitted a sleep apnea machine to be used as a makeshift ventilator. Those in the wearable device market now have a greater onus to deliver on quality, utility, security, and accuracy.
Obstetricians have had to dramatically change delivery of ante-, intra- and postpartum care. The recent commentary by Dr. McIntyre and Dr. Moses focuses on one particular area of concern: screening, diagnosis, and management of gestational diabetes mellitus (GDM).
Screening and diagnosis are mainstays to reduce the adverse maternal and neonatal outcomes of diabetes in pregnancy. Although there is no universally accepted approach to evaluating GDM, all current methods utilize an oral glucose tolerance test (OGTT), which requires significant time spent in a clinical office setting, thus increasing risk for COVID-19 exposure.
Several countries have adopted modified GDM criteria within the last months. At the time of this writing, the United States has not. Although not testing women for GDM, which is what Dr. McIntyre and Dr. Moses point out may be happening in countries with modified guidelines, seems questionable, perhaps we should think differently about our approach.
More than 20 years ago, it was reported that jelly beans could be used as an alternative to the 50-g GDM screening test (Am J Obstet Gynecol. 1999 Nov;181[5 Pt 1]:1154‐7; Am J Obstet Gynecol. 1995 Dec;173[6]:1889‐92); more recently, candy twists were used with similar results (Am J Obstet Gynecol. 2015 Apr;212[4]:522.e1-5). In addition, a number of articles have reported on the utility of capillary whole blood glucose measurements to screen for GDM in developing and resource-limited countries (Diabetes Technol Ther. 2011;13[5]:586‐91; Acta Diabetol. 2016 Feb;53[1]:91‐7; Diabetes Technol Ther. 2012 Feb;14[2]:131-4). Therefore, rather than forgo GDM screening, women could self-administer a jelly bean test at home, measure blood sugar with a glucometer, and depending on the results, have an OGTT. Importantly, this would allow ob.gyns. to maintain medical standards while managing patients via telemedicine.
We have evidence that GDM can establish poor health for generations. We know that people with underlying conditions have greater morbidity and mortality from infectious diseases. We recognize that accurate screening and diagnosis is the key to prevention and management. Rather than accept a “least worst” scenario, as Dr. McIntyre and Dr. Moses state, we must find ways to provide the best possible care under the current circumstances.
E. Albert Reece, MD, PhD, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the University of Maryland School of Medicine. He said he had no relevant financial disclosures. He is a member of the Ob.Gyn. News editorial advisory board.
A major concern against the backdrop of COVID-19 is ensuring long-term health while urgent care is – understandably so – being prioritized over preventive care. We can already see the impact that the decrease in primary care has had: Rates of childhood vaccination appear to have dropped; the cancellation or indefinite delay of elective medical procedures has meant a reduction in preventive cancer screenings, such as colonoscopies and mammograms; and concerns about COVID-19 may be keeping those experiencing cardiac events from seeking emergency care.
However, an outcropping of the coronavirus pandemic is an ingenuity to adapt to our new “normal.” Medical licenses have been recognized across state lines to allow much-needed professionals to practice in the hardest-hit areas. Doctors retrofitted a sleep apnea machine to be used as a makeshift ventilator. Those in the wearable device market now have a greater onus to deliver on quality, utility, security, and accuracy.
Obstetricians have had to dramatically change delivery of ante-, intra- and postpartum care. The recent commentary by Dr. McIntyre and Dr. Moses focuses on one particular area of concern: screening, diagnosis, and management of gestational diabetes mellitus (GDM).
Screening and diagnosis are mainstays to reduce the adverse maternal and neonatal outcomes of diabetes in pregnancy. Although there is no universally accepted approach to evaluating GDM, all current methods utilize an oral glucose tolerance test (OGTT), which requires significant time spent in a clinical office setting, thus increasing risk for COVID-19 exposure.
Several countries have adopted modified GDM criteria within the last months. At the time of this writing, the United States has not. Although not testing women for GDM, which is what Dr. McIntyre and Dr. Moses point out may be happening in countries with modified guidelines, seems questionable, perhaps we should think differently about our approach.
More than 20 years ago, it was reported that jelly beans could be used as an alternative to the 50-g GDM screening test (Am J Obstet Gynecol. 1999 Nov;181[5 Pt 1]:1154‐7; Am J Obstet Gynecol. 1995 Dec;173[6]:1889‐92); more recently, candy twists were used with similar results (Am J Obstet Gynecol. 2015 Apr;212[4]:522.e1-5). In addition, a number of articles have reported on the utility of capillary whole blood glucose measurements to screen for GDM in developing and resource-limited countries (Diabetes Technol Ther. 2011;13[5]:586‐91; Acta Diabetol. 2016 Feb;53[1]:91‐7; Diabetes Technol Ther. 2012 Feb;14[2]:131-4). Therefore, rather than forgo GDM screening, women could self-administer a jelly bean test at home, measure blood sugar with a glucometer, and depending on the results, have an OGTT. Importantly, this would allow ob.gyns. to maintain medical standards while managing patients via telemedicine.
We have evidence that GDM can establish poor health for generations. We know that people with underlying conditions have greater morbidity and mortality from infectious diseases. We recognize that accurate screening and diagnosis is the key to prevention and management. Rather than accept a “least worst” scenario, as Dr. McIntyre and Dr. Moses state, we must find ways to provide the best possible care under the current circumstances.
E. Albert Reece, MD, PhD, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the University of Maryland School of Medicine. He said he had no relevant financial disclosures. He is a member of the Ob.Gyn. News editorial advisory board.
Clinicians and pregnant women are less likely to prescribe and undergo the oral glucose tolerance test (OGTT) to diagnose gestational diabetes in the context of the COVID-19 pandemic, according to a review by H. David McIntyre, MD, of the University of Queensland, Brisbane, Australia, and Robert G. Moses, MD, of Wollongong (Australia) Hospital.
National and international discussions of whether a one- or two-step test for gestational diabetes mellitus (GDM) is optimal, and which women should be tested are ongoing, but the potential for exposure risks to COVID-19 are impacting the test process, they wrote in a commentary published in Diabetes Care.
“Any national or local guidelines should be developed with the primary aim of being protective for pregnant women and workable in the current health crisis,” they wrote.
Key concerns expressed by women and health care providers include the need for travel to be tested, the possible need for two visits, and the several hours spent in a potentially high-risk specimen collection center.
“Further, a GDM diagnosis generally involves additional health service visits for diabetes education, glucose monitoring review, and fetal ultrasonography, all of which carry exposure risks during a pandemic,” Dr. McIntyre and Dr. Moses noted.
Professional societies in the United Kingdom, Canada, and Australia have issued guidance to clinicians for modifying GDM diagnoses criteria during the pandemic that aim to reduce the need for the oral glucose tolerance test both during and after pregnancy.
Pandemic guidelines for all three of these countries support the identification of GDM using early pregnancy hemoglobin A1c (HbA1c) of at least 41 mmol/mol (5.9%).
Then, professionals in the United Kingdom recommend testing based on risk factors and diagnosing GDM based on any of these criteria: HbA1c of at least 39 mmol/mol (5.7%), fasting venous plasma glucose of at least 5.6 mmol/L (preferred), or random VPG of at least 9.0 mmol/L.
The revised testing pathway for Canada accepts an HbA1c of at least 39 mmol/mol (5.7%) and/or random VPG of at least 11.1 mmol/L.
“The revised Australian pathway does not include HbA1c but recommends a fasting VPG with progression to OGTT only if this result is 4.7-5.0 mmol/L,” Dr. McIntyre and Dr. Moses explained.
Overall, the revised guidelines for GDM testing will likely miss some women and only identify those with higher levels of hyperglycemia, the authors wrote. In addition, “the evidence base for these revised pathways is limited and that each alternative strategy should be evaluated over the course of the current pandemic.”
Validation of new testing strategies are needed, and the pandemic may provide and opportunity to adopt an alternative to the OGTT. The World Health Organization has not issued revised guidance for other methods of testing, but fasting VPG alone may be the simplest and most cost effective, at least for the short term, they noted.
“In this ‘new COVID world,’ GDM should not be ignored but pragmatically merits a lower priority than the avoidance of exposure to the COVID-19 virus,” although no single alternative strategy applies in all countries and situations, the authors concluded. Pragmatic measures and documentation of outcomes at the local level will offer the “least worst” solution while the pandemic continues.
The authors had no relevant financial disclosures.
SOURCE: McIntyre HD, Moses RG. Diabetes Care. 2020 May. doi: 10.2337/dci20-0026.
Clinicians and pregnant women are less likely to prescribe and undergo the oral glucose tolerance test (OGTT) to diagnose gestational diabetes in the context of the COVID-19 pandemic, according to a review by H. David McIntyre, MD, of the University of Queensland, Brisbane, Australia, and Robert G. Moses, MD, of Wollongong (Australia) Hospital.
National and international discussions of whether a one- or two-step test for gestational diabetes mellitus (GDM) is optimal, and which women should be tested are ongoing, but the potential for exposure risks to COVID-19 are impacting the test process, they wrote in a commentary published in Diabetes Care.
“Any national or local guidelines should be developed with the primary aim of being protective for pregnant women and workable in the current health crisis,” they wrote.
Key concerns expressed by women and health care providers include the need for travel to be tested, the possible need for two visits, and the several hours spent in a potentially high-risk specimen collection center.
“Further, a GDM diagnosis generally involves additional health service visits for diabetes education, glucose monitoring review, and fetal ultrasonography, all of which carry exposure risks during a pandemic,” Dr. McIntyre and Dr. Moses noted.
Professional societies in the United Kingdom, Canada, and Australia have issued guidance to clinicians for modifying GDM diagnoses criteria during the pandemic that aim to reduce the need for the oral glucose tolerance test both during and after pregnancy.
Pandemic guidelines for all three of these countries support the identification of GDM using early pregnancy hemoglobin A1c (HbA1c) of at least 41 mmol/mol (5.9%).
Then, professionals in the United Kingdom recommend testing based on risk factors and diagnosing GDM based on any of these criteria: HbA1c of at least 39 mmol/mol (5.7%), fasting venous plasma glucose of at least 5.6 mmol/L (preferred), or random VPG of at least 9.0 mmol/L.
The revised testing pathway for Canada accepts an HbA1c of at least 39 mmol/mol (5.7%) and/or random VPG of at least 11.1 mmol/L.
“The revised Australian pathway does not include HbA1c but recommends a fasting VPG with progression to OGTT only if this result is 4.7-5.0 mmol/L,” Dr. McIntyre and Dr. Moses explained.
Overall, the revised guidelines for GDM testing will likely miss some women and only identify those with higher levels of hyperglycemia, the authors wrote. In addition, “the evidence base for these revised pathways is limited and that each alternative strategy should be evaluated over the course of the current pandemic.”
Validation of new testing strategies are needed, and the pandemic may provide and opportunity to adopt an alternative to the OGTT. The World Health Organization has not issued revised guidance for other methods of testing, but fasting VPG alone may be the simplest and most cost effective, at least for the short term, they noted.
“In this ‘new COVID world,’ GDM should not be ignored but pragmatically merits a lower priority than the avoidance of exposure to the COVID-19 virus,” although no single alternative strategy applies in all countries and situations, the authors concluded. Pragmatic measures and documentation of outcomes at the local level will offer the “least worst” solution while the pandemic continues.
The authors had no relevant financial disclosures.
SOURCE: McIntyre HD, Moses RG. Diabetes Care. 2020 May. doi: 10.2337/dci20-0026.
Severe disease not uncommon in children hospitalized with COVID-19
Children with COVID-19 are more likely to develop severe illness and require intensive care than previously realized, data from a single-center study suggest.
Jerry Y. Chao, MD, of the department of anesthesiology, Albert Einstein College of Medicine, New York, and colleagues reported their findings in an article published online May 11 in the Journal of Pediatrics.
“Thankfully most children with COVID-19 fare well, and some do not have any symptoms at all, but this research is a sobering reminder that children are not immune to this virus and some do require a higher level of care,” senior author Shivanand S. Medar, MD, FAAP, attending physician, Cardiac Intensive Care, Children’s Hospital at Montefiore, and assistant professor of pediatrics, Albert Einstein College of Medicine, said in a Montefiore Medical Center news release.
The study included 67 patients aged 1 month to 21 years (median, 13.1 years) who were treated for COVID-19 at a tertiary care children’s hospital between March 15 and April 13. Of those, 21 (31.3%) were treated as outpatients.
“As the number of patients screened for COVID-19 was restricted during the first weeks of the outbreak because of limited testing availability, the number of mildly symptomatic patients is not known, and therefore these 21 patients are not included in the analysis,” the authors wrote.
Of the 46 hospitalized patients, 33 (72%) were admitted to a general pediatric medical ward, and 13 (28%) were admitted to the pediatric intensive care unit (PICU).
Almost one-third (14 children; 30.4%) of the admitted patients were obese, and almost one-quarter (11 children; 24.4%) had asthma, but neither factor was associated with an increased risk for PICU admission.
“We know that in adults, obesity is a risk factor for more severe disease, however, surprisingly, our study found that children admitted to the intensive care unit did not have a higher prevalence of obesity than those on the general unit,” Dr. Chao said in the news release.
Three of the PICU patients (25%) had preexisting seizure disorders, as did one (3%) patient on the general medical unit. “There was no significant difference in the usage of ibuprofen prior to hospitalization among patients admitted to medical unit compared with those admitted to the PICU,” the authors wrote.
Platelet counts were lower in patients admitted to the PICU compared with those on the general medical unit; however, C-reactive protein, procalcitonin, and pro–brain natriuretic peptide levels were all elevated in patients admitted to the PICU compared with those admitted to the general medical unit.
Patients admitted to the PICU were more likely to need high-flow nasal cannula. Ten (77%) patients in the PICU developed acute respiratory distress syndrome (ARDS), and six (46.2%) of them needed “invasive mechanical ventilation for a median of 9 days.”
The only clinical symptom significantly linked to PICU admission was shortness of breath (92.3% vs 30.3%; P < .001).
Eight (61.5%) of the 13 patients treated in the PICU were discharged to home; four (30.7%) were still hospitalized and receiving ventilatory support on day 14. One patient had metastatic cancer and died as a result of the cancer after life-sustaining therapy was withdrawn.
Those admitted to the PICU were more likely to receive treatment with remdesivir via compassionate use compared with those treated in the general medical unit. Seven (53.8%) patients in the PICU developed severe sepsis and septic shock syndromes.
The average hospital stay was 4 days longer for the children admitted to the PICU than for the children admitted to the general medical unit.
Cough (63%) and fever (60.9%) were the most frequently reported symptoms at admission. The median duration of symptoms before admission was 3 days. None of the children had traveled to an area affected by COVID-19 before becoming ill, and only 20 (43.5%) children were confirmed to have had contact with someone with COVID-19. “The lack of a known sick contact reported in our study may have implications for how healthcare providers identify and screen for potential cases,” the authors explained.
Although children are believed to experience milder SARS-CoV-2 illness, these results and those of an earlier study suggest that some pediatric patients develop illness severe enough to require PICU admission. “This subset had significantly higher markers of inflammation (CRP, pro-BNP, procalcitonin) compared with patients in the medical unit. Inflammation likely contributed to the high rate of ARDS we observed, although serum levels of IL-6 and other cytokines linked to ARDS were not determined,” the authors wrote.
A retrospective cohort study found that of 177 children and young adults treated in a single center, patients younger than 1 year and older than 15 years were more likely to become critically ill with COVID-19 (J Pediatr. 2020 May. doi: 10.1016/j.jpeds.2020.05.007).
Each of the two age groups accounted for 32% of the hospitalized patients.
The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Children with COVID-19 are more likely to develop severe illness and require intensive care than previously realized, data from a single-center study suggest.
Jerry Y. Chao, MD, of the department of anesthesiology, Albert Einstein College of Medicine, New York, and colleagues reported their findings in an article published online May 11 in the Journal of Pediatrics.
“Thankfully most children with COVID-19 fare well, and some do not have any symptoms at all, but this research is a sobering reminder that children are not immune to this virus and some do require a higher level of care,” senior author Shivanand S. Medar, MD, FAAP, attending physician, Cardiac Intensive Care, Children’s Hospital at Montefiore, and assistant professor of pediatrics, Albert Einstein College of Medicine, said in a Montefiore Medical Center news release.
The study included 67 patients aged 1 month to 21 years (median, 13.1 years) who were treated for COVID-19 at a tertiary care children’s hospital between March 15 and April 13. Of those, 21 (31.3%) were treated as outpatients.
“As the number of patients screened for COVID-19 was restricted during the first weeks of the outbreak because of limited testing availability, the number of mildly symptomatic patients is not known, and therefore these 21 patients are not included in the analysis,” the authors wrote.
Of the 46 hospitalized patients, 33 (72%) were admitted to a general pediatric medical ward, and 13 (28%) were admitted to the pediatric intensive care unit (PICU).
Almost one-third (14 children; 30.4%) of the admitted patients were obese, and almost one-quarter (11 children; 24.4%) had asthma, but neither factor was associated with an increased risk for PICU admission.
“We know that in adults, obesity is a risk factor for more severe disease, however, surprisingly, our study found that children admitted to the intensive care unit did not have a higher prevalence of obesity than those on the general unit,” Dr. Chao said in the news release.
Three of the PICU patients (25%) had preexisting seizure disorders, as did one (3%) patient on the general medical unit. “There was no significant difference in the usage of ibuprofen prior to hospitalization among patients admitted to medical unit compared with those admitted to the PICU,” the authors wrote.
Platelet counts were lower in patients admitted to the PICU compared with those on the general medical unit; however, C-reactive protein, procalcitonin, and pro–brain natriuretic peptide levels were all elevated in patients admitted to the PICU compared with those admitted to the general medical unit.
Patients admitted to the PICU were more likely to need high-flow nasal cannula. Ten (77%) patients in the PICU developed acute respiratory distress syndrome (ARDS), and six (46.2%) of them needed “invasive mechanical ventilation for a median of 9 days.”
The only clinical symptom significantly linked to PICU admission was shortness of breath (92.3% vs 30.3%; P < .001).
Eight (61.5%) of the 13 patients treated in the PICU were discharged to home; four (30.7%) were still hospitalized and receiving ventilatory support on day 14. One patient had metastatic cancer and died as a result of the cancer after life-sustaining therapy was withdrawn.
Those admitted to the PICU were more likely to receive treatment with remdesivir via compassionate use compared with those treated in the general medical unit. Seven (53.8%) patients in the PICU developed severe sepsis and septic shock syndromes.
The average hospital stay was 4 days longer for the children admitted to the PICU than for the children admitted to the general medical unit.
Cough (63%) and fever (60.9%) were the most frequently reported symptoms at admission. The median duration of symptoms before admission was 3 days. None of the children had traveled to an area affected by COVID-19 before becoming ill, and only 20 (43.5%) children were confirmed to have had contact with someone with COVID-19. “The lack of a known sick contact reported in our study may have implications for how healthcare providers identify and screen for potential cases,” the authors explained.
Although children are believed to experience milder SARS-CoV-2 illness, these results and those of an earlier study suggest that some pediatric patients develop illness severe enough to require PICU admission. “This subset had significantly higher markers of inflammation (CRP, pro-BNP, procalcitonin) compared with patients in the medical unit. Inflammation likely contributed to the high rate of ARDS we observed, although serum levels of IL-6 and other cytokines linked to ARDS were not determined,” the authors wrote.
A retrospective cohort study found that of 177 children and young adults treated in a single center, patients younger than 1 year and older than 15 years were more likely to become critically ill with COVID-19 (J Pediatr. 2020 May. doi: 10.1016/j.jpeds.2020.05.007).
Each of the two age groups accounted for 32% of the hospitalized patients.
The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Children with COVID-19 are more likely to develop severe illness and require intensive care than previously realized, data from a single-center study suggest.
Jerry Y. Chao, MD, of the department of anesthesiology, Albert Einstein College of Medicine, New York, and colleagues reported their findings in an article published online May 11 in the Journal of Pediatrics.
“Thankfully most children with COVID-19 fare well, and some do not have any symptoms at all, but this research is a sobering reminder that children are not immune to this virus and some do require a higher level of care,” senior author Shivanand S. Medar, MD, FAAP, attending physician, Cardiac Intensive Care, Children’s Hospital at Montefiore, and assistant professor of pediatrics, Albert Einstein College of Medicine, said in a Montefiore Medical Center news release.
The study included 67 patients aged 1 month to 21 years (median, 13.1 years) who were treated for COVID-19 at a tertiary care children’s hospital between March 15 and April 13. Of those, 21 (31.3%) were treated as outpatients.
“As the number of patients screened for COVID-19 was restricted during the first weeks of the outbreak because of limited testing availability, the number of mildly symptomatic patients is not known, and therefore these 21 patients are not included in the analysis,” the authors wrote.
Of the 46 hospitalized patients, 33 (72%) were admitted to a general pediatric medical ward, and 13 (28%) were admitted to the pediatric intensive care unit (PICU).
Almost one-third (14 children; 30.4%) of the admitted patients were obese, and almost one-quarter (11 children; 24.4%) had asthma, but neither factor was associated with an increased risk for PICU admission.
“We know that in adults, obesity is a risk factor for more severe disease, however, surprisingly, our study found that children admitted to the intensive care unit did not have a higher prevalence of obesity than those on the general unit,” Dr. Chao said in the news release.
Three of the PICU patients (25%) had preexisting seizure disorders, as did one (3%) patient on the general medical unit. “There was no significant difference in the usage of ibuprofen prior to hospitalization among patients admitted to medical unit compared with those admitted to the PICU,” the authors wrote.
Platelet counts were lower in patients admitted to the PICU compared with those on the general medical unit; however, C-reactive protein, procalcitonin, and pro–brain natriuretic peptide levels were all elevated in patients admitted to the PICU compared with those admitted to the general medical unit.
Patients admitted to the PICU were more likely to need high-flow nasal cannula. Ten (77%) patients in the PICU developed acute respiratory distress syndrome (ARDS), and six (46.2%) of them needed “invasive mechanical ventilation for a median of 9 days.”
The only clinical symptom significantly linked to PICU admission was shortness of breath (92.3% vs 30.3%; P < .001).
Eight (61.5%) of the 13 patients treated in the PICU were discharged to home; four (30.7%) were still hospitalized and receiving ventilatory support on day 14. One patient had metastatic cancer and died as a result of the cancer after life-sustaining therapy was withdrawn.
Those admitted to the PICU were more likely to receive treatment with remdesivir via compassionate use compared with those treated in the general medical unit. Seven (53.8%) patients in the PICU developed severe sepsis and septic shock syndromes.
The average hospital stay was 4 days longer for the children admitted to the PICU than for the children admitted to the general medical unit.
Cough (63%) and fever (60.9%) were the most frequently reported symptoms at admission. The median duration of symptoms before admission was 3 days. None of the children had traveled to an area affected by COVID-19 before becoming ill, and only 20 (43.5%) children were confirmed to have had contact with someone with COVID-19. “The lack of a known sick contact reported in our study may have implications for how healthcare providers identify and screen for potential cases,” the authors explained.
Although children are believed to experience milder SARS-CoV-2 illness, these results and those of an earlier study suggest that some pediatric patients develop illness severe enough to require PICU admission. “This subset had significantly higher markers of inflammation (CRP, pro-BNP, procalcitonin) compared with patients in the medical unit. Inflammation likely contributed to the high rate of ARDS we observed, although serum levels of IL-6 and other cytokines linked to ARDS were not determined,” the authors wrote.
A retrospective cohort study found that of 177 children and young adults treated in a single center, patients younger than 1 year and older than 15 years were more likely to become critically ill with COVID-19 (J Pediatr. 2020 May. doi: 10.1016/j.jpeds.2020.05.007).
Each of the two age groups accounted for 32% of the hospitalized patients.
The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FDA approves apomorphine sublingual film for ‘off’ episodes in Parkinson’s disease
, the manufacturer has announced. This marks the first approval for a sublingual therapy for this indication, which is defined as the re-emergence or worsening of Parkinson’s disease symptoms that have otherwise been controlled with standard care of levodopa/carbidopa, Sunovion reports. Almost 60% of patients with Parkinson’s disease experience off episodes.
The approval “affords healthcare providers with a needed option that can be added to their patients’ medication regimen to adequately address off episodes as their Parkinson’s disease progresses,” Stewart Factor, DO, professor of neurology and director of the Movement Disorders Program at Emory University School of Medicine, Atlanta, Georgia, said in a press release from the manufacturer.
“We know from our research and discussion with the Parkinson’s community that off episodes can significantly disrupt a patient’s daily life,” Todd Sherer, PhD, CEO of the Michael J. Fox Foundation for Parkinson’s Research, said in the same release. He added that the Fox Foundation “supported early clinical development of sublingual apomorphine.”
The treatment is expected to be available in US pharmacies in September.
Disruptive symptoms
Off episodes can include periods of tremor, slowed movement, and stiffness and occur during daytime hours.
“Several years after a person is diagnosed with [Parkinson’s disease] they may notice problems such as having trouble getting out of bed in the morning or having difficulty getting out of a chair, or that they feel frozen while trying to walk as the effect of their maintenance medication diminishes,” Dr. Factor noted.
Subcutaneous infusion of the dopamine agonist apomorphine previously has shown benefit in treating persistent motor fluctuations in patients with Parkinson’s disease.
Apomorphine hydrochloride sublingual film is a novel formulation of apomorphine. It dissolves under the tongue to help improve off episode symptoms as needed up to five times per day.
A phase 3 study of 109 patients that was published in December in Lancet Neurology showed that those who received the sublingual film therapy had a mean reduction of 11.1 points on the Movement Disorder Society Unified Parkinson’s Disease Rating Scale Part III 30 minutes after dosing at the 12-week assessment. This was a significant improvement in motor symptoms versus those who received placebo (mean difference, -7.6 points; P = .0002).
In addition, initial clinical improvement was found 15 minutes after dosing.
The most frequently reported treatment-emergent adverse events in the study population were oropharyngeal reactions, followed by nausea, somnolence, and dizziness.
Long-term safety?
“The availability of this new apomorphine sublingual formulation, along with an inhaled formulation under development, will broaden the treatment options for off periods,” Angelo Antonini, MD, PhD, from University of Padua, Italy, wrote in an accompanying editorial in The Lancet Neurology.
Although the results were encouraging, he noted some caution should be heeded.
Because of “the high rate of oropharyngeal adverse events, long-term safety needs to be monitored once the product is registered and available for chronic use in patients with Parkinson’s disease,” Dr. Antonini wrote.
Other safety information issued by the manufacturer includes a warning that patients who take the 5HT3 antagonists ondansetron, dolasetron, palonosetron, granisetron, or alosetron for nausea should not also use apomorphine hydrochloride sublingual film.
“People taking ondansetron together with apomorphine, the active ingredient in Kynmobi, have had very low blood pressure and lost consciousness or ‘blacked out,’ “ the warning notes.
It also should not be taken by individuals who are allergic to the ingredients in the medication, including sodium metabisulfite.
This article first appeared on Medscape.com.
, the manufacturer has announced. This marks the first approval for a sublingual therapy for this indication, which is defined as the re-emergence or worsening of Parkinson’s disease symptoms that have otherwise been controlled with standard care of levodopa/carbidopa, Sunovion reports. Almost 60% of patients with Parkinson’s disease experience off episodes.
The approval “affords healthcare providers with a needed option that can be added to their patients’ medication regimen to adequately address off episodes as their Parkinson’s disease progresses,” Stewart Factor, DO, professor of neurology and director of the Movement Disorders Program at Emory University School of Medicine, Atlanta, Georgia, said in a press release from the manufacturer.
“We know from our research and discussion with the Parkinson’s community that off episodes can significantly disrupt a patient’s daily life,” Todd Sherer, PhD, CEO of the Michael J. Fox Foundation for Parkinson’s Research, said in the same release. He added that the Fox Foundation “supported early clinical development of sublingual apomorphine.”
The treatment is expected to be available in US pharmacies in September.
Disruptive symptoms
Off episodes can include periods of tremor, slowed movement, and stiffness and occur during daytime hours.
“Several years after a person is diagnosed with [Parkinson’s disease] they may notice problems such as having trouble getting out of bed in the morning or having difficulty getting out of a chair, or that they feel frozen while trying to walk as the effect of their maintenance medication diminishes,” Dr. Factor noted.
Subcutaneous infusion of the dopamine agonist apomorphine previously has shown benefit in treating persistent motor fluctuations in patients with Parkinson’s disease.
Apomorphine hydrochloride sublingual film is a novel formulation of apomorphine. It dissolves under the tongue to help improve off episode symptoms as needed up to five times per day.
A phase 3 study of 109 patients that was published in December in Lancet Neurology showed that those who received the sublingual film therapy had a mean reduction of 11.1 points on the Movement Disorder Society Unified Parkinson’s Disease Rating Scale Part III 30 minutes after dosing at the 12-week assessment. This was a significant improvement in motor symptoms versus those who received placebo (mean difference, -7.6 points; P = .0002).
In addition, initial clinical improvement was found 15 minutes after dosing.
The most frequently reported treatment-emergent adverse events in the study population were oropharyngeal reactions, followed by nausea, somnolence, and dizziness.
Long-term safety?
“The availability of this new apomorphine sublingual formulation, along with an inhaled formulation under development, will broaden the treatment options for off periods,” Angelo Antonini, MD, PhD, from University of Padua, Italy, wrote in an accompanying editorial in The Lancet Neurology.
Although the results were encouraging, he noted some caution should be heeded.
Because of “the high rate of oropharyngeal adverse events, long-term safety needs to be monitored once the product is registered and available for chronic use in patients with Parkinson’s disease,” Dr. Antonini wrote.
Other safety information issued by the manufacturer includes a warning that patients who take the 5HT3 antagonists ondansetron, dolasetron, palonosetron, granisetron, or alosetron for nausea should not also use apomorphine hydrochloride sublingual film.
“People taking ondansetron together with apomorphine, the active ingredient in Kynmobi, have had very low blood pressure and lost consciousness or ‘blacked out,’ “ the warning notes.
It also should not be taken by individuals who are allergic to the ingredients in the medication, including sodium metabisulfite.
This article first appeared on Medscape.com.
, the manufacturer has announced. This marks the first approval for a sublingual therapy for this indication, which is defined as the re-emergence or worsening of Parkinson’s disease symptoms that have otherwise been controlled with standard care of levodopa/carbidopa, Sunovion reports. Almost 60% of patients with Parkinson’s disease experience off episodes.
The approval “affords healthcare providers with a needed option that can be added to their patients’ medication regimen to adequately address off episodes as their Parkinson’s disease progresses,” Stewart Factor, DO, professor of neurology and director of the Movement Disorders Program at Emory University School of Medicine, Atlanta, Georgia, said in a press release from the manufacturer.
“We know from our research and discussion with the Parkinson’s community that off episodes can significantly disrupt a patient’s daily life,” Todd Sherer, PhD, CEO of the Michael J. Fox Foundation for Parkinson’s Research, said in the same release. He added that the Fox Foundation “supported early clinical development of sublingual apomorphine.”
The treatment is expected to be available in US pharmacies in September.
Disruptive symptoms
Off episodes can include periods of tremor, slowed movement, and stiffness and occur during daytime hours.
“Several years after a person is diagnosed with [Parkinson’s disease] they may notice problems such as having trouble getting out of bed in the morning or having difficulty getting out of a chair, or that they feel frozen while trying to walk as the effect of their maintenance medication diminishes,” Dr. Factor noted.
Subcutaneous infusion of the dopamine agonist apomorphine previously has shown benefit in treating persistent motor fluctuations in patients with Parkinson’s disease.
Apomorphine hydrochloride sublingual film is a novel formulation of apomorphine. It dissolves under the tongue to help improve off episode symptoms as needed up to five times per day.
A phase 3 study of 109 patients that was published in December in Lancet Neurology showed that those who received the sublingual film therapy had a mean reduction of 11.1 points on the Movement Disorder Society Unified Parkinson’s Disease Rating Scale Part III 30 minutes after dosing at the 12-week assessment. This was a significant improvement in motor symptoms versus those who received placebo (mean difference, -7.6 points; P = .0002).
In addition, initial clinical improvement was found 15 minutes after dosing.
The most frequently reported treatment-emergent adverse events in the study population were oropharyngeal reactions, followed by nausea, somnolence, and dizziness.
Long-term safety?
“The availability of this new apomorphine sublingual formulation, along with an inhaled formulation under development, will broaden the treatment options for off periods,” Angelo Antonini, MD, PhD, from University of Padua, Italy, wrote in an accompanying editorial in The Lancet Neurology.
Although the results were encouraging, he noted some caution should be heeded.
Because of “the high rate of oropharyngeal adverse events, long-term safety needs to be monitored once the product is registered and available for chronic use in patients with Parkinson’s disease,” Dr. Antonini wrote.
Other safety information issued by the manufacturer includes a warning that patients who take the 5HT3 antagonists ondansetron, dolasetron, palonosetron, granisetron, or alosetron for nausea should not also use apomorphine hydrochloride sublingual film.
“People taking ondansetron together with apomorphine, the active ingredient in Kynmobi, have had very low blood pressure and lost consciousness or ‘blacked out,’ “ the warning notes.
It also should not be taken by individuals who are allergic to the ingredients in the medication, including sodium metabisulfite.
This article first appeared on Medscape.com.
Chronic migraine is associated with changes in the amygdala
, according to researchers. This increased connectivity is associated with clinical and affective measures. The data suggest that changes in the amygdala’s structure and function may play a role in the transformation to chronic migraine, according to the researchers. The study was presented online as part of the American Academy of Neurology’s 2020 Science Highlights.
Approximately 3% of patients with episodic migraine progress to chronic migraine each year. Chronic migraine is associated with increased headache frequency, greater disability, and increased psychiatric comorbidities. The pathophysiological mechanisms of the transformation from episodic to chronic migraine are not completely understood.
Danielle D. DeSouza, PhD, instructor in neurology at Stanford (Calif.) University, and colleagues sought to investigate the role of the amygdala in the transformation of migraine. The amygdala is involved in nociceptive processing, emotional responses, and affective states such as depression and anxiety. Researchers have suggested that alterations in the structure or function of the amygdala might contribute to the worsening of pain and mood that coincides with the transformation of migraine.
Dr. DeSouza and colleagues enrolled 88 patients with migraine, diagnosed according to International Classification of Headache Disorders–3 criteria, in their study. Forty-four patients (36 women; mean age, 37.8 years) had chronic migraine, and 44 patients (36 women; mean age, 37.5 years) had episodic migraine. Participants underwent 3T MRI scanning during which investigators acquired T1-weighted structural and resting-state images of the brain. Participants also completed self-report questionnaires to evaluate depression and somatization (Patient Health Questionnaire), anxiety (Generalized Anxiety Disorder 7-item scale), pain catastrophizing (Pain Catastrophizing Scale), headache frequency, and headache intensity.
The investigators examined resting-state functional connectivity between the amygdala and the following three brain networks: DMN, salience network (SN), and central executive network (CEN). They assessed amygdala volume with voxel-based morphometry.
Analyses indicated that connectivity between the left amygdala and the DMN (i.e., the medial prefrontal cortex and the precuneus/posterior cingulate cortex) was increased in patients with chronic migraine, compared with those with episodic migraine. In all patients, resting-state functional connectivity between the amygdala and the DMN was positively associated with headache frequency. Connectivity between the left amygdala and the SN was positively associated with headache intensity, and connectivity between the right amygdala and the CEN was positively associated with pain catastrophizing. Both of these findings held in all patients.
In addition, Dr. DeSouza and colleagues found that bilateral amygdala volumes, including the basolateral and superficial/corticoid nuclei, were increased in patients with chronic migraine, compared with those with episodic migraine. Headache intensity and depression predicted differences in right amygdala volume, and depression alone predicted differences in left amygdala volume.
Dr. DeSouza reported no disclosures. One of the investigators acts as an adviser to Alder, Allergan, Amgen, Biohaven, Curex, Teva, and Xoc about matters unrelated to this study.
SOURCE: DeSouza DD et al. AAN 2020, Abstract 46914.
, according to researchers. This increased connectivity is associated with clinical and affective measures. The data suggest that changes in the amygdala’s structure and function may play a role in the transformation to chronic migraine, according to the researchers. The study was presented online as part of the American Academy of Neurology’s 2020 Science Highlights.
Approximately 3% of patients with episodic migraine progress to chronic migraine each year. Chronic migraine is associated with increased headache frequency, greater disability, and increased psychiatric comorbidities. The pathophysiological mechanisms of the transformation from episodic to chronic migraine are not completely understood.
Danielle D. DeSouza, PhD, instructor in neurology at Stanford (Calif.) University, and colleagues sought to investigate the role of the amygdala in the transformation of migraine. The amygdala is involved in nociceptive processing, emotional responses, and affective states such as depression and anxiety. Researchers have suggested that alterations in the structure or function of the amygdala might contribute to the worsening of pain and mood that coincides with the transformation of migraine.
Dr. DeSouza and colleagues enrolled 88 patients with migraine, diagnosed according to International Classification of Headache Disorders–3 criteria, in their study. Forty-four patients (36 women; mean age, 37.8 years) had chronic migraine, and 44 patients (36 women; mean age, 37.5 years) had episodic migraine. Participants underwent 3T MRI scanning during which investigators acquired T1-weighted structural and resting-state images of the brain. Participants also completed self-report questionnaires to evaluate depression and somatization (Patient Health Questionnaire), anxiety (Generalized Anxiety Disorder 7-item scale), pain catastrophizing (Pain Catastrophizing Scale), headache frequency, and headache intensity.
The investigators examined resting-state functional connectivity between the amygdala and the following three brain networks: DMN, salience network (SN), and central executive network (CEN). They assessed amygdala volume with voxel-based morphometry.
Analyses indicated that connectivity between the left amygdala and the DMN (i.e., the medial prefrontal cortex and the precuneus/posterior cingulate cortex) was increased in patients with chronic migraine, compared with those with episodic migraine. In all patients, resting-state functional connectivity between the amygdala and the DMN was positively associated with headache frequency. Connectivity between the left amygdala and the SN was positively associated with headache intensity, and connectivity between the right amygdala and the CEN was positively associated with pain catastrophizing. Both of these findings held in all patients.
In addition, Dr. DeSouza and colleagues found that bilateral amygdala volumes, including the basolateral and superficial/corticoid nuclei, were increased in patients with chronic migraine, compared with those with episodic migraine. Headache intensity and depression predicted differences in right amygdala volume, and depression alone predicted differences in left amygdala volume.
Dr. DeSouza reported no disclosures. One of the investigators acts as an adviser to Alder, Allergan, Amgen, Biohaven, Curex, Teva, and Xoc about matters unrelated to this study.
SOURCE: DeSouza DD et al. AAN 2020, Abstract 46914.
, according to researchers. This increased connectivity is associated with clinical and affective measures. The data suggest that changes in the amygdala’s structure and function may play a role in the transformation to chronic migraine, according to the researchers. The study was presented online as part of the American Academy of Neurology’s 2020 Science Highlights.
Approximately 3% of patients with episodic migraine progress to chronic migraine each year. Chronic migraine is associated with increased headache frequency, greater disability, and increased psychiatric comorbidities. The pathophysiological mechanisms of the transformation from episodic to chronic migraine are not completely understood.
Danielle D. DeSouza, PhD, instructor in neurology at Stanford (Calif.) University, and colleagues sought to investigate the role of the amygdala in the transformation of migraine. The amygdala is involved in nociceptive processing, emotional responses, and affective states such as depression and anxiety. Researchers have suggested that alterations in the structure or function of the amygdala might contribute to the worsening of pain and mood that coincides with the transformation of migraine.
Dr. DeSouza and colleagues enrolled 88 patients with migraine, diagnosed according to International Classification of Headache Disorders–3 criteria, in their study. Forty-four patients (36 women; mean age, 37.8 years) had chronic migraine, and 44 patients (36 women; mean age, 37.5 years) had episodic migraine. Participants underwent 3T MRI scanning during which investigators acquired T1-weighted structural and resting-state images of the brain. Participants also completed self-report questionnaires to evaluate depression and somatization (Patient Health Questionnaire), anxiety (Generalized Anxiety Disorder 7-item scale), pain catastrophizing (Pain Catastrophizing Scale), headache frequency, and headache intensity.
The investigators examined resting-state functional connectivity between the amygdala and the following three brain networks: DMN, salience network (SN), and central executive network (CEN). They assessed amygdala volume with voxel-based morphometry.
Analyses indicated that connectivity between the left amygdala and the DMN (i.e., the medial prefrontal cortex and the precuneus/posterior cingulate cortex) was increased in patients with chronic migraine, compared with those with episodic migraine. In all patients, resting-state functional connectivity between the amygdala and the DMN was positively associated with headache frequency. Connectivity between the left amygdala and the SN was positively associated with headache intensity, and connectivity between the right amygdala and the CEN was positively associated with pain catastrophizing. Both of these findings held in all patients.
In addition, Dr. DeSouza and colleagues found that bilateral amygdala volumes, including the basolateral and superficial/corticoid nuclei, were increased in patients with chronic migraine, compared with those with episodic migraine. Headache intensity and depression predicted differences in right amygdala volume, and depression alone predicted differences in left amygdala volume.
Dr. DeSouza reported no disclosures. One of the investigators acts as an adviser to Alder, Allergan, Amgen, Biohaven, Curex, Teva, and Xoc about matters unrelated to this study.
SOURCE: DeSouza DD et al. AAN 2020, Abstract 46914.
FROM AAN 2020
COVID-19: Psychiatrists assess geriatric harm from social distancing
One of the greatest tragedies of the first wave of the COVID-19 pandemic has been the failure of health policy makers to anticipate and mitigate the enormous havoc the policy of social distancing would wreak on mental health and cognitive function in older persons, speakers agreed at a webinar on COVID-19, social distancing, and its impact on social and mental health in the elderly hosted by the International Psychogeriatric Association in collaboration with INTERDEM.
“Social distancing” is a two-edged sword: It is for now and the foreseeable future the only available effective strategy for protecting against infection in the older population most vulnerable to severe forms of COVID-19. Yet social distancing also has caused many elderly – particularly those in nursing homes and other long-term care facilities – to plunge into a profound experience of loneliness, isolation, distress, feelings of abandonment, anxiety, depression, and accelerated cognitive deterioration. And this needn’t have happened, the mental health professionals asserted.
“When are we going to get rid of the term ‘social distancing?’ ” asked IPA President William E. Reichman, MD. “Many have appreciated – including the World Health Organization – that the real issue is physical distancing to prevent contagion. And physical distancing doesn’t have to mean social distancing.”
Social connectedness between elderly persons and their peers and family members can be maintained and should be emphatically encouraged during the physical distancing required by the pandemic, said Myrra Vernooij-Dassen, PhD, of Radboud University in Nigmegen, the Netherlands, and chair of INTERDEM, a pan-European network of dementia researchers.
This can be achieved using readily available technologies, including the telephone and videoconferencing, as well as by creating opportunities for supervised masked visits between a family member and an elderly loved one in outdoor courtyards or gardens within long-term care facilities. And yet, as the pandemic seized hold in many parts of the world, family members were blocked from entry to these facilities, she observed.
Impact on mental health, cognition
Dr. Vernooij-Dassen noted that studies of previous quarantine periods as well as preliminary findings during the COVID-19 pandemic demonstrate an inverse relationship between social isolation measures and cognitive functioning in the elderly.
“ Conversely, epidemiologic data indicate that a socially integrated lifestyle had a favorable influence on cognitive functioning and could even delay onset of dementia,” she said.
INTERDEM is backing two ongoing studies evaluating the hypothesis that interventions fostering increased social interaction among elderly individuals can delay onset of dementia or favorably affect its course. The proposed mechanism of benefit is stimulation of brain plasticity to enhance cognitive reserve.
“This is a hypothesis of hope. We know that social interaction for humans is like water to plants – we really, really need it,” she explained.
Diego de Leo, MD, PhD, emeritus professor of psychiatry and former director of the Australian Institute for Suicide Research and Prevention at Griffith University in Brisbane, was living in hard-hit Padua, Italy, during the first surge of COVID-19. He described his anecdotal experience.
“What I hear from many Italian colleagues and friends and directors of mental health services is that emergency admissions related to mental disorders declined during the first wave of the COVID pandemic. For example, not many people attended emergency departments due to suicide attempts; there was a very marked decrease in the number of suicide attempts during the worst days of the pandemic,” he said.
People with psychiatric conditions were afraid to go to the hospital because they thought they would contract the infection and die there. That’s changing now, however.
“Now there is an increased number of admissions to mental health units. A new wave. It has been a U-shaped curve. And we’re now witnessing an increasing number of fatal suicides due to persistent fears, due to people imagining that there is no more room for them, and no more future for them from a financial point of view – which is the major negative outcome of this crisis. It will be a disaster for many families,” the psychiatrist continued.
A noteworthy phenomenon in northern Italy was that, when tablets were made available to nursing home residents in an effort to enhance their connectedness to the outside world, those with dementia often became so frustrated and confused by their difficulty in using the devices that they developed a hypokinetic delirium marked by refusal to eat or leave their bed, he reported.
It’s far too early to have reliable data on suicide trends in response to the pandemic, according to Dr. de Leo. But one thing is for sure: The strategy of social distancing employed to curb COVID-19 has increased the prevalence of known risk factors for suicide in older individuals, including loneliness, anxiety, and depression; increased alcohol use; and a perception of being a burden on society. Dr. de Leo directs a foundation dedicated to helping people experiencing traumatic bereavement, and in one recent week, the foundation was contacted by eight families in the province of Padua with a recent death by suicide apparently related to fallout from the COVID-19 pandemic. That’s an unusually high spike in suicide in a province with a population of 1 million.
“People probably preferred to end the agitation, the fear, the extreme anxiety about their destiny by deciding to prematurely truncate their life. That has been reported by nursing staff,” he said.
The Italian government has determined that, to date, 36% of all COVID-related deaths have occurred in people aged 85 years or older, and 84% of deaths were in individuals aged at least 70 years. And in Milan and the surrounding province of Lombardy, it’s estimated that COVID-19 has taken the lives of 25% of all nursing home residents. The North American experience has been uncomfortably similar.
“Almost 80% of COVID deaths in Canada have occurred in congregate settings,” observed Dr. Reichman, professor of psychiatry at the University of Toronto, and president and CEO of Baycrest Health Sciences, a geriatric research center.
“Certainly, the appalling number of deaths in nursing homes is the No. 1 horror of the pandemic,” declared Carmelle Peisah, MBBS, MD, a psychiatrist at the University of New South Wales in Kensington, Australia.
The fire next time
The conventional wisdom holds that COVID-19 has caused all sorts of mayhem in the delivery of elder care. Not so, in Dr. Reichman’s view.
“I would suggest that the pandemic has not caused many of the problems we talk about, it’s actually revealed problems that have always been there under the surface. For example, many older people, even before COVID-19, were socially isolated, socially distant. They had difficulty connecting with their relatives, difficulty accessing transportation to get to the store to buy food and see their doctors, and to interact with other older people,” the psychiatrist said.
“I would say as well that the pandemic didn’t cause the problems we’ve seen in long-term congregate senior care. The pandemic revealed them. We’ve had facilities where older people were severely crowded together, which compromises their quality of life, even when there’s not a pandemic. We’ve had difficulty staffing these kinds of environments with people that are paid an honest wage for the very hard work that they do. In many of these settings they’re inadequately trained, not only in infection prevention and control but in all other aspects of care. And the pandemic has revealed that many of these organizations are not properly funded. The government doesn’t support them well enough across jurisdictions, and they can’t raise enough philanthropic funds to provide the kind of quality of life that residents demand,” Dr. Reichman continued.
Could the pandemic spur improved elder care? His hope is that health care professionals, politicians, and society at large will learn from the devastation left by the first surge of the pandemic and will lobby for the resources necessary for much-needed improvements in geriatric care.
“We need to be better prepared should there be not only a second wave of this pandemic, but for other pandemics to come,” Dr. Reichman concluded.
The speakers indicated they had no financial conflicts regarding their presentations.
One of the greatest tragedies of the first wave of the COVID-19 pandemic has been the failure of health policy makers to anticipate and mitigate the enormous havoc the policy of social distancing would wreak on mental health and cognitive function in older persons, speakers agreed at a webinar on COVID-19, social distancing, and its impact on social and mental health in the elderly hosted by the International Psychogeriatric Association in collaboration with INTERDEM.
“Social distancing” is a two-edged sword: It is for now and the foreseeable future the only available effective strategy for protecting against infection in the older population most vulnerable to severe forms of COVID-19. Yet social distancing also has caused many elderly – particularly those in nursing homes and other long-term care facilities – to plunge into a profound experience of loneliness, isolation, distress, feelings of abandonment, anxiety, depression, and accelerated cognitive deterioration. And this needn’t have happened, the mental health professionals asserted.
“When are we going to get rid of the term ‘social distancing?’ ” asked IPA President William E. Reichman, MD. “Many have appreciated – including the World Health Organization – that the real issue is physical distancing to prevent contagion. And physical distancing doesn’t have to mean social distancing.”
Social connectedness between elderly persons and their peers and family members can be maintained and should be emphatically encouraged during the physical distancing required by the pandemic, said Myrra Vernooij-Dassen, PhD, of Radboud University in Nigmegen, the Netherlands, and chair of INTERDEM, a pan-European network of dementia researchers.
This can be achieved using readily available technologies, including the telephone and videoconferencing, as well as by creating opportunities for supervised masked visits between a family member and an elderly loved one in outdoor courtyards or gardens within long-term care facilities. And yet, as the pandemic seized hold in many parts of the world, family members were blocked from entry to these facilities, she observed.
Impact on mental health, cognition
Dr. Vernooij-Dassen noted that studies of previous quarantine periods as well as preliminary findings during the COVID-19 pandemic demonstrate an inverse relationship between social isolation measures and cognitive functioning in the elderly.
“ Conversely, epidemiologic data indicate that a socially integrated lifestyle had a favorable influence on cognitive functioning and could even delay onset of dementia,” she said.
INTERDEM is backing two ongoing studies evaluating the hypothesis that interventions fostering increased social interaction among elderly individuals can delay onset of dementia or favorably affect its course. The proposed mechanism of benefit is stimulation of brain plasticity to enhance cognitive reserve.
“This is a hypothesis of hope. We know that social interaction for humans is like water to plants – we really, really need it,” she explained.
Diego de Leo, MD, PhD, emeritus professor of psychiatry and former director of the Australian Institute for Suicide Research and Prevention at Griffith University in Brisbane, was living in hard-hit Padua, Italy, during the first surge of COVID-19. He described his anecdotal experience.
“What I hear from many Italian colleagues and friends and directors of mental health services is that emergency admissions related to mental disorders declined during the first wave of the COVID pandemic. For example, not many people attended emergency departments due to suicide attempts; there was a very marked decrease in the number of suicide attempts during the worst days of the pandemic,” he said.
People with psychiatric conditions were afraid to go to the hospital because they thought they would contract the infection and die there. That’s changing now, however.
“Now there is an increased number of admissions to mental health units. A new wave. It has been a U-shaped curve. And we’re now witnessing an increasing number of fatal suicides due to persistent fears, due to people imagining that there is no more room for them, and no more future for them from a financial point of view – which is the major negative outcome of this crisis. It will be a disaster for many families,” the psychiatrist continued.
A noteworthy phenomenon in northern Italy was that, when tablets were made available to nursing home residents in an effort to enhance their connectedness to the outside world, those with dementia often became so frustrated and confused by their difficulty in using the devices that they developed a hypokinetic delirium marked by refusal to eat or leave their bed, he reported.
It’s far too early to have reliable data on suicide trends in response to the pandemic, according to Dr. de Leo. But one thing is for sure: The strategy of social distancing employed to curb COVID-19 has increased the prevalence of known risk factors for suicide in older individuals, including loneliness, anxiety, and depression; increased alcohol use; and a perception of being a burden on society. Dr. de Leo directs a foundation dedicated to helping people experiencing traumatic bereavement, and in one recent week, the foundation was contacted by eight families in the province of Padua with a recent death by suicide apparently related to fallout from the COVID-19 pandemic. That’s an unusually high spike in suicide in a province with a population of 1 million.
“People probably preferred to end the agitation, the fear, the extreme anxiety about their destiny by deciding to prematurely truncate their life. That has been reported by nursing staff,” he said.
The Italian government has determined that, to date, 36% of all COVID-related deaths have occurred in people aged 85 years or older, and 84% of deaths were in individuals aged at least 70 years. And in Milan and the surrounding province of Lombardy, it’s estimated that COVID-19 has taken the lives of 25% of all nursing home residents. The North American experience has been uncomfortably similar.
“Almost 80% of COVID deaths in Canada have occurred in congregate settings,” observed Dr. Reichman, professor of psychiatry at the University of Toronto, and president and CEO of Baycrest Health Sciences, a geriatric research center.
“Certainly, the appalling number of deaths in nursing homes is the No. 1 horror of the pandemic,” declared Carmelle Peisah, MBBS, MD, a psychiatrist at the University of New South Wales in Kensington, Australia.
The fire next time
The conventional wisdom holds that COVID-19 has caused all sorts of mayhem in the delivery of elder care. Not so, in Dr. Reichman’s view.
“I would suggest that the pandemic has not caused many of the problems we talk about, it’s actually revealed problems that have always been there under the surface. For example, many older people, even before COVID-19, were socially isolated, socially distant. They had difficulty connecting with their relatives, difficulty accessing transportation to get to the store to buy food and see their doctors, and to interact with other older people,” the psychiatrist said.
“I would say as well that the pandemic didn’t cause the problems we’ve seen in long-term congregate senior care. The pandemic revealed them. We’ve had facilities where older people were severely crowded together, which compromises their quality of life, even when there’s not a pandemic. We’ve had difficulty staffing these kinds of environments with people that are paid an honest wage for the very hard work that they do. In many of these settings they’re inadequately trained, not only in infection prevention and control but in all other aspects of care. And the pandemic has revealed that many of these organizations are not properly funded. The government doesn’t support them well enough across jurisdictions, and they can’t raise enough philanthropic funds to provide the kind of quality of life that residents demand,” Dr. Reichman continued.
Could the pandemic spur improved elder care? His hope is that health care professionals, politicians, and society at large will learn from the devastation left by the first surge of the pandemic and will lobby for the resources necessary for much-needed improvements in geriatric care.
“We need to be better prepared should there be not only a second wave of this pandemic, but for other pandemics to come,” Dr. Reichman concluded.
The speakers indicated they had no financial conflicts regarding their presentations.
One of the greatest tragedies of the first wave of the COVID-19 pandemic has been the failure of health policy makers to anticipate and mitigate the enormous havoc the policy of social distancing would wreak on mental health and cognitive function in older persons, speakers agreed at a webinar on COVID-19, social distancing, and its impact on social and mental health in the elderly hosted by the International Psychogeriatric Association in collaboration with INTERDEM.
“Social distancing” is a two-edged sword: It is for now and the foreseeable future the only available effective strategy for protecting against infection in the older population most vulnerable to severe forms of COVID-19. Yet social distancing also has caused many elderly – particularly those in nursing homes and other long-term care facilities – to plunge into a profound experience of loneliness, isolation, distress, feelings of abandonment, anxiety, depression, and accelerated cognitive deterioration. And this needn’t have happened, the mental health professionals asserted.
“When are we going to get rid of the term ‘social distancing?’ ” asked IPA President William E. Reichman, MD. “Many have appreciated – including the World Health Organization – that the real issue is physical distancing to prevent contagion. And physical distancing doesn’t have to mean social distancing.”
Social connectedness between elderly persons and their peers and family members can be maintained and should be emphatically encouraged during the physical distancing required by the pandemic, said Myrra Vernooij-Dassen, PhD, of Radboud University in Nigmegen, the Netherlands, and chair of INTERDEM, a pan-European network of dementia researchers.
This can be achieved using readily available technologies, including the telephone and videoconferencing, as well as by creating opportunities for supervised masked visits between a family member and an elderly loved one in outdoor courtyards or gardens within long-term care facilities. And yet, as the pandemic seized hold in many parts of the world, family members were blocked from entry to these facilities, she observed.
Impact on mental health, cognition
Dr. Vernooij-Dassen noted that studies of previous quarantine periods as well as preliminary findings during the COVID-19 pandemic demonstrate an inverse relationship between social isolation measures and cognitive functioning in the elderly.
“ Conversely, epidemiologic data indicate that a socially integrated lifestyle had a favorable influence on cognitive functioning and could even delay onset of dementia,” she said.
INTERDEM is backing two ongoing studies evaluating the hypothesis that interventions fostering increased social interaction among elderly individuals can delay onset of dementia or favorably affect its course. The proposed mechanism of benefit is stimulation of brain plasticity to enhance cognitive reserve.
“This is a hypothesis of hope. We know that social interaction for humans is like water to plants – we really, really need it,” she explained.
Diego de Leo, MD, PhD, emeritus professor of psychiatry and former director of the Australian Institute for Suicide Research and Prevention at Griffith University in Brisbane, was living in hard-hit Padua, Italy, during the first surge of COVID-19. He described his anecdotal experience.
“What I hear from many Italian colleagues and friends and directors of mental health services is that emergency admissions related to mental disorders declined during the first wave of the COVID pandemic. For example, not many people attended emergency departments due to suicide attempts; there was a very marked decrease in the number of suicide attempts during the worst days of the pandemic,” he said.
People with psychiatric conditions were afraid to go to the hospital because they thought they would contract the infection and die there. That’s changing now, however.
“Now there is an increased number of admissions to mental health units. A new wave. It has been a U-shaped curve. And we’re now witnessing an increasing number of fatal suicides due to persistent fears, due to people imagining that there is no more room for them, and no more future for them from a financial point of view – which is the major negative outcome of this crisis. It will be a disaster for many families,” the psychiatrist continued.
A noteworthy phenomenon in northern Italy was that, when tablets were made available to nursing home residents in an effort to enhance their connectedness to the outside world, those with dementia often became so frustrated and confused by their difficulty in using the devices that they developed a hypokinetic delirium marked by refusal to eat or leave their bed, he reported.
It’s far too early to have reliable data on suicide trends in response to the pandemic, according to Dr. de Leo. But one thing is for sure: The strategy of social distancing employed to curb COVID-19 has increased the prevalence of known risk factors for suicide in older individuals, including loneliness, anxiety, and depression; increased alcohol use; and a perception of being a burden on society. Dr. de Leo directs a foundation dedicated to helping people experiencing traumatic bereavement, and in one recent week, the foundation was contacted by eight families in the province of Padua with a recent death by suicide apparently related to fallout from the COVID-19 pandemic. That’s an unusually high spike in suicide in a province with a population of 1 million.
“People probably preferred to end the agitation, the fear, the extreme anxiety about their destiny by deciding to prematurely truncate their life. That has been reported by nursing staff,” he said.
The Italian government has determined that, to date, 36% of all COVID-related deaths have occurred in people aged 85 years or older, and 84% of deaths were in individuals aged at least 70 years. And in Milan and the surrounding province of Lombardy, it’s estimated that COVID-19 has taken the lives of 25% of all nursing home residents. The North American experience has been uncomfortably similar.
“Almost 80% of COVID deaths in Canada have occurred in congregate settings,” observed Dr. Reichman, professor of psychiatry at the University of Toronto, and president and CEO of Baycrest Health Sciences, a geriatric research center.
“Certainly, the appalling number of deaths in nursing homes is the No. 1 horror of the pandemic,” declared Carmelle Peisah, MBBS, MD, a psychiatrist at the University of New South Wales in Kensington, Australia.
The fire next time
The conventional wisdom holds that COVID-19 has caused all sorts of mayhem in the delivery of elder care. Not so, in Dr. Reichman’s view.
“I would suggest that the pandemic has not caused many of the problems we talk about, it’s actually revealed problems that have always been there under the surface. For example, many older people, even before COVID-19, were socially isolated, socially distant. They had difficulty connecting with their relatives, difficulty accessing transportation to get to the store to buy food and see their doctors, and to interact with other older people,” the psychiatrist said.
“I would say as well that the pandemic didn’t cause the problems we’ve seen in long-term congregate senior care. The pandemic revealed them. We’ve had facilities where older people were severely crowded together, which compromises their quality of life, even when there’s not a pandemic. We’ve had difficulty staffing these kinds of environments with people that are paid an honest wage for the very hard work that they do. In many of these settings they’re inadequately trained, not only in infection prevention and control but in all other aspects of care. And the pandemic has revealed that many of these organizations are not properly funded. The government doesn’t support them well enough across jurisdictions, and they can’t raise enough philanthropic funds to provide the kind of quality of life that residents demand,” Dr. Reichman continued.
Could the pandemic spur improved elder care? His hope is that health care professionals, politicians, and society at large will learn from the devastation left by the first surge of the pandemic and will lobby for the resources necessary for much-needed improvements in geriatric care.
“We need to be better prepared should there be not only a second wave of this pandemic, but for other pandemics to come,” Dr. Reichman concluded.
The speakers indicated they had no financial conflicts regarding their presentations.
Social isolation tied to higher risk of cardiovascular events, death
“These results are especially important in the current times of social isolation during the coronavirus crisis,” Janine Gronewold, PhD, University Hospital in Essen, Germany, told a press briefing.
The mechanism by which social isolation may boost risk for stroke, MI, or death is not clear, but other research has shown that loneliness or lack of contact with close friends and family can affect physical health, said Dr. Gronewold.
The findings were presented at the sixth Congress of the European Academy of Neurology (EAN) 2020, which transitioned to a virtual/online meeting because of the COVID-19 pandemic.
For this new study, researchers analyzed data from 4,139 participants, ranging in age from 45 to 75 years (mean 59.1 years), who were recruited into the large community-based Heinz Nixdorf Recall study. The randomly selected study group was representative of an industrial rural area of Germany, said Dr. Gronewold.
Study participants entered the study with no known cardiovascular disease and were followed for a mean of 13.4 years.
Social supports
Investigators collected information on three types of social support: instrumental (getting help with everyday activities such as buying food), emotional (provided with comfort), and financial (receiving monetary assistance when needed). They also looked at social integration (or social isolation) using an index with scores for marital status, number of contacts with family and friends, and membership in political, religious, community, sports, or professional associations.
Of the total, 501 participants reported a lack of instrumental support, 659 a lack of emotional support, and 907 a lack of financial support. A total of 309 lacked social integration, defined by the lowest level on the social integration index.
Participants were asked annually about new cardiovascular events, including stroke and MI. Over the follow-up period, there were 339 such events and 530 deaths.
After adjustment for age, sex, and social support, the analysis showed that social isolation was significantly associated with an increased risk of cardiovascular events (hazard ratio, 1.44; 95% confidence interval, 0.97-2.14) and all-cause mortality (HR, 1.47; 95% CI, 1.09-1.97).
The new research also showed that lack of financial support was significantly associated with increased risk for a cardiovascular event (HR, 1.30; 95% CI, 1.01-1.67).
Direct effect
Additional models that also adjusted for cardiovascular risk factors, health behaviors, depression, and socioeconomic factors, did not significantly change effect estimates.
“Social relationships protect us from cardiovascular events and mortality, not only via good mood, healthy behavior, and lower cardiovascular risk profile,” Dr. Gronewold said. “They seem to have a direct effect on these outcomes.”
Having strong social relationships is as important to cardiovascular health as classic protective factors such as controlling blood pressure and cholesterol levels, and maintaining a normal weight, said Dr. Gronewold.
The new results are worrying and are particularly important during the current COVID-19 pandemic, as social contact has been restricted in many areas, said Dr. Gronewold.
It is not yet clear why people who are socially isolated have such poor health outcomes, she added.
Dr. Gronewold has reported no relevant financial relationships.
This article first appeared on Medscape.com.
“These results are especially important in the current times of social isolation during the coronavirus crisis,” Janine Gronewold, PhD, University Hospital in Essen, Germany, told a press briefing.
The mechanism by which social isolation may boost risk for stroke, MI, or death is not clear, but other research has shown that loneliness or lack of contact with close friends and family can affect physical health, said Dr. Gronewold.
The findings were presented at the sixth Congress of the European Academy of Neurology (EAN) 2020, which transitioned to a virtual/online meeting because of the COVID-19 pandemic.
For this new study, researchers analyzed data from 4,139 participants, ranging in age from 45 to 75 years (mean 59.1 years), who were recruited into the large community-based Heinz Nixdorf Recall study. The randomly selected study group was representative of an industrial rural area of Germany, said Dr. Gronewold.
Study participants entered the study with no known cardiovascular disease and were followed for a mean of 13.4 years.
Social supports
Investigators collected information on three types of social support: instrumental (getting help with everyday activities such as buying food), emotional (provided with comfort), and financial (receiving monetary assistance when needed). They also looked at social integration (or social isolation) using an index with scores for marital status, number of contacts with family and friends, and membership in political, religious, community, sports, or professional associations.
Of the total, 501 participants reported a lack of instrumental support, 659 a lack of emotional support, and 907 a lack of financial support. A total of 309 lacked social integration, defined by the lowest level on the social integration index.
Participants were asked annually about new cardiovascular events, including stroke and MI. Over the follow-up period, there were 339 such events and 530 deaths.
After adjustment for age, sex, and social support, the analysis showed that social isolation was significantly associated with an increased risk of cardiovascular events (hazard ratio, 1.44; 95% confidence interval, 0.97-2.14) and all-cause mortality (HR, 1.47; 95% CI, 1.09-1.97).
The new research also showed that lack of financial support was significantly associated with increased risk for a cardiovascular event (HR, 1.30; 95% CI, 1.01-1.67).
Direct effect
Additional models that also adjusted for cardiovascular risk factors, health behaviors, depression, and socioeconomic factors, did not significantly change effect estimates.
“Social relationships protect us from cardiovascular events and mortality, not only via good mood, healthy behavior, and lower cardiovascular risk profile,” Dr. Gronewold said. “They seem to have a direct effect on these outcomes.”
Having strong social relationships is as important to cardiovascular health as classic protective factors such as controlling blood pressure and cholesterol levels, and maintaining a normal weight, said Dr. Gronewold.
The new results are worrying and are particularly important during the current COVID-19 pandemic, as social contact has been restricted in many areas, said Dr. Gronewold.
It is not yet clear why people who are socially isolated have such poor health outcomes, she added.
Dr. Gronewold has reported no relevant financial relationships.
This article first appeared on Medscape.com.
“These results are especially important in the current times of social isolation during the coronavirus crisis,” Janine Gronewold, PhD, University Hospital in Essen, Germany, told a press briefing.
The mechanism by which social isolation may boost risk for stroke, MI, or death is not clear, but other research has shown that loneliness or lack of contact with close friends and family can affect physical health, said Dr. Gronewold.
The findings were presented at the sixth Congress of the European Academy of Neurology (EAN) 2020, which transitioned to a virtual/online meeting because of the COVID-19 pandemic.
For this new study, researchers analyzed data from 4,139 participants, ranging in age from 45 to 75 years (mean 59.1 years), who were recruited into the large community-based Heinz Nixdorf Recall study. The randomly selected study group was representative of an industrial rural area of Germany, said Dr. Gronewold.
Study participants entered the study with no known cardiovascular disease and were followed for a mean of 13.4 years.
Social supports
Investigators collected information on three types of social support: instrumental (getting help with everyday activities such as buying food), emotional (provided with comfort), and financial (receiving monetary assistance when needed). They also looked at social integration (or social isolation) using an index with scores for marital status, number of contacts with family and friends, and membership in political, religious, community, sports, or professional associations.
Of the total, 501 participants reported a lack of instrumental support, 659 a lack of emotional support, and 907 a lack of financial support. A total of 309 lacked social integration, defined by the lowest level on the social integration index.
Participants were asked annually about new cardiovascular events, including stroke and MI. Over the follow-up period, there were 339 such events and 530 deaths.
After adjustment for age, sex, and social support, the analysis showed that social isolation was significantly associated with an increased risk of cardiovascular events (hazard ratio, 1.44; 95% confidence interval, 0.97-2.14) and all-cause mortality (HR, 1.47; 95% CI, 1.09-1.97).
The new research also showed that lack of financial support was significantly associated with increased risk for a cardiovascular event (HR, 1.30; 95% CI, 1.01-1.67).
Direct effect
Additional models that also adjusted for cardiovascular risk factors, health behaviors, depression, and socioeconomic factors, did not significantly change effect estimates.
“Social relationships protect us from cardiovascular events and mortality, not only via good mood, healthy behavior, and lower cardiovascular risk profile,” Dr. Gronewold said. “They seem to have a direct effect on these outcomes.”
Having strong social relationships is as important to cardiovascular health as classic protective factors such as controlling blood pressure and cholesterol levels, and maintaining a normal weight, said Dr. Gronewold.
The new results are worrying and are particularly important during the current COVID-19 pandemic, as social contact has been restricted in many areas, said Dr. Gronewold.
It is not yet clear why people who are socially isolated have such poor health outcomes, she added.
Dr. Gronewold has reported no relevant financial relationships.
This article first appeared on Medscape.com.
FROM EAN 2020